Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Triamterene
Alliance Healthcare (Distribution) Ltd
C03DB02
Triamterene
50mg
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02020300
PATIENT INFORMATION LEAFLET DYTAC ® 50MG CAPSULES TRIAMTERENE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Dytac 50mg Capsules are and what they are used for 2. Before you take Dytac 50mg Capsules 3. How to take Dytac 50mg Capsules 4. Possible side effects 5. How to store Dytac 50mg Capsules 6. Further information 1. WHAT DYTAC 50MG CAPSULES ARE AND WHAT THEY ARE USED FOR Dytac 50mg Capsules belong to a group of medicines called diuretics. They help the kidneys remove water from the body. Dytac 50mg Capsules act by stopping potassium being lost from the body. The capsules are 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, with liver and kidney problems or with heart failure (when the heart doesn’t pump efficiently). Dytac 50mg Capsules can be used with another type of diuretic which normally allows potassium to be lost from the body. This combination increases the amount of water being removed and prevents potassium loss at the same time. 2. BEFORE YOU TAKE DYTAC 50MG CAPSULES DO NOT TAKE DYTAC 50MG CAPSULES IF YOU: • know that you are allergic to triamterene or any of the other ingredients of Dytac 50mg Capsules (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 have (hyperkalaemia). Your doctor will advise you. • have a disease of the adrenal glands causing weakness, weight loss and a deficiency of hormones in the blood (Addison’s disease) • you are allergic to S Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dytac 50mg Capsules Triamterene 50mg Capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 50mg triamterene EP. 3. PHARMACEUTICAL FORM Opaque, maroon-coloured capsules containing as a yellow, granular powder. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Triamterene is a potassium-conserving diuretic, thought to act by directly inhibiting the exchange of sodium for potassium and hydrogen in the distal renal tubule. Potassium-conserving diuretic for the control of oedema in cardiac failure, cirrhosis of the liver or the nephrotic syndrome, and in that associated with corticosteroid treatment. When Dytac is used as an adjuvant to potassium- depleting diuretics, such loss may be inhibited and diuresis enhanced. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION METHOD OF ADMINISTRATION Oral DOSAGE Adults only: When given alone, the usual dosage range is from 3 to a maximum of 5 Dytac capsules a day. The optimal daily dosage is 4 capsules, given in divided doses after breakfast and lunch. After the first week, treatment should preferably be given on alternate days to ensure satisfactory maintenance diuresis without an increase in blood urea levels. When given with another diuretic, lower dosages of both should be used initially. Elderly: A lower dosage may be sufficient. The normally occurring reduction in glomerular filtration with age should be borne in mind. 4.3 CONTRAINDICATIONS Hyperkalaemia, progressive renal failure, increasing hepatic dysfunction, addison’s disease, known hypersensitivity to the drug and anuria. Routine concomitant administration of potassium supplements, or other potassium-conserving drugs, including ACE inhibitors. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Use with caution in patients with diabetes mellitus, hepatic or renal insufficiency; in those predisposed to gout since Dytac has been shown in rare instances to elevate uric acid levels; with hypotensive agents since an additive effect may result; Read the complete document