Lipogen Side Effects

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Explain possible side effects and interaction/safety considerations for lipogen without overstating causality or efficacy.

What is Lipogen?

Lipogen contains the active ingredient Atorvastatin.

• Active ingredient — Atorvastatin
• Registration number — 42/7.5/0556; 42/7.5/0557; 42/7.5/0558; 42/7.5/0559
• Registration holder — Ranbaxy Pharmaceuticals (Pty) LTD

It is approved for:

• 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 life style 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

Possible side effects of Lipogen

Not everyone gets side effects. The effects below are those listed in the South African approved leaflet, grouped using the leaflet’s own frequency wording.

Frequent side effects

• diarrhoea (loose stools), constipation, nausea (feeling sick), indigestion, winds
• 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 side effects

• 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
• frightening dreams
• vision problems/disturbance, vision blurred, hearing loss
• enlarged breasts in men
• skin disease with blisters
• pain in legs or arms. 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

Interactions and medicines to check

The approved leaflet names these interactions.

• medicines used to alter the way your immune system works (e.g. ciclosporin)
• medicines used to treat certain bacterial or fungal infections [e.g. macrolide antibiotics (e.g. erythromycin, telithromycin, clarithromycin, azithromycin); rifampicin; azole antifungals (e.g. ketoconazole, fluconazole, itraconazole, voriconazole, posaconazole, clotrimazole); fusidic acid]
• medicines used to regulate lipid levels (e.g. gemfibrozil, fenofibrate, other fibrates, ezetimibe, niacin/nicotinic acid, nicotinic acid derivatives, colestipol, cholestyramine)
• medicines used to treat chest pain (angina) or high blood pressure (e.g. amlodipine, diltiazem, verapamil)
• medicines used to regulate your heart rhythm (e.g. digoxin, amiodarone)
• medicine used to treat high blood pressure and certain types of swelling (e.g. spironolactone)
• medicines used for the treatment of HIV infection (e.g. delavirdine, efavirenz, HIV protease inhibitors like lopinavir, darunavir, tipranavir plus ritonavir, lopinavir plus ritonavir, saquinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, fosamprenavir plus ritonavir; nelfinavir, atazanvir, indinavir)
• medicine used for the treatment of hepatitis C (e.g. hepatitis C protease inhibitor like telaprevir, boceprevir, elbasvir/grazoprevir)
• medicines used as blood thinning agents (e.g. warfarin/ other anticoagulants)
• medicines used for indigestion [e.g. antacid (containing magnesium and aluminium hydroxides), cimetidine]
• hormonal contraceptive pills [e.g. birth controlling pills (norethindrone + ethinyl estradiol)]
• medicine used to treat joint pain (e.g. colchicine)
• medicine used to treat fever and pain (e.g. antipyrine/ phenazone)
• a herbal medicine for treating mild forms of depression: St John’s Wort
• medicine used to treat epilepsy (e.g. stiripentol)
• medicines used for high blood pressure and hormone (oestrogen) replacement medicines

Who should use extra caution?

The approved leaflet identifies the following cautions and factors.

Do not use it at all 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
• 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

Use with care, and tell your doctor, 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. Laboratory tests Your doctor may carry out a few blood tests before and possibly during your LIPOGEN treatment. LIPOGEN contains lactose monohydrate which may have an effect on the control of your blood sugar if you have diabetes mellitus. While you are on LIPOGEN, your doctor will monitor you closely if you have diabetes or are at risk of developing diabetes. LIPOGEN should be taken with caution if you have been told by your doctor that you have an intolerance to lactose. Contact your doctor before taking LIPOGEN. Taking LIPOGEN tablets with food and drink: LIPOGEN tablets can be taken any time of the day, with or without food. LIPOGEN must not be taken with grapefruit juice. Alcohol: Avoid drinking too much alcohol while taking LIPOGEN

Pregnancy and breastfeeding

• 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
• Pregnancy Do not take LIPOGEN if you are pregnant, or planning to become pregnant, or are breastfeeding your baby
• Women of child bearing age should use adequate contraceptive measures while taking LIPOGEN
• If you are trying to become pregnant your doctor will advise you to stop taking LIPOGEN about one month before you plan to conceive
• If you are pregnant or breastfeeding your baby, please consult your doctor, pharmacist or other healthcare professional for advice before taking LIPOGEN Breast-feeding LIPOGEN must not be used during breast-feeding
• Fertility No data available

Dose, timing and other factors that can affect side effects

The approved leaflet identifies the following cautions and factors.

Do not use it at all 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
• 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

Use with care, and tell your doctor, 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. Laboratory tests Your doctor may carry out a few blood tests before and possibly during your LIPOGEN treatment. LIPOGEN contains lactose monohydrate which may have an effect on the control of your blood sugar if you have diabetes mellitus. While you are on LIPOGEN, your doctor will monitor you closely if you have diabetes or are at risk of developing diabetes. LIPOGEN should be taken with caution if you have been told by your doctor that you have an intolerance to lactose. Contact your doctor before taking LIPOGEN. Taking LIPOGEN tablets with food and drink: LIPOGEN tablets can be taken any time of the day, with or without food. LIPOGEN must not be taken with grapefruit juice. Alcohol: Avoid drinking too much alcohol while taking LIPOGEN

Pregnancy and breastfeeding

• 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
• Pregnancy Do not take LIPOGEN if you are pregnant, or planning to become pregnant, or are breastfeeding your baby
• Women of child bearing age should use adequate contraceptive measures while taking LIPOGEN
• If you are trying to become pregnant your doctor will advise you to stop taking LIPOGEN about one month before you plan to conceive
• If you are pregnant or breastfeeding your baby, please consult your doctor, pharmacist or other healthcare professional for advice before taking LIPOGEN Breast-feeding LIPOGEN must not be used during breast-feeding
• Fertility No data available

Serious symptoms and warning signs

This leaflet does not set out a separate list of serious side effects. The general warning signs below apply to any medicine.

General warning signs that apply to any medicine

What to do if side effects occur

If you think you are having a side effect, the response depends on how severe it is. Use the warning signs above first — if any of those apply, treat it as urgent.

If the symptom is severe or frightening

Get medical help immediately. Call 10177 for an ambulance, or 112 from a mobile phone, or go to the nearest emergency department. Take the product and its packaging with you if you can.

If the symptom is mild but bothering you

• Write down what the symptom is, when it started, and how it relates to when you take the product
• Check the leaflet that came with the product to see whether the symptom is listed
• Speak to your pharmacist — for many questions this is the fastest route to a useful answer
• Contact the prescriber if the symptom is affecting your daily life or is not settling

You can also report a suspected side effect in South Africa. Reporting does not replace getting medical advice, and you do not need to be certain the product was the cause.

How to report a suspected side effect in South Africa

South Africa has an official system for reporting suspected side effects, run by the South African Health Products Regulatory Authority (SAHPRA). Reports from the public and from healthcare professionals are how safety signals get detected after a product is already in use.

Who can report

Anyone can report — you do not have to be a healthcare professional, and you do not need to prove that the product caused the problem. A suspicion is enough. Patients, caregivers and family members can all submit a report.

What to have ready

• The name of the product, its strength and form, and the batch number if you have it
• Why it was being used, and when it was started and stopped
• What the suspected reaction was, when it began, and how long it lasted
• Any other medicines, supplements or remedies being used at the same time
• Basic details about the person affected — age and sex are usually enough

How to report

SAHPRA accepts adverse reaction reports through its e-Services reporting system and through the Med Safety mobile app. Healthcare professionals can also report through the same routes. Current forms and access points are published on the SAHPRA site.

• SAHPRA Health Products Vigilance — the main vigilance and reporting hub
• SAHPRA e-Services — current adverse reaction reporting access

For a fuller walkthrough see how to report an adverse drug reaction.

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