Pravastatine Na STADA 10 mg, filmomhulde tabletten

Land: Holland

Sprog: hollandsk

Kilde: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Aktiv bestanddel:

PRAVASTATINE NATRIUM 10 mg/stuk

Tilgængelig fra:

Stada Arzneimittel AG Stadastrasse 2-18 61118 BAD VILBEL (DUITSLAND)

ATC-kode:

C10AA03

INN (International Name):

PRAVASTATINE NATRIUM 10 mg/stuk

Lægemiddelform:

Filmomhulde tablet

Sammensætning:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; COPOVIDON (E 1208) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROLOSE (E 463) ; HYPROMELLOSE (E 464) ; IJZEROXIDE ROOD (E 172) ; LACTOSE 1-WATER ; MAGNESIUMCARBONAAT, ZWAAR (E 504 (II)) ; MAGNESIUMSTEARAAT (E 470b) ; POLYETHYLEENGLYCOL (E 1521) ; SILICIUMDIOXIDE (E 551), CELLULOSE, MICROKRISTALLIJN (E 460) ; COPOVIDON ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROLOSE (E 463) ; HYPROMELLOSE (E 464) ; IJZEROXIDE ROOD (E 172) ; LACTOSE 1-WATER ; MAGNESIUMCARBONAAT, ZWAAR (E 504 (II)) ; MAGNESIUMSTEARAAT (E 470b) ; POLYETHYLEENGLYCOL (E 1521) ; SILICIUMDIOXIDE (E 551), CELLULOSE, MICROKRISTALLIJN (E 460) ; COPOVIDON ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROLOSE (E 463) ; HYPROMELLOSE (E 464) ; IJZEROXIDE ROOD (E 172) ; LACTOSE 1-WATER ; MAGNESIUMCARBONAAT, ZWAAR (E 504 (II)) ; MAGNESIUMSTEARAAT (E 470b) ; POLYETHYLEENGLYCOL (E 1521) ; SILICIUMDIOXIDE (E 551),

Indgivelsesvej:

Oraal gebruik

Terapeutisk område:

Pravastatin

Produkt oversigt:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); COPOVIDON; CROSCARMELLOSE NATRIUM (E 468); HYPROLOSE (E 463); HYPROMELLOSE (E 464); IJZEROXIDE ROOD (E 172); LACTOSE 1-WATER; MAGNESIUMCARBONAAT, ZWAAR (E 504 (II)); MAGNESIUMSTEARAAT (E 470b); POLYETHYLEENGLYCOL (E 1521); SILICIUMDIOXIDE (E 551);

Autorisation dato:

1900-01-01

Indlægsseddel

PACKAGE LEAFLET: INFORMATION FOR THE USER
PRAVASTATINE NA CF 10 MG FILM-COATED TABLETS
PRAVASTATINE NA CF 20 MG FILM-COATED TABLETS
PRAVASTATINE NA CF 40 MG FILM-COATED TABLETS
pravastatin sodium
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 Pravastatine Na CF is and what it is used for
2. What you need to know before you take Pravastatine Na CF
3. How to take Pravastatine Na CF
4. Possible side effects
5. How to store Pravastatine Na CF
6. Contents of the pack and other information
1. WHAT PRAVASTATINE NA CF IS AND WHAT IT IS USED FOR
Pravastatin, the active substance of Pravastatine Na CF, belongs to a
group of medicines
called statins (or HMG-CoA reductase inhibitors). It prevents the
production of cholesterol by
the liver and consequently reduces the levels of cholesterol and other
fats (triglycerides) in
your body. When there are excessive levels of cholesterol in the
blood, the cholesterol
accumulates on the walls of blood vessels and blocks them.
This condition is called hardening of the arteries or atherosclerosis
and it may lead to:
•
chest pain (angina pectoris), when a blood vessel in the heart is
partially blocked
•
a heart attack (myocardial infarction), when a blood vessel in the
heart is completely blocked
•
a stroke (cerebrovascular accident), when a blood vessel in the brain
is completely blocked
This medicine is used in 3 situations:
In the treatment of high levels of cholesterol and fats in the blood
Pravastatine Na CF is used to lower high levels of "bad" cholesterol

Produktets egenskaber

1
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Pravastatin Na CF 10 mg film-coated tablets
Pravastatin Na CF 20 mg film-coated tablets
Pravastatin Na CF 40 mg film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg pravastatin sodium.
Each tablet contains 20 mg pravastatin sodium.
Each tablet contains 40 mg pravastatin sodium.
Excipient(s) with known effect
One film-coated tablet contains 52.15 mg lactose monohydrate.
One film-coated tablet contains 104.60 mg lactose monohydrate.
One film-coated tablet contains 207.36 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet
Pink-peach, indented capsule-shape tablet with “10” on one side._
_
Yellow, indented capsule-shape tablet with “20” on one side._ _
Yellow, indented capsule-shape tablet with “40” on one side._ _
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.
Primary prevention
Reduction of cardiovascular mortality and morbidity in patients with
moderate or severe
hypercholesterolaemia and at high risk of a first cardiovascular
event, as an adjunct to diet
(see section 5.1).
Secondary prevention
Reduction of cardiovascular mortality and morbidity in patients with a
history of myocardial
infarction (MI) or unstable angina pectoris and with either normal or
increased cholesterol
levels, as an adjunct to correction of other risk factors (see section
5.1).
Post transplantation
Reduction of post transplantation hyperlipidaemia in patients
receiving immunosuppressive
therapy following solid organ transplantation (see sections 4.2, 4.5
and 5.1).
2
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Prior to initiating pravastatin tablets, secondary causes of
hypercholesterolaemia