Dafraclav Tablet, Film-coated 625

Country: Tanzania

Language: English

Source: Tanzania Medicinces & Medical Devices Authority

Active ingredient:

Amoxicillin , Clavulanic acid

Available from:

Dafra Pharma GmbH, SWITZERLAND

ATC code:

Antibacterials for systemic use, Combinations of

INN (International Name):

Amoxicillin and Clavulanic acid

Dosage:

625

Pharmaceutical form:

Tablet, Film-coated

Manufactured by:

BILIM PHARMACEUTICALS, TURKEY

Product summary:

Physical description: White to off-white coloured, oblong film coated tablets; Local technical representative: Harleys (T) Limited (4194)

Authorization status:

Registered/Compliant

Authorization date:

2020-11-07

Patient Information leaflet

PATIENT INFORMATION LEAFLET
DAFRACLAV
®
625
AMOXICILLIN 500 MG + CLAVULANIC ACID 125 MG FILM COATED TABLETS
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.
1.
WHAT IS DAFRACLAV® 625 AND WHAT IT IS USED FOR
Dafraclav®625 contains amoxicillin and clavulanic acid (ATC code:
J01CR02). These are antibiotics, working by killing bacteria
that cause infections. Amoxicillin belongs to the group of
“penicillins”. Clavulanic acid prevents amoxicillin from being
inactivated by enzymes produced by the bacteria.
Dafraclav®625 is used in the treatment of the following infections:

respiratory tract infections (including middle ear and sinus
infections),

skin and skin structure infections (including dental infections),

urinary tract infections.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DAFRACLAV® 625
_DO NOT TAKE DAFRACLAV® 625 IF YOU _

are allergic (hypersensitive) to amoxicillin, clavulanic acid,
penicillin or any of the other ingredients of Dafraclav® 625 (listed
in section 6),

have ever had a severe allergic (hypersensitive) reaction to any other
antibiotic; this can include a skin rash or swelling of
the face or neck,

have ever had liver problems or jaundice (yellowing of the skin) when
taking an antibiotic.
_TAKE SPECIAL CARE WITH DAFRACLAV® 625 IF YOU _

have glandular fever (infectious mononucleosis),

have liver or kidney problems,

are not passing water regularly.
If you are not sure if any of the above apply to you, talk to your
doctor or pharmacist before taking Dafraclav® 625.
_SPECIAL WARNINGS AND PRECAUTIONS FOR USE _

inflammation of the large intestine has been reported in association
with all antibiotics including amoxicillin/clav

Summary of Product characteristics

DAFRACLAV®
625 MG
FILMCOATED TABLETS
1. QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each white FILMCOATED TABLET contains Amoxicillin trihydrate
equivalent to 500 mg amoxicillin,
potassium clavulanate equivalent to 125 mg clavulanic acid as active
ingredients.
2. PHARMACEUTICAL FORM:
Cardboard containing 3 blisters with 15 filmcoated tablets.
OTHER PHARMACEUTICAL DOSAGE FORMS: Dafraclav® 1 g Filmcoated tablet
(10 tablets); Dry powder
Dafraclav® BD 400/57 mg Forte Oral Suspension, 70 ml; Dry powder
Dafraclav® BD 200/28 mg
Pediatric Oral Suspension, 70 ml.
3. CLINICAL PROPERTIES
3.1 THERAPEUTIC INDICATIONS: Dafraclav® is indicated in the treatment
of the following infections caused
by the microorganisms indicated below. UPPER RESPIRATORY TRACT
INFECTIONS (including otitis media and
sinusitis) due to beta-lactamase producing strains of Haemophilus
influenzae and Moraxella catarrhalis.
LOWER
RESPIRATORY
TRACT
INFECTIONS
due
to
beta-lactamase
producing
strains
of
Haemophilus
influenzae and Moraxella catarrhalis. SKIN AND SKIN STRUCTURE
INFECTIONS due to beta-lactamase
producing strains of Staphylococcus aureus, Escherichia coli and
Klebsiella spp. URINARY TRACT
INFECTIONS. Since Dafraclav® contains amoxicillin, it can be used in
the treatment of infections caused
by bacteria susceptible to ampicillin. Additionally, if in a mixed
infection a microorganisms is susceptible
to ampicillin and the other which is a beta-lactamase producer is
susceptible to Dafraclav®, such an
infection can be treated by the administration of Dafraclav® alone,
addition of another antibiotic is not
required. Since in vitro Streptococcus pneumoniae is more susceptible
to amoxicillin compared to
ampicillin and penicillin, Streptococcus pneumoniae strains that are
moderately susceptible to penicillin
and ampicillin in microbiological tests are fully susceptible to
Dafraclav®.
3.2 POSOLOGY AND METHOD OF ADMINISTRATION: Dafraclav® must be taken
before or during meals. The
absorption of Clavulanic acid is better when Dafraclav® is taken
bef