Aspire Allergy Relief 2% eye drops

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Sodium cromoglicate

Tilgjengelig fra:

Aspire Pharma Ltd

ATC-kode:

S01GX01

INN (International Name):

Sodium cromoglicate

Dosering :

20mg/1ml

Legemiddelform:

Eye drops

Administreringsrute:

Ocular

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 11040200; GTIN: 5060209731513

Informasjon til brukeren

PACKAGE LEAFLET: INFORMATION FOR THE USER
EM PHARMA ALLERGY RELIEF 2% W/V EYE DROPS
Sodium cromoglicate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
Always use this medicine exactly as described in this leaflet or as
your doctor or
pharmacist has 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, pharmacist or
nurse.
This includes any possible side effects not listed in this leaflet.
See section 4.
• You must talk to your doctor if your eyes do not feel better or if
they feel worse
after 2 days.
WHAT IS IN THIS LEAFLET:
1. What this medicine is and what it is used for
2. What you need to know before you use this medicine
3. How to use this medicine
4. Possible side effects
5. How to store this medicine
6. Contents of the pack and other information
1.WHAT THIS MEDICINE IS AND WHAT IT IS USED FOR
This medicine contains sodium cromoglicate which belongs to a group of
medicines called anti-allergics.
It works by stopping the release of the natural substances in your
eyes that can
lead to an allergic reaction. Signs of an allergic reaction include
itchy, watery, red
or inflamed eyes and puffy eyelids.
This medicine is used for the prevention and treatment of eye
allergies.
These allergies can happen:
• At any time of the year and is called ‘perennial allergic
conjunctivitis’
• In different seasons of the year caused by different pollens.
This is called ‘seasonal allergic conjunctivitis’ or hay fever
2.WHAT YOU NEED TO KNOW BEFORE YOU USE THIS MEDICINE
DO NOT USE THIS MEDICINE
• If you are allergic (hypersensitive) to sodium cromoglicate or any
of the other
ingredients of this medicine (listed in Section 6).
Signs of an allergic reaction include: a rash, swallowing or breathing
problems,
swelling of your lips, face, throat, tongue and worsening of redness,
itching or
swelling of the eye or eyelid.

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Aspire Allergy Relief 2% w/v eye drops, Solution
Optrex Allergy 2%w/v Eye Drops, Solution
EM Pharma Allergy Relief 2%w/v Eye Drops, Solution
Opticrom Allergy 2%w/v Eye Drops, Solution
Lloyds Pharmacy Allergy Relief 2% w/v Eye Drops, Solution
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of eye drops contains
Active substance: 20 mg sodium cromoglicate (2.0% w/v), (one drop
contains 0.7mg
sodium cromoglicate).
Excipient with known effect: 0.1mg benzalkonium chloride
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Eye Drops, Solution (eye drops)
Clear colourless to pale yellow solution
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the relief and treatment of seasonal and perennial allergic
conjunctivitis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Topical ophthalmic administration
One or two drops in each eye four times a day or as indicated by the
doctor.
Older people
There is no evidence to suggest that dosage alteration is required for
elderly patients.
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
Discard any remaining contents four weeks after opening the bottle.
Sodium cromoglicate eye drops contains benzalkonium chloride.
As with other ophthalmic solutions containing benzalkonium chloride,
soft contact
lenses should not be worn during the treatment period.
From the limited data available, there is no difference in the adverse
event profile in
children compared to adults. Generally, however, eyes in children show
a stronger
reaction for a given stimulus than the adult eye. Irritation may have
an effect on
treatment adherence in children.
Benzalkonium chloride has been reported to cause eye irritation,
symptoms of dry
eyes and may affect the tear film and corneal surface. Should be used
with caution in
dry eye patients and in patients where the cornea may be compromised.
Patients should be monitor