TRO-AMOXICLAV 625mg film-coated tablets tablets film-coated

Riik: Armeenia

keel: inglise

Allikas: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Toimeaine:

amoxicillin (amoxicillin trihydrate), clavulanic acid (potassium clavulanate)

Saadav alates:

Medopharm Private Limited

ATC kood:

J01CR02

INN (Rahvusvaheline Nimetus):

amoxicillin (amoxicillin trihydrate), clavulanic acid (potassium clavulanate)

Annus:

500mg+ 125mg

Ravimvorm:

tablets film-coated

Ühikuid pakis:

(10/1x10/) in blister

Retsepti tüüp:

Prescription

Volitamisolek:

Registered

Loa andmise kuupäev:

2017-05-11

Infovoldik

TRO-AMOXICLAV 625 mg
film-coated tablets
READ ALL OF THE INFORMATION CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE

Keep this leaflet. You may need to read it again. Ask your doctor
or pharmacist if you need more information or advice.

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 ef-
fects not listed in this leaflet, please tell your doctor or
pharmacist.
IN THIS LEAFLET:
1. What this medicine is
2. What this medicine is used for
3. Before you take this medicine
4. How to take this medicine
5. Possible side effects
6. How to store this medicine
7. Further information
1. WHAT THIS MEDICINE IS
2. WHAT THIS MEDICINE IS USED FOR
3. BEFORE YOU TAKE THIS MEDICINE
The name of this medicine is TRO-AMOXICLAV 625 mg. The key in-
gredients in this medicine are called amoxicillin and clavulanic acid.
Amoxicillin belongs to a group of medicines called “penicillins”
that can
sometimes be stopped from working (made inactive). The other active
component (clavulanic acid) stops this from happening.
TRO-AMOXICLAV is used in adults and children to treat the following
infections:

middle ear and sinus infections

urinary tract infections

respiratory tract infections

skin and soft tissue infections including dental infections

bone and joint infections
DO NOT TAKE THIS MEDICINE IF:

If you are allergic (hypersensitive) to amoxicillin, clavulanic acid,
penicillins or any of the other ingredients of TRO-AMOXICLAV.

If you 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

If you have ever had liver problems or jaundice (yellow of the skin)
when taking an antibiotic.
TAKE SPECIAL CARE WITH TRO-AMOXICLAV AND TELL YOUR DOCTOR:

If you have glandular fever

If you are being treated for liver or kidney problems

If you a

Toote omadused

SUMMARY PRODUCT
CHARACTERISTICS
for:
TRO-AMOXICLAV
625 mg
film-coated tablets
TROGE
®
Register-Nr. HRB 35614
DEPARTMENT FOR SCIENTIFIC RESEARCH AND PRODUCT DEVELOPMENT
DEPARTMENT FOR INTERNATIONAL REGULATORY AFFAIRS
– March 2017 –
PRODUCT:
TRO-AMOXICLAV 625 MG
FILM-COATED TABLETS
SUMMARY OF PRODUCT CHARACTERISTICS
TROGE MEDICAL GMBH · HAMBURG · GERMANY
Page 2 of 20
SUMMARY OF PRODUCT CHARACTERISTICS (SPC)
1. NAME OF THE MEDICINAL PRODUCT
TRO-AMOXICLAV 625 mg film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
_Each film-coated tablet contains: _
Amoxicillin trihydrate equivalent to 500 mg of Amoxicillin.
Potassium clavulanate (as diluted Potassium clavulanate) equivalent to
125 mg
Clavulanic acid.
For full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Film-coated tablets for oral use.
Description: White oval shape film-coated tablets.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
The formulation of amoxicillin, a bactericidal beta-lactam penicillin
antibiotic,
and clavulanic acid, an irreversible beta-lactamase inhibitor, is a
bactericidal
antibiotic with a broad spectrum of bactericidal activity against
Gram-positive
and Gram-negative aerobic and anaerobic bacteria. The presence of
clavulanic
acid in the formulation extends the spectrum of activity of
amoxicillin to include
many beta-lactamase-producing bacteria normally resistant to
amoxicillin and
other beta-lactam antibiotics.
The combination of amoxicillin and clavulanic acid is indicated for
the
treatment of:
- Upper respiratory tract infections (sinusitis, tonsillitis, otitis
media)
PRODUCT:
TRO-AMOXICLAV 625 MG
FILM-COATED TABLETS
SUMMARY OF PRODUCT CHARACTERISTICS
TROGE MEDICAL GMBH · HAMBURG · GERMANY
Page 3 of 20
- Lower respiratory tract infections (pneumonia, bronchitis)
- Genito-urinary tract and abdominal infections (cystitis,
pyelonephritis)
- Soft tissue and dermal infections (wound infections, animal bites
and severe
dental abscess with spreading cellulitis)
- Bone and joint infections (osteomyelitis)
4.2