Qulam-Co Tablets

QULAM-CO contains both abacavir and lamivudine. QULAM-CO belongs to a group of antiretroviral medicines called nucleoside analogue reverse transcriptase inhibitors (NRTIs) and is used in combination with other antiretrovirals to treat Human Immunodeficiency Virus (HIV) infection in adults and adolescents from 12 years of age, weighing at least 40 kg.

Do not take QULAM-CO:

• If you are hypersensitive (allergic) to the active substances abacavir, lamivudine or any of the other ingredients in QULAM-CO.
• If you have serious liver disease, QULAM-CO may not be suitable for you.
• If you are below 12 years of age and or weigh less than 40 kg.
• If you are pregnant, intend to become pregnant or if you are breastfeeding your baby.
• If you are taking the following medicines:
• cladribine (for hairy cell leukemia),
• zalcitabine or emtricitabine (for HIV infection)

Warnings and precautions

Tell your doctor or healthcare professional before you take QULAM-CO: Take special care with QULAM-CO: Hypersensitivity reaction (serious allergic reaction): QULAM-CO contains abacavir. Abacavir can cause a serious allergic reaction known as a hypersensitivity reaction, which can be life-threatening if treatment with abacavir containing products is not stopped.

• Do not share medicines prescribed for you with any other person.

• Always take QULAM-CO exactly as your doctor has instructed. You should check with your doctor or pharmacist if you are unsure.

• Take QULAM-CO for as long as your doctor recommends. Do not stop unless your doctor advises you to.

• Take great care not to miss any doses if at all possible. Swallow the tablet whole with water.

• The usual dose in adults and adolescents from 12 years of age, who weigh at least 40 kg, is one tablet daily.

If you take more QULAM-CO 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 QULAM-CO:

It is important to take QULAM-CO as prescribed to ensure you get maximum benefit. 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. It is important to take QULAM-CO regularly because irregular intake may increase the risk of hypersensitivity reactions.

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

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

• A serious allergic reaction known as a hypersensitivity reaction, see ‘Hypersensitivity reaction’ in ‘Take special care with QULAM-CO’. It is important that you read and understand the information about this serious reaction.
• Hives; swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing. These are all very serious side effects. If you have them, you may have had a serious allergic reaction to QULAM-CO. You may need urgent medical attention or hospitalization.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Adult respiratory distress syndrome (ARDS) occurs when fluid builds up in the tiny, elastic air sacs (alveoli) in your lungs. The fluid keeps your lungs from filling with enough air, which means less oxygen reaches your bloodstream. This deprives your organs of the oxygen they need to function.
• Respiratory failure (a condition in which your blood doesn't have enough oxygen or has too much carbon dioxide) with symptoms of shortness of breath and confusion.
• A failure of the bone marrow to produce new red blood cells (pure red cell aplasia). Symptoms include fatigue, shortness of breath with exertion, rapid or irregular heart rate, pale skin, frequent or prolonged infections, unexplained or easy bruising, nosebleeds and bleeding gums, prolonged bleeding from cuts, skin rash, dizziness and headache.
• Swelling under the skin of face, throat, limbs and genitals (angioedema) with difficulty in breathing.
• Lactic acidosis characterised by nausea (feeling sick), vomiting, diarrhoea, abdominal (stomach) pain, difficulty or abnormality in breathing, fatigue and weight loss.
• Liver damage – nausea; stomach pain; low fever; loss of appetite; dark urine; clay-coloured stools; jaundice (yellowing of the skin or eyes).
• Kidney damage – little or no urination, swelling in the ankles and feet, shortness of breath, nausea and vomiting, metallic taste in the mouth.
• Fever, chills, sore throat, cough, or other signs of infection.
• 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 on large parts of your body surface (toxic epidermal necrolysis).
• Inflammation of the pancreas - severe upper stomach pain with nausea (feeling sick) and vomiting.
• Changes in body shape because of changes in fat distribution.
• Stiffness in the joints, aches and pains (especially in the hip, knee or shoulder), difficulty moving as these are signs of osteonecrosis (see Take special care with QULAM-CO).

Store at or below 30 °C. Protect from light and moisture. Keep in original packaging until required for use. Keep the container tightly closed and in the carton until required for use. Keep blisters in the carton until required for use. Store all medicines out of the reach of children. Do not take the medicine after the expiry date stated on the bottle or blister and carton. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).