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PRAVASTATIN SODIUM 20MG TABLETS

Active substance(s): PRAVASTATIN SODIUM

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PACKAGE LEAFLET: INFORMATION FOR THE USER

SZ00000LT000

Pravastatin Sodium 10 mg, 20 mg and 40 mg
Tablets

(Pravastatin Sodium)

Read all of the 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 Pravastatin is and what it is used for
2. Before you take Pravastatin
3. How to take Pravastatin
4. Possible side effects
5. How to store Pravastatin
6. Further information

1

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 developing muscle-related side effects. You may also
need this blood test if you are aged older than 70 years.
If you feel any unexplained cramps or muscle pains
during treatment, tell your doctor immediately.

What Pravastatin is and what it is
used for

Pravastatin 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.

Also tell your doctor or pharmacist if you have a muscle
weakness that is constant. Additional tests and
medicines may be needed to diagnose and treat this.
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.

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.

Check with your doctor or pharmacist before taking
Pravastatin if you have:
• severe respiratory failure.

Using other medicines:
When combined with this treatment, the medicines
stated below may result in an increased risk of
developing muscle problems (see Possible side effects).
It is important that you inform your doctor whether you
are already being treated with:
• a group of cholesterol lowering medicines called
fibrates (e.g. gemfibrozil, fenofibrate);
• medicines used to adjust or adapt the immune
response, e.g. ciclosporin;
• a medicine which treats the infections caused by
bacteria (an antibiotic such as erythromycin or
clarithromycin);
• another medicine which lowers the level of
cholesterol in your blood (nicotinic acid);
• 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 closely together);
• Warfarin and other oral anticoagulants (agents that
help in thinning the blood);
• Product metabolized by cytochrome P450 (diltiazem,
verapamil, itraconazole, ketoconazole, protease
inhibitors and CYP2C9 inhibitors like fluconazole).

This medicine is used in 3 situations:

In the treatment of high levels of cholesterol and fats in
the blood
Pravastatin 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 exercise have
failed to adequately do this.

In the prevention of heart and blood vessel diseases
• If you have high levels of cholesterol in your blood
and risk factors favouring these diseases (if you
smoke, are overweight, if you have high blood sugar
levels or high blood pressure, if you take little
exercise), Pravastatin is used to reduce the risk of
you having heart and blood vessel diseases and to
lower your risk of dying from these diseases.
• If you have already had a stroke or if you have pains
in the chest (unstable angina), and even if you have
normal cholesterol levels, Pravastatin is used to
reduce the risk of you having another heart attack or
stroke in the future, and to lower your risk of dying
from these diseases.

After organ transplants
If you have had an organ transplant and receive
medication to prevent your body rejecting the transplant,
Pravastatin is used to reduce increased levels of fats in
the blood.

2

Please tell your doctor or pharmacist if you are using or
have recently used other medicines, including medicines
obtained without a prescription.
Taking Pravastatin with food and drink
This treatment can be taken with or without food, with
half a glass of water.
You should always keep your alcohol intake to a
minimum. If you are concerned about how much alcohol
you can drink while you are taking this medicine, you
should discuss this with your doctor.

Before you take Pravastatin

Do not take Pravastatin Tablets:
• if you are hypersensitive (allergic) to pravastatin
sodium or any of the other ingredients of this
medicine (see section 2 Important information about
some of the ingredients and Further information);
• if you are pregnant or trying to become pregnant or if
you are breast-feeding (see Pregnancy and
Breast-feeding);
• if you have any liver disease (active liver diseases);
• if several blood tests have shown abnormal
functioning of your liver (increased levels of liver
enzymes in the blood).

Pregnancy and Breast-feeding:
Do not take Pravastatin if you are pregnant, trying to
become pregnant or suspect you may be pregnant, as
the safety in pregnant women has not been established,
if you become pregnant while using Pravastatin, you
must stop taking tablets immediately and contact your
doctor.
A small amount of the active substance of Pravastatin
passes into breast milk. Therefore, you must not take
Pravastatin while breast-feeding.

Take special care with Pravastatin
Tell your doctor if you have ever had any of the
following:
• Kidney disease;
• an underactive thyroid gland (hypothyroidism);
• A liver disease or 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 a fibrate.

Ask your doctor or pharmacist for advice before taking
any medicine.

Driving and using machines:
Pravastatin does not usually affect your ability to drive or
use machines. If you experience any dizziness, blurred
or double vision during treatment, make sure that you
are fit to drive and operate machinery before attempting
to do so.

Continued on the next page >>

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Important information about some of the ingredients
of Pravastatin Tablets:
This medicine contains lactose. If you have been told by
your doctor that you have an intolerance to some sugars
(e.g. lactose), contact your doctor before taking this
medicinal product.

3




How to take Pravastatin



Your doctor will advise you on a low fat diet which you
should continue over the full treatment period.
Always take Pravastatin exactly as your doctor has
instructed you.
You should check with your doctor or pharmacist if you
are not sure.

Side effects of unknown frequency (frequency cannot
be estimated from the available data)
• muscle weakness that is constant

Possible side effects
• Nightmares
• Memory loss
• Depression
• Breathing problems including persistent cough and/or
shortness of breath or fever.

Pravastatin can be taken with or without food, with half a
glass of water.
Dosage

Children (8 13 years) and adolescents (14 18 years)
with a hereditary disease which increases the level
of cholesterol in the blood:
The usual dose is 10 to 20 mg once a day between 8
and 13 years and from 10 to 40 mg once a day between
14 and 18 years.

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.

After organ transplantation:
Your doctor may prescribe a starting dose of 20 mg
once a day. The dose may be adjusted up to 40 mg by
your doctor.
If you are also taking a medicine which lowers the
bodyʼs immune system (ciclosporin), your doctor may
prescribe a starting dose of 20 mg once a day. The dose
may be adjusted up to 40 mg by your doctor.
If you have the impression that the effect of Pravastatin
is too strong or too weak, talk to your doctor or
pharmacist.

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 your pharmacist.

5

How to store Pravastatin

Keep all medicines out of the reach and sight of
children.

Prevention of heart attack or stroke:
The usual dose is 40 mg.

Do not take Pravastatin Tablets after the expiry date
shown on the pack.
The expiry date refers to the last day of that month.

If you suffer from kidney or severe liver disease, your
doctor may prescribe a lower dose (usually 10 mg once
a day) of Pravastatin to you.

Do not store above 25°C. Store in the original
packaging.

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.

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

If you forget to take Pravastatin:
If you miss a dose, simply take your normal dose when
it is next due. Do not take a double dose to make up for
a forgotten dose.

If you stop taking Pravastatin
Always tell your doctor or pharmacist if you want to stop
the treatment.

Further information

The active ingredient is pravastatin sodium. Each tablet
contains 10 mg, 20 mg or 40 mg of pravastatin sodium.

The other ingredients are: lactose monohydrate (see
section 2 Important information about some of the
ingredients), sodium phosphate, sodium lauryl sulphate,
povidone, microcrystalline cellulose, croscarmellose
sodium, colloidal anhydrous silica, magnesium stearate,
ferric oxide, brown (E 172).

If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

4

Effects on liver: inflammation of the liver or
pancreas; jaundice (recognisable by a yellowing of
the skin and of whites of the eyes; very rapid death of
liver cells (fulminant hepatic necrosis);
Effects on muscles and bones: inflammation of
one or more muscles leading to pain or weakness in
muscles (myositis or polymyositis); pain or weakness
in muscles, inflammation of tendons which may be
complicated by rupture of tendons;
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.

Possible side effects

What Pravastatin looks like and contents of the pack
Pravastatin 10 mg tablets are light brown, mottled, oval,
scored on both sides and debossed with “P 10” on one
side.
Pravastatin 20 mg tablets are light brown, mottled, oval,
scored on both sides and debossed with “P 20” on one
side.
Pravastatin 40 mg tablets are light brown, mottled, oval,
scored on both sides and debossed with “P 40” on one
side.

Like all medicines, Pravastatin can cause side effects,
although not everybody gets them.

Stop taking Pravastatin and tell your doctor
immediately 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, muscle problems can be serious
(rhabdomylosis) and can lead to a serious,
life-threatening kidney disease.
Sudden severe allergic reactions including swelling of
the face, lip, tongue or wind pipe which can cause great
difficulty in breathing. This is a very rare reaction which
can be serious if it occurs. You should tell your doctor
immediately if it happens.
The following side effects are uncommon and may affect
more than 1 out of 1,000 persons:
• Effects on nervous system: dizziness, tiredness,
headache or sleep disturbances, including insomnia;
• Effects on vision: blurred or double vision;
• Digestive effects: indigestion, nausea, vomiting,
stomach pain or discomfort, diarrhoea or constipation
and wind;
• Effects on skin and hair: itching, pimples, hives,
rashes, scalp and hair problems (including hair loss);
• Urinary and genital effects: bladder problems
(painful or more frequent urination, having to pass
water at night) and sexual difficulties;
• Effects on muscles and joints: muscle and joint pain.

Pravastatin tablets are available in blister packs of 20,
28, 50, 98, and 100.
Not all pack sizes may be marketed.
Marketing Authorisation holder:
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.
Manufacturer:
Lek Pharmaceuticals,
Verovškova 57, SI-1526 Ljublijana,
Slovenia.

This leaflet was last revised in 03/2015

The following side effects are very rare and may affect
less than 1 out of 10,000 persons:
• Effects on nervous system: problems with touch
including burning or tingling sensations or numbness
which may indicate damage to nerves;
• Effects on skin: a severe skin disease (lupus
erythematous-like syndrome);

SZ00000LT000

Artwork Proof Box
Ref: N014: SPC & PIL update in line with PRAC recommendation
Proof no.
004.0

Date prepared:
26/03/2015

Colours:
Black
Black 20%
Dimensions: 130 x 300 mm

Font size:
6pt
Fonts:
Helvetica

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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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