Simvastatin 10mg Tablets
Out of date information, search anotherRead all of this leaflet carefully before you start taking this medicine.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 pharmacist.
- This medicine has been prescribed 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 the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
PACKAGE LEAFLET: INFORMATION FOR THE USER
SIMVASTATIN 5 mg, 10 mg, 20 mg & 40 mg TABLETS
THIS LEAFLET CONTAINS
1. What Simvastatin is for
2. Before you take Simvastatin
3. How to take Simvastatin
4. Possible side effects
5. How to store Simvastatin
6. Further information
1. WHAT SIMVASTATIN IS FOR
Simvastatin belongs to a group of medicines called HMG-CoA reductase inhibitors, also known as ‘statins’, which work by lowering the level of cholesterol and fatty substances (triglycerides) in your blood.
Simvastatin can be used to:
• treat raised levels of cholesterol (hypercholesterolaemia) or triglycerides (hyperlipidaemia) in your blood, when a low fat diet and other measures (such as exercise and weight loss) have failed.
• treat inherited increased levels of cholesterol in your blood (homozygous familial hypercholesterolaemia), together with dieting and other treatments (e.g. LDL-apheresis), or when such treatments are not appropriate.
• prevent coronary heart disease (CHD) in patients with hardening of the arteries (atherosclerosis) or diabetes, even in those with normal cholesterol levels, along with dieting and other treatments.
If you are not sure why you have been prescribed this medicine then please ask your doctor.
2. BEFORE YOU TAKE SIMVASTATIN
Do not take Simvastatin and tell your doctor if you:
• are allergic (hypersensitive) to Simvastatin or any of the other ingredients in these tablets (listed in section 6 of this leaflet)
• have liver problems
• are pregnant or breast-feeding (see the section ’Pregnancy and Breast-feeding’ below)
• are taking any of the following medicines, (also see the section Taking other medicines’ below)
- antifungals (fluconazole, itraconazole, ketoconazole or posaconazole)
- HIV-protease inhibitors (ritonavir, indinavir or nelfinavir)
- certain antibiotics (erythromycin, clarithromycin or telithromycin)
- the antidepressant nefazodone
Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Simvastatin.
Take special care with Simvastatin
Tell your doctor immediately if you experience unexplained muscle pain, tenderness or muscle weakness while being treated with Simvastatin.
Simvastatin may cause muscle breakdown (see section 4, ‘Possible Side Effects’). The risk of muscle breakdown is greater at higher doses, and if you:
• regularly drink large amounts of alcohol
• have had liver problems in the past
• have kidney problems
• have ever had problems with your muscles while using statins or fibrates (medicines to reduce fat levels in the blood)
• or your family members suffer from hereditary muscle disorders
• are more than 70 years old
• have thyroid problems which are not being treated
Your doctor will monitor you closely while you are taking Simvastatin if you have diabetes, or are at risk of developing diabetes. You are more 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.
Operations and tests
If you are going to have an operation, tell the doctor, dentist or nurse that you are taking Simvastatin.
Taking Simvastatin may affect the results of some clinical tests. If you are going to have a test, it is important to tell your doctor or nurse that you are taking Simvastatin.
Your doctor may want you to have some simple blood tests to check your liver both before you start taking Simvastatin and during your treatment.
Taking other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines bought without a prescription. This is because Simvastatin can affect the way some medicines work. Also some medicines can affect the way Simvastatin works.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
• medicines to treat irregular or uneven heart beat, such as amiodarone
• antibiotics such as clarithromycin, erythromycin, telithromycin or fusidic acid, to treat bacterial infections
• antifungals such as fluconazole, itraconazole, ketoconazole or posaconazole, to treat fungal infections
• antivirals such as indinavir, nelfinavir, ritonavir or saquinavir, to treat viral infections
• medicines to treat high blood pressure or chest pain, such as diltiazem, verapamil or amlodipine
• medicines used to thin the blood and stop blood clots from forming, such as coumarins for example warfarin
• other cholesterol-lowering medicines known as fibrates, such as bezafibrate and gemfibrozil
• niacin or nicotinic acid also to lower cholesterol (in doses greater than 1 gram a day)
• ciclosporin to stop the rejection of organs after transplants
• colchicine to treat gout
• danazol to treat endometriosis and breast cysts in women
• nefazodone to treat depression
• rifampicin, an antibiotic used to treat tuberculosis
Taking Simvastatin with food and drink
You should not drink grapefruit juice whilst you are being treated with Simvastatin. It may increase the amount of Simvastatin in your blood and could increase the risk of muscle problems.
Pregnancy and breast-feeding
Do not take Simvastatin if you:
• are pregnant or trying to become pregnant
• are breast-feeding
You should stop taking Simvastatin before trying to get pregnant.
If you become pregnant while taking Simvastatin, stop taking it and see your doctor straight away.
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’ below).
Simvastatin has not been studied in children under the age of 10 years. For more information, talk to your doctor.
Driving and using machines
There are no indications that Simvastatin negatively affects the ability to react. Simvastatin may cause dizziness in rare cases. If you feel dizzy, then do not drive or operate any machines.
Important information about some of the ingredients in Simvastatin tablets
This medicine contains lactose. If you know you have an intolerance to lactose or other sugars, contact your doctor before taking this medicine.
3. HOW TO TAKE SIMVASTATIN
Taking this medicine
Always take Simvastatin exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Swallow the tablets with water. Simvastatin tablets may be taken with or without food.
Remember to keep to a low-fat diet and exercise while taking Simvastatin.
Dosage in adult and elderly patients:
People with high levels of blood cholesterol (Hypercholesterolaemia) or fats (Hyperlipidaemia)
The usual starting dose is 10-20 mg a day, taken as a single dose in the evening. The maximum dose is 80 mg a day, taken as a single dose in the evening.
People with inherited high cholesterol levels (Homozygous familial hypercholesterolaemia)
The usual dose is 40 mg a day, taken as a single dose in the evening. Your doctor may ask you to take a higher dose of 80 mg each day, taken in three doses of 20 mg in the morning, 20 mg in the afternoon and 40 mg in the evening.
Patients at risk of coronary heart disease (CHD)
The usual dose is 20-40 mg a day, taken as a single dose in the evening. The maximum dose is 80 mg a day, taken as a single dose in the evening.
The 80 mg dose is only recommended for adult patients with very high cholesterol levels and at high risk of heart disease problems.
Taking another medicine for lowering your cholesterol at the same time as Simvastatin
Your doctor may ask you to take a bile acid sequestrant (another type of medicine for lowering cholesterol, such as cholestyramine) at the same time as taking Simvastatin. This type of medicine can change the way Simvastatin works. You should take Simvastatin at least two hours before or at least four hours after taking the bile acid sequestrant.
Patients with severe kidney problems:
Your doctor may prescribe a lower dose, which will usually not be more than 10 mg per day.
Children and adolescents:
For children (10 -17 years old), the recommended usual starting dose is 10 mg a day in the evening. The maximum recommended dose is 40 mg a day.
If you take more Simvastatin than you should
If you (or someone else) take too many tablets, contact your doctor or the nearest hospital casualty department immediately. Take this leaflet and the package with you so they know what has been taken.
If you forget to take Simvastatin
If you forget to take a dose, take it as soon as you remember. Flowever, if it is nearly time for the next dose, skip the missed dose and take the next dose when it is due. Do not take a double dose (two doses at the same time) to make up for a forgotten dose.
If you stop taking Simvastatin
If you suddenly stop taking Simvastatin, your blood cholesterol levels may rise again. Do not stop taking this medicine without consulting your doctor beforehand. Your doctor will advise you on how best to do this.
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 can cause side effects, although not everybody gets them.
If you get any of the following side effects, STOP TAKING Simvastatin and tell your doctor immediately or go to the nearest hospital emergency department:
• an allergic reaction to Simvastatin
You experience some of the following symptoms;
- swelling of the face, tongue or throat which may cause difficulty breathing
- Lupus-like syndrome (an inflammatory disease which causes joint pain, skin rashes and fever)
- severe muscle pain and stiffness usually in the shoulders and hips
- rash with weakness of the limbs and neck muscles
- inflammation of the blood vessels
- increased incidents of bleeding or bruising
- stiffness, pain or inflammation of the joints
- red, raised lumps (hives), skin sensitivity to the sun, fever, flushing
- shortness of breath, feeling unwell
• Muscle pain, tenderness, weakness or cramps. On rare occasions, these muscle problems can be serious, including muscle breakdown resulting in kidney damage.
If you get the following rare side effects, see a doctor straight away:
• inflammation ofthe liver, (hepatitis), which may cause yellowing ofthe skin or whites ofthe eyes (jaundice), darker urine or paler stools
• inflammation ofthe pancreas, (pancreatitis), which causes severe pain in the abdomen and back
Tell your doctor or pharmacist if you get any of these side effects:
Uncommon side effects (affect less than 1 in 100 people):
• sexual dysfunction
• sleep disturbances, including sleeplessness and nightmares
• depression
• memory loss
Rare side effects (affect less than 1 in 1000 people):
• low levels of red blood cells, (anaemia), which can make your skin pale and cause tiredness and breathlessness
• constipation, stomach pain, wind (flatulence), indigestion, diarrhoea, feeling sick or being sick (nausea or vomiting)
• weakness
• headache, tingling or ‘pins and needles’, dizziness, a disorder ofthe nerves which can cause weakness or numbness ofthe arms and legs
• rash, itching, hair loss
Very rare side effects (affect less than 1 in 10,000 people):
• liver failure
• breathing problems including a persistent cough and/or shortness of breath
Statins may increase the risk of developing 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.
If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE SIMVASTATIN
Keep out ofthe reach and sight of children.
Do not use the tablets after the expiry date stated on the pack. The expiry date refers to the last day of that month.
Do not store above 25°C. Store the tablets in the original package.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Simvastatin tablets contain
The active substance (the ingredient that makes the tablets work) is Simvastatin. Each tablet contains 5 mg, 10 mg, 20 mg or 40 mg ofthe active substance.
The other ingredients are: lactose anhydrous, microcrystalline cellulose (E460), pregelatinised maize starch, butylhy-droxyanisole (E320), talc (E553b), magnesium stearate (E572), hydroxypropylcellulose (E463), hypromellose (E464) and titanium dioxide (E171).
The 5 mg tablets also contain yellow iron oxide (E172).
What Simvastatin tablets look like and contents of the pack
Simvastatin 5 mg Tablets are yellow, oblong, film-coated tablets, with ‘SVT’ and a logo on one side, and ‘5’ and a score-line on the other.
Simvastatin 10 mg Tablets are white, oblong, film-coated tablets, with ‘SVT’ and a logo on one side, and ‘10’ and a score-line on the other.
Simvastatin 20 mg Tablets are white, oblong, film-coated tablets, with ‘SVT’ and a logo on one side, and ‘20’ and a score-line on the other.
Simvastatin 40 mg Tablets are white, oblong, film-coated tablets, with ‘SVT’ and a logo on one side, and ‘40’ and a score-line on the other.
All strengths are supplied in blister packs of 28 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Chelonia Flealthcare Limited Boumpoulinas 11,3rd Floor,
Nicosia, P.C. 1060, Cyprus
Manufacturer
DDSA Pharmaceuticals Limited,
310 Old Brompton Road,
London, SW5 9JQ
For more information about this product, please contact the Marketing Authorisation Holder.
This leaflet was last revised in 07/2012
CL0101 -0104/O/PIL/G2