Klacid Forte 500 mg film-coated tablets

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

Clarithromycin

Dostupné z:

PCO Manufacturing Ltd.

ATC kód:

J01FA; J01FA09

INN (Medzinárodný Name):

Clarithromycin

Dávkovanie:

500 milligram(s)

Forma lieku:

Film-coated tablet

Typ predpisu:

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

Terapeutické oblasti:

Macrolides; clarithromycin

Stav Autorizácia:

Authorised

Dátum Autorizácia:

2002-01-11

Príbalový leták

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PACKAGE LEAFLET: INFORMATION FOR THE USER
KLACID
® FORTE 500 MG
FILM-COATED TABLETS
(clarithromycin)
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 further questions, ask your doctor, pharmacist or nurse.
-
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 you get any side effects, talk to your doctor, pharmacist or nurse.
This
includes any side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Klacid Forte tablets are and what they are used for
2.
What you need to know before you take Klacid Forte tablets
3.
How to take Klacid Forte tablets
4.
Possible side effects
5.
How to store Klacid Forte tablets
6.
Contents of the pack and other information
1.
WHAT KLACID FORTE TABLETS ARE AND WHAT THEY ARE USED FOR
Each Klacid Forte tablet contains 500 mg of the active ingredient
clarithromycin.
Klacid belongs to a group of medicines called macrolide antibiotics.
Antibiotics stop the growth of bacteria (bugs) which cause infections.
Klacid Forte tablets are used to treat infections such as:
1.
Chest infections such as bronchitis and pneumonia
2.
Throat and sinus infections
3.
Skin and soft tissue infections such as cellulitis, folliculitis or
erysipelas
4.
Infections caused by certain types of bacteria called Mycobacteria
5.
_Helicobacter pylori_ infection associated with duodenal ulcer
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE KLACID FORTE
DO NOT TAKE KLACID FORTE TABLETS IF:
-
you know that you are ALLERGIC to clarithromycin, other macrolide
antibiotics such as erythromycin or azithromycin, or any of the other
ingredients in the tablets.
-
you are taking medicines called ergot alkaloids, for example
ergotamine
or dihydroergotamine tablets or use ergotamine inhalers for migraine.
Consult your doctor for advice on alternative medicines.
-
you are t

Súhrn charakteristických

Health Products Regulatory Authority
19 November 2019
CRN009GH0
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Klacid Forte 500 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500 mg of clarithromycin
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet.
_Product imported from the Czech Republic, Greece and Spain: _
Yellow, ovaloid, film-coated tablets
_Product imported from the Netherlands: _
Yellow, ovaloid, film-coated tablets with a symbol embossed on one
side and plain on the other side.
4 CLINICAL PARTICULARS
As per PA2010/004/002
5 PHARMACOLOGICAL PROPERTIES
As per PA2010/004/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
_Excipients present in the product imported from Greece:_
Croscarmellose sodium
Microcrystalline cellulose
Pregelatinised starch
Silicon dioxide
Povidone
Stearic acid
Magnesium stearate
Talc
Hypromellose
Hyprolose
Propylene glycol
Sorbitan oleate
Titanium dioxide (E171)
Sorbic acid
Vanillin
Quinoline yellow (E104)
_Excipients present in the product imported from the Netherlands:_
Carmellose sodium
Health Products Regulatory Authority
19 November 2019
CRN009GH0
Page 2 of 3
Microcrystalline cellulose
Pregelatinised starch
Silicon dioxide
Povidone
Stearic acid
Magnesium stearate
Talc
Hypromellose
Hyprolose
Propylene glycol
Sorbitan oleate
Titanium dioxide (E171)
Sorbic acid
Vanillin
Quinoline yellow (E104)
_Excipients present in the product imported from Spain:_
Croscarmellose sodium
Microcrystalline cellulose
Silicon dioxide
Povidone
Stearic acid
Magnesium stearate
Talc
Hypromellose
Hyprolose
Propylene glycol
Sorbitan oleate
Titanium dioxide (E171)
Sorbic acid
Vanillin
Quinoline yellow (E104)
_Excipients present in the product imported from The Czech Republic:_
Croscarmellose
microcrystalline cellulose
anhydrous colloidal silica
povidone 40
stearic acid 95%
magnesium stearate
talc
hypromellose
hydroxypropyl cellulose
propylene glycol
sorbitan oleate
titanium dioxide (E171)
va