Šalis: Naujoji Zelandija
kalba: anglų
Šaltinis: Medsafe (Medicines Safety Authority)
Timolol maleate 10mg; ; ;
Apotex NZ Ltd
Timolol maleate 10 mg
10 mg
Tablet
Active: Timolol maleate 10mg Excipient: Brilliant blue FCF Croscarmellose sodium Indigo carmine Lactose monohydrate Magnesium stearate Microcrystalline cellulose
Bottle, 1 x 100, 100 tablets
Prescription
Prescription
Santen Oy
Timolol is indicated for patients with: - Essential hypertension including the hyperkinetic heart syndrome - the management of atrial fibrillation or flutter. - angina pectoris due to ischaemic heart disease. - prophylaxis of common or classical migraine. - ischaemic heart disease to reduce the risk of cardiac death, including sudden death, and reinfarction in those who have survived the acute phase of myocardial infarction.
Package - Contents - Shelf Life: Bottle, - 100 tablets - 36 months from date of manufacture stored at or below 30°C
1989-03-15
New Zealand Consumer Medicine Information APO-TIMOL _TIMOLOL MALEATE _ 10mg Tablets USP WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start using Apo-Timol. This leaflet answers some common questions about Apo-Timol. 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-Timol 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-TIMOL IS USED FOR The name of your medicine is Apo-Timol tablet. It contains the active ingredient timolol maleate. Timolol is a hydrophilic non-cardioselective beta-adrenergic blocking agent. Apo-Timol is indicated for patients with • high blood pressure, including conditions that makes your heart work harder than normal • the management of irregular heartbeat • chest pain due to reduced supply of blood to the heart • treatment of common or classical migraine • reduced supply of blood to the heart to reduce the risk of cardiac death, including sudden death, and another heart attack in those who have survived the acute phase of a heart attack Your doctor may have prescribed Apo-Timol for another reason. Ask your doctor if you have any questions about why Apo-Timol has been prescribed for you. 2 If you have any concerns, you should discuss this with your doctor. This medicine is available only with a doctor's prescription. There is no evidence that this medicine is addictive. Apo-Timol should not be administered to children. BEFORE YOU USE APO-TIMOL _ _ _WHEN YOU MUST NOT USE IT _ Do not use Apo-Timol if: • YOU ARE ALLERGIC TO TIMOLOL OR ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET INCLUDING LACTOSE AND THE DYES FD&C BLUE NO. 1 AND FD&C BLUE NO. 2. Symptoms of an allergic reaction may include cough, shortness of breath, wheezing or Perskaitykite visą dokumentą
NEW ZEALAND DATA SHEET APO-TIMOL Please refer to Medsafe website (www.medsafe.govt.nz) for the most recent datasheet Page 1 of 11 1. PRODUCT NAME APO-TIMOL (10MG TABLETS) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10mg timolol maleate 10mg equivalent to 10mg timolol. EXCIPIENT(S) WITH KNOWN EFFECT_ _ APO-TIMOL contains lactose, FD&C Blue No. 1 and FD&C Blue No. 2. For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM APO-TIMOL tablets are round, light blue, flat-faced, bevelled-edged tablets. Scored and engraved T10 on one side, other side plain. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Timolol is indicated for patients with: • Essential hypertension including the hyperkinetic heart syndrome • the management of atrial fibrillation or flutter. • angina pectoris due to ischaemic heart disease. • prophylaxis of common or classical migraine. • ischaemic heart disease to reduce the risk of cardiac death, including sudden death, and re-infarction in those who have survived the acute phase of myocardial infarction. 4.2 DOSE AND METHOD OF ADMINISTRATION DOSE Hypertension: Therapy should be initiated with a daily single or divided oral dose of 10mg, increasing to a maximum daily dose of 60mg, subject to the patient’s response. Daily dosages above 20mg should be administered on a divided dose schedule. Timolol may also be used with thiazides, hydralazine, or methyldopa, although dosage adjustments are usually required. For concomitant use with catecholamine-depleting medicines such as reserpine or guanethidine (see section 4.4 Special Warnings and Precautions for Use. When Timolol is administered concomitantly with hydrochlorothiazide and amiloride hydrochloride, most patients will respond to a regimen of 10 or 20mg of timolol given orally once daily and one tablet of 50mg hydrochlorothiazide/5mg amiloride hydrochloride. APO-TIMOL Please refer to Medsafe website (www.medsafe.govt.nz) for the most recent datasheet Page 2 of 11 Angina: Therapy should begin with a Perskaitykite visą dokumentą