Viread 300 mg Film-Coated Tablets

VIREAD is a type of medicine called an HIV - 1 (human immunodeficiency virus - 1) nucleotide analogue reverse transcriptase inhibitor (NRTI).

1. VIREAD is always used in combination with other anti - HIV medicines to treat adults and adolescents ≥ 12 years of age weighing ≥ 35 kg with HIV - 1 infection.
2. VIREAD is used in the treatment of chronic (long - lasting) hepatitis (liver infection) B virus (HBV) in adults and adolescents ≥ 12 years of age weighing ≥ 35 kg.

Do not take VIREAD:

• If you are hypersensitive (allergic) to tenofovir or any of the other ingredients of VIREAD (listed in section 6).
• If you suffer from lactose intolerance, you should avoid this product as it contains lactose monohydrate.
• If you have kidney problems or are on dialysis.
• If you are already taking emtricitabine/tenofovir disoproxil fumarate co - formulation because VIREAD contains one of the active ingredients in these medicines.
• If you are already taking other medicines containing tenofovir.
• If you are taking medicines containing adefovir dipivoxil.
• If you are breastfeeding your baby.
• If you are pregnant (see Pregnancy, breastfeeding and fertility below).

Warnings and precautions

Take special care with VIREAD:

• VIREAD does not cure HIV - 1 infection or AIDS. The long - term effects of VIREAD are not known at this time. People taking VIREAD may still get opportunistic infections or other conditions that happen with HIV - 1 infection. Opportunistic infections are infections that develop because the immune system is weak. Some of these conditions are pneumonia, herpes virus infections, Mycobacterium avium complex (MAC) infections and Mycobacterium tuberculosis.
• VIREAD does not reduce the risk of passing HIV - 1 to others through sexual contact or blood contamination. Continue to practice safe sex and do not use or share needles.
• Talk to your doctor about taking an HIV test before starting treatment with VIREAD for chronic hepatitis B. You should also get a test for HBV if you are taking VIREAD for treatment of HIV.
• If you have bone problems.
• If you have liver problems, including Hepatitis B Virus infection.
• If you have kidney problems, your doctor may recommend that you not take VIREAD. Your doctor may need to monitor your kidney function while you are taking VIREAD.
• If you are taking other medicines, as VIREAD may interact with these other medicines. You should read the professional information or patient information leaflet of the other HIV medicines that you will be taking in combination with VIREAD.

Adolescents

It is not known if VIREAD is safe and effective in patients with HIV - 1 infection who are under 12 years of age.

It is not known if VIREAD is safe and effective in the treatment of chronic hepatitis B in patients who are under 12 years of age.

Other medicines and VIREAD

Always tell your healthcare provider if you are taking any other medicine (this includes complementary or traditional medicines).

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

HIV infection:

Adults: The usual dose is 300 mg taken once daily, with or without food, in combination with other anti - HIV medicines. If you are an adult with kidney problems, your doctor or healthcare provider may tell you to take VIREAD less often.

Adolescents (≥ 12 Years of Age and ≥ 35 kg): The usual dose is 300 mg taken once daily, with or without food, in combination with other anti - HIV medicines.

Chronic hepatitis B virus:

Adults: The usual dose is 300 mg taken once daily, with or without food.

Adolescents (≥ 12 Years of Age and ≥ 35 kg): The usual dose is 300 mg taken once daily, with or without food, in combination with other anti - HIV medicines.

The safety and efficacy (effectiveness) of VIREAD in children under 12 years of age and weighing less than 35 kg has not been established. Your doctor will tell you how long your treatment with VIREAD will last. Do not stop treatment unless your doctor instructs you to. When your VIREAD supply starts to run low, get more from your doctor or pharmacy. This is very important because the amount of virus in your blood may increase if VIREAD is stopped for even a short time. The virus may develop resistance to VIREAD and become harder to treat.

If you have the impression that the effect of VIREAD is too strong or too weak, tell your doctor or pharmacist.

If you take more VIREAD than you should

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

If you forget to take VIREAD

Take your missed dose as soon as you remember, if it is within a few hours after missing a dose. Do not take a double dose to make up for forgotten individual doses.

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

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

• swelling of the hands, feet, ankles, face, lips, mouth, tongue 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 allergic reaction to VIREAD. 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: Lactic acidosis. Some people who have taken medicine like VIREAD (nucleoside analogues) 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. Call your doctor right away if you experience the following signs or symptoms of lactic acidosis:

• 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 light - headed.
• You have a fast or irregular heartbeat.

Severe liver problems. Some people who have taken medicines like VIREAD have developed serious liver problems called hepatotoxicity, with liver enlargement (hepatomegaly) and fat in the liver (steatosis). Call your doctor right away if you experience the following signs or symptoms of liver problems:

• Your skin or the white part of your eyes turns yellow (jaundice).
• Your urine turns dark.
• Your bowel movements (stools) turn light in colour.
• You don’t feel like eating food for several days or longer.
• You feel sick to your stomach (nausea).
• You have lower stomach area (abdominal) pain.

Worsening of your Hepatitis B infection. Patients with Hepatitis B Virus who take VIREAD and then stop it, may get “flare - ups” of their hepatitis infection. A “flare - up” is when the HBV infection suddenly returns in a worse way than before.

• Kidney failure, rhabdomyolysis (abnormal muscle breakdown), osteomalacia (softening of the bones).
• Changes in your immune system (Immune Reconstitution Syndrome) can happen when an HIV - infected person starts taking 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 healthcare provider right away if you start having any new symptoms after starting your HIV medicine.
• Dyspnoea (shortness of breath).
• Pancreatitis (inflammation of the pancreas).

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:

• Nausea,
• rash, itching,
• diarrhoea, flatulence (gas), vomiting,
• headache, dizziness,
• pain,
• depression, difficulty falling asleep (insomnia).

Side effects with an unknown frequency

• New or worse kidney problems, including diabetes insipidus (the body is unable to regulate water), Fanconi syndrome (kidneys have difficulty absorbing electrolytes) and proteinuria (protein in the urine) can happen in some patients taking VIREAD. Your healthcare provider should do blood tests to check your kidneys before you start using VIREAD. If you have had kidney problems in the past or need to take another medicine that can cause kidney problems, your healthcare provider may need to do blood tests to check your kidneys during your treatment with VIREAD.
• Bone problems can happen in some patients taking VIREAD. Bone problems include bone pain, softening or thinning (which may lead to fractures). Your healthcare provider may need to do additional tests to check your bones.
• Changes in body fat have been seen in some patients taking VIREAD. 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.
• Hypophosphataemia (lower - than - normal level of phosphate in the blood that may result in muscle weakness).
• Abdominal pain, increased amylase.
• Myopathy (muscle weakness).
• Asthenia (lack or loss of strength and energy), fever.

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: https://www.sahpra.org.za/health - products - vigilance/ Aspen Pharmacare: E - mail: [email protected] Tel: 0800 118 088 By reporting side effects, you can help provide more information on the safety of VIREAD.

Store all medicines out of reach of children.

Store at or below 30 o C.

Do not use if seal over bottle opening is broken or missing or if there is evidence of tampering with the blister pack.

Keep in original packaging until required for use. Keep the bottle tightly closed.

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

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