Didivir 200 mg/300 mg Film-Coated Tablets

DIDIVIR (emtricitabine and tenofovir disoproxil fumarate) belongs to a class of medicine known as antiviral medicines. DIDIVIR is indicated for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults and children age 12 years and older and is always used in combination with other anti-HIV medication. To help reduce the risk of getting HIV-1 infection in adults who are HIV-negative, DIDIVIR must be used in combination with safer sex practices and rigorously precise use at all times. This is called Pre-Exposure Prophylaxis or Pr-EP.

WARNINGS: DIDIVIR may lead to serious problems with your liver or cause too much lactic acid in your blood. If left untreated, this may even cause death. The safety and efficacy of DIDIVIR in patients who are infected with both human immunodeficiency virus (HIV) and hepatitis B virus (HBV) have not been established. You should not use DIDIVIR for the treatment of a chronic HBV infection. You should be closely monitored by your doctor for several months if you are infected with HBV and discontinue the use of DIDIVIR. Do not take DIDIVIR to reduce the risk of getting HIV-1 unless you are confirmed to be HIV-negative.

Do not take DIDIVIR:

• if you are hypersensitive (allergic) to emtricitabine, tenofovir disoproxil fumarate or any of the other ingredients contained in DIDIVIR (listed in section 6).
• if you are pregnant or breastfeeding (see “Pregnancy, breastfeeding and fertility”).
• if you have kidney problems, kidney failure or are on dialysis.
• if you are already taking any other medicines containing tenofovir or emtricitabine or lamivudine, as these medicines contain the same or similar active ingredients as DIDIVIR.
• if you are a woman taking DIDIVIR to prevent HIV infection and become pregnant while taking DIDIVIR.
• if you do not know your HIV infection status or if you already have HIV-1 infection as you need to take other medicines together with DIDIVIR to treat HIV-1.
• if you are not fully committed to use DIDIVIR every day for the prevention of HIV infection. See the section under “What DIDIVIR is and what it is used for” and talk to your healthcare provider for more information about how to prevent HIV infection.

Warnings and precautions

Take special care with DIDIVIR:

• if you have liver problems including hepatitis B or C virus infection
• if you have any kidney disease or reduced kidney function or you are on dialysis.
• if you are taking other medicines as DIDIVIR may interact with these other medicines. These medicines include antiretrovirals such as lamivudine, zidovudine, abacavir sulphate and co-formulations, didanosine, atazanavir and lopinavir/ritonavir.
• if you suffer from bone disease, including previous fractures and low bone mineral density (osteopenia).
• if you have any other medical conditions.
• if you are older than 65 years.
• are also infected with the Hepatitis B or C Virus (HBV or HCV) as you need to be closely monitored as other HIV treatment might be considered.

Do not share medicines prescribed for you with any other person. Always take DIDIVIR exactly as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are not sure. The usual dose is one tablet once a day with or without food. Take DIDIVIR at the same time every day. Tell your doctor if you have kidney problems so the dose of DIDIVIR can be altered. If you have the impression that the effect of DIDIVIR is too strong or too weak, tell to your doctor or pharmacist.

Treatment of HIV: If you are taking DIDIVIR for the treatment of HIV infection, you should take it in combination with other antiretroviral medicines.

Prevention of HIV: If you are taking DIDIVIR for reducing the risk of HIV infection, you must also use other preventative methods that can reduce the risk of getting HIV (e.g. condoms) (see Warnings and precautions).

If you take more DIDIVIR 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 DIDIVIR, always take DIDIVIR as prescribed. If you miss a dose, take it as soon as you remember. If you do not remember the missed dose until the next day, skip the missed dose and go back to your regular dosing schedule. Do not take a double dose to make up for the forgotten individual dose. It is important to take DIDIVIR regularly, because irregular intake may increase the risk of the virus developing resistance to your medication.

DIDIVIR can have side effects. Not all side effects reported for DIDIVIR are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking DIDIVIR, please consult your health care provider for advice. If any of the following happens, stop taking DIDIVIR and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing. These are all very serious side effects. If you have them, you may have had a serious reaction to DIDIVIR. 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:

• stomach discomfort, diarrhoea, fast shallow breathing, general feeling of discomfort, muscle pain or cramping, nausea, shortness of breath, sleepiness, and unusual tiredness or weakness, as these are symptoms associated with the development of lactic acidosis (see Warnings and precautions)
• less urine than is normal for you, signs of serious liver problems e.g. jaundiced (yellow discolouration of the skin and/or white part of the eyes), if your urine turns dark and your stools become light, if you lose your appetite for several days or longer or if you develop stomach pain, since DIDIVIR may cause inflammation of your liver. These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects:

• stomach ache
• joint pain, muscle aching or cramping, muscle pain or stiffness, pain in joints, swollen joints, back pain
• weakness in arms, hands, legs or feet
• increased cough
• sore throat, runny and itchy nose and sneezing
• excess gas (wind)
• diarrhoea
• headache
• nausea (feeling sick), vomiting
• dizziness
• sleep disturbances (including abnormal dreams and sleeplessness)
• stomach discomfort, belching, passing of gas, heartburn, indigestion
• Rashes (including red spots or blotches sometimes with blistering and swelling of the skin which may be allergic reactions), itching, changes in skin discolouration including darkening of the skin in patches
• difficulty breathing

Blood tests may also show:

• low white blood cell count (a reduced white blood cell count can make you more prone to infection)
• increased triglycerides (fatty acids), bile or sugar in the blood
• increased enzymes that helps with the metabolism of sugars and fats
• increased liver enzymes.
• increased creatine kinase (an enzyme resulting from breakdown of your muscles)

Less frequent side effects:

• joint or muscle pain
• tingling feelings like pins and needles
• back pain caused by kidney problems
• anaemia (low red blood cell count), which may include symptoms e.g. fatigue, skin pallor, shortness of breath, light-headedness, dizziness, or a fast heartbeat
• breakdown of muscle, muscle pain or weakness which may occur due to damage to the kidney tubule cells
• inflammation of the pancreas which most commonly begins with abdominal pain in the middle or upper left part of the abdomen and may increase after eating or lying flat the back
• fatty liver disease

Blood and urine tests may also show:

• decreases in potassium in the blood
• changes to your urine.
• decreases in phosphate in the blood
• increased creatinine in your blood
• decreases in phosphate in the blood

Side effects with unknown frequency:

• loss of bone mass
• blood in the urine
• trouble sleeping
• nervousness
• mood disturbances (depression)
• chest pain
• lung infection (e.g. pneumonia)
• inflammation of the pancreas which most commonly begins with abdominal pain in the middle or upper left part of the abdomen and may increase after eating or lying flat the back
• increased liver enzymes
• kidney problems
• fever
• sweating
• weight loss.

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

Reporting of suspected adverse reactions

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 requested to report any suspected adverse reactions to SAHPRA via Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website or to Cipla Medpro (Pty) Ltd. by email: [email protected] or telephone: 080 222 6662 (toll free).

Store at or below 30 °C. Do not use if the seal over bottle opening is broken or missing. KEEP THIS MEDICINE OUT OF REACH OF CHILDREN. Keep the container in the outer carton. Keep the container tightly closed. Do not use the medication after the expiry date stated on the container. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems, for example toilets.