Co-Trimoxazole 80mg/400 mg per 5 ml Adult Suspension

Country: United Kingdom

Language: English

Source: myHealthbox

Active ingredient:

Sulfamethoxazole/Trimethoprim

Available from:

Aspen Pharma Trading Limited

ATC code:

J01EE01

INN (International Name):

Sulfamethoxazole/Trimethoprim

Dosage:

80mg/400 mg per 5 ml

Pharmaceutical form:

Suspension

Administration route:

Oral use

Units in package:

Pack size: 100 ml

Prescription type:

POM - Prescription Only Medicine

Manufactured by:

Aspen Bad Oldesloe GmbH

Therapeutic group:

Combinations of sulfonamides and trimethoprim, incl. derivatives

Therapeutic indications:

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 infections; Acute otitis media; Acute exacerbation of chronic bronchitis

Authorization status:

Authorised

Authorization date:

2006-11-08

Patient Information leaflet

Sulf,trim_OralSol_UK_P_400mg+80mg-5ml_Jul2015_v2.docx 

PACKAGE LEAFLET: INFORMATION FOR THE USER 
CO-TRIMOXAZOLE 80 MG/400 MG PER 5 ML ADULT SUSPENSION 
CO-TRIMOXAZOLE 
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE 
• 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. Do not pass it on to
others. It may harm them, 
even if their symptoms are the same as yours. 
• If any of the side effects gets serious, or if you notice
any side effects not listed in this 
leaflet, please tell your doctor or pharmacist. 

IN THIS LEAFLET: 
1 What Co-Trimoxazole is and what it is used for 
2 Before you take Co-Trimoxazole 
3 How to take Co-Trimoxazole 80 mg/400 mg per 5 ml Adult
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 80 mg/400 mg per 5 ml Adult Suspension (called
‘Co-Trimoxazole’ 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, 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 af

Summary of Product characteristics

Co­Trimoxazole 80 mg/400 mg per 5 ml Adult Suspension
Summary of Product Characteristics Updated 21­Aug­2015 | Aspen
1. Name of the medicinal product
Co­Trimoxazole 80 mg/400 mg per 5 ml Adult Suspension
2. Qualitative and quantitative composition
Each 5 ml contains 400 mg Sulfamethoxazole and 80 mg Trimethoprim.
Excipients:
This product contains less than 1 mmol of sodium (23 mg) per dose, and therefore is essentially sodium free.
Also contains 2.5 g sucrose 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. Off­white in colour.
4. Clinical particulars
4.1 Therapeutic indications
Co­Trimoxazole Adult 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 Co­Trimoxazole where 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 infections
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
_Adults and children over 12 years:_
Adult Suspension:     10ml every 12 hours
This dosage approximates to 6mg trimethoprim and 30mg sulfamethoxazole per kilo