Simvastatin 80 Mg Film-Coated Tablets
Out of date information, search anotherIn very rare cases (affects less than 1 user in 10,000):
Breathing problems including persistent cough and/ or shortness of breath or fever or effect on some blood tests such as elevated serum transaminase, elevated alkaline phosphatase, elevated creatinine kinase levels may occur.
Side effects of unknown frequency:
Muscle weakness that is constant.
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.
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 Yellow Card Scheme Website:
By reporting side effects you can help provide more information on the safety of this medicine.
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 and Manufacturer
BROWN & BURK UK LIMITED,
5 Marryat Close, Hounslow West, Middlesex, TW4 5DQ,
United Kingdom
This leaflet was last amended in February 2015
Package leaflet: Information for the user
Simvastatin 10 mg film-coated tablet Simvastatin 20 mg film-coated tablet Simvastatin 40 mg film-coated tablet Simvastatin 80 mg film-coated tablet
Simvastatin
BROWN & BURK
5. How to store Simvastatin Tablets
Keep out of the reach and sight of children.
Do not use Simvastatin Tablets after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
There are no special storage precautions for Simvastatin Tablets.
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 contains
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 looks like and contents of the pack
White, oblong, biconvex film-coated tablets scored on one side,
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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 the leaflet. See section 4.
What is in this leaflet:
1. What Simvastatin
Tablets is and what it is 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
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
I.What Simvastatin Tablets is and what it is used for
Simvastatin Tablets belongs 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 is used in: • Patients with too high levels of cholesterol in their blood (hypercholesterolaemia),
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 TABLETS). Simvastatin Tablets 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 (hypersensitive) to simvastatin or to any of the other ingredients of Simvastatin Tablets;
• If you are pregnant or breast-feeding (see section 2);
• If you have liver disease;
• If you are taking the antifungal agents called itraconazole or ketoconazole, fluconazole, posaconazole;
• 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.
Warnings and precautions
Talk to your doctor or pharmacist before taking Simvastatin Tablets if you:
• Have severe respiratory failure
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Simvastatin Tablets can occasionally cause muscle problems manifested as muscle pain, tenderness or weakness. The risk of muscle problems is greater at higher doses of Simvastatin Tablets and in certain groups of patients.
Tell your doctor:
• If you are over 70 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 cholesterol-lowering 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 have reduced function of certain liver proteins (Hepatic OATP transport proteins). These can increase concentration of Simvastatin in your body and increase the risk of pain or weakness in muscles (Myopathy) and abnormal muscle breakdown which can lead to kidney problems (Rhabdomyolysis). Disclose your genotyping if available to your doctor for the benefit-risk assessment.
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.
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. The doctor may perform a blood test to check the condition of your muscles before and after starting treatment.
This medicine contains lactose. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.
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
- 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
- An antibiotic medicine containing erythromycin, clarithromycin, telithromycin, fusidic acid, rifampicin
- 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.
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.
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.
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 has no or negligible influence on the ability to drive and use machines. However, simvastatin may cause dizziness in rare cases.
Important information about some of the ingredients of Simvastatin Tablets
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 1 Simvastatin 5 mg,
10 mg, 20 mg, 40 mg, or 80 mg 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
If you stop taking Simvastatin Tablets
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 Tablets 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.
Contact your doctor promptly if you experience
pain, tenderness,
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. Liver disease (possibly presenting as yellowing of the eyes and/or skin, itchiness of the skin, dark coloured urine, pale coloured stools),
The following side effects were reported rarely (affects 1 to 10 users in 10,000):
Stomach upsets (such as sickness, constipation, diarrhoea, flatulence, indigestion and abdominal pain), anemia, weakness, headache, dizziness, numbness or loss of sensation in the arms and legs, hair loss, rash, itchiness,
Uncommon (affects 1 to 10 users in 1,000):
• Sleep disturbances, including insomnia and nightmares
• Memory loss
• Sexual difficulties
• Depression
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