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

Терапеутска област:

Trimethoprim and derivatives; trimethoprim

Статус ауторизације:

Marketed

Датум одобрења:

2006-10-27

Информативни летак

IR2-1/L/h/12
PACKAGE LEAFLET: INFORMATION FOR THE USER
MONOTRIM 10 MG/ML ORAL SUSPENSION
trimethoprim
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.
WHAT IS IN THIS LEAFLET
1. What Monotrim suspension is and what it is used for
2. What you need to know before you take Monotrim suspension
3. How to take Monotrim suspension
4. Possible side effects
5. How to store Monotrim suspension
6. Contents of the pack and other information
1.
WHAT MONOTRIM SUSPENSION IS AND WHAT IT IS USED FOR
Monotrim suspension contains 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.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MONOTRIM SUSPENSION
DO NOT TAKE MONOTRIM SUSPENSION:
-
if you are allergic to trimethoprim or any of the other ingredients of
this medicine (listed in
section 6)
-
if you are pregnant or planning to become pregnant
-
if you have a blood disorder
-
DO NOT give Monotrim suspension 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.
WARNING AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Monotrim suspension:
-
if you have a folic acid deficiency
-
if you have kidney problems or are having dialysis treatment
-
if you have a high concentration of potassium ions in the blood
I

Карактеристике производа

Health Products Regulatory Authority
16 October 2020
CRN009W6X
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
16 October 2020
CRN009W6X
Page 2 of 6
3. Dosage in renal impairment:
eGFR (ml/min)
Dosage advised
Over 30
normal
15-30
normal for 3 days then half dose
Under 15
half normal dose
Monitoring of renal func