Bactrim forte tablets

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

sulfamethoxazole, trimethoprim

Available from:

Eumedica Pharmaceuticals AG

ATC code:

J01EE01

INN (International Name):

sulfamethoxazole, trimethoprim

Dosage:

800mg+ 160mg

Pharmaceutical form:

tablets

Units in package:

(10/1x10/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2023-04-08

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BACTRIM
® FORTE
800 MG+ 160 MG TABLETS
_sulfamethoxazole + trimethoprim _
-
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 Bactrim
®
Forte is and what it is used for
2. What you need to know before you take Bactrim
®
Forte
3. How to take Bactrim
®
Forte
4. Possible side effects
5. How to store Bactrim
®
Forte
6. Contents of the pack and other information
1. WHAT BACTRIM
® FORTE IS AND WHAT IT IS USED FOR
Bactrim
®
Forte tablets contain two active substances: trimethoprim and
sulfamethoxazole. Combined,
they complement each other to form a medicine that can kill a wide
range of organisms that cause disease.
Because there are two active substances, the risk that the bacteria
“get used to” the medicine (i.e. develop
resistance) is also lower.
Bactrim
®
Forte is used in the following diseases:
-
Infections of the upper and lower airways and ears, such as
inflammation of the bronchi, pneumonia,
otitis media, sinus infections;
-
Infections of the kidneys, bladder, urinary and genital organs;
-
Gastrointestinal infections, such as diarrhoea caused by bacteria,
cholera, and typhoid and
paratyphoid fever.
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2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BACTRIM
® FORTE
This medicine has been prescribed for you to treat your current
illness. The active substance combination
in Bactrim
®
Forte is not effective against all microorganisms that cause
infectious diseases. Use of

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Bactrim Forte 800 mg+160 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sulfamethoxazole (SMZ) and trimethoprim (TMP)
2.1 GENERAL DESCRIPTION
Sulfamethoxazole (SMZ) and trimethoprim (TMP). The combination of the
two active substances SMZ and
TMP has established itself under the name co-trimoxazole.
10 beige-to-white, scored tablets in blister.
_ _
_ _
2.2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Bactrim Forte tablets contains 800 mg SMZ and 160 mg TMP.
_ _
_Excipients which shall be taken into account in the medicinal product
composition: _
Sodium starch glycolate (type A), povidone K 30, magnesium stearate,
docusate sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets. The scored tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Owing to the sometimes-serious side effects of Bactrim and the
emergence of resistance, a risk-benefit
assessment should always be made prior to using Bactrim, compared to
other active substances that may also
be considered for these indications.
Infections due to co-trimoxazole-sensitive organisms, such as:
Infections of the upper and lower respiratory tract and of the ear:
acute exacerbations of chronic bronchitis,
bronchiectasis, pneumonia (including
_Pneumocystis jirovecii_
(formerly
_carinii_
) pneumonia), sinusitis, otitis
media.
Urogenital infections: acute and chronic cystitis, pyelonephritis,
urethritis, prostatitis.
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Gastrointestinal infections including: travellers' diarrhoea, chronic
typhoid fever carriers, cholera (as a
complementary measure to fluid and electrolyte intake).
Cotrimoxazole should only be used for the following infections if the
following currently recommended
antibiotics cannot be administered:
Typhoid
fever,
paratyphoid
fever A
and B,
_Salmonella _
_enteritidis_
with
a
septic
progression
in
immunocomprom