Simvastatin 80 Mg Film-Coated Tablets
|
TEVA UK Ref: 231-30-13358-K LEA SIMVASTATIN 10mg, 20mg, 40mg & 80mg TAB TUK <DEB Version: 1 01 September 2016 | |||||
|
Width Depth Foil W |
Changed?: No : 460 mm : 160 mm N/A dth: N/A |
Colours Used: 1 Template 1 ^PANTONE®GREENCJ | |||
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. See section 4.
isin
1. What Simvastatin Film-coated Tablets are and what they are used for
2. What you need to know before you take Simvastatin Film-coated Tablets
3. How to take Simvastatin Film-coated Tablets
4. Possible side effects
5. How to store Simvastatin Film-coated Tablets
6. Contents of the pack and other information
OWhat Simvastatin film coated
tablets are and what they are used for
Simvastatin is a medicine used to lower levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. In addition, it raises levels of "good" cholesterol (HDL cholesterol). You should stay on a cholesterol-lowering diet while taking this medicine. Simvastatin is a member of the class of drugs called statins. 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 goals with your doctor.
What you need to know before you take Simvastatin
The risk of muscle breakdown is greater at higher doses of Simvastatin Film-coated Tablets 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 old 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.
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.
Children
Safety and effectiveness have been studied in 10-17-year-old boys and girls who had started their menstrual period at least one year before (see 3. How to take Simvastatin Film-coated Tablets). Simvastatin Film-coated Tablets has not been studied in children under the age of 10 years. For more information, talk to your doctor.
Other medicines and Simvastatin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
It is particularly important to tell your doctor if you are taking any of the following drugs. Taking Simvastatin Film-coated Tablets 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 Film-coated Tablets):
• ciclosporin (a medicine often used in organ transplant patients),
• danazol (a man-made hormone used to treat endometriosis),
• medicines such as 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), Do not take fusidic acid while using this medicine. Also see section 4 of this leaflet.
• HIV protease inhibitors such as indinavir, nelfinavir, ritonavir or saquinavir (medicines for AIDS),
• nefazodone (a medicine for depression),
• amiodarone (a medicine 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).
as
j=
.c
Do NOT take Simvastatin Film-coated Tablets
• If you are allergic (hypersensitive) to simvastatin, or any of the other ingredients of this medicine (listed in section 6).
• If you currently have liver problems.
• If you are pregnant or breast-feeding.
• If you are taking one or more than one of the following drugs at the same time:
• itraconazole, ketoconazole or posaconazole (medicines for fungal infections),
• erythromycin, clarithromycin or telithromycin (antibiotics for infections),
• HIV protease inhibitors such as indinavir, nelfinavir, ritonavir and saquinavir (HIV protease inhibitors are used for HIV infections),
• nefazodone (a medicine for depression).
• If you are taking or, in the last 7 days, have taken or been given a medicine called fusidic acid (used to treat bacterial infection).
Warnings and precautions
Talk to your doctor or pharmacist before taking Simvastatin Film-coated Tablets Tell your doctor:
• about all your medical conditions including allergies,
• if you drink large amounts of alcohol,
• if you have ever had liver disease. Simvastatin Film-coated Tablets may not be right for you.
• if you are due to have an operation. You may need to stop taking Simvastatin Film-coated Tablets for a short time.
Your doctor should do a blood test before you start taking Simvastatin Film-coated Tablets. 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 Film-coated Tablets.
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.
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 your are taking any of the following:
• medicines to prevent blood clots, such as warfarin, phenprocoumon 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.
Simvastatin Film-coated Tablets with food and drink
Grapefruit juice contains one or more components that alter how the body uses some medicinal products, including Simvastatin Film-coated Tablets. Consuming grapefruit juice should be avoided.
Pregnancy and breast-feeding Do not take simvastatin if you are pregnant, trying to get 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 for advice from your doctor or pharmacist before taking any medicine. Driving and using machines
Simvastatin Film-coated Tablets is not expected to interfere with your ability to drive or use machinery. However, it should be taken into account that some people get dizzy after taking it.
Simvastatin Film-coated Tablets contain lactose
Simvastatin Film-coated Tablets contain a sugar called lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
|
teva UK Ref: 231-30-13358-K LEA SIMVASTATIN 10mg, 20mg, 40mg & 80mg TAB TUK <DEB Version: 1 01 September 2016 | ||||
|
UK |
Eittboumo Artwork Origin tlkm |
Dim's Changed?: No Length: 460 mm Width: 160 mm Depth: N/A Foil Width: N/A |
Colours Used: 1 Template 1 Jpantgne®green"cJ | |
©How to take Simvastatin Film-coated Tablets
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
• depression
• inflammation of the lungs causing breathing problems including persistent cough and/or shortness of breath or fever
• tendon problems, sometimes complicated by rupture of the tendon.
a>
8
£
You should stay on a cholesterol-lowering diet while taking Simvastatin Film-coated Tablets.
The recommended dose is one Simvastatin 10 mg, 20 mg, 40 mg or 80 mg Film-coated Tablet by mouth once a day.
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.
The 80 mg dose is only recommended for adult patients with very high cholesterol levels and at high risk of heart disease problems who have not reached their cholesterol goal on lower doses.
Your doctor will determine the appropriate tablet strength for you, depending on your condition, your current treatment and your personal risk status.
Take Simvastatin Film-coated Tablets in the evening. You can take it with or without food. The usual starting dose is 10 mg, 20 mg or, in some cases, 40 mg a day. Your doctor may adjust your dose after at least 4 weeks to a maximum of 80 mg a day. Do not take more than 80 mg a day. Your doctor may prescribe lower doses, particularly if you are taking certain medicinal products listed above or have certain kidney conditions. Keep taking Simvastatin Film-coated Tablets unless your doctor tells you to stop.
If your doctor has prescribed simvastatin along with a bile acid sequestrant (medicines for lowering cholesterol), you should take Simvastatin Film-coated Tablets at least 2 hours before or 4 hours after taking the bile acid sequestrant.
The 10 mg, 20 mg, 40 mg and 80 mg tablets can be divided into equal doses.
If you take more simvastatin than you should Please contact your doctor or pharmacist.
If you forget to take Simvastatin Film-coated Tablets
Do not take a double dose to make up for a forgotten tablet.
Do not take an extra dose, just take your normal amount of Simvastatin Film-coated Tablets at the usual time the next day.
If you stop taking Simvastatin Film-coated Tablets
Your cholesterol may rise again.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following rare (may affect up to 1 in 1,000 people) serious side effects were reported. If any of these serious side effects happen, stop taking the medicine and tell your doctor immediately or got 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; 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,
• 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 may affect up to 1 in 10,000 people)
• inflammation of the pancreas often with severe abdominal pain.
The following side effects have also 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
• trouble sleeping (very rare)
• poor memory (very rare)
The following side effects have also been reported but the frequency cannot be estimated from the available information (frequency not known):
• erectile dysfunction
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.
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.
©How to store Simvastatin Film-coated Tablets
Keep this medicine out of the sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date which is stated on the carton and blister packs after EXP. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines no longer use. These measures will help to protect the environment.
©Contents of the pack and other information
What Simvastatin Film-coated Tablets contain
The active substance is simvastatin. Each tablet contains 10 mg, 20 mg, 40 mg or 80 mg simvastatin.
The other ingredients are lactose monohydrate, microcrystalline cellulose, pregelatinised maize starch, butylhydroxyanisole (E320), magnesium stearate, ascorbic acid and citric acid monohydrate, hypromellose, titanium dioxide, macrogol 3350, triacetin (E1518), red iron oxide, 10 mg, 20 mg, 80 mg: yellow iron oxide, 80 mg: black iron oxide.
What Simvastatin Film-coated Tablets look like and contents of the pack
Film-coated tablets.
• Simvastatin 10 mg Film-Coated Tablets are light pink, oval-shaped, film coated tablets with a breakline on one side.
• Simvastatin 20 mg Film-Coated Tablets are tan, oval-shaped, film coated tablets with a breakline on one side.
• Simvastatin 40 mg Film-Coated Tablets are pink, oval-shaped, film coated tablets with a breakline on one side.
• Simvastatin 80 mg Film-Coated Tablets are brick-red oval-shaped, film-coated tablets with a breakline on one side.
The 10 mg, 20 mg, 40 mg and 80 mg tablets can be divided into equal doses.
Simvastatin 10 mg Film-Coated Tablets are available in aluminium blisters containing 20, 28, 30, 50, 60, 90, 100 or 250 film-coated tablets and a hospital pack of 50x1 tablets. Simvastatin 20 mg Film-Coated Tablets are available in aluminium blisters containing 10, 28, 30, 50, 60, 90, 100 or 250 film-coated tablets and a hospital pack of 50x1 tablets. Simvastatin 40 mg Film-Coated Tablets are available in aluminium blisters containing 10, 28, 30, 50, 60, 90, 100 or 250 film-coated tablets and a hospital pack of 50x1 tablets. Simvastatin 80 mg Film-Coated Tablets are available in aluminium blisters containing 28, 30, 50, 60, 90, 100 or 250 film-coated tablets and a hospital pack of 50x1 tablets. Simvastatin 10 mg, 20 mg, 40 mg and 80 mg Film-coated Tablets are also available in HDPE containers containing 250 film-coated tablets. Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Teva UK Limited, Eastbourne, BN22 9AG, UK
Manufacturer
TEVA Pharmaceutical Works Private Limited Company, Pallagi ut 13, 4042 Debrecen, Hungary
This leaflet was last revised in September 2016
PL 00289/1451 PL 00289/1452 PL 00289/1453 PL 00289/1454
inTwn
13358-K
.c
|
TEVA UK Ref: 231-30-13320-G LEA SIMVASTATIN 10mg, 20mg, 40mg & 80mg TAB TUK <DEB Version: 1 01 September 2016 | ||||
|
■uIZITTI |
UK |
Eastbourne Artmrit Origination |
Dim's Changed?: No Length: 460 mm Width: 160 mm Depth: N/A Foil Width: N/A |
Colours Used: 1 Template 1 Jpantone®green"c ^ |
PACKAGE LEAFLET: INFORMATION FOR THE USER
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
• 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. See section 4.
1. What Simvastatin Film-coated Tablets are and what they are used for
2. What you need to know before you take Simvastatin Film-coated Tablets
3. How to take Simvastatin Film-coated Tablets
4. Possible side effects
5. How to store Simvastatin Film-coated Tablets
6. Contents of the pack and other information
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 Film-coated Tablets 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 old 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.
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.
Children
Safety and effectiveness have been studied in 10-17-year-old boys and girls who had started their menstrual period at least one year before (see 3. How to take Simvastatin Film-coated Tablets). Simvastatin Film-coated Tablets has not been studied in children under the age of 10 years. For more information, talk to your doctor.
Other medicines and Simvastatin
OWhat Simvastatin film coated
tablets are and what they are used for
Simvastatin is a medicine used to lower levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. In addition, it raises levels of "good" cholesterol (HDL cholesterol). You should stay on a cholesterol-lowering diet while taking this medicine. Simvastatin is a member of the class of drugs called statins. 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 goals with your doctor.
What you need to know before you take Simvastatin
Do NOT take Simvastatin Film-coated Tablets
• If you are allergic (hypersensitive) to simvastatin, or any of the other ingredients of this medicine (listed in section 6).
• If you currently have liver problems.
• If you are pregnant or breast-feeding.
• If you are taking one or more than one of the following drugs at the same time:
• itraconazole, ketoconazole or posaconazole (medicines for fungal infections),
• erythromycin, clarithromycin or telithromycin (antibiotics for infections),
• HIV protease inhibitors such as indinavir, nelfinavir, ritonavir and saquinavir (HIV protease inhibitors are used for HIV infections),
• nefazodone (a medicine for depression).
• If you are taking or, in the last 7 days, have taken or been given a medicine called fusidic acid (used to treat bacterial infection).
Warnings and precautions
Talk to your doctor or pharmacist before taking Simvastatin Film-coated Tablets Tell your doctor:
• about all your medical conditions including allergies,
• if you drink large amounts of alcohol,
• if you have ever had liver disease.
Simvastatin Film-coated Tablets may not be right for you.
• if you are due to have an operation. You may need to stop taking Simvastatin Film-coated Tablets for a short time.
Your doctor should do a blood test before you start taking Simvastatin Film-coated Tablets. 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 Film-coated Tablets.
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
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
It is particularly important to tell your doctor if you are taking any of the following drugs. Taking Simvastatin Film-coated Tablets 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 Film-coated Tablets):
• ciclosporin (a medicine often used in organ transplant patients),
• danazol (a man-made hormone used to treat endometriosis),
• medicines such as 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), Do not take fusidic acid while using this medicine. Also see section 4 of this leaflet.
• HIV protease inhibitors such as indinavir, nelfinavir, ritonavir or saquinavir (medicines for AIDS),
• nefazodone (a medicine for depression),
• amiodarone (a medicine 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). 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 your are taking any of the following:
• medicines to prevent blood clots, such as warfarin, phenprocoumon 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.
Simvastatin Film-coated Tablets with food and drink
Grapefruit juice contains one or more components that alter how the body uses some medicinal products, including Simvastatin Film-coated Tablets. Consuming grapefruit juice should be avoided.
Pregnancy and breast-feeding
Do not take simvastatin if you are pregnant, trying to get 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 for advice from your doctor or pharmacist before taking any medicine.
Driving and using machines
Simvastatin Film-coated Tablets is not expected to interfere with your ability to drive or use machinery. However, it should be taken into account that some people get dizzy after taking it.
Simvastatin Film-coated Tablets contain lactose
Simvastatin Film-coated Tablets contain a sugar called lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
|
TEVA UK Ref: 231-30-13320-G LEA SIMVASTATIN 10mg, 20mg, 40mg & 80mg TAB TUK <DEB Version: 1 01 September 2016 | ||||
|
TEHJ1 |
UK |
EtsttMurm Origlmtlon |
Dim's Changed?: No Length: 460 mm Width: 160 mm Depth: N/A Foil Width: N/A |
Colours Used: 1 Template 1 Jpantone®green"c^ |
a
How to take Simvastatin Film-coated Tablets
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
You should stay on a cholesterol-lowering diet while taking Simvastatin Film-coated Tablets.
The recommended dose is one Simvastatin 10 mg, 20 mg, 40 mg or 80 mg Film-coated Tablet by mouth once a day.
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.
The 80 mg dose is only recommended for adult patients with very high cholesterol levels and at high risk of heart disease problems who have not reached their cholesterol goal on lower doses.
Your doctor will determine the appropriate tablet strength for you, depending on your condition, your current treatment and your personal risk status.
Take Simvastatin Film-coated Tablets in the evening. You can take it with or without food. The usual starting dose is 10 mg, 20 mg or, in some cases, 40 mg a day. Your doctor may adjust your dose after at least 4 weeks to a maximum of 80 mg a day. Do not take more than 80 mg a day. Your doctor may prescribe lower doses, particularly if you are taking certain medicinal products listed above or have certain kidney conditions. Keep taking Simvastatin Film-coated Tablets unless your doctor tells you to stop.
If your doctor has prescribed simvastatin along with a bile acid sequestrant (medicines for lowering cholesterol), you should take Simvastatin Film-coated Tablets at least 2 hours before or 4 hours after taking the bile acid sequestrant.
The 10 mg, 20 mg, 40 mg and 80 mg tablets can be divided into equal doses.
If you take more simvastatin than you should Please contact your doctor or pharmacist.
If you forget to take Simvastatin Film-coated Tablets
Do not take a double dose to make up for a forgotten tablet.
Do not take an extra dose, just take your normal amount of Simvastatin Film-coated Tablets at the usual time the next day.
If you stop taking Simvastatin Film-coated Tablets
Your cholesterol may rise again.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
^ Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following rare (may affect up to 1 in 1,000 people) serious side effects were reported. If any of these serious side effects happen, stop taking the medicine and tell your doctor immediately or got 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; 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,
• 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 may affect up to 1 in 10,000 people)
• inflammation of the pancreas often with severe abdominal pain.
The following side effects have also 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
• trouble sleeping (very rare)
• poor memory (very rare)
The following side effects have also been reported but the frequency cannot be estimated from the 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, 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.
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.
©How to store Simvastatin Film-coated Tablets
Keep this medicine out of the sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date which is stated on the carton and blister packs after EXP. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines no longer use. These measures will help to protect the environment.
©Contents of the pack and other information
What Simvastatin Film-coated Tablets contain
The active substance is simvastatin. Each tablet contains 10 mg, 20 mg, 40 mg or 80 mg simvastatin.
The other ingredients are lactose monohydrate, microcrystalline cellulose, pregelatinised maize starch, butylhydroxyanisole (E320), magnesium stearate, ascorbic acid and citric acid monohydrate, hypromellose, titanium dioxide, macrogol 3350, triacetin (E1518), red iron oxide, 10 mg, 20 mg, 80 mg: yellow iron oxide, 80 mg: black iron oxide.
What Simvastatin Film-coated Tablets look like and contents of the pack
Film-coated tablets.
• Simvastatin 10 mg Film-Coated Tablets are light pink, oval-shaped, film coated tablets with a breakline on one side.
• Simvastatin 20 mg Film-Coated Tablets are tan, oval-shaped, film coated tablets with a breakline on one side.
• Simvastatin 40 mg Film-Coated Tablets are pink, oval-shaped, film coated tablets with a breakline on one side.
• Simvastatin 80 mg Film-Coated Tablets are brick-red oval-shaped, film-coated tablets with a breakline on one side.
The 10 mg, 20 mg, 40 mg and 80 mg tablets can be divided into equal doses.
Simvastatin 10 mg Film-Coated Tablets are available in aluminium blisters containing 20, 28, 30, 50, 60, 90, 100 or 250 film-coated tablets and a hospital pack of 50x1 tablets. Simvastatin 20 mg Film-Coated Tablets are available in aluminium blisters containing 10, 28, 30, 50, 60, 90, 100 or 250 film-coated tablets and a hospital pack of 50x1 tablets. Simvastatin 40 mg Film-Coated Tablets are available in aluminium blisters containing 10, 28, 30, 50, 60, 90, 100 or 250 film-coated tablets and a hospital pack of 50x1 tablets. Simvastatin 80 mg Film-Coated Tablets are available in aluminium blisters containing 28, 30, 50, 60, 90, 100 or 250 film-coated tablets and a hospital pack of 50x1 tablets. Simvastatin 10 mg, 20 mg, 40 mg and 80 mg Film-coated Tablets are also available in HDPE containers containing 250 film-coated tablets. Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Teva UK Limited, Eastbourne, BN22 9AG, UK
Manufacturer
TEVA Pharmaceutical Works Private Limited Company, Pallagi ut 13, 4042 Debrecen, Hungary
This leaflet was last revised in September 2016
PL 00289/1451 PL 00289/1452 PL 00289/1453 PL 00289/1454
13320-G