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SIMVASTATIN ROSEMONT 20MG/5ML ORAL SUSPENSION

Active substance(s): SIMVASTATIN / SIMVASTATIN

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stomach upset including constipation, diarrhoea, wind, heartburn and stomach pain
rash, itching, hair loss
feeling weak
trouble sleeping (very rare)
poor memory (very rare).
The following side effects have also been reported but the frequency cannot be estimated from the available information
(frequency not known):
n erectile dysfunction
n depression
n breathing problems including persistent cough and/or shortness of breath or fever
n tendon problems, sometimes complicated by rupture of the tendon
n muscle weakness that is constant.
Additional possible side effects reported with some statins:
n sleep disturbances, including nightmares
n sexual difficulties
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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
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muscle pain, tenderness, or weakness that is constant that may not go
away after stopping simvastatin (frequency not known).
Laboratory Values
Elevations in some laboratory blood tests of liver function and a muscle enzyme (creatine kinase) have been observed.
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
Yellow Card Scheme
HPRA Pharmacovigilance
Website: www.mhra.gov.uk/yellowcard
Earlsfort Terrace, IRL - Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie

Patient Information Leaflet

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Simvastatin Rosemont 20mg/5ml Oral Suspension
Simvastatin

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

1. What Simvastatin Rosemont is and what it is used for
The name of your medicine is Simvastatin Rosemont 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 along with diet for:
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lowering high cholesterol levels or fat levels in the blood when diet, exercise and weight loss are not enough
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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
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lowering risk of coronary heart disease (CHD) if you have diabetes, have had a stroke or you have other blood vessel diseases.
In most people, there are no immediate symptoms of high cholesterol. Your doctor can measure your cholesterol with a simple
blood test. Visit your doctor regularly, keep track of your cholesterol, and discuss your goals with your doctor.

5. How to store Simvastatin Rosemont
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2. What you need to know before you take Simvastatin Rosemont

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and label after EXP. The expiry date refers to the
last day of that month.
After first opening: Use within 1 month.
Do not store above 25°C.
Do not throw away any 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.

Do not take Simvastatin if:
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you are allergic to simvastatin or any of the other ingredients of this medicine (listed in section 6). An allergic reaction can
include a rash, itching or shortness of breath
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you have liver problems
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you are pregnant or breast-feeding (see section below ‘Pregnancy and breast-feeding’)
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you are taking antifungal drugs such as itraconazole, ketoconazole, posaconazole or voriconazole
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you are taking antibiotics such as erythromycin, clarithromycin or telithromycin
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you are taking medicines to treat HIV infections such as indinavir, nelfinavir, ritonavir or saquinavir
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you are taking boceprevir or telaprevir, used to treat hepatitis C virus
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you are taking a medicine to treat depression called nefazodone
n
you are taking cobicistat
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you are taking a medicine to lower cholesterol called gemfibrozil
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you are taking ciclosporin (a medicine often used in transplant patients)
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you are taking danazol (a man-made hormone used to treat endometriosis).
Do not take more than 40 mg simvastatin if you are taking lomitapide (used to treat a serious and rare genetic cholesterol condition).
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:
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you have an existing medical condition including allergies
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you drink large amounts of alcohol
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you have a history of liver disease. Your doctor may give you some blood tests to check your liver before and after starting
treatment
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you have kidney problems
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you have severe lung disease (respiratory failure).
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you are due to have an operation, you may need to stop taking simvastatin for a short time
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you are Asian, because a different dose may be applicable to you
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you are taking or have taken in the last 7 days a medicine called fusidic acid, (a medicine for bacterial infection) orally or by
injection. The combination of fusidic acid and simvastatin can lead to serious muscle problems (rhabdomyolysis).
Your doctor should do a blood test before you start taking simvastatin and if you have any symptoms of liver problems while you
take simvastatin. This is to check how well your liver is working.
Your doctor may also want you to have blood tests to check how well your liver is working after you start taking simvastatin.
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.
Tell your doctor if you have severe lung disease.
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.
Continued overleaf

6. Contents of the pack and other information
What Simvastatin Rosemont 20mg/5ml Oral Suspension contains
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The active ingredient is simvastatin. Each 1ml contains 4mg simvastatin, (each 5ml contains 20mg simvastatin).
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The other ingredients are methyl parahydroxybenzoate (E218), ethyl parahydroxybenzoate (E214), propyl parahydroxybenzoate
(E216), propylene glycol (E1520), aluminium magnesium silicate, carmellose sodium (E466), simeticone emulsion, citric acid
monohydrate (E330), disodium hydrogen phosphate anhydrous (E339), sodium laurilsulfate (E470a), acesulfame potassium
(E950), butylhydroxyanisole (BHA) strawberry flavour and purified water.
What Simvastatin Rosemont 20mg/5ml Oral Suspension looks like and contents of the pack
A white to off-white suspension with a flavour and odour of strawberry.
It comes in a brown glass bottle 150ml with HDPE, EPE wadded, tamper evident, child resistant closure. A double-sided dosing
spoon is provided to measure 1.25ml, 2.5ml and 5ml doses as prescribed.
Marketing Authorisation Holder and Manufacturer
Rosemont Pharmaceuticals Ltd., Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK.
This medicinal product is authorised in the Member States of the EEA under the following names:
Austria
Simvastatin Rosemont 20 mg/5 ml Suspension zum Einnehmen
Denmark
Simvastatin Rosemont 4 mg/ml Oral Suspension
Finland
Simvastatin Rosemont 4 mg/ml Oraalisuspensio
France
Simvastatin Rosemont 20 mg/5 ml Suspension Buvable
Germany
SimvaLiquid GeriaSan 20 mg/5 ml Suspension zum Einnehmen
Greece
KYMORAL Πόσιμο εναιώρημα 20 mg/5 ml
Ireland
Simvastatin Rosemont 20mg/5ml Oral Suspension
Italy
Simvastatina Rosemont 20 mg/5 ml Sospensione Orale
Netherlands
Simvastatine Rosemont 4 mg/ml suspensie voor oraal gebruik
Norway
Simvastatin Rosemont 4 mg/ml mikstur, suspensjon
Portugal
Sinvastatina Rosemont 4 mg/ml Suspensão Oral
Spain
Simvastatin Rosemont 20 mg/5 ml Suspensión Oral EFG
Sweden
Simvastatin Rosemont
United Kingdom
Simvastatin Rosemont 20mg/5ml Oral Suspension
This leaflet was last updated in: 01/2017
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Pharmacode:

324

Simvastatin Rosemont 20mg/5ml
Oral Suspension (UK & IRL)

Dimensions:

210 x 300mm

EAN Code:

N/A

Folded Size:

30 x 150mm

No. of Colours: 1

No

Strength:

20mg/5ml

New Item Code:

E3WD1RBJ2

Tabbed:

Pack Size:

150ml

Previous Item Code:

E3WD1RBJ1

MAIN BODY TEXT

150ml

Supplier Code:

N/A

Page Number:

1 of 2

Date:

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Operator:

DH

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Operator:

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Bottle Size:

16/01/17

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The risk of muscle breakdown is greater at higher doses of simvastatin, particularly the 80 mg dose. The risk of muscle breakdown
This medicine can also be administered via nasogastric (NG) or percutaneous endoscopic gastrostomy (PEG) tubes. There is
further information in the SmPC, ask your doctor, pharmacist or nurse for this information.
is also greater in certain patients. Talk with your doctor if any of the following applies:
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you drink large amounts of alcohol
Do not use with a tube which is made of latex.
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you have kidney problems
Instructions for use via NG or PEG tube:
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you have thyroid problems
1. Ensure the tube is clear before taking the medicine
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you are 65 years or older
2. Flush the tube with sufficient amount of water to remove any feed left in the tube
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you are female
3. Administer the medicine into the tube, with a suitable measuring device
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you have ever had muscle problems during treatment with cholesterol-lowering medicines called “statins” or fibrates
4. Flush the tube again with 10ml of water.
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you or a close family member have a hereditary muscle disorder.
Shake the bottle well before use.
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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
Also tell your doctor or pharmacist if you have a muscle weakness that is constant. Additional tests and medicines may be needed
pharmacist.
to diagnose and treat this.
The usual doses are given below. Your doctor may change these.
If you are not sure if any of the above apply to you, talk to your doctor or
Adults including older people
pharmacist before taking simvastatin.
The usual dose range is 5mg to 80mg each day. The 80mg dose is only
Other medicines and Simvastatin
recommended in patients with very high cholesterol levels and at high risk
It is particularly important to tell your doctor if you are taking any of the
of heart disease problems. The dose will be decided by your doctor
following medicines. Taking simvastatin with any of these medicines can
depending upon what you are being treated for.
increase the risk of muscle problems (some of these have already been
This product strength is the most suitable presentation when doses of 20mg
listed in the above section ‘Do not take Simvastatin’):
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If you need to take oral fusidic acid to treat a bacterial infection you will need to temporarily
or below are required. For higher doses use the 40mg/5ml strength presentation.
stop using this medicine. Your doctor will tell you when it is safe to restart simvastatin. Treatment of high cholesterol levels:
Taking simvastatin with fusidic acid may rarely lead to muscle weakness, tenderness or pain
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The usual starting dose is 10mg (2.5ml) to 20mg (5ml) each day. This may be increased gradually by your doctor up to 40mg
(rhabdomyolysis). See more information regarding rhabdomyolysis in section 4.
(10ml) each day.
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ciclosporin, used to dampen the immune system
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Take this dose in the evening.
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danazol, a steroid used to treat endometriosis and breast cysts in women
Treatment of high cholesterol levels if there is a family history of this:
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medicines to treat fungal infections such as itraconazole, ketoconazole, fluconazole, posaconazole
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The usual dose is 40mg (10ml) in the evening, or
or voriconazole
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20mg (5ml) in the morning, 20mg (5ml) at lunch time and 40mg (10ml) in the evening.
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medicines to lower cholesterol called fibrates (such as gemfibrozil or bezafibrate)
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antibiotics, such as erythromycin, clarithromycin or telithromycin
Prevention of coronary heart disease (CHD):
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medicines to treat HIV infections such as indinavir, nelfinavir, ritonavir or saquinavir
The usual dose is 20mg (5ml) to 40mg (10ml) each day.
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boceprevir or telaprevir, used to treat hepatitis C virus infection
Take this dose in the evening.
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nefazodone, used to treat depression
People with kidney problems
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medicines with the active ingredient cobicistat
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The doctor will start you on a lower dose and gradually increase it.
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amiodarone, used to treat irregular heart beats
Use in children and adolescents (10 – 17 years old)
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verapamil, diltiazem or amlodipine, used to treat heart conditions
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The recommended usual starting dose is 10mg (2.5ml) a day in the evening.
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lomitapide (used to treat a serious and rare genetic cholesterol condition)
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The maximum recommended dose is 40mg (10ml) a day.
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colchicines, used to treat gout.
If you take more Simvastatin than you should
As well as the medicines listed above, tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
If you take more of this medicine than you should, talk to your doctor or go to your nearest hospital straight away. Take the
This includes medicines bought without a prescription, including herbal medicines.
medicine pack with you.
In particular tell your doctor if you are taking any of the following medicines:
If you forget to take Simvastatin
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medicines that stop blood clots from forming such as warfarin, phenprocoumon or acenocoumarol (anticoagulants)
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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
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fenofibrate (another medicine for lowering cholesterol)
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Do not take a double dose (two doses at the same time) to make up for a forgotten dose.
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niacin (nicotinic acid, another medicine for lowering cholesterol)
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rifamapicin (used to treat tuberculosis).
If you stop taking Simvastatin
Do not stop taking simvastatin unless your doctor tells you to. It may make your cholesterol levels rise again.
Also tell your doctor if you are taking niacin (nicotinic acid) or a niacin-containing product and are Chinese.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Also tell any doctor who is prescribing a new medicine for you that you are taking simvastatin.
Having operations and tests
4. Possible side effects
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.
Like all medicines, this medicine can cause side effects although not everybody gets them.
Simvastatin with food and drink
The following terms are used to describe how often side effects have been reported:
Grapefruit juice contains one or more components that alter how the body uses some medicinal products, including simvastatin.
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Rare (occurring in 1 or more of 10,000 and less than 1 of 1000 patients treated)
Consuming grapefruit juice should be avoided.
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Very rare (occurring in less than 1 of 10,000 patients treated)
Pregnancy and Breast-feeding
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Frequency not known.
Do not use simvastatin if you are pregnant or planning to become pregnant. If you become pregnant while on this medicine, stop
The following rare serious side effects were reported.
taking it and talk to your doctor straight away.
Do not use simvastatin if you are breast-feeding.
If any of these serious side effects happen, stop taking simvastatin and tell your doctor immediately or go to the emergency
Children and adolescents
room at your nearest hospital:
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Safety and effectiveness have been studied in 10 -17 year old boys and in girls who had started their menstrual period at least one
muscle pain, tenderness, weakness or cramps. On rare occasions, muscle problems can be serious, including muscle
year before (see How to take Simvastatin Rosemont). Simvastatin has not been studied in children under the age of 10 years. For
breakdown resulting in kidney damage; and very rare, deaths have occurred
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more information, talk to your doctor.
an allergic reaction including:
- swelling of the face, tongue and throat which may cause difficulty in breathing
Driving and using machines
- severe muscle pain usually in the shoulders and hips
This medicine should not affect your ability to drive or operate machinery. However, this medicine may cause dizziness. If you feel
- rash with weakness of limbs and neck muscles
this, take extra care when driving or using tools or machines.
- pain or inflammation of the joints
Simvastatin Rosemont contains methyl parahydroxybenzoates, ethyl parahydroxybenzoate and propyl parahydroxybenzoate:
- inflammation of the blood vessels
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Methyl parahydroxybenzoate (E218), ethyl parahydroxybenzoate (E214) and propyl parahydroxybenzoate (E216). These may
- unusual bruising, skin eruptions and swelling, hives, skin sensitivity to the sun, fever, flushing
cause an allergic reaction. This allergy may happen some time after starting the medicine.
- shortness of breath and feeling unwell
- lupus-like disease picture (including rash, joint disorders and effects on blood cells)
3. How to take Simvastatin Rosemont
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inflammation of the liver with yellowing of the skin and eyes, itching, dark-coloured urine or pale-coloured stools, liver failure
(very rare)
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
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inflammation of the pancreas often with severe abdominal pain.
You should stay on a cholesterol-lowering diet while taking simvastatin.
The following side effects have also been reported rarely:
Taking this medicine
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low red blood cell count (anaemia)
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This medicine contains 4mg of simvastatin in each 1ml, (20mg of simvastatin in each 5ml).
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numbness or weakness of the arms and legs
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Take this medicine by mouth using the double-sided measuring spoon provided. The measuring spoon is graduated to deliver
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headache, tingling sensation, feeling dizzy
a 1.25ml, 2.5ml or 5ml dose as prescribed by your doctor or pharmacist.
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feeling sick (nausea) or being sick (vomiting)
E3WD1RBJ2
Continued overleaf

0

10

20

30

40

50

-

Pharmacode:

324

Simvastatin Rosemont 20mg/5ml
Oral Suspension (UK & IRL)

Dimensions:

210 x 300mm

EAN Code:

N/A

Folded Size:

30 x 150mm

No. of Colours: 1

No

Strength:

20mg/5ml

New Item Code:

E3WD1RBJ2

Tabbed:

Pack Size:

150ml

Previous Item Code:

E3WD1RBJ1

MAIN BODY TEXT

150ml

Supplier Code:

N/A

Page Number:

2 of 2

Date:

COLOURS

Operator:

DH

-

100

JOB SPECIFICATION

Date:
Operator:

90

Keyline Ref:

Bottle Size:

16/01/17

80

Product Name:

PREFLIGHT
VERSION:

-

70

JOB INFORMATION

ARTWORK
VERSION:

3

60

Design Icon: -

Print
Colours:

APPROVALS

Third Party Approval Required

Font Type:

Font Size:

7pt

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Non-print
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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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