Fromilid 500 mg film-coated tablets

Država: Malta

Jezik: engleski

Izvor: Medicines Authority

Dostupno od:

NeoFarma Pharmaceuticals Limited 42-46, Mill Street, Qormi, QRM 3105, Malta

ATC koda:

J01FA09

INN (International ime):

CLARITHROMYCIN 500 mg

Farmaceutski oblik:

FILM-COATED TABLET

Sastav:

CLARITHROMYCIN 500 mg

Tip recepta:

POM

Područje terapije:

ANTIBACTERIALS FOR SYSTEMIC USE

Proizvod sažetak:

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

Status autorizacije:

Authorised

Datum autorizacije:

2024-02-16

Uputa o lijeku

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 taking medicines called terfenadine or ast

Svojstava lijeka

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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
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.
Film-coated tablet
Oval, biconvex film-coated tablets slightly yellow – brown
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 ye