Bactrim 80 mg/400 mg/5 ml Solution

BACTRIM treats and prevents a type of lung infection (Pneumocystis jirovecii pneumonia) in adults and children, particularly in patients with a severely low immune system. BACTRIM is also used to treat a disease called toxoplasmosis; the parasite is often found in cat faeces (soil) and undercooked meat.

BACTRIM should not be administered

• If you are hypersensitive (allergic) to BACTRIM, sulfamethoxazole, trimethoprim, any other sulfonamide, or any of the other ingredients of BACTRIM (listed in section 6).
• If you have severe liver or kidney disease, any blood disorder or megaloblastic anaemia.
• If it is for a child who is prematurely or newly born or in the first 6 weeks of life.
• If you have vitamin B12 or folic acid deficiencies.
• If you are pregnant and breastfeeding.
• If you have porphyria (a group of disorders that result from a build-up of natural chemicals that produce porphyrin in your body).
• If you are taking dofetilide (used to treat heart rhythm disorders).

Warnings and precautions

Take special care with BACTRIM

• If you have a serious adverse reaction such as:
• Blood dyscrasias is a blood disorder with symptoms such as fast heartbeat, shortness of breath, fainting, tiredness and pale skin
• Stevens - Johnson syndrome or toxic epidermal necrolysis with symptoms such as a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals
• Drug reaction with eosinophilia and systemic symptoms (DRESS) consists of flu-like symptoms with a rash, fever, swollen glands, and abnormal blood test results (including increased white blood cells (eosinophilia) and liver enzymes)
• Liver failure with symptoms such as nausea, weakness, fatigue and abdominal pain.
• If you have a history of severe allergy and bronchial asthma with symptoms such as shortness of breath, chest pain, coughing and wheezing.
• If you have kidney problems.
• If you are elderly.
• If you have thyroid problems.

You will not be expected to administer BACTRIM to yourself. It will be administered to you by a person who is qualified to do so. Your doctor will determine the dose for you or your child and the length of treatment.

If you have the impression that the effect of BACTRIM is too strong or too weak, talk to your doctor or pharmacist.

If more BACTRIM is administered to you than should be Since a health care provider will administer BACTRIM, he/she will control the dosage. However, in the event of overdosage your health care provider will manage the overdosage.

BACTRIM can have side effects. Not all side effects reported for BACTRIM are included in this leaflet. Should your general health worsen or if you experience any untoward effects after administration of BACTRIM, please consult your health care provider for advice.

If any of the following happens after administration of BACTRIM, tell your doctor immediately or go to the casualty department at your nearest hospital:

• Swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing.
• Rash or itching.
• Fainting.

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

• Bleeding or bruising more easily than normal.
• Signs of recurrent infections such as fever or sore throat.
• Shortness of breath.
• Changes in the way your heart beats, for example, if you notice it beating faster or irregular.
• Low sugar levels in your blood (sweating, weakness, hunger, dizziness, trembling, headache, flushing or paleness, numbness).
• Meningitis (infection around the brain or spinal cord with fever, headache, stiff neck and extreme sensitivity to bright light).
• Chest pain.
• Too high or too low levels of potassium in your blood (abnormal or slow heart rate, low blood pressure, cramps, weakness).
• Too low levels of sodium in your blood (headache, dizziness, confusion, convulsions (fits), coma).
• Yellowing of the skin and eyes, dark urine and tiredness which may be symptoms of liver problems.
• Painful, blistering or peeling skin rash.
• Passing more of less urine than is normal for you.
• Urgency to pass urine.
• Blood in your urine.

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects:

• Nausea (feeling sick), vomiting (being sick).

Less frequent side effects:

• Oral and/or vaginal thrush (white, furry sore tongue and mouth, sore itchy vagina with vaginal discharge).
• Seeing, feeling or hearing things that are not there.
• Numbness and tingling in your feet or hands.
• Clumsiness and lack of coordination, affecting balance and manner of walking, limb or eye movements.
• Red, painful eyes, blurred vision, decreased vision.
• Vertigo (sensation of spinning or swaying).
• Ringing in your ears.
• Reddish-purple spots on your legs and feet.
• Diarrhoea.
• Swollen tongue or mouth.
• Redness, warmth, pain itching around a vein.
• Temporary paralysis or weakness of muscles.

Side effects with frequency unknown:

• Abdominal pain that radiates to your back.
• Joint pain, pain in a muscle or group of muscles.

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 Reaction Reporting Form, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of BACTRIM.

• Store all medicines out of reach of children.
• Store at or below 30 °C.
• Protect from light.
• Store in the original package.
• Do not use this medicine after the expiry date printed on the outer pack.
• Return all unused medicines to your pharmacist.
• Do not dispose of unused medicines in drains or sewerage systems (e.g. toilets).