SIMVASTATIN 5MG TABLETS

Active substance: SIMVASTATIN

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Chelonia

SIMVASTATIN 5 mg, 10 mg,
20 mg & 40 mg TABLETS

Version No: 001

Print proof Checked by Regulatory:
xx/xx/xxxx

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 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 become serious, or if you
notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist.

THIS LEAFLET CONTAINS
1. What Simvastatin is for
2. Before you take Simvastatin
3. How to take Simvastatin
4. Possible side effects
5. How to store Simvastatin
6. Further information

Approved to print:

1. WHAT SIMVASTATIN IS FOR
Simvastatin belongs to a group of medicines called
HMG-CoA reductase inhibitors, also known as ‘statins’,
which work by lowering the level of cholesterol and fatty
substances (triglycerides) in your blood.
Simvastatin can be used to:
 treat raised levels of cholesterol
(hypercholesterolaemia) or triglycerides
(hyperlipidaemia) in your blood, when a low fat diet and
other measures (such as exercise and weight loss)
have failed.
 treat inherited increased levels of cholesterol in your
blood (homozygous familial hypercholesterolaemia),
together with dieting and other treatments (e.g.
LDL-apheresis), or when such treatments are not
appropriate.
 prevent coronary heart disease (CHD) in patients with
hardening of the arteries (atherosclerosis) or diabetes,
even in those with normal cholesterol levels, along with
dieting and other treatments.
If you are not sure why you have been prescribed this
medicine then please ask your doctor.

Date: 21/03/2012

Font size: Arial Narrow
Font type: 7.5 pt
Comments:

Product Code: CL0101-0104/O/PIL/G1

2. BEFORE YOU TAKE SIMVASTATIN

Bar Code: N/A

PL Number: 33414/0101-0104

148 x 297 mm

Contract Manufacturer:
Dimensions:

Date MHRA Approved:
20/04/2011 (User Testing)

Avani
Regulatory:
Black

Colours:
Designer: A Patel
Livery: Chelonia/Genesis

Product: Simvastatin 5, 10, 20 & 40 mg Tablets

Design:

Leaflet

Healthcare Limited

Do not take Simvastatin and tell your doctor if you:
 are allergic (hypersensitive) to Simvastatin or any of the
other ingredients in these tablets (listed in section 6 of
this leaflet)
 have liver problems
 are pregnant or breast-feeding (see the section
‘Pregnancy and Breast-feeding’ below)
 are taking any of the following medicines, (also see the
section ‘Taking other medicines’ below)
- antifungals (fluconazole, itraconazole, ketoconazole
or posaconazole)
- HIV-protease inhibitors (ritonavir, indinavir or
nelfinavir)
- certain antibiotics (erythromycin, clarithromycin or
telithromycin)
- the antidepressant nefazodone
Do not take this medicine if any of the above apply to you. If
you are not sure, talk to your doctor or pharmacist before
taking Simvastatin.
Take special care with Simvastatin
Tell your doctor immediately if you experience unexplained
muscle pain, tenderness or muscle weakness while being
treated with Simvastatin.
Simvastatin may cause muscle breakdown (see section 4,
‘Possible Side Effects’). The risk of muscle breakdown is
greater at higher doses, and if you:
 regularly drink large amounts of alcohol
 have had liver problems in the past
 have kidney problems
 have ever had problems with your muscles while using
statins or fibrates (medicines to reduce fat levels in the
blood)
 or your family members suffer from hereditary muscle
disorders
 are more than 70 years old
 have thyroid problems which are not being treated
Your doctor will monitor you closely while you are taking
Simvastatin if you have diabetes, or are at risk of developing
diabetes. You are more at risk of developing diabetes if you
have high levels of sugars and fats in your blood, are
overweight and have high blood pressure.

If you are not sure if any of the above apply to you, talk to
your doctor or pharmacist before taking Simvastatin.
Operations and tests
If you are going to have an operation, tell the doctor, dentist
or nurse that you are taking Simvastatin.
Taking Simvastatin may affect the results of some clinical
tests. If you are going to have a test, it is important to tell
your doctor or nurse that you are taking Simvastatin.
Your doctor may want you to have some simple blood tests
to check your liver both before you start taking Simvastatin
and during your treatment.
Taking other medicines
Tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines
bought without a prescription. This is because Simvastatin
can affect the way some medicines work. Also some
medicines can affect the way Simvastatin works.
In particular, tell your doctor or pharmacist if you are taking
any of the following medicines:
 medicines to treat irregular or uneven heart beat, such
as amiodarone
 antibiotics such as clarithromycin, erythromycin,
telithromycin or fusidic acid, to treat bacterial infections
 antifungals such as fluconazole, itraconazole,
ketoconazole or posaconazole, to treat fungal infections
 antivirals such as indinavir, nelfinavir, ritonavir or
saquinavir, to treat viral infections
 medicines to treat high blood pressure or chest pain,
such as diltiazem, verapamil or amlodipine
 medicines used to thin the blood and stop blood clots
from forming, such as coumarins for example warfarin
 other cholesterol-lowering medicines known as fibrates,
such as bezafibrate and gemfibrozil
 niacin or nicotinic acid also to lower cholesterol (in
doses greater than 1 gram a day)
 ciclosporin to stop the rejection of organs after
transplants
 colchicine to treat gout
 danazol to treat endometriosis and breast cysts in
women
 nefazodone to treat depression
 rifampicin, an antibiotic used to treat tuberculosis
Taking Simvastatin with food and drink
You should not drink grapefruit juice whilst you are being
treated with Simvastatin. It may increase the amount of
Simvastatin in your blood and could increase the risk of
muscle problems.
Pregnancy and breast-feeding
Do not take Simvastatin if you:
 are pregnant or trying to become pregnant
 are breast-feeding
You should stop taking Simvastatin before trying to get
pregnant.
If you become pregnant while taking Simvastatin, stop
taking it and see your doctor straight away.
Children
Safety and effectiveness have been studied in 10-17 year
old boys and in girls who had started their menstrual period
at least one year before (see ‘How to Take Simvastatin’
below).
Simvastatin has not been studied in children under the age
of 10 years. For more information, talk to your doctor.
Driving and using machines
There are no indications that Simvastatin negatively affects
the ability to react. Simvastatin may cause dizziness in rare
cases. If you feel dizzy, then do not drive or operate any
machines.
Important information about some of the ingredients in
Simvastatin tablets
This medicine contains lactose. If you know you have an
intolerance to lactose or other sugars, contact your doctor
before taking this medicine.

3. HOW TO TAKE SIMVASTATIN
Taking this medicine
Always take Simvastatin exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are
not sure.
Swallow the tablets with water. Simvastatin tablets may be
taken with or without food.
Remember to keep to a low-fat diet and exercise while
taking Simvastatin.
Dosage in adult and elderly patients:
People with high levels of blood cholesterol
(Hypercholesterolaemia) or fats (Hyperlipidaemia)
The usual starting dose is 10-20 mg a day, taken as a single
dose in the evening. The maximum dose is 80 mg a day,
taken as a single dose in the evening.

People with inherited high cholesterol levels
(Homozygous familial hypercholesterolaemia)
The usual dose is 40 mg a day, taken as a single dose in the
evening. Your doctor may ask you to take a higher dose of 80
mg each day, taken in three doses of 20 mg in the morning,
20 mg in the afternoon and 40 mg in the evening.
Patients at risk of coronary heart disease (CHD)
The usual dose is 20-40 mg a day, taken as a single dose in
the evening. The maximum dose is 80 mg a day, taken as a
single dose in the evening.
The 80 mg dose is only recommended for adult patients with
very high cholesterol levels and at high risk of heart disease
problems.
Taking another medicine for lowering your cholesterol
at the same time as Simvastatin
Your doctor may ask you to take a bile acid sequestrant
(another type of medicine for lowering cholesterol, such as
cholestyramine) at the same time as taking Simvastatin. This
type of medicine can change the way Simvastatin works. You
should take Simvastatin at least two hours before or at least
four hours after taking the bile acid sequestrant.
Patients with severe kidney problems:
Your doctor may prescribe a lower dose, which will usually
not be more than 10 mg per day.
Children and adolescents:
For children (10 -17 years old), the recommended usual
starting dose is 10 mg a day in the evening. The maximum
recommended dose is 40 mg a day.

 depression
 memory loss
Rare side effects (affect less than 1 in 1000 people):
 low levels of red blood cells, (anaemia), which can
make your skin pale and cause tiredness and
breathlessness
 constipation, stomach pain, wind (flatulence),
indigestion, diarrhoea, feeling sick or being sick
(nausea or vomiting)
 weakness
 headache, tingling or ‘pins and needles’, dizziness, a
disorder of the nerves which can cause weakness or
numbness of the arms and legs
 rash, itching, hair loss
Very rare side effects (affect less than 1 in 10,000
people):
 liver failure
 breathing problems including a persistent cough and/or
shortness of breath
Statins may increase the risk of developing 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 any of the side effects become serious, or if you notice
any side effects not listed in this leaflet, please tell your
doctor or pharmacist.

5. HOW TO STORE SIMVASTATIN
Keep out of the reach and sight of children.

If you take more Simvastatin than you should
If you (or someone else) take too many tablets, contact your
doctor or the nearest hospital casualty department immediately. Take this leaflet and the package with you so they
know what has been taken.

Do not use the tablets after the expiry date stated on the
pack. The expiry date refers to the last day of that month.

If you forget to take Simvastatin
If you forget to take a dose, take it as soon as you remember.
However, if it is nearly time for the next dose, skip the missed
dose and take the next dose when it is due. Do not take a
double dose (two doses at the same time) to make up for a
forgotten dose.

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.

If you stop taking Simvastatin
If you suddenly stop taking Simvastatin, your blood
cholesterol levels may rise again. Do not stop taking this
medicine without consulting your doctor beforehand. Your
doctor will advise you on how best to do this.
If you have any further questions on the use of this medicine,
ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Simvastatin can cause side effects,
although not everybody gets them.
If you get any of the following side effects, STOP
TAKING Simvastatin and tell your doctor immediately or
go to the nearest hospital emergency department:
 an allergic reaction to Simvastatin
You experience some of the following symptoms;
- swelling of the face, tongue or throat which may cause
difficulty breathing
- Lupus-like syndrome (an inflammatory disease which
causes joint pain, skin rashes and fever)
- severe muscle pain and stiffness usually in the
shoulders and hips
- rash with weakness of the limbs and neck muscles
- inflammation of the blood vessels
- increased incidents of bleeding or bruising
- stiffness, pain or inflammation of the joints
- red, raised lumps (hives), skin sensitivity to the sun,
fever, flushing
- shortness of breath, feeling unwell
 Muscle pain, tenderness, weakness or cramps. On rare
occasions, these muscle problems can be serious,
including muscle breakdown resulting in kidney damage.
If you get the following rare side effects, see a doctor
straight away:
 inflammation of the liver, (hepatitis), which may cause
yellowing of the skin or whites of the eyes (jaundice),
darker urine or paler stools
 inflammation of the pancreas, (pancreatitis), which
causes severe pain in the abdomen and back
Tell your doctor or pharmacist if you get any of these
side effects:
Uncommon side effects (affect less than 1 in 100
people):
 sexual dysfunction
 sleep disturbances, including sleeplessness and
nightmares

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

6. FURTHER INFORMATION
What Simvastatin tablets contain
The active substance (the ingredient that makes the tablets
work) is Simvastatin. Each tablet contains 5 mg, 10 mg, 20
mg or 40 mg of the active substance.
The other ingredients are: lactose anhydrous, microcrystalline cellulose (E460), pregelatinised maize starch, butylhydroxyanisole (E320), talc (E553b), magnesium stearate
(E572), hydroxypropylcellulose (E463), hypromellose
(E464) and titanium dioxide (E171).
The 5 mg tablets also contain yellow iron oxide (E172).
What Simvastatin tablets look like and contents of the
pack
Simvastatin 5 mg Tablets are yellow, oblong, scored
film-coated tablets, with ‘SVT’ on one side and ‘5’ on the
other.
Simvastatin 10 mg Tablets are white, oblong, scored
film-coated tablets, with ‘SVT’ on one side and ‘10’ on the
other.
Simvastatin 20 mg Tablets are white, oblong, scored
film-coated tablets, with ‘SVT’ on one side and ‘20’ on the
other.
Simvastatin 40 mg Tablets are white, oblong, scored
film-coated tablets, with ‘SVT’ on one side and ‘40’ on the
other.
All strengths are supplied in blister packs of 28 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Chelonia Healthcare Limited
Boumpoulinas 11, 3rd Floor,
Nicosia, P.C. 1060, Cyprus
Manufacturer
DDSA Pharmaceuticals Limited,
310 Old Brompton Road,
London, SW5 9JQ
For more information about this product, please contact the
Marketing Authorisation Holder.
This leaflet was last revised in 03/2012
CL0101-0104/O/PIL/G1

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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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