Mytenotrin Film-Coated Tablets

MYTENOTRIN is a type of medicine called an HIV (human immunodeficiency virus) nucleoside analogue reverse transcriptase inhibitor (NRTI). MYTENOTRIN contains 2 medicines, emtricitabine (200 mg) and tenofovir disoproxil fumarate (or tenofovir DF) (300 mg) combined in one pill.

Treatment for HIV Infection:

MYTENOTRIN is used in adults in combination with other anti-HIV medicines to treat people with HIV-1 infection.

Treatment for Pre-Exposure Prophylaxis (PrEP):

To reduce the risk of getting HIV-1 in adults, MYTENOTRIN 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 MYTENOTRIN:

• If you are hypersensitive (allergic) to tenofovir disoproxil fumarate or emtricitabine or any of the other ingredients contained in the MYTENOTRIN tablets (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 MYTENOTRIN to prevent HIV infection and you become pregnant while taking MYTENOTRIN.
• If you are HIV positive or if your HIV status is not known, when using MYTENOTRIN to prevent HIV infection.
• If you are not fully committed to use MYTENOTRIN every day for Pre-Exposure Prophylaxis.

See the section 1. What MYTENOTRIN is and what it is used for and talk to your health care provider for more information about how to prevent HIV infection.

Warnings and precautions

Take special care with MYTENOTRIN:

• If you have bone problems. Talk to your doctor if you suffer from osteoporosis, have a history of bone fracture or if you have problems with your bones. Bone problems (manifesting as persistent or worsening bone pain and sometimes resulting in fractures) may also occur due to damage to kidney tubule cells (see section 4, Possible side effects). Tell your doctor if you have bone pain or fractures. Tenofovir disoproxil may also cause loss of bone mass.
• 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 MYTENOTRIN 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 MYTENOTRIN. Follow up includes medical examinations and blood tests to check for HBV that could be getting worse.
• Patients with Hepatitis B Virus who take MYTENOTRIN 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. MYTENOTRIN is not approved for the treatment of Hepatitis B Virus infection. You should read the patient information leaflet of the other HIV medicines that you will be taking in combination with MYTENOTRIN.
• Changes in body fat have been seen in some patients taking MYTENOTRIN and other anti-HIV medicines. These changes may include increased amount of fat in the upper back and neck (“buffalo hump”), breast and around the main part of your body (trunk). Loss of fat from the legs, arms and face may also happen. 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 MYTENOTRIN and other HIV 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 health care provider if you start having any new symptoms after starting your HIV medicine.
• Some people who have taken medicine like MYTENOTRIN 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 Section 4 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 MYTENOTRIN have developed serious liver problems called hepatotoxicity, with liver enlargement (hepatomegaly) and fat in the liver (steatosis).
• Any child exposed in utero to nucleoside and nucleotide analogues (like MYTENOTRIN) even HIV negative children, should have clinical and laboratory follow up and should be fully investigated for possible mitochondrial dysfunction.

If you are diabetic, overweight or have high cholesterol, talk to your doctor.

Do not share medicines prescribed for you with any other person. Always take MYTENOTRIN exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.

Recommended dosage of MYTENOTRIN tablets:

The usual dose for adults is one (1) MYTENOTRIN tablet once a day. Take MYTENOTRIN at the same time each day.

Treatment of HIV:

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

Prevention of HIV:

If you take MYTENOTRIN to reduce the risk of getting HIV-1, you must also use other methods to reduce your risk of getting HIV. See Warnings and precautions, Take special care with MYTENOTRIN.

Your doctor will tell you how long your treatment with MYTENOTRIN will last. Do not stop treatment early.

If you have the impression that the effect of MYTENOTRIN is too strong or too weak, talk to your doctor or pharmacist.

If you take more MYTENOTRIN than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.

If you forget to take MYTENOTRIN

It is important that you do not miss any doses. If you miss a dose of MYTENOTRIN, 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 health care provider or pharmacist if you are not sure what to do. Do not take more than one dose of MYTENOTRIN in a day.

If you stop taking MYTENOTRIN

You should not stop treatment unless your doctor instructs you to. When your MYTENOTRIN supply starts to run low, get more from your health care 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 MYTENOTRIN and become difficult to treat.

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

If any of the following happens, stop taking MYTENOTRIN 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 (angioedema);
• Rash or itching;
• Fainting.

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

• Difficulty breathing;
• 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 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 frequently reported:

• 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;
• Other allergic reactions e.g. Wheezing, swelling or feeling lightheaded;
• Loss of bone mass.

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;
• Decreases in phosphate in the blood;
• Increased creatine kinase (an enzyme resulting from breakdown of your muscles);
• Increased amylase or lipase in the blood;
• Increased liver enzymes.

The following side effects have been less frequently reported:

• Lactic acidosis;
• 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;
• Swelling of the face, lips, tongue or throat;
• Softening of the bones (with bone pain and sometimes resulting in fractures).

Blood and urine tests may also show:

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

This list of side effects is not complete. If you have questions about side effects, ask your health care provider. You should report any new or continuing symptoms to your health care provider right away. Your health care provider may be able to help you manage these side effects. 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 Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of MYTENOTRIN.

• Store all medicines out of reach of children.

• Store at or below 30 ºC.

• Store the tablets in the original container.

• Do not remove from the carton until required for use.

• Keep the bottle tightly closed.

• Do not store in bathrooms.

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

• Return all unused medicine to your pharmacist.

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