Opatanol

Land: Den Europæiske Union

Sprog: engelsk

Kilde: EMA (European Medicines Agency)

Aktiv bestanddel:

olopatadine hydrochloride

Tilgængelig fra:

Novartis Europharm Limited

ATC-kode:

S01GX09

INN (International Name):

olopatadine

Terapeutisk gruppe:

Ophthalmologicals

Terapeutisk område:

Conjunctivitis, Allergic

Terapeutiske indikationer:

Treatment of ocular signs and symptoms of seasonal allergic conjunctivitis.,

Produkt oversigt:

Revision: 23

Autorisation status:

Authorised

Autorisation dato:

2002-05-16

Indlægsseddel

16
B. PACKAGE LEAFLET
17
PACKAGE LEAFLET: INFORMATION FOR THE USER
OPATANOL 1 MG/ML EYE DROPS, SOLUTION
olopatadine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 Opatanol is and what it is used for
2.
What you need to know before you use Opatanol
3.
How to use Opatanol
4.
Possible side effects
5.
How to store Opatanol
6.
Contents of the pack and other information
1.
WHAT OPATANOL IS AND WHAT IT IS USED FOR
OPATANOL IS USED FOR THE TREATMENT OF SIGNS AND SYMPTOMS OF SEASONAL
ALLERGIC CONJUNCTIVITIS.
ALLERGIC CONJUNCTIVITIS.
Some materials (allergens) like pollens, house dust or animal fur may
cause
allergic reactions resulting in itching, redness as well as swelling
of the surface of your eye.
OPATANOL IS A MEDICINE
for treatment of allergic conditions of the eye. It works by reducing
the
intensity of the allergic reaction.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE OPATANOL
DO NOT USE OPATANOL
•
IF YOU ARE ALLERGIC
(hypersensitive) to olopatadine or any of the other ingredients of
this
medicine (listed in section 6).
•
You should not use Opatanol if you are breast-feeding.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Opatanol.
You should remove contact lenses that are in your eyes before using
Opatanol.
CHILDREN
Do not use Opatanol in children under the age of 3 years. Do not give
this
medicine to children under
the ages of 3 years because there is no data to indicate that it is
safe and work in children under
3 years.
OTHER MEDICINES AND OPATANOL
Tell your doctor or

Produktets egenskaber

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Opatanol 1 mg/mL eye drops, solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One mL of solution contains 1 mg olopatadine (as hydrochloride).
Excipient(s) with known effect
Benzalkonium chloride 0.1 mg/ml.
Disodium phosphate dodecahydrate (E339) 12.61 mg/ml (equivalent to
3.34 mg/ml of phosphates).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Eye drops, solution (eye drops).
Clear, colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of ocular signs and symptoms of seasonal allergic
conjunctivitis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose is one drop of Opatanol 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 _
Opatanol may be used in paediatric patients three years of age and
older at the same dose as in adults.
The safety and efficacy of Opatanol 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 (Opatanol) 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).
3
Method of administration
For ocular use only.
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
CONTRAINDICATIONS
Hy