Clarithromycin 500mg film-coated Tablets

Država: Malta

Jezik: angleščina

Source: Malta Medicines Authority

Aktivna sestavina:

CLARITHROMYCIN

Dostopno od:

Wockhardt UK Limited

Koda artikla:

J01FA09

INN (mednarodno ime):

CLARITHROMYCIN

Farmacevtska oblika:

FILM-COATED TABLET

Sestava:

CLARITHROMYCIN 500 mg

Tip zastaranja:

POM

Terapevtsko območje:

ANTIBACTERIALS FOR SYSTEMIC USE

Status dovoljenje:

Authorised

Datum dovoljenje:

2011-10-18

Navodilo za uporabo

PACKAGE LEAFLET: INFORMATION FOR THE USER
CLARITHROMYCIN 250 MG FILM-COATED TABLETS
CLARITHROMYCIN 500 MG FILM-COATED TABLETS
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

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 (hypersensitive) to clarithromycin or other
macrolide antibiotics (such
as erythromycin or azithromycin) or any of the other ingredients in
the tablets.

are taking medicines called ergotamine or dihydroergotamine tablets or
use ergotamine inhalers
for migraine while taking Clarithromycin Tablets. Consult your doctor
for advice on alternative
medicines.
�

Lastnosti izdelka

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.
Excipients with known effect:
Lactose monohydrate – 40mg.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
White to off white, oval shaped, 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 ADULTS:_
In pat