SIMVASTATIN 40MG/5ML ORAL SUSPENSION

Active substance: SIMVASTATIN

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Website: www.mhra.gov.uk/yellowcard

Additional possible side effects reported with some statins:
Q sleep disturbances, including trouble sleeping and nightmares
Q memory loss
Q sexual difficulties
Q 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.
Laboratory Values
Elevations in some laboratory blood tests of liver
function and a muscle enzyme (creatine kinase)
have been observed.
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 directly (see details below).
By reporting side effects you can help provide more information on the safety of this
medicine.
United Kingdom

Ireland

5. How to store Simvastatin 40mg/5ml Oral Suspension

IMB Pharmacovigilance
Earlsfort Terrace, IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.imb.ie
e-mail: imbpharmacovigilance@imb.ie

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6. Contents of the pack and other information

Keep out of the sight and reach of children
Do not store above 25°C
Do not use 1 month after you first open it. Take it back to the pharmacy
Do not use after the expiry date (month, year) stated on the label and carton after EXP.
The expiry date refers to the last day of that month
If it is out of date or you no longer want it, take it back to the pharmacy
Do not use Simvastatin Oral Suspension if you notice anything wrong with the medicine.
Talk to your pharmacist
Do not throw away medicines via wastewater or household waste. Ask your pharmacist
how to throw away medicines you no longer use. These measures will help to protect the
environment.

What Simvastatin 40mg/5ml Oral Suspension contains
Q The active ingredient is simvastatin. Each 5ml contains 40mg simvastatin
Q The other ingredients are methyl parahydroxybenzoate (E218), ethyl
parahydroxybenzoate (E214), propyl parahydroxybenzoate (E216), propylene glycol
(E1520), aluminium magnesium silicate, carmellose sodium (E467), simeticone emulsion,
citric acid (E330), disodium hydrogen phosphate (E339), sodium laurilsulfate (E470a),
acesulfame potassium (E950), lime flavour and purified water.
What Simvastatin 40mg/5ml Oral Suspension looks like and contents of the pack
A white to off-white suspension with an odour of lime.
It comes in a brown glass bottle holding 150ml of suspension.
Marketing Authorisation Holder and Manufacturer
Rosemont Pharmaceuticals Ltd, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11
9XE, UK.
This leaflet was last revised in 06/2014.

P0722

Proof Number:

Date:

1 of: 2

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17.06.14

Simvastatin 40mg/5ml Oral Suspension

Rosemont Pharmaceuticals Ltd. Printed Packaging Origination and Approval

Page:

Product:

40mg/5ml

Pack Size

150ml

211

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330 x 300mm (folded 150 x 37mm)

Sugar-Free

New Pharmacode:

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Patient Information Leaflet
Simvastatin 40mg/5ml Oral Suspension

1. What Simvastatin 40mg/5ml Oral Suspension is and what it is used for

Read all of this leaflet carefully before you start taking this medicine because it
contains important information for you.
Q Keep this leaflet. You may need to read it again.
Q If you have any further questions, ask your doctor or pharmacist.
Q This medicine has been prescribed only for you. Do not pass it on
to others. It may harm them, even if their signs of
illness are the same as yours.
Q 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. What Simvastatin 40mg/5ml Oral Suspension is and what it is used for
2. What you need to know before you take Simvastatin 40mg/5ml Oral Suspension
3. How to take Simvastatin 40mg/5ml Oral Suspension
4. Possible side effects
5. How to store Simvastatin 40mg/5ml Oral Suspension
6. Contents of the pack and other information

2. What you need to know before you take Simvastatin 40mg/5ml Oral Suspension

The name of your medicine is Simvastatin 40mg/5ml Oral Suspension (called simvastatin in
this leaflet). This belongs to a group of medicines called HMG-CoA reductase inhibitors (also
known as statins).
This medicine works by lowering the amount of cholesterol and fatty substances called
triglycerides in your blood.
Simvastatin can be used for:
Q lowering high cholesterol levels or fat levels in the blood when diet, exercise and weight
loss are not enough
Q lowering high cholesterol levels that are hereditary (close members of your family also
have high cholesterol levels). Simvastatin may be given at the same time as other
medicines that lower your cholesterol
Q lowering risk of coronary heart disease (CHD) if you have diabetes, have had a stroke or
you have other blood vessel diseases.

Continued overleaf

Do not take simvastatin and tell your doctor if:
Q you are allergic (hypersensitive) to simvastatin or any other ingredients in this liquid (see
section 6). An allergic reaction can include a rash, itching or shortness of breath
Q you have liver problems
Q you are pregnant or breast-feeding (see section below ‘Pregnancy and breast-feeding')
Q you are taking antifungal drugs such as itraconazole, ketoconazole, posaconazole or
voriconazole
Q you are taking antibiotics such as erythromycin, clarithromycin or telithromycin
Q you are taking medicines to treat HIV infections such as indinavir, nelfinavir, ritonavir or
saquinavir
Q you are taking boceprevir or telaprevir, used to treat hepatitis C virus
Q you are taking a medicine to treat depression called nefazodone
Q you are taking gemfibrozil, used to lower cholesterol
Q you are taking ciclosporin, used in organ transplant patients
Q you are taking danazol, a man-made hormone used to treat endometriosis
Q you are taking, or have taken in the last 7 days, a medicine called fusidic acid, used to
treat bacterial infections.
Do not take this medicine if any of the above apply to you. If you are not sure, talk to your
doctor before taking simvastatin.
Warnings and precautions
Talk to your doctor or pharmacist before taking Simvastatin if:
Q you drink large amounts of alcohol
Q you have a history of liver disease. Your doctor may give you some blood tests to check
your liver before and after starting treatment
Q you have kidney problems
Q you have severe lung disease (respiratory failure).
Contact your doctor immediately if you experience unexplained muscle pain, tenderness or
weakness. This is because on rare occasions, muscle problems can be serious, including
muscle breakdown resulting in kidney damage and very rare deaths have occurred.
The risk of muscle breakdown is greater at higher doses of simvastatin and is greater in
certain patients. Talk with your doctor if any of the following applies:
Q you drink large amounts of alcohol
Q you have kidney problems
Q you have thyroid problems
Q you are 65 years or older
Q you are female
Q you or a close family member have a hereditary muscle problem
you have ever had muscle problems whilst taking other medicines used to lower
cholesterol (see Section 2 'Other medicines and Simvastatin Oral Suspension').
Q

Tick
applicable
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3. How to take Simvastatin 40mg/5ml Oral Suspension

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.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before
taking simvastatin.
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 Oral Suspension).
Simvastatin has not been studied in children
under the age of 10 years. For more information,
talk to your doctor.
Other medicines and Simvastatin Oral Suspension
It is particularly important to tell your doctor if you are taking any of the following medicines.
Taking simvastatin with any of these medicines can increase the risk of muscle problems
(some of these have already been listed in the above section ‘Do not take simvastatin’):
Q ciclosporin, used to dampen the immune system
Q danazol, a steroid used to treat endometriosis and breast cysts in women
Q medicines to treat fungal infections such as itraconazole, ketoconazole, fluconazole,
posaconazole or voriconazole
Q medicines to lower cholesterol called fibrates (such as gemfibrozil or bezafibrate)
Q antibiotics, such as erythromycin, clarithromycin, telithromycin or fusidic acid. Do not take
fusidic acid while using this medicine
Q medicines to treat HIV infections such as indinavir, nelfinavir, ritonavir or saquinavir
Q boceprevir or telaprevir, used to treat hepatitis C virus infection
Q nefazodone, used to treat depression
Q amiodarone, used to treat irregular heart beats
Q verapamil, diltiazem or amlodipine, used to treat heart conditions
Q colchicines, used to treat gout.
As well as the medicines listed above, tell your doctor or pharmacist if you are taking or have
recently taken any other medicines. This includes medicines bought without a prescription,
including herbal medicines.
In particular tell your doctor if you are taking any of the following medicines:
Q medicines that stop blood clots from forming such as warfarin
Q fenofibrate (another medicine for lowering cholesterol)
Q niacin (nicotinic acid, another medicine for lowering cholesterol)
Q medicines to lower cholesterol called bile acid sequestrants such as colestyramine. Take
simvastatin at least 2 hours before or 4 hours after taking the bile acid sequestrant
Q rifamapicin (a medicine used to treat tuberculosis).
Also tell your doctor if you are taking niacin (nicotinic acid) or a niacin-containing product and
are Chinese.
Having operations and tests
If you are going to have an operation, tell the doctor that you are taking simvastatin as it
should be stopped a few days before.
Simvastatin Oral Suspension with food and drink
You must not drink grapefruit juice while taking this medicine as it could increase your risk of
muscle damage.
Pregnancy and Breast-feeding
Do not use simvastatin if you are pregnant or planning to become pregnant. If you become
pregnant while on this medicine, stop taking it and talk to your doctor straight away.
Do not use simvastatin if you are breast-feeding.
Driving and using machines
This medicine should not affect your ability to drive or operate machinery. However, this
medicine may cause dizziness. If you feel this, take extra care when driving or using tools or
machines.
Simvastatin 40mg/5ml Oral Suspension contains methyl parahydroxybenzoate, ethyl
parahydroxybenzoate and propyl parahydroxybenzoate:
Q Methyl, ethyl and propyl parahydroxybenzoates. These may cause an allergic reaction. This
allergy may happen some time after starting the medicine.

Date:

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150ml

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Take this medicine as your doctor or pharmacist has told you. Look on the label and ask the
doctor or pharmacist if you are not sure.
Taking this medicine
Q This medicine contains 40mg of simvastatin in each 5ml
Q Take this medicine by mouth
Q Always shake the bottle before using it
Q If you feel that the effect of your medicine is too strong or too weak, do not change the
dose yourself, but talk to your doctor or pharmacist.
The usual doses are given below. Your doctor may change these.
Adults including older people
The usual dose range is 5mg to 80mg each day. The 80mg dose is only recommended in
patients with very high cholesterol levels and at high risk of heart disease problems who have
not reached their cholesterol goal on lower doses. The dose will be decided by your doctor
depending upon what you are being treated for.

Proof Number:

Simvastatin 40mg/5ml Oral Suspension

Rosemont Pharmaceuticals Ltd. Printed Packaging Origination and Approval

Page:

Product:

40mg/5ml

Pack Size

210

P0722
-

Barcode:

Strength:

-

YES

New Item Code:

330 x 300mm (folded 150 x 37mm)

Sugar-Free

New Pharmacode:

ONE

Keyline

P0612

Cutter Ref:

Design Icon:

Previous Item Code:

Dimensions:

Black

Number of
colours used:

4. Possible side effects

Treatment of high cholesterol levels:
Q The usual starting dose is 10mg (1.25ml) to 20mg (2.5ml) each day. This may be
increased gradually by your doctor up to 40mg (5ml) each day
Q Take this dose in the evening.
Treatment of high cholesterol levels if you have a family history of this:
Q The usual dose is 40mg (5ml) in the evening, or
Q 20mg (2.5ml) in the morning, 20mg (2.5ml) at lunch time and 40mg (5ml) in the
evening.
Prevention of coronary heart disease (CHD):
Q The usual dose is 20mg (2.5ml) to 40mg (5ml)
each day
Q Take this dose in the evening.
People with kidney problems
Q The doctor will start you on a lower dose and
gradually increase it.
Children (10 – 17 years old)
Q The recommended usual starting dose is 10mg (1.25ml) a day in the evening
Q The maximum recommended dose is 40mg (5ml) a day.
If you take more Simvastatin Oral Suspension than you should
If you take more of this medicine than you should, talk to your doctor or go to your nearest
hospital straight away. Take the medicine pack with you.
If you forget to take Simvastatin Oral Suspension
Q If you forget a dose, take it as soon as you remember. However, if it is nearly time for the
next dose, skip the missed dose
Q Do not take a double dose (two doses at the same time) to make up for a forgotten dose.
If you stop taking Simvastatin Oral Suspension
Do not stop taking Simvastatin Oral Suspension unless your doctor tells you to. It may make
your cholesterol levels rise again.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Continued overleaf

Like all medicines, Simvastatin Oral Suspension can cause side effects although not
everybody gets them.
The following terms are used to describe how often side effects have been reported:
Q Rare (occurring in 1 or more of 10,000 and less than 1 of 1000 patients treated)
Q Very rare (occurring in less than 1 of 10,000 patients treated).
Q Frequency not known
The following rare serious side effects were reported.
If any of these serious side effects happen, stop taking simvastatin and tell your doctor
immediately or go to the emergency room at your nearest hospital:
Q muscle pain, tenderness, weakness or cramps. On rare occasions, muscle problems can
be serious, including muscle breakdown resulting in kidney damage; and very rare,
deaths have occurred.
Q an allergic reaction 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)
Q inflammation of the liver with yellowing of the skin and eyes, itching, dark-coloured urine
or pale-coloured stools, liver failure (very rare)
Q inflammation of the pancreas often with severe abdominal pain.
The following side effects have also been reported rarely:
Q low red blood cell count (anaemia)
Q numbness or weakness of the arms and legs
Q headache, tingling sensation, feeling dizzy
Q feeling sick (nausea) or being sick (vomiting)
Q stomach upset including constipation, diarrhoea, wind, heartburn and stomach pain
Q rash, itching, hair loss
Q feeling weak
Q trouble sleeping (very rare)
Q poor memory (very rare).
Side effects where the frequency is not known (cannot be estimated from the available data):
Q erectile dysfunction
Q depression
inflammation of the lungs causing breathing problems including persistent cough and/or
shortness of breath or fever
tendon problems, sometimes complicated by rupture of the tendon.
Q

Q

Tick
applicable
box

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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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