Co-Trimoxazole

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Co-trimoxazole tablets are and what they are used for Co-trimoxazole

80mg/400mg Tablets (called ‘Co-trimoxazole tablets’ in this leaflet) are made up of two different medicines called sulfamethoxazole and trimethoprim.

Both belong to a group of medicines called antibiotics. They are used to treat infections caused by bacteria. Like all antibiotics, Co-trimoxazole only works against some types of bacteria.

This means that it is only suitable for treating some types of infections. Co-trimoxazole tablets are used for adults and children over 12 years.

Co-trimoxazole tablets can be used to treat or prevent:

• lung infections (pneumonia or PCP) caused by a bacteria called Pneumocystis jiroveci infections caused by a bacteria called Toxoplasma (toxoplasmosis).
• Co-trimoxazole tablets can be used to treat:
• bladder or urinary tract infections (water infections)
• lung infections such as bronchitis
• ear infections such as otitis media
• an infection called nocardiosis, which can affect the lungs, skin and brain.

2. What you need to know before you take Co-trimoxazole tablets

Do not take Co-trimoxazole tablets if:

• you are allergic to sulfamethoxazole, trimethoprim or Co-trimoxazole or any of the other ingredients of this medicine (listed in section 6)
• you are allergic to sulfonamide medicines. Examples include sulfonylureas (such as gliclazide and glibenclamide) or thiazide diuretics (such as bendroflumethiazide – a water tablet)
• you have liver or kidney problems
• you have ever had a problem with your blood causing bruises or bleeding (thrombocytopenia)
• you have been told that you have a rare blood problem called porphyria, which can affect your skin or nervous system
• Co-trimoxazole should not be given to infants during the first 6 weeks of life. If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Co-trimoxazole tablets. Warnings and precautions Talk to your doctor or pharmacist before taking Co-trimoxazole if you:
• have severe allergies or asthma
• have been told that you have a rare blood problem called porphyria, which can affect your skin or nervous system
• don’t have enough folic acid (a vitamin) in your body – which can make your skin pale and make you feel tired, weak and breathless. This is known as anaemia
• have ever had jaundice which can cause yellowing of your skin or the whites of your eyes
• have a problem with your metabolism called phenylketonuria and are not on a special diet to help your condition
• are elderly

3. How to take Co-trimoxazole tablets

• Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
• The recommended dose is:
• Adults (>18 years old):2 Tablets every 12 hours
• Children over 12 years
• The schedules for children are according to the child’s age and body weight provided in the table below:>12 years and over OR >Weighing 53kg or above : Two tablets in a morning and two tablets in an evening.
• Co-trimoxazole should be taken for at least five days.
• Make sure that you finish the course of Co-trimoxazole which your doctor has prescribed. Co-trimoxazole 80mg/400mg tablets are not usually given to children under 12 years old.
• If they have been given to your child under 12 years, please speak to your doctor or pharmacist for more information.
• If you take more Co-trimoxazole tablets than you should
• If you take more Co-trimoxazole tablets than you should, talk to your doctor or go to a hospital straight away.
• Take the medicine pack with you. If you have taken too many Co-trimoxazole tablets you may:
• feel or be sick
• feel dizzy or confused.

4. Possible side effects

• Like all medicines, this medicine can cause side effects, although not everybody gets them. Stop taking Co-trimoxazole tablets and tell your doctor immediately if you have an allergic reaction.
• Signs of an allergic reaction include:
• Very rare (may affect up to 1 in 10,000 people):
• Sudden wheeziness or difficulty breathing
• Fainting
• Swelling of face
• Swelling of mouth, tongue or throat which may be red and painful and/or cause difficulty in swallowing
• Chest pain
• Red patches on the skin.
• Stop taking Co-trimoxazole tablets and tell your doctor immediately if you develop the following symptoms: Very rare (may affect up to 1 in 10,000 people):
• A widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome) or on much of the body surface (toxic epidermal necrolysis) (see section 2 ‘Warnings and Precautions’)
• A red, scaly widespread rash with bumps under the skin and blisters accompanied by fever at the initiation of treatment (acute generalised exanthematouspustulosis (AGEP)) (see section 2)
• Mouth ulcers, cold sores and ulcers or soreness of your tongue
• Skin lumps or hives (raised, red or white, itchy patches of skin)
• Jaundice (the skin and the whites of your eyes turn yellow). This can occur at the same time as unexpected bleeding or bruising
• Very Common (may affect more than 1 in 10 people):
• Excessive potassium in the blood (may occur as muscle cramps or pain, irregular heartbeats, unusual tiredness or weakness).
• Common (may affect up to 1 in 10 people):
• An infection called thrush or candidiasis which can affect your mouth or vagina.
• It is caused by a fungus
• Headache
• Feeling sick (nausea)
• Diarrhoea
• Skin rashes

5. How to store Co-trimoxazole tablets

• Keep this medicine out of the sight and reach of children.
• Store below 25ºC in a dry place and protect from light.
• Do not take this medicine after the expiry date which is stated on the label/carton/ bottle.
• The expiry date refers to the last day of that month.