PATANOL

Țară: Israel

Limbă: engleză

Sursă: Ministry of Health

Ingredient activ:

OLOPATADINE AS HYDROCHLORIDE

Disponibil de la:

NOVARTIS ISRAEL LTD

Codul ATC:

S01GX09

Forma farmaceutică:

EYE DROPS

Compoziție:

OLOPATADINE AS HYDROCHLORIDE 1 MG/ML

Calea de administrare:

OCULAR

Tip de prescriptie medicala:

Required

Produs de:

ALCON PHARMACEUTICALS LTD, SWITZERLAND

Grupul Terapeutică:

OLOPATADINE

Zonă Terapeutică:

OLOPATADINE

Indicații terapeutice:

For the temporary prevention of itching of the eye due to allergic conjunctivitis.

Data de autorizare:

2012-11-30

Prospect

IF YOU ACCIDENTALLY TOOK A HIGHER DOSAGE,
wash the eye thoroughly with warm water. Do
not instill any more into the eye until it is time
for the next dose.
If you took an overdose, or if a child has
accidentally swallowed the medicine, refer
immediately to a doctor or proceed to a hospital
emergency room and bring the package of the
medicine with you.
IF YOU FORGOT TO TAKE THE MEDICINE at the
required time, take a dose as soon as you
remember and then return to your normal
dosing regimen. However, if it is almost time
to take the next dose, skip the forgotten dose
and return to your normal dosing regimen at
the next administration. Do not take two doses
together to compensate for the forgotten dose.
Adhere to the treatment regimen as
recommended by the doctor. Even if there is
an improvement in your health, do not stop
treatment with the medicine without consulting
the doctor.
IF YOU STOP TAKING THE MEDICINE
Do not stop taking the medicine without
consulting with the doctor.
DO NOT TAKE MEDICINES IN THE DARK! CHECK
THE LABEL AND THE DOSE EACH TIME YOU TAKE
THE MEDICINE. WEAR GLASSES IF YOU NEED
THEM.
IF YOU HAVE FURTHER QUESTIONS REGARDING
USE OF THE MEDICINE, CONSULT THE DOCTOR
OR PHARMACIST.
4. SIDE EFFECTS:
As with any medicine, use of Patanol may cause
side effects in some users. Do not be alarmed
by the list of side effects. You may not suffer
from any of them.
The following side effects were observed with
use of Patanol:
COMMON SIDE EFFECTS - EFFECTS THAT OCCUR
IN 1-10 IN 100 USERS:
Eye effects:
eye pain, eye irritation, dry eye, an abnormal
eye sensation, eye discomfort.
General effects:
headache, fatigue, dry nose, bad taste in the
mouth.
UNCOMMON SIDE EFFECTS - EFFECTS THAT OCCUR
IN 1-10 IN 1,000 USERS:
Eye effects:
blurred vision, reduced vision, abnormal vision,
corneal disorder, eye surface inflammation with
or without eye surface damage, inflammation
or infection of the conjunctiva, eye discharge,
sensitivity to light, increased tear production,
itchiness of the eye, redness of the eye,
unusual sensa

Caracteristicilor produsului

PAT API MAY21 V3
EU update
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
PATANOL®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One mL of solution contains 1 mg olopatadine (as hydrochloride),
olopatadine hydrochloride 0.111%.
Excipient(s) with known effect:
Benzalkonium chloride 0.1 mg/ml.
Dibasic sodium phosphate 5 mg/ml (equivalent to 3.35 mg/ml of
phosphates)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Eye drops, solution (ocular).
Colourless to pale yellow.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the temporary prevention of itching of the eye due to allergic
conjunctivitis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose is one drop of PATANOL in the conjunctival sac of the
affected eye(s) twice daily (8 hourly).
Treatment may be maintained for up to four months, if considered
necessary.
Use in elderly
No dosage adjustment in elderly patients is necessary.
Paediatric patients
PATANOL may be used in paediatric patients three years of age and
older at the same dose as in
adults. The safety and efficacy of PATANOL in children aged under 3
years has not been established.
No data are available.
Use in hepatic and renal impairment
Olopatadine in the form of eye drops (PATANOL) has not been studied in
patients with renal or
hepatic disease. However, no dosage adjustment is expected to be
necessary in hepatic or renal
impairment (see section 5.2).
Method of administration
For ocular use only.
PAT API MAY21 V3
EU update
After the bottle cap is removed, if the tamper evident snap collar is
loose, remove before using the
product. To prevent contamination of the dropper tip and solution,
care must be taken not to touch
the eyelids, surrounding areas, or other surfaces with the dropper tip
of the bottle. Keep the bottle
tightly closed when not in use.
In case of concomitant therapy with other topical ocular medicines, an
interval of five minutes should
be allowed between successive applications. Eye ointments should be
administered last.
4.3
CO