Co-Trimoxazole Tablets Bp
For oral administration as directed by the doctor.
Also contains lactose (see patient information leaflet for further information).
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN
Protect from heat,light and moisture.
Product Licence holder: Crescent Pharma Ltd, Overton, Hants RG25 3ED M0187TB PL20416/0052
r-
5
in
+
Children aged 6 - 12 years: Give one tablet twice a day.
Children under 6 years: Not recommended.
For the prevention and treatment of recurrent or long lasting infections
The recommended doses are:
Adults and children over 12 years: Take one tablet at night.
Children under 12 years: Your doctor will decide the right dose, depending on the child’s weight.
Treatment may continue for 3 to 12 months or more if necessary.
PM00790102
For the treatment of Pneumocystis jirovecii lung infection
Your doctor will decide the right dose, depending on your, or the child’s, bodyweight.
The daily dose will be divided into two or more doses per day and should be taken for two weeks.
For the prevention of Pneumocystis jimvecii lung infection
The standard dosage should be taken (see above) for the duration of the period you are at risk of this infection.
If you have kidney problems your doctor may prescribe a smaller dose
and take blood to test if the medicine is working properly. It is important to finish your prescribed dose of this medicine. If you stop taking this medicine too soon, your infection may come back.
If you take too many Co-Trimoxazole Tablets
If you think you have taken too many tablets, contact your doctor straight away or go to the nearest hospital casualty department. Take with you any remaining tablets and the pack so that the medicine can be identified.
If you forget to take Co-Trimoxazole Tablets
If you forget to take a dose of this medicine, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take the next dose at the usual time. DO NOT TAKE TWO DOSES AT THE SAME TIME.
4. Possible side-effects
Like all medicines, Co-Trimoxazole Tablets can cause side-effects, although not everybody gets them. Side-effects may be more severe if you are taking high doses of these tablets to treat pneumocystis
jirovecii pneumonia.
If any of the following occur STOP TAKING the tablets IMMEDIATELY and contact your doctor, as these may be signs of a very rare serious allergic reaction (affects less than 1 in 10,000 people):
• sudden wheeziness or difficulty breathing
• swelling of the eyelids, face, lips or throat
• raised itchy, red lumps on the skin (hives) or skin rash
• potentially life-threatening skin rashes or blistering of the skin, mouth, eyes or genitals (these may be signs of Stevens-Johnson
syndrome or toxic epidermal necrolysis - see section 2).
If you notice any of the following effects tell your doctor straightaway:
• feeling weak or tired, looking pale, easier bruising, high temperature, sore throat or frequent infections (these may be signs of a blood disorder). Symptoms may be worse if you are elderly or you have liver or kidney problems or low levels of folic acid
• fever, headache, stiff neck and back, feeling sick, skin rash, eyes being very sensitive to bright light (these may be signs of aseptic meningitis).
The following other side-effects have been reported, if you do notice any of these effects or any others not mentoned in this leaflet, please inform your doctor or pharmacist.
Very common effects (that could happen to more than 1 in 10 people):
• abnormal heart rhythm (beat), which may be caused by high levels of potassium in the blood. (This effect is more likely to occur if you are elderly or taking a high dose of this medicine).
Common effects (that could happen to less than 1 in 10 people):
• an infection called thrush or candidiasis which can affect your mouth • or vagina. It is caused by a fungus
• headache, feeling sick, diarrhoea. •
Uncommon effects (that could happen to less than 1 in 100 people): •
Very rare effects (that could happen to less than 1 in 10,000 people):
• convulsions, weakness, tingling, numbness, difficulty controlling •
movements, joint and muscle pain
cough or shortness of breath •
increased skin sensitivity to sunlight
low levels of sodium in the blood which may cause tiredness and •
confusion, muscle twitching, fits or coma. (This effect is more likely to •
occur if you are elderly or taking a high dose of this medicine) •
jaundice, inflammation of the liver, liver damage, changes in liver •
function or an inflamed pancreas. Symptoms include yellowing of the
skin and whites of the eyes, fever and severe stomach and back pain changes in blood tests
low blood glucose levels which may cause weakness, dizziness and disorientation
colitis (inflammation that causes abdominal pain or diarrhoea) loss of appetite
swollen or sore mouth or tongue, mouth ulcers
difficulty passing urine, passing more or less urine than usual, blood or
cloudiness in your urine, change in electrolyte levels in the body, crystals
in the urine or swollen kidneys causing kidney failure, fever or rash • inflammation of the eye which causes pain and redness.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Co-Trimoxazole Tablets
KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN. Keep the tablets in the pack provided and protect from heat, light and moisture.
Do not take the tablets if the expiry date on the pack has passed. If you have any medicines that are out of date, return them to your pharmacist for safe disposal.
6. Further information
Ingredients
Each Co-trimoxazole tablet contains 80mg of trimethoprim and 400mg sulfamethoxazole as the active ingredients. Also contains lactose, sodium starch glycolate, magnesium stearate and pregelatinised maize starch.
What Co-Trimoxazole Tablets look like
The tablets are round and white with the company logo on one side and a breakline and A286 on the other side. They are available in pack
sizes of 9,10,14,15,20,21,28,30,50,56,84,100,250,500, and 1000 tablets. (Not all pack sizes may be marketed).
Product Licence Holder and Manufacturer is Crescent Pharma Limited, Units 3 & 4, Quidhampton Business Units, Polhampton Lane, Overton, Hants, RG25 3ED.
Date leaflet revised: October 2014
If you would like this leaflet in a different format please contact the
licence holder at the above address.
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PATIENT INFORMATION LEAFLET CO-TRIMOXAZOLE Tablets (Trimethoprim 80mg & Sulfamethoxazole 400mg) Please read all of this leaflet carefully before you start taking this medicine. Keep the leaflet; you may need to read it again. If you have any questions or are not sure about anything, 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 get 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 Tablets are and what they are used for 2. Before you take Co-Trimoxazole Tablets |
3. How to take Co-Trimoxazole Tablets 4. Possible side effects 5. How to store Co-Trimoxazole Tablets 6. Further information 1. What Co-Trimoxazole Tablets are and what they are used for Co-trimoxazole belongs to a group of medicines called antibacterials. These medicines work by killing bacteria. Co-trimoxazole is used for the: |
• treatment and prevention of lung infections caused by the bacteria Pneumocystis jirovecii • treatment and prevention of toxoplasmosis (an infectious disease) • treatment of nocardiasis (an infectious lung disease) • treatment of urinary tract infections (bladder or kidney infections) • treatment of sudden worsening of chronic bronchitis (long term lung disease) • treatment of acute otitis media (an ear infection) in children. |
2. Before you take Co-Trimoxazole Tablets Do not take these tablets if you: • are allergic to trimethoprim, sulfamethoxazole or any of the other ingredients in the tablets which are listed in section 6. (An allergic reaction may be recognised as shortness of breath, blocked nose, rash, itching, swollen face or lips) • have severe kidney damage or disease • have severe liver damage • have a blood disorder |
• are pregnant (see “pregnancy and breast-feeding" section) • are taking amiodarone or clozapine. Check with your doctor before taking these tablets if you: • suffer from a lack of folic acid in your body • have mild to moderate liver or kidney damage or disease • are underweight or malnourished • suffer from glucose-6-phosphate dehydrogenase deficiency (G6PD) • suffer from a severe allergy or bronchial asthma • have porphyria |
• have a group A beta-haemolytic streptococci bacterial infection e.g. scarlet fever • have phenylketonuria (a genetic disorder of metabolism) • are elderly • have high levels of blood potassium. • 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 of the body. |
• 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 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. • If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis with the use of Co-trimoxazole, you must not be re-started on Co-trimoxazole at any time. Taking other medicines Check with your doctor or pharmacist before taking these tablets if you are taking any other medicines especially: • pyrimethamine in doses greater than 25mg per week (used for the |
treatment of malaria or toxoplasmosis) • warfarin or acenocoumarol (to prevent blood clotting) • phenytoin (used to treat epilepsy) • rifampicin or dapsone (antibacterials) • procainamide or digoxin (used to treat heart conditions) • amantadine (used to treat Parkinson’s disease) • ciclosporin or azathioprine (used to prevent rejection after an organ or tissue transplant) • methotrexate or mercaptopurine (used to treat some cancers or |
severe rheumatoid arthritis) • zidovudine, lamivudine or zalcitabine (used to treat HIV infection) • thiopental or prilocaine (anaesthetics) • potassium aminobenzoate (used to treat inflammation or thickening of the skin) • any medicines used to treat diabetes • medicines that increase the amount of potassium in your blood e.g. eplerenone or diuretics (also known as water tablets) e.g. bendroflumethiazide. |
You must stop taking these tablets if a blood disorder develops (symptoms of this are feeling weak or tired, looking pale, easier bruising, high temperature, sore throat or frequent infections). Regular blood tests may be performed by your doctor if you: • are taking these tablets for a long time • have low levels of folic acid in your body • are elderly. Drink plenty of fluid such as water while you are taking these tablets. |
Pregnancy and breast-feeding Do not take if you are pregnant. Check with your doctor before taking this medicine if you are breast-feeding. Driving and using machinery When you take these tablets you may get a headache, see things that are not there, or feel dizzy. Do not drive or operate machinery if you experience any of these effects. Important information about an ingredient of Co-Trimoxazole |
Tablets: Contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. 3. How to take Co-Trimoxazole Tablets Swallow the tablets with a drink of water. The dose will be different for different medical conditions and patients. Your doctor has decided the dose which is best for you. Always follow |
your doctor’s instructions. The pharmacist’s label will also tell you how many tablets to take and how often. If you do not understand anything, ask your doctor or pharmacist. The usual dosage(s) are:- Standard dosage for treatment of infections: Adults and children over 12 years: Take two tablets twice a day, usually for 5 days. For more severe infections your doctor may increase your dose to three tablets twice a day. |
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Peel here to open but do not remove A
Crescent Pharma Limited, Units 3 & 4, Qufctiampton Business Units, Potiampton Lane,
M0187TB
Code: DD/DRUGS/DD/375
Batch No.: Expiry Date:
Base Label: 30 x 100mm
Leaflet Page 1: 30 x 72mm
Left Hand Opening ✓
Overall Leaflet Size: 30 x 998 Page Widths: 72 67 66 65 65 64 66 67 66 69 69 66 66 66 64
Text Size 8 pt
• •
• • • • •
• • • • • •
• • •
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Each laJe.fcohftins trimethoprim 80mg and . sujtamql1 '
40hmg
For oral ^i#str#)n as # • 0ected by the doctor^
Also contains lactose (see patient imormatjon leaflet foi further information).
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN
Protect from heat, light and moisture.
Product Licere holder:
Crescent Pharma Ltd, oVe.ton, Hants RG25 3ED i.i0187Tb PL20416/0052
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