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PRAVASTATIN SODIUM 10 MG TABLETS

Active substance(s): PRAVASTATIN SODIUM

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TEVA UK Ref:

Version:

231-30-70512-ZB LEA PRAVASTATIN A/S TABS TUK
Dimensions:
Length:
Width:

2

Colours Used:
323 mm
160 mm

05 July 2016

Template
PANTONE® GREEN C
BLACK

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:
1.
2.
3.
4.
5.
6.

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

(Main)

Pharma code 247

1

What Pravastatin is and what it is used for

Pravastatin belongs to a group of drugs called statins (or
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 in your
blood but do not have coronary heart disease. If you
are at risk of developing coronary heart disease
including the following risk factors: if you smoke, if
you are overweight, if you have high blood sugar
levels, if you have high blood pressure or if you take
little exercise.
• to reduce your risk of having a further heart attack or
stroke, if you have already had a heart attack or have
unstable angina (pains in the chest)
• to reduce increased lipid levels (level of fats in the
blood), if you have had an organ transplant and are
taking medication to stop your body rejecting the
transplant.
Some further information:
• 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. 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. This condition is called hardening of the
arteries (atherosclerosis). This 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. 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

• if you have an underactive thyroid gland (hypothyroidism)
• 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 (HMG-CoA
reductase inhibitor drugs) 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 are taking or have taken in the last 7 days a
medicine called fusidic acid, (a medicine for bacterial
infection) orally or by injection. The combination of
fusidic acid and Pravastatin can lead to serious muscle
problems (rhabdomyolysis).
If any of the above apply to you, your doctor will need to
carry out a blood test before and possibly during your
treatment. These blood tests will be used to evaluate your
risk of muscle-related side effects.
Also talk to your doctor or pharmacist before taking
Pravastatin:
• 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
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines. Including:
• a group of cholesterol lowering medicines called
fibrates e.g. fenofibrate or gemfibrozil, a medicine which
lowers the body’s immune defences (ciclosporin an
immunosuppressant used after an organ transplant),
another medicine which lowers the level of cholesterol
in your body (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 and lowers the level of fat in
your blood) e.g. colestyramine, colestipol (please see
section 3, If you are also taking a bile acid sequestrant)
• a medicine which treats infections caused by bacteria
(the antibiotics erythromycin, clarithromycin or fusidic
acid. If you need to take oral fusidic acid to treat a
bacterial infection you will need to temporarily stop
using this medicine. Your doctor will tell you when it is
safe to restart Pravastatin.Taking Pravastatin with
fusidic acid may rarely lead to muscle weakness,
tenderness or pain (rhabdomyolysis). See more
information regarding rhabdomyolysis in section 4.
• If you are taking a drug used to treat and prevent
formation of blood clots called “vitamin K antagonist”,
tell your doctor before taking Pravastatin because the
use of vitamin K antagonists concomitantly with
Pravastatin might increase the results of blood tests
used to monitor the treatment with vitamin K antagonists.
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. If you are concerned about how much
alcohol you can drink while you are taking this
medicine, you should discuss this with your doctor.
Pregnancy, breast-feeding and fertility
Do not take Pravastatin:
• if you are pregnant or breast-feeding (as this medicine
passes into the mother’s milk), 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. Make sure you are fit to drive and use
machines before attempting to do so.
Pravastatin contains 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.

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 (see
“pregnancy, breast-feeding and fertility).
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
3 How to take Pravastatin
an adult body capable of reproduction). In this case your
doctor should properly evaluate the risk/benefit of
Always take Pravastatin exactly as your doctor has told
treatment carefully before starting this medicine.
you. You should check with your doctor or pharmacist if
• if you are over 70 years of age
you are not sure. Your doctor will have explained the
• if you have suffered with liver problems in the past

Top of page cut-off to middle of registration mark: 44 mm.

Pravastatin sodium
10 mg, 20 mg and 40 mg tablets

Pravastatin sodium
10 mg, 20 mg and 40 mg tablets
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.

TEVA UK Ref:

BLACK

Template

PANTONE® GREEN C

Colours Used:
360 mm
160 mm
Length:
Width:

Dimensions:

231-30-88310-F LEA PRAVASTATIN A/S TAB TUK
Version:

2

05 July 2016

What is in this leaflet:

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 statins
(or 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
in your blood but do not have coronary heart
disease. If you are at risk of developing coronary
heart disease including the following risk factors:
if you smoke, if you are overweight, if you have
high blood sugar levels, if you have high blood
pressure or if you take little exercise.
• to reduce your risk of having a further heart
attack or stroke, if you have already had a heart
attack or have unstable angina (pains in the chest)
• to reduce increased lipid levels (level of fats in
the blood), if you have had an organ transplant
and are taking medication to stop your body
rejecting the transplant.
Some further information:
• 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. 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. This condition
is called hardening of the arteries (atherosclerosis).
This 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. 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 (see
“pregnancy, breast-feeding and fertility).
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
(hypothyroidism)
• 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
(HMG-CoA reductase inhibitor drugs) 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 are taking or have taken in the last 7 days a
medicine called fusidic acid, (a medicine for
bacterial infection) orally or by injection. The
combination of fusidic acid and Pravastatin can
lead to serious muscle problems (rhabdomyolysis).
If any of the above apply to you, your doctor will need
to carry out a blood test before and possibly during
your treatment. These blood tests will be used to
evaluate your risk of muscle-related side effects.
Also talk to your doctor or pharmacist before taking
Pravastatin:
• 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
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
Including:
• a group of cholesterol lowering medicines called
fibrates e.g. fenofibrate or gemfibrozil, a medicine
which lowers the body’s immune defences
(ciclosporin an immunosuppressant used after an
organ transplant), another medicine which lowers
the level of cholesterol in your body (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 and lowers the level of
fat in your blood) e.g. colestyramine, colestipol
(please see section 3, If you are also taking a bile
acid sequestrant)
• a medicine which treats infections caused by
bacteria (the antibiotics erythromycin,
clarithromycin or fusidic acid. If you need to take
oral fusidic acid to treat a bacterial infection you
will need to temporarily stop using this medicine.
Your doctor will tell you when it is safe to restart
Pravastatin.Taking Pravastatin with fusidic acid
may rarely lead to muscle weakness, tenderness or
pain (rhabdomyolysis). See more information
regarding rhabdomyolysis in section 4.
• If you are taking a drug used to treat and prevent
formation of blood clots called “vitamin K
antagonist”, tell your doctor before taking
Pravastatin because the use of vitamin K
antagonists concomitantly with Pravastatin might
increase the results of blood tests used to monitor
the treatment with vitamin K antagonists.
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. If you are concerned
about how much alcohol you can drink while you
are taking this medicine, you should discuss this
with your doctor.
Pregnancy, breast-feeding and fertility
Do not take Pravastatin:
• if you are pregnant or breast-feeding (as this
medicine passes into the mother’s milk), 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. Make sure you are fit to drive
and use machines before attempting to do so.
Pravastatin contains 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.

TEVA UK Ref:

BLACK

Template

PANTONE® GREEN C

Colours Used:
360 mm
160 mm
Length:
Width:

Dimensions:

231-30-88310-F LEA PRAVASTATIN A/S TAB TUK
Version:

2

05 July 2016

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 and you should continue this diet
over the full treatment period.
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 for Pravastatin
should not be exceeded. Your doctor will tell you
which dose suits you.
• Following 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
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 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
• 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.
• If you have breathing problem including persistent
cough and or/shortness of breath or fever
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.
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 and Hair problems (including hair loss)
Bladder problems (painful or more frequent
urination, having to pass water at night)
• Sexual difficulties
• Muscle and joint pain
Very rare (may affect up to 1 in 10 000 people):
• Weakness, problems with touch including
burning or tingling sensation or numbness, which
may indicate damage to the nerves (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 tendons which may be
complicated by rupture of tendons
• 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
• Diabetes mellitus: Frequency will depend on the
presence or absence of risk factors (fasting
blood glucose at 5.6 mmol/L, BMI>30kg/m 2,
raised triglycerides, history of hypertension).
• Dermatomyositis (condition characterized by an
inflammation of the muscles and the skin).
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: TEVA UK Limited,
Eastbourne, BN22 9AG.
Company Responsible for Manufacture: Teva
Pharmaceutical Works Private Limited Company,
Pallagi Street 13, H-4042, Debrecen, Hungary.
This leaflet was last revised: April 2016
PL 00289/0407-0409

88310-F

TEVA UK Ref:

Version:

231-30-70512-ZB LEA PRAVASTATIN A/S TABS TUK
Dimensions:
Length:
Width:

2

Colours Used:

05 July 2016

Template

323 mm
160 mm

PANTONE® GREEN C
BLACK

PAGE 2: REAR FACE (OUTSIDE OF REEL)

importance of a low fat diet as well as taking Pravastatin
and you should continue this diet over the full treatment
period.
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 for Pravastatin should not
be exceeded. Your doctor will tell you which dose suits you.
• Following 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 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 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
• 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.
• If you have breathing problem including persistent
cough and or/shortness of breath or fever
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.
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 and Hair problems (including hair loss)
• Bladder problems (painful or more frequent urination,
having to pass water at night)

• Sexual difficulties
• Muscle and joint pain
Very rare (may affect up to 1 in 10 000 people):
• Weakness, problems with touch including burning or
tingling sensation or numbness, which may indicate
damage to the nerves (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 tendons which may be complicated
by rupture of tendons
• 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
• Diabetes mellitus: Frequency will depend on the
presence or absence of risk factors (fasting blood
glucose at 5.6 mmol/L, BMI>30kg/m 2, raised
triglycerides, history of hypertension).
• Dermatomyositis (condition characterized by an
inflammation of the muscles and the skin).
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: TEVA UK Limited,
Eastbourne, BN22 9AG.
Company Responsible for Manufacture: Teva
Pharmaceutical Works Private Limited Company, Pallagi
Street 13, H-4042, Debrecen, Hungary.
This leaflet was last revised: April 2016
PL 00289/0407-0409

70512-ZB
160 x 323

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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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