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Patient information leaflet

PATIENT INFORMATION LEAFLET
Trimoptin Tablets 100mg
Trimoptin Tablets 200mg

(Trimethoprim)
Read all of this leaflet carefully 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. Do not pass it on to others. It may
harm them, even if their symptoms are the same as yours. If any of these 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 Trimoptin Tablets are and what they are used for
2) What you need to know before you take Trimoptin Tablets
3) How to take Trimoptin Tablets
4) Possible side effects
5) How to store Trimoptin Tablets
6) Contents of the pack and other information
1. What Trimoptin Tablets are and what are they used for
Trimoptin Tablets belong to a group of medicines known as antibacterials and they contain
trimethoprim as the antibiotic. They are used to treat infections in your body, primarily
urinary and respiratory tract infections and for the prevention of recurrent urinary tract
infections.
2. What you need to know before you take Trimoptin Tablets
Do not take Trimoptin Tablets if you:

o are allergic to trimethoprim, or to any of the other ingredients mentioned in Section 6 (consult your doctor if you think you might be) o suffer from severe kidney or liver impairment o suffer with fragile X chromosome (an inherited physical and intellectual impairment) o suffer with porphyria (a disorder that may cause skin sensitivity to the sun, pain o suffer from anaemia or other blood disorders o are pregnant Trimethoprim is not suitable for babies less than 6 weeks old.
Warnings and precautions
Talk to your doctor or pharmacist before taking Trimoptin Tablets:
o if you suffer from kidney or liver impairment o if you are receiving long-term treatment or are prone to anaemia, as your doctor may o if you have a deficiency (are low) in folic acid – if you are elderly, you may be more o if you are taking other types of medicine, such as potassium conserving water tablets as your doctor may wish to check your blood levels of potassium o if you are taking the medicine repaglinide (to treat diabetes) o if you have been told by your doctor that you have an intolerance to some sugars, as Trimoptin Tablets can interfere with some diagnostic kidney function and blood tests. Children
Trimethoprim is NOT recommended for use in infants under 6 weeks of age.
Trimoptin Tablets are not recommended for use in children under 12 years of age –
other forms of medicine may be more suitable for children: please ask your doctor or
pharmacist.

Other medicines and Trimoptin Tablets
Your medicine may interfere with other medicines that you are taking. Please inform your
doctor or pharmacist if you are taking, or have recently taken any other medicines, even those
not prescribed.
Take care with the following medicines:
∗ Immunosuppressant drugs - used in cancer treatment (e.g. methotrexate) or to treat organ rejection after transplant (e.g. azathioprine or ciclosporin) ∗ Mercaptopurine (used to treat leukaemia) ∗ Warfarin and other anticoagulant drugs (used to prevent clots from forming in the blood) ∗ Diuretics (water tablets), e.g. furosemide, eplerenone ∗ ACE inhibitors (used to treat high blood pressure, e.g. ramipril) ∗ Medicines used to treat irregular heartbeat and heart failure, e.g. digoxin, procainamide, ∗ Anticonvulsants (medicines used to treat epilepsy) such as phenytoin ∗ Pyrimethamine, used to treat malaria ∗ Rifampicin and dapsone (used to treat TB) ∗ Oral contraceptives (the pill) – other forms of contraception, such as condoms, should be used during treatment and for the following 7 days
Pregnancy and breast-feeding
DO NOT
take Trimoptin 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 Trimoptin Tablets affect the ability to drive or to operate
machinery.

Trimoptin Tablets contain lactose
These tablets contain lactose monohydrate. 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 Trimoptin Tablets
Trimoptin Tablets should be taken orally according to your doctor’s instructions. They can be
swallowed with a glass of water but not chewed.
Dosage
Adults and children over 12 years:

Treatment of Respiratory and Urinary Tract Infections: usually your doctor will prescribe
200mg, taken twice daily for 7 to 10 days.
Prevention of Recurrent Urinary Tract Infections: 100mg at night is the usual dose.
Elderly:
Elderly patients with kidney problems will usually be prescribed a reduced dose. Elderly
patients should be monitored carefully because of the increased risk of side effects, which can
be fatal.
Children under 12 years:
Trimethoprim is NOT recommended for use in infants under 6 weeks of age.
Trimoptin Tablets are not recommended in children under 12 years of age – other forms of
this medicine may be more suitable for children: please ask your doctor or pharmacist.

Kidney Problems
Patients suffering from kidney problems will usually be prescribed a reduced dose.
Your doctor has carefully chosen the correct dosage for you taking into account the severity
of your condition, your age and any other particular reasons special to you. Instructions of
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.
If you take more Trimoptin Tablets than you should

If you take too much medicine, contact your doctor or pharmacist or nearest hospital casualty
department who will recommend what action you should take. Remember to take the
Trimoptin Tablets container with you.

If you forget to take Trimoptin Tablets
If you forget to take a dose of your medicine at the correct time, take it as soon as you
remember, then carry on as before. Do not take a double dose.
If you stop taking Trimoptin Tablets
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.
4. Possible side effects
Like all medicines, Trimoptin Tablets can have side effects although not everybody gets
them.
Rarely, serious allergic reactions have occurred known as anaphylactic or anaphylactoid
reactions. Serious allergic skin reactions known as Stevens-Johnson syndrome and toxic
epidermal necrolysis also occur rarely.

Should you notice any of the following symptoms, STOP taking Trimoptin Tablets and
contact your doctor immediately or go to your nearest hospital casualty department:

o Allergic reaction – signs may include swelling of the face, lips, tongue, or throat, difficulty breathing, shortness of breath, wheezing, shock or collapse, skin eruptions or lesions, deep swelling of the skin (angioedema) o Blistering/peeling of the skin o Severe diarrhoea, possibly with bleeding o Jaundice (skin and whites of your eyes may turn yellow), which may be fatal
Tell your doctor as soon as possible if you notice any of the following side effects:
Common side effects (occurs in more than 1 in 10 and less than 1 in 100 people)
o Hyperkalaemia (high levels of potassium in the blood): symptoms include pins and needles in the fingers and toes, muscle weakness, paralysis o Feeling sick (nausea), vomiting, diarrhoea o Skin rashes including itching (pruritis), hives and ‘nettle rash’ (urticaria)
Very rare side effects (occurs in less than 1 in 10,000 people)
o Blood disorders. If you notice increased sore throats or infections; nosebleeds or unusual bruising; or anaemia (causes skin to be pale, weakness and breathlessness), you should consult your doctor. o Sore mouth or tongue o Hypoglycaemia (low blood sugar) o Hyponatraemia (low blood sodium) – can cause tiredness, confusion, muscle o Constipation o Depression, confusion, agitation, anxiety, abnormal behaviour o Hallucinations, nightmares, difficulty in sleeping o Kidney problems (you may notice difficulty in passing urine or presence of blood in o Tremors, difficulty in controlling movements o Vertigo, tinnitus (ringing in the ears) o Painful, red eyes (uveitis) o Dizziness, fainting, weakness o Very severe abdominal pain (which may indicate inflammation of the pancreas) o Sensitivity of skin to light (photosensitivity) o Muscle or joint pain o Convulsions o Loss of appetite o Cough, shortness of breath, wheeze o Lupus erythematosus (an auto-immune disorder) o Aseptic meningitis – symptoms may include, headache, fever, stiff neck, tiredness, feeling ill and sensitivity to light (reversible on discontinuation of treatment) If you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. How to store Trimoptin Tablets
Do not use Trimoptin Tablets after the ‘Expiry’ date printed on the box.
The expiry date refers to the last day of the month.
KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.
Store your tablets below 25°C (room temperature) and protect from light.
Keep it in the pack in which it was given to you.
Do not transfer your medicine to another container.
If your doctor tells you to stop taking your medicine you should return any leftover tablets to
the pharmacist, unless your doctor tells you to keep them.

6. Contents of the pack and other information
What Trimoptin Tablets contain
The active ingredient is trimethoprim, 100mg or 200mg, which is an antibiotic. Other
ingredients are lactose monohydrate, povidone 25 CPS, Kollidone CL (crospovidone),
Primogel (sodium starch glycolate) and magnesium stearate.
What Trimoptin Tablets look like and contents of the pack
Trimoptin Tablets are available in two strengths, 100mg and 200mg.
Trimoptin Tablets 100mg are available in packs of 100 and 500.
Trimoptin Tablets 200mg are available in packs of 100 and 500.
The tablets are flat white tablets and contain the marking TR 100 on the 100mg strength tablet
and TR 200 on the 200mg strength.

Marketing Authorisation Holder and Manufacturer
Marketing authorisation holder: Athlone Laboratories Limited, Ballymurray, Co.
Roscommon, Ireland.
Manufacturer: Dragenopharm, Göllstraβe 1, D-84529 Tittmonig, Germany.
Distributor: Athlone Laboratories Limited, Ballymurray, Co. Roscommon, Ireland.
Leaflet last updated December 2011
PA 298/14/1-2

Source: http://www.athlone-laboratories.com/downloads/trimoptin200mgpil.pdf

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