Simva-Denk 40 tablets film-coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

simvastatin

Available from:

Denk Pharma GmbH & Co. KG

ATC code:

C10AA01

INN (International Name):

simvastatin

Dosage:

40mg

Pharmaceutical form:

tablets film-coated

Units in package:

(30/3x10/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2016-12-05

Patient Information leaflet

_Simva-Denk 40_
Film-coated tablet – oral use
Lipid-lowering agent
Active substance: simvastatin
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 SIMVA-DENK 40 IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
SIMVA-DENK 40
3. HOW TO TAKE SIMVA-DENK 40
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE SIMVA-DENK 40
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT SIMVA-DENK 40 IS
AND WHAT IT IS USED FOR
Simva-Denk 40 is a medicine used to lower high
cholesterol levels.
Simva-Denk 40 lowers total cholesterol, the lev-
els of “bad” LDL cholesterol and other fats known
as triglycerides in the blood. Simva-Denk 40 also
increases the levels of “good” HDL cholesterol.
Simva-Denk 40 belongs to the class of medicines
known as “statins”, which block the body’s pro-
duction of cholesterol in the liver.
You should continue your low cholesterol diet
during treatment.
SIMVA-DENK 40 IS USED IN ADDITION TO A LOW CHOLESTEROL DIET IF YOU
• have increased cholesterol levels in the blood
(primary hypercholesterolaemia) or increased
fat levels in the blood (mixed hyperlipidaemia),
• suffer from a hereditary disease (homozygous
familial hypercholesterolaemia) that leads to
increased cholesterol levels in the blood. You
may be given further treatments.
• have a cardiovascular disease (CHD – coronary
heart disease) or a high risk of cardiovascular
disease (because you have diabetes, have
already had a stroke or have any other vas

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCTS
_ _
Simva-Denk 20
Simva-Denk 40
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance : simvastatin
_Simva-Denk 20 _
Each film-coated tablet contains 20 mg of simvastatin.
_Simva-Denk 40 _
Each film-coated tablet contains 40 mg of simvastatin.
Excipient with known effect: lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
_Simva-Denk 20 _
Yellow-brown, oblong film-coated tablets with a score line.
_Simva-Denk 40 _
Light pink, oval shaped film-coated tablets with a score line.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hypercholesterolaemia
Treatment of primary or mixed hyperlipidaemia, as an adjunct to diet,
when response to diet and
other non-pharmacological treatments alone (e.g. exercise and weight
reduction), is inadequate.
For the treatment of homozygous familial hypercholesterolaemia.
Simva-Denk_ _is used as an
adjunct to diet and other lipid-lowering measures (e.g. LDL apheresis)
or when such measures 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
2
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 of simvastatin given as a single dose in the
evening. The 80 mg dose is
only recommended in patients with severe hypercholesterolaemia and
high risk for cardiovascular
complications, who have failed to reach their treatment goal with a
lower dose and when the
benefit of treatment can be expected to outweigh the potential risks
(see sections 4.4 and 5.1).
_Hypercholeste