Adco Abacavir 20 mg Solution

ADCO ABACAVIR SOLUTION contains active substance abacavir sulphate which belongs to a group of medicines, known as antiretrovirals. Abacavir sulphate is a nucleoside analogue reverse transcriptase inhibitor. These are used to treat Human Immunodeficiency Virus (HIV) infection.

ADCO ABACAVIR SOLUTION is used in combination with other antiretroviral medicines in the treatment of HIV infection in adults and children. A patient's response to treatment with ADCO ABACAVIR SOLUTION varies. The effectiveness of your treatment will be supervised by your doctor.

Do not take ADCO ABACAVIR SOLUTION:

• If you have had an allergic reaction (hypersensitive) to abacavir or any of the other ingredients of this medicine (listed in Section 6).
• If you have liver disease, you should not take ADCO ABACAVIR SOLUTION.
• If you are pregnant or breastfeeding your baby.

ADCO ABACAVIR SOLUTION is not a cure for HIV infection or AIDS. Patients taking ADCO ABACAVIR SOLUTION may still develop infections or other illnesses associated with HIV disease and AIDS. It is therefore important that you remain under the supervision of your doctor while taking this medicine. ADCO ABACAVIR SOLUTION does not reduce the risk of passing HIV to others through sexual contact or blood contamination. You should use appropriate precautions.

Warnings and precautions

Take special care with ADCO ABACAVIR SOLUTION

ADCO ABACAVIR SOLUTION may lead to serious problems with your liver or cause too much acid in your blood. If left untreated, this may even cause death. The safety and efficacy of ADCO ABACAVIR SOLUTION in patients who are infected with both human immunodeficiency virus (HIV) and hepatitis B virus (HBV) have not been established. ADCO ABACAVIR SOLUTION should not be used for the treatment of chronic HBV infection. You should be closely monitored by your doctor for several months if you are infected with HBV and discontinue the use of ADCO ABACAVIR SOLUTION.

Hypersensitivity reaction (serious allergic reaction): Patients treated with abacavir who did not have a gene called HLA-8*5701 developed a hypersensitivity reaction. Research has found that people with the gene HLA-8*5701 are more likely to have a hypersensitivity reaction to abacavir. However, even if you do not have this gene type, it is possible for you to get this reaction, which could be life-threatening if you continue to take ADCO ABACAVIR SOLUTION.

If you know you have this gene type, be sure to tell your doctor before you take ADCO ABACAVIR SOLUTION.

Do not share medicines prescribed for you with any other persons. Always take ADCO ABACAVIR SOLUTION exactly as your doctor has instructed told you. You should check with your doctor or pharmacist if you are not sure.

Your doctor will tell you how long your treatment with ADCO ABACAVIR SOLUTION will last. Do not stop treatment early because after stopping ADCO ABACAVIR SOLUTION if you need to restart taking it you may develop a life-threatening hypersensitivity reaction.

If you have the impression that the effect of ADCO ABACAVIR SOLUTION is too strong or too weak, tell your doctor or pharmacist. ADCO ABACAVIR SOLUTION must be taken in combination with other antiretrovirals. Shake the bottle before use.

ADCO ABACAVIR SOLUTION can be taken with or without food.

Adults and children over 12 years: The recommended dose of ADCO ABACAVIR SOLUTION is 600 mg (30 ml) daily.

Children from 3 months to 12 years: The recommended dosage is 8 mg/kg twice daily up to a maximum of 600 mg (30 ml) daily.

The oral solution is available for use in children and for those patients in whom the tablet dosage form is inappropriate. Therapy should be initiated by a doctor experienced in the management of HIV infection.

If you take more ADCO ABACAVIR SOLUTION 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 ADCO ABACAVIR SOLUTION: If you forget to take a dose of ADCO ABACAVIR SOLUTION, take it as soon as you remember, and then continue as before. Do not take a double dose to make up for forgotten individual doses. It is important to take ADCO ABACAVIR SOLUTION regularly because irregular intake may increase the risk of hypersensitivity reactions.

If you stop taking ADCO ABACAVIR SOLUTION: If you have stopped taking ADCO ABACAVIR SOLUTION for any reason, particularly because you think you are having side effects or for other illness, it is important that you contact your doctor before restarting. Your doctor will check whether your symptoms were related to a hypersensitivity reaction. If the doctor thinks they may have been related, you will be told never again to take ADCO ABACAVIR SOLUTION, or any other medicine containing abacavir. It is important that you follow this advice. In some cases, your doctor will ask you to restart ADCO ABACAVIR SOLUTION in a place where you will be able to get ready access to medical care if needed.

ADCO ABACAVIR SOLUTION can have side-effects. Not all side effects reported for ADCO ABACAVIR SOLUTION are included in this leaflet. Should your general health worsen while taking ADCO ABACAVIR SOLUTION, please consult your healthcare provider for advice.

If any of the following happens, stop taking/using ADCO ABACAVIR SOLUTION and tell your doctor immediately or go to the casualty department at your nearest hospital: This allergic reaction is severe and may be fatal. Symptoms of this allergic reaction include:

• Fever
• rash
• Cough
• Dyspnoea (difficulty breathing/shortness of breath)
• Malaise (general feeling of illness)
• Headache
• Lethargy (severe tiredness)
• Muscle pain, and gastrointestinal disturbances
• Diarrhoea

These are all very serious side effects. If you or your child have them you may have had a serious allergic reaction to ADCO ABACAVIR SOLUTION. You may need urgent medical attention or hospitalisation.

Stop taking ADCO ABACAVIR SOLUTION and call your doctor at once if you notice any of the following:

• Nausea and vomiting
• Abdominal pain and possibly shock.
• Joint pain
• Joint stiffness
• Yellowing of the skin and eyes, dark urine and tiredness
• Anaemia, neutropenia (low count of that are a type of white blood cell), loss of consciousness, difficulty in movement in infants (babies).

These are all serious side effects and may be due to issues in pancreas, liver, degenerative joint disease problem or mitochondrial damage of infants exposed to medicine. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects:

• Eating disorder (anorexia)
• High temperature
• Loss of appetite
• Fatigue

Less frequent side effects:

• Inflammation of the pancreas (pancreatitis)
• Serious skin reactions, skin rash, which may form blisters and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme)
• A widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens–Johnson syndrome), and a more severe form causing skin peeling in more than 30% of the body surface (toxic epidermal necrolysis)
• Excess lactic acid in the blood (lactic acidosis)

Frequency not known:

• Severe allergy
• Increase in blood sugar
• Increase fat in the blood

Other possible side effects of combination therapy for HIV Combination therapy including ADCO ABACAVIR SOLUTION may cause other conditions to develop during HIV treatment. Cases of a condition called lactic acidosis, which is a build-up of lactic acid in the body, that can cause dehydration and coma have been reported on rare occasions in patients taking antiretroviral therapies. Combination antiretroviral therapy may cause changes in body shape due to changes in fat distribution. These may include loss of fat from legs, arms and face, increased fat in the abdomen (belly) and other internal organs, breast enlargement and fatty lumps on the back of the neck ('buffalo hump'). The cause and long-term health effects of these conditions are not known at this time. Combination antiretroviral therapy may also cause raised lactic acid and sugar in the blood, hyperlipaemia (increased fats in the blood) and resistance to insulin.

Symptoms of infection and inflammation Old infections may flare up People with advanced HIV infection (AIDS) have weak immune systems, and are more likely to develop serious infections (opportunistic infections). When these people start treatment, they may find that old, hidden infections flare 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 these infections. Symptoms usually include fever, plus some of the following:

• headache
• stomach ache
• difficulty breathing

In rare cases, as the immune system becomes stronger, it can also attack healthy body tissue (autoimmune disorders). The symptoms of autoimmune disorders may develop many months after you start taking medicine to treat your HIV infection. Symptoms may include:

• palpitations (rapid or irregular heartbeat) or tremor
• hyperactivity (excessive restlessness and movement)
• weakness beginning in the hands and feet and moving up towards the trunk of the body

You may have problems with your bones Some people taking combination therapy for HIV develop a condition called osteonecrosis. With this condition, parts of the bone tissue die because of reduced blood supply to the bone. People may be more likely to get this condition:

• if they have been taking combination therapy for a long time
• if they are also taking anti-inflammatory medicines called corticosteroids
• if they drink alcohol
• if their immune systems are very weak
• if they are overweight

Signs of osteonecrosis include:

• stiffness in the joints
• aches and pains (especially in the hip, knee or shoulder)
• difficulty moving

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 nurse. This includes any possible side effects not listed in this leaflet. 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 information on the safety of ADCO ABACAVIR SOLUTION.

Store at or below 25 °C. Keep the bottles tightly closed. Store all medicines out of reach of children. Do not store in bathrooms. Do not use after expiry date on the bottle. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g., toilets).