Pays: Royaume-Uni
Langue: anglais
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Indapamide hemihydrate
Waymade Healthcare Plc
C03BA11
Indapamide hemihydrate
2.5mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02020100
WHAT IS IN THIS LEAFLET: 1. What Indapamide Tablets are and what they are used for 2. What you need to know before you take Indapamide Tablets 3. How to take Indapamide Tablets 4. Possible side effects 5. How to store Indapamide Tablets 6. Contents of the pack and other information 1. WHAT INDAPAMIDE TABLETS ARE AND WHAT THEY ARE USED FOR This medicine is intended to reduce high blood pressure (hypertension). The tablets contain indapamide as the active ingredient. Indapamide is a diuretic. Most diuretics increase the amount of urine produced by the kidneys. However, Indapamide is different from other diuretics, as it only causes a slight increase in the amount of urine produced. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE INDAPAMIDE TABLETS DO NOT TAKE INDAPAMIDE 2.5MG TABLETS: ■ if you are allergic to indapamide or any other sulphonamide drugs or any of the other ingredients of this medicine (listed in section 6), ■ if you have severe kidney disease, ■ if you have severe liver disease or suffer from a condition called hepatic encephalopathy (liver problems which affect the brain and central nervous system), ■ if you have low potassium levels in your blood. WARNING AND PRECAUTIONS Talk to your doctor or pharmacist before taking Indapamide Tablets. Take special care if you have: ■ liver problems, ■ if you have any heart rhythm problems or problems with your kidneys, ■ gout (painful inflammation of the joints), ■ diabetes, ■ if you need to have a test to check how well your parathyroid gland is working. You should tell your doctor if you have had photosensitivity reactions. Your doctor may give you blood tests to check for low sodium or potassium levels or high calcium levels. If you think any of these situations may apply to you or you have any questions or doubts about taking your medicine, you should consult your doctor or pharmacist. Athletes should be aware that this medicine contains an active ingredient, which may give a positive reaction in doping tests. OTHER MEDICINES AND INDAPAMIDE TABLET Lire le document complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Indapamide Tablets 2.5mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Indapamide Ph Eur as indapamide hemihydrate 2.5 mg. 3 PHARMACEUTICAL FORM Coated tablets. _Appearance_: white, circular, biconvex, sugar-coated tablet printed with the company logo or printed with ‘I’ 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of essential hypertension. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ADULTS: _ The dosage of one tablet, containing 2.5mg indapamide, to be taken daily in the morning. The action of indapamide is progressive and the reduction in blood pressure may continue and not reach a maximum until several months after the start of therapy. A larger dose than 2.5mg of indapamide daily is not recommended as there is no appreciable additional anti-hypertensive effect but a diuretic effect may become apparent. If a single daily tablet of indapamide does not achieve a sufficient reduction in blood pressure, another anti- hypertensive agent may be added such as beta-blockers, ACE inhibitors, methyldopa, clonidine and other adrenergic blocking agents. _CHILDREN: _ There is no experience of the use of this drug in children. _ADMINISTRATION: _ Route of administration: Oral. 4.3 CONTRAINDICATIONS Severe renal failure. Hepatic encephalopathy or severe impairment of liver function. Hypokalaemia. Hypersensitivity to sulphonamides. Hypersensitivity to the active ingredient or any of the excipients. Recent cerebrovascular accident 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE _WARNINGS: _ When liver function is impaired, thiazide-related diuretics may cause hepatic encephalopathy. Administration of the diuretic must be stopped immediately if this occurs or there are signs of increasing renal insufficiency. A slight weight loss has been reported in some patients taking indapamide. _PRECAUTIONS: _ -WATER AND ELECTROLYTE BALANCE: _PLASMA SODIUM: _ This must be measured before starting treatment, then at regular intervals Lire le document complet