Trimethoprim 100mg Tablets
Metwest
Pharmaceuticals
PACKAGE LEAFLET: INFORMATION FOR THE USER
TRIMETHOPRIM 100 mg & 200 mg TABLETS
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 become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
THIS LEAFLET CONTAINS
1. What Trimethoprim is for
2. Before you take Trimethoprim
3. How to take Trimethoprim
4. Possible side effects
5. How to store Trimethoprim
6. Further information
1. WHAT TRIMETHOPRIM IS FOR
Trimethoprim is an antibiotic, which may be used to treat urinary tract infections, as well as a wide range of other bacterial infections.
It may also be used to prevent urinary tract infections. If you are not sure why you have been prescribed these tablets then please ask your doctor.
2. BEFORE YOU TAKE TRIMETHOPRIM
Do not take Trimethoprim and tell your doctor if:
• you are allergic to Trimethoprim or any of the other ingredients in the tablets (listed in section 6 of this leaflet). The signs of an allergic reaction include a rash, itching or shortness of breath
• you have anaemia or any other blood disorder
• you have severe kidney or liver problems
• you are pregnant.
This medicine should not be given to premature babies or infants under 4 months old.
Take special care with Trimethoprim
Tell your doctor before you take this medicine if:
• you have a blood problem known as porphyria where you may have too many red blood cells
• you have a deficiency of folic acid (this may cause anaemia)
• you have kidney problems.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking this medicine.
Having tests
Your doctor will monitor you closely for any effects on your blood, especially if you are taking Trimethoprim for long-term treatment.
If you go into hospital or have any tests, tell the doctor that you are taking Trimethoprim.
Taking other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even medicines bought without a prescription.
This is because Trimethoprim can affect the way some other medicines work. Also, some medicines can affect the way Trimethoprim works.
In particular, tell your doctor or pharmacist if you are taking any of the following:
• Other antibiotics to treat bacterial infections, such as Rifampicin or Dapsone
• Pyrimethamine to treat malaria
• Zalcitabine to treat HIV (Human Immunodeficiency Virus)
• Digoxin, Eplerenone or Procainamide to treat heart problems
• Medicines to stop blood clots from forming, such as Warfarin
• Medicines to treat diabetes, such as Gliclazide, Tolbutamide or Repaglinide
• Phenytoin to treat epilepsy
• Methotrexate to treat certain cancers or skin, joint or gut diseases
• Probenecid to treat gout
• Azathioprine or Ciclosporin used after organ transplants or to treat joint diseases
• Mercaptopurine to treat certain cancers.
Trimethoprim can make birth control pills less effective. An additional form of contraception should be used.
Pregnancy and breast-feeding
Do not take Trimethoprim if you are pregnant or
planning a pregnancy.
If you are breast-feeding, ask your doctor for advice before taking Trimethoprim.
Driving and using machines
This medicine is not likely to affect you being able to drive or use any tools or machines.
Important information about some of the ingredients of Trimethoprim
This medicine contains lactose (a type of sugar). If you know you have an intolerance to some sugars contact your doctor before taking this medicine.
3. HOW TO TAKE TRIMETHOPRIM
Always take Trimethoprim tablets exactly as your doctor has told you.
Taking this medicine
• take this medicine by mouth
• as this medicine is an antibiotic, always finish the prescribed course.
Severe or sudden infections:
Treatment will usually be between 3 - 14 days, according to the type and severity of infection.
Your doctor may double your first dose.
• Adults and children over 12 years:
200 mg, every 12 hours
• Children 6 - 12 years:
100 mg, every 12 hours
Long-term treatment and prevention therapy:
• Adults and children over 12 years:
100 mg at night
• Children 6 - 12 years:
50 mg at night. The usual dose is around 2 mg per kg body weight of the child per day.
Elderly: Doses may be reduced in elderly patients, according to kidney function.
Children under 6 years: Not recommended, a more suitable dosage form should be used in this age group.
If you take more Trimethoprim than you should
Contact your doctor or go to a hospital immediately. Take the package or container with you so the doctor knows what you have taken.
If you forget to take Trimethoprim
Don't worry, just take your next scheduled dose at the correct time. Do not take a double dose to make up for the one you have missed.
If you stop taking Trimethoprim
Keep taking this medicine until the course is finished, unless you get any of the side effects listed in section 4 below. Keep taking the tablets even if you feel better after a few days.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Trimethoprim can cause side effects, although not everybody gets them.
If you have an allergic reaction to Trimethoprim see a doctor straight away
An allergic reaction may include:
• any kind of skin rash, flaking skin, itching or red and raised lumps (hives)
• blistering of the skin, mouth, eyes and genitals
• fever, joint pain or sore eyes
• swelling of the face or throat
• sudden wheezing, fluttering or tightness of the chest or collapse
• sensitivity to sunlight.
If you get any of the following side effects, STOP TAKING Trimethoprim and see your doctor as soon as possible:
• aseptic meningitis, which may cause stiff neck, headache, fever, nausea or vomiting
• blood disorders, which may cause fever, sore throat, ulcers in the mouth and throat, pale skin, unusual tiredness or weakness, purple spots on the skin, unusual bleeding and unexplained bruises. Your doctor will test your blood.
Tell your doctor if you get any of these side effects:
• feeling sick (nausea)
• being sick (vomiting)
• headache
• high blood levels of potassium, which may cause muscle weakness, tiredness or irregular heartbeats.
If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE TRIMETHOPRIM
Keep out of the reach and sight of children.
Do not store above 25°C. Store in the original package or container and keep the container tightly closed.
Do not use these tablets after the expiry date, which is stated on the package or container. The expiry date refers to the last day of that month.
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 to protect the environment.
6. FURTHER INFORMATION
What Trimethoprim tablets contain
The active ingredient in Trimethoprim 100 mg and 200 mg tablets is trimethoprim. The other ingredients are lactose monohydrate, povidone, crospovidone, sodium starch glycollate (type A) and magnesium stearate.
What Trimethoprim tablets look like and contents of the pack
Trimethoprim 100 mg tablets are round white tablets with the marking MP44 on one side.
Trimethoprim 200 mg tablets are round white tablets with the marking MP45 on one side.
The 100 mg tablets come in blister packs of 28 tablets and in containers of 50, 100, 500, 1000 and 5000 tablets.
The 200 mg tablets come in blister packs and containers of 14, 15, 21, 28, 30, 50, 56, 60, 84, 100, 250, 500, 1000 and 5000 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Metwest Pharmaceuticals Limited,
15 Runnelfield, Harrow on the Hill,
Middlesex HA1 3NY
Manufacturer
DDSA Pharmaceuticals Limited,
310 Old Brompton Road,
London SW5 9jQ
For more information about this product, please contact the Marketing Authorisation Holder.
This leaflet was last revised in 11/2010
TMP0044-45/0100&0200T/LEA006