• 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 is and what it is used for
2. What you need to know before you are given Co-Trimoxazole
3. How Co-Trimoxazole is given
4. Possible side effects
5. How to store Co-Trimoxazole
6. Contents of the pack and other information

• If you are allergic to sulfamethoxazole, trimethoprim or co-trimoxazole or any of the other ingredients of this medicine(listed in section 6).
  If you are allergic to sulphonamide medicines. Examples include sulphonylureas (such as gliclazide and glibenclamide) or thiazide diuretics (such as bendroflumethiazide–a water tablet).
• If you have severe liver or severe kidney problems.
• If you have ever had a problem with your blood causing bruises or bleeding (thrombocytopenia).
• If 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.

Talk to your doctor or pharmacist before being given Co-Trimoxazole:

• If you have severe allergies or asthma.
• Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis and drug reaction with eosinophilia and systemic symptoms) have been reported with the use of Co-Trimoxazole appearing initially as reddish target-like spots or circular patches often with central blisters on the trunk.
• At the start of treatment, the occurrence of a generalised skin redness with pustules, accompanied by fever, should raise the suspicion of a serious reaction called generalised acute exanthematous pustulosis (AGEP) (see section 4).
• Additional signs to look for include ulcers in the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes).
• These potentially life-threatening skin rashes are often accompanied by flu-like symptoms. The rash may progress to widespread blistering or peeling of the skin.
• the highest risk for occurrence of serious skin reactions is within the first weeks of treatment.
• If you have developed Stevens-Johnson syndrome, toxic epidermal necrolysis or drug reaction with eosinophilia and systemic symptoms with the use of Co-Trimoxazole you must not be re-started on Co-Trimoxazole at any time.
• If you develop a rash or these skin symptoms, seek immediate advice from a doctor and tell him that you are taking this medicine.
• Haemophagocytic lymphohistiocytosis
  There have been very rare reports about excessive immune reactions due to a dysregulated activation of white blood cells resulting in inflammations (haemophagocytic lymphohistiocytosis), which can be life-threatening if not diagnosed and treated early. If you experience multiple symptoms such as fever, swollen glands, feeling weak, lightheaded, shortness of breath, bruising, or skin rash simultaneously or with a slight delay, contact your doctor immediately.
• If you develop an unexpected worsening of cough and shortness of breath, inform your doctor immediately.
• If you have been told that you are at risk for a rare blood disorder called porphyria.
• If you 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.
• If you have a disease called glucose-6-phosphate dehydrogenase deficiency, which can cause jaundice or spontaneous destruction of red blood cells.
• If you have a problem with your metabolism called phenylketonuria and are not on a special diet to help your condition.
• If you are elderly.
• If you are underweight or malnourished.
• If you have been told by your doctor that you have a lot of potassium in your blood. Concomitant administration of Co-Trimoxazole with certain medicines, potassium supplements and food rich in potassium may lead to severe hyperkalaemia (increased potassium blood level). The symptoms of severe hyperkalaemia might include muscle cramps, irregular heart rhythm, diarrhoea, nausea, dizziness or headache.
• If you have a kidney disease.
• If you have severe allergy or bronchial asthma.
• If you have a severe blood disorder, such as a low number of red blood cells (anaemia), a low number of white blood cells (leucopenia) or a low number of platelets, which may cause bleeding and bruising (thrombocytopenia).

Tell your doctor or pharmacist if you are taking, have 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 doctor of pharmacist if you are taking any of the following medicines:

• Diuretics (water tablets), which help increase the amount of urine you produce.
• Pyrimethamine, used to treat and prevent malaria, and to treat diarrhoea.
• Ciclosporin, used after organ transplant surgeries.
• Blood thinners such as warfarin.
• Phenytoin, used to treat epilepsy (fits).
• Medicines used to treat diabetes, such as glibenclamide, glipizide or tolbutamide (sulphonylureas) and repaglinide.
• Medicines to treat problems with the way your heart beats such as digoxin or procainamide.
• Amantadine, used to treat Parkinson’s disease, multiple sclerosis, flu or shingles.
• Medicines to treat HIV (Human Immunodeficiency Virus), called zidovudine or lamivudine.
• Medicines that can increase the amount of potassium in your blood, such as diuretics (water tablets, which help increase the amount of urine you produce , such as spironolactone), steroids (like prednisolone) and digoxin digoxin or ACE inhibitors (may be used to treat high blood pressure or some heart problems).
• Azathioprine, may be used in patients following organ transplant or to treat immune system disorders or inflammatory bowel disease
• Methotrexate, a medicine used to treat certain cancers or certain diseases affecting your immune system.
• Rifampicin, an antibiotic.
• Folinic acid.
• Contraceptive medicines.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

See following section for more information about ethanol content in the formulation.

Effects on the ability to drive and operate machinery in patients taking this medicine have not been studied.

• Sodium metabisulphite. This can cause allergic type reactions including skin rash; swelling of eyelids, face or lips or difficulty in breathing. This is rare, but you may be more at risk if you suffer from allergies or asthma.
• 13.2 vol% ethanol (alcohol). There can be up to 521 mg per dose. This is equivalent to 13.22 ml of beer, or 5.5 ml of wine. It may be harmful if you are alcoholic. The ethanol content should also be taken in to account if you are pregnant or breast-feeding, a child or if you have liver problems or epilepsy.
• 1.7 mmoles (or 38.87 mg) of sodium. To be taken into consideration by patients on a sodium controlled diet.

Standard dosage recommendations for acute infections

Adults (>18 years old):

STANDARD DOSAGE

Age Solution for Infusion

>18 years old 2 ampoules (10 mL) every 12 hours

The standard dosage for children is equivalent to approximately 6 mg trimethoprim and 30 mg sulfamethoxazole per kg body weight per day, given in two equally divided doses. The schedules for children are according to the child’s age and eight and provided in the tables below:

Children over 12 years old (>12 to <18 years old):

STANDARD DOSAGE

Age Solution for Infusion

>12 to <18 years old 2 ampoules (10 mL) every 12 hours

Weight Solution for Infusion

>53 kg 2 ampoules (10 mL) every 12 hours

Children aged 12 years and under (>6 weeks to <12 years old):

Age Dosage

6 weeks to 5 months 1.25 mL every 12 hours.

6 months to 5 years 2.5 mL every 12 hours

6 to 12 years 5.0 mL every 12 hours.

Weight Dosage

>7 kg 1.25 mL every 12 hours

>13 kg 2.5 mL every 12 hours

>27 kg 5.0 mL every 12 hours

For severe infections in all age groups, dosage may be increased by 50%.

Treatment should be continued until the patient has been symptom free for two days; the majority will require treatment for at least 5 days.

• prescribe a lower dose of Co-Trimoxazole.
• take blood to test whether the medicine is working properly.

If you think you have been given more Co-Trimoxazole, talk to your doctor or nurse straight away.

If you have been given too much Co-Trimoxazole you may:

• feel or be sick.
• feel dizzy or confused.

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.

• Co-Trimoxazole is made up of two different medicines called sulfamethoxazole and trimethoprim.
• The other ingredients of Co-Trimoxazole 16 mg/80 mg per mL for Infusion are: propylene glycol (E1520), tromethamine, sodium hydroxide (E524), sodium metabisulphite (E223), ethanol, Water for Injections.

Co-Trimoxazole is available in 5 ml glass ampoules.

Each 5 ml ampoule contains 400 mg sulfamethoxazole and 80 mg trimethoprim.

The ampoules are supplied in packs of 10.

Marketing authorisation holder:

Manufacturer:

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