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PRAVASTATIN 40 MG FILM-COATED TABLETS

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Pravastatin Na 40 mg film-coated 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 or nurse.
- 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 or nurse. This includes any
possible side effects not listed in this leaflet.
In this leaflet:
1.
2.
3.
4.
5.
6.
1.

What Pravastatin Na is and what it is used for
What you need to know before you take Pravastatin Na
How to take Pravastatin Na
Possible side effects
How to store Pravastatin Na
Contents of the pack and other information
WHAT PRAVASTATIN NA IS AND WHAT IT IS USED FOR

Pravastatin Na 40 mg film-coated tablets contains 40 mg pravastatin sodium. Pravastatin, the
active substance of Pravastatin Na , 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 the heart muscle blood vessels (coronary heart disease).
Pravastatin Na is used
- to lower a high cholesterol level in the blood when there is no sufficient response to diet,
more exercise, weight reduction etcetera.
- 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 reduce the chance of having another heart attack if you have had a heart attack or if you
have chest pain attacks (unstable angina pectoris).
- to lower the fatty substances (lipids) in the blood following an organ transplant.
You must talk to a doctor if you do not feel better or if you feel worse after 7 days.
2.

WHAT YOU NEED TO KNOW BEFORE YOU TAKE PRAVASTATIN NA

Do not take Pravastatin Na
- if you are allergic to pravastatin or any of the other ingredients of this medicine (listed in
section 6).
- if you suffer from a liver disease in an active stage or if liver function tests keep showing
excessive values without any identifiable reason.
- if you are pregnant or breastfeeding.
Warnings and precautions
Talk to your doctor or pharmacist or nurse before taking Pravastatin Na
-

if you suffer from a kidney disease of have a history of liver disease.
if you regularly drink large amounts of alcohol.
if you suffer from a low function of your thyroid gland.
if you use other medication (fibrates) to lower the fatty substances at the same time.
if you experienced muscle problems during previous treatment medication to lower the fatty
substances or if anyone in your family suffers from a hereditary muscle disease.

Check with your doctor or pharmacist before taking Pravastatin Na
- if you have severe respiratory failure.
Consult your doctor if this applies to you or has applied to you in the past.

- if you suffer from muscle weakness or cramps during treatment or if certain parts of your
body become unusually sensitive to touching.
Consult your doctor immediately if, while using Pravastatin Na , you get unexplained
muscle ache, muscle weakness or muscle cramps, particularly in combination with
tiredness and fever. These complaints may be caused by the use of Pravastatin Na .
If necessary, your doctor may decide to stop treatment. Pravastatin Na should not be used if
you suffer from a muscle disease or if you develop kidney problems which are probably a result
of destruction of muscle tissue associated with muscle cramps, fever and red-brown discoloration of the urine (rhabdomyolysis).
While you are on this medicine your doctor will monitor you closely if you have diabetes or are
at risk of developing diabetes. You are likely to be at risk of developing diabetes if you have
high levels of sugars and fats in your blood, are overweight and have high blood pressure.
Children
Children younger than 8 years should not use this medicine, because safety and efficacy is not
proven in this patient group.
Other medicines and Pravastatin Na
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
If you take Pravastatin Na together with certain other medicines, the effect either of Pravastatin
Na or of the other medicine or of both may be influenced.
Inform your doctor or pharmacist especially if you use or have recently used any of the following
medicines:
- gemfibrozil and fenofibrate (medicines known as fibrates, which decrease fat levels in the
blood).The concomitant use with pravastatin, the active ingredient of Pravastatin Na , may
result in, sometimes severe, muscle disorders.
- colestyramine and colestipol (medicines used for the treatment of a high cholesterol level).
The effect of pravastatin is weakened when taken simultaneously with one of those medicines.
- ciclosporin (a medicine used to suppress the immune system). The effect of pravastatin is
highly intensified when being used together.
- erythromycin and clarithromycin. Those antibiotics intensify the effect of pravastatin.
Taking Pravastatin Na with food, drink and alcohol
It is best not to drink any alcohol until your treatment with Pravastatin Na has finished.
Pregnancy and breast-feeding
You should not use Pravastatin Na during pregnancy or breast-feeding.
During pregnancy the active substance pravastatin is very likely to harm the foetus. During
breast-feeding small amounts pass into the mother's milk which is bad for the baby's health. If
you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before taking this medicine. Girls and women of childbearing age should use reliable contraceptives. If, however, you become pregnant during treatment, you should stop using Pravastatin Na and consult your doctor.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Pravastatin Na does not usually affect the ability to drive and use machines. You may, however, feel dizzy. In this case make sure that you are fit to drive and operate machinery.
Pravastatin Na contains lactose.
If you have an intolerance to some sugars, contact your doctor before taking this medicinal
product.
3.

HOW TO TAKE PRAVASTATIN NA

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
Unless otherwise prescribed by the doctor, the usual dose is:

For lowering an increased cholesterol level in the blood
The recommended dose is 1 tablet of Pravastatin Na 10 mg, respectively 10 mg pravastatin
(your doctor will prescribe you this lower strength, if necessary) or ½-1 tablet of Pravastatin Na
40 mg (respectively 20-40 mg pravastatin) once daily. The maximum daily dosage is 1 tablet of
Pravastatin Na 40 mg (respectively 40 mg pravastatin).
To prevent heart and vessel diseases
The recommended dose is 1 tablet (respectively 40 mg pravastatin) once daily.
Following a transplant
The recommended dose is ½ tablet (respectively 20 mg pravastatin) once daily. The dosage
can be adjusted up to 1 tablet (respectively 40 mg pravastatin).
Use in children and adolescents with hereditarily increased cholesterol in the blood
(heterozygous familial hypercholesterolaemia)
The recommended dose is 1 tablet of Pravastatin Na 10 mg, respectively 10 mg pravastatin
(your doctor will prescribe you this lower strength, if necessary) or ½ tablet of Pravastatin Na 40
mg (respectively 20 mg pravastatin) once daily for children 8-13 years of age and 1 tablet of
Pravastatin Na 10 mg, respectively 10 mg pravastatin or ½-1 tablet of Pravastatin Na 40 mg
(respectively 20-40 mg pravastatin) once daily in adolescents 14-18 years of age.
Elderly
No dosage adjustment is required for this group. The same dosage as for adult patients can be
used.
Dosage adjustment in kidney or liver disorder
Initial dosage 1 tablet of Pravastatin Na 10 mg, respectively 10 mg pravastatin (your doctor will
prescribe you this lower strength) once daily; the dosage can be adjusted, if necessary.
Concomitant use with other medicines
In case of concomitant use of other medicines with the active ingredients colestyramine or
colestipol (medicines used for the treatment of high cholesterol levels), you should take
Pravastatin Na at least one hour before or four hours after these medicines.
If at the same time you use other medicines with the active ingredient ciclosporin (a medicine
used to suppress the immune system), the initial dosage of Pravastatin Na is ½ tablet (respectively 20 mg pravastatin) once daily. This can be adjusted to up to 1 tablet (respectively 40 mg
pravastatin).
Take Pravastatin Na once daily, preferably in the evening, whether or not during meals. Swallow the tablets with a sufficient quantity of liquid (e.g. one glass of water).
Follow these instructions unless your doctor gave you different advice. Remember to take your
medicine.
Your doctor will tell you how long you have to continue using Pravastatin Na . This depends on
the disease you have.
If you have the impression that the effect of Pravastatin Na is too strong or too weak, talk to
your doctor or pharmacist.
If you take more Pravastatin Na than you should
If you have taken too many tablets, or if someone has accidentally swallowed some tablets,
contact your doctor or pharmacist immediately.
If you forget to take Pravastatin Na
If you miss a dose do not worry. Simply take your normal dose when it is next due. Do not take
a double dose to make up for the one you have missed.
If you stop taking Pravastatin Na
Take Pravastatin Na as long as your doctor has told you. If you stop taking Pravastatin Na ,
your cholesterol levels may increase again.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4.

POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Generally, these are mild and transient. However, the following side effects may occur in some
patients during treatment.

Contact your doctor immediately if you develop one of these side effects during the use of
Pravastatin Na:


hypersensitivity reactions (angiooedema, anaphylaxis) such as serious allergic reactions
with swelling of the face, tongue and wind pipe [oedema] which can cause great difficulty in breathing. This is a very rare reaction which can be serious if it occurs.



inflammation of a muscle, destruction of fibres in skeletal muscle (rhabdomyolysis) that
may be associated with acute kidney failure. In some cases tendon disorders, sometimes
associated with tearing, yellowish discoloration of the skin (jaundice), tissues and body fluids, liver inflammation (hepatitis), sudden rapid destruction of all liver tissue (hepatitis necrosis). Muscle disorders may be serious in rare cases (see also 2. Before you take
Pravastatin Na ).

Common: may affect up to 1 in 10 people
tender muscles and bones, painful joints (athralgia), muscle cramps, muscle pain and muscle
weakness, increased production of liver enzymes.
Uncommon: may affect up to 1 in 100 people
dizziness, headache, sleep disturbances, lack of sufficient sleep, vision disturbance (blurred
vision or double vision, digestive problems or slow digestion (dyspepsia)/heartburn, abdominal
pain, nausea/vomiting, constipation, diarrhoea, wind, itching, rash, hives, scalp and hair problems (inclusive of hair loss), abnormal urination, e.g. pain, frequency, frequent urination at night
(dysuria), disturbed sexual functions, tiredness.
Very rare: may affect up to 1 in 10,000 people
problems with touch including burning/tingling sensation, numbness or pins and needles [paresthesia] may occur which may be a sign of damage to the nerve endings (peripheral polyneuropathy), inflammation of the pancreas (pancreatitis),
Not known: frequency cannot be estimated from the available data
breathing problems including persistent cough and/or shortness of breath or fever.
Other possible side effects include:
nightmares, memory loss, depression, breathing problems including persistent cough and/or
shortness of breath and fever
Diabetes. This is more likely if you have high levels of sugars and fats in your blood, are overweight and have high blood pressure. Your doctor will monitor you while you are taking this
medicine.

5.

HOW TO STORE PRAVASTATIN NA

Keep this medicine out of the reach and sight of children.
Do not store above 25°C. Store in the original package.
Do not use this medicine after the expiry date on the carton and blister which is stated after
"Exp:". The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist
how to throw away medicines you no longer use. These measures will help to protect the environment.
6.

FURTHER INFORMATION

What Pravastatin Na contains
The active substance is: pravastatin sodium.
Each tablet contains 40 mg pravastatin sodium.

The other ingredients are:
Tablet core: microcrystalline cellulose (E460), croscarmellose sodium (E468), macrogol 8000,
copovidone, heavy magnesium carbonate (E504), lactose monohydrate, magnesium
stearate (E470b), iron oxide yellow (E172), silica, colloidal anhydrous (E551).
Tablet coating: hyprolose (E463), macrogol 400, macrogol 3350, hypromellose (E464).
What Pravastatin Na looks like and contents of the pack
Yellow film-coated tablet with "40" on one side.
The tablet can be divided into equal halves.
Pravastatin Na is available in blister packs with 7, 10, 14, 20, 28, 30, 50, 56, 60, 98, 100 and
200 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Autorisation Holder:

Manufacturer:
Dragenopharm Apotheker Püschl GmbH
Göllstrasse 1
84529 Tittmoning
Germany
McDermott Laboratories Ltd t/a Gerard Laboratories
35/36 Baldoyle Industrial Estate
Grange Road
Dublin 13
Ireland
Mylan B.V.
Dieselweg 25
3752 LB Bunschoten
The Netherlands
This leaflet was last revised in April 2012

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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