Země: Nový Zéland
Jazyk: angličtina
Zdroj: Medsafe (Medicines Safety Authority)
Pindolol 5mg; ;
Apotex NZ Ltd
Pindolol 5 mg
5 mg
Tablet
Active: Pindolol 5mg Excipient: Croscarmellose sodium Lactose monohydrate Magnesium stearate Microcrystalline cellulose
Bottle, plastic, HDPE, 100 tablets
Prescription
Prescription
Daito Corporation
Package - Contents - Shelf Life: Bottle, plastic, HDPE - 100 tablets - 48 months from date of manufacture stored at or below 25°C protect from light
1989-10-06
New Zealand Consumer Medicine Information APO-PINDOLOL _PINDOLOL _ 5mg, 10mg and 15mg Tablets WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start using Apo-Pindolol. This leaflet answers some common questions about Apo-Pindolol. 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 you using Apo-Pindolol against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. Keep this leaflet with the medicine. You may need to read it again. WHAT APO-PINDOLOL IS USED FOR The name of your medicine is Apo-Pindolol tablet. It contains the active ingredient Pindolol. Apo-Pindolol is used for: • arterial hypertension • prophylaxis of angina pectoris • cardiac arrhythmias (sinus and atrial tachycardia, paroxysmal tachycardia, tachycardia in patients with atrial flutter or fibrillation, supraventricular extrasystoles) • hyperkinetic heart syndrome Your doctor may have prescribed Apo-Pindolol for another reason. Ask your doctor if you have any questions about why Apo-Pindolol has been prescribed for you. This medicine is available only with a doctor's prescription. There is no evidence that this medicine is addictive. Apo-Pindolol should not be administered to children. 2 BEFORE YOU USE APO-PINDOLOL _ _ _WHEN YOU MUST NOT USE IT _ Do not use Apo-Pindolol if: • YOU ARE HYPERSENSITIVE TO, OR HAVE HAD AN ALLERGIC REACTION TO PINDOLOL OR ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. Symptoms of an allergic reaction may include: cough, shortness of breath, wheezing, difficulty breathing or tightness in chest; swelling of the face, lips, tongue, throat or other parts of the body; rash, itching or hives on the skin; fainting; or hay fever-like symptoms. IF YOU THINK YOU ARE HAVING AN ALLERGIC REACTION, DO NOT TAKE ANY MORE OF THE MEDICINE AND CONTACT YOUR DOCTOR IMMEDIATELY OR GO Přečtěte si celý dokument
NEW ZEALAND DATA SHEET APO-PINDOLOL 1. APO-PINDOLOL (5MG, 10MG AND 15MG TABLETS) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Pindolol 5mg, 10mg or 15mg EXCIPIENT(S) OF KNOWN EFFECT Apo-Pindolol does not contain gluten. Apo-Pindolol contains lactose. If you have been told by your doctor that you have intolerance to some sugars contact your doctor before taking this medicinal product. Contains 135 mg of lactose monohydrate per 50 mg and 85 mg of lactose monohydrate per 100 mg. This should be taken into account in patients with diabetes mellitus. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Apo-Pindolol 5mg tablets are white, round, 6.4 mm in diameter, flat faced with bevelled edges, identified APO over P5 on one side. Each tablet contains 5mg pindolol and typically weighs 80mg. Apo-Pindolol 10mg tablets are white, round, 7.9 mm in diameter, biconvex, identified APO over P10 on one side. Each tablet contains 10mg pindolol and typically weighs 160mg. Apo-Pindolol 15mg tablets are white, round, 8.7 mm in diameter, flat faced with bevelled edges, identified APO over P15 on one side. Each tablet contains 15mg pindolol and typically weighs 240mg. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Arterial hypertension • Prophylaxis of angina pectoris • Cardiac arrhythmias (sinus and atrial tachycardia, paroxysmal tachycardia, tachycardia in patients with atrial flutter or fibrillation, supraventricular extrasystoles) • Hyperkinetic heart syndrome 4.2 DOSE AND METHOD OF ADMINISTRATION DOSE Dosage should be adapted to the requirements of the individual person. HYPERTENSION: The usual dosage is 15mg/day. Up to 15mg may be given as a single daily dose usually in the morning. Doses above 15mg should be divided into two daily doses. In mild and moderate hypertension pindolol alone may be sufficient. In more severe or in resistant cases addition of other antihypertensive drugs may be required. Please refer to Medsafe website (www.medsafe.govt.nz) for the most recent datasheet Page 1 APO-PIND Přečtěte si celý dokument