Lipogen Film-Coated Tablets

LIPOGEN tablets are used to lower fats known as cholesterol and triglycerides in your blood when a low fat diet and other non-medicinal treatments such as exercise and lifestyle changes have failed. You should maintain a standard cholesterol lowering diet during treatment. LIPOGEN can lower risk of heart disease and disorders of the blood vessels of the brain, which are conditions due to reduced blood supply, in patients who have multiple risk factors for heart disease, such as smoking, hypertension, diabetes, low HDL-C, or a family history of early coronary heart disease. LIPOGEN can reduce heart events in patients with heart disease and high cholesterol levels.

Do not take LIPOGEN tablets if:

• you have previously had an allergic reaction to atorvastatin or to any of the tablet ingredients of LIPOGEN listed in section 6 (an allergic reaction may include rash, itching, swelling of face, lips, or hands/feet or breathing difficulties)
• you have a liver disease (symptoms may indicate fatigue, loss of appetite, right upper abdominal discomfort, dark urine, or jaundice – yellow discolouration of the skin)
• you have any unexplained abnormal blood test results for liver function
• you are pregnant, or planning to become pregnant (see also Pregnancy, breastfeeding and fertility)
• you are breastfeeding
• you are taking rifampicin (used to treat tuberculosis), diltiazem (used to treat chest pain or high blood pressure) and grapefruit juice at the same time.

Do not take LIPOGEN if any of the above applies to you. If you are not sure, please talk to your doctor or pharmacist before taking LIPOGEN.

Warnings and precautions

Take special care with LIPOGEN tablets if:

• you have kidney problems or a history of kidney problems
• you have or have had repeated or unexplained muscle pains or cramps, muscle tenderness, weakness particularly if accompanied by fever
• you have had previous muscular problems during treatment with other lipid-lowering medicines (e.g. simvastatin, fenofibrate classes of medicines)
• you consume substantial quantities of alcohol and/or have a history of liver disease. Your doctor may perform some blood tests called liver function tests
• you are an elderly patient
• you have severe acute infection, low blood pressure, major surgery, trauma, diseases of metabolism (e.g. diabetes) or hormonal diseases or electrolytes disorders (abnormalities in the blood levels of sodium, potassium), or uncontrolled seizures (fits)
• you have a disease of low thyroid levels
• you have had a previous stroke with bleeding into the brain
• you have serious problems with your breathing (Interstitial lung disease) with symptoms including shortness of breath, persistent cough and deterioration in general health (fatigue, weight loss and fever).

Please consult your doctor if these statements are applicable or were applicable to you any time in the past or if you are not sure if these are applicable to you.

Do not share medicines prescribed for you with any other person. Make sure you continue with your recommended diet, exercise and other lifestyle changes while on LIPOGEN. Always take LIPOGEN exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. LIPOGEN tablets should be swallowed whole with a drink or water, and can be taken at any time of day, with or without food. However, try to take your tablet at the same time every day.

Adults and elderly patients

The usual starting dose of LIPOGEN tablets is 10 mg once a day. This may be increased if deemed necessary by your doctor. Your doctor will adjust the dosage at intervals of 4 weeks or more. The maximum dose of LIPOGEN is 80 mg once daily.

Children (> 10 to 17 years of age)

The usual starting dose of LIPOGEN tablets is 10 mg once a day. The maximum dose of LIPOGEN is 20 mg once daily. LIPOGEN tablets are not recommended in patients below the age of 10 years. The duration of treatment with LIPOGEN tablets will be determined by your doctor.

If you have the impression that the effect of LIPOGEN tablets is too strong or too weak, talk to your doctor or pharmacist.

If you take more LIPOGEN 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 this leaflet or some tablets with you so your doctor will know what you have taken.

If you forget to take a dose of LIPOGEN:

If you forget to take LIPOGEN at the right time, take them as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take a double dose to make up for forgotten individual doses.

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

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

• sudden signs of allergic (hypersensitivity) reactions or allergy, which may manifest as an itchy skin rash [including severe skin rash (bullous rash)], hives, chest constriction, shortness of breath, breathing problems, wheezing or ‘swelling of face, lips, eyelids, throat or tongue, hands/feet (angioedema)’, loss of circulation (anaphylactic reaction), high temperature (these may be symptoms of a serious allergic reaction)
• detachment of the top layer of skin (the epidermis) from the lower layers of the skin (the dermis) all over the body (including lips, eyes, mouth, nose and genitals) known as toxic epidermal necrolysis
• a serious skin disorder which begins with flu-like symptoms, followed by a painful red or purplish rash that spreads and blisters, eventually causing the top layer of the skin to die and shed (Stevens-Johnson Syndrome)
• a skin disorder with symptoms of fever, general ill feeling, itching of the skin, joint aches and multiple skin lesions (erythema multiforme)
• muscle weakness, tenderness or pain and particularly, if at the same time, you feel unwell or have a high temperature; it may be caused by an abnormal muscle breakdown which can be life-threatening and lead to kidney problems (rhabdomyolysis and myopathy)
• collapse, numbness or weakness of the arms or legs, headache, dizziness and confusion, visual disturbance, difficulty swallowing, slurred speech and loss of speech. These may be symptoms of stroke/haemorrhagic stroke (damage to part of the brain caused by an interruption to its blood supply).

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

• sudden onset of severe abdominal pain with vomiting
• yellowing of skin and whites of eyes with decreased appetite, abdominal pain. These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent:

• diarrhoea (loose stools), constipation, nausea (feeling sick), indigestion, wind
• headache
• muscle cramps, muscle and joint pains, back pain
• high sugar (glucose) levels in the blood with symptoms such as passing large amounts of urine, excessive thirst and having a dry mouth and skin
• swelling of hands, ankles or feet
• inflammation of muscles, muscle cramps/spasms
• sore throat, sinusitis, throat pain
• muscle tiredness
• nose bleed

Less frequent:

• difficulty in sleeping
• vomiting (being sick), loss of appetite, abdominal pain
• weakness
• skin rash, itching, hair loss
• dizziness
• pins and needles sensation, burning, tingling sensation, pain in hands/feet
• ringing of the ears
• weight gain
• chest pain
• generally feeling unwell
• reduction in blood platelets, which increases risk of bleeding or bruising
• low sugar (glucose) levels in the blood with symptoms such as sweating, weakness, hunger, dizziness, trembling, headache, flushing or paleness, numbness, having a fast, pounding heart beat
• numbness or weakness of the arms and legs (peripheral neuropathy), loss of memory, taste disturbances
• tiredness
• pain and weakness in muscles
• fever
• neck pain, joint swelling

The following side effects have been reported but the frequency is unknown:

• urinary tract infection
• abdominal discomfort
• muscle and bone pain
• depression, memory loss/impairment, confusion, forgetfulness
• sexual inability or difficulties
• diabetes
• a disorder that results in progressive scarring of lung tissue that eventually affects the ability to breathe and get enough oxygen into the bloodstream (interstitial lung disease).

There may be changes in the results of certain laboratory tests:

• increased blood levels of liver enzymes
• increased blood alkaline phosphatise
• elevated creatine phosphokinase
• decrease in platelet count (a type of blood cells)
• white blood cells in urine
• increase in blood HbA1c and change in blood glucose.

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. 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 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 LIPOGEN.

Store at or below 25 ºC in the original package, protected from light and moisture. Do not remove the blisters from the carton until required for use. Do not use after the expiry date stated on the label. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems e.g. toilets.