Odinsti Dispersible 10 mg Dispersible Tablets

Odinsti Dispersible Tablets is used to treat HIV (human immunodeficiency virus) infection in adults and in children, in combination with other anti-retroviral medicines (combination therapy). The active ingredient in Odinsti Dispersible Tablets is dolutegravir. Odinsti Dispersible Tablets is a type of medicine known as an anti-retroviral. It belongs to a group of medicines called integrase inhibitors (INIs).

Do not take Odinsti Dispersible Tablets:

• if you or your child are allergic (hypersensitive) to dolutegravir or any of the other ingredients of Odinsti Dispersible Tablets (listed in section 6).
• if you or your child are taking another medicine called dofetilide or pilsicainide (to treat heart conditions).
• if you have severe liver disease.
• if you are in the first trimester of your pregnancy and if you are breastfeeding.

Warnings and precautions

Take special care with Odinsti Dispersible Tablets:

• if you get any rash as it may be an indication that you are having an allergic reaction. You should stop taking Odinsti Dispersible Tablets and contact your doctor immediately if you get other symptoms of an allergic reaction such as fever, fatigue, muscle or joint aches, blisters, sores in your mouth, swelling of your feet or face.
• if you get any other symptoms of other serious infections, usually due to your already weakened immune system. When you start treatment, you may find that old, hidden infections (such as tuberculosis) flares up, causing signs and symptoms of inflammation. These symptoms are probably caused by the body's immune system becoming stronger, so that the body starts to fight against these infections.

Keep in touch with your doctor, and do not stop taking Odinsti Dispersible Tablets without your doctor’s advice. HIV can still be transmitted despite taking Odinsti Dispersible Tablets. Odinsti Dispersible Tablets does not cure HIV infection; it reduces the amount of virus in your body. While you are taking Odinsti Dispersible Tablets, you will need regular blood tests. For as long as you are taking Odinsti Dispersible Tablets, your doctor will arrange regular blood tests to check for side effects. There is more information about these side effects in this leaflet. See section 4.

Protect other people. HIV infection is spread by sexual contact with someone who has the infection, or by transfer of infected blood (for example, by sharing injection needles). Odinsti Dispersible Tablets will not stop you passing HIV infection on to other people. To protect other people from becoming infected with HIV:

• Use a condom when you have oral or penetrative sex.
• Do not risk blood transfer - for example, don’t share needles.

Do not share medicines prescribed for you with any other person. Always take Odinsti Dispersible Tablets exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. Your doctor will determine the correct dose for you or your child which will depend on your weight.

• The tablet can be divided into two equal halves.
• Odinsti Dispersible Tablets may be swallowed whole or dispersed in drinking water and should not be chewed or crushed.
• Swallow the dispersible tablet whole (if more than one tablet is required, swallow one tablet at a time to reduce the risk of choking), or
• Fully disperse the dispersible tablet in 5 ml of drinking water (if using ½ or 1½ dispersible tablet) or 10 ml (if using 2, 2½, or 3 dispersible tablets). Swirl or stir until the tablets disperse completely. After full dispersion, administer or drink the oral suspension within 30 minutes of mixing.
• Dolutegravir tablets are not the same as Odinsti Dispersible Tablets and cannot be substituted for each other. Check to make sure you receive the correct form of Dolutegravir each time you or your child’s prescription is filled to avoid using the wrong medicine.
• Do not change your dose, switch medicines or stop taking Odinsti Dispersible Tablets without talking with your healthcare provider first.

If you take more Odinsti Dispersible Tablets 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 or give Odinsti Dispersible Tablets, if you miss a dose of Odinsti Dispersible Tablets, take or give it as soon as you remember. Do not take 2 doses at the same time or take more than your prescribed dose.

Effects when treatment with Odinsti Dispersible Tablets is stopped: Do not stop taking Odinsti Dispersible Tablets before talking to your doctor. The virus in your blood may increase and the virus may become harder to treat.

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

If any of the following happens, stop taking Odinsti Dispersible Tablets 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,
• rash or itching.

These are all very serious side effects. If you have them, you may have had a serious reaction to Odinsti Dispersible Tablets. 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:

• Liver problems. People with a history of hepatitis B or C virus may have an increased risk of developing new or worsening changes in certain liver tests during treatment with Odinsti Dispersible Tablets. Liver problems, including liver failure, have also happened in people without a history of liver disease or other risk factors. Your healthcare provider may do blood tests to check your liver. Call your healthcare provider right away if you develop any of the following signs or symptoms of liver problems:

o your skin or the white part of your eyes turns yellow (jaundice)
o dark or “tea-colored” urine
o light-colored stools (bowel movements)
o nausea or vomiting
o loss of appetite
o pain, aching, or tenderness on the right side of your stomach area

Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV-1 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 new symptoms after you start taking Odinsti Dispersible Tablets. These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

• Frequent headache
• diarrhoea
• feeling sick (nausea)
• rash
• itching (pruritus)
• vertigo
• being sick (vomiting)
• stomach pain (upper abdominal pain), stomach discomfort
• difficulty in sleeping (insomnia)
• dizziness
• abnormal dreams
• depression (feeling of deep sadness and unworthiness)
• anxiety
• lack of energy (fatigue)
• wind (flatulence).

Less frequent:

• inflammation of the liver (hepatitis)
• suicide thoughts (mainly in patients who have had depression or mental health problems before)
• an inflammatory condition which may develop as the immune system becomes stronger (immune reconstitution inflammatory syndrome or ‘IRIS’)
• allergic reaction (hypersensitivity) (see earlier in this section for more details).

Other side effects:

• liver failure (signs may include yellowing of the skin and the whites of the eyes or unusually dark urine)
• joint pain
• muscle pain
• weight gain.

Side effects that may show up in blood tests:

• increase in bilirubin (a substance produced by the liver) in the blood.
• an increase in the level of enzymes produced in the muscles (creatine phosphokinase, creatinine).

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 Reactions & Quality Problem Reporting Form”, found online under SAHPRA’s publications: https://sahpra.org.za/wpcontent/uploads/2020/01/6.04_ARF1_v5.1_27Jan2020.pdf. By reporting side effects, you can help provide more information on the safety of Odinsti Dispersible Tablets.

Store all medicines out of reach of children.

• Store at or below 30 °C in the original container.
• Keep the bottle tightly closed and protected from moisture.
• 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).