Klacid Forte 500 mg film-coated tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
23-04-2021
Summary of Product characteristics
(SPC)
23-04-2021
Active ingredient:
Clarithromycin
Available from:
Mylan IRE Healthcare Limited
ATC code:
J01FA; J01FA09
INN (International Name):
Clarithromycin
Dosage:
500 milligram(s)
Pharmaceutical form:
Film-coated tablet
Administration route:
Oral use
Units in package:
14, 20 tablets
Prescription type:
Product subject to prescription which may not be renewed (A)
Manufactured by:
AbbVie S.r.l.
Therapeutic group:
Antibacterial for systemic use, macrolide
Therapeutic area:
Macrolides; clarithromycin
Therapeutic indications:
It is indicated for treatment of infections due to susceptible organisms. Such infections include. 1. Lower respiratory tract infections (e.g. bronchitis, pneumonia). 2. Upper respiratory tract infections (e.g. pharyngitis, sinusitis). 3. Skin and soft tissue infections (e.g. folliculitis, cellulitis, erysipelas). 4. Disseminated or localised mycobacterial infections due to Mycobacterium avium or Mycobacterium intracellulare. Localised infections due to Mycobacterium chelonae, Mycobacterium fortuitum or Mycobacterium kansasii. 5. Is indicated also for the prevention of disseminated Mycobacterium avium complex infection in HIV- infected patients with CD4 lymphocyte counts less than or equal to 100/mm3. 6. In the presence of acid suppression is indicated for the eradication of H. pylori, resulting in decreased recurrence of duodenal ulcer.
Authorization status:
Marketed
Authorization date:
1995-04-13
Patient Information leaflet
Package leaflet: Information for the user
KLACID
®
250mg FILM-COATED TABLETS and
KLACID
®
FORTE 500mg 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 tablets and Klacid Forte tablets are and what they are
used for
2. What you need to know before you take Klacid tablets or Klacid
Forte tablets
3. How to take Klacid tablets or Klacid Forte tablets
4. Possible side effects
5. How to store Klacid tablets or Klacid Forte tablets
6. Further information
1. WHAT KLACID TABLETS AND KLACID FORTE TABLETS ARE AND WHAT THEY ARE
USED FOR
Each Klacid tablet contains 250mg of the active ingredient
clarithromycin. Each Klacid Forte tablet contains 500mg 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 tablets and 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 Mycobacteriae
5. _Helicobacter pylori _infection associated with duodenal ulcer
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE KLACID TABLETS OR KLACID
FORTE
DO NOT TAKE KLACID TABLETS OR 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 ingredie
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Summary of Product characteristics
Health Products Regulatory Authority
22 April 2021
CRN00C7WV
Page 1 of 18
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
A yellow ovaloid film-coated tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Clarithromycin is indicated for treatment of infections due to
susceptible organisms. Such infections include.
1. Lower respiratory tract infections (e.g. bronchitis, pneumonia)
(see section 4.4 and 5.1 regarding Sensitivity Testing).
2. Upper respiratory tract infections (e.g. pharyngitis, sinusitis).
3. Skin and soft tissue infections (e.g. folliculitis,
cellulitis,erysipelas) (see section 4.4 and 5.1 regarding Sensitivity
Testing).
4. Disseminated or localised mycobacterial infections due to
_Mycobacterium avium_ or _Mycobacterium intracellulare_. Localised
infections due to _Mycobacterium chelonae_, _Mycobacterium fortuitum_
or _Mycobacterium kansasii_.
5. Clarithromycin is indicated for the prevention of disseminated
_Mycobacterium avium_ complex infection in HIV-infected
patients with CD4 lymphocyte counts less than or equal to 100/mm
3
.
6. Clarithromycin in the presence of acid suppression is indicated for
the eradication _of H. pylori_, resulting in decreased
recurrence of duodenal ulcer (see Further Information below).
Clarithromycin tablets are indicated in adults and children 12 years
and older.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
As with other antibiotics, it is recommended that guidelines on the
prevalence of local resistance, and associated medical
practice regarding the prescription of antibiotics, be consulted
before prescribing Klacid Forte.
FURTHER INFORMATION: _H. pylori_ is strongly associated with peptic
ulcer disease. Ninety to 100% of patients with duodenal ulcers
are infected with this
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