Maa: Yhdistynyt kuningaskunta
Kieli: englanti
Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Indapamide hemihydrate
Sigma Pharmaceuticals Plc
C03BA11
Indapamide hemihydrate
2.5mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02020100
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 questions, 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. See section 4 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 The name of your medicine is Indapamide 2.5mg Tablets. They contain the active ingredient called Indapamide. Indapamide Tablets belong to a group of medicines called anti-hypertensives. This medicine is used to treat high blood pressure and works by causing the kidneys to get rid of unneeded water and salt from the body into the urine. Indapamide is different from other medicines, 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 TABLETS: • If you are allergic (hypersensitive) to Indapamide or any other sulfonamide or to any of the other ingredients of Indapamide Tablets. See section 6 • If you have or ever had severe kidney failure and/or liver problems • 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 the blood WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Indapamide tablets • If you have or ever had liver and/or kidney problems • If you have or ever had hea Lue koko asiakirja
OBJECT 1 INDAPAMIDE 2.5MG TABLETS Summary of Product Characteristics Updated 13-Sep-2018 | Sigma Pharmaceuticals PLC (Special Concept Development / RxFarma) • 1. Name of the medicinal product • 2. Qualitative and quantitative composition • 3. Pharmaceutical form • 4. Clinical particulars • 4.1 Therapeutic indications • 4.2 Posology and method of administration • 4.3 Contraindications • 4.4 Special warnings and precautions for use • 4.5 Interaction with other medicinal products and other forms of interaction • 4.6 Fertility, pregnancy and lactation • 4.7 Effects on ability to drive and use machines • 4.8 Undesirable effects • 4.9 Overdose • 5. Pharmacological properties • 5.1 Pharmacodynamic properties • 5.2 Pharmacokinetic properties • 5.3 Preclinical safety data • 6. Pharmaceutical particulars • 6.1 List of excipients • 6.2 Incompatibilities • 6.3 Shelf life • 6.4 Special precautions for storage • 6.5 Nature and contents of container • 6.6 Special precautions for disposal and other handling • 7. Marketing authorisation holder • 8. Marketing authorisation number(s) • 9. Date of first authorisation/renewal of the authorisation • 10. Date of revision of the text 1. Name of the medicinal product Indapamide 2.5mg Tablets 2. Qualitative and quantitative composition Each tablet contains Indapamide as indapamide hemihydrate 2.5mg. For a full list of excipients, see section 6.1. 3. Pharmaceutical form Coated Tablets White, biconvex, sugar coated tablet. 4. Clinical particulars 4.1 Therapeutic indications Indapamide is indicated in the treatment of essential hypertension. Indapamide may be used as sole therapy or combined with other antihypertensive agents. 4.2 Posology and method of administration POSOLOGY 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 of blood pressure may continue and not reach a maximum until several months after the start of therapy. A lar Lue koko asiakirja