Land: Nieuw-Zeeland
Taal: Engels
Bron: Medsafe (Medicines Safety Authority)
Disulfiram 200mg; ;
Teva Pharma (New Zealand) Limited
Disulfiram 200 mg (Hydrofile)
200 mg
Effervescent tablet
Active: Disulfiram 200mg Excipient: Colloidal silicon dioxide Magnesium stearate Maize starch Microcrystalline cellulose Polysorbate 20 Povidone Purified talc Sodium bicarbonate Tartaric acid
Bottle, plastic, PET, 100 tablets
Prescription
Prescription
Synthexim
deterrent to alcohol consumption and an aid in the overall management of selected chronic alcoholic patients involved in an integrated program of counselling and psychiatry. Only alcoholic patients who are motivated to abstain from drinking and who are undergoing supportive psychotherapeutic treatment ancillary to a total program of rehabilitation should be selected for Antabuse administration.
Package - Contents - Shelf Life: Bottle, plastic, PET - 100 tablets - 60 months from date of manufacture stored at or below 25°C
1969-12-31
NEW ZEALAND CONSUMER MEDICINE INFORMATION ANTABUSE ® DISULFIRAM 200MG TABLETS _(DIE-SUL-FEAR-AM) _ WHAT IS IN THIS LEAFLET? This leaflet answers some common questions about Antabuse ® . It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of your taking Antabuse ® against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT ANTABUSE ® IS USED FOR ANTABUSE ® TABLETS are used to treat people with drinking problems. When you drink alcohol it is changed in the body into a chemical called acetaldehyde (a-seat-al-de-hide). Antabuse ® prevents the chemical from being broken down, resulting in a high level of acetaldehyde in the body. This high level of acetaldehyde causes unpleasant physical reactions in the body. These unpleasant physical reactions should stop you from drinking further alcohol. The physical reactions can be unpredictable and symptoms can vary from person to person. Your doctor will explain the type of symptoms you will experience if you drink alcohol while taking Antabuse ® . Your doctor may have prescribed Antabuse ® for another reason. Ask your doctor or pharmacist if you have any questions about why Antabuse ® has been prescribed for you. BEFORE YOU USE ANTABUSE ® _WHEN YOU MUST NOT USE IT _ • If you have consumed alcohol within the previous 24 hours. This includes alcohol-containing preparations such as food prepared with wine, vinegar and certain cough or cold medication. • If you have used any alcohol-containing remedies, tonics, toiletries, perfumes or sprays within the previous 24 hours. • If you are sensitive (allergic) to any of the ingredients listed at the end of this leaflet. • If you have severe heart disease or heart failure. • If you suffer severe mood or personality disorder. • I Lees het volledige document
Version 1.1 1 NEW ZEALAND DATA SHEET 1. PRODUCT NAME Antabuse 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each effervescent tablet contains 200 mg disulfiram (equivalent to disulfiram hydrofile 201 mg). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Round white, effervescent flat tablet, 11 mm diameter, engraved CDC with a breakline on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Deterrent to alcohol consumption and an aid in the overall management of selected chronic alcoholic patients involved in an integrated program of counselling and psychiatry. Only alcoholic patients who are motivated to abstain from drinking and who are undergoing supportive psychotherapeutic treatment ancillary to a total program of rehabilitation should be selected for Antabuse administration. 4.2 DOSE AND METHOD OF ADMINISTRATION ADULTS Dose _Initial dosage: _ Four 200 mg tablets (800 mg) daily for 2 to 3 days. _Maintenance dose: _ Reduce by 200 mg daily until a daily dose of 100 to 200 mg is attained. Antabuse should be taken for six weeks to six months as required. A review of the effectiveness of therapy should be undertaken before continuation on a longer term basis. A few patients would require higher doses of disulfiram and longer duration of treatment under close supervision. Method of administration Add the prescribed dose to a quarter glass of water or fruit juice, until completely dispersed and drink immediately. Antabuse should be taken preferably on waking although in patients who experience a sedative effect, it may be taken on retiring. Alternatively, to minimise the sedative effect the initial dosage may be reduced. PAEDIATRIC POPULATION No data are available. 4.3 CONTRAINDICATIONS Hypersensitivity to this drug or to other thiuram derivatives used in pesticides and rubber vulcanisation; severe myocardial disease, ischaemic heart disease or uncompensated heart failure; pregnancy; advanced hepatic and renal disease; suicidal risk or psychosis; serious organic brain damage. Under a Lees het volledige document