Stop-Allerg Eye 1 ml Solution

Allergic conjunctivitis

Posology
Adults (including the elderly) and children: 1-2 drops into each eye 4 times daily. STOP-ALLERG EYE DROPS should be used regularly to ensure optimal control of symptoms.
It is recommended that treatment is continued during the period to the allergen, even when free of symptoms.

Method of administration
For ophthalmic use only
Care should be taken to avoid contamination of the contents during use. Patient should be advised not to wear soft contact lenses during treatment with STOP-ALLERG EYE DROPS.

• Known hypersensitivity to sodium cromoglycate or any of the other excipients listed in 6.1.

• Where concomitant steroid and sodium cromoglycate treatment has rendered it possible to reduce the steroid dose, precautions must be taken to prevent a severe attack if/when sodium cromoglycate is withdrawn from the treatment regime.
• Patients should be monitored in case of prolonged use.
• STOP-ALLERG EYE DROPS can be used prophylactically. Patients should seek advice before they discontinue use of STOP-ALLERG EYE DROPS.
• STOP-ALLERG EYE DROPS contains benzalkonium chloride as a preservative.
  This medicine contains 0,24 mg benzalkonium chloride 50 % solution in 1 litre which is equivalent to 0,01 % m/v.
  As the possibility of adverse effects on the corneal permeability and the danger of disruption of the corneal epithelium with prolong or repeated usage of benzalkonium chloride, preserved ophthalmological preparations cannot be excluded, regular ophthalmological examination is required.
  Caution should be exercised in the use of benzalkonium chloride preserved topical medication over an extended period in patients with extensive ocular surface disease.
  Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses. You should remove contact lenses before using this medicine and put them back 15 minutes afterwards.
  Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or disorders of the cornea (the clear layer at the front of the eye). If you feel abnormal eye sensation, stinging or pain in the eye after using this medicine, talk to your doctor.

None known.

Fertility: No available data
Pregnancy: STOP-ALLERG EYE DROPS should be used with caution during the first trimester of pregnancy as safety has not been established. Cumulative experience with sodium cromoglycate suggests that it has no adverse effects on foetal development.
Lactation: It is not known whether sodium cromoglycate is excreted in human breast milk but, on the basis of its physiochemical properties, this is considered unlikely. There is no information to suggest the use of sodium cromoglycate and any effects on the baby.

Transient stinging or blurred vision may occur on instillation (see section 4.8). Do not drive or operate machinery until proper vision is restored.

System Organ Class Frequency Undesirable effect
Immune System Disorders Unknown Hypersensitivity reactions (including headache, skin rash, bronchospasm, breathlessness, anaphylaxis).
Eye Disorders Less frequent Local irritation
Unknown Transient burning or stinging and blurring may occur after instillation.

As sodium cromoglycate is absorbed only to a very limited extent from eye drops, no action other than medical observation should be necessary. In the event of accidental ingestion, symptomatic treatment is recommended. If a hypersensitive reaction occurs, withdraw treatment.