Pravastatin Mylan 10 mg Tablets

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

Pravastatin sodium

Tilgængelig fra:

McDermott Laboratories Ltd., T/A Gerard Laboratories

ATC-kode:

C10AA; C10AA03

INN (International Name):

Pravastatin sodium

Dosering:

10 milligram(s)

Lægemiddelform:

Tablet

Recept type:

Product subject to prescription which may be renewed (B)

Terapeutisk område:

HMG CoA reductase inhibitors; pravastatin

Autorisation status:

Not marketed

Autorisation dato:

2010-12-17

Indlægsseddel

PAGE 1 OF 7
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PRAVASTATIN MYLAN 10 MG, 20 MG, 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 of the 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 Mylan is and what it is used for
2.
What you need to know before you take Pravastatin Mylan
3.
How to take Pravastatin Mylan
4.
Possible side effects
5.
How to store Pravastatin Mylan
6.
Contents of the pack and other information
1.
WHAT PRAVASTATIN MYLAN IS AND WHAT IT IS USED FOR
Pravastatin, the active substance of Pravastatin Mylan, belongs to a
group of medicines called statins
which work by reducing high cholesterol levels in the blood.
Cholesterol is a fatty substance (lipid)
that can cause the narrowing of blood vessels in the heart causing
coronary heart disease.
Pravastatin Mylan is used
-
to lower high cholesterol levels in your blood if diet, exercise or
weight loss has not lowered your
cholesterol level
-
if you are at risk of narrowing of the blood vessels in your heart
caused by too much cholesterol
in your blood, as a supplement to your diet
-
to lower the fatty substances (lipids) in your blood if you have had
an organ transplant
-
to reduce the chance of having another heart attack if you have
previously had a heart attack or if
you suffer from chest pain attacks (unstable angina pectoris)
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PRAVASTATIN MYLAN
DO NOT TAKE PRAVASTATIN MYLAN
-
if you are allergic to pravastatin, or any of the other ingredients of
this medicine (listed in section
6)
-
if you

Produktets egenskaber

Health Products Regulatory Authority
08 May 2023
CRN00DK8M
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pravastatin Mylan 10 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10 mg tablet contains 10 mg of pravastatin sodium.
Excipient(s) with known effect:
Each 10 mg tablet contains 72.9 mg of lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
Pravastatin Mylan 10 mg tablets:
Light pink colour, mottled, round, flat, bevelled tablet (6 mm)
debossed with "10" on one side and plain on the other.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hypercholesterolaemia
Treatment of primary hypercholesterolemia 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 hypercholesterolemia 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 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
Posology
Prior to initiating Pravastatin Mylan Tablets, secondary causes of
hypercholesterolaemia should be excluded and patients
should be placed on a standard lipid-lowering diet that should be
continued during treatment.
Hypercholesterolaemia
The recommended dose range is 10-40 mg once daily. The therapeutic
response is seen within a week and the full effect of a
given dose occurs within four weeks, therefore periodic lipid
determinations should be performed