CO-TRIMOXAZOLE 40 MG / 200 MG PER 5ML PAEDIATRIC SUSPENSION, SEPTRIN40 MG / 200 MG PER 5ML PAEDIATRIC SUSPENSION - patient leaflet, side effects, dosage

1. what co-trimoxazole is and what it is used for

Co-Trimoxazole 40mg/200mg per 5ml 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:

• ■ Lung infections (pneumonia or PJP) caused by a bacteria called Pneumocystis jirovecii.

• ■ Infections caused by a bacteria called Toxoplasma (toxoplasmosis).

Co-Trimoxazole can be used to treat:

• ■ Urinary bladder or urinary tract infections (water infections).

• ■ Respiratory tract infections such as bronchitis.

• ■ Ear infections such as otitis media.

• ■ An infection called nocardiosis which can affect the lungs, skin and brain.

Consideration should be given of official guidance on the appropriate use of antibacterial agents.

Co-Trimoxazole 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:

• ■ If they are allergic to sulfamethoxazole, trimethoprim or co-trimoxazole or any of the other ingredients of this medicine (listed in section 6).

• ■ If they are allergic to sulphonamide medicines. Examples include sulphonylureas (such as gliclazide and glibenclamide) or thiazide diuretics (such as bendroflumethi­azide – a water tablet).

• ■ If they have severe liver or severe kidney problems.

• ■ If they have ever had a problem with their blood causing bruises or bleeding (thrombocytopenia).

• ■ If you have been told that your child has a rare blood problem called porphyria, which can affect their 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 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:

• ■ If they 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 your child has developed Stevens-Johnson syndrome, toxic epidermal necrolysis or drug reaction with eosinophilia and systemic symptoms with the use of Co-Trimoxazole your child must not be re-started on Co-Trimoxazole at any time.

• ■ If your child develops a rash or these skin symptoms, stop giving Co-Trimoxazole, seek urgent advice from a doctor and tell him that your child is 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 your child is at risk for a rare blood disorder called porphyria.

• ■ If they don’t have enough folic acid (a vitamin) in their body – which can make their skin pale and make them feel tired, weak and breathless. This is known as anaemia.

• ■ If they have a disease called glucose-6-phosphate dehydrogenase deficiency, which can cause jaundice or spontaneous destruction of red blood cells.

• ■ If they have a problem with their metabolism called phenylketonuria and are not on a special diet to help their condition.

• ■ If they are underweight or malnourished.

• ■ If you have been told by your child’s doctor that your child has a lot of potassium in their 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 they have a kidney disease.

• ■ If they have severe allergy or bronchial asthma.

• ■ If your child has 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).

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:

• ■ Diuretics (water tablets), which help increase the amount of urine produced.

• ■ 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 the 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 the blood, such as diuretics (water tablets, which help increase the amount of urine produced, 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 the immune system.

• ■ Folinic acid.

• ■ Rifampicin, an antibiotic.

• ■ Contraceptive 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

• 3.25g sorbitol in every 5ml 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.

• ■ A small amount of ethanol (alcohol), less than 100mg per 5ml spoonful.

• ■ Methyl parahydroxybenzoate (E-218), which may cause allergic reactions (possibly delayed).

• ■ Sodium benzoate (E-211), which may increase the risk of jaundice in newborn babies.

• ■ Less than 1mmol sodium (23mg) per 5ml, i.e. essentially ‘sodium free’.

• 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 6mg trimethoprim and 30mg 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 5ml spoonfuls in a morning and two 5ml spoonfuls in an evening
6 months to 5 years	One 5ml spoonful in a morning and one 5ml spoonful in an evening
6 weeks to 5 months	One 2.5ml spoonful in a morning and one 2.5ml spoonful in an evening
Weight	Paediatric Suspension
>27kg	Two 5ml spoonfuls in the morning and two 5ml spoonfuls in the evening
>20kg	One 5ml + one 2.5ml spoonful in the morning and one 5ml + one 2.5ml spoonful in the evening
>13kg	One 5ml spoonful in the morning and one 5ml spoonful in the evening
>7kg	One 2.5ml spoonful in the morning and one 2.5ml 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: ■ Treat urinary tract (water) infections.

• ■ Treat and prevent lung infections caused by the bacteria Pneumocystis jirovecii.

• ■ Treat infections caused by the bacteria Toxoplasma (toxoplasmosis) or Nocardia (nocardiosis).

If your child takes Co-Trimoxazole for a long time their doctor may

• ■ Take blood to test whether the medicine is working properly.

• ■ Prescribe folic acid (a vitamin) for your child to take at the same time as Co-Trimoxazole.

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

• ■ Feel or be sick.

• ■ Feel dizzy or confused.

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

• ■ 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 the 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 child’s 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 the tongue.

• ■ Skin lumps or hives (raised, red or white, itchy patches of skin).

• ■ Blisters on the skin or inside the mouth, nose, vagina or bottom.

• ■ Inflammation of the eye which causes pain and redness.

• ■ The appearance of a rash or sunburn when your child has been outside (even on a cloudy day).

• ■ Low levels of sodium in the blood.

• ■ Changes in blood tests.

• ■ Feeling weak, tired or listless, pale skin (anaemia).

• ■ Heart problems.

• ■ Jaundice (the skin and the whites of the eyes turn yellow). This can occur at the same time as unexpected bleeding or bruising.

• ■ Pains in the stomach, which can occur with blood in the faeces (poo).

• ■ Pains in the chest, muscles or joints and muscle weakness.

• ■ Arthritis.

• ■ Problems with the urine. Difficulty passing urine. Passing more or less urine than usual. Blood or cloudiness in the urine.

• ■ Kidney problems.

• ■ Sudden headache or stiffness of the neck, accompanied by fever (high temperature).

• ■ Problems controlling movements.

• ■ Fits (convulsions or seizures).

• ■ Feeling unsteady or giddy.

• ■ Ringing or other unusual sounds in the ears.

• ■ Tingling or numbness in the 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) (changes in behaviour).

• ■ 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 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 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: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.

• ■ Do not use the suspension after the expiry date shown on the bottle label and carton. The expiry date refers to the last day of that month.

• ■ Do not store above 25°C.

• ■ Store in the original package in order to protect from light.

• ■ After the first opening of the bottle, use within 1 month.

• ■ If your solution becomes discoloured or show signs of deterioration, you should seek the advice of your pharmacist.

• ■ If your doctor decides to stop your treatment, take any leftover medicine back to the pharmacy.

• ■ 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 to protect the environment.

6. contents of the pack and other information

What Co-Trimoxazole contains

Co-Trimoxazole is made up of two different medicines called sulfamethoxazole and trimethoprim. These medicines are sometimes given the combined name co-trimoxazole.

The active ingredients are trimethoprim and sulfamethoxazole.

Each 5ml contains 40mg trimethoprim and 200mg sulfamethoxazole.

The other ingredients are: sorbitol solution 70%, glycerol (E-422), dispersible cellulose, carmellose sodium, polysorbate 80, methyl parahydroxybenzoate (E-218), sodium benzoate (E-211), saccharin sodium, banana flavour (propylene glycol E-1520, sodium citrate E-331), ethanol 96%, vanilla flavour (benzyl alcohol, caramel colour E-150d, propylene glycol E-1520, glycerol E-422, water) and purified water.

What Co-Trimoxazole looks like and contents of the pack

Co-Trimoxazole is an off-white suspension with characteristic banana and vanilla odour.

Co-Trimoxazole is available as 1 bottle containing 100ml suspension supplied in an amber-coloured glass bottle with metal screw cap.

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.

Manufacturer

Manufactured by: Alcala Farma, S.L., Avenida de Madrid 82, Alcala de Henares, 28802 Madrid, Spa­in.

Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.

Product Licence holder: Landmark Pharma Ltd., 7 Regents Drive, Prudhoe, Northumberland, NE42 6PX.

PL No: 21828/0726 POM

Leaflet revision & issue date (Ref): 02.03.22

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Co-Trimoxazole 40mg/200mg per 5ml Paediatric Suspension Reference No: 21828/0726

P23135

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