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Package Leaflet: Information for the User

Co-Trimoxazole 80 mg/400 mg Tablets

co-trimoxazole

Read all of this leaflet carefully before you start taking

this medicine

•    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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    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 pharmacist.

In this leaflet:

1.    What Co-Trimoxazole is and what it is used for

2.    Before you take Co-Trimoxazole

3.    How to take Co-Trimoxazole 80 mg/400 mg Tablets

4.    Possible side effects

5.    How to store Co-Trimoxazole

6.    Further information

1 What Co-Trimoxazole is and what it is used for

Co-Trimoxazole 80 mg/400 mg Tablets (called 'Co-Trimoxazole' in this leaflet) are made up of two different medicines called sulfamethoxazole and trimethoprim. Both belong to a group of medicines called antibiotics. They are 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 PCP) caused by a bacteria called Pneumocystis jiroveci (previously known as Pneumocystis carinii)

•    infections caused by a bacteria called Toxoplasma (toxoplasmosis). Co-Trimoxazole can be used to treat:

•    bladder or urinary tract infections (water infections)

•    lung infections such as bronchitis

•    ear infections such as otitis media

•    an infection called nocardiosis, it can affect the lungs, skin and brain.

2 Before you take Co-Trimoxazole

Do not take Co-Trimoxazole if:

•    you are allergic (hypersensitive) to sulfamethoxazole, trimethoprim or any of the other ingredients of Co-Trimoxazole (see section

6: Further information)

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

•    you have liver or kidney problems

•    you have ever had a problem with your blood

•    it is for your child and they are less than 6 weeks old or were premature. Unless it is for the treatment or prevention of PCP. In this case, babies should be at least 4 weeks old.

If you are not sure if any of the above apply to you, talk to your doctor

or pharmacist before taking Co-Trimoxazole.

Take special care with Co-Trimoxazole

Before you take Co-Trimoxazole, tell your doctor or pharmacist if:

•    you have severe allergies or asthma

•    potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) 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.

•    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 or toxic epidermal necrolysis with the use of Co-Trimoxazole you must not be restarted 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.

•    • you have been told that you have 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 ever had jaundice which can cause yellowing of your skin or the whites of your eyes

•    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.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Co-Trimoxazole.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This includes herbal 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 transplant operations or for your immune system

Medicines used to thin the blood such as warfarin Phenytoin, used to treat epilepsy (fits)

Medicines for diabetes, such as glibenclamide, glipizide or tolbutamide (sulphonylureas)

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), steroids (like prednisolone) and digoxin Methotrexate, a medicine used to treat cancer or for your immune system. If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Co-Trimoxazole.

Taking 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

Talk to your doctor before taking this medicine if you are pregnant, planning to get pregnant, or breast-feeding.

3 How to take Co-Trimoxazole 80 mg/400 mg Tablets

Always take Co-Trimoxazole exactly as your doctor has told you. The label on your pack will tell you how much to take and how often to take it. You should check with your doctor or pharmacist if you are not sure.

Usual Dose

Adults and children over 12 years

•    The usual dose is two tablets in a morning and two tablets in an evening.

•    Co-Trimoxazole should be taken for at least five days.

•    Make sure that you finish the course of Co-Trimoxazole which your doctor has prescribed.

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

The dose of Co-Trimoxazole 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 Co-Trimoxazole to

•    treat urinary tract (water) infections

•    treat and prevent lung infections caused by the bacteria Pneumocystis jiroveci