Lennon Sulphacetamide Eye 3,5 g Ointment

LENNON SULPHACETAMIDE EYE OINTMENT is indicated in adults for treatment of infections of the eye and eye socket, sties and trachoma.

Posology

LENNON SULPHACETAMIDE EYE OINTMENT is usually applied as a thin strip into the conjunctival sac of the infected eye every 6 hours and at bedtime. Consult your doctor if no improvement has occurred within 6 days.

Paediatric population

No data are available.

Method of administration

Topical

LENNON SULPHACETAMIDE EYE OINTMENT is contraindicated in:

• Patients with hypersensitivity to sulphacetamide sodium, sulphonamides or to any excipients in LENNON SULPHACETAMIDE EYE OINTMENT (see section 6.1).
• The application to penetrating wounds of the cornea.
• Concurrent administration with preparations containing silver salts.

Treatment with sulphonamides should be stopped immediately when a rash appears because of the danger of severe allergic reactions such as the Stevens - Johnson syndrome. Patients with glucose 6 - phosphate dehydrogenase deficiency may be at risk of haemolytic reactions.

Sulphonamides have been associated with acute attacks of porphyria and are considered unsafe in porphyric patients. It should be used with caution in patients with dry - eye syndrome. Caution is also needed in the elderly, who may be more likely to have other risk factors for adverse reactions.

Sulphonamides have been reported to interfere with some diagnostic tests, including those for urea, creatinine, and urinary glucose and urobilinogen. Local application to the eye may cause burning or stinging, but this is rarely severe enough to necessitate discontinuance of treatment. Patients sensitive to furosemide, thiazide diuretics, sulphonylureas, or carbonic anhydrase inhibitors may be sensitive to sulphonamides also.

Paediatric population

Daytime use of LENNON SULPHACETAMIDE EYE OINTMENT is not advocated in children over one year of age because it may temporarily interfere with vision.

Silver preparations

Silver preparations such as silver nitrate or mild silver protein (see section 4.3)

Oral anticoagulants (warfarin), methotrexate and phenytoin: The effects of these medications may be potentiated due to the displacement of the medicine from plasma binding sites or to inhibition of metabolism.

The safety and efficacy during pregnancy and lactation has not been established.

Fertility

No data available.

LENNON SULPHACETAMIDE EYE OINTMENT has moderate influence as it may cause blurred vision and should be used with caution if driving or operating machinery.

System organ class

Frequent

Less frequent

Frequency unknown

Eye disorders

Blurred vision, burning and stinging

Respiratory, thoracic and mediastinal disorders

Nasal irritation

Gastrointestinal disorders

Bitter taste, unpleasant sensation in the throat

Skin and subcutaneous tissue disorders

Hypersensitivity reactions including itching, redness, swelling, or other signs of irritation not present before therapy (see section 4.4)

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Health care providers are requested to report any suspected adverse drug reactions to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who - umc.org) found on SAHPRA website Aspen Pharmacare: E - mail: [email protected] Tel: 0800 118 088 /+27 (0)11 239 - 6200

Symptoms

In overdose, side effects can be precipitated and/or be of increased severity (see section 4.8).

Treatment

Treatment is symptomatic and supportive.