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PRAVALAN

Active substance(s): PRAVASTATIN SODIUM

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PATIENT INFORMATION LEAFLET

Pravastatin sodium 10mg, 20mg, 30mg
and 40mg Tablets
(Each tablet contains 10mg, 20mg, 30mg or 40mg 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 further questions, ask your doctor or your 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.
In this leaflet:
1
2
3
4
5
6

1

What Pravastatin is and what it is used for
What you need to know before you take Pravastatin
How to take Pravastatin
Possible side effects
How to store Pravastatin
Contents of the pack and other information

What Pravastatin is and what it is
used for

Pravastatin belongs to a group of medicines called
HMG-CoA reductase inhibitors (or statins) which work
by reducing your body's production of "bad
cholesterol" and raising the levels of "good"
cholesterol. Cholesterol is a lipid that can cause
coronary heart disease by narrowing the vessels that
supply the heart with blood. This condition, called
hardening of the arteries or atherosclerosis, may lead
to chest pain (angina pectoris), a heart attack
(myocardial infarction) or stroke.
If you have already had a heart attack or have chest
pain at rest (unstable angina pectoris), Pravastatin
reduces the risk of having another heart attack or
stroke in the future, regardless of your cholesterol
levels.
If you have raised levels of cholesterol but do not have
coronary heart disease, Pravastatin reduces the risk of
this occurring or of you having a heart attack in the
future.
When you use Pravastatin, your doctor will
recommend other actions as part of your treatment,
such as a low-fat diet, exercise and weight reduction.
If you have had an organ transplant and are taking
medication to stop your body rejecting the transplant,
Pravastatin reduces increased lipid levels.

2

Before you take Pravastatin

Do not take Pravastatin:






if you are allergic to pravastatin sodium or any of
the other ingredients of this medicine (listed in
section 6);
if you are pregnant or if there is a possibility that
you may become pregnant;
if you are breast feeding;
if you have liver problems.

Ask your doctor if you are uncertain whether you can
take Pravastatin.
Warnings and precautions:
Talk to your doctor or pharmacist before taking
Pravastatin if you have ever had any of the following:








Kidney disease or an underactive thyroid
Alcohol problems (regularly drinking large amounts
of alcohol)
A hereditary muscle disorder in yourself or a blood
relative
Side effects affecting your muscles when taking
another cholesterol-lowering medicine such as a
statin or fibrate.
If you have had a history of liver problems.
If you have severe respiratory failure.

If you have suffered from any of these problems, your
doctor will need to carry out a blood test before and
possibly during Pravastatin treatment to assess your
risk of muscle-related side effects. You may also need
this blood test if you are aged older than 70 years.
Go back to your doctor as soon as possible to discuss
your concerns and follow the advice given.
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 and adolescents
In children before puberty, the benefit/risk of treatment
should be carefully evaluated by physicians before
treatment initiation.
Other medicines and Pravastatin
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.

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It is important that you inform your doctor if you are
already being treated with any of the following:
 other cholesterol lowering drugs called
fibrates(e.g. gemfibrozile, fenofibrate). The
combination may increase the risk of side effects.
 medicines used to adjust or adapt the immune
response, e.g. ciclosporin. The combination may
increase the risk of side effects.
 the antibiotics erythromycin or clarithromycin. The
combination may result in an increased risk of
developing muscle problems.
 a resin-type lipid-lowering agent such as
colestyramine or colestipol Pravastatin should
usually be taken at least one hour before or four
hours after you have taken the resin. This is
because the resin can affect the absorption of
Pravastatin if the two medicines are taken too
closely together).
Pravastatin with food, drink and alcohol
Pravastatin can be taken with or without food. Inform
your doctor if you regularly consume larger quantities
of alcohol.
If you are not sure about this please follow your
doctor's guidelines.
Pregnancy and breast-feeding
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.
You must not take Pravastatin during pregnancy.
Doctors will take special care when prescribing this
medicine to young women that might become
pregnant and they will properly explain the potential
risk associated with pravastatin therapy during
pregnancy. If you have plans to become pregnant or if
you have become pregnant, you should stop taking
Pravastatin and inform your doctor immediately (see
Section 2: Do not take Pravastatin).
You must not take Pravastatin during breast- feeding,
as Pravastatin passes into the mother's milk (see
Section 2: Do not take Pravastatin).
Driving and using machines
Pravastatin does not usually affect your ability to drive
but if you experience any dizziness, blurred or double
vision make sure you are fit to drive and operate
machinery before attempting to do so.

3

How to take Pravastatin

Always take Pravastatin exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
Adults
The usual dose of Pravastatin is 10 - 40mg once a
day, preferably in the evening. Pravastatin can be
taken with or without food, with half a glass of water.
Use in children and adolescents (from 8 to 18
years of age) with heterozygous familial
hypercholesterolemia
Use in children and adolescents (8 – 13 years of age):
The recommended dose range is 10 - 20 mg once a
day.
Use in children and adolescents (14 – 18 years of
age): The recommended dose range of is 10 - 40 mg
once a day.
Renal and hepatic impairment
The usual dose is 10 mg once a day in patients with
renal or hepatic impairment.
Following organ transplantation
The usual starting dose is 10-20mg once a day. The
dose may be increased up to 40 mg under close
medical supervision.

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continued....

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Other medicines
Pravastatin should usually be taken at least one hour
before or four hours after you have taken the
Colestyramin or Colestipol.
The usual starting-dose for person who uses
medicines which adjust or adapt the immune
response, (Ciclosporin) is 20 mg once a day. The
dose may be increased up to 40 mg under close
medical supervision.
If you have the impression that the effect of
Pravastatin is too strong or too weak, talk to your
doctor or pharmacist.
If you take more Pravastatin than you should
If you have taken too many tablets, or if someone
accidentally swallows some, contact your doctor or the
nearest hospital for advice.
If you forget to take Pravastatin
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 forgotten individual doses.
If you stop taking Pravastatin
Always tell your doctor if you want to stop the
treatment.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

4

How to store Pravastatin

Keep out of reach and sight of children.
Blister (Al/OPA/Al/PVC):
Do not store above 30°C.
Store in the original package.
Blister (Al/PVC/COC/PVdC):
Do not store above 25°C.
Store in the original package.
Tablet container:
Do not store above 30°C.
Keep the tablet container tightly closed.
Do not use Pravastatin after expiry date which is
stated on the outer carton and blister/container after
'EXP'. The expiry date refers to the last day of that
month.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose
of medicines no longer required. These measures will
help to protect the environment.

6

Contents of the pack and other
information

What Pravastatin contains
The active substance is pravastatin sodium

Possible side effects

Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Serious side effects which occur very rarely (may
affect up to 1 in 10,000 people)
Contact your doctor as soon as possible and stop
taking Pravastatin if you develop any unexplained or
persistent muscle pain, tenderness, weakness or
cramps, especially, if at the same time you feel unwell
or have a high temperature. In very rare cases this has
progressed to become a serious and potentially lifethreatening condition (called rhabdomyolysis).
You should stop taking Pravastatin and see your
doctor immediately if you experience symptoms of




5

swollen face, tongue or pharynx
difficulty to swallow
hives and difficulties to breathe

These are symptoms of a serious allergic reaction
which must be treated immediately, usually in a
hospital.
Other side effects
Uncommon side effects (may affect up to 1 in 100
people):
 dizziness, headache, sleep disturbances, difficulty
in sleep
 problems with sight such as blurred or double
vision
 stomach and bowel problems such as indigestion,
abdominal pain, the pain of heartburn, sickness,
vomiting, diarrhoea or constipation and wind
 skin reactions such as itching and rashes, hives
(urticaria) or scalp and hair problems including hair
loss
 bladder problems (painful or frequent urination,
having to pass water at night)
 tiredness
 sexual difficulties
 muscle and joint pain.
Very rare side effects (may affect up to 1 in 10,000
people):
 problems with touch including burning/tingling
sensations or numbness which may indicate
damage to nerve endings
 allergic condition which causes joint pain, skin
rashes and fever (lupus erythematosus), acute and
severe hypersensitivity reaction (anaphylaxis)
 inflammation of the liver (which may cause
yellowing of the skin or the whites of the eyes) or
pancreas (which may cause stomach pain)
 muscle damage (myopathy)
 isolated cases of tendon disorders, sometimes
complicated by rupture
 inflammation of the muscles (myositis,
polymyositis)
 abnormal blood tests: increases in transaminases
(a group of enzymes occurring naturally in the
blood) which may be a sign of liver problems. Your
doctor may want to perform tests periodically to
check these.

10 mg tablets:
Each tablet contains pravastatin sodium 10 mg
20 mg tablets:
Each tablet contains pravastatin sodium 20 mg
30 mg tablets:
Each tablet contains pravastatin sodium 30 mg
40 mg tablets:
Each tablet contains pravastatin sodium 40 mg.
The other ingredients are:
Calcium hydrogen phosphate, anhydrous, Sodium
starch glycolate, Cellulose, microcrystalline,
Trometamol, Disodium phosphate dehydrate,
Povidone, Magnesium stearate, Ferric oxide, yellow
(E172)
What Pravastatin looks like and contents of the pack
Pravastatin 10 mg tablets
A yellow, oblong, biconvex, side wall scored tablet
encoded P 10
Pravastatin 20 mg tablets
A yellow, oblong, biconvex, side wall scored tablet
encoded P 20
Pravastatin 30 mg tablets
A yellow, oblong, biconvex, side wall scored tablet
encoded P 30
Pravastatin 40 mg tablets
A yellow, oblong, biconvex, side wall scored tablet
encoded P 40
Blister (Al/PVC/COC/PVdC)
Blister (Al/OPA/Al/PVC)
Pack sizes: 7, 10, 14, 20, 28, 30, 50, 56, 60, 98, 100x1
and 100 tablets.
Polyethylene tablet container and polypropylene cap
with desiccant (silica gel) insert.
Pack sizes: 28, 30, 98, 100 and 250 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Tillomed Laboratories Ltd
3 Howard Road, Eaton Socon, St. Neots,
Cambridgeshire PE19 8ET, UK
Manufacturer
Salutas Pharma GmbH,
Otto-Von-Guericke-Allee 1,
39179 Barleben, Germany
Product Licence Numbers:
Pravastatin sodium 10mg Tablets: PL 11311/0271
Pravastatin sodium 20mg Tablets: PL 11311/0272
Pravastatin sodium 30mg Tablets: PL 11311/0273
Pravastatin sodium 40mg Tablets: PL 11311/0274

Date of last revision August 2012.

Side effects of unknown frequency (frequency
cannot be estimated from the available data)
The following side effects have been reported with
some statins (medicines of the same type):
 nightmares
 memory loss
 depression
 breathing problems including persistent cough
and/or shortness of breath or 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.
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet.

Hard to Read?

Phone

0800 970 6115

Pravastatin sodium 10mg, 20mg, 30mg and 40mg Tablets
Tablets
PIL
165 x 420 mm
Font SansSerif − Min Font Size 8pt
Till−Ver.5.1s
08/08/2012
1 − Pantone Black CVC

Tillomed Laboratories Ltd, 3 Howard Road Eaton Socon, St Neots, Cambs PE19 8ET, UK

for help
Till−Ver.5.1s

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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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