MONOTRIM

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

TRIMETHOPRIM

Διαθέσιμο από:

Chemidex Pharma Limited

Φαρμακολογική κατηγορία (ATC):

J01EA01

INN (Διεθνής Όνομα):

TRIMETHOPRIM

Δοσολογία:

200 Milligram

Φαρμακοτεχνική μορφή:

Tablets

Τρόπος διάθεσης:

Product subject to prescription which may not be renewed (A)

Θεραπευτική περιοχή:

trimethoprim

Καθεστώς αδειοδότησης:

Marketed

Ημερομηνία της άδειας:

1982-04-16

Φύλλο οδηγιών χρήσης

MONOTRIM 100 MG TABLETS
MONOTRIM 200 MG TABLETS
Trimethoprim
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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.
IN THIS LEAFLET:
1. WHAT THIS MEDICINE IS AND WHAT IT IS USED FOR
2. BEFORE YOU TAKE
3. HOW TO TAKE
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE
6. FURTHER INFORMATION
1. WHAT THIS MEDICINE IS AND WHAT IT IS USED FOR
Monotrim tablets contain trimethoprim which is an antibiotic.
It is used to treat certain infections caused by bacteria sensitive to
trimethoprim such as:

urinary tract infections

chest infections.
Trimethoprim may also be given to patients who often suffer from
urinary tract infections, to stop
the infections from returning. 2. BEFORE YOU TAKE
DO NOT TAKE MONOTRIM TABLETS IF YOU:

are allergic to trimethoprim or any of the other ingredients (see
Section 6)

are pregnant or planning to become pregnant

have a blood disorder

have severe kidney problems.
DO NOT give Monotrim tablets to very young babies (premature babies or
babies less than 6 weeks
old).
If any of the above apply to you, speak to your doctor or pharmacist.
TAKE SPECIAL CARE WITH MONOTRIM TABLETS
Before taking the tablets, tell your doctor if you:

have a folic acid deficiency

have kidney problems

have high concentration of potassium ions in the blood

are elderly

are breast-feeding.
Concomitant administration of Monotrim Tablets with certain medicines,
potassium supplements
and food rich in potassium may lead to severe hyperkalaemia (increased
potassium blood level). The
symptoms of severe hyperkalaemia might include muscle cramps,
irregular heart rhythm, diarrhoea,
na

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Monotrim 200 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200mg Trimethoprim.
Excipient: each tablet also contains 48mg of lactose monohydrate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
White, round tablet with a single score line separating the
identifying code DE on one side.
5
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of infections caused by trimethoprim-sensitive organisms
including urinary and respiratory tract infections
and prophylaxis of recurrent urinary tract infections.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Montrim 200mg tablets are not recommended for use in children below
age 12 years. Other suitable formulations (e.g.
Montrim 10mg/ml Suspension) are available for this patient population.
1. Treatment of respiratory and urinary tract infections:
_Adults and children over 12 years:_
200 mg twice daily for 7-10 days
The first dosage on the first day can be doubled.
2. Prophylaxis of recurrent urinary tract infection:
_Adults and children over 12 years:_ The usual dose is 100 mg at
night. An extra 100 mg may be taken in the morning, if
necessary.
3. Dosage in renal impairment:
Creatinine clearance (ml/sec)
Plasma creatinine
(micromole/l)
Dosage advised
Over 0.45
Men < 250
Women <175
Normal
0.25 – 0.45
Men 250 – 600
Women 175 – 400
Normal
for
3 days
then half
dose
Under 0.25
Men > 600
Women > 400
Half normal dose
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