Inechol 10 mg Tablets

INECHOL contains ezetimibe and simvastatin, one of a group of medicines called serum-cholesterol reducers. INECHOL is taken by patients who cannot control their cholesterol levels by diet alone. You should stay on a cholesterol-lowering diet while taking INECHOL. INECHOL is used in addition to your cholesterol-lowering diet if you have:

• a raised cholesterol level in your blood (primary hypercholesterolaemia [heterozygous familial and non-familial]) or elevated fat levels in your blood (mixed hyperlipidaemia):
  • that is not well controlled with a statin alone;
  • for which you have used a statin and ezetimibe as separate tablets.
• a hereditary illness (homozygous familial hypercholesterolaemia) that increases the cholesterol level in your blood. You may also receive other treatments.

Do not take INECHOL:

• if you are hypersensitive (allergic) to ezetimibe, simvastatin or to any of the ingredients of INECHOL (see section 5);
• if you have liver disease;
• if you are pregnant or breastfeeding your baby;
• if you are a child;
• 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 (used to treat infections),
  • protease inhibitors such as indinavir, nelfinavir, ritonavir and saquinavir (HIV protease inhibitors are used to treat HIV infections),
  • boceprevir or telaprevir (used to treat hepatitis C virus infections),
  • nefazodone (used to treat depression),
  • cobicistat,
  • gemfibrozil (used to lower cholesterol),
  • ciclosporin (often used in organ transplant patients),
  • danazol (a man-made hormone used to treat endometriosis, a condition in which the lining of the uterus grows outside the uterus).
• if you 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 INECHOL can lead to serious muscle problems (rhabdomyolysis).
• Do not take more than 10/40 mg INECHOL if you are taking lomitapide (used to treat a serious and rare genetic cholesterol condition).

Warnings and precautions

Take special care with INECHOL:

• if you have moderate to severe liver problems;
• if you are taking medicines containing danazol (to treat endometriosis), niacin (nicotinic acid), acipimox (also used to lower cholesterol);
• if you are taking medicine containing ciclosporin (used in organ transplant patients), as your doctor will want to monitor your progress;
• if you are taking medicine to treat fungal or bacterial infections (e.g. itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin);
• if you are taking medicine to treat HIV or medicine to treat depression (nefazodone);
• if you are taking fibrates (to lower cholesterol levels), especially gemfibrozil and bezafibrate;
• if you are taking medicines to treat a heart condition (amiodarone or verapamil);
• if you experience any unexplained muscle pain, tenderness, or weakness, contact your doctor immediately. This is because on rare occasions, muscle problems can be serious, including muscle breakdown resulting in kidney damage. The risk of muscle breakdown is greater at higher doses of INECHOL. The risk of muscle breakdown is also greater in certain patients:
  • if you have kidney problems,
  • if you have thyroid problems,
  • if you are 65 years old or older,
  • if you are female,
  • if you have ever had muscle problems during treatment with cholesterol lowering medicines called “statins” (such as simvastatin, atorvastatin, and rosuvastatin),
  • if you or close family members have a hereditary muscle disorder.
• if you drink large amounts of alcohol;
• if you are taking any medicines that may increase the risk of myopathy and rhabdomyolysis (disease of the muscle tissue);
• if you are taking medicines to thin your blood (e.g. warfarin);
• if you have diabetes or are at risk of developing diabetes;
• if you have severe lung disease;
• if you have porphyria (a rare hereditary blood disease);
• if you are taking medicine that contains “statins”, such as INECHOL, you might be at risk of developing weakness of skeletal muscles that control body movement (arms and legs) and breathing (myasthenia gravis) or weakness of the muscles that control eye and eyelid movement (ocular myasthenia).

Do not share medicines prescribed for you with any other person. Always use INECHOL exactly as your doctor has instructed. You should check with your doctor or pharmacist if you are unsure.

Before starting, and during treatment with INECHOL, you should be on a diet to lower your cholesterol.

Adults: The usual starting dose, depending on your condition, is one INECHOL 10/20 mg tablet per day. One tablet is to be taken in the evening, either with or without food. The dosage range is 10/10 mg to 10/80 mg per day.

If your doctor has prescribed INECHOL with a bile acid sequestrant such as cholestyramine (a medicine to lower cholesterol), INECHOL should be taken at least 2 hours before or 4 hours after taking the bile acid sequestrant.

Children: INECHOL is not for use in children (see ‘Do not take INECHOL’). Your doctor will tell you how long your treatment with INECHOL will last. Do not stop treatment early because cholesterol level may increase again. If you have the impression that the effect of INECHOL is too strong or too weak, tell your doctor or pharmacist.

If you take more INECHOL than you should: In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.

If you forget to take INECHOL: If you forget to take INECHOL, take a dose as soon as you remember, then continue to take INECHOL at the usual times. Do not take a double dose to make up for forgotten individual doses.

If you stop taking INECHOL: If you stop taking INECHOL without consulting your doctor, your cholesterol levels may rise again.

Not all side effects reported for INECHOL are included in this leaflet. Should your general health worsen, or if you experience any untoward effects while using INECHOL, please consult your healthcare provider for advice.

If any of the following happens, stop using INECHOL and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing;
• rash or itching;
• pain or inflammation of the joints, unusual bruising, skin eruptions and swelling, skin sensitivity to the sun, fever, flushing, feeling unwell.

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to INECHOL. 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:

• muscle breakdown (with symptoms such as muscle pain, tenderness, weakness, swollen muscles, tendon rupture/tear, kidney disorder with reddish-brown urine;
• liver problems (you may experience jaundice – yellowing of the skin and eyes - stomach pain and swelling, dark coloured urine);
• an increase in blood sugar which could lead to problems if you are a diabetic (your diabetic medicine may need to be adjusted).

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:

• headache;
• cough;
• viral infections, sore throat (pharyngitis), sinusitis, chest infections;
• stomach pain/disturbances, flatulence, diarrhoea;
• muscle pain, back pain;
• extreme tiredness, chest pain;
• elevations in laboratory blood tests of liver (transaminases) and/or muscle (CK) function.

Less frequent side effects:

• low red blood cell count (anaemia); reduction in blood cell counts, which may cause bruising/bleeding (thrombocytopenia), increased blood clotting time (longer than normal bleeding);
• weight loss;
• sleep disorder, trouble sleeping, depression;
• dizziness, pins and needles, poor memory, weakness/ numbness/pain (peripheral neuropathy);
• inflammation of the pancreas often with severe abdominal pain, pain that worsens with deep breathing or pain that travels to the right shoulder or back;
• gastrointestinal problems such as wind, discomfort or bloating, indigestion or heartburn, nausea, vomiting, dry mouth, constipation;
• itchy or red skin, rash, hair loss, skin or mouth lesions that have a pink-red centre surrounded by a pale ring border and an outer pink-red ring (erythema multiforme);
• pain in the joints or neck, back pain, muscle pain and weakness with skin rash, muscle cramps, muscle spasm, inflammation of the muscle, weakness in the arm and leg muscles, double vision and difficulties with speech and chewing (myasthenia gravis);
• abnormal lack of energy, feeling generally unwell, swelling of the hands or feet;
• abnormal liver function test results.

The following side effects have been reported but the frequency for them to occur is not known:

• difficulty breathing, chest infection;
• decrease in appetite;
• changes to the content of your urine which will be seen in a test performed by your doctor, kidney failure;
• trouble remembering, learning new things, concentrating, or making decisions, nightmares, sleep disturbances;
• hot flush, high blood pressure;
• gall stones, inflammation of the gall bladder;
• erectile dysfunction, sexual dysfunction, decreased sex drive, testicular pain, impotence;
• weakness of skeletal muscles that control body movement (arms and legs) and breathing (myasthenia gravis);
• weakness of the muscles that control eye and eyelid movement (ocular myasthenia).

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

Reporting of side effects

If you get 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 to SAHPRA via the “6.04 Adverse Drug 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 INECHOL.

• Store all medicines out of reach of children.

• Store at or below 25 ˚C.

• Keep the blisters in the carton until required for use.

• Do not use after the expiry date stated on the carton / label.

• Return all unused medicine to your pharmacist.

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