Monotrim 10 mg/ml Oral Suspension

Држава: Ирска

Језик: Енглески

Извор: HPRA (Health Products Regulatory Authority)

Активни састојак:

Trimethoprim

Доступно од:

Chemidex Pharma Limited

АТЦ код:

J01EA; J01EA01

INN (Међународно име):

Trimethoprim

Дозирање:

10 milligram(s)/millilitre

Фармацеутски облик:

Oral suspension

Тип рецептора:

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

Терапеутска област:

Trimethoprim and derivatives; trimethoprim

Статус ауторизације:

Marketed

Датум одобрења:

1982-04-16

Информативни летак

31017370.05 IR2-1/L/h/8a
_Continued over page_
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 or pharmacist. This
includes any possible
side effects not listed in this leaflet. See section 4.
Package leaflet: Information for the user
Monotrim 10 mg/ml Oral Suspension
trimethoprim
SEEK IMMEDIATE MEDICAL ATTENTION IF YOU
HAVE ANY OF THE FOLLOWING SYMPTOMS:

eye pain, redness, or sensitivity to bright
light, blurred vision, floaters (dots that
move across the field of vision)

sudden headache, stiff neck, fever,
sensitivity to bright light, drowsiness and
muscle pain, with or without a rash

unusual bleeding or bruising; repeated
infections or infections that will not go
away. This may be due to changes in your
blood. Blood tests may be carried out to
check for this

yellowing of the skin or whites of the eyes
caused by liver or blood problems
.
TELL YOUR DOCTOR IF YOU GET ANY OF THE
FOLLOWING SIDE EFFECTS:

muscle pain or muscle weakness

nausea, vomiting or an upset stomach

reactions to the sun. Skin may become
red, painful and swollen - do not sunbathe,
use a sun bed, or expose your skin to UV
light.
Some people may get an increased amount of
potassium in their blood (especially the elderly
or those with kidney problems). You cannot
feel or see this but your doctor may test your
blood for this side effect.
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
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: [phone]
Fax: +353 1

Карактеристике производа

Health Products Regulatory Authority
27 February 2019
CRN008QQG
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Monotrim 10 mg/ml Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 10 mg trimethoprim.
Excipients with known effect:
Each ml of this medicine contains 408 mg sorbitol, 1.3 mg methyl
parahydroxybenzoate and 0.85 mg sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral suspension.
White, homogenous suspension with odour of aniseed.
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
Posology
1. Treatment of respiratory and urinary tract infections:
_Adults and children over 12 years:_ The usual dosage is 200 mg (four
5 ml spoonfuls) twice daily for 7-10 days.
_Paediatric population (under 12 years):_ Based on 6 mg/kg/day in two
divided dosages as follows:
_ _
_6 weeks to 5 months: _ 25 mg (half a 5 ml spoonful) twice daily for
7-10 days.
_6 months to 3 years (8-15 kg):_ 25-50 mg (half to one 5 ml spoonful)
twice daily for 7-10 days.
_4-7 years (15-25 kg):_ 50-75 mg (one to one-and-a-half 5 ml
spoonfuls) twice daily for 7- 10 days.
_8-12 years (25-40 kg):_ 75-125 mg (one-and-a-half to two-and-a-half 5
ml spoonfuls) 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 (two 5
ml spoonfuls) at night.
An extra 100 mg may be taken in the morning, if necessary.
_Paediatric population under 12 years_: 2.5 mg/kg/day once daily in
the evening.
Health Products Regulatory Authority
27 February 2019
CRN008QQG
Page 2 of 6
3. Dosage in renal impairment:
Creatinine clearance (ml/sec)
Plasma creatinine (micromol/l)
Dosage advised
Over 0.45
men < 250
women < 175
normal
0.25–0.45
men