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ILUBE Eye drops, solution (2020)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης Moorfields Pharmaceuticals
Διεύθυνση 25 Provost Street, London, N1 7NH
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Περιεχόμενα

Name of the medicinal product

ILUBE 5% w/v Eye Drops, Solution.

Qualitative and quantitative composition

Acetylcysteine 5.0% w/v. Excipient(s) with known effect: Benzalkonium chloride 0.01% w/v. For the full list of excipients, see section 6.1.

Pharmaceutical form

Eye drops, solution. A clear and colourless eye drops solution.

Therapeutic indications

ILUBE Eye Drops are artificial tears with mucolytic and lubricant properties, suitable for the relief of dry eye syndromes associated with deficient tear secretion, impaired or abnormal mucus production. ...

Posology and method of administration

Posology The usual dose is 1 or 2 drops instilled into the affected eye(s) 3 or 4 times daily. Paediatric population No data are available. Method of administration ILUBE Eye Drops are administered by ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Special warnings and precautions for use

ILUBE Eye Drops contain benzalkonium chloride which may cause eye irritation or discolour soft contact lenses. Avoid contact with soft contact lenses. Patients should be instructed to remove contact lenses ...

Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed. Medical advice must be sought before taking ILUBE Eye Drops with any medication, including medicines obtained without a prescription.

Pregnancy and lactation

This product should not be taken if the patient is pregnant, might get pregnant, or is breast-feeding without seeking medical advice.

Effects on ability to drive and use machines

Patients must be advised that their vision may be blurred after using Ilube Eye Drops and must not drive or use any machines, unless their vision is clear.

Undesirable effects

Patient may experience itching, redness and/or irritation in their eye(s). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is ...

Overdose

None known.

Pharmacodynamic properties

Pharmacotherapeutic Group: Ophthalmologicals, other ophthalmologicals ATC Code: S01XA08 Acetylcysteine, a derivative of the naturally occurring amino acid L-cysteine, with marked mucolytic properties. ...

Pharmacokinetic properties

No specific work has been carried out on the pharmacokinetic properties of acetylcysteine when used as a topical preparation for the eye. Acetylcysteine reduces the viscosity and tenacity of mucus in the ...

Preclinical safety data

There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

List of excipients

Disodium edetate Hypromellose Benzalkonium chloride Sodium hydroxide Purified water

Incompatibilities

Not applicable.

Shelf life

2 years (unopened), 28 days (after first opening).

Special precautions for storage

Do not store above 25°C. Keep the bottle in the outer carton in order to protect from light. Keep the bottle tightly closed. For storage conditions after first opening of the medicinal product, see section ...

Nature and contents of container

A lipped Type I amber glass bottle with a push-in closure (chlorobutyl bung) containing 10 ml of solution. The bung is held in place by a polypropylene and aluminium overseal. The bung and overseal form ...

Special precautions for disposal and other handling

Discard 28 days after first opening the pack. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Marketing authorization holder

Rayner Pharmaceuticals Ltd, 10 Dominion Way, Worthing, West Sussex, BN14 8AQ, United Kingdom

Marketing authorization number(s)

PL 47069/0002

Date of first authorization / renewal of the authorization

Date of first authorisation: 17 December 1992 Date of last renewal: 25 June 2007

Date of revision of the text

December 2020

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