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TRIMETHOPRIM TABLETS 200 MG

Active substance(s): TRIMETHOPRIM

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TEVA UK Ref:

Version:

231-30-76470-Y LEA TRIMETHOPRIM A/S TAB TUK
Dimensions:
Length:
Width:

Colours Used:
210 mm
160 mm

1

22 April 2016

TEVA UK Ref:

Dimensions:

PANTONE® GREEN C

Length:
Width:

BLACK

Template

Version:

231-30-76470-Y LEA TRIMETHOPRIM A/S TAB TUK
Colours Used:
210 mm
160 mm

Trimethoprim 100 and
200 mg Tablets

IN THIS LEAFLET:
1.
2.
3.
4.
5.
6.

What Trimethoprim is and what it is used for
Before you take Trimethoprim
How to take Trimethoprim
Possible side effects
How to store Trimethoprim
Further information

1

What Trimethoprim is and what it is used for

• Trimethoprim belongs to a group of medicines called
antibacterials.
• Trimethoprim is used for the prevention and treatment of
infections, particularly in the urinary and respiratory tracts.
Pharma code 235

2

Before you take Trimethoprim

Do not take Trimethoprim:
• If you are allergic (hypersensitive) to trimethoprim or any of
the other ingredients of this medicine
• If you are pregnant or breast-feeding
• If you have any blood disorders
• If you suffer from severe liver problems
• If you suffer from severe kidney problems, unless your
doctor is checking the levels of trimethoprim in your blood.
Take special care with Trimethoprim
Tell your doctor before you start to take this medicine if you:
• Have kidney problems
• Have folate-deficiency anaemia (a decrease in red blood
cells due to a poor diet, which can cause tiredness,
headache, a sore mouth and tongue and pale skin).

Pregnancy and breast-feeding
Do not take trimethoprim if you are pregnant or breast-feeding.
Ask your doctor or pharmacist for advice before taking any
medicine.
Important information about some of the ingredients of
Trimethoprim
Patients who are intolerant to lactose should note that
Trimethoprim tablets contain a small amount of lactose. If you
have been told by your doctor that you have an intolerance to
some sugars, contact your doctor before taking this medicinal
product.

3

How to take Trimethoprim

Always take Trimethoprim exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are not
sure.
The tablets should be swallowed with a drink of water. The
usual dose is:
Severe or sudden infections:
Adults and children over 12 years of age: 200 mg twice a day.
Children aged 6 to 12: 100 mg twice a day.
Children under 6 years of age: Not recommended; a more
suitable dosage form should be used in this age group.
Trimethoprim suspension is available for use in children.
Elderly: The adult dose may need to be reduced depending on
how well your kidneys function. Your doctor will advise you.
The treatment should continue for at least one week but no
longer than two weeks.
For long term treatment and for the prevention of infections:
Adults and children over 12 years of age: 100 mg at night.
Children under 12 years of age: Not recommended; a more
suitable dosage form should be used in this age group.
Trimethoprim suspension is available for use in children.
Elderly: The adult dose may need to be reduced depending on
how well your kidneys function. Your doctor will advise you.

Taking other medicines

Renal impairment:
It may be necessary to reduce the dosage if you are suffering
from kidney problems. Your doctor will advise you.

Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines
obtained without a prescription.

Dialysis patients:
Dialysis removes trimethoprim. Blood tests will be carried out
before and after dialysis.

The effect of Trimethoprim may be increased or decreased by
other medicines and vice versa. These medicines include:
• Azathioprine (used following organ transplant and for
arthritis)
• Ciclosporin (used to prevent organ rejection after transplant
surgery)
• Digoxin or procainamide (used to treat heart problems)

You should continue to take these tablets for as long as your
doctor tells you to. Take the full course. Even if you start to feel
better the original infection may still be present and may recur
if treatment is stopped.

REG0048187

You may need to have blood tests if you take Trimethoprim for a
long time or if your doctor thinks you are at special risk.

Version 3.6

Approved

Top of page cut-off to middle of registration mark: 21mm. Registration Pitch: 210mm -0.45mm (Sheet depth / cut-off length: 210mm)

PACKAGE LEAFLET: INFORMATION FOR THE USER
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 get serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor
or pharmacist.

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• Mercaptopurine or methotrexate (used as bone marrow
depressants)
• Phenytoin (used to treat epilepsy)
• Pyrimethamine (used to treat malaria)
• Rifampicin (used to treat infections)
• Warfarin (used to prevent blood clots).

If you take more Trimethoprim than you should
If you (or someone else) swallow a lot of the tablets all
together, or if you think a child has accidentally swallowed any
of the tablets, contact your nearest hospital casualty
department or your doctor immediately. Please take this leaflet,
any remaining tablets and the container with you to the
hospital or doctor so that they know which tablets were
consumed.
If you forget to take Trimethoprim
If you forget to take a tablet, take one as soon as you
remember, unless it is nearly time to take the next one. Do not
take a double dose to make up for a forgotten tablet. Take the
remaining doses at the correct time.
If you have any further questions on the use of this product,
ask your doctor or pharmacist.

4

Possible side effects

Like all medicines, Trimethoprim can cause side effects,
although not everybody gets them.
If the following happens, stop taking Trimethoprim and tell your
doctor immediately or go to the casualty department at your
nearest hospital:
• Difficulty in breathing and swelling of the lips, face and neck
• 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.
• Severe skin reactions such as exfoliative dermatitis (itchy,
scaly, flaking, swollen skin), erythema multiforme (circular,
irregular red patches), Stevens-Johnson syndrome (severe
skin rash with flushing, fever, blisters or ulcers) or toxic
epidermal necrolysis (severe rash involving reddening,
peeling and swelling of the skin that resembles severe
burns).
These are very serious but rare side effects. You may need
urgent medical attention or hospitalisation.
Other side effects may include:
• Stomach upset, abdominal pain
• Headache, fever, muscle pain
• Feeling sick or being sick, sore mouth, swollen tongue
• Skin redness, skin rashes and itching
• Sensitivity to light
• Anaemia (characterised by unusual tiredness or weakness)
• Jaundice (yellowing of the skin or whites of the eyes),
changes in liver enzymes (seen in tests)
• Altered number and type of blood cells. If you get increased
bruising, nose bleeds, sore throats or infections you should
consult your doctor. Too much potassium in the blood (you
may experience muscle cramps or pain, irregular
heartbeats, unusual tiredness or weakness)
• Kidney problems: increase in blood creatinine and urea
levels (seen in tests).

5

How to store Trimethoprim

Keep this medicine out of the sight and reach of children. Do
not take Trimethoprim after the expiry date that is stated on the
outer packaging.
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

22 April 2016

PANTONE® GREEN C

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PAGE 1: FRONT FACE (INSIDE OF REEL)

1

Further information

What Trimethoprim contains:
• The active ingredient is Trimethoprim 100 or 200 mg. Each
tablet contains 100 or 200 mg of the active substance,
trimethoprim.
• The other ingredients are lactose monohydrate, maize
starch, microcrystalline cellulose, sodium starch glycolate
(Type A), povidone, colloidal anhydrous silica, magnesium
stearate and stearic acid.
What Trimethoprim looks like and contents of the pack:
• The name of your medicine is Trimethoprim 100 or 200 mg
Tablets
• Trimethoprim 100 mg Tablets are white, normal biconvex
tablets, engraved “Berk 2H7” or “2H7” with a breakline on
reverse. The breakline is only there to help you break the
tablet if you have difficulty swallowing it whole.
• Trimethoprim 200 mg Tablets are white, normal biconvex
tablets, engraved “Berk 3H7” or “3H7” with a breakline on
the reverse. The breakline is only there to help you break
the tablet if you have difficulty swallowing it whole.
• The 100 mg product is available in pack sizes of 7, 10, 14, 20,
21, 28, 30, 56, 60, 84, 90, 100, 110, 112, 120, 150, 160, 168, 500
and 5000 tablets
• The 200 mg product is available in pack sizes of 7, 10, 14, 21,
24, 28, 30, 50, 56, 60, 70, 84, 90, 100, 110, 112, 120, 150, 160, 168
and 500 tablets.
• Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation holder and company responsible for
manufacture: TEVA UK Limited, Eastbourne, BN22 9AG.
This leaflet was last revised: March 2016
PL 00289/0196-7

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.

76470-Y
210 x 160

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PAGE IS THE MANIFESTATION OF THE ELECTRONIC SIGNATURE

Teva Pharmaceuticals Europe B.V
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APPROVALS
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REG0048187

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Regulatory Affairs Approval

Version 3.6

Approved

Server Date
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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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