• 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 or 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 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 the 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.

• This medicine contains 535mg of alcohol (ethanol) in each ampoule which is equivalent to 535mg/5ml (11% w/v). The amount in 5ml of this medicine is equivalent to 13ml beer or 5ml wine. The alcohol in this preparation is likely to affect children. These effects may include feeling sleepy and changes in behaviour. It may also affect their ability to concentrate and take part in physical activities. The amount of alcohol in this medicine can affect your ability to drive or use machines. This is because it may affect your judgement and how fast you react. If you have epilepsy or liver problems, talk to your doctor or pharmacist before taking this medicine. The amount of alcohol in this medicine may alter the effects of other medicines. Talk to your doctor or pharmacist if you are taking other medicines. If you are pregnant or breast-feeding, talk to your doctor or pharmacist before taking this medicine. If you are addicted to alcohol, talk to your doctor or pharmacist before taking this medicine.
• This product contains 36.36mg of sodium. Talk to your doctor or pharmacist if you need 11 or more ampoules daily for a prolonged period, especially if you have been advised to follow a low salt (sodium) diet.
• This medicinal product contains 2250mg of propylene glycol in each 5ml. If your child is less than 5 years old, talk to your doctor or pharmacist before giving them this medicine, in particular if they use other medicines that contain propylene glycol or alcohol. If you are pregnant or breast-feeding, do not take this medicine unless recommended by your doctor. If you suffer from a liver or kidney disease, do not take this medicine unless recommended by your doctor. Your doctor may carry out extra checks while you are taking this medicine.

Standard dosage recommendations for acute infections

Adults (>18 years old):

STANDARD DOSAGE

Age Solution for Infusion

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

The standard dosage for children is equivalent to approximately 6mg trimethoprim and 30mg 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 weight 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 (10ml) every 12 hours

Weight Solution for Infusion

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

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

Age Dosage

6 weeks to 5 months 1.25ml every 12 hours

6 months to 5 years 2.5ml every 12 hours

6 to 12 years 5.0ml every 12 hours

Weight Dosage

>7kg 1.25ml every 12 hours

>13kg 2.5ml every 12 hours

>27kg 5.0ml 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.

• Difficulty in 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

Very Common (more than 1 in 10 people)

• High levels of potassium in your blood, which can cause abnormal heart beats (palpitations)

Common (less than 1 in 10 people)

• A fungal infection called thrush or candidiasis which can affect your mouth or vagina
• Headache
• Feeling sick (nausea)
• Diarrhoea
• Skin rashes

Uncommon (less than 1 in 100)

• Being sick (vomiting)

Very Rare (less than 1 in 10,000 people)

• Fever (high temperature) or frequent infections
• Sudden wheeziness or difficulty breathing
• Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported (see Warnings and precautions)
• Very rare cases of redness generalising to the whole body (generalised acute exanthematous pustulosis (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)
• Blisters on your skin or inside your mouth, nose, vagina or bottom
• Inflammation of the eye which causes pain and redness
• The appearance of a rash or sunburn when you have been outside (even on a cloudy day)
• Low levels of sodium in your blood
• Changes in blood tests
• Feeling weak, tired or listless, pale skin (anaemia)
• Heart problems
• Jaundice (the skin and the whites of your eyes turn yellow). This can occur at the same time as unexpected bleeding or bruising
• Pains in your stomach, which can occur with blood in your faeces (stools)
• Pains in your chest, muscles or joints and muscle weakness
• Arthritis
• Problems with your urine. Difficulty passing urine. Passing more or less urine than usual. Blood or cloudiness in your urine
• Kidney problems
• Sudden headache or stiffness of your neck, accompanied by fever (high temperature)
• Problems controlling your movements
• Fits (convulsions or seizures)
• Feeling unsteady or giddy
• Ringing or other unusual sounds in your ears
• Tingling or numbness in your hands and feet
• Seeing strange or unusual sights (hallucinations)
• Depression
• Muscle pain and/or muscle weakness in HIV patients
• Loss of appetite

Unknown frequency (cannot be estimated from the available data)

• Psychotic disorder (a mental state in which you may lose touch with reality)
• Plum-coloured raised painful sores on the limbs and sometimes on the face and neck with a fever (Sweets syndrome)
• Drug reaction with eosinophilia and systemic symptoms (an allergic type of reaction in which you may develop fever, skin rash, and abnormalities in blood and liver function tests (these may be signs of a multi-organ sensitivity disorder)).

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.

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 16mg/80mg per ml solution for infusion are: propylene glycol (E1520), tromethamine, sodium hydroxide (E524), ethanol, water for injections.

Co-trimoxazole is available in 5ml type I colourless glass ampoules.

Each 5ml ampoule contains 400mg sulfamethoxazole and 80mg trimethoprim. The ampoules are supplied in packs of 10.