Septrin 80mg/400mg Tablets

Warnings and precautions

Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis and drug reaction with eosinophilia and systemic symptoms (DRESS)) have been reported with the use of Septrin appearing initially as reddish target-like spots or circular patches often with central blisters on the trunk.The occurrence of a generalised skin redness with pustules, accompanied by fever, should raise the suspicion of a serious reaction called acute generalised 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 including fever. 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, but it could take up to 8 weeks after drug administration in cases of DRESS (see section 4).

If you have developed Stevens-Johnson syndrome, toxic epidermal necrolysis or drug reaction with eosinophilia and systemic symptoms with the use of Septrin you must not be re-started on Septrin at any time. If you develop a rash or these skin symptoms, stop taking Septrin, 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.

Talk to your doctor or pharmacist before taking Septrin if:

• you have severe allergies or bronchial asthma.
• you have been told that you are at risk for a rare blood problem called porphyria, which can affect your skin or nervous system.
• 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.
• you have a disease called glucose 6 phosphate dehydrogenase deficiency, which can cause jaundice or spontaneous destruction of red blood cells.
• you have a problem with your metabolism called phenylketonuria and are not on a special diet to help your condition.
• you are elderly.
• you are underweight or malnourished.
• you have been told by your doctor that you have a lot of potassium in your blood or if you take 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) steroids (like prednisolone) and digoxin. High levels of potassium in your blood, can cause abnormal heart beats (palpitations), nausea, dizziness or headache.
• you have been told by your doctor that you have an abnormally low level of sodium in your blood.
• you have a kidney disease.
• you have been told by your doctor that you have any serious disorders of the blood and blood forming tissues (haematological disorders) e.g. low blood cell counts.

Other medicines and Septrin

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Septrin can affect the way some medicines work. Also some other medicines can affect the way Septrin 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 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.

• 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.
• Folinic acid.
• Rifampicin, an antibiotic.
• Contraceptive medicines.

 Septrin with food and drink

You should take Septrin 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 Septrin.

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.

Septrin Tablets contains sodium:

This medicine contains less than 1 mmol sodium (23 mg) per dose i.e. that is to say essentially ‘sodium free’.

Standard dose

Standard dosage recommendations for acute infections

 Adults (>18 years old):

Two tablets in a morning and two tablets in an evening.

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

 The schedules for children are according to the child’s age and body weight provided in the table below:

Age >12 to <18 years old

Two tablets in a morning and two tablets in an evening.

The dosage for children is equivalent to approximately 6 mg trimethoprim and 30 mg sulfamethoxazole per kg body weight per day

• Septrin should be taken for at least five days.
• Make sure that you finish the course of Septrin which your doctor has prescribed.

Septrin 80 mg/400 mg Tablets are not usually given to children under 12 years old. If they have been given to your child under 12 years please speak to your doctor or pharmacist for more information.

Special Dose

The dose of Septrin and how long you need to take it depends on the infection you have and how bad it is. Your doctor may prescribe you a different dose or length of course of Septrin to:

• treat urinary tract (water) infections.
• treat and prevent lung infections caused by the bacteria pneumocystis jirovecii (PJP).
• treat infections caused by the bacteria toxoplasma (toxoplasmosis) or nocardia (nocardiosis) or brucella (brucellosis).

If you have kidney problems your doctor may:

• Prescribe a lower dose of Septrin.
• Take blood to test whether the medicine is working properly.
   
  If you take Septrin for a long time your doctor may:
• Take blood to test whether the medicine is working properly.
• Prescribe folic acid (a vitamin) for you to take at the same time as Septrin.
   
  If you take more Septrin than you should
  If you take more Septrin than you should, talk to your doctor or go to a hospital straight away. Take the medicine pack with you. If you have taken too much Septrin you may:

• Feel or be sick.
• Feel dizzy or confused.
   
  If you forget to take Septrin
  If you forget to take a dose, take it as soon as you remember it. Do not take a double dose to make up for the forgotten dose.