Simva-Denk 20 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:

20mg

Pharmaceutical form:

tablets film-coated

Units in package:

(30/3x10/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2022-04-12

Patient Information leaflet

_ Simva- _
_Denk 20_
Film-coated tablet – oral use
HMG-CoA reductase inhibitor
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 phar
-
macist.
– 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 20 IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
SIMVA- DENK 20
3.
HOW TO TAKE
SIMVA- DENK 20
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE
SIMVA- DENK 20
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
What Simva- Denk 20 is and what it is used for
Simva- Denk 20 is a medicine used to lower high cholesterol levels.
Simva- Denk 20 contains the active substance simvastatin. Simvas-
tatin lowers total cholesterol, the levels of “bad” LDL
cholesterol
and other fats known as triglycerides in the blood. Simvastatin
also increases the levels of “good” HDL cholesterol. Simvastatin
belongs to the class of medicines known as “statins”, which block
the body’s production of cholesterol in the liver.
You should continue your low cholesterol diet during treatment.
Simva- Denk 20 is used in addition to a low cholesterol
diet if you
• have increased blood cholesterol levels (_primary hypercho-_
_lesterolaemia_) or increased fat levels in the blood (_mixed _
_hyperlipidaemia_).
• have a hereditary disease (_homozygous familial hypercholestero-_
_laemia_) that leads to increased cholesterol levels in the blood.
You may be given other treatments.
• have a cardiovascular disease _(CHD - coronary heart disease)_ or
a
high risk of cardiovascular disease (b

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 simvastatin.
Excipients with known effect: Each film-coated tablet contains 144.42
mg of lactose monohydrate and less
than 1 mmol sodium (23 mg).
_Simva-Denk 40 _
Each film-coated tablet contains 40 mg simvastatin.
Excipients with known effect: Each film-coated tablet contains 288.84
mg of lactose monohydrate and less
than 1 mmol sodium (23 mg).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
_Simva-Denk 20 _
Yellow-brown, oblong film-coated tablet with a one-sided break-line,
lateral notches and with intact coating.
_ _
_Simva-Denk 40 _
Light pink, oval-shaped film-coated tablet with one-sided break-line,
lateral notches and with intact coating.
The film-coated tablets can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hypercholesterolaemia
For treatment of primary or mixed hyperlipidaemia as an adjunct to
diet when diet and other non-
pharmacological measures alone (e.g. physical exercise and weight
reduction) are inadequate.
For treatment of homozygous familial hypercholesterolaemia (HoFH).
Simvastatin is used as an adjunct to
diet and other lipid-lowering measures (e.g. LDL [low density
lipoprotein] apheresis) or if such measures are
not appropriate.
Cardiovascular prevention
For 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
2
adjunct to correction of other risk factors and cardioprotective
therapy (see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
The dosage range is 5 mg - 80 mg simvastatin per day, given orally as
a single dose in the evening. Dose
adjustments, if required, should be implemented at intervals of no
less than 4 weeks, up to