Efamat 50 mg Film-Coated Tablets

What EFAMAT is: EFAMAT contains the active substance efavirenz, which belongs to a class of antiretroviral medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs). It is an antiretroviral medicine that fights human immunodeficiency virus (HIV) infection by reducing the amount of the virus in blood.

What EFAMAT is used for: EFAMAT tablets are used with other medicines in the treatment of infections caused by the human immunodeficiency virus (HIV). HIV is the virus that causes acquired immune deficiency syndrome (AIDS).

Do not take EFAMAT:

• if you are hypersensitive (allergic) to efavirenz or any of the other ingredients of EFAMAT;
• if you are pregnant or breastfeeding;
• if you had a liver disorder or liver failure attributed to treatment with EFAMAT.
• if you have severe liver disease (Child Pugh Grade C);
• if you have a heart condition, such as changes in the rhythm or rate of the heartbeat, a slow heartbeat, or severe heart disease.
• if any member of your family (parents, grandparents, brothers or sisters) has died suddenly due to a heart problem or was born with heart problems.
• if your doctor has told you that you have high or low levels of electrolytes such as potassium or magnesium in your blood.

Take special care with EFAMAT:

• if you have liver problems;
• if you have a history of psychiatric disorders including inappropriate behaviour (including aggressive reactions), depression, or of substance or alcohol abuse. Tell your doctor immediately if you feel depressed, have suicidal thoughts or have strange thoughts (see section 4, Possible side effects);
• if you have a history of convulsions (fits or seizures) or if you are being treated with anticonvulsant therapy such as carbamazepine, phenobarbital and phenytoin. If you are taking any of these medicines, your doctor may need to check the level of anticonvulsant medicine in your blood to ensure that it is not affected while taking EFAMAT. Your doctor may give you a different anticonvulsant;
• if you have a history of liver disease, including active chronic hepatitis. Patients with chronic hepatitis B or C and treated with combination antiretroviral agents have a higher risk for severe and potentially life-threatening liver problems. Your doctor may conduct blood tests in order to check how well your liver is working or may switch you to another medicine. If you have severe liver disease, do not take EFAMAT (see section 2 Do not take EFAMAT);
• if you have a heart disorder, such as abnormal electrical signal called prolongation of the QT interval;

Once you start taking EFAMAT, look out for:

• signs of dizziness, difficulty sleeping, drowsiness, difficulty concentrating or abnormal dreaming. These side effects may start in the first 1 or 2 days of treatment and usually go away after the first 2 to 4 weeks.
• any signs of skin rash. If you see any signs of a severe rash with blistering or fever, stop taking EFAMAT and tell your doctor at once. If you had a rash while taking another NNRTI, you may be at a higher risk of getting a rash with EFAMAT.
• any signs of inflammation or infection. In some patients with advanced HIV infection (AIDS) and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started. It is believed that these symptoms are due to an improvement in the body's immune response, enabling the body to fight infections that may have been present with no obvious symptoms. If you notice any symptoms of infection, please tell your doctor immediately.
• In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection. Autoimmune disorders may occur many months after the start of treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness beginning in the hands and feet and moving up towards the trunk of the body, palpitations, tremor or hyperactivity, please inform your doctor immediately to seek necessary treatment.
• bone problems. Some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone). The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this disease. Signs of osteonecrosis are joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement. If you notice any of these symptoms please inform your doctor.

EFAMAT will not cure or prevent HIV infection or AIDS; but it helps to keep HIV from reproducing and appears to slow down the destruction of the immune system. EFAMAT will not keep you from spreading HIV to other people.

Children and adolescents: EFAMAT has not been studied in paediatric patients below 3 years of age or who weigh less than 13 kg.

Do not share medicines prescribed for you with any other person. Always take EFAMAT exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

• Your doctor will prescribe the appropriate dosage in relation to your age and weight.
• Your doctor will tell you how long your treatment with EFAMAT will last.
• Do not suddenly stop taking EFAMAT without consulting your doctor first.
• EFAMAT should be taken without food on an empty stomach, preferably at bedtime.
• The central nervous system side effects (the system that controls most functions of the body and mind) that may occur with EFAMAT usually lessen after you have taken the medicine for a while. Also, taking the medicine at bedtime, especially during the first 2 – 4 weeks, may lessen these side effects.
• If you have the impression that the effect of EFAMAT is too strong or too weak, tell your doctor or pharmacist.

If you take more EFAMAT 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 EFAMAT

Do not take a double dose to make up for forgotten individual doses. If you miss a dose of EFAMAT, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

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

During HIV therapy there may be an increase in weight and in the levels of blood lipids and glucose. This is partly linked to restored health and lifestyle, and in the case of blood lipids sometimes to the HIV medicines themselves. Your doctor will test for these changes.

The most notable unwanted effects reported with EFAMAT in combination with other anti-HIV medicines are skin rash and nervous system symptoms such as memory loss, lack of coordination, severe headache and loss of sight or double vision. You should consult your doctor if you have a rash, since some rashes may be serious; however, most cases of rash disappear without any change to your treatment with EFAMAT. Rash was more common in children than in adults treated with EFAMAT. The nervous system symptoms such as memory loss, lack of coordination, severe headache and loss of sight or double vision tend to occur when treatment is first started, but generally decrease in the first few weeks. If you are affected your doctor may suggest that you take EFAMAT at bedtime and on an empty stomach. Some patients have more serious symptoms that may affect mood or the ability to think clearly. Some patients have actually committed suicide. These problems tend to occur more often in those who have a history of mental illness. Always notify your doctor immediately if you have these symptoms or any side effects while taking EFAMAT.

If any of the following happens, stop taking EFAMAT 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, hives
• fainting;
• tightness in the chest;
• convulsions (seizures);
• fast or abnormal heartbeat;
• fever; chills;
• skin rash; hives
• dizziness;
• liver failure, in some cases leading to death or liver transplant;
• suicidal thoughts or attempting to kill yourself.

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

• Nausea, vomiting;
• diarrhoea;
• worsening of depression;
• headache;

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

The following side effects have been reported frequently:

• Trouble in sleeping;
• tiredness; drowsiness; difficulty to concentrate;
• taste disorders;
• itching;

Tests may show:

• Increased liver enzymes in the blood;
• increased triglycerides (fatty acids) in the blood.

The following side effects have been reported less frequently:

• Inflammation of the pancreas;
• anorexia;
• abnormal behaviour; forgetfulness; anxiety; confusion; mood changes;
• abnormal vision;
• ringing in the ears; feeling of movement (vertigo);
• flushing;
• asthma;
• heartburn;
• yellow eyes or skin (jaundice);
• hair loss or painful hair follicles;
• eczema; flaking of skin;
• joint or muscle pain;
• breast enlargement in males.

Tests may show:

• increased cholesterol in the blood

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

• increased appetite; changes in body or face shape due to changes in fat distribution; weight gain or loss; you may lose fat from your legs, arms and face, gain fat around the abdomen (tummy) and other internal organs, get larger breasts or fatty lumps on the back of the neck ('buffalo hump');
• abnormal dreams;
• unsteadiness;
• tingling or burning of hands, arms, feet or legs;
• speech impairment;
• tremor (shaking);
• sinusitis; upper respiratory tract infections;
• constipation; indigestion; weakness;
• liver failure;
• acne; dandruff;
• increased sweating;
• discolouration of finger or toe nails;
• increased or decreased sexual drive; impotence;
• intolerance to alcohol;
• flu-like symptoms;
• combination antiretroviral therapy may develop death of bone tissue caused by loss of blood supply to the bone (osteonecrosis). You may experience joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement;
• combination antiretroviral therapy may also cause raised lactic acid and sugar in the blood, increased fat levels in the blood (hyperlipaemia) and resistance to insulin. Your doctor will test for these changes.

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

Reporting of side effects

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the “6.04 Adverse Drug Reactions 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 EFAMAT.

• Store all medicines out of reach of children.

• Store at or below 30 °C.

• Store in the original package/container.

• Keep the bottle tightly closed.

• Do not store in a bathroom.

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

• Return all unused medicine to your pharmacist.

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