Země: Velká Británie
Jazyk: angličtina
Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)
Fluvoxamine maleate
IVAX Pharmaceuticals UK Ltd
N06AB08
Fluvoxamine maleate
50mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04030300
Pharma code 691 TAKING OTHER MEDICINES DO NOT TAKE FLUVOXAMINE IN COMBINATION WITH: • antidepressants known as MAOIs (monoamine oxidase inhibitors) e.g. phenelzine, moclobemide. You should not take Fluvoxamine until at least 14 days after you have stopped taking an MAOI. If you stop treatment with Fluvoxamine, you should wait at least 1 week before starting any treatment with a MAOI. • terfenadine or astemizole to treat allergies such as hay fever • tizanidine (used as a muscle relaxant) • cisapride (used for stomach problems). If you are taking any of these medicines, DO NOT take Fluvoxamine, and return to your doctor to discuss your treatment. TALK TO YOUR DOCTOR IF YOU ARE TAKING ANY OF THE FOLLOWING: • any other antidepressants such as amitriptyline, clomipramine, imipramine, lithium or tryptophan • other SSRIs for depression or obsessive-compulsive disorders such as fluoxetine • St. John’s Wort_ _(_Hypericum perforatum_), a herbal remedy used for depression • any benzodiazepines (used to treat anxiety and insomnia) such as midazolam, triazolam, diazepam or alprazolam • any antipsychotic drugs (used to treat mental illnesses) such as risperidone, chlorpromazine or haloperidol • antidiabetic agents • carbamazepine or phenytoin (used to treat epilepsy) • clozapine, olanzapine or thioridazine (used to treat schizophrenia) • theophylline (used to treat asthma and bronchitis) • propranolol or mexiletine (used to treat high blood pressure and heart problems) • ciclosporin (an immunosuppressant) used after organ transplant • tramadol (a painkiller) or methadone (used to treat severe pain or in the management of drug dependency) • anticoagulants (used to prevent blood clots) such as warfarin • ropinirole (used to treat Parkinson’s disease) • tacrine (used to treat Alzheimer’s disease) • sildenafil (used to treat erectile dysfunction (impotence)). Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. FLUVOXAMINE WIT Přečtěte si celý dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fluvoxamine 50 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredient: fluvoxamine maleate Each film coated tablet contains fluvoxamine as 50 mg of fluvoxamine maleate. For a full list of excipients see Section 6.1 3 PHARMACEUTICAL FORM Film-coated tablet. Yellow, film coated capsule shaped tablet, scored and debossed with “93” on one side (“9” and “3” on either side of the score-line) and “56” on the other side. The tablet can be divided into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS - Major depressive episode. - Obsessive Compulsive Disorder (OCD). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Fluvoxamine tablets should be swallowed with water and without chewing. _Depression _ _Adults _ The recommended dose is 100 mg daily. Patients should start on 50 or 100 mg, given as a single dose in the evening. Dosage should be reviewed and adjusted if necessary within 3 to 4 weeks of initiation of therapy and thereafter as judged clinically appropriate. Although there may be an increased potential for undesirable effects at higher doses, if after some weeks on the recommended dose insufficient response is seen some patients may benefit from having their dose increased gradually up to a maximum of 300 mg a day. Doses up to 150 mg can be given as a single dose, preferably in the evening. It is advisable that a total daily dose of more than 150 mg is given in 2 or 3 divided doses. Dosage adjustments should be made carefully on an individual patient basis, to maintain the patients at the lowest effective dose. Patients with depression should be treated for a sufficient period of at least 6 months to ensure that they are free from symptoms. _Children/adolescents _ Fluvoxamine should not be used in children and adolescents under the age of 18 years for the treatment of major depressive episode. The efficacy and safety of fluvoxamine have not been established in the treatment of paediatric major depressive epis Přečtěte si celý dokument