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SIMVASTATIN 20MG TABLET

Active substance(s): SIMVASTATIN / SIMVASTATIN

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Simvastatin 10mg Tablets
Simvastatin 20mg Tablets
Simvastatin 40mg Tablets
(simvastatin)
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 gets serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor.
In this leaflet:
1. What Simvastatin Tablets are and what they are used for
2. Before you take Simvastatin Tablets
3. How to take Simvastatin Tablets
4. Possible side effects
5. How to store Simvastatin Tablets
6. Further information
1. WHAT SIMVASTATIN TABLETS ARE AND WHAT THEY ARE USED FOR
Simvastatin belongs to a group of medicines called ‘HMG-CoA reductase inhibitors’ which
reduce the amount of cholesterol and fatty substances called triglycerides in the blood.
Cholesterol is vital to the normal functioning of the body but if levels in the bloodstream are too
high, it can be deposited on the walls of the arteries and build up to form plaques which can
eventually block the blood vessel.
Simvastatin Tablets are used to:
lower levels of cholesterol (and triglycerides) in the blood, thereby reducing the risk of heart
disease
slow or reduce the progression of :
o atherosclerosis (clogging of blood vessels by cholesterol) which can lead to angina
(chest pain) and heart attack.
o coronary heart disease (CHD) - Simvastatin Tablets can help to lessen the risk of a
heart attack.
2. BEFORE YOU TAKE SIMVASTATIN TABLETS
DO NOT take Simvastatin Tablets if you:
are allergic (hypersensitive) to simvastatin or any of the other ingredients in the product (see
Section 6 and end of section 2)
have liver problems or continual raised transaminase levels (liver enzymes) in your blood
are taking any of the following medicines: itraconazole, ketoconazole, HIV protease
inhibitors, erythromycin, clarithromycin, telithromycin or nefazodone (see ‘Taking other
medicines’)
are pregnant or breast-feeding
Take special care with Simvastatin Tablets
When taking this medicine, it is important that you tell your doctor if you have persistent muscle
aches or pain.

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.
Your doctor will monitor your blood levels for the enzyme creatine kinase before, during and
after taking these tablets especially if you:
are over 70 years
have problems with your kidneys.
have uncontrolled thyroid problems
have repeated or unexplained muscle aches or pains (either personal or family history of
muscle problems)
have a history of muscle problems when taking other cholesterol lowering medicines
You regularly drink large amounts of alcohol.
Tell your doctor if you have severe lung disease
It is important to stay on a low-fat diet as well as taking this medicine.
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.
Taking other medicines
Please tell your doctor if you are taking or have recently taken any other medicines, including
those obtained without a prescription.
You must not take any of the following medicines with Simvastatin Tablets. If you need to
take any of these medicines, treatment with Simvastatin Tablets must be stopped:
itraconazole, ketoconazole – for the treatment of fungal infection
HIV protease inhibitors (indinavir, nelfinavir, ritonavir or saquinavir) for the treatment of
HIV infection
erythromycin, clarithromycin, telithromycin - antibiotics
nefazodone – for the treatment of depression.
Simvastatin Tablets may occasionally interact with the following medicines:
digoxin (for heart conditions)
warfarin (for thinning the blood)
two other kinds of lipid-lowering agents: fibric acid derivatives (e.g. benzafibrate,
fenofibrate, gemfibrozil) and large doses of niacin or nicotinic acid.
ciclosporin (an immunosuppressant medicine)
amiodarone, verapamil or diltiazem (heart drugs).
Taking Simvastatin Tablets with food and drink
Do not drink grapefruit juice while you are taking this medicine as it can increase the level of
simvastatin in your blood.
Also avoid alcoholic drinks as too much alcohol during treatment with simvastatin can increase
your cholesterol level.
Pregnancy and breastfeeding
Do not take Simvastatin Tablets if you are pregnant, planning to become pregnant or are
breastfeeding.
Ask your doctor for advice before taking any medicine.
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 Section 3 How to take Simvastatin Tablets).
Simvastatin has not been studied in children under the age of 10 years. For more information,
please talk to your doctor.
Driving and use of machines
Although Simvastatin Tablets are not expected to affect your ability to drive or operate
machinery, dizziness has been reported rarely. If you feel dizzy after taking these tablets, do not
drive or operate machinery.
Important information about some of the ingredients of Simvastatin Tablets
If you have been told by your doctor that you have an intolerance to some sugars, contact your
doctor before taking this medicinal product.
3. HOW TO TAKE SIMVASTATIN TABLETS
Always take Simvastatin Tablets exactly as your doctor has told you. You should check with
your doctor or pharmacist if you are not sure.
It is important you should stay on a low-fat diet as well as taking simvastatin tablets.
The dose is one simvastatin 5mg, 10mg, 20mg, 40mg or 80mg Tablet by mouth once a day.
For children (10-17 years old), the recommended usual starting dose is 10mg a day in the
evening. The maximum recommended dose is 40mg a day.
For high cholesterol levels: the usual starting dose is 10-20mg per day.
For coronary heart disease: the usual starting dose is 20-40mg per day, given as a single dose
in the evening.
Your doctor may adjust your dose (maximum 80mg) in order to have the best effect. The 80mg
dose is only recommended for adult patients with very high cholesterol levels and at high risk of
heart disease problems.
Keep taking Simvastatin Tablets for as long as your doctor has told you to.
If you notice muscle pain, weakness or cramps whilst taking these tablets, tell your doctor
immediately so that your blood levels can be monitored. Your doctor may decide to stop the
treatment and re-introduce the tablets at a lower dose with close monitoring. Always speak to
your doctor before stopping any medication.
If you have need to have surgery
If you are going to hospital for an operation, please tell the doctor as Simvastatin Tablets should
be temporarily stopped a few days before the operation. Your doctor will advise you when to
stop and restart taking them.
If you take more Simvastatin Tablets than you should
If you or someone else swallows several of these tablets together, contact your doctor or nearest
hospital emergency department immediately (taking any remaining tablets as well as the box
with you if possible).
If you forget to take Simvastatin Tablets
If you miss a dose, take one as soon as you can then carry on as before. Do not take an extra
dose to make up for a forgotten dose.
If you stop taking Simvastatin Tablets

Talk to your doctor if you want to stop taking these tablets. Your cholesterol levels might
increase again if you stop taking them.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Simavastatin Tablets can cause side effects, although not everybody gets
them. If any of the following side effects come on soon after taking these tablets, stop the tablets
and tell your doctor immediately:
hypersensitivity (allergic) reactions including:
swelling of the face, tongue and throat which may cause difficulty in breathing
severe muscle pain usually in the shoulders and hips
rash with weakness of limbs and neck muscles
pain or inflammation of the joints
inflammation of the blood vessels
unusual bruising, skin eruptions and swelling, hives, skin sensitivity to the sun,
fever, flushing shortness of breath and feeling unwell
lupus-like disease picture (including rash, joint disorders, and effects on blood
cells)
muscle pain, tenderness, weakness, or cramps. On rare occasions, these muscle problems
can be serious, including muscle breakdown resulting in kidney damage; and very rare
deaths have occurred
inflammation of the liver with yellowing of the skin and eyes, itching, dark-coloured urine
or pale-coloured stool, liver failure (very rare)
inflammation of the pancreas often with severe abdominal pain.
The following side effects have also been reported rarely:
low red blood cell count (anaemia)
numbness or weakness of the arms and legs
headache, tingling sensation, dizziness
digestive disturbances (abdominal pain, constipation, flatulence, indigestion, diarrhoea,
nausea, vomiting)
rash, itching, hair loss
weakness.
Side effects of unknown frequency:
Muscle weakness that is constant.
Other possible side effects:
sleep disturbances, including nightmares
memory loss
sexual difficulties
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 gets serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
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 via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide information on the
safety of this medicine.

5. HOW TO STORE SIMVASTATIN TABLETS
Keep out of the reach and sight of children.
This medicinal product does not require any special storage conditions.
Do not use the tablets after the expiry date stated on the label.
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. FURTHER INFORMATION
What Simvastatin Tablets contain
The active substance is simvastatin, 10mg, 20mg or 40mg.
The other ingredients are lactose anhydrous, microcrystalline cellulose, pregelatinised maize
starch, butylhydroxyanisole, magnesium stearate, talc, hydroxypropylcellulose, hydroxypropyl
methylcellulose and titanium dioxide (E171).(See also end of Section 2 ‘I mportant information
about some of the ingredients of Simvastatin Tablets’ ).
What Simvastatin Tablets look like and contents of the pack
Simvastatin Tablets are white, oblong, biconvex film-coated, scored/embossed tablets.
They are available in blister packs of 2x 14 tablets of 10mg, 20mg or 40mg strength.
Marketing Authorisation Holder :
Special Concept Development (UK) Limited t/a Rx farma,
Units 1-7 Colonial Way, Watford, Hertfordshire, WD24 4YR
Manufacturer:
Medley Pharma Ltd.,
Unit 2A, Olympic Way, Sefton Business Park, Liverpool, L30 1RD, UK
This leaflet was revised : October 2016

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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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