Zocor 80mg tablets

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Simvastatin

Tilgjengelig fra:

Organon Pharma (UK) Ltd

ATC-kode:

C10AA01

INN (International Name):

Simvastatin

Dosering :

80mg

Legemiddelform:

Oral tablet

Administreringsrute:

Oral

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 02120000; GTIN: 5013945182767

Informasjon til brukeren

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ZOCOR
® 80 MG FILM-COATED TABLETS
Simvastatin
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
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.
You should stay on a cholesterol-lowe

Preparatomtale

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
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. The tan-coloured,
oval-shaped tablets marked 'MSD 740' contain 20 mg simvastatin. The
brick-red coloured, oval-shaped
tablets marked 'MSD 749' contain 40 mg simvastatin. The brick-red
coloured, capsule-shaped tablets
marked '543' on one side and '80' on the other contain 80 mg
simvastatin.
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 Po