Tladeez Film-Coated Tablets

TLADEEZ belongs to a group of medicines, known as antiretrovirals. Combination antiretroviral medicines, such as TLADEEZ, are used in the treatment of HIV-1 (human immunodeficiency virus) infection in adults aged 18 years and older.

Do not take TLADEEZ

• If you are hypersensitive (allergic) to tenofovir disoproxil fumarate, lamivudine, dolutegravir or any of the other ingredients in TLADEEZ tablets.
• If you have or had kidney problems (see Take special care with TLADEEZ).
• If you are pregnant or breastfeeding your baby (see Pregnancy, breastfeeding and fertility).
• If you are a woman of child-bearing age and you are not using highly effective contraception.
• If you are taking any other tenofovir-containing or other lamivudine-containing, or emtricitabine-containing medicines.
• If you are taking a medicine called adefovir dipivoxil (used for the treatment of chronic hepatitis B).
• If you are taking a medicine called dofetilide and pilsicainide (used for the treatment of abnormal heartbeat – cardiac dysrhythmias).
• If you are taking a medicine called didanosine (used for the treatment of HIV infection).
• If you are taking a medicine called metformin (used for the treatment of diabetes).
• If you are younger than 18 years of age.
• If you have moderate to severe liver failure.

Take special care with TLADEEZ

TLADEEZ does not cure or prevent HIV infection; however, it helps to keep HIV from reproducing and appears to slow down the destruction of the immune system. TLADEEZ will not keep you from spreading HIV to other people. Appropriate precautions must continue to be used.

Do not share medicines prescribed for you with any other person. Treatment should be prescribed and initiated by a doctor experienced in the management of HIV infection. Always take TLADEEZ exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. The usual dose of TLADEEZ is one tablet once a day. TLADEEZ must be taken without regard of food. You can only take TLADEEZ if you are older than 18 years.

If you have taken more TLADEEZ than you should

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

If you forget to take TLADEEZ

If you forget to take a dose of TLADEEZ, take it as soon as you remember and then continue as before. Do not take a double dose to make up for missed individual doses.

Effects when treatment with TLADEEZ is stopped

You should not stop treatment unless your doctor instructs you to. When your TLADEEZ 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 the ingredients in TLADEEZ and become harder to treat. If you have the impression that the effect of TLADEEZ is too strong or too weak, talk to your doctor or pharmacist.

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

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

• Sudden swelling of the skin or mucous membranes (e.g. throat or tongue) with difficulty breathing and/or itching and rash (see Take special care with TLADEEZ).

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

Serious liver problems (hepatitis) with liver enlargement (hepatomegaly) and fat in the liver (steatosis) (see Take special care with TLADEEZ). The following are signs of the liver problems:

• 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.

LACTIC ACIDOSIS: Some people who have taken medicines like TLADEEZ (nucleoside analogues) have developed a serious condition called lactic acidosis (build-up of acid in the blood). Lactic acidosis can be a medical emergency and may need to be treated in the hospital. Call your doctor immediately if you get 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 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 TLADEEZ, your doctor will monitor you closely for any signs that you may be developing lactic acidosis.

STORE ALL MEDICINES OUT OF REACH OF CHILDREN. Store at or below 30 °C. Store in the original container. Do not remove from the carton until required for use. Keep the bottle tightly closed. 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).