Septrin Paediatric 40 mg/200 mg per 5 ml Oral Suspension

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

Sulphamethoxazole; Trimethoprim

Tillgänglig från:

Aspen Pharma Trading Limited

ATC-kod:

J01EE; J01EE01

INN (International namn):

Sulphamethoxazole; Trimethoprim

Dos:

40 mg/200 mg/5ml

Läkemedelsform:

Oral suspension

Receptbelagda typ:

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

Terapiområde:

Combinations of sulfonamides and trimethoprim, incl. derivatives; sulfamethoxazole and trimethoprim

Bemyndigande status:

Not marketed

Tillstånd datum:

1975-11-14

Bipacksedel

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SEPTRIN PAEDIATRIC 40 MG/200 MG PER 5ML ORAL SUSPENSION
TRIMETHOPRIM AND SULFAMETHOXAZOLE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOUR CHILD STARTS TAKING
THIS MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR THEM.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your child’s doctor or
pharmacist.
-
This medicine has been prescribed for your child only. Do not pass it
on to others. It may harm them,
even if their signs of illness are the same as your child.
-
If your child gets any side effects, talk to your child’s doctor or
pharmacist. This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Septrin Paediatric Suspension is and what it is used for.
2.
What you need to know before your child takes Septrin Paediatric
Suspension.
3.
How to give Septrin Paediatric Suspension.
4.
Possible side effects.
5.
How to store Septrin Paediatric Suspension.
6.
Contents of the pack and other information.
1.
WHAT SEPTRIN
PAEDIATRIC SUSPENSION IS AND WHAT IT IS USED FOR
Septrin Paediatric 40 mg/200 mg per 5 ml Oral Suspension (called
‘Septrin Paediatric Suspension’ in this
leaflet) is a combination of two different antibiotics called
sulfamethoxazole and trimethoprim, which is used
to treat infections caused by bacteria. This medicine combination is
also named as co-trimoxazole. Like all
antibiotics, Septrin Paediatric Suspension only works against some
types of bacteria. This means that it is
only suitable for treating some types of infections.
Septrin Paediatric Suspension can be used to treat or prevent:
•
lung infections (pneumonia) caused by the micro-organism,
_Pneumocystis_
_jirovecii_
(previously known
as
_Pneumocystis carinii_
) (some people call this ‘PJP’).
Septrin Paediatric Suspension can be used to treat:
•
urinary bladder or urinary tract infections (water infections).
•
respiratory tract infections such as bronchitis.
•

Produktens egenskaper

Health Products Regulatory Authority
09 November 2022
CRN00D4ZM
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Septrin Paediatric 40 mg/200 mg per 5 ml Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml contains 40 mg Trimethoprim and 200 mg Sulfamethoxazole.
Excipients with known effect:
Contains 2.3 g of sorbitol (E 420) per 5 ml, 13.50 μL of ethanol per
5 ml, 5 mg of methyl hydroxybenzoate (E218) per 5 ml, 10.95
mg of sodium per 5 ml (inclusive of 5mg of sodium benzoate E 211),
vanilla flavour with 0.00015 μL sulphur dioxide per 5 ml
and 750 mg of glycerol per 5ml.
For the full list of excipients, see section 6.1,
3 PHARMACEUTICAL FORM
Oral suspension
An off-white, banana and vanilla flavoured syrup.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Septrin Paediatric Suspension is indicated in children aged 12 years
and under (infants (>6 weeks to <2 years old) and children
(>2 to <12 years old) for the treatment of the following infections
when owing to sensitive organisms (see section 5.1):
_- Urinary tract infections: _For simple urinary tract infections,
trimethoprim alone or another single antimicrobial agent is the
preferred treatment. Since trimethoprim is also as efficacious as
Septrin for the prophylaxis of recurrent urinary tract infections,
Septrin is not indicated for prophylactic use.
_- Respiratory tract infections: _Septrin may be used as second line
therapy in chronic obstructive airways disease or other
respiratory tract infections, including acute otitis media where
sensitivity has been demonstrated or is highly probable. (Septrin
is not indicated for prophylactic or prolonged administration in
otitis media).
- Treatment and prevention of _Pneumocystis jirovecii pneumonitis
(PJP)_.
- Septrin may be used in the management of other serious conditions
such as nocardiasis, toxoplasmosis and brucellosis.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION