Pays: Royaume-Uni
Langue: anglais
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Timolol maleate
Alliance Healthcare (Distribution) Ltd
C07AA06
Timolol maleate
10mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02040000
123/L/a/6 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT TIMOLOL/AMILORIDE/HYDROCHLOROTHIAZIDE 10 MG/2.5 MG/25 MG TABLETS Timolol maleate/Amiloride hydrochloride/Hydrochlorothiazide 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 or pharmacist. 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 any of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. WHAT TIMOLOL/AMILORIDE/HYDROCHLOROTHIAZIDE TABLETS IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TIMOLOL/AMILORIDE/HYDROCHLOROTHIAZIDE TABLETS 3. HOW TO TAKE TIMOLOL/AMILORIDE/HYDROCHLOROTHIAZIDE TABLETS 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE TIMOLOL/AMILORIDE/HYDROCHLOROTHIAZIDE TABLETS 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT TIMOLOL/AMILORIDE/HYDROCHLOROTHIAZIDE TABLETS IS AND WHAT IT IS USED FOR These tablets contain three active ingredients: timolol, amiloride and hydrochlorothiazide. Timolol is a beta-blocker to help lower your blood pressure. Amiloride is a potassium-sparing diuretic that acts by increasing the amount of urine you produce. Hydrochlorothiazide is a thiazide diuretic that acts by increasing the amount of urine you produce. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TIMOLOL/AMILORIDE/HYDROCHLOROTHIAZIDE TABLETS DO NOT TAKE THESE TABLETS IF YOU: are allergic to timolol, amiloride, hydrochlorothiazide, or any of the other ingredients (see section 6) are allergic to sulphonamides with include co-trimoxazole (an antibiotic) and acetazolamide (for glaucoma, heart problems, epilepsy) are pregnant or planning to become pregnant are breast-feeding have high levels of potassium in your blood Lire le document complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Timolol/Amiloride/Hydrochlorothiazide 10 mg/2.5 mg/25 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 25 mg hydrochlorothiazide, 2.5 mg amiloride hydrochloride and 10 mg timolol maleate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Light-blue coloured, square, compressed tablets with rounded corners; one side flat with bevelled edges and scored, the other side convex and imprinted ‘17’. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of mild to moderate hypertension. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION 1 to 2 tablets once a day, taken orally. _Use in the elderly_: Timolol/amiloride/hydrochlorothiazide has been shown to be as well tolerated in the elderly as in younger patients. The recommended starting dose is 1 tablet daily. _Children_: Because the safety and efficacy has not been established in children, it is not recommended for paediatric use. 4.3 CONTRAINDICATIONS • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. • Patients with bronchial asthma or with a history of bronchial asthma, severe chronic obstructive pulmonary disease, sinus bradycardia, second- or third- degree AV block, overt cardiac failure, right ventricular failure secondary to pulmonary hypertension, significant cardiomegaly and cardiogenic shock. • Hyperkalaemia (plasma potassium over 5.5 mmol/l). • Anuria, acute and chronic renal insufficiency, severe progressive renal disease, and diabetic nephropathy. • Patients with blood urea over 10 mmol/l or serum creatinine over 130 µmol/l or diabetes mellitus should not receive Timolol/Amiloride/Hydrochlorothiazide without careful and frequent serum urea and serum electrolyte monitoring. • Anaesthetic agents causing myocardial depression, hypersensitivity to any component of the medicinal product or other sulphonamide-derived drugs. • Use with other potassium-conserving agents. Use with potassium-ric Lire le document complet