Product Details

What you need to know before you take Primpex Suspension – Co-trimoxazole 40mg/200mg

Do not take Co-Trimoxazole • 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. 2 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 CoTrimoxazole. Warnings and precautions Talk to your doctor or pharmacist before taking 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 CoTrimoxazole 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, stop taking Co-Trimoxazole, seek urgent 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 an older person. • If you are underweight or malnourished. • If you have been told by your doctor that you have a lot of potassium in your blood. • 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).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. Other medicines and Co-Trimoxazole 3 Tell your doctor or pharmacist if you are taking, have recently taken or may 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. Co-Trimoxazole with food and drink You should take Co-Trimoxazole with some food or drink. This will stop you feeling sick (nausea) or having diarrhoea. Although it is better to take it with food, you can still take it on an empty stomach. Drink plenty of fluid such as water while you are taking Co-Trimoxazole. Pregnancy and breast-feeding 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. Driving and using machines Effects on the ability to drive and operate machinery in patients taking this medicine have not been studied. Co-Trimoxazole contains • 2.5 g sucrose in every 5 ml spoonful. If you have been told by your doctor that you cannot tolerate or digest some sugars (have an intolerance to some sugars), contact your doctor before taking this medicinal product. • A small amount of ethanol (alcohol), less than 100 mg per ml spoonful. • Methyl hydroxybenzoate, which may cause allergic reactions (possibly delayed). • Less than 1 mmol sodium (23 mg) per 5 ml, i.e. essentially ‘sodium free’.