Allergo-COMOD eye drops

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CROMOGLICATE SODIUM

Available from:

Ursapharm Arzeneitmittel GmbH Industriestrasse, 66129 Saarbrucken, Germany

ATC code:

S01GX01

INN (International Name):

CROMOGLICATE SODIUM 20 mg/ml

Pharmaceutical form:

EYE DROPS, SOLUTION

Composition:

CROMOGLICATE SODIUM 20 mg/ml

Prescription type:

POM

Therapeutic area:

OPHTHALMOLOGICALS

Authorization status:

Authorised

Authorization date:

2006-08-16

Patient Information leaflet

Page 1 of 4
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ALLERGO-COMOD EYE DROPS
Active substance: Sodium cromoglicate
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 Allergo-COMOD eye drops are and what they are used for
2.
What you need to know before you use Allergo-COMOD eye drops
3.
How to use Allergo-COMOD eye drops
4.
Possible side effects
5.
How to store Allergo-COMOD eye drops
6.
Contents of the pack and other information
1.
WHAT ALLERGO-COMOD EYE DROPS ARE AND WHAT THEY ARE USED FOR
Allergic
acute
and
chronic
conjunctival
irritation
(conjunctivitis),
e.g.
hayfever-induced
conjunctivitis, spring catarrh (keratoconjunctivitis vernalis)
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ALLERGO-COMOD EYE DROPS
DO NOT USE ALLERGO-COMOD EYE DROPS
if you are allergic to sodium cromoglicate or any of the other
ingredients of this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
Immediately after use, you will notice a temporary impairment of your
vision.
If you have an inflammation, including allergic conjunctivitis, you
should ask your ophthalmologist
whether you can continue wearing contact lenses despite your
condition. If the ophthalmologist
allows you to wear contact lenses, you should note the following:
Remove the contact lenses before applying the eye drops and do not
replace them for at least 15
minutes.
OTHER MEDICINES AND ALLERGO-COMOD EYE DROPS
Tell your doctor or pharmacist if you are using, have recently used or
might use any other
medicines.
_ _
PREGNANCY AND BREAST-FEEDING
If you

Summary of Product characteristics

Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Allergo-COMOD eye drops
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of eye drops contains 20 mg sodium cromoglicate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Eye drops, solution
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Acute
and
chronic
allergic
conjunctivitis
as
e.g.
hay-fever
conjunctivitis
or
vernal
keratoconjunctivitis
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Adults and children:
1 drop of Allergo-COMOD eye drops into each eye, up to 4 times a day.
The daily dose can be increased up to 6 times 1 drop, however the
maximum daily dose should not
exceed 8 times 1 drop of Allergo-COMOD eye drops into each eye. After
the therapeutic effect has
been achieved, the frequency of administration can be reduced,
provided that the symptoms do not
return.
In order to optimise the therapeutic effect the patient has to be
instructed in the use of Allergo-
COMOD eye drops.
Allergo-COMOD eye drops is only suitable for prophylaxis and long-term
therapy, respectively.
Therefore, the treatment has to be continued even if the complaints
attenuate as long as the patient
is in contact with the allergens (pollen, house dust, mould spores,
food allergens). The therapeutic
effect should be controlled regularly. Following stabilisation of
clinical symptoms, a trial of
gradually reducing the dose can be attempted.
METHOD OF ADMINISTRATION
For ocular use.
INSTRUCTIONS FOR USE
Remove the protective cap before use. Before using Allergo-COMOD eye
drops for the first time,
hold the bottle with the dropper tip pointing downwards and press the
base of the bottle until the
first drop comes out of the end of the dropper. The bottle is then
ready for subsequent uses. Hold
the bottle with the dropper tip pointing downwards and press without
interruption down to the stop
on the base of the bottle. This activates the mechanism for dispensing
one drop. Due to the special
COMOD valve system, the size and speed of each