POSIFORLID Eye ointment Ref.[51135] Active ingredients: Bibrocathol

Source: Medicines Authority (MT)  Revision Year: 2021  Publisher: URSAPHARM Arzneimittel GmbH, IndustriestraรŸe, 66129 Saarbrรผcken, Germany Tel.: +49 (0)6805/92 92-0 Fax: +49 (0)6805/92 92-88 e-mail: info@ursapharm.de

4.1. Therapeutic indications

Chronic inflammation of the lid margin (Blepharitis chronica) not requiring antibiotic treatment.

4.2. Posology and method of administration

Posology

Adults

If not otherwise prescribed, a 0.5 cm strip of eye ointment should be applied in adults 3 to 5 times daily into the conjunctival sac or on the affected position of the eye lid for a maximum of 14 days.

Adolescents and Children 6 years and older

If not otherwise prescribed, a 0.5 cm strip of eye ointment should be applied in children aged 6 to less than 18 years 3 times daily into the conjunctival sac or on the affected position of the eye lid for a maximum of 10 days.

Paediatric population

The safety and efficacy of Posiforlid in children less than 6 years of age have not been established. No data are available.

Posiforlid 20 mg/g may be applied until relief of the symptoms. When the complaints persist or the symptoms do not improve a physician should be consulted after 7 days.

Method of administration

For ocular use.

A contact between the tip of the tube and eye or facial skin should be avoided.

4.9. Overdose

Systemic medicinal product reactions after local application of ophthalmic ointment containing bibrocathol to the eye are not to be expected due to the extremely low penetration of the poorly soluble bibrocathol.

In the improbable event of systemic side effects following incorrect use or an accidental overdose these should be treated symptomatically.

6.3. Shelf life

3 years.

After first opening: 4 weeks.

6.4. Special precautions for storage

Do not store above 30ยฐC.

6.5. Nature and contents of container

Aluminium tube with inner protective lacquer made of epoxy phenolic resin, high-density polyethylene nozzle and screw cap.

The following packsize is available: Folding carton with one tube of 5 g.

6.6. Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

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