Simvastatin 5 Mg Film-Coated Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
Simvastatin 5 mg film-coated tablets 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 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.
What is in this leaflet:
1. What Simvastatin is and what it is used for
2. What you need to know before you take Simvastatin
3. How to take Simvastatin
4. Possible side effects
5. How to store Simvastatin
6. Contents of the pack and other 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.
2. What you need to know before you take Simvastatin DO NOT take Simvastatin
• if you are allergic (hypersensitive) to simvastatin or any of the other ingredients of this medicine (listed in section
6)
• if you currently have a liver disorder Page 1 of 7
• 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 or posaconazole
- the drugs erythromycin, clarithromycin or telithromycin, which are used to prevent/fight against certain infections
- HIV drugs (e.g. indinavir, nelfinavir, ritonavir and saquinavir - see Other medicines and Simvastatin)
- the antidepressant drug, nefazodone
- gemfibrozil (a medicine for lowering cholesterol)
- cyclosporin (a medicine used in organ transplant patients)
- danazol (a synthetic hormone used to treat endometriosis).
Warnings and precautions
Talk to your doctor or pharmacist before using Simvastatin
• if you are female
• if you have severe respiratory failure
• 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)
• 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 65 years of age or over
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 problems can be increased by the simultaneous use of certain drugs (see “Other medicines and Simvastatin”).
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). Simvastatin has not been studied in children under the age of 10 years. For more information, talk to your doctor.
Consult your doctor if any of the above warnings is applicable to you or has been applicable to you in the past.
Other medicines and Simvastatin
It is particularly important to tell your doctor or pharmacist if you are taking, have recently taken or might Page 2 of 7
take 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 or fluconazole (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)
• amlodipine (a medicine for high blood pressure)
• amiodarone (a medicine used for an irregular heart beat)
• verapamil or diltiazem (medicines for high blood pressure, chest pain associated with heart disease, or other heart conditions)
• colchicines (a medicine used in the treatment of gout)
• rifampicin (a medicine for tuberculosis or leprosy)
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).
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.
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.
Simvastatin contains Lactose
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 take Simvastatin
Always take this medicine exactly as your doctor or pharmacist 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 without 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. Simvastatin tablets should be used in addition to other lipidlowering 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 certain cholesterol-lowering medicines (other fibrates (except gemfibrozil or 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, verapamil or diltiazem (medicines for heart disorders) together with simvastatin, the simvastatin dose should be no higher than 20 mg/day (see “Warnings and precautions”).
Dosage for decreased renal function:
If your kidney function is severely impaired, your doctor may prescribe a lower initial dose.
Use in children and adolescents (10-17 years of age):
For children (10 -17 years old) with a hereditary illness called familial hypercholesterolaemia, the recommended usual starting dose is 10 mg a day in the evening. The maximum recommended dose is 40 mg 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 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, this medicine can cause side effects, although not everybody gets them.
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.
• 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
• 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.
• muscle pain (including inflammation or swelling of muscles), 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.
• breathing problems including persistent cough and/or shortness of breath or fever (very rare).
The following side effects have been reported rarely - may affect up to 1 in 1,000 people:
• 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.
The following side effects have been reported very rarely - may affect up to 1 in 10,000 people:
• trouble sleeping (insomnia)
• memory loss
The following side effects have also been reported but their frequency cannot be estimated from the available information:
• erectile dysfunction
• depression
• breathing problems, persistent cough and/or shortness of breath or fever caused by inflammation of the lungs
• Inflammation or sometimes tearing of the tendon Additional possible side effects reported with some statins:
• Sleep disturbance, including nightmares
• Sexual difficulties
in your blood, are overweight are taking this medicine.
enzyme (creatine kinase) have
• Diabetes - this is more likely if you have high levels of sugars and fats and have high blood pressure. Your doctor will monitor you while you
Laboratory values
Elevations in some laboratory blood tests of liver function and a muscle been observed.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
5. How to store Simvastatin
Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special storage conditions.
Do not use this medicine 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 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. Contents of the pack and other information What Simvastatin tablets contain
The active ingredient is simvastatin.
Simvastatin 5mg film-coated tablet contains 5 mg simvastatin. Simvastatin 10mg film-coated tablet contains 10 mg simvastatin. Simvastatin 20mg film-coated tablet contains 20 mg simvastatin. Simvastatin 40mg film-coated tablet contains 40 mg simvastatin. Simvastatin 80mg 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
Hydroxypropyl cellulose (E463)
Titanium dioxide (E171)
Talc (E553b).
Iron oxide yellow (E 172) - For 5,10 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 5 mg film-coated tablets:
Yellow, round, and biconvex with the inscription “A” on one side and “15” on the other.
Simvastatin 10 mg film-coated tablets:
Light pink, round, and biconvex with the inscription “A” on one side and “01” on the other.
Simvastatin 20 mg film-coated tablets:
Light pink, round, and biconvex with the inscription “A” on one side and “02” on the other.
Simvastatin 40 mg film-coated tablets:
Pink, round, and biconvex with the inscription “A” on one side and “03” on the other.
Simvastatin 80 mg film-coated tablets:
Pink, capsule-shaped and biconvex with the inscription “A” on one side and “04” on the other.
Simvastatin 5, 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.
Marketing Authorisation Holder
Amneal Pharma Europe Limited 70 Sir John Rogerson’s Quay Dublin 2 Ireland
Manufacturer
APL Swift Services (Malta) Limited.,
HF26, Hal Far Industrial Estate,
Hal Far, Birzebbugia, BBG 3000 Malta
This leaflet was last revised in 04/2014
Page 7 of 7