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SPC, UK: Emadine 0.05% w/v, Eye Drops, Solution (2011)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
Alcon Laboratories (U.K) Limited
Διεύθυνση :
Pentagon Park, Boundary Way, Hemel Hempstead, Hertfordshire, HP2 7UD
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Δωρεάν εγγραφή

Name of the medicinal product

EMADINE 0.5 mg/ml, Eye Drops, solution.

Qualitative and quantitative composition

1 ml of solution contains emedastine 0.5 mg (as difumarate) Excipients: Benzalkonium chloride 0.1 mg/ml For a full list of excipients, see section 6.1

Pharmaceutical form

Eye drops, (solution). Clear, colourless solution.

Therapeutic indications

Symptomatic treatment of seasonal allergic conjunctivitis.

Posology and method of administration

EMADINE has not been studied in clinical trials beyond six weeks. Posology The dose is one drop of EMADINE to be applied to the affected eye(s) twice daily. When used with other ophthalmic medicines, an ...

Contraindications

Hypersensitivity to emedastine or to any of the excipients.

Special warnings and precautions for use

Ocular corneal infiltrates Ocular corneal infiltrates were reported in conjunction with the use of EMADINE. In case of corneal infiltrates, the product should be discontinued and appropriate management ...

Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed.

Pregnancy and lactation

Pregnancy There are no adequate data from the use of emedastine in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown. Nevertheless, ...

Effects on ability to drive and use machines

As with any ocular medication, if transient blurred vision occurs at instillation, the patient should wait until the vision clears before driving or using machinery.

Undesirable effects

In 13 clinical studies involving 696 patients, Emadine was administered one to four times daily in both eyes for up to 42 days. In clinical trials, approximately 7% of patients experienced an adverse drug ...

Overdose

No data are available in humans regarding overdose by accidental or deliberate ingestion. In case of accidental ingestion of the content of a bottle of EMADINE, the potential of emedastine to increase ...

Pharmacodynamic properties

Pharmacotherapeutic group: decongestants and antiallergics; other antiallergics ATC code: S01GX06 Emedastine is a potent selective and topically effective histamine H<sub>1</sub> antagonist (K<sub>i</sub> ...

Pharmacokinetic properties

Absorption Emedastine is absorbed systemically, as are other topically administered drug substances. In a study involving ten normal volunteers dosed bilaterally twice daily for 15 days with EMADINE 0.5 ...

Preclinical safety data

Emedastine difumarate demonstrated low acute toxicity in a number of species by various routes of administration. No clinically significant local or systemic effects were observed in long-term topical ...

List of excipients

Benzalkonium chloride 0.1 mg/ml Trometamol Sodium chloride Hypromellose Hydrochloric acid/sodium hydroxide (to adjust pH) Purified water

Incompatibilities

Not applicable.

Shelf life

30 months. EMADINE should not be used for longer than 4 weeks after first opening.

Special precautions for storage

Do not store above 25°C.

Nature and contents of container

EMADINE is supplied in 5 ml and 10 ml opaque plastic DROP-TAINER bottles. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

Alcon Laboratories (UK) Ltd Pentagon Park Boundary Way Hemel Hempstead Herts HP2 7UD United Kingdom

Marketing authorization number(s)

EU/1/98/095/001-2

Date of first authorization / renewal of the authorization

Date of first authorisation: 27th January 1999 Date of last renewal: 29th January 2004

Date of revision of the text

30 November 2010