Pravastatin Aurobindo 10 mg tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

PRAVASTATIN SODIUM

Available from:

Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta

ATC code:

C10AA03

INN (International Name):

PRAVASTATIN SODIUM 10 mg

Pharmaceutical form:

TABLET

Composition:

PRAVASTATIN SODIUM 10 mg

Prescription type:

POM

Therapeutic area:

LIPID MODIFYING AGENTS

Authorization status:

Authorised

Authorization date:

2012-12-06

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
PRAVASTATIN AUROBINDO 10 MG TABLETS
PRAVASTATIN AUROBINDO 20 MG TABLETS
PRAVASTATIN AUROBINDO 40 MG 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 Pravastatin Aurobindo is and what it is used for
2. What you need to know before you take Pravastatin Aurobindo
3. How to take Pravastatin Aurobindo
4. Possible side effects
5. How to store Pravastatin Aurobindo
6. Contents of the pack and other information
1.
WHAT PRAVASTATIN AUROBINDO IS AND WHAT IT IS USED FOR
Pravastatin Aurobindo 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
Pravastatin Aurobindo is used to lower high levels of "bad"
cholesterol and to raise the levels

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Pravastatin sodium Aurobindo 10 mg tablets
Pravastatin sodium Aurobindo 20 mg tablets
Pravastatin sodium Aurobindo 40 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg, 20 mg or 40 mg pravastatin sodium.
Excipient with known effect:
10 mg:
Each tablet contains 67.01 mg lactose monohydrate.
20 mg:
Each tablet contains 134.02 mg lactose monohydrate.
40 mg:
Each tablet contains 268.05 mg lactose monohydrate.
10 mg:
Each tablet contains 0.525mg of sodium.
20 mg:
Each tablet contains 1.05mg of sodium.
40 mg:
Each tablet contains 2.1mg of sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
10 mg:
Tablet: Yellow, capsule shaped, biconvex, mottled, uncoated tablets
with notched sides at double
bisect, debossed with a “Y” on one side and “60” on other
side. The size is 8.9 mm X 4.5 mm. The
tablet can be divided into equal doses.
20 mg:
Tablet: Yellow, capsule shaped, biconvex, mottled, uncoated tablets
with notched sides at double
bisect, debossed with a “Y” on one side and “61” on other
side. The size is 11.1 mm X 5.6 mm. The
tablet can be divided into equal doses.
Page 2 of 15
40 mg:
Tablet: Yellow, capsule shaped, biconvex, mottled, uncoated tablets
with notched sides at double
bisect, debossed with a “Z” on one side and “18” on other
side. The size is 14.1 mm X 7 mm. 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 mor