Natriumcromoglicaat FDC

Natriumcromoglicaat FDC Eye Drops are for the prophylaxis and symptomatic treatment of acute allergic conjunctivitis, chronic allergic conjunctivitis and vernal kerato conjunctivitis.

Natriumcromoglicaat FDC Hay Fever Eye Drops are for the treatment of acute seasonal allergic conjunctivitis.

For the relief and treatment of seasonal and perennial allergic conjunctivitis.

Catacrom 2% w/v eye drops are indicated for the relief and treatment of seasonal and perennial allergic conjunctivitis.

Natriumcromoglicaat FDC is indicated for food allergy (where adequate investigations have been performed to determine sensitivity to one or more ingested allergens) in conjunction with restriction of main causative allergens.

Route of Administration:

For topical administration to the eye.

Adults, Children and the Elderly

One or two drops into each eye up to four times daily.

Topical Ophthalmic administration

One or two drops in each eye four times a day or as indicated by the doctor.

Elderly

No current evidence for alteration of the dose.

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.

Natriumcromoglicaat FDC must be administered orally

Adults (including the elderly)

Initial dose: 2 capsules four times daily before meals

Children (2 - 14 years)

Initial dose: 1 capsule four times daily before meals

For adults (including the elderly) and children, if satisfactory control is not achieved within two to three weeks, the dosage may be doubled but should not exceed 40 mg/Kg/day.

Maintenance dose: Once a therapeutic response has been achieved, the dose may be reduced to the minimum required to maintain the patient free from symptoms.

Known hypersensitivity to benzalkonium chloride, sodium cromoglycate or other constituents.

The product is contraindicated in patients who have shown hypersensitivity to Sodium cromoglicate, Benzalkonium chloride or Disodium edetate.

Known hypersensitivity to Natriumcromoglicaat FDC.

Natriumcromoglicaat FDC is contraindicated in patients with a known hypersensitivity to sodium cromoglicate or to any of the excipients.

The solution should be discarded 1 month after first opening the bottle or if any turbidity develops. Do not use if the bottle has been opened prior to receipt. Natriumcromoglicaat FDC Eye Drops and Natriumcromoglicaat FDC Hay Fever Eye Drops contain benzalkonium chloride. Do not wear soft contact lenses during the period of use.

Discard any remaining contents four weeks after opening the bottle.

As with other ophthalmic solutions containing Benzalkonium chloride, soft contact lenses should not be worn during treatment period.

Sodium cromoglicate can be used prophylactically. Patients should seek advice before they discontinue use of the product.

Catacrom 2% w/v eye drops are sterile, preservative free and presented in a single-use container which should be discarded after use.

None stated

Transient stinging or blurred vision may occur on instillation. Do not drive or operate machinery until proper vision is restored.

As with all eye drops, instillation of these eye drops may cause a transient blurring of vision or cause local irritation that could impact driving or operating machinery. Do not drive or operate machinery if affected.

As with all eye drops, transient blurring of vision may occur on instillation. Do not drive or operate machinery until normal vision is restored.

None known.

Transient stinging and burning may occur after instillation, other symptoms of local irritation have been reported rarely.

Eye Disorders

Transient stinging and burning may occur after instillation. Other symptoms of local irritation have been reported rarely.

Reporting of suspected adverse reactions

Reporting of 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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

On instillation, transient stinging or burning may occur. Rarely, other symptoms of local irritation have been reported.

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

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

Nausea, skin rashes and joint pains have been reported in a few cases.

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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

As sodium cromoglycate is absorbed only to a very limited extent from eye drops, no action other than medical observation should be necessary.

No action other than medical observation should be necessary.

Medical supervision only should be necessary.

If the solution is accidentally ingested, as Natriumcromoglicaat FDC is only poorly absorbed, no action other than medical supervision should be necessary.

As Natriumcromoglicaat FDC is only absorbed to a minimum extent, no action other than medical supervision should be necessary.

Sodium cromoglycate has neither anti-histaminic or anti-inflammatory activity. Evidence suggests that sodium cromoglycate inhibits the release of mediators of the allergic reaction by stabilising the membranes of sensitised mast cells.

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.

Pharmacotherapeutic group: Other antiallergics; cromoglicic acid, ATC code: S01G X01

The solution exerts its effect locally in the eye. Natriumcromoglicaat FDC has been shown to inhibit the degranulation of sensitised mast cells occurring after exposure to specific antigens. Natriumcromoglicaat FDC inhibits release of histamine and various membrane derived mediators from mast cells.

Natriumcromoglicaat FDC has no intrinsic antihistaminic or vasoconstrictor activity.

Pharmacotherapeutic group: Antiallergic agents, excluding corticosteroids, ATC Code: A07EB01

Sodium cromoglicate inhibits the release from mast cells of mediators of the allergic reaction. In gastrointestinal allergy the release of mediators can result in gastrointestinal symptoms or may allow absorption of antigenic material leading to systemic allergic reactions.

Due to lipid insolubility, sodium cromoglycate is poorly absorbed following administration to the eye. In normal volunteers approximately 0.03% is systemically absorbed. Absorbed sodium cromoglycate is excreted unchanged in the bile and urine.

Trace amounts of sodium cromoglycate have been detected in the aqueous humor of rabbits for up to 24 hours after treatment.

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.

Limited systemic absorption may be expected via ocular instillation.

In normal volunteers, analysis of drug excretion has shown that approximately 0.03% of Natriumcromoglicaat FDC is absorbed following ocular administration.

Not applicable

The results of the studies do not add to the information needed by the prescriber, consequently, they are not repeated in the SPC.

None.

There are no findings of relevance to the prescriber other than those already mentioned elsewhere in the SPC.

Animal studies have shown that sodium cromoglicate has a very low order of local or systemic toxicity.

Sodium cromoglycate forms insoluble complexes with metal ions resulting in solution turbidity.

None known.

None known. In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

None stated.

The following instructions for use are included in the patient leaflet.

1. Before using your Natriumcromoglicaat FDC Eye Drops (Natriumcromoglicaat FDC Hay Fever Eye Drops) you should wash your hands.

2. You may find it helps to sit in front of a mirror, so that you can see what you are doing. Gently pull down your lower eyelid and carefully place one or two Natriumcromoglicaat FDC Eye Drops (Natriumcromoglicaat FDC Hay Fever Eye Drops) in the space between the eyelid and the eye. Take care not to touch the dropper with your eye or fingers.

3. Release the eyelid and blink a few times to make sure the liquid covers the whole surface of the eye.

4. Repeat the procedure with the other eye and then replace the cap on the bottle.

None.

For single use only. Discard immediately after first use. Any unused product or waste material should be disposed of in accordance with local requirements.

Instructions for use are supplied with each pack.