Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
FLUPENTIXOL DECANOATE
Lundbeck Limited
N05AF01
FLUPENTIXOL DECANOATE
100 Micromol
Solution for Injection
Product subject to prescription which may not be renewed (A)
flupentixol
Marketed
1988-01-25
• Medicines such as diuretics (water tablets) that cause a disturbed water or salt balance (too little potassium or magnesium in your blood) • Medicines known as phenothiazines used to treat mental illness (e.g. chlorpromazine, fluphenazine). • Medicines known as neuromuscular blocking agents (e.g. suxamethonium) as concomitant treatment with this medicine may prolong the effect of neuromuscular blocking agents • Adrenergic medicines (e.g. atenolol) as concomitant treatment with this medicine may reduce their effect The following medicines should not be taken with this medicine: • Medicines for heart rhythm problems such as medicines used to treat irregular heartbeats (e.g. quinidine, amiodarone, sotalol, dofetilide), certain antibiotics (e.g. erythromycin, gatifloxacin, moxifloxacin), certain antihistamines (e.g. astemizole, terfenadine) and other medicines such as cisapride and lithium • Other antipsychotic medicines (e.g. thioridazine) Depixol Conc. Injection with alcohol Depixol Conc. Injection may increase the sedative effects of alcohol making you drowsier. It is recommended not to drink alcohol during treatment with this medicine. Pregnancy, breast-feeding and fertility If you are pregnant or think you might be pregnant or planning to have a baby, ask your doctor, pharmacist or nurse for advice before taking this medicine. Pregnancy If you are pregnant or think you might be pregnant, tell your doctor. Depixol Conc. Injection should not be used during pregnancy unless clearly necessary. The following symptoms may occur in newborn babies of mothers that have used this medicine in the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding. If your baby develops any of these symptoms you may need to contact your doctor. Breast-feeding If you are breast-feeding, ask your doctor for advice. You should not this medicine when breast-feeding, as small amounts of the medicine can pass into the Preberite celoten dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Depixol Conc. 100mg/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 (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 assess 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. _Reduced hepatic function_ Dose reduction (relative to the degree of hepatic impairment) should be considered. If possible Preberite celoten dokument