Cromolux Hayfever 2% eye drops

Country: Bretland

Tungumál: enska

Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)

Virkt innihaldsefni:

Sodium cromoglicate

Fáanlegur frá:

Tubilux Pharma Ltd

ATC númer:

S01GX01

INN (Alþjóðlegt nafn):

Sodium cromoglicate

Skammtar:

20mg/1ml

Lyfjaform:

Eye drops

Stjórnsýsluleið:

Ocular

Tegund:

No Controlled Drug Status

Gerð lyfseðils:

Valid as a prescribable product

Vörulýsing:

BNF: 11040200

Upplýsingar fylgiseðill

FRONT
BACK
PATIENT INFORMATION LEAFLET
CROMOLUX 2%
HAYFEVER EYE DROPS
SODIUM CROMOGLICATE 2% W/V
PLEASE READ THIS LEAFLET CAREFULLY
BEFORE YOU START TO TAKE YOUR
MEDICINE.
• Keep this leaflet. You may need
to read it again.
• If you have any further questions,
please ask your doctor or
pharmacist.
• This medicine has been
prescribed for you. Do not pass
it on to others. It may harm them,
even if their symptoms are the
same as yours.
• If any of the side effects gets
serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or
pharmacist.
IN THIS LEAFLET:
1. WHAT CROMOLUX 2% HAYFEVER EYE
DROPS ARE AND WHAT THEY ARE
USED FOR
2. BEFORE YOU USE CROMOLUX 2%
HAYFEVER EYE DROPS
3. HOW TO USE CROMOLUX 2%
HAYFEVER EYE DROPS
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE CROMOLUX 2%
HAYFEVER EYE DROPS
6. FURTHER INFORMATION
1.WHAT CROMOLUX 2% HAYFEVER
EYE DROPS ARE AND WHAT THEY
ARE USED FOR
The name of this medicine is
Cromolux 2% Hayfever Eye Drops,
which is referred to as “eye drops”
throughout this leaflet.
Cromolux 2% Hayfever Eye Drops
are used for the relief and
treatment of itchy, runny eyes,
redness and discomfort caused by
seasonal allergies, such as
hayfever,and perennial allergies
such as those due to dust, mould
and pets.
2.BEFORE YOU USE EYE DROPS
DO NOT USE THE EYE DROPS:
• if you are sensitive/allergic to
sodium cromoglicate or to any of
the ingredients in this product
• if you wear soft contact lenses
because this medicine contains
benzalkonium chloride solution
and it can react with soft contact
lenses.
TAKE SPECIAL CARE WITH THE EYE
DROPS IF YOU:
• are pregnant or breast feeding
• are taking other medicines
TAKING OTHER MEDICINES
Please tell your doctor or
pharmacist if you are applying any
other type of eye drops or eye
ointment before you start to use this
medicine. Your medicine may affect
their action and could alter their
effect.
Please tell your doctor or
pharmacist if you are taking or have
recently taken any other medicines,
including medicines o

Vara einkenni

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cromolux 2% Hay fever Eye Drops
Tesco Allergy Eye Drops sodium cromoglicate 2%
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each one ml of solution contains 20.0 mg of Sodium Cromoglicate.
Pack size: 10.0 ml.
For excipients, see section 6.1
3
PHARMACEUTICAL FORM
Eye drops solution
A clear, colourless solution
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of Hayfever. For the treatment of acute seasonal and
perennial allergic
conjunctivitis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults (including elderly) and children: One or two drops in each eye
four times daily.
4.3
CONTRAINDICATIONS
Sodium cromoglicate eye drops are contraindicated in patients with
sensitivity to any ingredient,
including sodium cromoglicate, benzalkonium chloride and sodium
edetate.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Soft contact lenses should not be worn during treatment.
Sodium cromoglicate is to be used prophylactically. Therefore patients
should be advised not to
discontinue use of the product unless advised to do so.
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
None Known
4.6
PREGNANCY AND LACTATION
As with all medications during pregnancy, this product should be used
with caution especially
during the first trimester. There do not appear to be foetal
abnormalities in toxicity studies, but
this should not mitigate the care to be used with this product. The
product should therefore only
be used in pregnancy where there is a clear need.
There is no information to indicate that the use of sodium
cromoglicate has any undesirable
effects on the baby.
It is unlikely that this product would be excreted in breast milk but
this has not been fully
investigated.
4.7
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
Instillation of drops may cause transient alteration of vision.
Patients should be advised not to
drive or operate machinery until clarity of vision is restored.
4.8
UNDESIRABLE EFFECTS
Stinging, blurring of vi