Fromilid 250 mg film-coated tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CLARITHROMYCIN

Available from:

TAD Pharma GmbH Heinz-Lohmann-Strasse 5, 27472 Cuxhaven, Germany

ATC code:

J01FA09

INN (International Name):

CLARITHROMYCIN 250 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

CLARITHROMYCIN 250 mg

Prescription type:

POM

Therapeutic area:

ANTIBACTERIALS FOR SYSTEMIC USE

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2021-11-17

Patient Information leaflet

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PACKAGE LEAFLET
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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FROMILID 250 MG FILM-COATED TABLETS
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.
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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:
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Chest infections such as bronchitis and pneumonia,
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Throat and sinus infections,
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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 medici

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE MEDICINAL PRODUCT
Fromilid 250 mg film-coated tablets
Fromilid 500 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
250 mg: Each film-coated tablet contains 250 mg clarithromycin.
500 mg: Each film-coated tablet contains 500 mg clarithromycin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
250 mg: oval, biconvex, slightly brownish yellow film-coated tablets
of 15 to 15.2 mm in length and
8 mm in width.
500 mg: oval, biconvex, slightly brownish yellow film-coated tablets
of 19.5 to 19.8 mm in length and
10 mm in width.
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):
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Bacterial pharyngitis
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Mild to moderate community acquired pneumonia
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Acute bacterial sinusitis (adequately diagnosed)
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Acute exacerbation of chronic bronchitis
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Skin infections and soft tissue infections of mild to moderate
severity
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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 yea