Simvastatin 40mg Film-Coated Tablets
itchiness of the skin, dark coloured urine, pale coloured stools), muscle pain, tenderness or weakness.
On rare occasions, the muscle problems can be serious, including muscle breakdown resulting in kidney damage; and very rare deaths have occurred.
Very rare:
• Trouble sleeping,
• Memory loss, poor memory, confusion.
Side effects of unknown frequency
• Muscle weakness that is constant,
• Tendon problems, sometimes complicated by rupture of the tendon,
• Erectile dysfunction,
• Depression,
• Inflammation of the lungs causing breathing problems including persistent cough and/or shortness of breath or fever.
Contact your doctor promptly if you experience unexplained muscle pain, tenderness, weakness or cramps.
In rare cases Simvastatin Tablets can cause an allergic reaction. The allergic reaction may include some of the following: swelling of the face, tongue or throat, joint pains, joint and blood vessel inflammation, skin eruptions, swelling, hives, skin sensitivity to the sun, fever, flushing, difficulty in breathing, or tiredness. Stop taking Simvastatin Tablets and contact your doctor immediately, if you experience swelling of the face, tongue and/or throat and/or difficulties in swallowing, or if hives and breathing difficulties occur.
In very rare cases effect on some blood tests such as elevated serum transaminase, elevated alkaline phosphatase and elevated creatinine kinase levels may occur.
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.
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.
5. How to store Simvastatin Tablets
Keep this medicine out of the sight and reach of children.
Do not use Simvastatin Tablets after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
There are no special storage precautions for Simvastatin Tablets.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away any medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Simvastatin Tablets contain
The active substance is Simvastatin.
The other ingredients are lactose anhydrous, microcrystalline cellulose, pregelatinised maize starch, butylhydroxyanisole, magnesium stearate and talc. The film coat contains hydroxypropylcellulose, hypromellose, talc and titanium dioxide (E171).
What Simvastatin Tablets look like and contents of the pack
White, oblong, biconvex film-coated tablets scored on one side, embossed with “10”, “20”, “40” or “80” on the scored side and with “SVT” on the opposite side.
Pack size: Blister packs of 7, 10, 14, 15, 28, 30, 50, 56, 60, 98 and 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Morningside Healthcare Ltd 115 Narborough Road,
Leicester, LE3 0PA,
UK
Manufacturer
Morningside Pharmaceuticals Limited 5 Pavillion Way,
Loughborough, LE11 5GW,
UK
This leaflet was last revised in December 2015.
UKI-024
PACKAGE LEAFLET: INFORMATION FOR THE USER
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. See section 4.
In this leaflet:
1. What Simvastatin Tablets are and what they are used for
2. What you need to know before you take Simvastatin Tablets
3. How to take Simvastatin Tablets
4. Possible side effects
5. How to store Simvastatin Tablets
6. Contents of the pack and other information
1. What Simvastatin Tablets are and what they are used for
Simvastatin Tablets belong to a group of medicines called statins. These medicines inhibit the production of cholesterol in the liver and lower the cholesterol and fat content in the blood. Cholesterol is vital to the normal functioning of the body, but if the levels of cholesterol in the bloodstream are too high it can be deposited on the walls of the blood vessels. There it builds up to form plaque, which can eventually block the blood vessel.
Simvastatin Tablets are used in:
• Patients with too high a level of cholesterol in their blood (hypercholesterolaemia), when the combination of diet, physical exercise and weight loss has not lowered the cholesterol level adequately.
• Patients with existing heart problems (arterosclerotic cardiovascular disease) or diabetes, to lower a normal or raised cholesterol level and thereby reduce the risk of complications.
2. What you need to know before you take Simvastatin Tablets
Children and adolescents
Safety and effectiveness of Simvastatin Tablets have been studied in 10-17 year old boys and in girls who had started their menstrual period at least one year before (see section 3: How to take Simvastatin Tablets). Simvastatin has not been studied in children under the age of 10 years. For more information, talk to your doctor.
Do not take Simvastatin Tablets
• If you are allergic to simvastatin or any of the other ingredients of this medicine (listed in section 6);
• If you are pregnant or breastfeeding (see section 2);
• If you have liver disease;
• If you are taking the antifungal agents called itraconazole, ketoconazole, posaconazole or voriconazole;
• If you are taking the antibiotics called erythromycin, clarithromycin or telithromycin;
• If you are taking the antidepressant called nefazodone;
• If you are taking medicines for the treatment of HIV infections (HIV protease inhibitors) such as indinavir, nelfinavir, ritonavir or saquinavir;
• If you are taking boceprevir or telaprevir (used to treat hepatitis C virus infection);
• If you are taking cobicistat;
• If you are taking gemfibrozil (used to lower cholesterol);
4
• If you are taking ciclosporin (used in organ transplant patients);
• If you are taking danazol (a man-made hormone used to treat endometriosis, a condition in which the lining of the uterus grows outside the uterus).
Do not take more than 40 mg simvastatin if you are taking lomitapide (used to treat a serious and rare genetic cholesterol condition).
Warnings and precautions
Check with your doctor or pharmacist before taking Simvastatin Tablets, if you:
• have severe respiratory failure.
• are taking or have taken in the last 7 days a medicine called fusidic acid, (a medicine for bacterial infection) orally or by injection. The combination of fusidic acid and simvastatin can lead to serious muscle problems (rhabdomyolysis).
Tell your doctor:
• If you are over 65 years of age;
• If you have kidney problems;
• If you have thyroid problems;
• If you have ever had muscle problems during treatment with simvastatin or other statins (such as fluvastatin, atorvastatin, pravastatin or rosuvastatin), or cholesterollowering medicines called fibrates (such as gemfibrozil, bezafibrate);
• If you or close family members have a hereditary muscle disorder;
• If you consume substantial quantities of alcohol or if you have liver problems or a continuous high level of certain liver enzymes (serum transaminases);
• If you are Asian, because a different dose may be applicable to you.
If you are going to hospital for an operation, tell the doctor that you are taking simvastatin.
Tell your doctor immediately if you experience unexplained muscle pain, tenderness or weakness. This is because on rare occasions, there is a risk of muscle problems which may be serious, including muscle breakdown which can result in
kidney damage; and very rare deaths have occurred. The
doctor may perform a blood test to check the condition of your muscles before and after starting treatment.
Also tell your doctor or pharmacist if you have a muscle weakness that is constant. Additional tests and medicines may be needed to diagnose and treat this.
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.
Other medicines and Simvastatin Tablets
Simvastatin tablets may occasionally interfere with other medicines, so it is important that you tell your doctor about all the medicines you are taking, including those obtained without a doctor's prescription. These are;
• Medicines for thinning the blood, e.g. warfarin, phenprocoumon or acenocoumarol.
• Two other kinds of lipid lowering agents; fibric acid derivatives (e.g. benzafibrate, fenofibrate, gemfibrozil) and large doses of niacin or nicotinic acid.
• Immunosuppressant medicines e.g. ciclosporin.
• An antifungal medicine called itraconazole, ketoconazole, fluconazole, posaconazole or voriconazole.
• An antibiotic medicine containing erythromycin, clarithromycin, telithromycin or rifampicin.
• Fusidic acid. If you need to take oral fusidic acid to treat a bacterial infection you will need to temporarily stop using this medicine. Your doctor will tell you when it is safe to restart Simvastatin Tablets. Taking simvastatin with fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis). See more information regarding rhabdomyolysis in section 4.
• An antidepressant medicine nefazodone.
• Drugs such as indinavir, nelfinavir, ritonavir or saquinavir (HIV protease
inhibitor) for the treatment of HIV infections.
• Medicines against heart rhythm disturbances and/or high blood pressure (containing amiodarone, verapamil, amlodipine or diltiazem).
• Drugs such as danazol used in the treatment of endometriosis.
• Colchicine used in the treatment of gout.
• Boceprevir or telaprevir (used to treat hepatitis C virus infection).
• Medicines with the active ingredient cobicistat.
• Lomitapide (used to treat a serious and rare genetic cholesterol condition).
If you are taking these medicines you should talk to your doctor before taking simvastatin tablets.
Simvastatin Tablets with food and drink
Do not drink grapefruit juice when you are taking Simvastatin Tablets.
Grapefruit juice increases the effects of this medicine, which may lead to side effects.
Pregnancy and breast-feeding
Ask your doctor or pharmacist before taking any medicine.
Simvastatin should not be used during pregnancy. Simvastatin may only be used by women of childbearing age, if pregnancy has been excluded. If you wish to become pregnant or suspect that you may be pregnant, you should immediately stop using simvastatin and consult your doctor.
It is not known whether simvastatin passes into breast milk. Therefore, you should not use this medicine if you are breast-feeding.
Driving and using machines
Simvastatin Tablets have no or negligible influence on the ability to drive and use machines. However, simvastatin may cause dizziness in rare cases.
Simvastatin Tablets contains lactose
If you have intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to take Simvastatin Tablets
Always take Simvastatin Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
You should stay on a cholesterollowering diet while taking Simvastatin Tablets.
The dose is one 5mg, 10mg, 20mg, 40mg or 80mg Simvastatin 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 in for adult patients with very high cholesterol levels and at high risk of heart disease problems.
Keep taking the tablets as long as your doctor has asked you to.
If you take more Simvastatin Tablets than you should
It is important to stick to the dose on the label of the medicine. If you or someone else swallows several of these tablets all together, contact your doctor, pharmacist or hospital emergency department immediately. Always take any tablets left over with you and also the box, as this will allow easier identification of the tablets.
If you forget to take Simvastatin Tablets
If you miss a dose, just carry on with the next one as normal. Do not take a double dose to make up for a forgotten dose.
If you stop taking Simvastatin Tablets
Do not stop taking Simvastatin Tablets until your doctor tells you to. Talk to your doctor or pharmacist because your cholesterol may rise again.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following terms are used to describe how often side effects have been reported:
• Rare (may affect up to 1 of 1000 people)
• Very rare (may affect up to 1 of 10,000 people)
• Not known (frequency cannot be estimated from the available data)
The following side effects were reported rarely:
Stomach upsets (such as sickness, constipation, diarrhoea, flatulence, indigestion and abdominal pain), anaemia, weakness, headache, dizziness, numbness or loss of sensation in the arms and legs, hair loss, rash, itchiness, liver disease (possibly presenting as yellowing of the eyes and/or skin,