SIMVASTATIN 20MG/5ML ORAL SUSPENSION

Active substance: SIMVASTATIN

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5 01 61 19 206 894 >
Each 5ml contains 20mg Simvastatin.
The product also includes methyl, ethyl and propyl
parahydroxybenzoates (E218, E214, E216), propylene glycol
(E1520), carmellose sodium (E467), disodium hydrogen
phosphate anhydrous (E339), sodium laurilsulfate (E470a)
and acesulfame potassium (E950). See leaflet for further
information.
Administration:
For oral use.
Shake the bottle well before use.
Read the package leaflet before use.
Storage:
Do not store above 25°C.
Use within 1 month of opening.
Keep out of the reach and sight of children.

Dimensions:

TM

Rosemont

Date:
Pack Size

1 of: 1

Signature:

-

POM

Manufactured by the MA Holder:
Rosemont Pharmaceuticals Ltd., Leeds, LS11 9XE, UK.

5 01 61 19 2 06 894 >

Core size 76mm
Cutter Ref:

7474
rubine red

Name:
Barcode:
Sugar-Free

150ml

882
Cardiovascular

Regulatory Sign-off
New Pharmacode:

L0825
Previous Item Code:

YES
Design Icon:

Number of
colours used: 3

Page:

L1046
New Item Code:

20mg/5ml

Strength:

L1046

Date:
Proof Number:

TWO

Signature:

19.05.09

Name:
Date:
Simvastatin 20mg/5ml
Oral Suspension

Product:

PL 00427/0146

Tick
applicable
box

I NO I
Third Party Approval Required YES
Rosemont Pharmaceuticals Ltd. Printed Packaging Origination and Approval
TM

Rosemont

PA 312/014/001

Varnish & Ink Free
Area
Rosemont

TM

Affix dispensing label here

150ml

Each 5ml contains 20mg Simvastatin.

KEEP OUT OF THE REACH
AND SIGHT OF CHILDREN

The product also includes methyl, ethyl
and propyl parahydroxybenzoates (E218,
E214, E216), propylene glycol (E1520),
carmellose sodium (E467), disodium
hydrogen phosphate anhydrous (E339),
sodium laurilsulfate (E470a) and
acesulfame potassium (E950).

Storage:
Do not store above 25°C.
Use within 1 month of opening.
Administration:
For oral use.
Shake the bottle well before use.
Read the package leaflet before use.

See leaflet for further information.

Manufactured by the MA Holder:
Rosemont Pharmaceuticals Ltd,
Leeds, LS11 9XE, UK

Rosemont

PL 00427/0146
PA 312/014/001

Rosemont

TM

Rosemont

TM

TM

ROS4

C0365

5 016119 206894 >

Rosemont

TM

Rosemont Pharmaceuticals Ltd. Printed Packaging Origination and Approval

Product:
Strength:
New Item Code:
Previous Item Code:

Simvastatin 20mg/5ml
Oral Suspension

Date:
Proof Number:

C0365

ONE

Page:

20mg/5ml

19.05.09

1 of: 3

New Pharmacode:

N/A

Design Icon:

Cardiovascular

Sugar-Free

Cutter Ref:

ROS4

Pack Size

Dimensions:

3 + Varnish

YES

54 x 54 x 134mm

Number of
colours used:

Rubine red

321

150ml

7474

Barcode:
Black

Third Party Approval Required YES

I NO I

Name:
Signature:

Date:

Regulatory Sign-off
Name:

5 01 61 19 206 894 >

Braille

Keyline

Signature:

Date:

Tick
applicable
box

Varnish & Ink Free
Area
Rosemont

TM

Each 5ml contains 20mg Simvastatin.
The product also includes methyl, ethyl
and propyl parahydroxybenzoates (E218,
E214, E216), propylene glycol (E1520),
carmellose sodium (E467), disodium
hydrogen phosphate anhydrous (E339),
sodium laurilsulfate (E470a) and
acesulfame potassium (E950).
See leaflet for further information.

Manufactured by the MA Holder:
Rosemont Pharmaceuticals Ltd,
Leeds, LS11 9XE, UK

Rosemont

PL 00427/0146
PA 312/014/001

Rosemont

TM

KEEP OUT OF THE REACH
AND SIGHT OF CHILDREN
Storage:
Do not store above 25°C.
Use within 1 month of opening.
Administration:
For oral use.
Shake the bottle well before use.
Read the package leaflet before use.

Rosemont

TM

TM

simvastatin
#20 mg/#5 ml
Oral Suspension

simvastatin
#20 mg/#5 ml
Oral Suspension

Affix dispensing label here

150ml

ROS4

C0365

5 016119 206894 >

Rosemont

TM

Rosemont Pharmaceuticals Ltd. Printed Packaging Origination and Approval

Product:
Strength:
New Item Code:
Previous Item Code:

Simvastatin 20mg/5ml
Oral Suspension

Date:
Proof Number:

C0365

ONE

Page:

20mg/5ml

19.05.09

2 of: 3

New Pharmacode:

N/A

Design Icon:

Cardiovascular

Sugar-Free

Cutter Ref:

ROS4

Pack Size

Dimensions:

3 + Varnish

YES

54 x 54 x 134mm

Number of
colours used:

Rubine red

321

150ml

7474

Barcode:
Black

Third Party Approval Required YES

I NO I

Name:
Signature:

Date:

Regulatory Sign-off
Name:

5 01 61 19 206 894 >

Braille

Keyline

Signature:

Date:

Tick
applicable
box

TM

Rosemont Pharmaceuticals Ltd. Printed Packaging Origination and Approval

Product:
Strength:
New Item Code:
Previous Item Code:

Simvastatin 20mg/5ml
Oral Suspension

Date:
Proof Number:

C0365

ONE

Page:

20mg/5ml

19.05.09

3 of: 3

New Pharmacode:

N/A

Design Icon:

Cardiovascular

Sugar-Free

Cutter Ref:

ROS4

Pack Size

Dimensions:

3 + Varnish

YES

54 x 54 x 134mm

Number of
colours used:

Rubine red

321

150ml

7474

Barcode:
Black

simvastatin
#20 mg/#5 ml
Oral Suspension

simvastatin
#20 mg/#5 ml
Oral Suspension

Varnish & Ink Free
Area
Rosemont

Third Party Approval Required YES

I NO I

Name:
Signature:

Date:

Regulatory Sign-off
Name:

5 01 61 19 206 894 >

Braille

Keyline

Signature:

Date:

Tick
applicable
box






- 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)
n inflammation of the liver with yellowing of the skin and eyes, itching, dark-coloured urine or pale-coloured
stools, liver failure (very rare)
n inflammation of the pancreas often with severe abdominal pain.
The following side effects have also been reported rarely:
n low red blood cell count (anaemia)
n numbness or weakness of the arms and legs
n headache, tingling sensation, feeling dizzy
n feeling sick (nausea) or being sick (vomiting)
n stomach upset including constipation, diarrhoea, wind, heartburn and stomach pain
n rash, itching, hair loss
n feeling weak
n trouble sleeping (very rare)
n poor memory (very rare).
Side effects where the frequency is not known (cannot be estimated from the available data):
n erectile dysfunction
n depression
n inflammation of the lungs causing breathing problems including persistent cough and/or shortness of breath
or fever.
Additional possible side effects reported with some statins:
n sleep disturbances, including trouble sleeping and nightmares
n memory loss
n sexual difficulties
n 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.

The name of your medicine is Simvastatin 20mg/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:
n lowering high cholesterol levels or fat levels in the blood when diet, exercise and weight loss are not
enough
n 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
n lowering risk of coronary heart disease (CHD) if you have diabetes, have had a stroke or you have other
blood vessel diseases.

5. How to store Simvastatin 20mg/5ml Oral Suspension

2. Before you take Simvastatin 20mg/5ml Oral Suspension

n

Do not take simvastatin and tell your doctor if:
n you are allergic (hypersensitive) to simvastatin or any other ingredients in this liquid (see section 6
'Further information'). An allergic reaction can include a rash, itching or shortness of breath
n you have liver problems
n you are pregnant or breast-feeding (see section below ‘Pregnancy and breast-feeding')
n you are taking antifungal drugs such as itraconazole, ketoconazole or posaconazole
n you are taking antibiotics such as erythromycin, clarithromycin or telithromycin
n you are taking medicines to treat HIV infections such as indinavir, nelfinavir, ritonavir or saquinavir
n you are taking a medicine to treat depression called nefazodone
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.
Take special care with simvastatin
Before you take this medicine tell your doctor if:
n you drink large amounts of alcohol
n you have a history of liver disease. Your doctor may give you some blood tests to check your liver before and
after starting treatment
n you have kidney problems
n 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:
n you drink large amounts of alcohol
n you have kidney problems
Continued overleaf

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

6. Further information
What Simvastatin 20mg/5ml Oral Suspension contains
n The active ingredient is simvastatin. Each 5ml contains 20mg simvastatin
n 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), strawberry flavour and purified water.
What Simvastatin 20mg/5ml Oral Suspension looks like and contents of the pack
A white to off-white suspension with an odour of strawberry.
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 March 2012.
SMI - Diabetes





Patient Information Leaflet
Simvastatin 20mg/5ml Oral Suspension
n

Read all of this leaflet carefully before you start taking this medicine.
Keep this leaflet. You may need to read it again.
n If you have any further questions, ask your doctor or your pharmacist.
n This medicine has been prescribed only for you. Do not pass it on to others. It may harm them, even if their
symptoms are the same as yours.
n If any of these side effects gets serious, or if you notice any side effects not listed
in this leaflet, please tell your doctor or pharmacist.
In this leaflet
1. What is Simvastatin 20mg/5ml Oral Suspension and what is it used for
2. Before you take Simvastatin 20mg/5ml Oral Suspension
3. How to take Simvastatin 20mg/5ml Oral Suspension
4. Possible side effects
5. How to store Simvastatin 20mg/5ml Oral Suspension
6. Further information
n

45



1. What is Simvastatin 20mg/5ml Oral Suspension and what is it used for

n

you have thyroid problems
you are 65 years or older
n you are female
n you or a close family member have a hereditary muscle problem
n you have ever had muscle problems whilst taking other medicines used to lower cholesterol (see Section 2
‘Taking other medicines’).
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.
Taking other medicines
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’):
n ciclosporin, used to dampen the immune system
n danazol, a steroid used to treat endometriosis and breast cysts in women
n medicines to treat fungal infections such as itraconazole, ketoconazole, fluconazole or posaconazole
n medicines to lower cholesterol called fibrates (such as gemfibrozil or bezafibrate)
n antibiotics, such as erythromycin, clarithromycin, telithromycin or fusidic acid
n medicines to treat HIV infections such as indinavir, nelfinavir, ritonavir or saquinavir
n nefazodone, used to treat depression
n amiodarone, used to treat irregular heart beats
n verapamil, diltiazem or amlodipine, used to treat heart conditions
n 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:
n medicines that stop blood clots from forming such as warfarin
n fenofibrate (another medicine for lowering cholesterol)
n niacin (nicotinic acid, another medicine for lowering cholesterol)
n 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
n 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.
Taking 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.
Important information about what is in Simvastatin 20mg/5ml Oral Suspension:
This medicine contains:
n Methyl, ethyl and propyl parahydroxybenzoates. These may cause an allergic reaction. This allergy may
happen some time after starting the medicine.
n

SMI - Diabetes





3. How to take Simvastatin 20mg/5ml Oral Suspension
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
n This medicine contains 20mg of simvastatin in each 5ml
n Take this medicine by mouth
n Always shake the bottle before using it
n 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.
Treatment of high cholesterol levels:
n The usual starting dose is 10mg (2.5ml) to 20mg (5ml) each day. This may be increased gradually by
your doctor up to 40mg (10ml) each day
n Take this dose in the evening.
Treatment of high cholesterol levels if you have a family history of this:
n The usual dose is 40mg (10ml) in the evening, or
n 20mg (5ml) in the morning, 20mg (5ml) at lunch time and 40mg (10ml) in the evening.
Prevention of coronary heart disease (CHD):
n The usual dose is 20mg (5ml) to 40mg (10ml) each day
n Take this dose in the evening.
People with kidney problems
n The doctor will start you on a lower dose and gradually increase it.
Children (10 – 17 years old)
n The recommended usual starting dose is 10mg (2.5ml) a day in the evening
n The maximum recommended dose is 40mg (10ml) 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
n 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
n 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.

4. Possible side effects
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:
n Rare (occurring in 1 or more of 10,000 and less than 1 of 1000 patients treated)
n Very rare (occurring in less than 1 of 10,000 patients treated).
n 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:
n 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.
n 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
Continued overleaf

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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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