Co-Trimoxazole 40mg/200mg per 5ml Paediatric Suspension

Država: Velika Britanija

Jezik: engleski

Izvor: myHealthbox

Aktivni sastojci:

Sulfamethoxazole/Trimethoprim

Dostupno od:

Aspen Pharma Trading Limited

ATC koda:

J01EE01

INN (International ime):

Sulfamethoxazole/Trimethoprim

Doziranje:

40mg/200mg per 5ml

Farmaceutski oblik:

Suspension

Administracija rute:

Oral use

Jedinice u paketu:

Pack size: 100 and 50 ml bottle

Tip recepta:

POM - Prescription Only Medicine

Proizveden od:

Aspen Bad Oldesloe GmbH

Terapijska grupa:

Combinations of sulfonamides and trimethoprim, incl. derivatives

Terapijske indikacije:

It is indicated for: Treatment and prevention of Pneumocystis jiroveci (P. carinii) pneumonitis Treatment and prophylaxis of toxoplasmosis Treatment of nocardiosis Acute uncomplicated urinary tract infection Acute otitis media Acute exacerbation of chronic bronchitis

Status autorizacije:

Authorised

Datum autorizacije:

2006-10-17

Uputa o lijeku

Sulf,trim_OralSol_UK_P_200mg+40mg-5ml_Jul2015_v3.docx 

PACKAGE LEAFLET: INFORMATION FOR USER 
CO-TRIMOXAZOLE 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 Co-Trimoxazole is and what it is used for 
2 Before your child takes Co-Trimoxazole 
3 How to give Co-Trimoxazole 40 mg/200 mg per 5 ml Paediatric
Suspension 
4 Possible side effects 
5 How to store Co-Trimoxazole 
6 Further information 

1 WHAT CO-TRIMOXAZOLE IS AND WHAT IT IS USED FOR 
Co-Trimoxazole 40 mg/200 mg per 5 ml Paediatric Suspension (called
‘Co-Trimoxazole’ in 
this leaflet) is made up of two different medicines called
sulfamethoxazole and trimethoprim. 
Both belong to a group of medicines called antibiotics. They are used
to treat infections 
caused by bacteria. Like all antibiotics, Co-Trimoxazole only works
against some types of 
bacteria. 
This means that it is only suitable for treating some types
of infections. 

Co-Trimoxazole 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). 

Co-Trimoxazole 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 aff

Svojstava lijeka

Co­Trimoxazole 40 mg/200 mg per 5 ml Paediatric Suspension
Summary of Product Characteristics Updated 20­Aug­2015 | Aspen
1. Name of the medicinal product
Co­Trimoxazole 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
Co­Trimoxazole 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 Co­Trimoxazolewhere there is bacterial evidence of sensitivity to Co­
Trimoxazole and good reason to prefer the combination of antibiotics in Co­Trimoxazole 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 Co­Trimoxazole 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 h