Catacrom 2% eye drops 0.3ml unit dose

Land: Vereinigtes Königreich

Sprache: Englisch

Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)

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Herunterladen Gebrauchsinformation (PIL)
16-06-2018
Herunterladen Fachinformation (SPC)
16-06-2018

Wirkstoff:

Sodium cromoglicate

Verfügbar ab:

Rayner Pharmaceuticals Ltd

INN (Internationale Bezeichnung):

Sodium cromoglicate

Dosierung:

20mg/1ml

Darreichungsform:

Eye drops

Verabreichungsweg:

Ocular

Klasse:

No Controlled Drug Status

Verschreibungstyp:

Valid as a prescribable product

Produktbesonderheiten:

BNF: 11040200; GTIN: 5060132680018

Gebrauchsinformation

                                1
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
                                
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Fachinformation

                                OBJECT 1
CATACROM SODIUM CROMOGLICATE 2% PRESERVATIVE
FREE UNIT DOSE EYE DROPS
Summary of Product Characteristics Updated 25-Oct-2017 | Rayner
Pharmaceuticals Limited
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 6 mg of sodium cromoglicate
in 0.3 ml 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.
4.7 Effects on ability to drive and use machines
As with all eye drops, transient blurring of vision may occur on
instillation. Do not drive or operate
ma
                                
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