Clarithromycin 250mg tablets

País: Reino Unido

Idioma: inglés

Fuente: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes activos:

Clarithromycin

Disponible desde:

Teva UK Ltd

Código ATC:

J01FA09

Designación común internacional (DCI):

Clarithromycin

Dosis:

250mg

formulario farmacéutico:

Oral tablet

Vía de administración:

Oral

clase:

No Controlled Drug Status

tipo de receta:

Valid as a prescribable product

Resumen del producto:

BNF: 05010500; GTIN: 5017007025450

Información para el usuario

PACKAGE LEAFLET: INFORMATION FOR THE USER
CLARITHROMYCIN 250 MG AND 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 or your
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 the 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
Each Clarithromycin tablet contains 250 mg of the active
ingredient clarithromycin
Each Clarithromycin tablet contains 500 mg of the active
ingredient clarithromycin.
Clarithromycin belongs to a group of medicines called
macrolide antibiotics. Antibiotics stop the growth of
bacteria (bugs) which cause infections.
Clarithromycin tablets are used to treat infections such as:
•
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 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 (see section 6).
•
are taking medicines called ergot alkaloid tablets (e.g.
ergotamine or dihydroergotamine) or use ergo

Ficha técnica

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Clarithromycin 250mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 250mg Clarithromycin
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet
dark yellow, film-coated, capsule shaped tablets.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Clarithromycin film-coated tablets are indicated in adults and
adolescents
12 years and older for the treatment of the following bacterial
infections, when
caused by clarithromycin susceptible bacteria(see section 4.4 and
5.1).
•
Acute bacterial exacerbation of chronic bronchitis
•
Mild to moderate community acquired pneumonia
•
Acute bacterial sinusitis
•
Bacterial pharyngitis
•
Skin infections and soft tissue infections of mild to moderate
severity,
such as folliculitis, cellulitis and erysipelas
Clarithromycin film-coated tablets can also be used in appropriate
combination with antibacterial therapeutic regimens and an appropriate
ulcer
healing agent for the eradication of _Helicobacter pylori_ in patients
with
_Helicobacter pylori_ associated ulcers (see section 4.2).
Consideration should be given to official guidance on the appropriate
use of
antibacterial agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The dosage of Clarithromycin film-coated Tablets depends on the
clinical
condition of the patient and has to be defined in any case by the
physician.
_Children older than 12 years and adults: _
•
Standard dosage: The usual dose is 250 mg twice daily.
•
High dosage treatment (severe infections): The usual dose may be
increased to 500 mg twice daily in severe infections.
•
Clinical trials have been conducted using clarithromycin pediatric
suspension in children 6 months to 12 years of age. Therefore,
children
under 12 years of age should use clarithromycin pediatric suspension
(granules for oral suspension).
_Elimination of Helicobacter pylori in adults: _
In patients with gastro-duodenal ulcers due to H.