Active ingredient
- trimethoprim
- sulfamethoxazole
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL39699/0037 .
Co-Trimoxazole 40 mg/200 mg per 5ml Paediatric Suspension
Package leaflet: Information for the patient
Co-Trimoxazole 40 mg/200 mg per 5ml Paediatric Suspension
Co-trimoxazole
Read all of this leaflet carefully before your child starts taking this medicine because it contains important information for them.
What is in this leaflet
1. What Co-Trimoxazole is and what it is used for
2. What you need to know before your child takes Co-Trimoxazole
3. How to give Co-Trimoxazole
4. Possible side effects
5. How to store Co-Trimoxazole
6. Contents of the pack and other information
1. What Co-Trimoxazole is and what it is used for
Co-Trimoxazole 40 mg/200 mg per 5 ml Paediatric Suspension (called ‘Co-Trimoxazole’ in this leaflet) is a combination of two different antibiotics called sulfamethoxazole and trimethoprim, which is 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 can be used to treat or prevent:
Co-Trimoxazole can be used to treat:
Consideration should be given of official guidance on the appropriate use of antibacterial agents.
Co-Trimoxazole Paediatric Suspension is indicated in children aged 12 years and under (infants (>6 weeks to <2 years old) and children (>2 to <12 years old).
2. What you need to know before your child takes Co-Trimoxazole
Your child should not take Co-Trimoxazole:
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 your child, talk to their doctor or pharmacist before they take Co-Trimoxazole.
Warnings and precautions
Talk to your child’s doctor or pharmacist before taking Co-Trimoxazole:
Other medicines and Co-Trimoxazole
Tell your child’s doctor or pharmacist if your child is taking, has recently taken or might take any other medicines. This is because Co-Trimoxazole can affect the way some medicines work. Also some other medicines can affect the way Co-Trimoxazole works.
In particular tell your child’s doctor or pharmacist if your child is taking any of the following medicines:
Co-Trimoxazole with food and drink
Your child should take Co-Trimoxazole with some food or drink. This will stop them feeling sick (nausea) or having diarrhoea. Although it is better to take it with food, they can still take it on an empty stomach.
Make sure your child drinks plenty of fluid such as water while they are taking Co-Trimoxazole.
Co-Trimoxazole contains
3.25 g sorbitol in every 5 ml spoonful. If you have been told by your child’s doctor that they cannot tolerate or digest some sugars (has an intolerance to some sugars), contact your child’s doctor before giving this medicinal product to your child.
3. How to give Co-Trimoxazole
Always ensure your child takes Co-Trimoxazole exactly as their doctor or pharmacist has told you. Check with their doctor or pharmacist if you are not sure.
Standard Dose
Standard dosage recommendations for acute infections
Children aged 12 years and under (infants (>6 weeks to <2 years old) and children (>2 to <12 years old):
The dosage for children is equivalent to approximately 6 mg trimethoprim and 30 mg sulfamethoxazole per kg body weight per day.
The schedules for children are according to the child’s age and body weight and provided in the tables below:
Standard Dosage
Age Paediatric Suspension
6 to 12 years two 5 ml spoonfuls in a morning and two 5 ml spoonfuls in an evening
6 months to 5 years one 5 ml spoonful in a morning and one 5 ml spoonful in an evening
6 weeks to 5 months one 2.5 ml spoonful in a morning and one 2.5 ml spoonful in an evening
Weight Paediatric Suspension
>27 kg Two 5 ml spoonfuls in the morning and two 5 ml spoonfuls in the evening
>20 kg One 5 ml + one 2.5ml spoonful in the morning and one 5 ml + one 2.5 ml spoonful in the evening
>13 kg One 5 ml spoonful in the morning and one 5 ml spoonful in the evening
>7 kg One 2.5 ml spoonful in the morning and one 2.5 ml spoonful in the evening
Co-Trimoxazole should be taken for at least five days
Make sure that your child finishes the course of Co-Trimoxazole which their doctor has prescribed.
Special dose
The dose of Co-Trimoxazole and how long your child needs to take it depends on the infection they have and how bad it is. Your child’s doctor may prescribe you a different dose or length of course of Co-Trimoxazole to:
If your child takes Co-Trimoxazole for a long time their doctor may
If your child takes more Co-Trimoxazole than they should
If your child takes more Co-Trimoxazole than they should, talk to their doctor or go to a hospital straight away. Take the medicine pack with you.
If your child has taken too much Co-Trimoxazole they may
If you forget to give your child Co-Trimoxazole
If a dose is forgotten, your child should take it as soon as possible.
Do not give your child a double dose to make up for a forgotten dose.
4. Possible side effects
Like all medicines, Co-Trimoxazole can cause side effects, although not everybody gets them.
Your child may experience the following side effects with this medicine.
Stop giving your child Co-Trimoxazole and tell your child’s doctor immediately if your child has an allergic reaction. Chances of an allergic reaction is very rare (fewer than 1 in 10,000 people are affected), signs of an allergic reaction include
Allergic reactions
Very Common (more than 1 in 10 people)
Common (less than 1 in 10 people)
Uncommon (less than 1 in 100)
Very Rare (less than 1 in 10,000 people)
Unknown frequency (cannot be estimated from the available data)
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your child’s doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Co-Trimoxazole
Keep this medicine out of the sight and reach of children.
Keep away from direct heat or sunlight.
Do not store above 25ºC.
Do not use the suspension after the expiry date shown on the bottle label and carton.
Store in the original package with this leaflet.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.
6. Contents of the pack and other information
What Co-Trimoxazole contains
What Co-Trimoxazole looks like and contents of the pack
Co-Trimoxazole 40 mg/200 mg per 5 ml Paediatric Suspension is supplied to you in an amber-coloured glass bottle, containing 100 ml or 30 ml of an off-white liquid, which smells of banana and vanilla. The medicine comes with a double-ended measuring spoon. One end of the spoon will give you 5 ml of the suspension and the other will give you 2.5 ml.
Each 5 ml of Co-Trimoxazole 40 mg/200 mg per 5 ml Paediatric Suspension contains 200 mg sulfamethoxazole and 40 mg trimethoprim.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Manufacturer:
Medical Information Enquiries
For any Medical Information enquires about this product, please contact:
24 Hour Helpline +441748 828 391 (free phone UK only 0800 0087 392)
This leaflet was last revised in July 2021.
Other source of information:
To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:
Braille RNIB Helpline 0800 198 5000 (UK Only).
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Product name: Co-Trimoxazole 40 mg/200 mg per 5 ml Paediatric Suspension
Reference number: PL 39699/0037
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