Eflotela Tablets

EFLOTELA is used in the treatment of acquired immune deficiency syndrome (AIDS) in adults over 18 years of age. EFLOTELA will not cure or prevent HIV infection or AIDS; however it helps to keep the HIV virus from reproducing and to slow down the destruction of the immune system. EFLOTELA will not keep you from spreading HIV to other people.

Do not take EFLOTELA:

• If you are hypersensitive (allergic) to tenofovir disoproxil fumarate, lamivudine or efavirenz or to any of the other ingredients of EFLOTELA.
• If you have had liver problems when taking efavirenz previously.
• If you have severe liver problems.
• If you have moderate to severe kidney problems.
• If you are pregnant or breastfeeding your baby.
• If you are taking medicines containing any of the following: terfenadine, astemizole, cisapride, midazolam, triazolam, pimozide, bepridil, ergot alkaloids, St John’s wort (hypericum perforatum), zalcitabine or with elbasvir/grazoprevir.

Warnings and precautions

Redistribution, accumulation or loss of body fat may occur. Contact your doctor if you notice changes in body fat. Within the first few weeks of treatment with anti-HIV medicines, some people, particularly those that have been HIV positive for some time, may develop inflammatory reactions (e.g. pain, redness, swelling, high temperature) which may resemble an infection and may be severe. It is thought that these reactions are caused by a recovery in the body's ability to fight infections, previously suppressed by HIV. If you become concerned about any new symptoms, or any changes in your health after starting HIV treatment, please discuss with your doctor. If you experience joint aches and pain, joint stiffness or difficulty in movement, speak to your doctor as it could be a sign of bone problems. EFLOTELA does not cure or prevent HIV infection and the chances of still developing infections or illness associated with HIV is possible. The use of EFLOTELA does not reduce the risk of transmitting the virus to others through sexual contact or blood contamination. EFLOTELA can cause a condition called lactic acidosis (excess of lactic acid in your blood), which causes nausea, vomiting, stomach ache, problems breathing, tiredness and weight loss. If you have hepatitis B or C, treatment with EFLOTELA can increase severe liver adverse reactions. Tell your doctor or healthcare provider before taking EFLOTELA:

• If you have ever had mental illness or are using medicines for mental illness
• If you have ever had seizures or are taking medicines for seizures
• If you are older than 65 years of age
• If you have serious nervous system and psychiatric symptoms

Do not share medicines prescribed for you with any other person. Always take EFLOTELA exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The usual dose is one EFLOTELA tablet once daily taken orally on an empty stomach. Your doctor will tell you how long your treatment with EFLOTELA will last. If you have the impression that the effect of EFLOTELA is too strong or too weak, tell your doctor or pharmacist.

If you take more EFLOTELA 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 EFLOTELA

Do not take a double dose to make up for forgotten individual doses.

If you stop taking EFLOTELA

You should not stop treatment unless your doctor instructs you to. When your EFLOTELA supply starts to run low, get more from your healthcare provider or pharmacy. This is very important because the amount of virus in your blood may increase if the medicine is stopped for even a short time. The virus may develop resistance to EFLOTELA and become harder to treat.

EFLOTELA can have side effects. Not all side effects reported for EFLOTELA are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking EFLOTELA, please consult your health care provider for advice. If any of the following happens, stop taking EFLOTELA 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
• fainting

These are all very serious side effects. If you have them, you may have had a serious reaction to EFLOTELA. You may need urgent medical attention or hospitalisation. The following are signs of serious liver problems (hepatitis):

• Yellow discolouration of the skin and the white part of your eyeballs
• Darkening of your urine
• Your bowel movements turn lighter in colour
• You feel sick to your stomach (nausea)
• You have stomach pain

You may need urgent medical attention or hospitalisation. The following are signs of a serious condition called lactic acidosis (build-up of acid in the blood). Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• You feel very weak or tired
• You have unusual (not normal) muscle pain
• You have trouble breathing
• You have stomach pain with nausea and vomiting
• You feel cold, especially in your arms and legs
• You feel dizzy or lightheaded
• You have a fast or irregular heartbeat

This side effect can cause inflammation of the pancreas, liver and kidney failure, and has occasionally been fatal. Lactic acidosis also occurs more often in women, particularly if they are overweight. If you have liver disease, you may also be more at risk of getting this condition. While you are being treated with EFLOTELA, your doctor will monitor you closely for any signs that you may be developing lactic acidosis. Tell your doctor if you notice any of the following:

• Frequent:
• dizziness
• diarrhoea, nausea, vomiting, flatulence (wind)
• headache, insomnia (difficulty sleeping)
• cough, nose symptoms
• stomach pain or cramps
• rash, loss of hair
• joint pain, muscle problems
• fatigue (weakness), malaise (feel unwell), fever
• anxiety, depression
• abnormal dreams, disturbance in attention
• sleepiness
• itching

Less frequent:

• lactic acidosis (build-up of acid in the blood)
• shortness of breath
• Inflammation of the pancreas, which causes severe pain in the abdomen and back
• increases in enzymes produced by the liver, liver disease
• kidney problems
• asthenia (lack of energy)
• low white blood cell count, low red blood cell count, increased bruising or bleeding (thrombocytopenia), bone marrow stops making red blood cells (pure red cell aplasia)
• peripheral neuropathy (when the nerves carrying messages to and from the brain are damaged)
• rhabdomyolysis (muscle breaks down causing muscle pain, weakness, vomiting and confusion)
• allergy
• aggression, unrealistic feeling of wellbeing, false perceptions, mania, paranoia, suicide thoughts or attempts
• agitation, memory loss, loss of muscle coordination, abnormal coordination, confusion, fits, abnormal thinking, blurred vision
• erythema multiforme (skin eruption)
• increased size of male breasts

Frequency not known:

• myopathy (muscle weakness and wasting), osteomalacia (rickets)
• kidney inflammation

Changes in body fat. Changes in body fat develop in some patients taking EFLOTELA. These changes may include an increased amount of fat in the upper back and neck (“buffalo hump”), in the breasts and around the trunk. Loss of fat from the legs, arms and face may also happen. The cause and long-term health effects of these fat changes are not known. Opportunistic infections. 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 inform your doctor immediately. Osteonecrosis (death of bone tissue caused by loss of blood supply to the bone). You must contact your doctor if you experience joint aches and pain, joint stiffness or difficulty in movement. 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 EFLOTELA.

Store all medicines out of reach of children. Store at or below 25 °C. Store in the original container. Do not remove from the carton until required for use. Keep the bottles tightly closed.