Country: United Kingdom
Bahasa: Inggeris
Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)
Simvastatin
Arrow Generics Ltd
C10AA01
Simvastatin
80mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02120000; GTIN: 5060034832164
SIMVASTATIN 80MG TABLETS 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 SIMVASTATIN 80MG IS AND WHAT IT IS USED FOR 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE SIMVASTATIN 80MG 3 HOW TO TAKE SIMVASTATIN 80MG 4 POSSIBLE SIDE EFFECTS 5 HOW TO STORE SIMVASTATIN 80MG 6 CONTENTS OF THE PACK AND OTHER INFORMATION 1 WHAT SIMVASTATIN 80MG IS AND WHAT IT IS USED FOR Simvastatin is a medicine used to lower levels of total cholesterol, “bad” cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. In addition, Simvastatin raises levels of “good” cholesterol (HDL cholesterol). You should stay on a cholesterol-lowering diet while taking this medicine. Simvastatin is a member of the class of drugs called statins. Cholesterol is one of several fatty substances found in the bloodstream. Your total cholesterol is made up mainly of LDL and HDL cholesterol. LDL cholesterol is often called “bad” cholesterol because it can build up in the walls of your arteries forming plaque. Eventually this plaque build- up can lead to a narrowing of the arteries. This narrowing can slow or block blood flow to vital organs such as the heart and brain. This blocking of blood flow can result in a heart attack or stroke. HDL cholesterol is often called “good” cholesterol because it helps keep the bad cholesterol from building up in the arteries and protects against heart disease. Triglycerides are another form of fat in your blood that may increase your risk for heart disease. Simvastati Baca dokumen lengkap
OBJECT 1 SIMVASTATIN 80MG TABLETS Summary of Product Characteristics Updated 09-Mar-2020 | Accord-UK Ltd • 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 Simvastatin 80mg film-coated tablets 2. Qualitative and quantitative composition One film-coated Simvastatin 80mg tablets contains 80 mg of simvastatin. Excipient(s) with known effect Each tablet contains 525.84mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Film-coated tablet. Simvastatin 80mg is a dark pink-coloured, oblong shaped, film-coated tablet, scored on one side, containing 80mg simvastatin. The tablet can be divided into equal doses. 4. Clinical particulars 4.1 Therapeutic indications Hypercholesterolaemia Treatment of primary hypercholesterolaemia or mixed dyslipidaemia, as an adjunct to diet, when response to diet and other non-pharmacological treatments (e.g. exercise, weight reduction) is inadequate Treatment of homozygous familial hypercholesterolaemia ( Baca dokumen lengkap