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PRAVASTATIN SODIUM 40 MG TABLETS

Active substance: PRAVASTATIN SODIUM

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TEVA UK Ref:

Version:

231-30-70512-Z LEA PRAVASTATIN A/S TABS TUK

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26 June 2015

PAGE 1: FRONT FACE (INSIDE OF REEL)

Package leaflet: Information for the user:
The name of your medicine is Pravastatin sodium
10 mg , 20mg or 40mg tablets, which will be referred
to as Pravastatin throughout this leaflet
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:

(Main)

Pharma code 247

1. What Pravastatin is and what it is used for
2. What you need to know before you take
Pravastatin
3. How to take Pravastatin
4. Possible side effects
5. How to store Pravastatin
6. Contents of the pack and other information

1 What Pravastatin is and what it is used for
Pravastatin belongs to a group of drugs called
HMG-CoA reductase inhibitors. These reduce the
amount of cholesterol and triglycerides (fatty
substances) in your blood.
Pravastatin is used:
• to reduce your risk in the future of developing
coronary heart disease or having a heart attack or
stroke, if you have raised levels of cholesterol but
do not have coronary heart disease
• to reduce your risk of having a further heart attack
or stroke, if you have already had a heart attack or
have unstable angina
• to reduce increased lipid levels, if you have had
an organ transplant and are taking medication to
stop your body rejecting the transplant.
Some further information:
• While cholesterol is vital for the normal
functioning of the body, if the level in the blood
becomes too high it can build up on the walls of
the arteries. Eventually blood vessels can become
blocked. Only a small amount of cholesterol
comes from our diet, the majority is made by our
own livers. The body produces most cholesterol at
night.
• Even though you may be on a low fat diet, your
doctor has done some blood tests which show
that you still have too much fat (including
cholesterol) in your blood. A high cholesterol level
is generally recognised as adding to the risk of
heart disease. Additional factors such as existing
heart disease, high blood pressure, diabetes,
being overweight, lack of exercise and smoking
can also greatly increase the risk of the
development or progression of heart disease

2 What you need to know before you take
Pravastatin

Do not take Pravastatin:
• if you are allergic to Pravastatin or any of the
other ingredients of this medicine (listed in
section 6)
• if you have current liver problems
• if you suffer from porphyria (a deficiency of
specific enzymes within the body, causing an
increase of substances called porphyrins)
• if you are pregnant or there is a possibility that
you may become pregnant or are breast feeding.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Pravastatin :
• if you have kidney problems
• if you are a child before puberty (puberty is the
process of physical changes by which a child's
body becomes an adult body capable of
reproduction). In this case your doctor should
properly evaluate the risk/benefit of treatment
carefully before starting this medicine.
• if you are over 70 years of age
• if you have suffered with liver problems in the past
• if you have an underactive thyroid gland

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• if you have an hereditary muscle disorder or a
family history of such problems
• if you have previously suffered from side effects
affecting your muscles when taking another
cholesterol lowering medicine such as a statin or
a fibrate e.g. gemfibrozil
• if you feel any unexplained cramps or muscle
pains during treatment, tell your doctor
immediately
• if you have problems with alcohol abuse (regularly
drinking large amounts of alcohol).
• if you have severe respiratory failure.
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.
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.
Other medicines and Pravastatin
Please tell your doctor or pharmacist if you are
taking or have recently taken any other medicines,
including medicines obtained without a prescription.
Talk to your doctor if you are taking any of the
following:
• a group of cholesterol lowering medicines called
fibrates e.g. fenofibrate or gemfibrozil, ciclosporin
(an immunosuppressant used after an organ
transplant), or nicotinic acid (vitamin B3), as these
medicines can interfere with the way Pravastatin
works in your body.
• drugs known as bile acid sequestrants (a class of
drugs that prevents bile acids being reabsorbed
from the digestive system, so promoting
conversion of cholesterol into bile acids) e.g.
colestyramine, colestipol (please see section 3, If
you are also taking a bile acid sequestrant)
• the antibiotics erythromycin or clarithromycin.
Pravastatin with food, drink and alcohol
• Keep alcohol intake to a minimum, if you want to
drink then only have small quantities of alcohol
whilst taking this medicine, and make sure you do
not stop taking your medicine if you have an
alcoholic drink one evening.
Pregnancy, breast-feeding and fertility
Do not take Pravastatin:
• if you are pregnant or breast-feeding, or if you are
planning to become pregnant
• if you are a woman who could become pregnant
(unless you are using a reliable form of
contraception other than the pill or other
hormonal contraceptives). If you do become
pregnant when taking Pravastatin, stop taking the
tablets as soon as you become aware of it.
Ask your doctor or pharmacist for advice before
taking any medicine.
Driving and using machines
• Pravastatin may cause dizziness blurred or double
vision during treatment, if affected do not drive or
operate machinery.
Pravastatin contain lactose
• Patients who are intolerant to lactose should note
that Pravastatin tablets contain a small amount of
lactose. If your doctor has told you that you have
an intolerance to some sugars, contact your
doctor before taking this medicine.

3 How to take pravastatin
Always take Pravastatin exactly as your doctor has
told you. You should check with your doctor or
pharmacist if you are not sure. Your doctor will have
explained the importance of a low fat diet as well as
taking Pravastatin.
The tablets should be swallowed preferably with a
glass of water. Pravastatin can be taken with or
without food.
Adults and older people
• In the treatment of high levels of cholesterol and
fats in the blood: the recommended dose is
10-40 mg once a day, preferably in the evening.
• In the prevention of heart and blood vessel
diseases: the recommended dose is 40 mg once a
day, preferably in the evening.
The maximum daily dose of 40 mg of pravastatin
should not be exceeded. Your doctor shall tell you
which dose suits you.
• Following organ transplantation
Your doctor may prescribe a starting dose of 20 mg

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Pravastatin sodium
10 mg, 20 mg and 40 mg tablets

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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
body’s 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 suffer from kidney or severe liver disease,
your doctor may prescribe a lower dose of
Pavastatin to you.
If you have the impression that the effect of this
treatment is too strong or too weak, talk to your
doctor or pharmacist.
Duration of treatment
Your doctor will indicate the duration of your
treatment with Pravastatin. This medicine must be
used very regularly and for as long as your doctor
advises, even if it is for a very long time. Do not stop
your treatment by yourself.
• If you are also taking a bile acid sequestrant,
such as colestyramine or colestipol, Pravastatin
should be taken at least one hour before or four
hours after you have taken the bile acid
sequestrant. This is because the absorption of
Pravastatin can be affected by these medicines if
taken too closely together.
Liver or kidney problems
If you have either liver or kidney problems your
doctor may prescribe a lower dose.
Use in children and adolescents
Children adolescents (8-18 years of age) 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.
If you take more Pravastatin than you should
If you (or someone else) swallow a lot of the tablets
all together, or if you think a child has swallowed
any of the tablets, contact your nearest hospital
casualty department or your doctor immediately.
Please take this leaflet, any remaining tablets, and
the container with you to the hospital or doctor so
that they know which tablets were consumed.
If you forget to take Pravastatin
If you forget to take a dose, take one as soon as you
remember, unless it is nearly time to take the next
one. Do not take a double dose to make up for a
forgotten dose.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

4 Possible side effects
Like all medicines, this medicine 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.
Pravastatin can cause some other side effects:
Uncommon (may affect up to 1 in 100 people):
• Insomnia
• Dizziness
• Tiredness
• Headache or sleep disturbances
• Blurred or double vision
• Indigestion
• Nausea
• Vomiting
• Stomach pain or discomfort
• Painful sensation in chest due to stomach acidity
• Diarrhoea
• Constipation
• Wind (flatulence)
• Itching
• Pimples
• Hives
• Rashes
• Scalp
• Hair problems (including hair loss)
• Bladder problems (painful or more frequent
urination, having to pass water at night)

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• Sexual difficulties
• Muscle and joint pain
Very rare (may affect up to 1 in 10 000 people):
• Disorder of the nerves which can cause
weakness, tingling or numbness (especially if you
use pravastatin for a long time)
• A severe skin disease (lupus erythematous-like
syndrome)
• 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)
• 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
• Breakdown of muscle associated with acute
kidney failure
• 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.
Not known (frequency cannot be estimated from the
available data)
• Muscle weakness that is constant
Following side effects have been reported with some
Statins (Frequency unknown):
• Nightmare
• Memory loss
• Depression
• Breathing problem 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.
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more
information on the safety of this medicine.

5 How to store pravastatin
Keep this medicine out of the sight and reach of
children.
This medicinal product does not require any special
storage conditions.
Do not use this medicine after the expiry date that is
stated on the carton. 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 protect the environment.

6 Contents of the pack and other information
What Pravastatin Tablets contain:
• The active ingredient is Pravastatin sodium.
• The other ingredients are crospovidone, lactose
monohydrate and magnesium stearate.
What Pravastatin Tablets look like and contents of
the pack:
• The 10 mg tablets are white to off white, round
biconvex tablets, scored on one side of the tablet,
debossed “P” and “10” on the other side.
• The 20 mg tablets are white to off white, round
biconvex tablets, scored on one side of the tablet,
debossed “P” and “20” on the other side.
• The 40 mg tablets are white to off white
capsule-shaped tablets, scored on one side of the
tablet, debossed “P” on the other side.
• The tablets come in pack sizes of 20, 28, 50, 100
and 200 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation holder and Company
Responsible for Manufacture: TEVA UK Limited,
Eastbourne, BN22 9AG.
This leaflet was last revised: March 2015
PL 00289/0407-0409

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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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