Simvotin Tablets

SIMVOTIN Tablets are used to lower levels of total cholesterol, “bad” cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. In addition, SIMVOTIN Tablets raise levels of “good” cholesterol (HDL cholesterol). You should stay on a cholesterol-lowering diet while taking SIMVOTIN Tablets. [PRODUCT NAME] Tablets belongs to the class of medicines called statins. SIMVOTIN Tablets are used along with diet, if you have:

• a raised cholesterol level in your blood (primaty hypercholesterolaemia) or elevated fat levels in your blood (mixed hyperlipidaemia)
• a hereditary illness (heterozygous familial hypercholesterolaemia) that increases the cholesterol level in your blood.
• Heart disease and high cholesterol and not responding to change in diet to:
• reduce the risk of death
• reduce the risk of heart attack
• reduce the risk of receiving surgery such as a bypass
• slow the progression of heart disease

Do not take SIMVOTIN Tablets:

• if you are hypersensitive (allergic) to simvastatin or other statin or any of the other ingredients of SIMVOTIN Tablets (listed in section 6).
• if you current have liver problems
• if you have a disorder called porphyria
• if you are pregnant or breastfeeding
• Unexplained raised levels of liver enzymes
• if you are taking medicine (s) with one or more than one of the following active ingredients:
• Itraconazole, ketoconazole, posaconazole or voriconazole (used to treat fungal infections)
• erythromycin, clarithromycin or telithromycin (antibiotics for infections)
• HIV protease inhibitors such as ritonavir, saquinavir, nelfinavir (HIV protease inhibitors are used for HIV infections)
• boceprevir and telaprevir (medicines used to treat hepatitis C)
• nefazodone (a medicine for depression)
• medicines containing cobicistat
• gemfibrozil (a medicine for lowering cholesterol)
• ciclosporin (a medicine often used in organ transplant patients)
• danazol (a man-made hormone used to treat endometriosis: a female health disorder that occurs when cells from the lining of the womb (uterus) grow in other areas of the body.

Safety of SIMVOTIN Tablets in porphyria (a group of rare blood pigment disorders) has not been established.

Warnings and precautions

Take special care with SIMVOTIN Tablets:

• if you drink large amounts of alcohol
• if you have ever had liver disease. SIMVOTIN Tablets may not be right for you.
• if you develop kidney failure resulting from muscle breakdown(rhabdomyolysis). Other factors which can lead to kidney failure include severe infection, low blood pressure, severe problems with your metabolism (a process by which your body uses to get or make energy from the food you eat), problems with your hormonal system, imbalance of electrolyte (such as potassium, sodium), uncontrolled fits, operation or injury.
• if you are due to have an operation. You may need to stop taking SIMVOTIN Tablets for a short time.
• Your doctor should do a blood test before you start taking SIMVOTIN 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 SIMVOTIN Tablets.
• While you are taking SIMVOTIN Tablets 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 have severe lung disease.
• if you are Asian, because a different dose may be applicable to you.

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, rarely, death. You should stop SIMVOTIN Tablets immediately, if you have been diagnosed muscle problems (myopathy) or suspect that you have myopathy. The risk of muscle breakdown is greater at higher doses of SIMVOTIN Tablets, particularly the 80 mg dose. The risk of muscle breakdown is also greater in certain patients. Talk with your doctor if any of the following applies:

• if you are older than 65 years
• if you are a female
• if you have kidney problems
• If you have uncontrolled low levels thyroid (hypothyroidism)
• if you have a personal or family history of muscle disorders,
• if you previously experienced muscle disorders with statin or fibrate use,
• if you consume large amounts of alcohol

Children and adolescents

SIMVOTIN Tablets should not be given to children, since the safety and effectiveness of SIMVOTIN Tablets have not been determined in children.

Do not share medicines prescribed for you with any other person. Always take SIMVOTIN Tablets exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. The usual starting dose of SIMVOTIN Tablets is 10 mg to 20 mg taken once daily every evening. Your doctor may increase or decrease your daily dose at intervals of at least 4 weeks. The maximum recommended daily dose is 80 mg. Your doctor will determine the appropriate tablet strength for you, depending on your condition. Your doctor will tell you how long your treatment with SIMVOTIN Tablets will last.

If you have the impression that the effects of SIMVOTIN Tablets is too strong or too weak, tell your doctor or pharmacist.

If you take more SIMVOTIN Tablets than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. Take the SIMVOTIN Tablets pack with you.

If you forget to take SIMVOTIN Tablets

• If you forget to take a dose, take it as soon as you remember it. However, if it is almost time for your next dose, skip the missed dose and continue as usual
• Do not take a double dose (two doses at the same time) to make up for a forgotten dose.

If you stop taking using SIMVOTIN

Your levels of cholesterol may rise again. If you have any further questions on the use of SIMVOTIN Tablets, ask your doctor or pharmacist.

SIMVOTIN Tablets can have side effects. Not all side effects reported for SIMVOTIN Tablets are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking SIMVOTIN Tablets, please consult your health care provider for advice. If any of the following happens, stop taking SIMVOTIN Tablets and tell your doctor immediately or go to the casualty department 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, 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).
• These are all very serious side effects. If you have them, you may have had a serious allergic reaction to SIMVOTIN Tablets. You may need urgent medical attention or hospitalisation.
• Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:
• changes in the way your heart beats, for example, if you notice it beating irregular and often very fast,
• muscle pain, tenderness, weakness, or cramps. On rare occasions, these muscle problems can be serious, including muscle breakdown resulting in kidney damage,
• numbness or weakness of the arms and legs (peripheral neuropathy),
• inflammation of the pancreas, often with severe upper stomach pain, nausea and vomiting (pancreatitis),
• inflammation of the liver with the following symptoms: yellowing of the skin and eyes, itching, dark-coloured urine or pale-coloured stool, feeling tired or weak, loss of appetite, liver failure.
• These are all serious side effects. You may need urgent medical attention.
• Tell your doctor if you notice any of the following:
• Uncommon/Less frequent side effects:
• tiredness, headaches, being short of breath when exercising, dizziness and looking pale(low number of red blood cells), frequent infections such as fever, severe chills, sore throat or mouth (low number of white blood cells),
• headache, dizziness, tiredness, pins and needles (paraesthesia),
• constipation, diarrhoea, feeling sick (nausea), being sick (vomiting), wind, indigestion, stomach pain,
• skin rash, loss of hair (alopecia) muscle pain, muscle cramps, muscle inflammation, unusual weakness,
• trouble sleeping,
• sleep disturbances, including nightmares,
• poor memory, memory loss, confusion,
• diabetes.
• Side effects with unknown frequency
• weight gain,
• sexual dysfunction,
• 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.
• depression

Effect on Laboratory tests

• low level blood cells (red, white and platelets),
• increased creatine kinase (from muscle) in blood,
• presence of myoglobin in urine (marker for muscle breakdown),
• increase in blood transaminase, alkaline phosphatise, gamma glutamyl transpeptidase (liver function enzymes),
• increase in blood glucose.

If you notice any side effects not mentioned in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor or, pharmacist or nurse. You can also report side effects to SAHPRA via the “ 6.04 Adverse Drug Reaction Reporting Form ”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of SIMVOTIN Tablets.

• Store at or below 25 °C, protected from light and moisture.

• Do not remove the blister from the carton until required for use.

• Keep out of the reach and sight of children.

• Do not take SIMVOTIN Tablets after the expiry date stated on the pack. The expiry date refers to the last day of that month.

• Return all unused medicine to your Pharmacist.

• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).