Lipocomb 10 mg Capsules

Lipocomb contains two different active pharmaceutical ingredients in one capsule. One of the active pharmaceutical ingredients is rosuvastatin, belonging to the group of so called statins, the other active pharmaceutical ingredient is ezetimibe. Lipocomb is a medicine used to lower levels of total cholesterol, “bad” cholesterol (LDL cholesterol) and fatty substances called triglycerides in your blood. In addition, it also raises levels of “good” cholesterol (HDL cholesterol). This medicine works to reduce your cholesterol in two ways: it reduces the cholesterol absorbed in your digestive tract, as well as the cholesterol your body makes by itself. For most people, high cholesterol does not affect the way they feel because it does not produce any symptoms. However, if it is left untreated, fatty deposits can build up in the walls of your blood vessels causing them to narrow. Sometimes, these narrowed blood vessels can get blocked which can cut off the blood supply to the heart or brain leading to a heart attack or a stroke. By lowering your cholesterol levels, you can reduce your risk of having a heart attack, a stroke or related health problems. Lipocomb is used in patients whose cholesterol levels cannot be controlled by a cholesterol lowering diet alone. You should stay on your cholesterol lowering diet while taking this medicine. Your doctor may prescribe Lipocomb if you are already taking both rosuvastatin and ezetimibe at the same dose level. Lipocomb does not help you lose weight.

Do not take Lipocomb if you:

• are allergic to rosuvastatin, ezetimibe or any of the other ingredients of this medicine (listed in section 6).
• have moderate to severe liver disease.
• have severe kidney impairment.
• have repeated, unexplained muscle aches or pains (myopathy).
• If you are taking fenofibrate (another cholesterol lowering medicine) and have gall bladder disease.
• take a medicine called ciclosporin (used for example, after organ transplants).
• are pregnant or breastfeeding. If you become pregnant while taking Lipocomb stop taking it immediately and tell your doctor. Women should avoid becoming pregnant while taking Lipocomb by using suitable contraceptive measures.

If any of the above applies to you (or you are in doubt), contact your doctor.

Warnings and precautions

Tell your doctor or pharmacist before taking Lipocomb if you:

• have problems with your kidneys.
• have problems with your liver.
• have had repeated or unexplained muscle aches or pains, a personal or family history of muscle problems, or a previous history of muscle problems when taking other cholesterol-lowering medicines. Tell your doctor immediately if you have unexplained muscle aches or pains especially if you feel unwell or have a fever. Also tell your doctor or pharmacist if you have a muscle weakness that is constant.
• are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean and Indian). Your doctor needs to choose the right dose of Lipocomb to suit you.
• take medicines used to fight infections, including HIV or hepatitis C infection e.g. lopinavir/ritonavir and/or atazanavir or simeprevir, see “Other medicines and Lipocomb”.
• have severe respiratory failure.
• take other medicines called fibrates to lower your cholesterol. See “Other medicines and Lipocomb”.
• regularly drink large amounts of alcohol.
• have thyroid gland that is not working properly (hypothyroidism).
• are over 70 (as your doctor needs to choose the right dose of Lipocomb to suit 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 Lipocomb can lead to serious muscle problems (rhabdomyolysis).

If any of the above applies to you (or if you are not sure): check with your doctor or pharmacist before you actually start taking any dose of Lipocomb. In a small number of people, statins can affect the liver. This is identified by a simple test which looks for increased levels of liver enzymes in the blood. For this reason, your doctor will regularly out this blood test (liver function test) during treatment with Lipocomb. It is important to go to the doctor for the prescribed laboratory checks. 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.

Children and adolescents

The use of Lipocomb is not recommended in children and adolescents under the age of 18 years.

Other medicines and Lipocomb

Always tell your healthcare provider if you are taking any other medicine. (This includes complementary or traditional medicines). Tell your doctor if you are taking any of the following:

• Ciclosporin (used for example, after organ transplants to prevent rejection of the transplanted organ. The effect of rosuvastatin is increased with concomitant use). Do not take Lipocomb while taking ciclosporin.
• Blood thinners e.g. warfarin, acenocoumarol or fluindione (their blood thinning effect and the risk of bleeding may be increased while taken concomitantly with Lipocomb), or clopidogrel
• Other medicines to lower your cholesterol called fibrates, which correct also blood triglyceride levels (e.g. gemfibrozil and other fibrates). During concomitant use, the effect of rosuvastatin is increased.
• Colestyramine (a medicine for lowering cholesterol), because it affects the way ezetimibe works.
• Regorafenib (used to treat cancer).
• Simeprevir (used to treat chronic hepatitis C infection).
• Any of the following medicines used to treat viral infections, including HIV or hepatitis C infection, alone or in combination (see Warnings and precautions): ritonavir, lopinavir, atazanavir, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.
• Indigestion remedies containing aluminium and magnesium (used to neutralise acid in your stomach; they decrease the plasma level of rosuvastatin.) This effect may be mitigated with taking this type of medicine 2 hours after rosuvastatin.
• Erythromycin (an antibiotic). The effect of rosuvastatin is decreased with their concomitant use.
• 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 Lipocomb. Taking Lipocomb with fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis).
• An oral contraceptive (the pill). The levels of sexual hormones absorbed from the pill are increased.
• Hormone replacement therapy (increased hormone levels in the blood).

If you go into hospital or receive treatment for another condition, tell the medical staff that you are taking Lipocomb.

Always take Lipocomb exactly as your doctor or pharmacist has instructed you. You should check with your doctor or pharmacist if you are unsure. You should keep on being on low-cholesterol diet and doing exercises while taking Lipocomb. The recommended daily dose for adults is one capsule of the given strength. Take Lipocomb once daily. You can take it at any time of the day, with or without food. Swallow each capsule whole with a drink of water. Take your medicine at the same time every day. Lipocomb is not suitable to start a treatment. Treatment initiation or dose adjustment if necessary should only be done by giving the active substances separately and after setting the appropriate doses the switch to Lipocomb of the appropriate strength is possible. Regular cholesterol checks It is important to go back to your doctor for regular cholesterol checks to make sure your cholesterol has reached and is staying at the correct level. If you take more Lipocomb 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. Take your pack(s) of medicine with you. If you forget to take Lipocomb If you forget a dose, talk to your doctor or pharmacist. Do not take a double dose to make up for a forgotten dose. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. If you stop taking Lipocomb Talk to your doctor if you want to stop taking Lipocomb. Your cholesterol levels might increase again if you stop taking Lipocomb. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Lipocomb can cause side effects. Not all side effects reported for Lipocomb are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking Lipocomb, please consult your healthcare provider for advice. If any of the following happens, stop taking Lipocomb and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Allergic reactions such as swelling of the face, lips, tongue and/or throat, which may cause difficulty in breathing and swallowing.
• Rash or itching,
• Fainting
• Inflammation of the pancreas, which causes a severe stomach pain which can extend to the back,

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

• Unusual muscle aches or pains which go on for longer than you might expect. Rarely this can develop into potentially life-threatening muscle damage known as rhabdomyolysis, which leads to malaise, fever and kidney impairment.
• Lupus-like disease syndrome (including rash, joint disorders and effects on blood cells).
• Muscle rupture.
• Ulcers or blistering of the skin, mouth, eyes and genitals. These could be signs of Steven Johnson syndrome (a life-threatening allergic reaction affecting the skin and mucous membranes).

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,
• Constipation,
• Feeling sick,
• Muscle pain,
• Feeling weak,
• Dizziness,
• 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,
• stomach ache,
• diarrhoea,
• flatulence (excess gas in the intestinal tract),
• feeling tired,
• elevations in some laboratory blood tests of liver function (transaminases),

Less frequent side effects

• Rash, itching, hives,
• An increase in the amount of protein in the urine may occur – this usually returns to normal on its own without having to stop taking rosuvastatin,
• elevations in some laboratory blood tests of muscle (CK) function,
• cough,
• indigestion,
• heartburn,
• joint pain,
• muscle spasms,
• neck pain,
• decreased appetite,
• pain,
• chest pain,
• hot flush,
• high blood pressure,
• tingling sensation,
• dry mouth,
• inflammation of the stomach,
• back pain,
• muscle weakness,
• pain in arms and legs,
• swelling, especially in the hands and feet,
• Reduction in blood platelets,
• Jaundice (yellowing of the skin and eyes),
• Inflammation of the liver (hepatitis),
• Traces of blood in your urine,
• Damage to the nerves of your legs and arms (such as numbness),
• Memory loss,
• Breast enlargement in men (gynecomastia,)
• Oedema (swelling),
• Sleep disturbances, including insomnia and nightmares,
• Sexual difficulties,
• Depression,
• Breathing problems including persistent cough and/or shortness of breath or fever,
• Tendon injury,
• Muscle weakness that is constant,
• Gallstones or inflammation of the gallbladder (which may cause stomach ache, nausea, vomiting).

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, 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 Lipocomb.

Store at or below 25 °C. Store in the original package in order to protect from light and moisture. Store all medicines out of reach of children. Do not use this medicine after the expiry date which is stated on the carton and the blister. 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). Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.