Amoxicillin 500mg capsules

Riik: Armeenia

keel: inglise

Allikas: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Toimeaine:

amoxicillin (amoxicillin trihydrate)

Saadav alates:

Medopharm Private Limited

ATC kood:

J01CA04

INN (Rahvusvaheline Nimetus):

amoxicillin (amoxicillin trihydrate)

Annus:

500mg

Ravimvorm:

capsules

Ühikuid pakis:

(100/10x10/) in blister

Retsepti tüüp:

Prescription

Volitamisolek:

Registered

Loa andmise kuupäev:

2017-07-10

Infovoldik

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
AMOXICILLIN 250 MG _CAPSULES _
AMOXICILLIN 500 MG _CAPSULES_
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 AMOXICILLIN is and what it is used for
2.
What you need to know before you take AMOXICILLIN
3.
How to take AMOXICILLIN
4.
Possible side effects
5.
How to store AMOXICILLIN
6.
Contents of the pack and other information
1. WHAT
AMOXICILLIN IS AND WHAT IT IS USED FOR
The name of this medicine is AMOXICILLIN 250 mg
_capsules_
and AMOXICILLIN 500 mg
_ capsules_
referred to as AMOXICILLIN throughout the package leaflet.
AMOXICILLIN contains the active ingredient amoxicillin (in form of
amoxicillin trihydrate). It belongs
to a group of antibiotics medicines called ’penicillins’.
AMOXICILLIN is used to treat infections caused by bacteria in
different parts of the body.
AMOXICILLIN may also be used in combination with other medicines to
treat stomach ulcers.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE AMOXICILLIN
DO NOT TAKE AMOXICILLIN
•
if you are allergic (hypersensitivity) to amoxicillin, penicillin or
any of the other ingredients of this
medicine (listed in section 6).
•
if you have ever had an allergic reaction to any antibiotic. This can
include a skin rash or swelling of
the face or throat.
Do not take AMOXICILLIN if any of the above apply. If you are not
sure, talk to your doctor or
pharmacist before taking AMOXICILLIN.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist befor taking AMOXICILLIN if you:
Annex II: Proposed text
matter

Toote omadused

Annex I: Summary of Product
Characteristics (SmPC)
SUMMARY OF PRODUCT
CHARACTERISTICS (SmPC)
for:
AMOXICILLIN 250 mg
Capsules
AMOXICILLIN 500 mg
Capsules
TROGE
®
Register-Nr. HRB 35614
DEPARTMENT FOR SCIENTIFIC RESEARCH AND PRODUCT DEVELOPMENT
DEPARTMENT FOR INTERNATIONAL REGULATORY AFFAIRS
- May 2017
PRODUCT:
AMOXICILLIN 250 MG
capsules
AMOXICILLIN 500 MG
capsules
SUMMARY OF PRODUCT CHARACTERISTICS
Troge Medical GmbH · Milchstrasse 19 · 20148 Hamburg · Germany
2
SUMMARY OF PRODUCT CHARACTERISTICS (SPC)
1. NAME OF THE MEDICINAL PRODUCT
AMOXICILLIN 250 mg
_capsules _
AMOXICILLIN 500 mg
_capsules _
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
AMOXICILLIN 250 MG _CAPSULES _
Each capsule contains 250 mg amoxicillin (in form of amoxicillin
trihydrate)
_ _
_ _
Excipient with known effect
Contains Ponceau 4R (E124) - please refer to section 4.4 for further
details.
_For the full list of excipients, see section 6.1. _
AMOXICILLIN 500 MG _CAPSULES _
Each capsule contains 500 mg amoxicillin (in form of amoxicillin
trihydrate)
_ _
_ _
Excipient with known effect
Contains Ponceau 4R (E124) - please refer to section 4.4 for further
details.
_For the full list of excipients, see section 6.1._
3. PHARMACEUTICAL FORM
Capsules, hard
AMOXICILLIN 250 MG_ CAPSULES: _
Maroon and yellow hard capsules printed with “AMOXI 250“ and TROGE
®
logo.
AMOXICILLIN 500 MG_ CAPSULES: _
Maroon and yellow hard capsules printed with “AMOXI 500“ and TROGE
®
logo.
PRODUCT:
AMOXICILLIN 250 MG
capsules
AMOXICILLIN 500 MG
capsules
SUMMARY OF PRODUCT CHARACTERISTICS
Troge Medical GmbH · Milchstrasse 19 · 20148 Hamburg · Germany
3
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Amoxicillin capsules is indicated for the treatment of the following
infections in
adults and children:
• Acute bacterial sinusitis
• Acute otitis media
• Acute streptococcal tonsillitis and pharyngitis
• Acute exacerbations of chronic bronchitis
• Community acquired pneumonia
• Acute cystitis
• Asymptomatic bacteriuria in pregnancy
• Acute pyelo