SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE MEDICINAL PRODUCT
{Invented name} 20 mg/ml eye drops, solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml contains sodium cromoglicate 20 mg
Excipient with known effect: Benzalkonium chloride 0.1 mg/ml
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Eye drops, solution
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Allergic conjunctivitis.
4.2
Posology and method of administration
The dose should be determined individually for each patient.
Adults and children 7 years and above:
1-2 drops in each eye 4 times a day
Pediatric population
Sodium cromoglicate is not recommended for use in children below 7 years.
Sodium cromoglicate eye drops should be used regularly to obtain an optimal control of symptoms.
Treatment should continue as long as the patient is exposed to the allergen, even if the symptoms have
disappeared.
If additional eye preparations are used, an interval of 5 minutes between instillation of the different
preparations should be held.
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
{Invented name} contain benzalkonium chloride:
As with other ophthalmic solutions containing benzalkonium chloride, soft contact lenses should not be worn
during treatment period, as benzalkonium chloride may cause discolouration of the contact lenses and
irritaion of the eyes.
4.5
Interaction with other medicinal products and other forms of interaction
None.
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4.6
Fertility, pregnancy and lactation
Pregnancy
{Invented name} can be used during pregnancy.
A moderate amount of data on pregnant women indicate no harmful effects on pregnancy, no malformative
or feto/neonatal toxicity of sodium cromocligate. Animal studies do not indicate reproductive toxicity.
Breastfeeding
{Invented name} can be used during breastfeeding.
No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breast-feeding
woman to sodium cromocligate is negligible.
4.7
Effects on ability to drive and use machines
Transient blurring of vision may occur on instillation of eye drops. Do not drive or use machines unless
vision is clear.
4.8
Undesirable effects
Less than 1% of the treated patients can experience undesirable effects. The most common undesirable
effects are Transient stinging and local irritation of the eye.
Eye disorders:
Common (1/100 to <1/10)
Transient stinging and burning may
occur after instillation.
Immune system disorders:
Very rare (1/10,000)
Hypersensitivity reactions.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows
continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked
to report any suspected adverse reactions via the national reporting system listed in Appendix V.
4.9
Overdose
No action other than medical observation should be necessary.
5.
PHARMACOLOGICAL PROPERTIES
5.1
Pharmacodynamic properties
Pharmacotherapeutic group: Ophthalmologicals; Other antiallergics, ATC code: S01GX01
In vitro and in vivo animal studies have shown that sodium cromoglicate inhibits the degranulation of
sensitised mast cells which occurs after exposure to specific antigens. Sodium cromoglicate acts by
inhibiting the release of histamine and various membrane derived mediators from the mast cell.
Sodium cromoglicate has demonstrated the activity in vitro to inhibit the degranulation of non-sensitised rat
mast cells by phospholipase A and subsequent release of chemical mediators. Sodium cromoglicate did not
inhibit the enzymatic activity of released phospholipase A on its specific substrate.
Sodium cromoglicate has no intrinsic vasoconstrictor or antihistamine activity.
5.2
Pharmacokinetic properties
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Sodium cromoglicate is poorly absorbed. When multiple doses of sodium cromoglicate ophthalmic solution
are instilled into normal rabbit eyes, less than 0.07% of the administered dose of sodium cromoglicate is
absorbed into the systemic circulation (presumably by way of the eye, nasal passages, buccal cavity and
gastrointestinal tract). Trace amounts (less than 0.01%) of the sodium cromoglicate does penetrate into the
aqueous humour and clearance from this chamber is virtually complete within 24 hours after treatment is
stopped.
In normal volunteers, analysis of drug excretion indicates that approximately 0.03% of sodium cromoglicate
is absorbed following administration to the eye
5.3
Preclinical safety data
Animal studies have shown that sodium cromoglicate has low local systemic toxicity.
6.
PHARMACEUTICAL PARTICULARS
6.1
List of excipients
Benzalkonium chloride, disodium edetate, purified water.
6.2
Incompatibilities
None
6.3
Shelf life
30 months.
After opening: use contents within 4 weeks.
6.4
Special precautions for storage
Store the eye drop bottle in the outer package in order to protect from light.
Store below 25° C.
6.5
Nature and contents of container
Eye drop bottle: Transparent LDPE bottle with dropper and a white HDPE screw-on cap.
Pack sizes: 1 x 5 ml, 1 x 10 ml and 1 x 13.5 ml
Not all pack sizes may be marketed.
6.6
Special precautions for disposal
No special requirements.
Any unused medicinal product or waste material should be disposed of in accordance with local
requirements.
7.
MARKETING AUTHORISATION HOLDER
[To be completed nationally]
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8.
MARKETING AUTHORISATION NUMBER(S)
[To be completed nationally]
9.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
2014-09-30
10.
DATE OF REVISION OF THE TEXT
09/2014
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