Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
Bendroflumethiazide
Brillpharma (Ireland) Limited
C03AA01
Bendroflumethiazide
5 milligram(s)
Tablet
bendroflumethiazide
Marketed
2018-11-23
PATIENT LEAFLET: INFORMATION FOR THE USER BENDROFLUMETHIAZIDE 2.5 MG TABLETS BENDROFLUMETHIAZIDE 5 MG TABLETS BENDROFLUMETHIAZIDE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further queries, 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 you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET: 1. What Bendroflumethiazide Tablets are and what they are used for 2. What you need to know before you take Bendroflumethiazide tablets 3. How to take Bendroflumethiazide Tablets 4. Possible Side Effects 5. How to store Bendroflumethiazide Tablets 6. Contents of the pack and other information. 1. WHAT BENDROFLUMETHIAZIDE TABLETS ARE AND WHAT THEY ARE USED FOR The name of your medicine is Bendroflumethiazide 2.5 mg tablets or Bendroflumethiazide 5 mg tablets. The active ingredient is bendroflumethiazide. Bendroflumethiazide tablets belong to a group of medicines called thiazide diuretics (water tablets). Diuretic medicines are those that promote the excretion of urine. Bendroflumethiazide Tablets are used to treat hypertension (high blood pressure) and oedema (fluid retention). They are also used to stop the production of breast milk. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BENDROFLUMETHIAZIDE TABLETS DO NOT TAKE Bendroflumethiazide tablets and TELL your doctor if : • you ever had an allergic reaction to bendroflumethiazide or any other ingredients of this medicine (allergic reactions include mild symptoms such as itching and/or rash. More severe symptoms include swelling of the face, lips, tongue and/or throat with difficulty in swallowing or breathing); • you suffer from an imbalance of water and salts in the body; • you suffer Прочитать полный документ
Health Products Regulatory Authority 25 August 2023 CRN00DG50 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Bendroflumethiazide 5 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Bendroflumethiazide 5 mg. Excipient with known effect: Also contains 120 mg of lactose. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Tablet White to almost white, circular, flat, beveled edged, uncoated tablets with '5' debossed on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of oedema and hypertension. Bendroflumethiazide may also be used to suppress lactation. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults: Oedema: Initially, 5-10 mg in the morning, daily or on alternate days; maintenance dose 5-10 mg one to three times weekly. Hypertension: The usual dose is 2.5 mg taken in the morning. Higher doses are rarely necessary. Suppression of lactation: 5 mg in the morning and 5 mg at midday for about five days. Children: Dosage in children may be up to 400 mcg/kg bodyweight initially, reducing to 50-100 mcg/kg bodyweight daily for maintenance. Elderly: The dosage of thiazide diuretics may need to be reduced in the elderly, particularly when renal function is impaired, because of the possibility of electrolyte imbalance. Method of administration For oral administration 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance, other thiazides, or to any of the excipients listed in section 6.1 Refractory hypokalaemia, hyponatraemia, or hypercalcaemia Severe renal and hepatic insufficiency Health Products Regulatory Authority 25 August 2023 CRN00DG50 Page 2 of 6 Symptomatic hyperuricaemia Addison's disease 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Bendroflumethiazide may raise serum uric acid levels with consequent exacerbation of gout insusceptible patients. Bendroflumethiazide should be used with caution in patients with mild to moderate hepatic or renal impairment (avoid if severe). Re Прочитать полный документ