Simvastatin 80mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Simvastatin

Available from:

Accord-UK Ltd

ATC code:

C10AA01

INN (International Name):

Simvastatin

Dosage:

80mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02120000; GTIN: 5060149311745

Patient Information leaflet

BBBA7601
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SIMVASTATIN 80MG FILM-COATED TABLETS PIL - UK
Black
BBBA7601
C Fox
18/02/2020
19/02/2020
CF
190 x 600
11pt
Teva Bulgaria Dupnitsa
18/02/2020
19/02/2020
2
Version 7
12.02.2020
German GTIN 14
(incorporating PZN):
Cartons and label leaflets only
(labels only when specified)
SIMVASTATIN 80MG TABLETS
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
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 IS AND WHAT IT IS USED
FOR
2
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
SIMVASTATIN
3
HOW TO TAKE SIMVASTATIN
4
POSSIBLE SIDE EFFECTS
5
HOW TO STORE SIMVASTATIN
6
CONTENTS OF THE PACK AND OTHER
INFORMATION
1
WHAT SIMVASTATIN IS AND WHAT IT IS USED
FOR
Simvastatin contains the active substance
simvastatin. 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). Simvastatin is a
member of the class of medicines called statins.
Chol

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Simvastatin 80 mg, 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 (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
Posology
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).
_Hypercholesterolaemia _
The patient should be placed on a standard cholesterol-lowering diet,
and should
continue on