Lypovas Film-Coated Tablets

LYPOVAS tablets belong to a group of medicines called HMG-CoA reductase inhibitors, commonly known as, ’statins’. It contains the active substance called rosuvastatin. LYPOVAS tablets is used to correct the levels of fatty substances in the blood called lipids, the most common of which is cholesterol. There are different types of cholesterol found in the blood – ‘bad’ cholesterol (LDL-C) and ‘good’ cholesterol (HDL-C). LYPOVAS tablets can reduce the ‘bad’ cholesterol and increase the ‘good’ cholesterol. It works by helping to block your body’s production of ‘bad’ cholesterol. It also improves your body’s ability to remove it from your blood. You have been prescribed LYPOVAS tablets because:

• You have a high cholesterol level. This means you are at risk from a heart attack or stroke.
• Changing your diet and doing more exercise were not enough to correct your cholesterol levels. You should continue with your cholesterol-lowering diet and exercise while you are taking LYPOVAS tablets.
• You have other factors that increase your risk of having a heart attack, stroke, or related health problems.
• Heart attack, stroke and other problems can be caused by a disease called atherosclerosis. Atherosclerosis is due to build-up of fatty deposits in your arteries.

Do not take LYPOVAS:

• if you are allergic to rosuvastatin, or any of the other ingredients of LYPOVAS (listed in section 6).
• if you are pregnant or breast-feeding. If you become pregnant while taking LYPOVAS tablets stop taking it immediately and tell your doctor. Women should avoid becoming pregnant while taking LYPOVAS tablets by using suitable contraception.
• if you have liver disease
• if you have severe kidney problems
• if you have repeated or unexplained muscle aches or pains.
• if you take ciclosporin (used, for example, after organ transplants)

In addition, do not take LYPOVAS 40 mg tablets (the highest dose)

• if you have moderate kidney problems (if in doubt, please ask your doctor)
• if your thyroid gland is not working properly
• if you have had any 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.
• if you regularly drink large amounts of alcohol
• if you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean and Indian).
• if you take other medicines called fibrates to lower your cholesterol.

Warnings and precautions

Take special care with LYPOVAS 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.
• regularly drink large amounts of alcohol.
• your thyroid gland is not working properly.
• take medicines used to fight the HIV infection e.g. combinations of ritonavir with atazanavir, lopinavir, and/or tipranavir, see ‘Other medicines and LYPOVAS tablets.
• 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 LYPOVAS can lead to serious muscle problems (rhabdomyolysis), please see ‘Other medicines and LYPOVAS tablets.
• are over 70 (as your doctor needs to choose the right start dose of LYPOVAS tablets to suit you)
• have severe respiratory failure.
• are of Asian origin – that is Japanese, Chinese, Filipino, Vietnamese, Korean and Indian. Your doctor needs to choose the right start dose of LYPOVAS tablets to suit you.

Your doctor will usually carry out the blood test (liver function test) before and during treatment with LYPOVAS tablets. While you are on LYPOVAS 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:

• Children under 10 years old: LYPOVAS tablets should not be given to children younger than 10 years.
• Children below 18 years of age: The LYPOVAS 40 mg tablet is not suitable for use in children and adolescents below 18 years of age.
• Children can experience muscle soreness after physical activity, while taking LYPOVAS.

Other medicines and LYPOVAS:

Always tell your healthcare provider if you are taking any other medicine. This includes complementary or traditional medicines.

• Ciclosporin (used for example, after organ transplants)
• Fibrates (such as gemfibrozil, fenofibrate) or any other medicine used to lower cholesterol (such as ezetimibe).
• Indigestion remedies (used to neutralise acid in your stomach)
• Erythromycin (an antibiotic)
• Fusidic acid (an antibiotic – please see warnings and precautions). If you need to take oral fusidic acid to treat a bacterial infection you will need to temporarily stop using LYPOVAS. Your doctor will tell you when it is safe to restart LYPOVAS tablets. Taking LYPOVAS tablets with fusidic acid may lead to muscle weakness, tenderness, or pain (rhabdomyolysis). See more information regarding rhabdomyolysis in section 4.
• An oral contraceptive (the pill)
• Hormone replacement therapy
• Anti-viral medications such as ritonavir with lopinavir and/or atazanavir or simeprevir (used to treat infections, including HIV or hepatitis C infection – please see warnings and precautions). The effects of these medicines could be changed by LYPOVAS tablets or they could change the effect of LYPOVAS tablets.

Pregnancy and breastfeeding and fertility:

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Do not take LYPOVAS tablets if you are pregnant or breast feeding. If you become pregnant while taking LYPOVAS tablets stop taking it immediately and tell your doctor. Women should avoid becoming pregnant while taking LYPOVAS tablets by using suitable contraception.

Driving and using machines:

LYPOVAS may cause dizziness, which may affect your ability to drive and use machines. It is not always possible to predict to what extent LYPOVAS may interfere with your daily activities. You should ensure that you do not engage in the above activities until you are aware of the measure to which LYPOVAS affects you.

LYPOVAS contains lactose: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Do not share medicines prescribed for you with any other person. Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The usual dose for:

Adults:

If you are taking LYPOVAS tablets for high cholesterol: Your treatment with LYPOVAS tablets must start with the 5 mg. The choice of your start dose will depend upon:

• Your cholesterol levels.
• The level of risk you have of experiencing a heart attack or stroke.
• Whether you have a factor that may make you more sensitive to

Children and adolescents aged 10-17 years:

The dose range in children and adolescents aged 10 to 17 years is 5 to 20 mg once daily. The usual start dose is 5 mg per day, and your doctor may increase your dose gradually to find the right amount of LYPOVAS tablets for you. The maximum daily dose of LYPOVAS tablets is 10 mg or 20 mg for children aged 10 to 17 years depending on your underlying condition being treated. Take your dose once a day. LYPOVAS tablets 40 mg tablet should not be used by children.

Elderly:

Start treatment with one 5 mg tablet taken once a day.

Patients with kidney problems:

Start treatment with one 5 mg tablet taken once a day.

Patients with liver problems:

Start treatment with one 5 mg tablet taken once a day.

Asian patients:

Start treatment with one 5 mg tablet taken once a day.

Increasing the dose and maximum daily dose: Your doctor may decide to increase your dose. This is so that you are taking the amount of Rosuvastatin tablets that is right for you. There will be a gap of four weeks between every dose adjustment.

Swallow each tablet whole with a drink of water. Take LYPOVAS tablets once daily. You can take it at any time of the day with or without food. Try to take your tablet at the same time every day to help you to remember it.

If you take more LYPOVAS than you should: In the event of an overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre. In the event of suspected overdose, seek supportive medical care.

If you forget to take a dose of LYPOVAS: Do not take a double dose to make up for the forgotten individual doses. If you forget to take a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose.

If you stop taking LYPOVAS Suddenly stopping your treatment with LYPOVAS may lead to your symptoms getting worse. Do not stop taking LYPOVAS unless your doctor tells you to. Your doctor may tell you to reduce the dose over a few days before stopping completely. Talk to your doctor if you want to stop taking LYPOVAS tablets. Your cholesterol levels might increase again if you stop taking LYPOVAS tablets.

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

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

• Allergic reaction (e.g. swelling in the mouth, tongue, face and throat, itching)
• Skin inflammation, peeling and blistering

These are all very serious side effects. If you have them, you may have had a serious reaction to LYPOVAS. 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 aches or pains in your muscles which go on for longer than you might expect. Muscle symptoms are more common in children and adolescents than in adults. As with other statins, a very small number of people have experienced unpleasant muscle effects and rarely these have gone on to become a potentially life-threatening muscle damage known as rhabdomyolysis.

Tell your doctor if you notice any of the following:

Frequent side effects:

• Headache
• Stomach pain
• Constipation
• Feeling sick
• 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.

Less frequent side effects:

• Rash, itching or other skin reactions.
• A severe stomach pain (inflamed pancreas).
• Jaundice (yellowing of the skin and eyes).
• Hepatitis (an inflamed liver).
• Damage to the nerves of your legs and arms (such as numbness).
• Joint pain.
• Memory loss.
• Breast enlargement in men (Gynecomastia)

Frequency unknown:

• Diarrhoea (loose stools).
• Steven-Johnson syndrome (serious blistering condition of the skin, mouth, eyes and genitals).
• Cough.
• Shortness of breath.
• 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.

Laboratory results:

LYPOVAS can cause the following changes to your lab results which your doctor will inform you about:

• An increase in the amount of protein in the urine - this usually returns to normal on its own without having to stop taking your LYPOVAS tablets (only LYPOVAS tablets 40 mg)
• Less frequent
• An increase in the amount of protein in the urine – this usually returns to normal on its own without having to stop taking your LYPOVAS tablets (only LYPOVAS tablets 5 mg, 10 mg and 20 mg).
• Increase in liver enzymes in the blood.
• Low platelet count in blood (thrombocytopenia)

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 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 KOLESTOR.

• Keep out of reach and sight of children.

• Store at or below 25 °C in original container. Protect from moisture.

• This medication does not require any special storage conditions

• Return all unused medicine to your pharmacist.

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