Unisim Film-Coated Tablets

UNISIM is used to lower levels of total cholesterol, “bad” cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. In addition, UNISIM raises levels of “good” cholesterol (HDL cholesterol). You should stay on a cholesterol-lowering diet while taking UNISIM. UNISIM belongs to the class of medicines called statins.

UNISIM 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 (heterozygous familial hypercholesterolaemia) that increases the cholesterol level in your blood.

UNISIM is also used if you have:

• coronary heart disease (CHD) and high cholesterol levels not responding to diet.

Do not take UNISIM:

• if you are hypersensitive (allergic) to simvastatin or other statin or any of the other ingredients of UNISIM
• if you currently have liver problems
• if you have unexplained persistent elevation of serum transaminase (liver enzymes)
• if you are pregnant or breastfeeding
• if you are taking one or more of the following medicines at the same time:

• itraconazole, voriconazole, 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)
• boceprevir, telaprevir (medicine used to treat hepatitis C)
• nefazodone (a medicine for depression)
• cobicistat (used to treat HIV infection)
• 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)
• lomitapide (used to lower familial cholesterol) with more than 40 mg of UNISIM.

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

Warnings and precautions

Take special care with UNISIM:

• Tell your doctor if you drink large amounts of alcohol.
• Tell your doctor if you have ever had liver disease. UNISIM may not be right for you.

Tell your doctor 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.

Tell your doctor if you are due to have an operation. You may need to stop taking UNISIM for a short time.

Your doctor should do a blood test before you start taking UNISIM. 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 UNISIM.

While you are taking UNISIM 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 using any other medicines such as immunosuppressants, fibrates (except fenofibrate), lipid lowering doses of niacin, amiodarone, amlodipine, verapamil, diltiazem or daptomycin (also see Do not take UNISIM).

If you are Asian.

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, rarely, death.

Do not share medicines prescribed for you with any other person. Always take UNISIM exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The usual starting dose of UNISIM 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 UNISIM tablets will last.

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

Children

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

If you take more UNISIM 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 UNISIM pack with you.

If you forget to take a UNISIM

• 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 UNISIM

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

UNISIM can have side effects. Not all side effects reported for UNISIM are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking UNISIM, please consult your doctor, pharmacist or other healthcare professional for advice.

If any of the following happens, stop taking UNISIM 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 UNISIM. 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:

Frequent side effects:

• feeling sick (nausea), being sick (vomiting), wind, indigestion, stomach pain,
• myalgia (soreness and achiness in the muscles that can range from mild to severe),
• muscle cramps.

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),
• diabetes,
• trouble sleeping,
• headache, dizziness, tiredness, pins and needles (paraesthesia),
• poor memory, memory loss, confusion,
• photosensitivity, blurred vision, impaired vision,
• shortness of breath, hypersensitivity pneumonitis (inflamed lungs),
• constipation, diarrhoea,
• skin rash, itching, loss of hair (alopecia), urticaria (hives),
• lichenoid drug eruptions (violaceous, scaling papules and plaques that are typically symmetrical and widespread),
• muscle pain, muscle cramps, muscle inflammation, unusual weakness, muscle rupture,
• breast enlargement in men (gynaecomastia).

Frequency unknown:

• weight gain,
• depression,
• sleep disturbances, including nightmares,
• weakness and rapid fatigue of muscles under voluntary control (myasthenia gravis). The symptoms might only be limited to eye muscles (ocular myasthenia),
• interstitial lung disease,
• respiratory infections, bronchitis, sinusitis,
• immune-mediated necrotising myopathy (IMNM),
• erectile dysfunction,
• sexual dysfunction.

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 phosphatase, 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 UNISIM.

Store at or below 25 °C, protected from light and moisture. Do not remove the blisters from the carton until required for use.

Store all medicines out of reach of children.

Do not take UNISIM 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).