Clarithromycin 500mg film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CLARITHROMYCIN

Available from:

Pinewood Laboratories Limited Ballymacarbry, Clonmel, Co. Tipperary, Ireland

ATC code:

J01FA09

INN (International Name):

CLARITHROMYCIN 500 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

CLARITHROMYCIN 500 mg

Prescription type:

POM

Therapeutic area:

ANTIBACTERIALS FOR SYSTEMIC USE

Authorization status:

Withdrawn

Authorization date:

2011-10-18

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
CLARITHROMYCIN 250 MG FILM-COATED TABLETS
CLARITHROMYCIN 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 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 Clarithromycin Tablets are and what they are used for
2. What you need to know before you take Clarithromycin Tablets
3. How to take Clarithromycin Tablets
4. Possible side effects
5. How to store Clarithromycin Tablets
6. Contents of the pack and other information
1. WHAT CLARITHROMYCIN TABLETS ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Clarithromycin Tablets.
Clarithromycin belongs to a group of medicines called macrolide
antibiotics. Antibiotics stop
the growth of bacteria that cause infections.
Clarithromycin is used in the treatment of the following infections:
• Chest infections such as bronchitis and pneumonia
• Throat and sinus infections
• Mild to moderate skin and tissue infections
• Helicobacter pylori infection associated with duodenal ulcer.
Clarithromycin Tablets are indicated in adults and children 12 years
and older.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CLARITHROMYCIN TABLETS
DO NOT TAKE CLARITHROMYCIN IF YOU:
• know that you are
ALLERGIC
to clarithromycin or other macrolide antibiotics such as
erythromycin or azithromycin or any of the other ingredients of this
medicine (listed in
section 6).
• are taking medicines called ergot alkaloid tablets (e.g.
ergotamine or dihydroergotamine) or
use ergotamine inhalers for migraine.
• are taking medicines called terfe

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Clarithromycin 500 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 500 mg clarithromycin.
Excipient(s) with known effect
38 mg lactose (as monohydrate)
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Film-coated tablet.
White to off white, oval shaped, 18 x 9 mm, film coated tablets,
debossed with ‘W949’ on one side
and plain on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
Clarithromycin is indicated in adults and children 12 years and older.
Clarithromycin is indicated for the treatment of thefollowing
infections caused by clarithromycin
susceptible organisms (see sections 4.4 and 5.1).
•
Bacterial pharyngitis
• Mild to moderate community-acquired pneumonia
• Acute bacterial sinusitis (adequately diagnosed)
• Acute exacerbation of chronic bronchitis
• Skin and soft tissue infections of mild to moderate severity.
• In appropriate combination with antibacterial therapeutic regimens
and an appropriate ulcer healing
medicinal product for the eradication of
_Helicobacter pylori _
in adult patients with
_Helicobacter pylori_
-
associated ulcers (see section 4.2).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology:
The dosage of Clarithromycin film-coated tablets depends on the type
and severity of the infection and
has to be defined in any case by the physician.
_ADULTS: _
•
Standard dosage: The usual dose is 250mg twice daily (in the morning
and in the evening)
•
High dosage treatment (severe infections): The usual dose may be
increased to 500 mg twice daily
in severe infections.
_CHILDREN OLDER THAN 12 YEARS:_
As for adults.
_ _
_CHILDREN YOUNGER THAN 12 YEARS:_
Use of Clarithromycin 250mg Tablets are not recommended for
children younger than 12 years. Use clarithromycin Paediatric
Suspension.
_ _
_ERADICATION OF HELICOBACTER PYLORI IN