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CROMO SINGLES 2% W/V EYE DROPS

Active substance(s): SODIUM CROMOGLICATE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Cromo Singles 2% w/v Eye Drops

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium cromoglicate 2% w/v.
For a full list of excipients, see Section 6.1

3

PHARMACEUTICAL FORM
Eye drops, solution.
Clear, colourless to pale yellow sterile solution; practically free from visible particles

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
For prophylaxis and symptomatic relief in acute allergic conjunctivitis such as hay
fever, chronic allergic conjunctivitis and vernal kerato conjunctivitis.
Sodium cromoglicate inhibits the release of mediators of the allergic reaction from
sensitised mast cells.

4.2

Posology and method of administration
For ocular use.
The recommended dose for adults (including the elderly) and children is one or two
drops in each affected eye four times a day.
The eye drops are supplied in single-dose containers for single-dose administration
only. Prior to administration, the sterile eye drops should be visually inspected for
clarity, particulate matter, discolouration and the integrity of the container. The eye

drops should only be used if the solution is clear and the container is intact and
undamaged. The eye drops should be administered immediately after opening the
sealed container. Any unused solution should be discarded immediately after initial
administration.

4.3

Contraindications
Hypersensitivity to sodium cromoglicate.

4.4

Special warnings and precautions for use
The eye drops do not contain antimicrobial preservatives and are supplied in singledose containers for single-dose administration only.
Soft contact lenses should not be worn whilst using this product.

4.5

Interaction with other medicinal products and other forms of interaction
None reported. Sodium cromoglicate has a local action and is poorly absorbed
systemically. No interaction studies have been performed.

4.6

Fertility, Pregnancy and Lactation'
Pregnancy: Use of Cromo Singles in pregnancy has not been studied and anticipated
benefit should be weighed against possible hazards. Experience with sodium
cromoglicate suggests it has no effect on foetal development.
Breast feeding: It is unlikely that sodium cromoglicate is excreted in breast milk due
to its physico-chemical properties. Poor systemic absorption would suggest there
would be no adverse 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. If affected, do not drive
or operate machinery whilst vision is blurred.

4.8

Undesirable effects
Mild stinging or burning may occur for a short time after instillation.

4.9

Overdose
No action other than medical observation should be necessary.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Pharmocotherapeutic group: Other antiallergics. ATC Code: S01GX01
Sodium cromoglicate inhibits the release of the mediators of allergic reactions from
sensitised mast cells. The exact mechanism of action is unknown but it is suggested
that sodium cromoglicate stabilises the mast cell membrane.

5.2

Pharmacokinetic properties
Sodium cromoglicate is lipid insoluble and only effective by topical administration.
Very small amounts are absorbed systemically and it is excreted unchanged in the
bile and urine.

5.3

Preclinical safety data
None available.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Purified water

6.2

Incompatibilities
None known

6.3

Shelf life
Shelf life as packaged for sale: 3 years
Shelf life after first opening the single-dose container: For single-dose administration
only. To be administered immediately after opening. Any unused solution should be
discarded immediately after initial administration.

6.4

Special precautions for storage
Do not store above 25 °C. Keep the single-dose containers in the outer carton for
protection from light.

6.5

Nature and contents of container
Low density polyethylene (LDPE) single-dose container fitted with a twist and pull
off tamper-evident seal containing 0.4ml eye drops. Supplied as 20 single-dose
containers (4 strips of 5 single-dose containers) in an outer carton.

6.6

Special precautions for disposal
No special requirements.
Any unused product or waste material should be disposed of in accordance with local
requirements.

7

MARKETING AUTHORISATION HOLDER
Four Pharmaceuticals Ltd., 23 Upper Green Road, Tewin, Welwyn, Herts, AL6 0LE,
UK

8

MARKETING AUTHORISATION NUMBER(S)
PL 17248/0003

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
24/05/2013

10

DATE OF REVISION OF THE TEXT
24/05/2013

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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