Quốc gia: Vương quốc Anh
Ngôn ngữ: Tiếng Anh
Nguồn: MHRA (Medicines & Healthcare Products Regulatory Agency)
Bendroflumethiazide
Sandoz Ltd
C03AA01
Bendroflumethiazide
2.5mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02020100
PATIENT INFORMATION LEAFLET BENDROFLUMETHIAZIDE 2.5MG & 5MG TABLETS Please read this leaflet carefully before you start taking your tablets. If you have any questions or are not sure about anything, ask your doctor or pharmacist. WHAT YOU SHOULD KNOW ABOUT THIS MEDICINE Bendroflumethiazide Tablets are available in 2 strengths and contain Bendroflumethiazide 2.5mg or 5mg as the active ingredient. They also contain the following other ingredients: lactose, maize starch and magnesium stearate. This medicine is available in pack sizes of 28, 56, 84 or 112 tablets. The product licence holder of this medicine is: Sandoz Ltd, Woolmer Way, Bordon, Hampshire GU35 9QE. The manufacturer of this medicine is: Crescent Pharma Ltd, Units 3 & 4 Quidhampton Buisness Units, Polhampton Lane, Overton, Hampshire, RG25 3ED This medicine belongs to a group of drugs known as thiazide diuretics. These are used for increasing water loss through the kidneys; this makes you pass more water. This medicine is used for reducing swelling of any part of the body caused by heart, liver or kidney conditions and is frequently used to treat high blood pressure, either alone or in combination with other drugs which lower blood pressure. WHAT YOU SHOULD CHECK BEFORE TAKING THIS MEDICINE Do not take this medicine if you are allergic to Bendroflumethiazide or any of the ingredients listed above. Do not take this medicine if you have Addison’s disease (underactive adrenal gland), hyponatraemia (low levels of sodium in the blood), refractory hypokalaemia (long-term problems with low levels of potassium in the blood), hypercalcaemia (high levels of calcium in the blood), symptomatic hyperuricaemia (high levels of uric acid in the blood), acute porphyria (blood metabolism disorder) or if you have long-term kidney or liver problems. This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. Tell your doctor or pharmacist if you are taking Đọc toàn bộ tài liệu
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Bendroflumethiazide 2.5mg Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Bendroflumethiazide 2.5 mg per tablet. For excipients, see 6.1. 3. PHARMACEUTICAL FORM Tablet. Bendroflumethiazide 2.5 mg tablets are presented as white flat bevelled edge tablets engraved with the company logo on one side and A268 on the other side. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Oedema: Bendroflumethiazide is indicated in the treatment of oedema associated with conditions such as congestive heart failure, nephrotic syndrome, cirrhosis of the liver. Essential hypertension: Bendroflumethiazide may be used as the sole antihypertensive agent or used concurrently with other specific hypotensive agents whose action it potentiates. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Route of administration: Oral ADULTS: Oedema: 5.0 - 10.0 mg once daily or on alternate days Maintenance: 2.5 - 5.0 mg two or three times a week Essential hypertension: 2.5 mg in the morning, alone or in conjunction with other antihypertensive agents in more severe hypertension. The dosage should be reduced in the elderly with impaired renal function. CHILDREN: Diuretic - Initial: 0.4 mg per kg of body-weight per day. Maintenance: 0.05 to 0.1 mg per kg of body-weight per day. Antihypertensive: 0.05 to 0.4 mg/kg body-weight per day as a single dose or in two divided daily doses, adjusted according to response. 4.3 CONTRAINDICATIONS Bendroflumethiazide is contra-indicated in patients hypersensitive to this drug or any of the excipients and in patients with severe renal insufficiency, Addison’s disease, refractory hypokalaemia, hyponatraemia, hypercalcaemia, serious hepatic disorders and symptomatic hyperuricaemia. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE HYPOKALAEMIA Electrolytes should be monitored during treatment as continued or intensive use of bendroflumethiazide may result in hypokalaemia. This effect may be enhanced with concomitant use of medicines that can also cause hypok Đọc toàn bộ tài liệu