FLOXAL

Ülke: İsrail

Dil: İngilizce

Kaynak: Ministry of Health

Aktif bileşen:

OFLOXACIN

Mevcut itibaren:

FISCHER PHARMA RX LTD

ATC kodu:

S01AX11

Farmasötik formu:

OPHTHALMIC OINTMENT

Kompozisyon:

OFLOXACIN 3 MG / 1 G

Uygulama yolu:

OCULAR

Reçete türü:

Required

Tarafından üretildi:

DR.GERHARD MANN,CHEM.-PHARM. FABRIC GmbH

Terapötik alanı:

OFLOXACIN

Terapötik endikasyonlar:

Infections of the anterior eye sections with ofloxacin- sensitive pathogens: chronic conjunctivitis, keratitis and corneal ulcers, and chlamydia infections.

Yetkilendirme tarihi:

2020-09-21

Bilgilendirme broşürü

Patient leaflet in accordance with the Pharmacists' Regulations
(Preparations) - 1986
This medicine is dispensed with a doctor’s prescription only
Floxal
®
Eye ointment
Active ingredient
1 g contains 3 mg ofloxacin
Inactive ingredients and allergens, see section 2 'Important
information about some of this
medicine’s ingredients' and section 6 'Additional information'.
Read the entire leaflet carefully before you start using this
medicine. This leaflet contains
concise information about this medicine. If you have any further
questions, consult your doctor or
pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even
if it seems to you that their medical condition is similar to yours.
1.
What is this medicine intended for?
To treat infections of the anterior eye sections caused by
ofloxacin-sensitive pathogens
(bacteria):

chronic conjunctivitis

keratitis and corneal ulcers

chlamydia infections
Therapeutic group: Gyrase inhibitor antibiotics, fluoroquinolones.
2.
Before using this medicine
Do not use this medicine if:

You are sensitive (allergic) to the active ingredient (ofloxacin), to
other quinolones or to
any of the other ingredients in this medicine (see section 6
'Additional information').

You are breastfeeding.
Special warnings about using this medicine
Talk to your doctor before treatment with Floxal
®
.
During treatment with Floxal
®
, remember the following:

Tendon swelling and rupture have occurred in patients taking oral or
intravenous
fluoroquinolones, particularly in older patients and in those treated
concurrently with
corticosteroids. Stop using Floxal
®
and consult your doctor if you develop pain or swelling of
the tendons (tendinitis).

It is not recommended to use contact lenses during eye infection.

Extensive sunbathing or use of UV light (e.g. sunbathing lamps,
solarium) should be avoided
if possible.

Floxal
®
should be used with caution in patients with corneal defects or
corneal ulcers.

As with othe

Ürün özellikleri

Page 2 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
FLOXAL
®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: ofloxacin
1 g eye ointment contains 3 mg of ofloxacin. One single dose (a strip
of the eye ointment with
length of 1 cm) contains 0.12 mg of ofloxacin.
Excipients with known effect: wool fat (lanolin)
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Eye ointment
Light yellowish ointment with soft consistency
4.
CLINICAL PARTICULARS
4.1 Therapeutic indications
Infections of the anterior eye section with ofloxacin-sensitive
pathogens: chronic conjunctivitis,
keratitis and corneal ulcers, and chlamydia infections.
4.2 Posology and method of administration
Posology
Unless otherwise prescribed, insert a strip with length of 1 cm
(equivalent to 0.12 mg of
ofloxacin) three times daily (in chlamydia infections five times
daily).
The length of treatment should not exceed 14 days.
Notice: If different topical ocular medications are used
concomitantly, at least a 15-minute
interval is required between applications. Floxal
®
should always be applied last.
Method of administration
For topical ocular use
Page 3 of 10
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1, or any
other quinolones.
4.4 Special warnings and precautions for use
Ofloxacin is not intended for injection.
Safety and effectiveness in infants below the age of one year have not
been established.
Serious and occasionally fatal hypersensitivity
(anaphylactic/anaphylactoid) reactions, some
following the first dose, have been reported in patients receiving
systemic quinolones,
including ofloxacin. Some reactions were accompanied by cardiovascular
collapse, loss of
consciousness, angioedema (including laryngeal, pharyngeal or facial
oedema), airway
obstruction, dyspnoea, urticaria, and itching.
If an allergic reaction to ofloxacin occurs, discontinue the drug. Use
Floxal
®
with caution in
patients who have exhibited sensitivitie