Co-trimoxazole 80mg/400mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Sulfamethoxazole; Trimethoprim

Available from:

Aspen Pharma Trading Ltd

ATC code:

J01EE01

INN (International Name):

Sulfamethoxazole; Trimethoprim

Dosage:

400mg ; 80mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05010800; GTIN: 5060249177555

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
CO-TRIMOXAZOLE 80 MG/400 MG TABLETS
Co-trimoxazole
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 Co-Trimoxazole is and what it is used for
2.
What you need to know before you take Co-Trimoxazole
3.
How to take Co-Trimoxazole
4.
Possible side effects
5.
How to store Co-Trimoxazole
6.
Contents of the pack and other information
1.
WHAT CO-TRIMOXAZOLE IS AND WHAT IT IS USED FOR
Co-Trimoxazole 80 mg/400 mg Tablets (called ‘Co-Trimoxazole’ in
this leaflet) is a combination of
two different antibiotics called sulfamethoxazole and trimethoprim,
which is used to treat infections
caused by certain 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 PJP) caused by a bacteria called
_Pneumocystis jirovecii. _
•
Infections caused by a bacteria called Toxoplasma (toxoplasmosis).
Co-Trimoxazole can be used to treat:
•
Urinary bladder or urinary tract infections (water infections).
•
Respiratory tract infections such as bronchitis.
•
Ear infections such as otitis media.
•
An infection called nocardiosis which can affect the lungs, skin and
brain.
Co-Trimoxazole tablets are indicated in children (>12 to <18 years
old) and adults (>18 years old)
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
2.
WHAT YOU N

Summary of Product characteristics

OBJECT 1
CO-TRIMOXAZOLE 80 MG/400 MG TABLETS
Summary of Product Characteristics Updated 04-Apr-2018 | Aspen
1. Name of the medicinal product
Co-Trimoxazole 80 mg/400 mg Tablets.
2. Qualitative and quantitative composition
Each tablet contains 80 mg Trimethoprim and 400 mg Sulfamethoxazole.
Excipients:
For a full list of excipients, see Section 6.1.
3. Pharmaceutical form
Tablets.
White, round, biconvex tablets debossed with “S2” on one side with
scoreline on the other side.
The scoreline is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4. Clinical particulars
4.1 Therapeutic indications
Co-Trimoxazole tablets are indicated in children (>12 to <18 years
old) and adults (>18 years old) for the
treatment of the following infections when owing to sensitive
organisms (see section 5.1):
• Treatment and prevention of _Pneumocystis jirovecii _pneumonitis
or “PJP”.
• Treatment and prophylaxis of toxoplasmosis.
• Treatment of nocardiosis.
The following infections may be treated with Co-Trimoxazole where
there is bacterial evidence of
sensitivity to Co-Trimoxazole and good reason to prefer the
combination of antibiotics in Co-
Trimoxazole 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
Posology
General Dosage Recommendations
Where dosage is expressed as "tablets" this refers to the adult
tablet, i.e. 80 mg Trimethoprim BP and 400
mg Sulfamethoxazole BP. If other formulations are to be used
appropriate adjustment should be made.
Standard dosage recommendations for acute infections
_Adults (>18 years old)_:
STANDARD DOSAGE
AGE
TABLETS
>18 years old
2 tablets every 12 hours
_Children over 12 years old (>12 to <18 years old):_
The standard dosage for children is equivalent to approximately 6 mg
trimethoprim and 30 mg
sulfamethoxazole per kg b