Land: Storbritannia
Språk: engelsk
Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Simvastatin
Organon Pharma (UK) Ltd
C10AA01
Simvastatin
10mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02120000; GTIN: 5013945184839
PACKAGE LEAFLET: INFORMATION FOR THE USER ZOCOR ® 20MG (simvastatin) THE NAME OF YOUR PRODUCT IS ZOCOR 20MG BUT WILL BE REFERRED TO AS ZOCOR THROUGHOUT THIS LEAFLET. THIS PRODUCT IS AVAILABLE IN MULTIPLE STRENGTHS AND ALL STRENGTHS WILL BE REFERRED TO THROUGHOUT THIS LEAFLET. 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 ZOCOR is and what it is used for 2. What you need to know before you take ZOCOR 3. How to take ZOCOR 4. Possible side effects 5. How to store ZOCOR 6. Contents of the pack and other information 1. WHAT ZOCOR IS AND WHAT IT IS USED FOR ZOCOR contains the active substance simvastatin. ZOCOR is a medicine used to lower levels of total cholesterol, “bad” cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. In addition, ZOCOR raises levels of “good” cholesterol (HDL cholesterol). ZOCOR is a member of the class of medicines 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 Les hele dokumentet
OBJECT 1 ZOCOR 10MG FILM-COATED TABLETS Summary of Product Characteristics Updated 15-May-2018 | Merck Sharp & Dohme Limited • 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 Zocor ® 10 mg, film-coated tablets. Zocor ® 20 mg, film-coated tablets. Zocor ® 40 mg, film-coated tablets. Zocor ® 80 mg, film-coated tablets. 2. Qualitative and quantitative composition Each tablet contains 10 mg of simvastatin. Each tablet contains 20 mg of simvastatin. Each tablet contains 40 mg of simvastatin. Each tablet contains 80 mg of simvastatin. Excipient(s) with known effect For the full list of excipients, see section 6.1. Each 10 mg tablet contains 70.7 mg of lactose monohydrate. Each 20 mg tablet contains 141.5 mg of lactose monohydrate. Each 40 mg tablet contains 283.0 mg of lactose monohydrate. Each 80 mg tablet contains 565.8 mg of lactose monohydrate. 3. Pharmaceutical form Film-coated tablet. The peach-coloured, oval-shaped tablets marked 'MSD 735' contain 10 mg simvastatin. T Les hele dokumentet