FROMILID 500 mg film-coated tablets

País: Malta

Idioma: anglès

Font: Medicines Authority

Disponible des:

NM Pharma Limited 3/4, Cantrija Complex Triq it-Targa, il-Maghtab Naxxar NXR 6613 , Malta

Codi ATC:

J01FA09

Designació comuna internacional (DCI):

CLARITHROMYCIN 500 mg

formulario farmacéutico:

FILM-COATED TABLET

Composición:

CLARITHROMYCIN 500 mg

tipo de receta:

POM

Área terapéutica:

ANTIBACTERIALS FOR SYSTEMIC USE

Resumen del producto:

Licence number in the source country: Romania - 9033/2016/01

Estat d'Autorització:

Authorised

Data d'autorització:

2024-01-22

Informació per a l'usuari

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PACKAGE LEAFLET
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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FROMILID 500 MG FILM-COATED TABLETS
clartihromycin
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 Fromilid is and what it is used for
2.
What you need to know before you take Fromilid
3.
How to take Fromilid
4.
Possible side effects
5.
How to store Fromilid
6.
Contents of the pack and other information
1.
WHAT FROMILID IS AND WHAT IT IS USED FOR
Clarithromycin belongs to a group of medicine called macrolide
antibiotics. Antibiotics stop
the growth of bacteria which cause infections.
Fromilid is used in adults and children 12 years and older to treat
following infections:
-
Chest infections such as bronchitis and pneumonia,
-
Throat and sinus infections,
-
Skin and soft tissue infections,
-
_Helicobacter pylori _
infections associated with duodenal ulcers.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE FROMILID
DO NOT TAKE FROMILID 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 taking medicines called simvastatin or lovastatin (commonly
known as statins, used to
lower increased blood fats such as cholesterol and triglycerides).
-
if you are taking a medicine containing lomitapide.
-
you are

Fitxa tècnica

SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE MEDICINAL PRODUCT
FROMILID 500 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 500 mg of clarithromycin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Oval, biconvex, yellowish-brown film-coated tablets.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Fromilidfilm-coated tablets are indicated for the treatment of the
following bacterial infections in
adults and children 12 years and older, when caused by
clarithromycin-susceptible bacteria (see
section 4.4 and 5.1):
-
Bacterial pharyngitis
-
Mild to moderate community acquired pneumonia
-
Acute bacterial sinusitis (adequately diagnosed)
-
Acute exacerbation of chronic bronchitis
-
Skin infections and soft tissue infections of mild to moderate
severity
-
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
Posology
The dosage of Fromilidfilm-coated tablets depends on the type and
severity of the infection and has to
be defined in any case by the physician.
Patients with respiratory tract/skin and soft tissue infections:
_Adults and adolescents (12 years and older)_
The usual recommended dosage of clarithromycin in adults is one 250mg
tablet twice daily. In more
severe infections, the dosage can be increased to 500mg twice daily.
The usual duration of therapy is 6
to 14 days.
_Children younger than 12 years:_
The use of clarithromycin tablets has not been studied in children
under 12 years. Clinical trials have
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been conducted using clarithromycin paediatric suspension in children
6 months to 12 years of age.
Therefore,
children
under
12
years
of
age
should
use
clarithromycin
paediatric