Pravamel 10 mg film-coated tablets

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

Pravastatin sodium

제공처:

Clonmel Healthcare Ltd

ATC 코드:

C10AA; C10AA03

INN (국제 이름):

Pravastatin sodium

복용량:

10 milligram(s)

약제 형태:

Film-coated tablet

처방전 유형:

Product subject to prescription which may be renewed (B)

치료 영역:

HMG CoA reductase inhibitors; pravastatin

승인 상태:

Marketed

승인 날짜:

2004-09-24

환자 정보 전단

Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE USER
PRAVAMEL 10 MG FILM-COATED TABLETS
PRAVAMEL 20 MG FILM-COATED TABLETS
PRAVAMEL 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 Pravamel is and what it is used for
2. What you need to know before you take Pravamel
3. How to take Pravamel
4. Possible side effects
5. How to store Pravamel
6. Contents of the pack and other information
1. WHAT PRAVAMEL IS AND WHAT IT IS USED FOR
Pravastatin, the active substance of Pravamel, 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
Pravamel is used to lower high levels of "bad" cholesterol and to
raise the levels of "good" cholesterol
in the blood when changes to diet and exe

제품 특성 요약

Health Products Regulatory Authority
20 March 2024
CRN00F57S
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pravamel 10 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg pravastatin sodium.
Excipient(s) with known effect
One film-coated tablet contains 52.15 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.
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).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Prior to initiating pravastatin tablets, secondary causes of
hypercholesterolaemia should be excluded and patients should be
placed on a standard lipid-lowering diet which should be continued
during treatment.
Posology
_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 and the dosage