Simvastatin 80mg Film Coated Tablets
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- 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 stool, 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, dizziness
• digestive disturbances (abdominal pain, constipation, flatulence, indigestion, diarrhoea, nausea, vomiting)
• rash, itching, hair loss
• weakness.
• trouble sleeping (very rare)
• poor memory (very rare)
The following side effects have also been reported but the frequency cannot be estimated from available information (frequency not known):
• erectile dysfunction
• depression
• inflammation of the lungs causing breathing problems including persistent cough and/or shortness of breath or fever
• tendon problems, including rupture of the tendon
Additional possible side effects have been 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.
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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: http://www.mhra.gov.uk/yellowcard. By reporting side affects you can help provide more information on the safety of this medicine.
5. HOW TO STORE SIMVASTATIN
Keep out of the sight and reach of children.
This medicinal product does not require any special storage conditions.
Do not use Simvastatin tablets after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month.
Medicines should not be disposed off 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 is simvastatin.
Each film-coated tablet contains 10 mg simvastatin.
Each film-coated tablet contains 20 mg simvastatin.
Each film-coated tablet contains 40 mg simvastatin.
Each film-coated tablet contains 80 mg simvastatin.
- The other ingredients are:
Tablet core: Butylated hydroxyanisole (E320), Ascorbic acid (E300), Citric acid monohydrate (E330), Microcrystalline cellulose (E460a), Pregelatinised maize starch, Lactose monohydrate, Magnesium stearate (E470B)
Film coating: Hypromellose (E 464), Hydroxy propyl cellulose (E 463), Titanium dioxide (E171), Talc (E553b), Iron oxide yellow (E 172) - For 10 and 20 mg, Iron oxide red (E 172) - For 10, 20, 40 and 80 mg
What Simvastatin tablets look like and contents of the pack Film-coated tablets
Simvastatin 10 mg film-coated tablets: Light pink, round and biconvex plain on one side and marked 10 on the other.
Simvastatin 20 mg film-coated tablets: Light pink, round and biconvex plain on one side and marked 20 on the other.
Simvastatin 40 mg film-coated tablets: Pink, round and biconvex plain on one side and marked 40 on the other.
Simvastatin 80 mg film-coated tablets: Pink, capsule shaped and biconvex plain on one side and marked 80 on the other.
Simvastatin 10, 20, 40 and 80 mg film-coated tablets are available in blister packs containing 10, 14, 28, 30, 50, 56, 84, 98 and 100 tablets.
Not all pack sizes may be marketed.
This leaflet was revised in August 2013.
PL No.: 10 mg - 21880/0064 PL No.: 20 mg - 21880/0065 PL No.: 40 mg - 21880/0066 PL No.: 80 mg - 21880/0067
Marketing Authorisation Holder and Manufacturer:
MEDREICH PLC, Warwick House, Plane Tree Crescent, Feltham TW13 7HF, UK E-mail : info@medreich.co.uk
INFORMATION FOR PATIENTS Simvastatin 10 mg film-coated tablets Simvastatin 20 mg film-coated tablets Simvastatin 40 mg film-coated tablets Simvastatin 80 mg film-coated tablets (Simvastatin)
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 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 if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
■ Simvastatin is used to lower levels of cholesterol and triglycerides in your blood and can help reduce your risk of developing coronary heart disease. (See Section 1 'What Simvastatin is and what it is used for').
■ Simvastatin can cause serious muscle problems in a very small number of patients. If you suffer from unexplained pain, tenderness or weakness in your muscles STOP TAKING the medicine and talk to your doctor at once.
■ DO NOT TAKE this medicine if you are already taking medicines for fungal infections (such as itraconazole, ketoconazole and posaconazole), HIV protease inhibitors (such as indinavir, nelfinavir, ritonavir and saquinavir), antibiotics (such as erythromycin, clarithromycin, telithromycin), gemibrozil used to lower cholesterol, ciclosporin used in organ transplant patients, danazole an anti-hormonal medicine or nefazodone which is used to treat depression. (See Section 2 'Taking other medicines').
■ If you are pregnant or trying to get pregnant or breast feeding you MUST NOT take simvastatin (See Section 2 'Before you take simvastatin').
■ If you have high blood pressure, high levels of fats or sugars in your blood or have a body mass index of more than 30kg/m2 you may be at risk of developing diabetes. Your doctor will monitor you closely if this applies. (See section 2 'Before you take simvastatin' and Section 4 'Possible side effects')
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
1. WHAT SIMVASTATIN IS AND WHAT IT IS USED FOR
Simvastatin is a medicine used to lower levels of cholesterol, "bad" cholesterol (LDL cholesterol) and fatty substances called triglycerides in the blood. In addition Simvastatin raises levels of "good" cholesterol (HDL cholesterol). You should stay on a cholesterol-lowering diet while taking this medicine.
Simvastatin is used along with diet if you have:
• a raised cholesterol level in your blood (primary hypercholesterolaemia) or elevated fat levels in your blood (mixed hyperlipidaemia)
• a hereditary illness (homozygous familial hypercholesterolaemia) that increases the cholesterol level in your blood. You may also receive other treatments.
• coronary heart disease (CHD) or are at high risk of CHD (because you have diabetes, history of stroke, or other blood vessel disease).
Simvastatin may prolong your life by reducing the risk of heart disease problems, regardless of the amount of cholesterol in your blood.
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 goal with your doctor.
BEFORE YOU TAKE SIMVASTATIN
DO NOT use Simvastatin
• if you are allergic (hypersensitive) to simvastatin or any of the other ingredients of Simvastatin
• if you currently have a liver disorder
• if you are pregnant or breast-feeding
• if you are using at the same time one or more than one of the following drugs, which strongly inhibit a specific liver enzyme (CYP3A4):
- the antifungal agents itraconazole ,ketoconazole and posaconazole
- the drugs erythromycin, clarithromycin or telithromycin, which are used to prevent/fight against certain infections HIV drugs e.g. nelfinavir (see Using other medicines). Boceprevir and telaprevir used in the treatment of Hepatitis C
- the antidepressant drug, nefazodone
- gemfibrozil (a medicine for lowering cholesterol)
- ciclosporin (a medicine often used in organ transplant patients)
- danazole an anti-hormonal medicine that is used in the treatment of the development of uterine mucous membrane outside the uterus (endometriosis) and the treatment of painful or sensitive breasts.
Take special care with Simvastatin
• if you have kidney problems
• if you have uncontrolled thyroid problems (hypothyroidism)
• if you have or ever had muscle pain ,tenderness or weakness when using a statin (a group of cholesterol-lowering drugs) or when using fibrates (drugs that lower the lipid content of the blood)
• if you or close family member have a hereditary muscle disorder or previous history of muscle problems
• if you drink or have drunk large amounts of alcohol (alcohol abuse)
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• tell your doctor if you are due to have an operation. You may need to stop taking Simvastatin tablets for a short time.
• if you ever had liver problems
• if you are over 65 years of age
Your doctor may want to do simple blood tests to check your liver function before and during your treatment with 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.
The dose of 80 mg is only recommended for patients with a severely raised cholesterol level in the blood (hypercholesterolaemia) and a high risk of cardiovascular complications.
If you develop unexplained muscle pain, hypersensitive muscles, muscle weakness or muscle cramp, contact your doctor immediately.
Rarely during the use of simvastatin, muscle tissue breakdown (rhabdomyolysis) occurs, accompanied by pain, sensitivity, weakness or cramp in the muscles, fever, and reddish brown urine (see "Possible side effects"). The risk of muscle breakdown is greater at higher doses of simvastatin and is 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.
The risk of muscle problems can be increased by the simultaneous use of certain drugs (see "Using other medicines").
Consult your doctor if any of the above warnings is applicable to you or has been applicable to you in the past.
Using other medicines
It is particularly important to tell your doctor if you are taking any of the following medicinal products. Taking Simvastatin with any of these medicinal products can increase the risk of muscle problems (some of these have already been listed in the above section "Do not take Simvastatin.")
• cyclosporin (a medicine often used in organ transplant patients)
• danazol (an anti-hormonal medicine that is used in the treatment of the development of uterine mucous membrane outside the uterus (endometriosis) and the treatment of painful or sensitive breasts)
• medicines like itraconazole, ketoconazole, fluconazole, or posaconazole (medicines for fungal infections)
• fibrates like gemfibrozil and bezafibrate (medicines for lowering cholesterol)
• erythromycin, Clarithromycin, telithromycin or fusidic acid (medicines for bacterial infections)
• HIV protease inhibitors such as indinavir, nelfinavir, ritonavir and saquinavir (medicines for AIDS).
• nefazodone (a medicine for depression)
• amiodarone (a medicine used for an irregular heart beat)
• verapamil, diltiazem or amlodipine (medicines for high blood pressure, chest pain associated with heart disease, or other heart conditions)
• colchicine (a medicine used to treat gout)
Also tell your doctor if you are taking niacin (nicotinic acid) or a niacin-containing product and are Chinese.
As well as medicines listed above, tell your doctor or pharmacist if you are taking or have recently taken any 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 phenprocoumon or acenocoumarol (anticoagulants).
• fenofibrate (another medicine for lowering cholesterol).
• large amounts (at least 1 g each day) of niacin or nicotinic acid (medicines for lowering cholesterol).
• rifampicin ( a medicine used to treat tuberculosis)
Using Simvastatin with food and drink
Grapefruit juice contains one or more components that alter the transformation of other medicines, such as Simvastatin. Consumption of grapefruit juice must therefore be avoided.
Pregnancy and breast-feeding
Do not take Simvastatin if you are pregnant, trying to become pregnant or think you may be pregnant. If you get pregnant while taking Simvastatin, stop taking it immediately and contact your doctor. Do not take Simvastatin if you are breast-feeding, because it is not known if the medicine is passed into breast milk. Ask your doctor or pharmacist for advice before taking any medicine.
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 Use Simvastatin). Simvastatin has not been studied in children under the age of 10 years. For more information, talk to your doctor Driving and using machines
Simvastatin is not expected to affect your ability to drive and use machines. However, when driving vehicles or using machines, it should be borne in mind that dizziness has been rarely reported.
Important information about some of the ingredients of Simvastatin
Simvastatin contain lactose monohydrate (milk sugar); If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. HOW TO USE SIMVASTATIN
Always take Simvastatin exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Method of administration:
Simvastatin tablets should be taken with water. It can be taken with or with out food. Dosage
The dose is 5-80 mg simvastatin once daily in the evening. Your doctor may adjust your dose to a maximum of 80 mg per day, given as a single dose in the evening at least for 4 weeks.
The 80 mg dose is only recommended in patients with severely raised cholesterol level hypercholesterolaemia) and high risk cardiovascular complications who have not reached their cholesterol goal on lower doses.
Dosage for high cholesterol levels in blood (Hypercholesterolaemia):
You should follow a cholesterol-lowering standard diet before starting the treatment and continue this diet during treatment with simvastatin.
The usual starting dose is 10 mg or 20 mg simvastatin once daily in the evening. If cholesterol has to be lowered by a large amount, your doctor may prescribe an initial dose of 20 mg or 40 mg once daily in the evening.
If necessary your doctor will adjust the dose as described under "Dosage".
Dosage for homozygous familial hypercholesterolaemia (hereditary high blood cholesterol):
The recommended dose is 40 mg/day in the evening, or 80 mg/day (to be taken in three doses of 20 mg, 20 mg and 40 mg in the evening). Simvastatin tablets should be used in addition to other lipid-lowering treatments (e.g. LDL-apheresis) or if such supplementary treatments are not available.
Dosage for prevention of cardiovascular disease:
The usual dose is 20 mg or 40 mg once a day in the evening in patients at a high risk of coronary artery disease (with or without high blood lipids). Treatment can be started with diet and exercise. If necessary your doctor will adjust the dose as described in "Dosage".
Dosage for concomitant therapy with other medicines:
If Simvastatin is taken with other drugs (e.g. colestipol and colestyramine) to reduce cholesterol levels, it should be taken two hours before or four hours after taking these drugs.
If you are using cyclosporin (drug that suppresses the defence) or certain other cholesterol-lowering medicines (fibrates (except fenofibrate)) or niacin (in doses of more than 1 g/day) with simvastatin, the simvastatin dose must not be higher than 10 mg/day. If you are using amiodarone, amlodipine, diltiazem or verapamil (medicines for heart disorders) together with simvastatin, the simvastatin dose should be no higher than 20 mg/day (see "Take special care with Simvastatin"). Dosage for decreased renal function:
If your kidney function is severely impaired, your doctor may prescribe a lower initial dose. Dosage for children and adolescents (10 - 17 years old)The recommended usual starting dose is 10mg a day in the evening. The maximum recommended dose is 40mg a day.
Dosage for elderly patients:
There is no need of dosage adjustment.
Duration of treatment:
You will have to take simvastatin for a fairly long-time. Your doctor will tell you how long to take simvastatin for.
If you take more Simvastatin than you should
If you take more Simvastatin tablets than you should, talk to your doctor or pharmacist or contact with the nearest hospital.
If you forget to take Simvastatin
If you forget to take Simvastatin, just continue with your normal dose. Do not take a double dose to make up for a forgotten dose. Simply continue the treatment as usual the next day.
If you stop taking Simvastatin
Keep taking Simvastatin unless your doctor tells you to stop. If you stop taking Simvastatin your cholesterol levels may increase again.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Simvastatin can cause side effects, although not everybody gets them. The following term is used to describe how often side effects have been reported:
Rare: affecting more than 1 out of 10000 patients and less than 1 out of 1000 patients treated
Very rare: affecting less than 1 out of 10000 patients The following rare serious side effects were reported.
If any of these serious side effects happen, stop taking the medicine and tell your doctor immediately or go to the emergency room at your nearest hospital.
• muscle pain, tenderness, weakness, or cramps. On rare occasions, these muscle problems can be serious, including muscle breakdown resulting in kidney damage; and very rare deaths have occurred.
• hypersensitivity (allergic) reactions 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
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