Informations for option: Co-Trimoxazole Forte 160mg/800mg Tablets, show other option

Select option:

1. Co-Trimoxazole Forte 160mg/800mg Tablets
2. Co-Trimoxazole Forte 160mg/800mg Tablets

PATIENT INFORMATION LEAFLET

Co-trimoxazole 80/400mg Tablets Co-trimoxazole Forte 160/800mg Tablets

(trimethoprim and sulphamethoxazole)

1	What this medicine is and what it is used for	W	Possible side effects
2	Before you take		How to store
3	How to take	|6	Further information

What this medicine is and what it is used for

Co-trimoxazole Tablets belong to a group of medicines called antibacterials. The medicine contains two active ingredients trimethoprim and sulphamethoxazole and is used to treat certain types of infections caused by bacteria.

Co-trimoxazole can be used to treat or prevent:

■    lung infections (pneumonia) caused by Pneumocytosis carinii (Pneumocytosis jiroveci)

■    infections caused by the bacteria Toxoplasma (toxoplasmosis)

Co-trimoxazole can also be used to treat:

■    urinary tract infections

■    worsening of long term bronchitis

■    short-lived ear infections (acute otitis media)

■    a rare infection of the lungs, brain, or skin (nocardosis)

Before you take

Do not take Co-trimoxazole if:

■    you are allergic (hypersensitive) to sulphonamide, trimethoprim, Co-trimoxazole or any of the other ingredients (see section 6: Further information)

■    you have severe liver failure, liver damage or jaundice

■    you have severe kidney problems

■    you have a serious problem with your blood or porphyria (a genetic disease)

■    it is for a child and they are less than 6 weeks old or were premature. Unless it is for the treatment or prevention of lung infections caused by Pneumocytosis carinii (Pneumocytosis jiroveci). In this case, babies should be at least 4 weeks old

■    you are pregnant (see section 2 'Pregnancy and breast-feeding')

If any of the above apply to you, talk to your doctor or pharmacist before taking this medicine.

Take special care with Co-trimoxazole

Before you take this medicine, tell your doctor if:

■    you have a history of allergies or asthma

■    you have kidney problems

■    you do not have enough folic acid (vitamin) in your body - which can make your skin pale and make you feel tired, weak and breathless. This is known as anaemia

■    you are known to have a reduced amount of the enzyme glucose 6 phosphate dehydrogenase (G6PD).

It is a hereditary condition which causes the red blood cells to break down. It can cause fever and anaemia (see bullet above) and can be triggered by infections, certain foods (such as fava beans) and medicines

■    you have a problem with your metabolism called phenylketonuria and you are not on a special diet to help your condition

■    you are elderly. Especially if you have kidney or liver problems

■    you have a bacterial infection known as Group A beta-haemolytic streptococci

■    you are known to be at risk of having hyperkalaemia, which can cause abnormal heart rhythm due to high levels of blood potassium

■    you have malnutrition

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.

In particular, tell your doctor or pharmacist if you are taking the following:

■    Warfarin or acencoumarol, used to prevent the blood from clotting (anticoagulant)

■    Phenytoin, used to treat epilepsy

■    Digoxin used to treat heart conditions

■    Procainamide, amiodarone or dofetilide, used to treat an irregular heart beat

■    Amantadine, used to treat some viral infections and also Parkinson's disease

■    Medicines for diabetes, such as glibenclamide, glipizide or tolbutamide (sulphonylurea hypoglycaemic medicines)

■    Methotrexate, mercaptopurine and azathioprine, used to treat cancer or for your immune system

■    Cyclosporin, used after transplant operations or for your immune system

■    Pyrimethamine, used to prevent malaria

■    ACE inhibitors, used to treat high blood pressure, such as captopril or lisinopril

■    Anaesthetics, such as prilocaine

■    Rifampicin, dapsone or methenamine, used to treat bacterial infections (antibiotics)

■    Lamivudine, zidovudine and zalcitabine, used to treat viral infections

■    Clozapine, used to treat mental health problems

■    Potassium aminobenzoate, used to treat scleroderma (Peyronie's disease)

If you are elderly and taking the following:

■ Diuretics (water tablets), which help increase the amount of urine produced. In particular, thiazides, such as bendroflumethiazide

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

Co-trimoxazole should not be used during pregnancy.

If you are breast-feeding, ask your doctor for advice before taking this medicine.

Driving or operating machinery

Co-trimoxazole may make you feel dizzy, sleepy, see or hear things that are not real (hallucinations), have ringing in your ears or difficulty sleeping. If affected, you should not drive or operate machinery.

Laboratory tests

If you need to have laboratory tests, let your doctor know that you are taking Co-trimoxazole as it may affect the results.

How to take

Always take Co-trimoxazole exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

■    These tablets are for oral administration

■    The tablets should be swallowed with a little water and with some food

Usual dose

Adults and children over 12 years

Co-trimoxazole 80/400mg Tablets: The usual dose is 2 tablets twice a day.

For severe infections the dose may be increased to 3 tablets twice a day.

Co-trimoxazole Forte 160/800mg Tablets: The usual dose is 1 tablet twice a day.

For severe infections the dose may be increased to 1% tablets twice a day.

Children 6 - 12 years

Co-trimoxazole 80/400mg Tablets: The usual dose is 1 tablet twice a day.

Co-trimoxazole Forte 160/800mg Tablets is not recommended for children under 12 years.

Children 6 weeks - 5 years

(another form of this medicine may be used)

6 weeks - 5 months: 120mg twice daily 6 months - 5 years: 240mg twice daily

Premature babies or babies under 6 weeks

Co-trimoxazole should not be given to premature babies or infants under six weeks, except for the treatment of Pneumocytosis carinii (Pneumocytosis jiroveci). In this case, babies should be at least 4 weeks old.

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 a different dose and the length of treatment may vary for the following:

■    Long term prevention of urinary tract (water) infections

■    Treatment of long term inflammation of the prostate

■    Treatment and prevention of lung infections caused by Pneumocytosis carinii (Pneumocytosis jiroveci)

■    Treatment of gonorrhoea (sexually transmitted disease)

■    Treatment of acute brucellosis (bacterial infection which can be passed to humans either by contact with infected farm animals or by drinking non-pasteurised contaminated milk)

■    Treatment of nocardiosis

■    Treatment or prevention of toxoplasmosis

■    Treatment of patients carrying typhoid and paratyphoid

Patients with kidney problems

If you have kidney problems you may be given a lower dose. Your doctor may also take blood to test whether the medicine is working properly.

continued....

Elderly

If you are elderly, it is particularly important to take this medicine exactly as directed by the doctor, especially if you have kidney or liver problems and/or are taking other medicines.

Taking Co-trimoxazole for a long time

If you take Co-trimoxazole for a long time your doctor may take blood to test whether the medicine is working properly. You may be prescribed folic acid (vitamin) to take at the same time.

If you take more Co-trimoxazole that you should

If you (or someone else) take more Co-trimoxazole than you should, talk to your doctor or go to your nearest hospital immediately. Take this leaflet and any remaining tablets with you.

Symptoms of an overdose may include feeling or being sick, stomach pain, dizziness, confusion, rashes, headache, difficulty in controlling movements, sleepiness, painful or difficult urination, swelling of the face and weakness.

If you forget to take Co-trimoxazole

If you forget to take a dose, take it as soon as you remember, unless it is nearly time to take the next one. Do not take a double dose to make up for a forgotten dose. Take the remaining doses at the correct time.

If you stop taking Co-trimoxazole

You should finish all the tablets your doctor has prescribed. It can be dangerous to stop taking the medicine without your doctor's advice.

Possible side effects

Co-trimoxazole, like most other medicines, may cause side effects in some patients, although not everyone gets them.

Serious side effects

Stop taking the tablets and contact your doctor immediately if you have the following side effects:

Skin reactions

■    Blistering of the skin, mouth, eyes and genitals

■    Scaling of the skin

Allergic reactions

■    Fever

■    Skin rash

■    Difficulty in breathing or dizziness

■    Swelling of the face or throat

■    Joint pain

■    Cough

■    Irregular or rapid heart beat, shortness of breath, swollen legs or heart failure, due to inflammation of the heart

■    Fever, tiredness, weakness, loss of appetite, weight loss, muscle/joint pain, skin rashes or high blood pressure, due to swollen and damaged arteries

Blood disorder reactions

■    Increased risk of bleeding or bruising, due to a reduction in blood platelets

■    Skin rash resulting from bleeding into the skin from small blood vessels

■    Mouth ulcers, inflammation of the mucous lining of the mouth or lung problems, due to a reduction in white blood cells

■    Increased risk of infections, due to a reduction in the number of white blood cells

High dosage reactions for treatment of Pneumocytosis

carinii (Pneumocytosis jiroveci)

■    Abnormal heart rhythm, due to high levels of blood potassium

■    Tiredness and confusion, muscle twitching, fits and coma, due to low blood levels of sodium

■    Bone marrow depression requiring folate supplements

■    Increased risk of infections, due to a reduction in the number of white blood cells

■    Increased risk of bleeding or bruising, due to a reduction in blood platelets

■    Raised liver enzymes (detected through blood tests)

Below are other possible side effects

Less common

■    Pale yellow skin, weakness, bruising, breathlessness, tiredness, headache, dizziness, sore mouth and tongue or increased risk of infections, due to a reduction in blood cells (anaemia)

Rare

■    Abdominal pain or cramps, diarrhoea (sometimes watery and bloody) or fever, due to inflammation of the colon

■    Yellow skin and whites of the eyes, dark urine, light and foul smelling stools, due to abnormal bile flow

■    Inflammation of the mucous lining of the mouth

■    Loss of appetite

■    Severe pain in the abdomen and back, due to inflammation of the pancreas

■    Passing of more urine at night, tiredness, feeling or being sick or itching, due to inflammation of the kidney

■    Crystals in the urine (detected through a urine test), which can be avoided by adequate fluid intake

Very rare

■    Liver failure

■    Increased level of liver enzymes and bilirubin (detected by blood test)

■    Bone marrow depression, especially in the elderly

Other reported side effects

■    Feeling sick

■    Being sick

■    Diarrhoea

■    Inflammation of the tongue

■    Increased sensitivity of the skin to sunlight

■    Skin rashes

■    Sore mouth

■    Yellowing of the skin or whites of the eyes caused by liver or blood problems (jaundice)

■    Inflammation of the lining of the brain (aseptic meningitis) which may cause headache, fever, stiff neck, tiredness, feeling ill and sensitivity of the eyes to bright light

■    Fits

■    Weakness, tingling or numbness, due to nerve disorder

■    Difficulty in controlling movements

■    A feeling of dizziness or "spinning"

■    Ringing in the ears

■    Headache

■    Depression

■    Dizziness

■    Seeing or hearing things that are not real (hallucinations)

■    Joint or muscle pain

■    An infection called thrush or candidiasis which can affect your mouth or vagina. It is caused by a fungus

■    Kidney problems

■    Joint inflammation and stomach pain (Henoch-Schonlein purpura)

■    Increase in a certain type of white blood cell (eosinophilia - diagnosed through blood test)

■    Feeling sleepy or tired

■    Difficulty sleeping

■    Changes in the level of body chemicals

■    Increased production of metabolic acids, which may cause rapid breathing or confusion

If any of the side effects become serious or you notice any not listed, please tell your doctor or pharmacist.

How to store

Keep out of reach and sight of children.

Do not take after the expiry date, printed on the label after EXP. The expiry date refers to the last day of that month.

These tablets should be stored in a dry place below 25°C, protected from heat, light and moisture. Store in the original container.

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 protect the environment.

Further Information

What Co-trimoxazole Tablets contain

■    Active ingredient:

Co-trimoxazole 80/400mg Tablets contain 80mg of trimethoprim and 400mg of sulphamethoxazole

Co-trimoxazole Forte 160/800mg Tablets contain 160mg of trimethoprim and 800mg of sulphamethoxazole

■    Other ingredients:

microcrystalline cellulose, Sta-RX 1500 (pregelatinised maize starch), maize starch, nipastat, magnesium stearate, primojel (sodium starch glycollate), purified water.

Co-trimoxazole 80/400mg Tablets also contain hydrogenated castor oil.

Co-trimoxazole Forte 160/800mg Tablets also contain hydrogenated vegetable oil.

What Co-trimoxazole Tablets look like and the contents of the pack

Co-trimoxazole 80/400mg Tablets are white, round, flat bevel edged tablets marked "COT 480" on one side and a cross breakline on the other.

Co-trimoxazole Forte 160/800mg Tablets are white oblong shaped tablets marked "COT 960"on one side and a breakline on the other.

Co-trimoxazole 80/400mg Tablets are available in packs of 4, 8, 12, 16, 20, 28, 50, 100, 250, 500 or 1000 tablets

Co-trimoxazole Forte 160/800mg Tablets are available in packs of 2, 4, 6, 8, 10, 14, 100, 250, 500 and 1000 tablets

Not all sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Tillomed Laboratories Ltd 3 Howard Road Eaton Socon St. Neots

Cambridgeshire PE19 8ET United Kingdom

Product Licence Numbers

PL 11311/0352 (80/400mg)

PL 11311/0354 (160/800mg)

Date of last revision: January 2013

Hard to Read? Phone 0800 970 6115 for help

Till-Ver.7.1s