Patient leaflet - Co-trimoxazole 960 mg tablets

1. What Co-trimoxazole tablets are and what they are used for

Co-trimoxazole 960 mg tablets (called Co-trimoxazole tablets in this leaﬂet) are a combination of two diﬀerent antibiotics called sulfamethoxazole and trimethoprim, which are used to treat infections caused by certain bacteria. Like all antibiotics, Co-trimoxazole tablets only work against some types of bacteria. This means that they are only suitable for treating some types of infections.

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

Ÿ Lung infections (pneumonia or PJP) caused by Pneumocystis jirovecii. Ÿ Infections caused by Toxoplasma (toxoplasmosis).

Co-trimoxazole tablets can be used to treat:

Ÿ Urinary bladder or urinary tract infections (water infections). Ÿ Respiratory tract infections such as bronchitis.

Ÿ Ear infections such as otitis media.

Ÿ An infection called nocardiosis which can aﬀect the lungs, skin and brain.

Co-trimoxazole tablets are indicated in children (>12 to <18 years old) and adults (>18 years old).

Consideration should be given to oﬃcial guidance on the appropriate use of antibacterial agents.

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

Do not take Co-trimoxazole tablets

Ÿ if you are allergic to sulfamethoxazole, trimethoprim or co-trimoxazole or any of the other ingredients of this medicine (listed in section 6). Ÿ if you are allergic to sulphonamide medicines. Examples include sulphonylureas (such as gliclazide and glibenclamide) or thiazide diuretics (such as bendroﬂumethiazide – a water tablet). Ÿ if you have severe liver or severe kidney problems.

Ÿ if you have ever had a problem with your blood causing bruises or bleeding (thrombocytopenia).

Ÿ if you have been told that you have a rare blood problem called porphyria, which can aﬀect your skin or nervous system. Ÿ if you are pregnant (ﬁrst 3 months) or might be pregnant. 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 tablets: Ÿ If you have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after taking Co-trimoxazole tablets. Ÿ If you have severe allergies or asthma.

Ÿ Potentially life-threatening skin rashes (Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS)) have been reported with the use of Co-trimoxazole tablets, appearing initially as reddish target-like spots or circular patches often with central blisters on the trunk. Ÿ 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).

Ÿ Additional signs to look for include ulcers in the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes).

Ÿ 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.

Ÿ The highest risk for occurrence of serious skin reactions is within the ﬁrst weeks of treatment.

Ÿ If you have developed Stevens-Johnson syndrome, toxic epidermal necrolysis or drug reaction with eosinophilia and systemic symptoms with the use of Co-trimoxazole tablets you must not be re-started on Co-trimoxazole at any time.

Ÿ If you develop a rash or these skin symptoms, stop taking Co-trimoxazole tablets, seek urgent advice from a doctor and tell him that you are taking this medicine (see section 4).

Ÿ 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.

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

Ÿ If you have been told that you are at risk of a rare blood disorder called porphyria.

Ÿ If you have kidney disease.

Ÿ 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.

Ÿ 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. Ÿ If you are elderly.

Ÿ If you are underweight or malnourished.

Ÿ If you have been told by your doctor that you have a lot of potassium in your blood. 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. Ÿ If you have a severe blood disorder, such as a low number of red blood cells (anaemia), a low number of white blood cells (leukopenia) or a low number of platelets, which may cause bleeding and bruising (thrombocytopenia).

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 is because Co-trimoxazole tablets can aﬀect the way some medicines work. Also some other medicines can aﬀect the way Co-trimoxazole tablets work.

In particular tell your doctor or pharmacist if you are taking any of the following medicines:

Ÿ Diuretics (water tablets), which help increase the amount of urine you produce.

Ÿ Pyrimethamine, used to treat and prevent malaria, and to treat diarrhoea. Ÿ Ciclosporin, used after organ transplant surgeries.

Ÿ Blood thinners such as warfarin.

Ÿ Phenytoin, used to treat epilepsy (ﬁts).

Ÿ Medicines used to treat diabetes, such as glibenclamide, glipizide or tolbutamide (sulphonylureas) and repaglinide.

Ÿ Rifampicin, an antibiotic.

Ÿ Medicines to treat problems with the way your heart beats such as digoxin or procainamide.

Ÿ Amantadine, used to treat Parkinson's disease, multiple sclerosis, 'ﬂu' or shingles.

Ÿ Medicines to treat HIV (Human Immunodeﬁciency Virus) called zidovudine or lamivudine.

Ÿ 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).

Ÿ Azathioprine, may be used in patients following organ transplant or to treat immune system disorders or inﬂammatory bowel disease. Ÿ Methotrexate, a medicine used to treat certain cancers or certain diseases aﬀecting your immune system.

Ÿ Folinic acid.

Ÿ Contraceptive medicines.

Ÿ Methenamine hippurate. This medicine may interact with co-trimoxazole and contribute to the formation of crystals in the urine (crystalluria), potentially leading to kidney problems.

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 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 tablets.

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.

This medicine should not be taken during the ﬁrst three months of pregnancy. Treatment with trimethoprim in the ﬁrst three months of pregnancy may increase the risk of miscarriage. Children born to mothers treated with trimethoprim during the ﬁrst trimester of pregnancy may have an increased risk of birth defects, in particular neural tube defects (where the spine and spinal cord do not form properly), oral clefts (where the lip and palate do not form properly) and defects aﬀecting the heart.

Driving and using machines

Eﬀects on the ability to drive and operate machinery in patients taking this medicine have not been studied.

Excipients

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

3. How to take Co-trimoxazole tablets

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

Standard Dose

Standard dosage recommendations for acute infections

Adults (>18 years old):

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

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

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

Ÿ Co-trimoxazole tablets should be taken for at least ﬁve days. Ÿ Make sure that you ﬁnish the course of Co-trimoxazole which your doctor has prescribed.

Co-trimoxazole 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 them 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: Ÿ Treat urinary tract (water) infections.

Ÿ T Pneumocystis reat and prevent lung infections caused by the bacteria jirovecii.

Ÿ Treat infections caused by the bacteria Toxoplasma (toxoplasmosis) or Nocardia (nocardiosis).

If you have kidney problems your doctor may:

Ÿ t

Prescribe a lower dose of Co- rimoxazole tablets.

Ÿ Take blood to test whether the medicine is working properly.

If you take Co-trimoxazole tablets for a long time your doctor may: Ÿ Take blood to test whether the medicine is working properly. Ÿ Prescribe folic acid (a vitamin) for you to take at the same time as Co-trimoxazole.

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 much Co-trimoxazole you may:

Ÿ Feel or be sick.

Ÿ 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 up for a forgotten dose.

4. Possible side eﬀects

Like all medicines, this medicine can cause side eﬀects, although not everybody gets them. You may experience the following side eﬀects with this medicine.

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

Ÿ if you have an allergic reaction. Chances of an allergic reaction are very rare (fewer than 1 in 10,000 people are aﬀected), signs of an allergic reaction include:

Diﬃculty in breathing
Fainting
Swelling of face
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

Ÿ Reddish patches on the trunk, often with central blisters, skin peeling, ulcers of the mouth, throat, nose, genitals and eyes. These serious skin rashes can be preceded by fever and ﬂu-like symptoms (Stevens- Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN)) Ÿ Widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome). Call the emergency department immediately if you experience multiple symptoms such as fever, very low blood pressure or increased heart rate after taking this drug as it may be a sign of shock.

Very Common (more than 1 in 10 people)

Ÿ High levels of potassium in your blood, which can cause abnormal heart beats (palpitations)

Common (less than 1 in 10 people)

Ÿ A fungal infection called thrush or candidiasis which can aﬀect your mouth or vagina

Ÿ Headache

Ÿ Feeling sick (nausea)

Ÿ Diarrhoea

Ÿ Skin rashes

Uncommon (less than 1 in 100 people)

Ÿ B eing sick (vomiting)

Very rare (less than 1 in 10,000 people)

Ÿ Fever (high temperature) or frequent infections

Ÿ Sudden wheeziness or diﬃculty breathing

Ÿ Very rare cases of redness generalising to the whole body (generalised acute exanthematous pustulosis (AGEP)) (see section 2) Ÿ Mouth ulcers, cold sores and ulcers or soreness of your tongue Ÿ Skin lumps or hives (raised, red or white, itchy patches of skin) Ÿ Blisters on your skin or inside your mouth, nose, vagina or bottom Ÿ Inﬂammation of the eye which causes pain and redness Ÿ The appearance of a rash or sunburn when you have been outside (even on a cloudy day)

Ÿ Low levels of sodium in your blood

Ÿ Changes in blood tests

Ÿ Feeling weak, tired or listless, pale skin (anaemia)

Ÿ Heart problems

Ÿ Jaundice (the skin and the whites of your eyes turn yellow). This can occur at the same time as unexpected bleeding or bruising Ÿ Pains in your stomach, which can occur with blood in your faeces (stools) Ÿ Pains in your chest, muscles or joints and muscle weakness Ÿ Arthritis

Ÿ Problems with your urine. Diﬃculty passing urine. Passing more or less urine than usual

Ÿ Blood or cloudiness in your urine

Ÿ Kidney problems

Ÿ Sudden headache or stiﬀness of your neck, accompanied by fever (high temperature)

Ÿ Problems controlling your movements

Ÿ Fits (convulsions or seizures)

Ÿ Feeling unsteady or giddy

Ÿ Ringing or other unusual sounds in your ears

Ÿ Tingling or numbness in your hands and feet

Ÿ Seeing strange or unusual sights (hallucinations)

Ÿ Depression

Ÿ Muscle pain and/or muscle weakness in HIV patients

Ÿ Loss of appetite

Not known (frequency cannot be estimated from the available data)

Ÿ Psychotic disorder (a mental state in which you may lose touch with reality)

Ÿ Plum-coloured, raised, painful sores on the limbs and sometimes on the face and neck with a fever (Sweets syndrome)

If any of the side eﬀects get serious, or if you notice any side eﬀects not listed in this leaﬂet, please tell your doctor or pharmacist.

Reporting of side eﬀects

If you get any side eﬀects, talk to your doctor or pharmacist. This includes any possible side eﬀects not listed in this leaﬂet. You can also report side eﬀects via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side eﬀects, you can help provide more information on the safety of this medicine.

5. How to store Co-trimoxazole tablets

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the label and carton. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Co-trimoxazole tablets contain

Co-trimoxazole 960 mg tablets are made up of two diﬀerent medicines called sulfamethoxazole and trimethoprim.

Ÿ Each Co-trimoxazole 960 mg tablet contains 800 mg of the active substance sulfamethoxazole and 160 mg of the active substance trimethoprim.

Ÿ The other ingredients are docusate sodium, magnesium stearate, sodium starch glycolate (type A), and povidone (PVP K 30).

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

Co-trimoxazole 960 mg tablets are white, capsule shaped, uncoated tablets with standard curvature and a breakline on one side.

Co-trimoxazole 960 mg tablets are supplied in PVC/aluminium foil blister packs of 10, 14 (with and without calendar pack), 28 (with and without calendar pack), 30, 50 and 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Dawa Limited,

5 Sandridge Close,

Harrow, Middlesex,

HA1 1XD, UK.

Manufacturer

Drugsrus Limited,