Land: Ierland
Taal: Engels
Bron: HPRA (Health Products Regulatory Authority)
FLUPENTIXOL DECANOATE
Lundbeck Limited
FLUPENTIXOL DECANOATE
200 Micromol
Solution for Injection
Product subject to prescription which may not be renewed (A)
Withdrawn
2014-07-01
Package leaflet: Information for the user DEPIXOL 200 MG/ML SOLUTION FOR INJECTION (cis(Z)-flupentixol decanoate) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, please ask your doctor, pharmacist or nurse. • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. WHAT DEPIXOL 200MG INJECTION IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU USE DEPIXOL 200MG INJECTION 3. HOW TO USE DEPIXOL 200MG INJECTION 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE DEPIXOL 200MG INJECTION 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT DEPIXOL 200MG INJECTION IS AND WHAT IT IS USED FOR Depixol 200 mg Injection contains the active substance flupentixol. Depixol 200 mg Injection belongs to a group of medicines known as antipsychotics These medicines act on nerve pathways in specific areas of the brain and help to correct certain chemical imbalances in the brain that are causing the symptoms of your illness. This medicine is used for the treatment of schizophrenia and other related psychoses. Ask your doctor if you have any questions about why this medicine has been prescribed for you. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE DEPIXOL 200MG INJECTION DO NOT USE DEPIXOL 200MG INJECTION IF YOU: • are allergic to flupentixol or any of the other ingredien Lees het volledige document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Depixol 200 mg/ml Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1ml ampoule contains 200mg (20 % w/v) cis(Z)-flupentixol decanoate. For the full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection (injection). Clear yellowish oil, practically free from particles. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS The management of schizophrenia or paranoid psychoses. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults_ The dosage should be adjusted according to the severity of the patients' symptoms. The dosage range of Depixol 200 mg/ml lies between 50 mg (0.25ml) every 4 weeks and 300 mg (1.5ml) every 2 weeks but some patients may require up to 400 mg (2 ml) weekly. Adequate control of severe psychotic symptoms by Depixol 200 mg/ml Injection is usually achieved within 4 to 6 months and this may justify a return to lower dose maintenance treatment with Depixol Conc. (100 mg/ml) or standard Depixol (20 mg/ml) injection. _Older people_ Older people should receive dosages in the lower end of the dosage range. _Reduced renal function_ Flupentixol decanoate can be given in usual doses to patients with reduced renal function. _Reduced hepatic function_ Dose reduction (relative to the degree of hepatic impairment) should be considered. If possible, where assay facilities exist dosage should be adjusted according to serum levels. _Children_ Flupentixol decanoate is not indicated for children. Method of administration Flupentixol decanoate is administered by intramuscular injection into the upper outer quadrant of the gluteal region or lateral thigh. Note: As with all oil based injections it is important to ensure, by aspiration before injection, that inadverten Lees het volledige document