Emadine
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
10-07-2023
Charakterystyka produktu
(SPC)
10-07-2023
Sprawozdanie z oceny publicznego
(PAR)
23-05-2014
Składnik aktywny:
emedastine difumarate
Dostępny od:
Immedica Pharma AB
Kod ATC:
S01GX06
INN (International Nazwa):
emedastine
Grupa terapeutyczna:
Ophthalmologicals
Dziedzina terapeutyczna:
Conjunctivitis, Allergic
Wskazania:
Symptomatic treatment of seasonal allergic conjunctivitis.
Podsumowanie produktu:
Revision: 26
Status autoryzacji:
Authorised
Data autoryzacji:
1999-01-27
Ulotka dla pacjenta
27
B. PACKAGE LEAFLET
28
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
EMADINE 0.5 MG/ML EYE DROPS, SOLUTION
emedastine
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 your 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 of the 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 EMADINE is and what it is used for
2.
What you need to know before you use EMADINE
3.
How to use EMADINE
4.
Possible side effects
5.
How to Store EMADINE
6.
Contents of the pack and other information
1.
WHAT EMADINE IS AND WHAT IT IS USED FOR
EMADINE IS A MEDICINE
for the treatment of seasonal allergic conjunctivitis of the eye
(allergic
conditions of the eye). It works by reducing the intensity of the
allergic reaction.
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.
You must talk to a doctor if you do not feel better or if you feel
worse.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE EMADINE
DO NOT USE EMADINE
•
IF YOU ARE ALLERGIC
to emedastine or any of the other ingredients of this medicine listed
in
section 6.
Ask your doctor for advice.
WARNING AND PRECAUTIONS
•
DO NOT USE EMADINE IN CHILDREN UNDER THE AGE OF 3 YEARS.
•
IF YOU WEAR CONTACT LENSES
please see section ‘EMADINE contains benzalkonium chloride
below’.
•
EMADINE IS NOT RECOMMENDED
for use in patients over 65 years of age, as it has not been
studied in clinical trials in this age group.
•
EMADINE IS NOT RECOMMENDED
for use in patients with kidney or liver problems.
Talk to your doctor or pharmacist bef
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
EMADINE 0.5 mg/ml, eye drops, solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of solution contains emedastine 0.5 mg (as difumarate)
Excipient with known effect
Benzalkonium chloride 0.1 mg/ml
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Eye drops, solution.
Clear, colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symptomatic treatment of seasonal allergic conjunctivitis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
EMADINE has not been studied in clinical trials beyond six weeks.
Posology
The dose is one drop of EMADINE to be applied to the affected eye(s)
twice daily.
When used with other ophthalmic medicines, an interval of ten minutes
should be allowed between
applications of each medicinal product. Eye ointments should be
administered last.
_Elderly population _
EMADINE has not been studied in elderly patients older than 65 years,
and therefore its use is not
recommended in this population.
_Paediatric population _
EMADINE may be used in paediatric patients (3 years of age and older)
at the same posology as in
adults.
_Hepatic and Renal impairment Use _
EMADINE has not been studied in these patients and therefore, its use
is not recommended in this
population.
Method of administration
For ocular use.
3
To prevent contamination of the dropper tip and solution, care should
be taken not to touch the
eyelids, surrounding areas or other surfaces with the dropper tip of
the bottle.
After cap is removed, if tamper evident snap collar is loose, remove
before using product.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Ocular corneal infiltrates
Ocular corneal infiltrates were reported in conjunction with the use
of EMADINE. In case of corneal
infiltrates, the product should be discontinued and appropriate
management should be implemented.
Excipients
Benzalkonium chloride
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