Land: Malta
Sprog: engelsk
Kilde: Medicines Authority
FLUPENTIXOL DECANOATE
Lundbeck (Ireland) Limited 4045 Kingwood Road Citywest, Business Park Citywest Co.Dublin, Ireland
N05AF01
FLUPENTIXOL DECANOATE 100 mg/ml
SOLUTION FOR INJECTION
FLUPENTIXOL DECANOATE 100 mg/ml
POM
PSYCHOLEPTICS
Authorised
2006-04-18
Package Leaflet: Information for the user DEPIXOL CONC. 100 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, ask your doctor, pharmacist or nurse. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness 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 CONC. INJECTION IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU USE DEPIXOL CONC. INJECTION 3. HOW TO USE DEPIXOL CONC. INJECTION 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE DEPIXOL CONC. INJECTION 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT DEPIXOL CONC. INJECTION IS AND WHAT IT IS USED FOR Depixol Conc. Injection contains the active substance flupentixol. Depixol Conc. 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 CONC. INJECTION DO NOT USE DEPIXOL CONC. INJECTION IF YOU: • are allergic to flupentixol or any of the other ingredients of this medicine (listed in Section 6). Consult your doctor if you think you might be • have a reduced level of alertness due to any cause (this includes reduced alertness after the consumption of alcohol or drugs such as opiates (e.g. morphine) or barbiturates) • are an older person who suffers from confusion • are receiv Læs hele dokumentet
1/11 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Depixol Conc. 100 mg/ml Solution for Injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 ml ampoule contains 100 mg (10% w/v) cis (Z)-flupentixol decanoate. For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Solution for injection. Clear, yellowish to yellow oil, practically free from particles. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _ _ The management of schizophrenia and allied paranoid psychoses. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION_ _ Posology _ _ _Adults _ The usual dosage is between 50 mg every 4 weeks and 300 mg every two weeks. Subsequent dosage can be adjusted on the basis of the individual patient response and may reach 400mg weekly before a reduction can be made to maintenance levels. In patients who have not previously received depot neuroleptics, treatment is usually started with a small dose (e.g. 20 mg) to as sess tolerability. An interval of at least one week should be allowed before the second injection is given at a dose consistent with the patients' condition. Adequate control of severe psychotic symptoms may take up to 4 to 6 months at high enough dosage. Once stabilised lower maintenance doses may be considered, but must be sufficient to prevent relapse. The appropriate presentation of Depixol should be selected to achieve an injection volume which does not exceed 2 ml. Volumes greater than 2 ml should be distributed between two injection sites. When transferring patients from oral to depot neuroleptic treatment, the oral medication should not be discontinued immediately but gradually withdrawn over a period of several days after administering the first 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. 2/11 _Reduced hepatic function _ Dose reduction (relative to the degree of hepatic impairment) should be Læs hele dokumentet