Simvastatin 10mg tablets

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)

מרכיב פעיל:

Simvastatin

זמין מ:

Viatris UK Healthcare Ltd

קוד ATC:

C10AA01

INN (שם בינלאומי):

Simvastatin

כמות:

10mg

טופס פרצבטיות:

Oral tablet

מסלול נתינה (של תרופות):

Oral

סיווג:

No Controlled Drug Status

סוג מרשם:

Valid as a prescribable product

leaflet_short:

BNF: 02120000; GTIN: 5016695450520

עלון מידע

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SIMVASTATIN 10 MG, 20 MG, 40 MG, 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 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 is used to lower levels of cholesterol and fatty
substances called triglycerides in
your blood.
While taking this medicine you should stick to a cholesterol-lowering
diet. This medicine
belongs to the class of drugs called statins.
Simvastatin is used along with dieting if you have:
•
a raised cholesterol level in your blood (primary
hypercholesterolaemia) or high fat levels
in your blood (mixed hyperlipidaemia) when exercise and weight loss
have not worked.
•
a hereditary illness called homozygous familial hypercholesterolaemia
which causes the
cholesterol levels in your blood to rise. You may get other medicines
as well for this
condition.
•
coronary heart disease or are at high risk of suffering from coronary
heart disease. You
are more likely to suffer from coronary heart disease if you have
diabetes, have
previously had a stroke, or have other blood vessel disease.
Most people will not have any symptoms related to raised cholesterol.
Your doctor or
pharmacist can measure your cholesterol level by means of a simple
blood test. Having too
much choleste

מאפייני מוצר

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Simvastatin 10 mg Film-coated Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg of the active ingredient
simvastatin.
Excipient with known effect:
Lactose monohydrate (tablet core and tablet coat)
72.03 mg per film-coated tablet
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
Simvastatin 10 mg film-coated tablets are presented as “dark peach
to pink” coloured,
oval shaped, film-coated tablets with “G” on one side and “SM”
scoreline “10” on the
other side. The score line is only to facilitate breaking for ease of
swallowing and not
to divide 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