SIMVASTATIN ROSEMONT 20 MG / 5ML ORAL SUSPENSION - patient leaflet, side effects, dosage

Patient leaflet - SIMVASTATIN ROSEMONT 20 MG / 5ML ORAL SUSPENSION

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.

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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
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.
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:

lowering high cholesterol levels or fat levels in the blood when diet, exercise and weight loss are not enough
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
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.

2. what you need to know before you take simvastatin rosemontdo not take simvastatin if: 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

you have liver problems
you are pregnant or breast-feeding (see section below ‘Pregnancy and breastfeeding’)
you are taking antifungal drugs such as itraconazole, ketoconazole, posaconazole or voriconazole
you are taking antibiotics such as erythromycin, clarithromycin or telithromycin
you are taking medicines to treat HIV infections such as indinavir, nelfinavir, ritonavir or saquinavir
you are taking boceprevir or telaprevir, used to treat hepatitis C virus
you are taking a medicine to treat depression called nefazodone
you are taking cobicistat
you are taking a medicine to lower cholesterol called gemfibrozil
you are taking ciclosporin (a medicine often used in transplant patients)
you are taking danazol (a man-made hormone used to treat endometriosis)
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).

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:

you have an existing medical condition including allergies
you drink large amounts of alcohol
you have a history of liver disease. Your doctor may give you some blood tests to check your liver before and after starting treatment
you have kidney problems
you have severe lung disease (respiratory failure).
you are due to have an operation, you may need to stop taking simvastatin for a short time
you are Asian, because a different dose may be applicable to you.

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.

The risk of muscle breakdown is greater at higher doses of simvastatin, particularly the 80 mg dose. The risk of muscle breakdown is also greater in certain patients. Talk with your doctor if any of the following applies:

you drink large amounts of alcohol
you have kidney problems
you have thyroid problems
you are 65 years or older
you are female
you have ever had muscle problems during treatment with cholesterol-lowering medicines called “statins” or fibrates
you or a close family member have a hereditary muscle disorder.

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.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking simvastatin.

Other medicines and Simvastatin

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’):

If you need to take oral fusidic acid to treat a bacterial infection you will need to temporarily stop using this medicine. Your doctor will tell you when it is safe to restart simvastatin. Taking simvastatin with fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis). See more information regarding rhabdomyolysis in section 4.
ciclosporin, used to dampen the immune system
danazol, a steroid used to treat endometriosis and breast cysts in women
medicines to treat fungal infections such as itraconazole, ketoconazole,

fluconazole, posaconazole or voriconazole

medicines to lower cholesterol called fibrates (such as gemfibrozil or

bezafibrate)

antibiotics, such as erythromycin, clarithromycin or telithromycin
medicines to treat HIV infections such as indinavir, nelfinavir, ritonavir or saquinavir
boceprevir, telaprevir, elbasvir or grazoprevir used to treat hepatitis C virus infection
nefazodone, used to treat depression
medicines with the active ingredient cobicistat
amiodarone, used to treat irregular heart beats
verapamil, diltiazem or amlodipine, used to treat heart conditions
lomitapide (used to treat a serious and rare genetic cholesterol condition)
daptomycin (a drug used to treat complicated skin and skin structure infections

and bacteraemia). It is possible that side effects affecting the muscles may be higher when this medicine is taken during treatment with simvastatin. Your doctor may decide that you stop taking Simvastatin for a while

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:

medicines that stop blood clots from forming such as warfarin, phenprocoumon or acenocoumarol (anticoagulants)
fenofibrate (another medicine for lowering cholesterol)
niacin (nicotinic acid, another medicine for lowering cholesterol)
rifamapicin (used to treat tuberculosis).

Also tell your doctor if you are taking niacin (nicotinic acid) or a niacin-containing product and are Chinese.

Also tell any doctor who is prescribing a new medicine for you that you are taking simvastatin.

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 with food and drink

Grapefruit juice contains one or more components that alter how the body uses some medicinal products, including simvastatin. Consuming grapefruit juice should be avoided.

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.

Children and adolescents

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 Rosemont). Simvastatin has not been studied in children under the age of 10 years. For more information, talk to your doctor.

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 Rosemont contains methyl parahydroxybenzoates, ethyl parahydroxybenzoate, propyl parahydroxybenzoate sodium and propylene glycol:

Methyl parahydroxybenzoate (E218), ethyl parahydroxybenzoate (E214) and propyl parahydroxybenzoate (E216). These may cause an allergic reaction. This allergy may happen some time after starting the medicine.
less than 1 mmol sodium (23 mg) per 1ml, that is to say essentially ‘sodium-free’.
propylene glycol (E1520) (17.2mg in a 1ml) – if you are pregnant, breastfeeding or suffer from a liver or kidney disease, do not take this medicine unless recommended by your doctor. Your doctor may carry out extra checks while you are taking this medicine. If your child is less than 5 years old, talk to your doctor or pharmacist before giving them this medicine, in particular if they use other medicines that contain propylene glycol or alcohol.

3. how to take simvastatin rosemont

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

You should stay on a cholesterol-lowering diet while taking simvastatin.

Taking this medicine

This medicine contains 4mg of simvastatin in each 1ml, (20mg of simvastatin in each 5ml).
Take this medicine by mouth using the double-sided measuring spoon provided. The measuring spoon is graduated to deliver a 1.25ml, 2.5ml or 5ml dose as prescribed by your doctor or pharmacist.
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.
Do not use with a tube which is made of latex.
Instructions for use via NG or PEG tube:
1. Ensure the tube is clear before taking the medicine
2. Flush the tube with sufficient amount of water to remove any feed left in the tube
3. Administer the medicine into the tube, with a suitable measuring device
4. Flush the tube again with 10ml of water.

Shake the bottle well before use.
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. The dose will be decided by your doctor depending upon what you are being treated for.

This product strength is the most suitable presentation when doses of 20mg or below are required. For higher doses use the 40mg/5ml strength presentation.

Treatment of high cholesterol levels:

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.
Take this dose in the evening.
The usual dose is 40mg (10ml) in the evening, or
20mg (5ml) in the morning, 20mg (5ml) at lunch time and 40mg (10ml) in the evening.
The usual dose is 20mg (5ml) to 40mg (10ml) each day.
Take this dose in the evening.
The doctor will start you on a lower dose and gradually increase it.
The recommended usual starting dose is 10mg (2.5ml) a day in the evening.
The maximum recommended dose is 40mg (10ml) a day.

If you take more Simvastatin 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

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
Do not take a double dose (two doses at the same time) to make up for a forgotten dose.

If you stop taking Simvastatin

Do not stop taking simvastatin 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, this medicine can cause side effects although not everybody gets them.

The following terms are used to describe how often side effects have been reported:

Rare (may affect up to 1 of 1000 people).
Very rare (may affect up to 1 of 10,000 people).
Not known (frequency cannot be estimated from the available data).

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:

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
an allergic reaction including:
swelling of the face, tongue and throat which may cause difficulty in breathing (angioedema)
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)
inflammation of the liver with yellowing of the skin and eyes, itching, darkcoloured urine or pale-coloured stools, liver failure (very rare)
inflammation of the pancreas often with severe abdominal pain.

The following very rare serious side effects were reported:

a serious allergic reaction which causes difficulty in breathing or dizziness (anaphylaxis)
rash that may occur on the skin or sores in the mouth (lichenoid drug eruptions),
muscle rupture,
gynecomastia (breast enlargement in men).

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, feeling dizzy
blurred vision; impaired vision
feeling sick (nausea) or being sick (vomiting)
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):

erectile dysfunction
depression
breathing problems including persistent cough and/or shortness of breath or fever
tendon problems, sometimes complicated by rupture of the tendon

Additional possible side effects reported with some statins:

sleep disturbances, including nightmares
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
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

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5. how to store 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.

6. contents of the pack and other informationwhat simvastatin rosemont 20mg/5ml oral suspension contains the active ingredient is simvastatin. each 1ml contains 4mg simvastatin, (each 5ml contains 20mg simvastatin).

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:

Greece KYMORAL 1 Iogilio svaiwpnpa 20 mg/5 ml

United Kingdom Simvastatin Rosemont 20mg/5ml Oral Suspension

This leaflet was last updated in: 03/2021