Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Simvastatin
Genesis Pharmaceuticals Ltd
C10AA01
Simvastatin
40mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02120000; GTIN: 5060014442048
Product: MA Holder: CHELONIA PL No.: 33414/0101-0104 Pack Size: - Livery: GENESIS Manufacturer: - Market: UK Component: LEAFLET Dimensions: 148 X 297 MM Created By: DTAWDE Artwork Code: CL0101-0102-0103-0104/O/PIL/G6 Bar Code: - Font Type: ARIAL NARROW Font Size: 7.25 PT Printing Colours: Non-Printing Colours: Black Profile Final Preparation Date For Submission: 06/12/2019 Packing Site Technical Approval: 00/00/0000 Authority Approval Date: 09/01/2020 Latest Implementation Deadline: 09/07/2020 Print Proof Approval: 00/00/0000 SIMVASTATIN 5, 10, 20 & 40 MG TABLETS Simvastatin has not been studied in children under the age of 10 years. For more information, talk to your doctor. DRIVING AND USING MACHINES Simvastatin is not expected to interfere with your ability to drive or to use machinery. Simvastatin may cause dizziness in rare cases. If you feel dizzy, then do not drive or operate any machines. SIMVASTATIN TABLETS CONTAIN LACTOSE This medicine contains LACTOSE. If you have been told by your doctor that you have an intolerance to lactose or other sugars, contact your doctor before taking this medicine. Your doctor will determine the appropriate tablet strength for you, depending on your condition, your current treatment and your personal risk status. Always take Simvastatin exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Swallow the tablets with water. Simvastatin tablets may be taken with or without food. Remember to keep to a low-fat diet and exercise while taking Simvastatin. DOSAGE: The recommended dose is Simvastatin 10 mg, 20 mg, 40 mg or 80 mg by mouth once a day. ADULTS: The usual starting dose is 10, 20 or, in some cases, 40 mg a day. Your doctor may adjust your dose after at least 4 weeks to a maximum of 80 mg a day. Do not take more than 80 mg a day. Your doctor may prescribe lower doses, particularly if you are taking certain medicinal products listed above or certain kidney conditions. The 80 mg dose is only recommended for adult patients wit Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Simvastatin 40 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 40 mg of the active ingredient simvastatin. Excipient with known effect Lactose monohydrate (tablet core) 281.72_ _mg per film-coated tablet Polydextrose (tablet coat only) 3.84 mg per film-coated tablet (containing NMT 4% glucose and NMT 2% sorbitol (E420)) For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Simvastatin 40 mg film-coated tablets are presented as pink coloured, oval shaped, film-coated tablets with “G” on one side and “SM40” on the other side. 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 hypercholaesterolemia (HoFH) as an adjunct to diet and other lipid lowering treatments (e.g. LDL apheresis) or if such treatments are not appropriate. Cardiovascular prevention Reduction of cardiovascular mortality and morbidity in patients with manifest atherosclerotic cardiovascular disease or diabetes mellitus, with either normal or increased cholesterol levels, as an adjunct to correction of other risk factors and other cardioprotective therapy (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The dosage range is 5-80 mg/day of simvastatin given orally as a single dose in the evening. Adjustments of dosage, if required, should be made at intervals of not less than 4 weeks, to a maximum of 80 mg/day given as a single dose in the evening. The 80-mg dose is only recommended in patients with severe hypercholesterolaemia and at high risk for cardiovascular complications, who have not achieved their treatment goals on lower doses and when the benefits are expected to outweigh the potential risks (see sections 4.4 and 5.1) Read the complete document