Simvastatin Rosemont 20mg/5ml Oral Suspension
Out of date information, search anotherThe following side effects have also been reported but the frequency cannot be estimated from the available information (frequency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
■ 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.
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.
Rosemant®^
Simvastatin Rosemont 20mg/5ml Oral Suspension
Simvastatin
■ Keep out of the reach and sight of children.
■ Do not use Simvastatin Oral Suspension after the expiry date which is stated on the carton and bottle 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.
■ Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This measure will help to protect the environment.
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 your pharmacist.
■ 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.
■ 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 Rosemont 20mg/5ml Oral Suspension and what is it used for
2. Before you take Simvastatin Rosemont 20mg/5ml Oral Suspension
3. How to take Simvastatin Rosemont 20mg/5ml Oral Suspension
4. Possible side effects
5. How to store Simvastatin Rosemont 20mg/5ml Oral Suspension
6. Further information
What 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.
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.
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 Orale
Germany SimvaLiquid GeriaSan 20 mg/5 ml Suspension zum Einnehmen
Greece KYMORAL nooipo evaiwpqpa 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 Sinvastatin Rosemont 20 mg/5 ml Suspensao Oral
Spain Simvastatin Rosemont 20 mg/5 ml Suspension Oral EFG
Sweden Simvastatin Rosemont 4 mg/ml Oral Suspension
United Kingdom Simvastatin Rosemont 20mg/5ml Oral Suspension
This leaflet was last revised in: 06/2015
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Do not take simvastatin and tell your doctor if:
■ 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
■ you have liver problems
■ you are pregnant or breast-feeding (see section below 'Pregnancy and breast-feeding')
■ you are taking antifungal drugs such as itraconazole, ketoconazole or posaconazole
■ 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 a medicine to treat depression called nefazodone
■ 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).
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:
■ 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.
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.
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 to your doctor if any of the following applies:
■ you drink large amounts of alcohol
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■ you have kidney problems
■ you have thyroid problems
■ you are female
■ you are 65 years or older
■ 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 'Taking other medicines').
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking simvastatin.
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'):
■ 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 or posaconazole
■ medicines to lower cholesterol called fibrates (such as gemfibrozil or bezafibrate)
■ antibiotics, such as erythromycin, clarithromycin, telithromycin or fusidic acid
■ medicines to treat HIV infections such as indinavir, nelfinavir, ritonavir or saquinavir
■ nefazodone, used to treat depression
■ amiodarone, used to treat irregular heart beats
■ verapamil, diltiazem or amlodipine, used to treat heart conditions
■ 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 Rosemont 20mg/5ml Oral Suspension.
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
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
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.
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 Rosemont 20mg/5ml Oral Suspension:
This medicine contains:
■ 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.
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.
Treatment of high cholesterol levels if there is a family history of this:
■ 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.
Prevention of coronary heart disease (CHD):
■ The usual dose is 20mg (5ml) to 40mg (10ml) each day.
■ Take this dose in the evening.
People with kidney problems
■ The doctor will start you on a lower dose and gradually increase it.
Children (10 - 17 years old)
■ 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 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
■ 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 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.
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.
You should stay on a cholesterol-lowering diet while taking Simvastatin Rosemont 20mg/5ml Oral Suspension.
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.
■ 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.
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:
■ Rare (occurring in 1 or more of 10,000 and less than 1 of 1000 patients treated)
■ Very rare (occurring in less than 1 of 10,000 patients treated)
■ 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:
■ 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
- 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, dark-coloured urine or pale-coloured stools, 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, feeling dizzy
■ 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).
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