SIMVASTATIN 40MG FILM COATED TABLETS

Active substance: SIMVASTATIN

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140 mm

Simvastatin 10mg, 20mg and 40mg
Tablets

210 mm

• Please read this leaflet carefully
before you start taking your
medicine.
• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your
doctor or your pharmacist.
• This medicine has been prescribed for you
personally and you should not pass it on to
others. It may harm them, even if their
symptoms are the same as yours.

Front Side

In this leaflet:
1. What Simvastatin is and what it is used for
2. Before you take Simvastatin
3. How to take Simvastatin
4. Possible side effects
5. Storing Simvastatin
Your medicine is called Simvastatin 10mg, 20mg and
40mg tablets referred to throughout the leaflet as
Simvastatin.
• The active substance in this medicine is simvastatin
which is available in 3 strengths. The peach
coloured oval shaped tablets contain 10mg
simvastatin, the tan coloured oval tablets contain
20mg simvastatin and the brick red coloured
tablets contain 40mg of simvastatin.
• The other ingredients are lactose monohydrate,
microcrystalline cellulose, pregelatinised starch,
butylated hydroxyanisole (E320), ascorbic acid,
anhydrous citric acid, colloidal anhydrous silica,
talc, magnesium stearate, hypromellose, red iron
oxide (E172), yellow iron oxide (E172),
triethylcitrate, titanium dioxide (E171), povidone.
• Simvastatin 10mg tablets are supplied in blister
packs of 28 tablets. Simvastatin 20mg tablets and
Simvastatin 40mg tablets are supplied in blister
packs of 14 tablets. Two blister packs per carton.
The Marketing Authorisation Numbers are PL
20395/0004-6
The Marketing Authorisation Holder and
Manufacturer is: Relonchem Limited, 27 Old
Gloucester Street, London, England WC1 3XX.
1.WHAT SIMVASTATIN IS AND WHAT IT IS USED
FOR
Simvastatin belong to a group of medicines called
‘HMG-CoA reductase inhibitors’. These medicines
work by reducing the amount of cholesterol and
fatty substances, called triglycerides, in the blood.
Cholesterol is vital for the body to function.
Sometimes cholesterol can build up in the blood
stream and become deposited in the walls of the
blood vessels. There it forms plaques which will
eventually block the blood vessels similar to scale
furring up of a water pipe. Your doctor has done
some blood tests, which shows that you have high
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amounts of cholesterol and fatty substances in your
blood even though you have been following a low
fat diet. Your doctor may have prescribed
Simvastatin because you have a high risk of
developing heart disease. It is generally accepted
that if you have high amounts of cholesterol in your
blood it adds to your risk of heart disease. Other
factors such as existing heart disease, high blood
pressure, high blood sugar (diabetes), increased
weight, lack of exercise, smoking and a diet high in
fat increase your risk further to the development of
heart disease.
Cholesterol may cause coronary heart disease by
obstructing the blood vessels that carry oxygen and
nutrients to the heart. This obstruction or hardening
of arteries, is called atherosclerosis. Atherosclerosis
may cause chest pain (called angina) and heart
attack. If you suffer from coronary heart disease, your
doctor has prescribed simvastatin to prolong your
life. Simvastatin can decrease the risk of heart attack
and decrease the risk of having to undergo surgery
in order to increase blood flow to the heart.
Simvastatin also delays the progression of
atherosclerosis and reduces the development of new
atherosclerosis.
2. BEFORE YOU TAKE SIMVASTATIN
Make sure it is safe for you to take Simvastatin.
Do not take Simvastatin:
• if you think you may be pregnant
• if you are planning to become pregnant. You should
stop taking Simvastatin at least one month before
trying to become pregnant
• if you discover you are pregnant while taking
Simvastatin you should stop taking Simvastatin
immediately
• if you are a woman who could bear children unless
you are using a reliable form of contraception other
than the pill (you may want to discuss this with your
doctor)
• if you are breast feeding
• if you are hypersensitive (allergic) to any of the
ingredients
• if you have active liver disease
• if you are taking mibefradil, a drug for the
treatment of hypertension and angina
• if you have a rare inherited disease called porphyria.
It is important to talk to your doctor if you have
any other following conditions:
• persistent muscles aches or pains
• have a history of liver disease. Your doctor may
want to do a simple blood test to check your liver is
working properly before you take simvastatin.
Tell your doctor of your present and past medical
problems and any allergies you have.
Simvastatin is not recommended for children.
continued...

140 mm

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go to your nearest casualty department.
If you forget to take Simvastatin:
If you forget to take a tablet, wait until
the next dose is due then continue as
before. Do not take a double dose to
make up for forgotten individual doses.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Simvastatin can have
side effects in some people. The most
common side effects are stomach upsets
(such as feeling or being sick, stomach
pain, constipation, diarrhoea and
flatulence), rash, itchiness, weakness,
headache or indigestion. Other possible
but less common side effects include dizziness, hair
loss, pancreatitis (which may include acute and
persistent gastric pain, feeling sick or being sick and
a temperature), abnormal sensations in the arms
and legs, muscle cramps, urticaria (small pale or
reddened swellings) and
thrombocytopaenia/eosinophilia (problems with
blood which may result in fever, sore throat, unusual
bleeding/bruising).
Rarely a few patients have experienced liver disease,
muscle disease presenting as aches and pains or an
allergic reaction which may include swelling of the
face or neck, muscle and joint pains, joint and blood
vessel inflammation, urticaria, a high temperature,
flushing, difficulty in breathing or tiredness.
If you experience any of these side effects or you
have any other unusual symptoms or feelings, stop
taking the tablets and consult your doctor
immediately. If you notice any side effects not
mentioned in this leaflet, please inform your doctor
or pharmacist.
5. STORING SIMVASTATIN
KEEP OUT OF THE REACH AND SIGHT OF
CHILDREN. STORE IN THE ORIGINAL PACKAGING.
Do not store above 30°C. Do not use after the expiry
date stated on the carton. Any unused medicine
should be returned to your doctor or pharmacist. If
you notice any visible signs of deterioration in the
tablets, take them to your pharmacist for advice
before taking it.
PL 20395/0004
PL 20395/0005
PL 20395/0006
This leaflet was last updated in March 2007

Actavis, Barnstaple, EX32 8NS, UK

210 mm

Back Side

Taking other medicines:
Please check with your doctor before taking
Simvastatin if you are taking or have recently taken
any other medicines even if not prescribed. Some
medicines may occasionally interfere with
Simvastatin including the following:
• immunosuppressants e.g.ciclosporin
• antifungal agents (such as itraconazole
orketoconazole)
• other cholesterol lowering agents such as fibric
acid derivatives (benzafibrate, phenofibrate and
gemfibrozil)
• antibiotics erythromycin and clarithromycin
• the anti-depressant nefazodone
• high doses (> 1g/day) of niacin if nicotinic acid
• HIV protease inhibitors used in the treatment of HIV
infections (indinavir, nelfinavir, ritonavir or
saquinavir)
• blood thinning agents such as warfarin
• digoxin used in the treatment of heart conditions
• amiodarone a drug used to treat an irregular
heartbeat
• mibefradil, verapamil and diltiazem (drugs used to
treat high blood pressure, angina or other heart
conditions)
Taking Simvastatin with food and drink:
Grapefruit juice has one or more components that
alter the metabolism of some medications including
Simvastatin. Large volumes of grapefruit juice (more
than 1 litre) may have adverse effects, however
typical consumption (one 250ml glass daily) is
unlikely to cause problems. If you are unsure ask
your doctor for advice.
Your doctor will have told you to keep alcohol to a
minimum. If you are concerned about how much
alcohol you can drink you should discuss this with
your doctor.
Driving and using machines:
According to current information, Simvastatin does
not affect the capacity to drive or use machines.
Important information about some of the
ingredients of Simvastatin.
These tablets contain Lactose. If you have been told
by your doctor that you have an intolerance to some
sugars, contact your doctor before taking this
medicine.
3. HOW TO TAKE SIMVASTATIN
Your doctor will decide what is the right dose for you
to take and how long you will need to continue
taking the medicine. Check the label and if you’re
not sure ask your doctor or pharmacist.
Usual Dose:
The usual starting dose is 10mg daily for high
cholesterol levels and 20mg daily for coronary heart
disease, taken as a single dose in the evening. Your
doctor may adjust the dose to a maximum daily
dose of 80mg, taken as a single dose in the evening.
Your doctor may prescribe lower doses, especially if
you are taking ciclosporin or suffer from certain
kidney disorders. Continue taking Simvastatin until
your doctor tells you to stop treatment. Take your
tablet whole with a glass of water. Your doctor will
inform you how long to take Simvastatin. If you stop
taking Simvastatin your cholesterol levels may rise
again.
While Taking Your Medicine
If you take more Simvastatin than you should:
Contact your doctor or pharmacist immediately or

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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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