Amoclav 250mg/125mg Film-coated Tablets

Страна: Ирландия

Язык: английский

Источник: HPRA (Health Products Regulatory Authority)

Активный ингредиент:

Amoxicillin trihydrate; potassium clavulanate

Доступна с:

Rowex Ltd

код АТС:

J01CR; J01CR02

ИНН (Международная Имя):

Amoxicillin trihydrate; potassium clavulanate

дозировка:

250 mg/125 milligram(s)

Фармацевтическая форма:

Film-coated tablet

Тип рецепта:

Product subject to prescription which may not be renewed (A)

Терапевтические области:

Combinations of penicillins, incl. beta-lactamase inhibitors; amoxicillin and enzyme inhibitor

Статус Авторизация:

Marketed

Дата Авторизация:

2003-03-21

тонкая брошюра

PACKAGE LEAFLET: INFORMATION FOR THE USER
AMOCLAV 250MG/125MG FILM-COATED TABLETS
amoxicillin/clavulanic acid
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 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 or pharmacist or
nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
IN THIS LEAFLET
1. What Amoclav is and what it is used for
2. What you need to know before you take Amoclav
3. How to take Amoclav
4. Possible side effects
5. How to store Amoclav
6. Contents of the pack and other information
1.
WHAT AMOCLAV IS AND WHAT IT IS USED FOR
Amoclav is an antibiotic and works by killing bacteria that cause
infections. It contains two
different medicines 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.
Amoclav is used in adults and children to treat the following
infections:
• sinus infections
• urinary tract infections
• skin infections
• dental infections.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE AMOCLAV
DO NOT TAKE AMOCLAV:
• if you are allergic (hypersensitive) to amoxicillin, clavulanic
acid, penicillin or any of the
other ingredients of Amoclav (listed in section 6)
• 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 (yellowing of the
skin) when taking an
antibiotic.
➔
DO NOT TAKE AMOCLAV IF ANY OF THE ABOVE APPLY TO YOU.
If you are not sure, talk to
your doctor or phar

Характеристики продукта

Health Products Regulatory Authority
03 April 2023
CRN00DHNQ
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Amoclav 250mg/125mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 film-coated tablet contains:
Amoxicillin trihydrate equivalent to 250mg amoxicillin
Potassium clavulanic potassium equivalent to 125mg clavulanic acid
Excipients: each tablet contains 0.63mmol (24.5mg) of potassium.
_For the full list of excipients, see section 6.1._
3 PHARMACEUTICAL FORM
Film coated tablet.
Oblong, convex, white to light-yellow, film-coated tablets with
markings 'AXC 375' on one side and 'G G' on the other side.
Both sides carry a scoreline.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Amoclav is indicated for the treatment of the following infections in
adults and children (see sections 4.2, 4.4 and 5.1).

Acute bacterial sinusitis (adequately diagnosed)

Cystitis

Pyelonephritis

Cellulitis

Animal bites

Severe dental abscess with spreading cellulitis.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Doses are expressed throughout in terms of amoxicillin/clavulanic acid
content except when doses are stated in terms of an
individual component.
The dose of Amoclav that is selected to treat an individual infection
should take into account:

The expected pathogens and their likely susceptibility to
antibacterial agents (see section 4.4)

The severity and the site of the infection

The age, weight and renal function of the patient as shown below
The use of alternative presentations of Amoclav (e.g. those that
provide higher doses of amoxicillin and/or different ratios of
amoxicillin to clavulanic acid) should be considered as necessary (see
sections 4.4 and 5.1).
For adults and children ≥ 40 kg, this formulation of Amoclav
provides a total daily do