CO-TRIMOXAZOLE TABLETS BP 80/400 MG - patient leaflet, side effects, dosage

e] contents of the pack and other information

What Co-trimoxazole tablets contain

• The active substances (the ingredients that make the tablets work) are 80mg of trimethoprim and 400mg of sulfamethoxazole.
• The other ingredients are docusate sodium, magnesium stearate, maize starch, silica, sodium lauryl sulfate and stearic acid.

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

Co-trimoxazoleTablets 80/400mg are white, circular, biconvex uncoated tablets, impressed"C"on one face and the identifying letters „CF“ on either side of a central division line on the reverse.

Pack sizes are 28 tablets.

Marketing Authorisation Holder and Manufacturer

Accord, Barnstaple, EX32 8NS, UK

This leaflet was last revised in February 2022.

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Package leaflet: Information for the patient

Co-trimoxazole tablets 80/400mg

(Trimethoprim and Sulfamethoxazole)

What is in this leaflet

□ What Co-trimoxazole tablets are and what they are used for

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What you need to know before you take Co-trimoxazole tablets

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How to take Co-trimoxazole tablets

□ Possible side effects

0 Howto store Co-trimoxazole tablets

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Contents of the pack and other information

□ What Co-trimoxazole tablets are and what they are used for Co-trimoxazole 80mg/400mgTablets (called 'Co-trimoxazole tablets'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 tablets are used for adults and children over 12 years.

Co-trimoxazole tablets can be used to treat or prevent:

• lung infections (pneumonia or PCP) caused by a bacteria called Pneumocystis jiroveci
• infections caused by a bacteria called Toxoplasma (toxoplasmosis).

Co-trimoxazole tablets 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, which can affect the lungs, skin and brain.
• 0 What you need to know before you take Co-trimoxazole tabletsDo not take Co-trimoxazole tablets if: you are allergic to sulfamethoxazole, trimethoprim or Co-trimoxazole or any of the other ingredients of this medicine (listed in section 6)
• you are allergic to sulfonamide medicines. Examples include sulfonylureas (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 causing bruises or bleeding (thrombocytopenia)
• you have been told that you have a rare blood problem called porphyria, which can affectyour 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 you, talk to your doctor or pharmacist before taking Co-trimoxazole tablets.

Warnings and precautions

Talk to your doctor or pharmacist before taking Co-trimoxazole if you:

• have severe allergies or asthma
• have been told that you have a rare blood problem called porphyria, which can affectyour skin or nervous system
• 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
• have a disease called glucose-6-phosphate dehydrogenase deficiency, which can cause jaundice or spontaneous destruction of red blood cells
• have ever had jaundice which can cause yellowing of your skin or the whites of your eyes
• have a problem with your metabolism called phenylketonuria and are noton a special diet to help your condition
• are elderly
• have a kidney disease
• If you have a severe blood disorder, such as a low number of red blood cells (anaemia), a low number of white blood

Continued over page cells (leucopenia) or a low number of platelets, which may cause bleeding and bruising (thrombocytopenia)

• are underweight or malnourished
• have been told byyourdoctorthat you have a lot of potassium in your blood. Concomitant administration of Co-trimoxazole tablets with certain medicines, potassium supplements and food rich in potassium may lead to severe hyperkalaemia (increased potassium blood levelJ.The symptoms of severe hyperkalaemia might include muscle cramps, irregular heart rhythm, diarrhoea, nausea, dizziness or headache.

Skin reactions – if you develop a rash or any of the following symptoms, seek immediate advice from a doctor and tell them that you are taking this medicine:

• 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 Co-trimoxazole appearing initially as reddish target-like spots or circular patches often with central blisters on the trunk. If you have developed Stevens-Johnson syndrome, toxic epidermal necrolysis or DRESS with the use of Co-trimoxazole tablets you must not be re-started on Co-trimoxazole tablets at any time

• additional signs to look for include ulcers in the mouth, throat, nose and 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
• 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 acute generalised exanthematous pustulosis (AGEP) (see section 4).

If you develop an unexpected worsening of cough and shortness of breath, inform your doctor immediately.

There have been very rare reports about excessive immune reactions due to a dysregulated activation of white blood cells resulting in inflammations (haemophagocy­ticlymphohisti­ocytosis), 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.

Other medicines and Co-trimoxazole tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

This includes herbal medicines.This is because Co-trimoxazole tablets can affect the way some medicines work. Also some other medicines can affect the way Co-trimoxazole tablets work, especially:

• Diuretics (water tablets) such as spironolactone, 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 (sulfonylureas) and repaglinide
• Rifampicin, an antibiotic
• 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), 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
• Folinicacid
• Contraceptive medicines.

Co-trimoxazole tablets with food and drink

You should take Co-trimoxazole tablets with some food or drink.This will stop you feeling sick (nausea) or having diarrhoea. Although it is better to take them with food, you can still take them on an empty stomach.

Drink plenty of fluid such as water while you are taking Co-trimoxazole tablets.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you maybe pregnant or are planning to havea baby,ask yourdoctor 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. Contlnuedoverpage

Information on sodium content

This medicine contains less than 1 mmol sodium (23mg) per tablet, that is to say essentially'sodium-free'.

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How to take Co-trimoxazole tablets

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is:

Adults (>18 years old): STANDARD DOSAGE
Age	Tablets
>18 years old	2 Tablets every 12 hours

Children over 12 years

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

>12 years and over OR >Weighing 53kg or above

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 80mg/400mg 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 Co-trimoxazole tablets 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 Pneumocystisjiroved
• treat infections caused by the bacteria Toxoplasma (toxoplasmosis) or Nocardia (nocardiosis).

If you have kidney problems your doctor may:

• prescribea lowerdoseofCo-trimoxazole tablets
• take blood to test whether the medicine is working properly.

If you take Co-trimoxazole tablets 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 Co-trimoxazole tablets.

If you take more Co-trimoxazole tablets than you should

If you take more Co-trimoxazole tablets 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 many Co-trimoxazole tablets you may:

• feel or be sick
• feel dizzy or confused.

If you forget to take Co-trimoxazole tablets

If you forget to take a dose, take it as soon as you remember it. Do not take a double dose to make upfor the forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Co-trimoxazole tablets and tell your doctor immediately if you have an allergic reaction. Signs of an allergic reaction include:

Very rare (may affect up to 1 in 10,000 people):

• Sudden wheeziness or difficulty breathing
• Fainting
• Swelling efface
• 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.

Stop taking Co-trimoxazole tablets and tell your doctor immediately if you develop the following symptoms:

Very rare (may affect up to 1 in 10,000 people):

• A widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome) or on much of the body surface (toxic epidermal necrolysis) (see section 2'Warnings and Precautions')
• A red, scaly widespread rash with bumps under the skin and blisters accompanied by fever at the initiation of treatment (acute generalised exanthematous pustulosis (AGEP)) (see section 2)
• Mouth ulcers, cold sores and ulcers or soreness of your tongue
• Skin lumps or hives (raised, red or white, itchy patches of skin)
• Jaundice (the skin and the whites of your eyes turn yellowJ.This can occur at the same time as unexpected bleeding or bruising
• Pains in your stomach, which can occur with blood in yourfaeces (poo)