Auro Abacavir/Lamivudine 300 mg Tablets

AURO ABACAVIR/LAMIVUDINE 600/300 mg TABLETS is a prescription medicine used in combination with other medicines to treat adults and children from 12 years of age who are infected with HIV (human immunodeficiency virus), the virus that causes AIDS.

Do not take AURO ABACAVIR/LAMIVUDINE 600/300 mg TABLETS:

• If you are hypersensitive (allergic) to abacavir or lamivudine or any of the other ingredients of AURO ABACAVIR/LAMIVUDINE 600/300 mg TABLETS (listed in section 6).
• If you have moderate to severe liver disease.
• If you are pregnant or breastfeeding.
• If you have moderate to severe kidney disease.
• Children < 12 years old.
• Patients who weigh < 40kg.

Do not share medicines prescribed for you with any other person. Always take AURO ABACAVIR/LAMIVUDINE 600/300 mg TABLETS exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. If you have the impression that the effect of AURO ABACAVIR/LAMIVUDINE 600/300 mg TABLETS is too strong or too weak, talk to your doctor or pharmacist.

− The usual dose in adults and adolescents is one tablet once a day. Do not skip doses.

− AURO ABACAVIR/LAMIVUDINE 600/300 mg TABLETS should not be given to children less than 12 years old or people weighing less than 40 kg.

If you take more AURO ABACAVIR/LAMIVUDINE 600/300 mg TABLETS than you should:

− Seek emergency medical attention if you think you have used too much of this medicine. In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.

If you forget to take AURO - ABACAVIR/LAMIVUDINE 600/300 mg TABLETS:

If you forget to take a dose, 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.

AURO ABACAVIR/LAMIVUDINE 600/300 mg TABLETS can have side effects. Not all side effects reported for AURO ABACAVIR/LAMIVUDINE 600/300 mg TABLETS are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking AURO ABACAVIR/LAMIVUDINE 600/300 mg TABLETS, please consult your doctor, pharmacist or other healthcare professional for advice.

If any of the following happens, stop taking AURO ABACAVIR/LAMIVUDINE 600/300 mg TABLETS and tell your doctor immediately or go to the casualty department at your nearest hospital:

• hives, difficulty breathing, swelling of your face, lips, tongue, or throat or any of the serious signs or symptoms described in the Boxed warnings of abacavir hypersensitivity. These are all very serious side effects. If you have them, you may have had a serious allergic reaction to AURO ABACAVIR/LAMIVUDINE 600/300 mg 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:

• Lactic acidosis (severe increase of lactic acid in the blood) - Inform your doctor immediately if you experience any of the following symptoms of lactic acidosis: nausea, vomiting, stomach pain, deep rapid difficult breathing, feeling very weak and tired, or weight loss.
• Severe liver enlargement.
• Peripheral neuropathy - tingling, numbness, and pain in the hands and feet.
• Pancreatitis (inflammation of the pancreas) - stomach pain, nausea or vomiting.
• skin rash, serious skin reactions. 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 occur frequently:

• abdominal pain, diarrhoea, nausea, vomiting, headache, fever, inability to sleep, lack of well-being, lethargy, fatigue, cough, nasal symptoms (irritation, runny nose), loss of appetite.

The following side effects occur less frequently:

• anaemia (decreased number of red blood cells), too few white blood cells, too few blood platelets, loss of hair, numbness, tingling, joint pain, muscle disorders, increase in enzymes produced by the liver, raised sugar in the blood, increased fats in the blood, changing of body shape due to changes in fat distribution.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Store at or below 30 °C (room temperature). Keep the container tightly closed. Store all medicines out of the reach and sight of children. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).