Fromilid uno 500 mg prolonged-release tablets

Country: Malta

Language: English

Source: Medicines Authority

Available from:

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

ATC code:

J01FA09

INN (International Name):

CLARITHROMYCIN 500 mg

Pharmaceutical form:

PROLONGED-RELEASE TABLET

Composition:

CLARITHROMYCIN 500 mg

Prescription type:

POM

Therapeutic area:

ANTIBACTERIALS FOR SYSTEMIC USE

Product summary:

Licence number in the source country: Romania - 9268/2016/01-02-03

Authorization status:

Authorised

Authorization date:

2024-02-16

Patient Information leaflet

Package leaflet: Information for the patient
FROMILID UNO 500 MG PROLONGED-RELEASE 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 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 uno is and what it is used for
2.
What you need to know before you take Fromilid uno
3.
How to take Fromilid uno
4.
Possible side effects
5.
How to store Fromilid uno
6.
Contents of the pack and other information
1.
WHAT FROMILID UNO IS AND WHAT IT IS USED FOR
Fromilid uno is an antibiotic from the group of macrolides. It acts by
stopping the
growth of bacteria that cause infections in the human body.
Fromilid uno is indicated for the treatment of respiratory tract
infections (e.g.
infections of the sinuses, throat, tonsils, bronchi and lungs), and
skin and
subcutaneous tissue infections.
Fromilid uno is used in adults and children 12 years of age and older.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE FROMILID UNO DO NOT TAKE
FROMILID UNO
-
if you are allergic to clarithromycin or any of the other ingredients
of
this medicine (listed in section 6), or other macrolide antibiotics;
-
if you have low blood potassium or magnesium levels (hypokalaemia
or hypomagnesaemia);
-
if you have very severe liver impairment and kidney problems at the
same time;
-
if you are taking oral midazolam (a sedative);
-
if you are taking medicines for high cholesterol (such as lovastatin
or
simvastatin);
-
if you are taking a medicine containing lomitapide;
-
if you have or someone in your family has heart rhythm disorders
(ventricular cardiac arrhythmia, includ

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Fromilid uno 500 mg prolonged-release tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet contains 500 mg clarithromycin.
Excipients with known effect:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Prolonged-release tablet
The tablets are brownish yellow, oval, biconvex, film-coated and
imprinted with U on one side. Tablet
dimension: 20 x 10 mm
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Upper respiratory tract infections (e.g. tonsillopharyngitis, acute
sinusitis).
Lower respiratory tract infections (e.g. acute bacterial bronchitis,
acute exacerbation of chronic
bronchitis, and pneumonia).
Skin and subcutaneous tissue infections.
Fromilid uno is indicated in adults and children 12 years and older.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults and children over 12 years usually take one 500 mg tablet every
24 hours. In more severe
infections, two 500 mg tablets should be taken every 24 hours.
The usual duration of treatment is 6 to 14 days.
Paediatric population
_Children under 12 years of age _
Clinical trials have been conducted using clarithromycin suspension in
children 6 months to 12 years
of age. Therefore, children under 12 years of age should use
clarithromycin granules for oral
suspension.
_Renal impairment _
lactose
213.75 mg/tablet
sodium
12.85 mg/tablet
In patients with renal impairment with creatinine clearance less than
30 ml/min, the dosage of
clarithromycin should be reduced by one half, i.e. 250 mg once daily,
or 250 mg twice daily in more
severe infections. Treatment should not be continued beyond 14 days in
these patients. Because the
prolonged-release tablet cannot be split, the dose cannot be reduced
from 500 mg daily and this
pharmaceutical form should not be used in this patient population (see
section 4.3).
Method of administration
Oral use.
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