Maa: Irlanti
Kieli: englanti
Lähde: HPRA (Health Products Regulatory Authority)
TRIAMTERENE, HYDROCHLOROTHIAZIDE
Mercury Pharmaceuticals Ltd
C03EA01
TRIAMTERENE, HYDROCHLOROTHIAZIDE
50mg/25mg Milligram
Tablets
Product subject to prescription which may be renewed (B)
Low-ceiling diuretics and potassium-sparing agents
Authorised
1998-04-01
PACKAGE LEAFLET: INFORMATION FOR THE USER DYAZIDE® 50MG/25MG TABLETS TRIAMTERENE 50MG AND HYDROCHLOROTHIAZIDE 25MG READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE. 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Dyazide Tablets are and what they are used for 2. Before you take Dyazide Tablets 3. How to take Dyazide Tablets 4. Possible side effects 5. How to store Dyazide Tablets 6. Further information 1. WHAT DYAZIDE TABLETS ARE AND WHAT THEY ARE USED FOR 1. WHAT DYAZIDE TABLETS ARE AND WHAT THEY ARE USED FOR Dyazide Tablets belong to a group of medicines called thiazides, which act as diuretics. They make the kidneys remove water from the body and they have the effect of lowering the blood pressure. Dyazide Tablets are used to treat mild to moderate high blood pressure and they may be used in combination with other medicines. They can also be used to treat oedema, which is a build-up of fluid in the body. This may occur in many situations, for instance during treatment with steroids, or with liver and kidney problems, or with heart failure (when the heart doesn’t pump efficiently). 2. BEFORE YOU TAKE DYAZIDE TABLETS BEFORE YOU TAKE DYAZIDE TABLETS YOU SHOULD NOT BE GIVEN DYAZIDE TABLETS IF YOU: • know that you are allergic to triamterene and hydrochlorothiazide or any of the other ingredients of Dyazide Tablets (see section 6 of this leaflet) • have a serious liver or kidney disorder (your doctor will advise you) • have high levels of potassium in your blood or high levels of calcium in the blood. Your doctor will advise you • have disease of the adrenal glands causing weakness, weight loss and a deficiency of hormo Lue koko asiakirja
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dyazide 50mg/25mg Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 50 mg of Triamterene and 25 mg of Hydrochlorothiazide. Excipient: Contains 0.12mg of Sunset Yellow (E110) per tablet. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet Peach coloured, compressed, flat circular, bevel-edged tablet with a single scoreline on one surface and the code ‘E93’ on the other. The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS It is recommended for the treatment of mild to moderate hypertension, alone or in combination with other antihypertensive drugs. It is also recommended in the control of oedema due to cardiac failure, cirrhosis of the liver or the nephrotic syndrome. It can also be used to control the oedema associated with corticosteroid treatment, but only when the concomitant use of diuretics is considered essential. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Route of administration: oral. Adults: In hypertension The recommended dosage is one tablet a day after the morning meal. If “Dyazide” is added to already established therapy with another antihypertensive drug, the dosage of the latter should be reduced, and later adjusted if necessary. If another antihypertensive drug is added to “Dyazide” therapy, the dosage of the latter will not normally be reduced. Adults: In oedema One “Dyazide” tablet a day after the morning meal. Elderly Dosage as for adults. “Dyazide” has been widely used and is usually well tolerated in patients over the age of 60 years. The normally occurring reduction in glomerular filtration with age should be borne i Lue koko asiakirja