CATACROM 2 %w/v Eye Drops Solution

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

SODIUM CROMOGLICATE

Tilgjengelig fra:

Moorfields Eye Hospital NHS Foundation Trust

ATC-kode:

S01GX01

INN (International Name):

SODIUM CROMOGLICATE

Dosering :

2 %w/v

Legemiddelform:

Eye Drops Solution

Resept typen:

Product not subject to medical prescription

Terapeutisk område:

Other antiallergics

Autorisasjon status:

Authorised

Autorisasjon dato:

2009-11-27

Informasjon til brukeren

2
PACKAGE LEAFLET: INFORMATION FOR THE USER
CATACROM 2 % W/V EYE DROPS, SOLUTION
Sodium cromoglicate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
For brevity, this medicine will be referred to as Catacrom Eye Drops
throughout this leaflet. Catacrom
Eye Drops are available without prescription but you still need to
take care to get the best results from
them.
Always use this medicine exactly as described in this leaflet or as
your doctor or pharmacist have told
you.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
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.
-
You must talk to a doctor if you do not feel better or if you feel
worse.
WHAT IS IN THIS LEAFLET
1.
What Catacrom Eye Drops are and what they are used for
2.
What you need to know before you use Catacrom Eye Drops
3.
How to use Catacrom Eye Drops
4.
Possible side effects
5.
How to store Catacrom Eye Drops
6.
Contents of the pack and other information
1.
WHAT CATACROM EYE DROPS ARE AND WHAT THEY ARE USED FOR
Catacrom Eye Drops are for the relief and treatment of allergic red,
watery, itchy and puffy eyes
caused by hayfever, house mites, and other causes of allergy such as
pet hairs. Eye allergy can happen
when sensitive eyes are exposed to these causes of allergy.
Catacrom Eye Drops is a medicine which affects cells called mast
cells. It prevents them from
releasing chemical substances which cause symptoms such as the
redness, watering, itching and
puffiness of allergic reactions.
These eye drops can be used by wearers of rigid or gas permeable
contact lenses and can be used by
people who are sensitive to preservatives in other kinds of eye drops.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE CATACROM EYE DROPS
DO NOT USE CATACROM EYE DROPS:
-
if you are allergic to sodium cromoglicate or any of the other
ingredients of t

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Catacrom 2% w/v eye drops, solution.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium cromoglicate 2.0% w/v.
Each individual single-dose unit contains 6mg of sodium cromoglicate
in 0.3ml of solution
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution (eye drops)
Clear, colourless solution in a single-dose container.
The eye drops are sterile and preservative free.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Catacrom 2% w/v eye drops are indicated for the relief and treatment
of seasonal and perennial allergic conjunctivitis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Topical ophthalmic use.
Adults, children and the elderly: one or two drops into each eye four
times per day, or as directed by the doctor.
4.3 CONTRAINDICATIONS
Known hypersensitivity to sodium cromoglicate
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Catacrom 2% w/v eye drops are sterile, preservative free and presented
in a single-use container which should be
discarded after use.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
None known
4.6 FERTILITY, PREGNANCY AND LACTATION
Catacrom 2% w/v eye drops should be used with caution in pregnancy,
especially during the first trimester. Extensive
experience with sodium cromoglicate suggests that there are no adverse
effects on foetal development. Nevertheless, it
should only be used in pregnancy where there is a clinical need.
It is not known whether sodium cromoglicate is excreted in breast
milk; however, on the basis of its physicochemical
properties, it is considered unlikely. There is no evidence that the
use of sodium cromoglicate has any undesirable
effects on the baby.
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