Co-Trimoxazole Crescent Tablets 80mg/400mg

Land: Malta

Taal: Engels

Bron: Medicines Authority

Werkstoffen:

TRIMETHOPRIM, SULFAMETHOXAZOLE

Beschikbaar vanaf:

Crescent Pharma International Limited 260, Triq San Albert, Gzira GZR 1150, Malta

ATC-code:

J01EE01

INN (Algemene Internationale Benaming):

TRIMETHOPRIM 80 mg SULFAMETHOXAZOLE 400 mg

farmaceutische vorm:

TABLET

Samenstelling:

TRIMETHOPRIM 80 mg SULFAMETHOXAZOLE 400 mg

Prescription-type:

POM

Therapeutisch gebied:

ANTIBACTERIALS FOR SYSTEMIC USE

Product samenvatting:

Licence number in the source country: NOT APPLICAPABLE

Autorisatie-status:

Authorised

Autorisatie datum:

2019-10-23

Bijsluiter

Page 1 of 6
PATIENT INFORMATION LEAFLET
CO-TRIMOXAZOLE CRESCENT TABLETS 80 MG/400 MG
Trimethoprim 80mg & Sulfamethoxazole 400mg
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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
IN THIS LEAFLET
1.
What Co-Trimoxazole Crescent Tablets 80 mg/400 mg are and what they
are used for
2.
What you need to know before you take Co-Trimoxazole Crescent Tablets
80 mg/400 mg
3.
How to take Co-Trimoxazole Crescent Tablets 80 mg/400 mg
4.
Possible side effects
5.
How to store Co-Trimoxazole Crescent Tablets 80 mg/400 mg
6.
Contents of the pack and other information
1.
WHAT CO-TRIMOXAZOLE CRESCENT TABLETS 80 MG/400 MG
ARE AND WHAT THEY ARE USED FOR
Co-trimoxazole belongs to a group of medicines called antibacterials.
These medicines work by
killing bacteria.
Co-trimoxazole is used in adults and children aged 6 years and over
for the:
•
treatment and prevention of lung infections (pneumonia or
_Pneumocystis _
pneumonia (PCP))
caused by the bacteria
_Pneumocystis _
_jirovecii_
•
treatment and prevention of toxoplasmosis (an infectious disease)
•
treatment of nocardiosis (an infectious disease affecting either the
lungs or whole body)
•
treatment of urinary tract infections (bladder or kidney infections)
•
treatment of sudden worsening of chronic bronchitis (long term lung
disease)
•
treatment of acute otitis media (an ear infection).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CO-TRIMOXAZOLE CRESCENT TABLETS
80 MG/400 MG
DO NOT TAKE
CO-TRIMOXAZOLE CRESCENT TABLETS 80 MG/400 MG
IF
YOU:
•
are allergic to trimethoprim, sulfam

Productkenmerken

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Co-trimoxazole Crescent Tablets 80 mg/400 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 80 mg of trimethoprim and 400 mg of
sulfamethoxazole.
For excipients, see 6.1
3.
PHARMACEUTICAL FORM
Tablet.
White, normal convex tablets engraved with Crescent moon logo on one
side, a breakline and A286 on
the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Co-trimoxazole tablets are indicated in adults and children aged 6
years and over for the treatment of
the following infections when owing to sensitive organisms (see
section 5.1):
Treatment and prophylaxis -of
_Pneumocystis jirovecii (pneumocystis carinii) _
pneumonitis
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 infections
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-Acute exacerbations of chronic bronchitis
-Acute otitis media
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 co-trimoxazole with some food or drink to
minimise the possibility of
gastrointestinal disturbances.
Standard dosage recommendations for acute infections
_Adults: _
2 tablets every 12 hours.
_Paediatric population: _
The dosage for children is equivalent to approximately 6 mg
trimethoprim and
30 mg sulfamethoxazole per kilogram body weight per day.
The schedules for children are according to the child’s age and
provided in the table below.
Children over 12 years
2 tablets every 12 hours
Children 6 to 12 years
1 tablet twice a day
Children under 6 years
Not recommended
Treatment should be continued until the patient has been symptom-free
for two days; the majority will
require tre