Thursday, October 27, 2016

Gen-Clindamycin




Gen-Clindamycin may be available in the countries listed below.


Ingredient matches for Gen-Clindamycin



Clindamycin

Clindamycin hydrochloride (a derivative of Clindamycin) is reported as an ingredient of Gen-Clindamycin in the following countries:


  • Canada

International Drug Name Search


Calci-Mix




Ingredient matches for Calci-Mix



Calcium Carbonate

Calcium Carbonate is reported as an ingredient of Calci-Mix in the following countries:


  • United States

International Drug Name Search


Proton-P




Proton-P may be available in the countries listed below.


Ingredient matches for Proton-P



Pantoprazole

Pantoprazole sodium (a derivative of Pantoprazole) is reported as an ingredient of Proton-P in the following countries:


  • Bangladesh

International Drug Name Search


Edicin




Edicin may be available in the countries listed below.


Ingredient matches for Edicin



Vancomycin

Vancomycin is reported as an ingredient of Edicin in the following countries:


  • Slovakia

Vancomycin hydrochloride (a derivative of Vancomycin) is reported as an ingredient of Edicin in the following countries:


  • Bosnia & Herzegowina

  • Bulgaria

  • Croatia (Hrvatska)

  • Czech Republic

  • Estonia

  • Georgia

  • Latvia

  • Lithuania

  • Poland

  • Romania

  • Russian Federation

  • Serbia

  • Slovenia

  • Turkey

International Drug Name Search


Wednesday, October 26, 2016

Bactin




Bactin may be available in the countries listed below.


Ingredient matches for Bactin



Ciprofloxacin

Ciprofloxacin hydrochloride (a derivative of Ciprofloxacin) is reported as an ingredient of Bactin in the following countries:


  • Bangladesh

International Drug Name Search


Coronax




Coronax may be available in the countries listed below.


Ingredient matches for Coronax



Amiodarone

Amiodarone is reported as an ingredient of Coronax in the following countries:


  • Argentina

International Drug Name Search


Teranex




Teranex may be available in the countries listed below.


Ingredient matches for Teranex



Terazosin

Terazosin is reported as an ingredient of Teranex in the following countries:


  • Vietnam

International Drug Name Search


Reodon




Reodon may be available in the countries listed below.


Ingredient matches for Reodon



Repaglinide

Repaglinide is reported as an ingredient of Reodon in the following countries:


  • Croatia (Hrvatska)

International Drug Name Search


Thiocolchicoside Qualimed




Thiocolchicoside Qualimed may be available in the countries listed below.


Ingredient matches for Thiocolchicoside Qualimed



Thiocolchicoside

Thiocolchicoside is reported as an ingredient of Thiocolchicoside Qualimed in the following countries:


  • France

International Drug Name Search


Pantrixon




Pantrixon may be available in the countries listed below.


Ingredient matches for Pantrixon



Ceftriaxone

Ceftriaxone disodium salt (a derivative of Ceftriaxone) is reported as an ingredient of Pantrixon in the following countries:


  • Philippines

International Drug Name Search


Tuesday, October 25, 2016

Risperidone 2 mg Orodispersible Tablets





1. Name Of The Medicinal Product



Risperidone 2 mg Orodispersible Tablets


2. Qualitative And Quantitative Composition



Each orodispersible tablet 2 mg contains 2 mg risperidone.



Excipients: aspartame (E951), sorbitol (E420).



For a full list of excipients, see section 6.1.



3. Pharmaceutical Form



Orodispersible tablet.



Round, slightly convex, pink marbled orodispersible tablets



4. Clinical Particulars



4.1 Therapeutic Indications



Risperidone is indicated for the treatment of schizophrenia.



Risperidone is indicated for the treatment of moderate to severe manic episodes associated with bipolar disorders.



Risperidone is indicated for the short-term treatment (up to 6 weeks) of persistent aggression in patients with moderate to severe Alzheimer's dementia unresponsive to non-pharmacological approaches and when there is a risk of harm to self or others.



Risperidone is indicated for the short-term symptomatic treatment (up to 6 weeks) of persistent aggression in conduct disorder in children from the age of 5 years and adolescents with subaverage intellectual functioning or mental retardation diagnosed according to DSM-IV criteria, in whom the severity of aggressive or other disruptive behaviours require pharmacologic treatment. Pharmacological treatment should be an integral part of a more comprehensive treatment programme, including psychosocial and educational intervention. It is recommended that risperidone be prescribed by a specialist in child neurology and child and adolescent psychiatry or physicians well familiar with the treatment of conduct disorder of children and adolescents.



4.2 Posology And Method Of Administration



Schizophrenia



Adults



Risperidone may be given once daily or twice daily.



Patients should start with 2 mg/day risperidone. The dosage may be increased on the second day to 4 mg.



Subsequently, the dosage can be maintained unchanged, or further individualised, if needed. Most patients will benefit from daily doses between 4 and 6 mg. In some patients, a slower titration phase and a lower starting and maintenance dose may be appropriate.



Doses above 10 mg/day have not demonstrated superior efficacy to lower doses and may cause increased incidence of extrapyramidal symptoms. Safety of doses above 16 mg/day has not been evaluated, and are therefore not recommended.



Elderly



A starting dose of 0.5 mg twice daily is recommended. This dosage can be individually adjusted with 0.5 mg twice daily increments to 1 to 2 mg twice daily.



Paediatric population



Risperidone is not recommended for use in children below age 18 with schizophrenia due to a lack of data on efficacy.



Manic episodes in bipolar disorder



Adults



Risperidone should be administered on a once daily schedule, starting with 2 mg risperidone. Dosage adjustments, if indicated, should occur at intervals of not less than 24 hours and in dosage increments of 1 mg per day. Risperidone can be administered in flexible doses over a range of 1 to 6 mg per day to optimize each patient's level of efficacy and tolerability. Daily doses over 6 mg risperidone have not been investigated in patients with manic episodes.



As with all symptomatic treatments, the continued use of risperidone must be evaluated and justified on an ongoing basis.



Elderly



A starting dose of 0.5 mg twice daily is recommended. This dosage can be individually adjusted with 0.5 mg twice daily increments to 1 to 2 mg twice daily. Since clinical experience in elderly is limited, caution should be exercised.



Paediatric population



Risperidone is not recommended for use in children below age 18 with bipolar mania due to a lack of data on efficacy.



Persistent aggression in patients with moderate to severe Alzheimer's dementia



A starting dose of 0.25 mg twice daily is recommended. This dosage can be individually adjusted by increments of 0.25 mg twice daily, not more frequently than every other day, if needed. The optimum dose is 0.5 mg twice daily for most patients. Some patients, however, may benefit from doses up to 1 mg twice daily.



Risperidone should not be used more than 6 weeks in patients with persistent aggression in Alzheimer's dementia. During treatment, patients must be evaluated frequently and regularly, and the need for continuing treatment reassessed.



Conduct disorder



Children and adolescents from 5 to 18 years of age



For subjects



As with all symptomatic treatments, the continued use of risperidone must be evaluated and justified on an ongoing basis.



Risperidone is not recommended in children less than 5 years of age, as there is no experience in children less than 5 years of age with this disorder.



Renal and hepatic impairment



Patients with renal impairment have less ability to eliminate the active antipsychotic fraction than in adults with normal renal function. Patients with impaired hepatic function have increases in plasma concentration of the free fraction of risperidone.



Irrespective of the indication, starting and consecutive dosing should be halved, and dose titration should be slower for patients with renal or hepatic impairment.



Risperidone should be used with caution in these groups of patients.



Method of administration



Risperidone is for oral use. Food does not affect the absorption of risperidone.



Do not open the blister until ready to administer. Peel open the blister to expose the tablet. Do not push the tablet through the foil because it may break. Remove the tablet from the blister with dry hands.



Immediately place the tablet on the tongue. The tablet will begin disintegrating within seconds. Water may be used if desired. No attempt should be made to divide the tablet.



Upon discontinuation, gradual withdrawal is advised. Acute withdrawal symptoms, including nausea, vomiting, sweating, and insomnia have very rarely been described after abrupt cessation of high doses of antipsychotic medicines (see section 4.8). Recurrence of psychotic symptoms may also occur, and the emergence of involuntary movement disorders (such as akathisia, dystonia and dyskinesia) has been reported.



Switching from other antipsychotics



When medically appropriate, gradual discontinuation of the previous treatment while risperidone therapy is initiated is recommended. Also, if medically appropriate, when switching patients from depot antipsychotics, initiate risperidone therapy in place of the next scheduled injection. The need for continuing existing anti-Parkinson medicines should be re-evaluated periodically.



4.3 Contraindications



Hypersensitivity to the active substance or to any of the excipients.



4.4 Special Warnings And Precautions For Use



Elderly patients with dementia



Overall mortality



Elderly patients with dementia treated with atypical antipsychotics have an increased mortality compared to placebo in a meta-analysis of 17 controlled trials of atypical antipsychotics, including risperidone. In placebo-controlled trials with risperidone in this population, the incidence of mortality was 4.0% for risperidone -treated patients compared to 3.1% for placebo-treated patients. The odds ratio (95% exact confidence interval) was 1.21 (0.7, 2.1). The mean age (range) of patients who died was 86 years (range 67-100).



Concomitant use with furosemide



In the risperidone placebo-controlled trials in elderly patients with dementia, a higher incidence of mortality was observed in patients treated with furosemide plus risperidone (7.3%; mean age 89 years, range 75-97) when compared to patients treated with risperidone alone (3.1%; mean age 84 years, range 70-96) or furosemide alone (4.1%; mean age 80 years, range 67-90). The increase in mortality in patients treated with furosemide plus risperidone was observed in two of the four clinical trials. Concomitant use of risperidone with other diuretics (mainly thiazide diuretics used in low dose) was not associated with similar findings.



No pathophysiological mechanism has been identified to explain this finding, and no consistent pattern for cause of death observed. Nevertheless, caution should be exercised and the risks and benefits of this combination or co-treatment with other potent diuretics should be considered prior to the decision to use.



There was no increased incidence of mortality among patients taking other diuretics as concomitant treatment with risperidone. Irrespective of treatment, dehydration was an overall risk factor for mortality and should therefore be carefully avoided in elderly patients with dementia.



Cerebrovascular Adverse Events (CVAE)



In placebo-controlled trials in elderly patients with dementia there was a significantly higher incidence (approximately 3-fold increased) of CVAEs, such as stroke (including fatalities) and transient ischaemic attack in patients treated with risperidone compared with patients treated with placebo (mean age 85 years; range 73 to 97). The pooled data from six placebo-controlled studies in mainly elderly patients (>65 years of age) with dementia showed that CVAEs (serious and non-serious, combined) occurred in 3.3% (33/1009) of patients treated with risperidone and 1.2% (8/712) of patients treated with placebo. The odds ratio (95% exact confidence interval) was 2.96 (1.34, 7.50). The mechanism for this increased risk is not known. An increased risk cannot be excluded for other antipsychotics or other patient populations. Risperidone should be used with caution in patients with risk factors for stroke.



The risk of CVAEs was significantly higher in patients with mixed or vascular type of dementia when compared to Alzheimer's dementia. Therefore, patients with other types of dementias than Alzheimer's should not be treated with risperidone.



Physicians are advised to assess the risks and benefits of the use of risperidone in elderly patients with dementia, taking into account risk predictors for stroke in the individual patient. Patients/caregivers should be cautioned to immediately report signs and symptoms of potential CVAEs such as sudden weakness or numbness in the face, arms or legs, and speech or vision problems. All treatment options should be considered without delay, including discontinuation of risperidone.



Risperidone should only be used short term for persistent aggression in patients with moderate to severe Alzheimer's dementia to supplement non-pharmacological approaches which have had limited or no efficacy and when there is potential risk of harm to self or others.



Patients should be reassessed regularly, and the need for continuing treatment reassessed.



Orthostatic hypotension



Due to the alpha-blocking activity of risperidone, (orthostatic) hypotension can occur, especially during the initial dose-titration period. Clinically significant hypotension has been observed postmarketing with concomitant use of risperidone and antihypertensive treatment. Risperidone should be used with caution in patients with known cardiovascular disease (e.g., heart failure, myocardial infarction, conduction abnormalities, dehydration, hypovolemia, or cerebrovascular disease), and the dosage should be gradually titrated as recommended (see section 4.2). A dose reduction should be considered if hypotension occurs.



Tardive dyskinesia/extrapyramidal symptoms (TD/EPS)



Medicines with dopamine receptor antagonistic properties have been associated with the induction of tardive dyskinesia characterised by rhythmical involuntary movements, predominantly of the tongue and/or face. The onset of extrapyramidal symptoms is a risk factor for tardive dyskinesia. If signs and symptoms of tardive dyskinesia appear, the discontinuation of all antipsychotics should be considered.



Neuroleptic malignant syndrome (NMS)



Neuroleptic Malignant Syndrome, characterised by hyperthermia, muscle rigidity, autonomic instability, altered consciousness and elevated serum creatine phosphokinase levels has been reported to occur with antipsychotics. Additional signs may include myoglobinuria (rhabdomyolysis) and acute renal failure. In this event, all antipsychotics, including risperidone, should be discontinued.



Parkinson's disease and dementia with Lewy bodies



Physicians should weigh the risks versus the benefits when prescribing antipsychotics, including risperidone, to patients with Parkinson's Disease or Dementia with Lewy Bodies (DLB). Parkinson's Disease may worsen with risperidone. Both groups may be at increased risk of Neuroleptic Malignant Syndrome as well as having an increased sensitivity to antipsychotic medicinal products; these patients were excluded from clinical trials. Manifestation of this increased sensitivity can include confusion, obtundation, postural instability with frequent falls, in addition to extrapyramidal symptoms.



Hyperglycemia



Hyperglycemia or exacerbation of pre-existing diabetes has been reported in very rare cases during treatment with risperidone. Appropriate clinical monitoring is advisable in diabetic patients and in patients with risk factors for the development of diabetes mellitus.



Hyperprolactinaemia



Tissue culture studies suggest that cell growth in human breast tumours may be stimulated by prolactin. Although no clear association with the administration of antipsychotics has so far been demonstrated in clinical and epidemiological studies, caution is recommended in patients with relevant medical history. Risperidone should be used with caution in patients with pre-existing hyperprolactinaemia and in patients with possible prolactin-dependent tumours.



QT prolongation



QT prolongation has very rarely been reported postmarketing. As with other antipsychotics, caution should be exercised when risperidone is prescribed in patients with known cardiovascular disease, family history of QT prolongation, bradycardia, or electrolyte disturbances (hypokalaemia, hypomagnesaemia), as it may increase the risk of arrhythmogenic effects, and in concomitant use with medicines known to prolong the QT interval.



Seizures



Risperidone should be used cautiously in patients with a history of seizures or other conditions that potentially lower the seizure threshold.



Priapism



Priapism may occur with risperidone treatment due to its alpha-adrenergic blocking effects.



Body temperature regulation



Disruption of the body's ability to reduce core body temperature has been attributed to antipsychotic medicines. Appropriate care is advised when prescribing risperidone to patients who will be experiencing conditions which may contribute to an elevation in core body temperature, e.g., exercising strenuously, exposure to extreme heat, receiving concomitant treatment with anticholinergic activity, or being subject to dehydration.



Children and adolescents



Before risperidone is prescribed to a child or adolescent with conduct disorder they should be fully assessed for physical and social causes of the aggressive behaviour such as pain or inappropriate environmental demands.



The sedative effect of risperidone should be closely monitored in this population because of possible consequences on learning ability. A change in the time of administration of risperidone could improve the impact of the sedation on attention faculties of children and adolescents.



Risperidone was associated with mean increases in body weight and body mass index (BMI). Changes in height in the long-term open-label extension studies were within expected age-appropriate norms. The effect of long-term risperidone treatment on sexual maturation and height have not been adequately studied.



Because of the potential effects of prolonged hyperprolactinemia on growth and sexual maturation in children and adolescents, regular clinical evaluation of endocrinological status should be considered, including measurements of height, weight, sexual maturation, monitoring of menstrual functioning, and other potential prolactin-related effects.



During treatment with risperidone regular examination for extrapyramidal symptoms and other movement disorders should also be conducted.



For specific posology recommendations in children and adolescents see section 4.2.



Excipients



The orodispersible tablets contain aspartame. Aspartame is a source of phenylalanine which may be harmful for people with phenylketonuria.



The orodispersible tablets contain sorbitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine.



4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction



The risks of using risperidone in combination with other products have not been systematically studied. Caution should be exercised when combining risperidone with other substances that act on the central nervous system.



Antipsychotics may potentiate the sedative effect of alcohol. Patients should therefore be advised not to consume alcohol.



The risk of onset of tardive dyskinesia is increased by concomitant use of other antipsychotics, lithium, antidepressants, antiparkinson agents and active substances that have a central anticholinergic effect.



The anti alpha-1 adrenergic effect (especially with other antipsychotics or antihistamines of the phenothiazines group, or tricyclic antidepressants as well) can induce orthostatic hypotension and thus increase the blood pressure lowering effect of phenoxybenzamine, labetalol and other alpha-blocking sympatholytics, methyldopa, reserpine and other centrally acting antihypertensive agents. Conversely, the hypotensive effect of guanethidine is blocked.



Risperidone may reduce the effect of levodopa and other dopaminergic agonists. If this combination is deemed necessary, particularly in end-stage Parkinson's disease, the lowest effective dose of each treatment should be prescribed.



Carbamazepine causes a reduction in risperidone and its active metabolite plasma levels. Similar effects can be observed with other products that induce liver enzymes. When discontinuing treatment with carbamazepine or other liver enzyme-inducing products, the risperidone dose must be re-evaluated and (if necessary) reduced.



Quinidine, fluoxetine, paroxetine, terbinafine and other potent CYP2D6 inhibitors can increase plasma concentrations of the antipsychotic fraction. Therefore dosage of risperidone should be re-evaluated on initiation or discontinuation of such medicinal products.



Phenothiazines, tricyclic antidepressants and some beta-blockers may increase the plasma concentration of risperidone, but only slightly that of the active antipsychotic fraction.



Ranitidine and cimetidine may increase the plasma concentration of risperidone but the antipsychotic effect does not necessarily increase as the plasma concentration of active metabolites is decreased.



Caution is advised with the concomitant treatment of other medicinal products that can prolong the QT-interval, e.g. other neuroleptics, class IA and III antiarrhythmics, moxifloxacin, erythromycin, methadone, mefloquine, tricyclic antidepressants, lithium or cisapride. Caution is advised when risperidone is co-administered with other medicinal products that may cause electrolyte disturbances, e.g. thiazide diuretics (hypokalaemia), as they increase the risk of malignant arrhythmia (see also section 4.4). Similarly, caution is also advised when risperidone is co-administered with other medicinal products that can increase the concentration of risperidone in the blood.



The cholinesterase-inhibitors galantmin and donezepil do not have a clinical relevant effect on the pharmacokinetic of risperidone and the active antipsychotic fraction.



Risperidone has no clinically relevant effect on the pharmacokinetics of lithium, valproate, digoxin or topiramate.



For interactions with furosemide in elderly patients with dementia see section 4.4.



During co-administration with other highly protein-bound medicinal products, no clinically relevant displacement of either medicinal product from the plasma proteins has been seen.



4.6 Pregnancy And Lactation



Pregnancy



There are no adequate data from the use of risperidone in pregnant women. According to postmarketing data reversible extrapyramidal symptoms in the neonate were observed following the use of risperidone during the last trimester of pregnancy. Consequently newborns should be monitored carefully. Risperidone was not teratogenic in animal studies but other types of reproductive toxicity were seen (see section 5.3). The potential risk for humans is unknown. Therefore, risperidone should not be used during pregnancy unless clearly necessary. If discontinuation during pregnancy is necessary, it should not be done abruptly.



Lactation



In animal studies, risperidone and 9-hydroxy-risperidone are excreted in the milk. It has been demonstrated that risperidone and 9-hydroxy-risperidone are also excreted in human breast milk in small quantities. There are no data available on adverse reactions in breast-feeding infants. Therefore, the advantage of breastfeeding should be weighed against the potential risks for the child.



4.7 Effects On Ability To Drive And Use Machines



Risperidone can have minor or moderate influence on the ability to drive and use machines due to potential nervous system and visual effects (see section 4.8). Therefore, patients should be advised not to drive or operate machinery until their individual susceptibility is known.



4.8 Undesirable Effects



The most frequently reported adverse drug reactions (ADRs) (incidence



The following are all the ADRs that were reported in clinical trials and postmarketing. The following terms and frequencies are applied: very common (



Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.



Adverse Drug Reactions by System Organ Class and Frequency




















































































































































Investigations


 


Common




Blood prolactin increaseda, Weight increased




Uncommon




Electrocardiogram QT prolonged, Electrocardiogram abnormal, Blood glucose increased, Transaminases increased, White blood cell count decreased, Body temperature increased, Eosinophil count increased, Haemoglobin decreased, Blood creatine phosphokinase increased




Rare




Body temperature decreased




Cardiac disorders


 


Common




Tachycardia




Uncommon




Atrioventricular block, Bundle branch block, Atrial fibrillation, Sinus bradycardia, Palpitations




Blood and lymphatic system disorders


 


Uncommon




Anaemia, Thrombocytopenia




Rare




Granulocytopenia




Not known




Agranulocytosis




Nervous system disorders


 


Very common




Parkinsonismb, Headache




Common




Akathisiab, Dizziness, Tremorb, Dystoniab, Somnolence, Sedation, Lethargy, Dyskinesiab




Uncommon




Unresponsive to stimuli, Loss of consciousness, Syncope, Depressed level of consciousness, Cerebrovascular accident, Transient ischaemic attack, Dysarthria, Disturbance in attention, Hypersomnia, Dizziness postural, Balance disorder, Tardive dyskinesia, Speech disorder, Coordination abnormal, Hypoaesthesia




Rare




Neuroleptic malignant syndrome, Diabetic coma, Cerebrovascular disorder, Cerebral ischaemia, Movement disorder




Eye disorders


 


Common




Vision blurred




Uncommon




Conjunctivitis, Ocular hyperaemia, Eye discharge, Eye swelling, Dry eye, Lacrimation increased, Photophobia




Rare




Visual acuity reduced, Eye rolling, Glaucoma




Ear and labyrinth disorders


 


Uncommon




Ear pain, Tinnitus




Respiratory, thoracic and mediastinal disorders


 


Common




Dyspnoea, Epistaxis, Cough, Nasal congestion, Pharyngolaryngeal pain




Uncommon




Wheezing, Pneumonia aspiration, Pulmonary congestion, Respiratory disorder, Rales, Respiratory tract congestion, Dysphonia




Rare




Sleep apnea syndrome, Hyperventilation




Gastrointestinal disorders


 


Common




Vomiting, Diarrhoea, Constipation, Nausea, Abdominal pain, Dyspepsia, Dry mouth, Stomach discomfort




Uncommon




Dysphagia, Gastritis, Faecal incontinence, Faecaloma




Rare




Intestinal obstruction, Pancreatitis, Lip swelling, Cheilitis




Renal and urinary disorders


 


Common




Enuresis




Uncommon




Dysuria, Urinary incontinence, Pollakiuria




Skin and subcutaneous tissue disorders


 


Common




Rash, Erythema




Uncommon




Angioedema, Skin lesion, Skin disorder, Pruritus, Acne, Skin discolouration, Alopecia, Seborrhoeic dermatitis, Dry skin, Hyperkeratosis




Rare




Dandruff




Musculoskeletal and connective tissue disorders


 


Common




Arthralgia, Back pain, Pain in extremity




Uncommon




Muscular weakness, Myalgia, Neck pain, Joint swelling, Posture abnormal, Joint stiffness, Musculoskeletal chest pain




Rare




Rhabdomyolysis




Endocrine disorders


 


Rare




Inappropriate antidiuretic hormone secretion




Metabolism and nutrition disorders


 


Common




Increased appetite, Decreased appetite




Uncommon




Anorexia, Polydipsia




Very rare




Diabetic ketoacidosis




Not known




Water intoxication




Infections and infestations


 


Common




Pneumonia, Influenza, Bronchitis, Upper respiratory tract infection, Urinary tract infection




Uncommon




Sinusitis, Viral infection, Ear infection, Tonsillitis, Cellulitis, Otitis media, Eye infection, Localised infection, Acarodermatitis, Respiratory tract infection, Cystitis, Onychomycosis




Rare




Otitis media chronic




Vascular disorders


 


Uncommon




Hypotension, Orthostatic hypotension, Flushing




General disorders and administration site conditions


 


Common




Pyrexia, Fatigue, Peripheral oedema, Asthenia, Chest pain




Uncommon




Face oedema, Gait disturbance, Feeling abnormal, Sluggishness, Influenza like illness, Thirst, Chest discomfort, Chills




Rare




Generalised oedema, Hypothermia, Drug withdrawal syndrome, Peripheral coldness




Immune system disorders


 


Uncommon




Hypersensitivity




Rare




Drug hypersensitivity




Not known




Anaphylactic reaction




Hepatobiliary disorders


 


Rare




Jaundice




Reproductive system and breast disorder


 


Uncommon




Amenorrhoea, Sexual dysfunction, Erectile dysfunction, Ejaculation disorder, Galactorrhoea, Gynaecomastia, Menstrual disorder, Vaginal discharge,




Not known




Priapism




Psychiatric disorders


 


Very common




Insomnia




Common




Anxiety, Agitation, Sleep disorder




Uncommon




Confusional state, Mania, Libido decreased, Listless, Nervousness




Rare




Anorgasmia, Blunted affect



a Hyperprolactinemia can in some cases lead to gynaecomastia, menstrual disturbances, amenorrhoea, galactorrhea.



b Extrapyramidal disorder may occur: Parkinsonism (salivary hypersecretion, musculoskeletal stiffness, parkinsonism, drooling, cogwheel rigidity, bradykinesia, hypokinesia, masked facies, muscle tightness, akinesia, nuchal rigidity, muscle rigidity, parkinsonian gait, and glabellar reflex abnormal),akathisia ( akathisia, restlessness, hyperkinesia, and restless leg syndrome), tremor, dyskinesia (dyskinesia, muscle twitching, choreoathetosis, athetosis, and myoclonus), dystonia.



Dystonia includes dystonia, muscle spasms, hypertonia, torticollis, muscle contractions involuntary, muscle contracture, blepharospasm, oculogyration, tongue paralysis, facial spasm, laryngospasm, myotonia, opisthotonus, oropharyngeal spasm, pleurothotonus, tongue spasm, and trismus. Tremor includes tremor and parkinsonian rest tremor. It should be noted that a broader spectrum of symptoms are included, that do not necessarily have an extrapyramidal origin.



The following is a list of additional ADRs associated with risperidone that have been identified as ADRs during clinical trials investigating the long-acting injectable risperidone formulation but were not determined to be ADRs in the clinical trials investigating oral risperidone. This table excludes those ADRs specifically associated with the formulation or injection route of administration of long-acting injectable risperidone.



Additional adverse drug reactions reported with long-acting injectable risperidone but not with Oral risperidone by System Organ Class



Investigations



Weight decreased, Gamma-glutamyltransferase increased, Hepatic enzyme increased



Cardiac Disorders



Bradycardia



Blood and Lymphatic Disorders



Neutropenia



Nervous System Disorders



Paresthesia, Convulsion



Eye Disorders



Blepharospasm



Ear and Labyrinth Disorders



Vertigo



Gastrointestinal Disorders



Toothache, Tongue spasm



Skin and Subcutaneous Tissue Disorders



Eczema



Musculoskeletal, Connective Tissue, and Bone Disorders



Buttock pain



Infections and Infestations



Lower respiratory tract infection, Infection, Gastroenteritis, Subcutaneous abscess



Injury and Poisoning



Fall



Vascular Disorders



Hypertension



General Disorders and Administration Site Conditions



Pain



Psychiatric Disorders



Depression



Class effects



As with other antipsychotics, very rare cases of QT prolongation have been reported postmarketing with risperidone. Other class-related cardiac effects reported with antipsychotics which prolong QT interval include ventricular arrhythmia, ventricular fibrillation, ventricular tachycardia, sudden death, cardiac arrest and Torsades de Pointes.



Weight gain



The proportions of risperidone and placebo-treated adult patients with schizophrenia meeting a weight gain criterion of



In a population of children and adolescents with conduct and other disruptive behaviour disorders, in longterm studies, weight increased by a mean of 7.3 kg after 12 months of treatment. The expected weight gain for normal children between 5-12 years of age is 3 to 5 kg per year. From 12-16 years of age, this magnitude of gaining 3 to 5 kg per year is maintained for girls, while boys gain approximately 5 kg per year.



Additional information on special populations



Adverse drug reactions that were reported with higher incidence in elderly patients with dementia or paediatric patients than in adult populations are described below:



Elderly patients with dementia



Transient ischaemic attack and cerebrovascular accident were ADRs reported in clinical trials with a frequency of 1.4% and 1.5%, respectively, in elderly patients with dementia. In addition, the following ADRs were reported with a frequency



Paediatric patients



The following ADRs were reported with a frequency



4.9 Overdose



Symptoms



In general, reported signs and symptoms have been those resulting from an exaggeration of the known pharmacological effects of risperidone. These include drowsiness and sedation, tachycardia and hypotension, and extrapyramidal symptoms. In overdose, QT-prolongation and convulsions have been reported. Torsade de Pointes has been reported in association with combined overdose of risperidone and paroxetine.



In case of acute overdose, the possibility of multiple drug involvement should be considered.



Treatment



Establish and maintain a clear airway and ensure adequate oxygenation and ventilation. Gastric lavage (after intubation, if the patient is unconscious) and administration of activated charcoal together with a laxative should be considered only when drug intake was less than one hour before. Cardiovascular monitoring should commence immediately and should include continuous electrocardiographic monitoring to detect possible arrhythmias.



There is no specific antidote to risperidone. Therefore, appropriate supportive measures should be instituted. Hypotension and circulatory collapse should be treated with appropriate measures such as intravenous fluids and/or sympathomimetic agents. In case of severe extrapyramidal symptoms, an anticholinergic medicinal product should be administered. Close medical supervision and monitoring should continue until the patient recovers.



5. Pharmacological Properties



5.1 Pharmacodynamic Properties



Pharmacotherapeutic group: Other antipsychotics ATC code: N05AX08



Mechanism of action



Risperidone is a selective monoaminergic antagonist with unique properties. It has a high affinity for serotoninergic 5-HT2 and dopaminergic D2 receptors. Risperidone binds also to alpha1-adrenergic receptors, and, with lower affinity, to H1-histaminergic and alpha2-adrenergic receptors. Risperidone has no affinity for cholinergic receptors. Although risperidone is a potent D2 antagonist, which is considered to improve the positive symptoms of schizophrenia, it causes less depression of motor activity and induction of catalepsy than classical antipsychotics. Balanced central serotonin and dopamine antagonism may reduce extrapyramidal side effect liability and extend the th


Tramadol Angenerico




Tramadol Angenerico may be available in the countries listed below.


Ingredient matches for Tramadol Angenerico



Tramadol

Tramadol hydrochloride (a derivative of Tramadol) is reported as an ingredient of Tramadol Angenerico in the following countries:


  • Spain

International Drug Name Search


Isoproterenol




In the US, Isoproterenol (isoproterenol systemic) is a member of the following drug classes: adrenergic bronchodilators, catecholamines, vasopressors and is used to treat Adams-Stokes Syndrome, Asthma - acute, AV Heart Block, Bronchospasm During Anesthesia, Cardiac Arrhythmia, COPD - Acute and Shock.

US matches:

  • Isoproterenol

  • Isoproterenol inhalation

  • Isoproterenol Hydrochloride

Ingredient matches for Isoproterenol



Isoprenaline

Isoprenaline hydrochloride (a derivative of Isoprenaline) is reported as an ingredient of Isoproterenol in the following countries:


  • Argentina

  • Canada

International Drug Name Search


Fludecasin




Fludecasin may be available in the countries listed below.


Ingredient matches for Fludecasin



Fluphenazine

Fluphenazine is reported as an ingredient of Fludecasin in the following countries:


  • Japan

International Drug Name Search


Monday, October 24, 2016

Glibenclamide Sandoz




Glibenclamide Sandoz may be available in the countries listed below.


Ingredient matches for Glibenclamide Sandoz



Glibenclamide

Glibenclamide is reported as an ingredient of Glibenclamide Sandoz in the following countries:


  • France

  • Netherlands

International Drug Name Search


Sunday, October 23, 2016

Midazolam Panpharma




Midazolam Panpharma may be available in the countries listed below.


Ingredient matches for Midazolam Panpharma



Midazolam

Midazolam is reported as an ingredient of Midazolam Panpharma in the following countries:


  • France

  • Sweden

International Drug Name Search


RH-Vita 12




RH-Vita 12 may be available in the countries listed below.


Ingredient matches for RH-Vita 12



Cyanocobalamin

Cyanocobalamin is reported as an ingredient of RH-Vita 12 in the following countries:


  • Germany

International Drug Name Search


Rafuront




Rafuront may be available in the countries listed below.


Ingredient matches for Rafuront



Afloqualone

Afloqualone is reported as an ingredient of Rafuront in the following countries:


  • Japan

International Drug Name Search


Coepratenz Plus




Coepratenz Plus may be available in the countries listed below.


Ingredient matches for Coepratenz Plus



Eprosartan

Eprosartan mesilate (a derivative of Eprosartan) is reported as an ingredient of Coepratenz Plus in the following countries:


  • Austria

  • Poland

Hydrochlorothiazide

Hydrochlorothiazide is reported as an ingredient of Coepratenz Plus in the following countries:


  • Austria

  • Poland

International Drug Name Search


Fluseminal




Fluseminal may be available in the countries listed below.


Ingredient matches for Fluseminal



Norfloxacin

Norfloxacin is reported as an ingredient of Fluseminal in the following countries:


  • Greece

  • Malta

  • Romania

International Drug Name Search


Flecainidacetat Stada




Flecainidacetat Stada may be available in the countries listed below.


Ingredient matches for Flecainidacetat Stada



Flecainide

Flecainide acetate (a derivative of Flecainide) is reported as an ingredient of Flecainidacetat Stada in the following countries:


  • Germany

International Drug Name Search


Saturday, October 22, 2016

Agrocillina




Agrocillina may be available in the countries listed below.


In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Agrocillina



Ampicillin

Ampicillin sodium salt (a derivative of Ampicillin) is reported as an ingredient of Agrocillina in the following countries:


  • Italy

International Drug Name Search


PMS-Alendronate




PMS-Alendronate may be available in the countries listed below.


Ingredient matches for PMS-Alendronate



Alendronic Acid

Alendronic Acid sodium trihydrate (a derivative of Alendronic Acid) is reported as an ingredient of PMS-Alendronate in the following countries:


  • Canada

International Drug Name Search


Bell Homatropine




Bell Homatropine may be available in the countries listed below.


Ingredient matches for Bell Homatropine



Homatropine

Homatropine Hydrobromide is reported as an ingredient of Bell Homatropine in the following countries:


  • India

International Drug Name Search


Friday, October 21, 2016

Povidona Iodada Sintesina




Povidona Iodada Sintesina may be available in the countries listed below.


Ingredient matches for Povidona Iodada Sintesina



Povidone Iodine

Povidone-Iodine is reported as an ingredient of Povidona Iodada Sintesina in the following countries:


  • Argentina

International Drug Name Search


Procain Penicillin G Animedica




Procain Penicillin G Animedica may be available in the countries listed below.


In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Procain Penicillin G Animedica



Benzylpenicillin

Benzylpenicillin procaine (a derivative of Benzylpenicillin) is reported as an ingredient of Procain Penicillin G Animedica in the following countries:


  • Austria

International Drug Name Search


Monolin




Monolin may be available in the countries listed below.


Ingredient matches for Monolin



Isosorbide Mononitrate

Isosorbide Mononitrate is reported as an ingredient of Monolin in the following countries:


  • Myanmar

International Drug Name Search


Ticlopidina Bluepharma




Ticlopidina Bluepharma may be available in the countries listed below.


Ingredient matches for Ticlopidina Bluepharma



Ticlopidine

Ticlopidine is reported as an ingredient of Ticlopidina Bluepharma in the following countries:


  • Portugal

International Drug Name Search


Thursday, October 20, 2016

Metvix




Metvix may be available in the countries listed below.


UK matches:

  • Metvix 160 mg/g cream (SPC)

Ingredient matches for Metvix



Methyl-5-aminolevulinate

Methyl-5-aminolevulinate is reported as an ingredient of Metvix in the following countries:


  • Greece

  • Italy

  • South Africa

  • Spain

Methyl-5-aminolevulinate hydrochloride (a derivative of Methyl-5-aminolevulinate) is reported as an ingredient of Metvix in the following countries:


  • Australia

  • Belgium

  • Canada

  • Czech Republic

  • Denmark

  • Finland

  • Germany

  • Iceland

  • Luxembourg

  • Netherlands

  • New Zealand

  • Norway

  • Portugal

  • Slovakia

  • Slovenia

  • Sweden

  • Switzerland

  • United Kingdom

International Drug Name Search

Glossary

SPC Summary of Product Characteristics (UK)

Click for further information on drug naming conventions and International Nonproprietary Names.

Teniverme




Teniverme may be available in the countries listed below.


Ingredient matches for Teniverme



Flubendazole

Flubendazole is reported as an ingredient of Teniverme in the following countries:


  • Portugal

International Drug Name Search


Repace




Repace may be available in the countries listed below.


Ingredient matches for Repace



Hydrochlorothiazide

Hydrochlorothiazide is reported as an ingredient of Repace in the following countries:


  • Myanmar

Losartan

Losartan potassium salt (a derivative of Losartan) is reported as an ingredient of Repace in the following countries:


  • Myanmar

  • Sri Lanka

International Drug Name Search


Aeromax Diskus




Aeromax Diskus may be available in the countries listed below.


Ingredient matches for Aeromax Diskus



Salmeterol

Salmeterol xinafoate (a derivative of Salmeterol) is reported as an ingredient of Aeromax Diskus in the following countries:


  • Germany

International Drug Name Search


Fada Ibuprofeno




Fada Ibuprofeno may be available in the countries listed below.


Ingredient matches for Fada Ibuprofeno



Ibuprofen

Ibuprofen is reported as an ingredient of Fada Ibuprofeno in the following countries:


  • Argentina

International Drug Name Search


Wednesday, October 19, 2016

Enalapril-corax comp




Enalapril-corax comp may be available in the countries listed below.


Ingredient matches for Enalapril-corax comp



Enalapril

Enalapril maleate (a derivative of Enalapril) is reported as an ingredient of Enalapril-corax comp in the following countries:


  • Germany

Hydrochlorothiazide

Hydrochlorothiazide is reported as an ingredient of Enalapril-corax comp in the following countries:


  • Germany

International Drug Name Search


Filicine




Filicine may be available in the countries listed below.


Ingredient matches for Filicine



Folic Acid

Folic Acid is reported as an ingredient of Filicine in the following countries:


  • Greece

  • Malta

International Drug Name Search


Ambroxol Ratiopharm




Ambroxol-ratiopharm may be available in the countries listed below.


Ingredient matches for Ambroxol-ratiopharm



Ambroxol

Ambroxol hydrochloride (a derivative of Ambroxol) is reported as an ingredient of Ambroxol-ratiopharm in the following countries:


  • France

  • Germany

  • Luxembourg

  • Spain

International Drug Name Search


Ampavit




Ampavit may be available in the countries listed below.


Ingredient matches for Ampavit



Cyanocobalamin

Cyanocobalamin is reported as an ingredient of Ampavit in the following countries:


  • Myanmar

International Drug Name Search


Fatrox




Fatrox may be available in the countries listed below.


In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Fatrox



Rifaximin

Rifaximin is reported as an ingredient of Fatrox in the following countries:


  • Belgium

  • France

International Drug Name Search


Tuesday, October 18, 2016

Moxotens




Moxotens may be available in the countries listed below.


Ingredient matches for Moxotens



Moxonidine

Moxonidine is reported as an ingredient of Moxotens in the following countries:


  • South Africa

International Drug Name Search


Adco-Cefotaxime




Adco-Cefotaxime may be available in the countries listed below.


Ingredient matches for Adco-Cefotaxime



Cefotaxime

Cefotaxime is reported as an ingredient of Adco-Cefotaxime in the following countries:


  • South Africa

International Drug Name Search


Monday, October 17, 2016

Rynatan D




Rynatan D may be available in the countries listed below.


Ingredient matches for Rynatan D



Oxymetazoline

Oxymetazoline is reported as an ingredient of Rynatan D in the following countries:


  • Peru

International Drug Name Search


Invanz




In the US, Invanz (ertapenem systemic) is a member of the drug class carbapenems and is used to treat Infection Prophylaxis, Intraabdominal Infection, Kidney Infections, Pelvic Infections, Pneumonia, Skin Infection and Urinary Tract Infection.

US matches:

  • Invanz

  • Invanz ADD-Vantage

UK matches:

  • INVANZ 1g powder for concentrate for solution for infusion
  • INVANZ 1g powder for concentrate for solution for infusion (SPC)

Ingredient matches for Invanz



Ertapenem

Ertapenem is reported as an ingredient of Invanz in the following countries:


  • Argentina

  • Chile

  • China

  • Costa Rica

  • El Salvador

  • Guatemala

  • Honduras

  • Ireland

  • Luxembourg

  • Malaysia

  • Nicaragua

  • Panama

  • Peru

  • Serbia

  • Singapore

  • South Africa

  • Taiwan

  • Tunisia

  • United Kingdom

  • Venezuela

  • Vietnam

Ertapenem sodium salt (a derivative of Ertapenem) is reported as an ingredient of Invanz in the following countries:


  • Australia

  • Austria

  • Bahrain

  • Bosnia & Herzegowina

  • Canada

  • Colombia

  • Croatia (Hrvatska)

  • Czech Republic

  • Denmark

  • Ecuador

  • Finland

  • France

  • Germany

  • Greece

  • Hong Kong

  • Hungary

  • Iceland

  • Israel

  • Italy

  • Mexico

  • Netherlands

  • New Zealand

  • Norway

  • Philippines

  • Poland

  • Portugal

  • Romania

  • Russian Federation

  • Slovakia

  • Slovenia

  • Spain

  • Sweden

  • Switzerland

  • Thailand

  • United States

International Drug Name Search

Glossary

SPC Summary of Product Characteristics (UK)

Click for further information on drug naming conventions and International Nonproprietary Names.

Lopresor OROS




Lopresor OROS may be available in the countries listed below.


Ingredient matches for Lopresor OROS



Metoprolol

Metoprolol fumarate (a derivative of Metoprolol) is reported as an ingredient of Lopresor OROS in the following countries:


  • Israel

  • Luxembourg

International Drug Name Search


Cyproterone




Scheme

Rec.INN

ATC (Anatomical Therapeutic Chemical Classification)

G03HA01

CAS registry number (Chemical Abstracts Service)

0002098-66-0

Chemical Formula

C22-H27-Cl-O3

Molecular Weight

374

Therapeutic Categories

Contraceptive

Antiandrogen

Chemical Name

3'H-Cyclopropa[1,2]pregna-1,4,6-triene-3,20-dione, 6-chloro-1,2-dihydro-17-hydroxy-, (1ß,2ß)-

Foreign Names

  • Cyproteronum (Latin)
  • Cyproteron (German)
  • Cyprotérone (French)
  • Ciproterona (Spanish)

Generic Names

  • Ciproterone (OS: DCIT)
  • Cyproterone (OS: BAN)
  • Cyprotérone (OS: DCF)
  • SH 714 (IS)
  • SH 881 (IS)
  • Cyproterone Acetate (OS: BANM, USAN, JAN)
  • NSC 81430 (IS)
  • SH 80714 (IS)
  • Cyproteronacetat (PH: Ph. Eur. 6)
  • Cyprotérone (acétate de) (PH: Ph. Eur. 6)
  • Cyproterone Acetate (PH: BP 2010, Ph. Eur. 6)
  • Cyproteroni acetas (PH: Ph. Eur. 6)

Brand Names

  • Androcur
    Schering, Tunisia


  • Ciprocur
    Grey Inversiones, Peru


  • Ciproterona Servycal
    Servycal, Argentina


  • Ciproterona
    Servycal, Peru


  • Climen (Cyproterone and Estradiol)
    Schering, Slovenia


  • Climene (Cyproterone and Estradiol)
    Schering, Tunisia


  • Diane (Cyproterone and Ethinylestradiol)
    Bayer, Bulgaria; Bayer Animal Health, Luxembourg; Schering, Colombia; Schering, Tunisia


  • Dixi 35 (Cyproterone and Ethinylestradiol)
    Gynopharm, Peru


  • Drina (Cyproterone and Ethinylestradiol)
    ABL, Peru


  • Acétate de Cyprotérone Arrow
    Arrow, France


  • Acétate de Cyprotérone EG
    EG Labo, France


  • Acétate de Cyprotérone Sandoz
    Sandoz, France


  • Acétate de Cyprotérone Teva
    Teva Santé, France


  • Acetato De Ciproterona Etinilestradiol Davur (Cyproterone and Ethinylestradiol)
    Davur, Spain


  • Acetato De Ciproterona Etinilestradiol Sandoz (Cyproterone and Ethinylestradiol)
    Sandoz, Spain


  • Adco-Fem (Cyproterone and Ethinylestradiol)
    Adcock Ingram Pharmaceuticals, South Africa


  • Andelux
    Novartis, Brazil


  • Androbas
    Stragen Pharma, Switzerland


  • Androcur Depot
    Bayer, Austria; Bayer, Bulgaria; Bayer, Germany; Schering, Czech Republic; Schering, Russian Federation


  • Androcur
    Bayer, Austria; Bayer, Belgium; Bayer, Bulgaria; Bayer, Canada; Bayer, Switzerland; Bayer, Germany; Bayer, Estonia; Bayer, Spain; Bayer, United Kingdom; Bayer, Croatia (Hrvatska); Bayer, Italy; Bayer, Latvia; Bayer, Netherlands; Bayer, Peru; Bayer, Sweden; Bayer, Turkey; Bayer, Taiwan; Bayer Animal Health, Luxembourg; Bayer Santé, France; Bayer Schering, Australia; Bayer Schering, Finland; Bayer Schering, Greece; Bayer Schering, Indonesia; Bayer Schering, Ireland; Bayer Schering, South Africa; Bayer Schering Pharma, Denmark; Bayer Schering Pharma, Norway; Bayer Schering Pharma, Vietnam; Berlex, United States; Eurim, Austria; Gobbi, Argentina; Mobipharma, Estonia; Schering, United Arab Emirates; Schering, Bosnia & Herzegowina; Schering, Bahrain; Schering, Brazil; Schering, Cote D'ivoire; Schering, Colombia; Schering, Cyprus; Schering, Czech Republic; Schering, Dominican Republic; Schering, Algeria; Schering, Egypt; Schering, Georgia; Schering, Hong Kong; Schering, Hungary; Schering, Israel; Schering, Iraq; Schering, Jordan; Schering, Kuwait; Schering, Lebanon; Schering, Lithuania; Schering, Libya; Schering, Malta; Schering, Malaysia; Schering, Oman; Schering, Poland; Schering, Portugal; Schering, Qatar; Schering, Romania; Schering, Serbia; Schering, Russian Federation; Schering, Saudi Arabia; Schering, Sudan; Schering, Singapore; Schering, Slovakia; Schering, Thailand; Schering, Yemen; Schering-Plough, Slovenia


  • Androcur Depot
    Bayer, Switzerland


  • Andro-Diane
    Bayer, Austria


  • Androstat
    Bagó, Ecuador; Bioprofarma, Argentina


  • Apo-Cyproterone
    Apotex, Canada


  • Asoteron
    Nolver, Venezuela; Raffo, Argentina


  • Attempta-ratiopharm (Cyproterone and Ethinylestradiol)
    Ratiopharm, Germany


  • Bagopront
    Armstrong, Mexico


  • Bella Hexal (Cyproterone and Ethinylestradiol)
    Hexal, Germany


  • Bellgyn Ratiopharm (Cyproterone and Ethinylestradiol)
    Ratiopharm, Austria


  • Bellune (Cyproterone and Ethinylestradiol)
    Pliva, Croatia (Hrvatska)


  • Brenda-35 ED (Cyproterone and Ethinylestradiol)
    Alphapharm, Australia


  • C.P.D.
    Ivax, Argentina


  • Ceprater
    Richmond, Argentina; Richmond, Peru


  • Cetoteron
    Eurofarma, Brazil


  • Chloe (Cyproterone and Ethinylestradiol)
    Zentiva, Bulgaria; Zentiva, Latvia; Zentiva, Poland; Zentiva, Slovakia


  • Ciclamil
    LKM, Argentina


  • Cipla-Cyproterone Acetate
    Cipla Medpro, South Africa


  • Ciprofarma
    Varifarma, Argentina


  • Ciproplex
    Teva, Argentina


  • Ciprostat
    Apsen, Brazil


  • Ciproterona acetato
    Sandoz, Colombia


  • Ciproterona Delta Farma
    Delta Farma, Argentina


  • Ciproterona Generis
    Generis, Portugal


  • Ciproterona Microsules
    Microsules, Argentina


  • Ciproterona Rontag
    Rontag, Argentina


  • Ciproterona Sandoz
    Sandoz, Argentina


  • Clairette (Cyproterone and Ethinylestradiol)
    Durbin, United Kingdom


  • Claudia (Cyproterone and Ethinylestradiol)
    Sandoz, Belgium


  • Clevia (Cyproterone and Ethinylestradiol)
    Almirall Hermal, Germany


  • Climen (Cyproterone and Estradiol)
    Bayer, Austria; Bayer, Belgium; Bayer, Bulgaria; Bayer, Switzerland; Bayer, Germany; Bayer, Croatia (Hrvatska); Bayer, Hungary; Bayer, Italy; Bayer, Turkey; Bayer, Taiwan; Bayer Animal Health, Luxembourg; Bayer Schering, Indonesia; Bayer Schering, South Africa; Schering, Bulgaria; Schering, Bahrain; Schering, Poland


  • Climene (Cyproterone and Estradiol)
    Bayer, Netherlands; Bayer, Peru; Bayer Schering, Singapore; Schering, Colombia


  • Climène (Cyproterone and Estradiol)
    Bayer Santé, France


  • CyEstra (Cyproterone and Cyproterone)
    Pharmascience, Canada


  • Cypestra-35 (Cyproterone and Ethinylestradiol)
    Mepha Pharma, Switzerland


  • Cyprelle (Cyproterone and Ethinylestradiol)
    Sandoz, Switzerland


  • Cyprene-35 ED (Cyproterone and Ethinylestradiol)
    Pharmaplan, South Africa


  • Cyprest (Cyproterone and Ethinylestradiol)
    Polfa Pabianice, Poland


  • Cyproderm (Cyproterone and Ethinylestradiol)
    Dermapharm, Germany


  • Cyprodiol (Cyproterone and Ethinylestradiol)
    Eurogenerics, Belgium; Eurogenerics, Luxembourg


  • Cyprohexal
    Sandoz, Australia


  • Cypromix (Cyproterone and Ethinylestradiol)
    Stragen, Hungary


  • Cypron
    Generics, Israel


  • Cyprone
    Alphapharm, Australia


  • Cyproplex
    Pharmachemie, Malaysia; Pharmachemie, Peru; Pharmachemie, South Africa; Teva, Belgium; Teva, Czech Republic; Teva, Lithuania; Teva, Latvia; Teva, Slovakia


  • Cyprostat
    Bayer, United Kingdom; Bayer, Iran; Bayer, Jordan; Bayer, Lebanon; Bayer Schering, Australia; Schering, United Arab Emirates; Schering, Bahrain; Schering, Egypt; Schering, Iraq; Schering, Kuwait; Schering, Oman; Schering, Yemen; Schering-Plough, Qatar; Schering-Plough, Saudi Arabia; Schering-Plough, Syria


  • Cyproteron / Ethinylestradiol A (Cyproterone and Ethinylestradiol)
    Apothecon, Netherlands


  • Cyproteron / Ethinylestradiol Actavis (Cyproterone and Ethinylestradiol)
    Actavis, Netherlands


  • Cyproteron / Ethinylestradiol CF (Cyproterone and Ethinylestradiol)
    Centrafarm, Netherlands


  • Cyproteron / Ethinylestradiol Katwijk (Cyproterone and Ethinylestradiol)
    Apotex Europe, Netherlands


  • Cyproteron / Ethinylestradiol Mylan (Cyproterone and Ethinylestradiol)
    Mylan, Netherlands


  • Cyproteron / Ethinylestradiol PCH (Cyproterone and Ethinylestradiol)
    Pharmachemie, Netherlands


  • Cyproteron / Ethinylestradiol Ratiopharm (Cyproterone and Ethinylestradiol)
    ratiopharm, Netherlands


  • Cyproteron / Ethinylestradiol Sandoz (Cyproterone and Ethinylestradiol)
    Sandoz, Netherlands


  • Cyproteron Betapharm
    Betapharm, Netherlands


  • Cyproteron Mylan
    Mylan, Netherlands; Mylan, Sweden


  • Cyproteron NM Pharma
    Generics, Iceland


  • Cyproteron PCH
    Pharmachemie, Netherlands


  • Cyproteron TAD
    TAD, Germany


  • Cyproteronacetat beta
    Betapharm, Germany


  • Cyproteronacetat dura
    Mylan dura, Germany


  • Cyproteronacetat EE Sandoz (Cyproterone and Ethinylestradiol)
    Sandoz, Switzerland


  • Cyproteronacetat Italchimici
    Italchimici, Slovakia


  • Cyproteronacetat/Ethinylestradiol ratiopharm (Cyproterone and Ethinylestradiol)
    ratiopharm, Denmark


  • Cyproteronacetat-GRY
    Teva-Gry, Germany


  • Cyproterone Acetate
    CP, Malta; Wockhardt, United Kingdom


  • Cyproterone Acetate-Generics
    Generics, Luxembourg


  • Cyprotérone Biogaran
    Biogaran, France


  • Cyprotérone Mylan
    Mylan, France


  • Cyprotérone/Ethinylestradiol Bayer (Cyproterone and Ethinylestradiol)
    Bayer Santé, France


  • Cyprotérone/Ethinylestradiol EG (Cyproterone and Ethinylestradiol)
    EG Labo, France


  • Cyprotérone/Ethinylestradiol Ranbaxy (Cyproterone and Ethinylestradiol)
    Ranbaxy, France


  • Cyprotérone/Ethinylestradiol Ratiopharm (Cyproterone and Ethinylestradiol)
    Ratiopharm, France


  • Cyprotérone/Ethinylestradiol Sandoz (Cyproterone and Ethinylestradiol)
    Sandoz, France


  • Cyprotérone/Ethinylestradiol Teva (Cyproterone and Ethinylestradiol)
    Teva Santé, France


  • Cyprotérone/Ethinylestradiol Zydus (Cyproterone and Ethinylestradiol)
    Zydus, France


  • Cyproterone-APC (Cyproterone and Ethinylestradiol)
    Merckle, Poland


  • Daphne (Cyproterone and Ethinylestradiol)
    Mithra, Belgium


  • Diacare (Cyproterone and Ethinylestradiol)
    Cantabria, Spain


  • Diane (Cyproterone and Cyproterone)
    Bayer, Canada


  • Diane (Cyproterone and Ethinylestradiol)
    Bayer, Belgium; Bayer, Germany; Bayer, Estonia; Bayer, Spain; Bayer, Croatia (Hrvatska); Bayer, Hungary; Bayer, Italy; Bayer, Latvia; Bayer, Peru; Bayer, Poland; Bayer, Sweden; Bayer, Turkey; Bayer, Taiwan; Bayer Santé, France; Bayer Schering, Australia; Bayer Schering Pharma, Norway; Bayer Schering Pharma, Vietnam; Schering, Antigua & Barbuda; Schering, Netherlands Antilles; Schering, Aruba; Schering, Barbados; Schering, Bahrain; Schering, Bermuda; Schering, Bahamas; Schering, Belize; Schering, Dominican Republic; Schering, Grenada; Schering, Guyana; Schering, Haiti; Schering, Jamaica; Schering, Cayman Islands; Schering, Saint Lucia; Schering, Lithuania; Schering, Malta; Schering, Oman; Schering, Portugal; Schering, Slovenia; Schering, Slovakia; Schering, Suriname; Schering, Thailand; Schering, Trinidad & Tobago; Schering-Plough, Indonesia


  • Diane mite (Cyproterone and Ethinylestradiol)
    Bayer, Austria; Bayer Schering Pharma, Denmark


  • Diane Nova (Cyproterone and Ethinylestradiol)
    Bayer Schering, Finland


  • Diane-35 (Cyproterone and Ethinylestradiol)
    Bayer, Netherlands; Bayer, New Zealand; Bayer Schering, South Africa


  • Dianette (Cyproterone and Ethinylestradiol)
    Bayer, United Kingdom; Pharmacia, Ireland


  • Dianova Mite (Cyproterone and Ethinylestradiol)
    Alternova, Denmark


  • Diva-35 (Cyproterone and Ethinylestradiol)
    Dr Reddys Laboratories, South Africa


  • Dixi
    Vivax, Venezuela


  • Docdonna (Cyproterone and Ethinylestradiol)
    Docpharma, Belgium


  • Elisamylan (Cyproterone and Ethinylestradiol)
    Mylan, Belgium


  • Elleacnelle (Cyproterone and Ethinylestradiol)
    Stragen Pharma, Switzerland


  • Ergalea (Cyproterone and Ethinylestradiol)
    Taurus, Germany


  • Estelle-35 (Cyproterone and Ethinylestradiol)
    Douglas, New Zealand; Genepharm, Australia


  • Etinilestradiol Ciproterona Gineservice (Cyproterone and Ethinylestradiol)
    Effik, Spain


  • Evépar (Cyproterone and Ethinylestradiol)
    Mylan, France


  • Facetix (Cyproterone and Ethinylestradiol)
    GYNOpharm, Colombia


  • Femilar (Cyproterone and Estradiol)
    Bayer Schering, Finland


  • Femina (Cyproterone and Ethinylestradiol)
    Nycomed, Estonia; Nycomed, Latvia


  • Feminac 35 (Cyproterone and Ethinylestradiol)
    Nycomed, Lithuania; Spirig Pharma, Switzerland


  • Feminil Sandoz (Cyproterone and Ethinylestradiol)
    Sandoz AS, Norway


  • Feminil (Cyproterone and Ethinylestradiol)
    Sandoz, Finland


  • Feminil mite (Cyproterone and Ethinylestradiol)
    Sandoz, Denmark


  • Gen-Cyproterone
    Genpharm, Canada


  • GenRX Cyproterone Acetate
    Apotex, Australia


  • Ginette (Cyproterone and Ethinylestradiol)
    Cipla, Oman; Cipla Medpro, South Africa


  • Gratiella (Cyproterone and Ethinylestradiol)
    3DDD Pharma, Belgium


  • Gynelle (Cyproterone and Ethinylestradiol)
    Eczacibasi, Turkey


  • Gyneplen (Cyproterone and Ethinylestradiol)
    Effik, Spain


  • Gynofen (Cyproterone and Ethinylestradiol)
    Bayer, Greece


  • Holgyeme (Cyproterone and Ethinylestradiol)
    Effik, Switzerland; Effik, France


  • Jennifer (Cyproterone and Ethinylestradiol)
    Steiner & Co, Germany


  • Juliet-35 ED (Cyproterone and Ethinylestradiol)
    Bayer Schering, Australia


  • Juliette (Cyproterone and Ethinylestradiol)
    Mylan dura, Germany


  • Linface (Cyproterone and Cyproterone 17α-acetate)
    Chalver, Colombia


  • Linface (Cyproterone and Ethinylestradiol)
    Chalver, Colombia


  • Lumalia (Cyproterone and Ethinylestradiol)
    Pierre Fabre Médicament, France


  • Midane (Cyproterone and Ethinylestradiol)
    Pelpharma, Austria


  • Minerva (Cyproterone and Ethinylestradiol)
    Bayer, Austria; Bayer, Croatia (Hrvatska); Berlipharm, Netherlands; Berlis, Switzerland; Biogaran, France; Schering, Czech Republic; Schering, Hungary; Schering, Slovakia; Schering, South Africa


  • Morea (Cyproterone and Ethinylestradiol)
    Sanol, Germany; Schwarz, Germany


  • Omnigeriat
    Fabra, Argentina


  • Oncoterona
    Biotoscana, Colombia


  • Pausene (Cyproterone and Estradiol)
    Theramex, Italy


  • Procur
    Genepharm, Australia


  • Prostarin (Cyproterone and Ethinylestradiol)
    Gynocare Limited, Vietnam


  • Purfilx
    Filaxis, Argentina


  • Ratiopharmeva (Cyproterone and Ethinylestradiol)
    Ratiopharm, Belgium


  • Siterone
    Rex, New Zealand


  • Syndi (Cyproterone and Ethinylestradiol)
    SymPhar, Poland


  • Virilit
    Bayer, Germany


  • Visofid (Cyproterone and Ethinylestradiol)
    Fidia, Italy


  • Vreya (Cyproterone and Ethinylestradiol)
    Stragen, Czech Republic; Stragen, Denmark


  • Xylia (Cyproterone and Ethinylestradiol)
    Sandoz, Austria


  • Zyrona (Cyproterone and Ethinylestradiol)
    Copyfarm, Denmark; Orifarm, Sweden

International Drug Name Search

Glossary

BANBritish Approved Name
BANMBritish Approved Name (Modified)
DCFDénomination Commune Française
DCITDenominazione Comune Italiana
ISInofficial Synonym
JANJapanese Accepted Name
OSOfficial Synonym
PHPharmacopoeia Name
Rec.INNRecommended International Nonproprietary Name (World Health Organization)
USANUnited States Adopted Name

Click for further information on drug naming conventions and International Nonproprietary Names.