Simvastatin 40mg Film Coated 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Out of date information, search anotherRead all of this leaflet carefully before you start taking this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 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 gets serious, or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
• Your doctor may have given you this medicine before from another company and it may have looked slightly different. Either brand will have the same effect.
In this leaflet:
1. What simvastatin is and what it is used for
2. Before you take simvastatin
3. How to take simvastatin
4. Possible side effects
5. How to store simvastatin
6. Further information
The name of your medicine is Simvastatin 10mg, 20mg or 40mg film-coated tablets. Each Simvastatin tablet contains 10 mg, 20 mg or 40 mg of the active ingredient simvastatin. Simvastatin belongs to a group of medicines called HMG-CoA reductase inhibitors. They work by reducing the level of cholesterol and fats (triglycerides) in your blood.
It is used to treat:
• Coronary heart disease (CHD)
• Higher than normal levels of fats in the blood (hyperlipidaemia)
• An inherited condition causing high levels of cholesterol in the blood (homozygous familial hypercholesterolaemia)
Having too much cholesterol in your blood can lead to coronary heart disease. It can clog blood vessels, leading to hardening of the arteries (atherosclerosis). Hardened arteries are less able to carry blood to the heart and around the body. This can lead to chest pain (angina) and heart attacks. Simvastatin can both prevent hardening of the arteries and slow it down.
If you have high levels of cholesterol you are more likely to get heart disease if you also:
• Have high blood pressure (hypertension) or high blood sugar (diabetes)
• Take little exercise
• Smoke
• Are overweight or eat a high fat diet
Ask your doctor or pharmacist if you would like advice about any of the above factors.
Do not take simvastatin:
• if you are allergic (hypersensitive) to simvastatin or any of the other ingredients of these tablets (see Section 6: Further Information)
• if you have liver problems
• if you are pregnant or breast-feeding (see the section “Pregnancy and breast-feeding” below)
• if you are a woman of child bearing age and you are not using a reliable method of contraception (see the section on pregnancy below)
• if you are taking one or more of the following medicines at the same time:
o itraconazole, ketoconazole, posaconazole or voriconazole (medicines for fungal infections) o erythromycin, clarithromycin, or telithromycin (antibiotics for infections)
o HIV protease inhibitors such as indinavir, nelfinavir, ritonavir, and saquinavir (HIV protease inhibitors are used for HIV infections)
o boceprivir or telaprevir (medicines for hepatitis C virus infection)
o nefazodone (a medicine for depression) o gemfibrozil (a medicine for lowering cholesterol) o ciclosporin (a medicine often used in organ transplant patients)
o danazol (a man-made hormone used to treat endometriosis).
• If you are taking or, in the last 7 days, have taken or been given a medicine called fusidic acid (used to treat bacterial infections)
Ask your doctor if you are not sure if your medicine is listed above.
Take special care with simvastatin:
• Tell your doctor about all your medical conditions including allergies.
• Tell your doctor if you drink large amounts of alcohol.
• Tell your doctor if you have ever had liver disease. Simvastatin may not be right for you.
• Tell your doctor if you are due to have an operation. You may
need to stop taking simvastatin tablets for a short time. _
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. Also tell your doctor or pharmacist if you have muscle weakness that is constant. Additional tests and medicines may be needed to diagnose and treat this.
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 consume 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.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. If you take simvastatin at the same time as some other medicines, it may change the way that simvastatin or the other medicine works.
It is particularly important to tell your doctor if you are taking any of the following drugs. Taking simvastatin with any of these drugs can increase the risk of muscle problems (some of these have already been listed in the above section “Do not take simvastatin”).
• Ciclosporin (a medicine often used in organ transplant patients)
• Danazol (a man-made hormone used to treat endometriosis)
• Other medicines to lower cholesterol known as fibrates (such as bezafibrate or gemfibrozil)
• Itraconazole, ketoconazole, fluconazole, posaconazole or voriconazole (medicines for fungal infections)
• Erythromycin, clarithromycin telithromycin, or fusidic acid (antibiotics). Do not take fusidic acid while using this medicine. Also see section 4 of this leaflet.
• Nefazodone (a medicine to treat depression)
• Medicines to treat HIV infections (such as indinavir, nelfinavir, ritonavir, or saquinavir)
• Boceprivir or telaprevir (medicines for hepatitis C virus infection)
• Amiodarone (a medicine for your heart)
• Verapamil, diltiazem or amlodipine (for high blood pressure, chest pain associated with heart disease, or other heart conditions)
• Colchicine (a medicine 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, including those obtained without a prescription. In particular, tell your doctor if you are taking any of the following:
• medicines to prevent blood clots, such as warfarin, phenpro-coumon or acenocoumarol (anticoagulants)
• fenofibrate (another medicine for lowering cholesterol)
• niacin (another medicine for lowering cholesterol)
• rifampicin (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.
You should also tell any doctor who is prescribing a new medicine for you that you are taking simvastatin.
Taking simvastatin with food and drink
You should not drink grapefruit juice when you are taking simvastatin. It may increase the amount of simvastatin in your blood and could increase the risk of muscle problems.
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). Simvastatin has not been studied in children under the age of 10 years. For more information, talk to your doctor.
Pregnancy and Breast-feeding
Do not take simvastatin if:
• You are pregnant, planning to get pregnant or think you may be pregnant
• You are breast-feeding
If you get pregnant while taking simvastatin, stop taking it and see your doctor straight away.
You should stop taking simvastatin 1 month before trying to get pregnant. If there is a chance that you may get pregnant when taking simvastatin, 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 of Simvastatin tablets
Simvastatin tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Blood tests
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.
Your doctor will determine the appropriate tablet strength for you, depending on your condition, your current treatment and your personal risk status.
Always take simvastatin exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Remember to keep to a low-fat diet and exercise while taking simvastatin.
The usual doses are:
People with coronary heart disease (CHD)
The usual dose is 20 to 40 mg a day, taken in the evening. The maximum dose is 80 mg a day, taken in the evening.
People with high levels of blood fats (Hyperlipidaemia)
The usual starting dose is 10 mg a day, taken in the evening. The maximum dose is 80 mg a day, taken in the evening.
People with inherited high cholesterol levels (Homozygous familial hypercholesterolaemia)
The usual dose is 40 mg a day, taken in the evening. The doctor may ask you to take a higher dose of 80 mg each day, taken in three doses through the day (20 mg, 20 mg and a 40 mg dose taken in the evening).
The 80 mg dose is only recommended for adult patients with very high cholesterol levels and at high risk of heart problems who have not reached their cholesterol goal on lower doses.
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.
Your doctor may ask you to take a lower dose, particularly if you are taking certain medicines listed above or if you have kidney problems.
Keep taking the medicine until your doctor tells you to stop.
Always swallow the tablets with plenty of water.
Taking another medicine for lowering your cholesterol at the same time as simvastatin
Your doctor may ask you to take another medicine for lowering your cholesterol at the same time as taking simvastatin. This includes medicines such as cholestyramine (a resin-type medicine). 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 a resin-type medicine.
If you take more simvastatin than you should
If you take more simvastatin than you should, tell your doctor or go to your nearest hospital straight away. Take the carton and any simvastatin tablets left with you so that the doctors know what you have taken.
If you forget to take simvastatin
If you forget to take a dose, take it as soon as you remember, unless it is time for your next dose.
Do not take a double dose.
If you stop taking simvastatin
Continue taking simvastatin, unless your doctor tells you to stop. Your blood cholesterol levels may rise again once you stop taking simvastatin.
If you have any further questions on the use of this product, ask your doctor or your pharmacist.
o shortness of breath and feeling unwell o lupus-like disease picture (including rash, joint disorders, and effects on blood cells)
• You get liver problems, such as yellowing of the skin or eyes (jaundice/hepatitis)
• You get severe stomach pain which may reach through to your back. This could be a sign of pancreatitis.
These are all serious but rare side effects.
Other rare side effects (affect between 1 in 1000 and 1 in 10,000 people)
• Stomach pain
• Constipation
• Wind (flatulence)
• Weakness
• Headache
• Feeling sick or being sick (nausea or vomiting)
• Diarrhoea
• Skin rash or itching
• Pins and needles
• Feeling breathless and very tired. This could mean you have low levels of red blood cells (anaemia)
• Hair loss
• Dizziness
• Weakness
Very rare side effects (affect less than 1 in 10,000 people)
• Poor memory
• Difficulty sleeping (insomnia)
Not known (frequency cannot be estimated)
• Depression
• Erectile dysfunction
• Breathing problems including persistent cough and/or shortness of breath or fever
• Muscle weakness that is constant
Other 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 tests: increase in some blood tests of liver function and a muscle enzyme (creatine kinase) have been seen.
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 via the Yellow card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
Keep out of the reach and sight of children.
Do not use simvastatin after the expiry date which is stated on the packaging after 'EXP'. The first two digits indicate the month and the last four digits indicate the year. The expiry date refers to the last day of the month.
This medicinal product does not require any special storage conditions.
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.
Like all medicines, simvastatin can cause side effects, although not everybody gets them.
Stop taking simvastatin and see a doctor or go to a hospital straight away if:
• You get unexplained pain, tenderness or weakness in the muscles or pain in your joints, high temperature or tiredness
• You experience symptoms of hypersensitivity (allergic) reactions including:
o swelling of the face, tongue and throat which may cause difficulty in breathing
o severe muscle pain usually in the shoulders and hips o rash with weakness of limbs and neck muscles o pain or inflammation of the joints o inflammation of the blood vessels
o unusual bruising, skin eruptions and swelling, hives, skin sensitivity to the sun, fever, flushing
What Simvastatin tablets contain
• The active substance is simvastatin.
• The other ingredients are: lactose anhydrous, microcrystalline cellulose, pre-gelatinised maize starch, butylhydroxyanisole (E320), magnesium stearate and talc. The tablets are film-coated with a solution containing hydroxypropyl cellulose, hypromellose, titanium dioxide (E171) and talc.
What Simvastatin tablets look like and contents of the pack
Simvastatin 10 mg film-coated tablets are oblong, white scored tablets, with SVT on one side and 10 on the other side. Simvastatin 20 mg film-coated tablets are oblong, white scored tablets, with SVT on one side and 20 on the other side. Simvastatin 40 mg film-coated tablets are oblong, white scored tablets, with SVT on one side and 40 on the other side. They are supplied in blister packs of 28 tablets.
Marketing Authorisation Holder and Manufacturer
Marketing authorisation Holder:
Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS, UK
Manufacturers:
Sanoff-Aventis Sp. z o.o.
Drug Production and Distribution Plant
ul. Lubelska 52
35-233 Rzeszow, Poland
This leaflet does not contain all the information about your medicine. If you have any questions or you are not sure about anything ask your doctor or pharmacist.
This leaflet was last updated in March 2015 © 2015 Zentiva 598723