Prepetam Film-Coated Tablets

PREPETAM is a type of medicine called an HIV (human immunodeficiency virus) nucleoside analogue reverse transcriptase inhibitor (NRTI). PREPETAM contains 2 medicines, emtricitabine 200 mg and tenofovir disoproxil fumarate (tenofovir DF) 300 mg combined in one tablet. Both of these active substances are antiretroviral medicines used to treat HIV infection. PREPETAM is used to treat HIV - 1 Infections in adults, in combination with other antiretroviral medicines. PREPETAM is also used as a Treatment for Pre - Exposure Prophylaxis (PrEP). To reduce the risk of getting HIV - 1 in adults, PREPETAM is to be used in combination with safer sex practices and rigorous use at all times. This is called Pre - Exposure Prophylaxis or PrEP.

Do not take PREPETAM

• if you are hypersensitive (allergic) to tenofovir disoproxil, emtricitrabine or any of the other ingredients of PREPETAM (listed in section 6).
• If you are pregnant or breastfeeding.
• If you have kidney problems or are on dialysis.
• If you are already taking any other tenofovir or emtricitabine containing medicines or medicines containing lamivudine because these medicines contain the same or similar active ingredients.
• If you are a female who is taking PREPETAM to prevent HIV infection and you become pregnant while taking PREPETAM.
• If you are HIV positive or if your HIV status is not known, when using PREPETAM to prevent HIV infection.
• If you are not fully committed to use PREPETAM every day for Pre - Exposure Prophylaxis.

Talk to your healthcare provider for more information about how to prevent HIV infection. If you are not sure if any of these apply to you, talk to your doctor or pharmacist before taking PREPETAM

Warnings and precautions

Take special care with PREPETAM

• Tell your doctor or health care provider before being given PREPETAM:

• If you have bone problems.
• If you have liver problems including Hepatitis B Virus infection.
• If you have had kidney problems in the past or take other medicines that can cause kidney problems.
• If you are taking other medicines as PREPETAM may interact with these other medicines.
• If you are also infected with the Hepatitis B Virus (HBV), you need close medical follow up for several months after stopping treatment with PREPETAM. Follow - up includes medical examinations and blood tests to check for HBV that could be getting worse.
• Patients with Hepatitis B Virus who take PREPETAM and then stop it, may get “flare - ups” of their hepatitis. A “flare - up” is when the disease suddenly returns in a worse way than before. PREPETAM is not approved for the treatment of Hepatitis B Virus infection.

You should read the patient information leaflet of the other antiretroviral medicines that you will be taking in combination with PREPETAM.

• Changes in body fat have been seen in some patients taking PREPETAM and other antiretroviral medicines. These changes may include an increased amount of fat in the upper back and neck (“buffalo hump”), breasts, and around the main part of your body (trunk). Loss of fat from the legs, arms and face may also occur. The cause and long - term health effect of these conditions are not known at this time.
• Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking PREPETAM and other antiretroviral medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider if you start having any new symptoms after starting your antiretroviral medicine.
• Some people who have taken medicine like PREPETAM have developed a serious condition called lactic acidosis (build - up of an acid in the blood). Lactic acidosis can be a medical emergency and may need to be treated in the hospital (see possible side effects).
• The following side effects may be signs of lactic acidosis:

• deep rapid breathing
• drowsiness
• feeling sick (nausea), being sick (vomiting) and stomach pain

Some people who have taken medicines like PREPETAM have developed serious liver problems called hepatotoxicity, with liver enlargement (hepatomegaly) and fat in the liver (steatosis).

Do not share medicines prescribed for you with any other person. Always take PREPETAM 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 tablet once daily. Your doctor will tell you how long your treatment with PREPETAM will last. Do not stop treatment early. If you have the impression that the effect of PREPETAM is too strong or too weak, tell your doctor or pharmacist.

Treatment of HIV - 1

If you take PREPETAM for the treatment of HIV - 1 infection, it should be used in combination with other antiretroviral medicines.

Prevention of HIV

If you take PREPETAM to reduce the risk of getting HIV - 1, you must also use other methods to reduce your risk of getting HIV. See “Take special care with PREPETAM”.

If you take more PREPETAM than you should

If you take more PREPETAM than prescribed by your doctor, contact a doctor or pharmacist immediately for advice. If neither is available, contact the nearest hospital or poison control centre.

If you forget to take PREPETAM

It is important that you do not miss any doses. If you miss a dose of PREPETAM, take it as soon as possible that day and then take your next scheduled dose at its regular time. If it is almost time for your next dose, do not take 2 doses at the same time. Contact your healthcare provider or pharmacist if you are not sure what to do. Do not take more than one dose of PREPETAM in a day.

If you stop taking PREPETAM

You should not stop treatment unless your doctor instructs you to. When your PREPETAM 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 will increase if the medicine is stopped for even a short time. The virus may develop resistance to PREPETAM and become difficult to treat.

PREPETAM can have side effects. Not all side effects reported for PREPETAM are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking PREPETAM, please consult your health care provider for advice.

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

• Difficulty breathing, swelling of the face, throat and tongue
• Less urine than is normal for you
• Signs or symptoms of lactic acidosis (build - up of acid in the blood) e.g. feeling weak or tired, having unusual muscle pain, trouble breathing, stomach pain with nausea and vomiting, feeling cold (especially in your arms and legs), feeling dizzy and lightheaded and having a fast or irregular heartbeat
• Signs or symptoms of serious liver problems e.g. skin or white part of the eye turns yellow (jaundice), urine turns dark, stools turn light in colour, feeling sick to your stomach (nausea), have lower stomach area pain (abdominal pain) and not feeling like eating food for several days or longer
• Signs of softening of the bones (bone pain and sometimes resulting in fractures)

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

• Frequent stomach pain
• Pain
• Abnormal physical weakness or lack of energy
• Diarrhoea
• Headache
• Nausea (feeling sick), vomiting
• Dizziness
• Difficulty sleeping, abnormal dreams
• Problems with digestion resulting in discomfort after meals, feeling bloated, flatulence
• Rashes (including red spots or blotches sometimes with blistering and swelling of the skin which may be allergic reactions), itching, changes in skin colour including darkening of the skin in patches

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 creatine kinase (an enzyme resulting from breakdown of your muscles)
• Increased enzymes that helps with the metabolism of sugars and fats
• Increased liver enzymes.

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

Tell your doctor if you notice any of the following:

• Less frequent side effects:

• 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.

Blood and urine tests may also show:

• Decreases in potassium in the blood
• Decreases in phosphate in the blood
• Increased creatinine in your blood
• Changes to your urine.

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. 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 PREPETAM.

Store all medicines out of reach of children

Store below 30 o C. Protect the medicine from light. Keep this medicine in the original container until required for use. Keep the bottle tightly closed. Discard 90 days after first opening. Do not use this medicine after the expiry date which is stated on the carton.

The expiry date refers to the last day of that month. Return all unused or expired medicine to your pharmacist. Do not use if seal over bottle opening is broken or missing. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).