Lipostat 10mg tablets
Country: United Kingdom
Language: English
Source: myHealthbox
Patient Information leaflet
(PIL)
26-04-2024
Summary of Product characteristics
(SPC)
26-04-2024
Active ingredient:
Pravastatin sodium
Available from:
Bristol Myers Squibb Pharmaceuticals Ltd.
ATC code:
C10AA03
INN (International Name):
Pravastatin sodium
Dosage:
10mg
Pharmaceutical form:
Tablets
Administration route:
Oral use
Units in package:
blister packs of 10, 14, 20, 28, 30, 50, 60, 84, 98, 100, 200, and 280 tablets
Prescription type:
POM - Prescription Only Medicine
Manufactured by:
Bristol-Myers Squibb
Therapeutic group:
serum lipid reducing agents/cholesterol and triglyceride reducers/HMG-CoA reductase inhibitors
Therapeutic indications:
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; 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; 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; reduction of post transplantation hyperlipidaemia in patients receiving immunosuppressive therapy following solid organ transplantation.
Authorization status:
Authorised
Authorization date:
1997-01-10
Patient Information leaflet
PACKAGE LEAFLET: INFORMATION FOR THE USER
LIPOSTAT 10MG, 20MG AND 40MG TABLETS
Pravastatin sodium
READ ALL OF THIS LEAFLET CAREFULLY BEFORE
YOU START TAKING THIS MEDICINE.
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. Do not pass it on to
others. It may harm them, even
if their symptoms are the same as yours.
If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What LIPOSTAT is and what it is used for
2.
Before you take LIPOSTAT
3.
How to take LIPOSTAT
4.
Possible side effects
5.
How to store LIPOSTAT
6.
Further information
1.
WHAT LIPOSTAT IS AND WHAT IT IS USED FOR
LIPOSTAT 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
LIPOSTAT is used to lower high levels
of "bad" cholesterol and to raise the
Read the complete document
Summary of Product characteristics
Lipostat 10mg Tablets
Summary of Product Characteristics Updated 03Jul2015 | BristolMyers Squibb Pharmaceutical Limited
1. Name of the medicinal product
Lipostat 10mg tablets
2. Qualitative and quantitative composition
Each tablet contains 10mg pravastatin sodium.
Each tablet contains 64.95 mg of lactose monohydrate.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet.
10 mg: yellow, capsule shaped biconvex scored tablet with a "10" engraved on one 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 nonpharmacological 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).
4.2 Posology and method of administration
Prior to initiating Lipostat, secondary causes of hypercholesterolaemia should be excluded and patients should be
placed on a standard lipidlowering diet which should be continued during treatment.
Lipostat is admin
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