Septrin Paediatric 40mg/200mg/5ml oral suspension

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Sulfamethoxazole; Trimethoprim

Tilgjengelig fra:

Aspen Pharma Trading Ltd

ATC-kode:

J01EE01

INN (International Name):

Sulfamethoxazole; Trimethoprim

Dosering :

40mg/1ml ; 8mg/1ml

Legemiddelform:

Oral suspension

Administreringsrute:

Oral

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 05010800; GTIN: 5010706008403

Informasjon til brukeren

Sulf trim_OralSol_UK_P_200mg+40mg-5ml_Apr2015 clean_v2.docx
Sulf trim_OralSol_UK_P_200mg+40mg-5ml_Apr2015 clean_v2.docx
PACKAGE LEAFLET: INFORMATION FOR USER
SEPTRIN 40 MG/200 MG PER 5ML PAEDIATRIC SUSPENSION
CO-TRIMOXAZOLE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOUR CHILD STARTS TAKING
THIS MEDICINE
• 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. Do not pass it
on to others. It may harm
them, even if their symptoms are the same as your child’s.
• If any of the side effects gets serious, or if you notice any side
effects not listed in this
leaflet, please tell your child’s doctor or pharmacist.
IN THIS LEAFLET:
1
What Septrin is and what it is used for
2
Before your child takes Septrin
3
How to give Septrin 40 mg/200 mg per 5 ml Paediatric Suspension
4
Possible side effects
5
How to store Septrin
6
Further information
1 WHAT SEPTRIN IS AND WHAT IT IS USED FOR
Septrin 40 mg/200 mg per 5 ml Paediatric Suspension (called
‘Septrin’ in this leaflet) is made
up of two different medicines called sulfamethoxazole and
trimethoprim. These medicines
are sometimes given the combined name co-trimoxazole.
Both belong to a group of medicines called antibiotics. They are used
to treat infections
caused by bacteria. Like all antibiotics, Septrin only works against
some types of bacteria.
This means that it is only suitable for treating some types of
infections.
Septrin can be used to treat or prevent:
• lung infections (pneumonia or PCP) caused by a bacteria called
_Pneumocystis jiroveci _
(previously known as
_Pneumocystis carinii _
)
• infections caused by a bacteria called Toxoplasma (toxoplasmosis).
Septrin can be used to treat:
• bladder or urinary tract infections (water infections)
• lung infections such as bronchitis
• ear infections such as otitis media
• an infection called nocardiosis, it can affect the lungs, skin and
brain.
2 BEFORE YOUR CHILD TAKES SEPTR

Preparatomtale

OBJECT 1
SEPTRIN 40 MG/200 MG PER 5 ML PAEDIATRIC
SUSPENSION
Summary of Product Characteristics Updated 08-Dec-2014 | Aspen
1. Name of the medicinal product
Septrin 40 mg/200 mg per 5 ml Paediatric Suspension
2. Qualitative and quantitative composition
Each 5 ml contains 200 mg Sulfamethoxazole and 40 mg Trimethoprim
Excipients:
This product contains less than 1 mmol of sodium (23 mg) per dose, and
therefore is essentially sodium
free.
Also contains 3.25 g sorbitol per 5 ml and less than 100 mg of ethanol
per 5 ml.
For a full list of excipients, see Section 6.1
3. Pharmaceutical form
Suspension
Off white in colour.
4. Clinical particulars
4.1 Therapeutic indications
Septrin Paediatric Suspension is indicated for the treatment of the
following infections when owing to
sensitive organisms (see section 5.1):
Treatment and prevention of _Pneumocystis jiroveci (P. carinii)_
pneumonitis
Treatment and prophylaxis of toxoplasmosis
Treatment of nocardiosis
The following infections may be treated with Septrin where there is
bacterial evidence of sensitivity to
Septrin and good reason to prefer the combination of antibiotics in
Septrin to a single antibiotic:
Acute uncomplicated urinary tract infection
Acute otitis media
Acute exacerbation of chronic bronchitis
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 Posology and method of administration
Method of administration: oral.
It may be preferable to take Septrin with some food or drink to
minimise the possibility of gastrointestinal
disturbances.
Standard dosage recommendations for acute infections
_Children aged 12 years and under:_
STANDARD DOSAGE
Age
Paediatric Suspension
6 to 12 years
10 ml every 12 hours
6 months to 5 years
5 ml every 12 hours
6 weeks to 5 months
2.5 ml every 12 hours
This dosage approximates to 6 mg trimethoprim and 30 mg
sulfamethoxazole per kilogram body weight
per 24 hours.
Treatment should be continued until the patient has been symptom free
for two days; the majority will
require treatment f