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TRIMETHOPRIM 200MG TABLETS

Active substance(s): TRIMETHOPRIM / TRIMETHOPRIM / TRIMETHOPRIM

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CP.TRM.JNT.T.FL.V4P1

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

TRIMETHOPRIM 100mg AND 200mg TABLETS
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the
same as yours.
• If you get any side effects, talk to your doctor. This includes any side effects not listed in this leaflet, see section 4.

1.

Trimethoprim Tablets belong to a group of medicines known as
antibacterials. They are used to kill a wide range of bacteria that
cause infections in your body, primarily urinary and respiratory tract
infections. This medicine can also be used for prevention of recurrent
urinary tract infections.

2.

WHAT YOU NEED TO KNOW BEFORE YOU TAKE
TRIMETHOPRIM TABLETS

DO NOT take Trimethoprim Tablets if you:
• are allergic (hypersensitive) to trimethoprim or to any of the other
ingredients (see section 6, Contents of the pack and other
information)
• are pregnant
• suffer from severe kidney or liver problems
• suffer from any blood disorders such as anaemia
Trimethoprim should not be administered to premature babies or
infants under 4 months of age.
The tablet form is NOT recommended for use in children under
6 years – the oral liquid form should be used.
Warnings and precautions
• Talk to your doctor or pharmacist before taking Trimethoprim
Tablets if you:
• are pregnant
• suffer from kidney problems/kidney disease or are having dialysis
treatment.
• have a deficiency (are low) in folic acid (may cause anaemia)
• are at greater risk of high levels of potassium in your blood
(hyperkalaemia), e.g. the elderly or those on higher doses
• are also taking repaglinide (medicine for treating diabetes)
• suffer from porphyria (a disorder that causes skin sensitivity to
light, pain attacks and muscle weakness)
• Trimethoprim should not be given to premature babies or babies
during the first few weeks of life
You should let your doctor know and ask his/her advice if you suffer
from or have ever had any of the above.
Your doctor may wish to do regular blood tests if you need long-term
treatment or are prone to anaemia.
Children
This dosage form is not suitable for use in children younger than 6
years.
Other medicines and Trimethoprim
Please inform your doctor or pharmacist if you are taking, or have
recently taken any other medicines, even those not prescribed. Your
medicine may interfere with other medicines that you are taking.
Take care with the following medicines:
• repaglinide, used to treat diabetes
• procainamide, to treat abnormal heart rhythm
• digoxin, to treat certain heart conditions

Customer: FL

Originated by: SCY

• diuretics (e.g. water tablets such as frusemide or eplerenone)
• rifampicin (antibiotic), used to treat TB
• anticoagulants (to prevent clots from forming in the blood e.g.
warfarin)
• phenytoin, to treat epilepsy
• pyrimethamine and dapsone, used to treat malaria
• immunosuppressant drugs - used in cancer treatment (e.g.
methotrexate) or to treat organ rejection after transplant (e.g.
azathioprine or ciclosporin)
• bone marrow depressants
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or a
planning to have a baby, ask your doctor or pharmacist for advice
before taking this medicine. Trimethoprim should not be used in
pregnancy. DO NOT take Trimethoprim Tablets if you are pregnant. If
you are breast-feeding, ask your doctor or pharmacist for advice
before taking this medicine.
Driving and using machines
There is no evidence to suggest that Trimethoprim Tablets affect the
ability to drive or operate machinery.
Important information about some of the ingredients of
Trimethoprim Tablets
These tablets contain a sugar called lactose. If your doctor has told
you that you have an intolerance to some sugars, contact your doctor
before taking this medicinal product.

3.

HOW TO TAKE TRIMETHOPRIM 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.
They can be swallowed with a glass of water, but not chewed, at the
same time each day.
Dosage
Adults and children over 12 years
Severe or sudden infections: usually your doctor will prescribe 200mg
taken twice daily. Long term treatment and prevention therapy:
100mg at night
Elderly
Dosage is dependent on kidney function.
Elderly patients with kidney problems will usually be prescribed a
reduced dose.
Children aged 6 – 12 years
Severe or sudden infections: 100mg twice daily
Long term treatment and prevention therapy: 50mg at night. The
usual dose is around 2mg/kg body weight of the child per day.
Children under 6
This tablet form of Trimethoprim is not recommended for use in
children under 6 years.
Your doctor has carefully chosen the correct dosage for you, taking
into account the severity of your condition, your age and any other

Colours

Product: Trimethoprim JNT Tablets
Dimensions: 210mm x 297mm
Item Code: CP.TRM.JNT.T.FL.V4P1
Proof No and Date: 3

08/12/2016

Revision:
ARTWORK FOR SUBMISSION
Supersedes:

If you take more of your medicine than you should
If you (your child or someone else) take too many tablets, tell a
doctor or pharmacist or go to the nearest hospital casualty
department straight away. Remember to take this leaflet and the
tablet packaging with you.
If you forget to take your medicine
If you do forget to take a dose of your medicine at the correct time,
take it as soon as you remember, then take the next dose at the right
time. DO NOT take a double dose.

WHAT IS IN THIS LEAFLET
1. What Trimethoprim Tablets are and what they are used for
2. What you need to know before you take Trimethoprim Tablets
3. How to take Trimethoprim Tablets
4. Possible side effects
5. How to store Trimethoprim Tablets
6. Contents of the pack and other information

WHAT TRIMETHOPRIM TABLETS ARE AND WHAT THEY
ARE USED FOR

particular reasons special to you. Instructions on how many tablets to
take and when to take them will be printed on the dispensing label on
the pack.
Never change the dose of your medicine without talking to your
doctor first.

Pantone Blue
280 C

If you stop taking your medicine
Keep taking this medicine until your doctor tells you to stop. Do not
stop taking it just because you feel better. If you stop taking this
medicine, your condition may re-occur or get worse. If you experience
symptoms on stopping treatment, contact your doctor.
If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.

4.

POSSIBLE SIDE EFFECTS

Like all medicines, Trimethoprim Tablets can cause side effects,
although not everybody gets them.
Rare serious allergic reactions have occurred known as anaphylactic
or anaphylactoid reactions.
STOP taking Trimethoprim Tablets and contact your doctor or go
to your nearest hospital casualty department IMMEDIATELY if
you notice any of the following symptoms:
• difficulty breathing
• swelling of the face, lips, tongue and throat
• chest pain
• shock, fainting or collapse
• blistering/peeling of the skin
• pancreatitis (signs may include a sudden, severe upper abdominal
pain)
• skin eruptions/lesions
• deep swelling of the skin (angioedema)
Tell your doctor or pharmacist if you notice any of the following
side effects:
Very Common (may affect more than 1 in 10 people)
• high levels of potassium in the blood (may result in abnormal
heart rhythm)
Common (may affect up to 1 in 10 people)
• feeling and being sick, diarrhoea
• headache
• skin rashes
• Urticaria
• anaemia (may cause you to feel tired and look pale)
• sore throats or mouth ulcers (due to a decrease in white blood cells)
• thrush
Very rare (may affect up to 1 in 10,000 people)
• constipation, severe watery/bloody diarrhoea
• cough
• agitation
• abnormal behaviour
• Aseptic meningitis can occur in some patients. This may show as a
combination of symptoms such as headache, fever, stiff neck,
tiredness, feeling ill and your eyes become very sensitive to bright
light
• jaundice (yellowing of the skin or whites of the eyes)
• kidney problems (signs may include painful urination or blood in
the urine)
• dizziness, tiredness
• convulsions
• involuntary movements
• pins and needles, shakiness, tremors
• ringing in the ears, vertigo
• eye redness and pain
• increased sensitivity of the skin to the sun

• low blood sugar
• low levels of sodium in the blood (may cause nausea, tiredness,
muscle cramping)
• anorexia
• depression, anxiety, sleeping difficulties and nightmares
• confusion, hallucinations
• elevation of serum transaminases, (an indication of liver damage)
• elevation of bilirubin levels
• joint and muscle ache
• Shortness of breath, wheezing, nosebleeds
• meningitis (signs may include stiff neck, fever and vomiting)
• lupus erythematosus (an auto-immune disorder)
• Purple discolorations of the skin
• Fever
• Reduction in numbers of blood cells
• Anaemia
Unknown (frequency cannot be estimated)
• sore tongue and mouth
• Gastrointestinal disturbances
• Pruritus (itching)
• Elevation of serum creatinine and blood urea nitrogen levels
If any 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 directly via the internet 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 TRIMETHOPRIM TABLETS

KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF
CHILDREN.
Do not use Trimethoprim Tablets after the ‘expiry date’ printed on the
pack. The expiry date refers to the last day of that month.
Store your tablets below 25ºC (room temperature) in a dry place and
protect from light.Keep it in the pack in which it was given to you. Do
not transfer your tablets to another container. Return any leftover
tablets to your pharmacist, unless your doctor tells you to keep them.
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.

CONTENTS OF THE PACK AND OTHER INFORMATION

What Trimethoprim Tablets contain
Trimethoprim Tablets are available in two strengths, 100mg and
200mg.The active ingredient is trimethoprim, which is an antibiotic.
Other ingredients are lactose monohydrate, povidone K30,
crospovidone, sodium starch glycolate Type A and magnesium
stearate.
What Trimethoprim Tablets look like and contents of the pack
Trimethoprim 100mg tablets are available in pack sizes of 28, 100
and 500. The tablets are flat, white tablets and contain the marking
TR100.
Trimethoprim 200mg Tablets are available in pack sizes of 6, 14, 100
and 500. The tablets are flat, white tablets and contain the marking
TR200.
Marketing Authorisation Holder
Athlone Laboratories Limited, Ballymurray, Co. Roscommon, Ireland.
Distributor
Kent Pharmaceuticals Limited, Repton Road, Measham, DE12 7DT,
U.K.
Manufacturers responsible for batch release
Kent Pharmaceuticals Limited, Crowbridge Road, Ashford, Kent,
TN24 0GR, U.K.
Kent Pharmaceuticals Limited, Repton Road, Measham, DE12 7DT,
U.K.
PL 06453/0043-44
This leaflet was revised in December 2016.

CP.TRM.JNT.T.FL.V4P1

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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