Document: Azelastine OmniVision eye drops, solution SmPC ENG change

• Azelastine OmniVision 0.5 mg per ml eye drops, solution SmPC
• Azelastine OmniVision eye drops, solution SmPC ENG

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SUMMARY OF PRODUCT CHARACTERISTICS

Azelastine OmniVision0.5 mg/ml eye drops, solution.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One mL contains 0.5 mg azelastine hydrochloride.

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Eye drops, solution.

Clear and colourless to nearly colourless, slightly viscous solution.

4. CLINICAL PARTICULARS

4.1. Therapeutic indications

Treatment and prevention of the symptoms of seasonal allergic conjunctivitis in adults and children 4 years and older.

Treatment of the symptoms of non-seasonal allergic conjunctivitis in adults and children 12 years and older.

Posology

Seasonal allergic conjunctivitis

The usual dosage in adults and children 4 years and older is one drop in each eye twice daily that can be increased, if necessary to four times daily. If allergen exposure is anticipated, Azelastine OmniVision should be administered prophylactically, prior to the exposure.

Non-seasonal (perennial) allergic conjunctivitis:

The usual dosage in adults and children 12 years and older is one drop in each eye twice daily that can be increased, if necessary to four times daily. As safety and efficacy have been demonstrated in clinical trials for a period of up to 6 weeks, the duration of any course should be limited to a maximum of 6 weeks.

Paediatric population

Safety and efficacy of Azelastine OmniVision in children aged less than 4 years has not been established.

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

Azelastine OmniVision is not intended for treatment of eye infections.

No specific interaction studies with Azelastine OmniVision have been performed.

Interaction studies at high oral doses have been performed however they bear no relevance to Azelastine OmniVision as systemic levels, after administration of the eye drops, are in the picogram range.

There is insufficient information available to establish the safety of azelastine in human pregnancy. At high oral doses azelastine has shown to induce adverse effects (foetal death, growth retardation and skeletal malformation) in experimental animals. Local ocular application will result in minimal systemic exposure (picogram range). However, caution should be exercised when using Azelastine OmniVisionduring pregnancy.

Azelastine is excreted into the milk in low quantities. For that reason, Azelastine OmniVisionis not recommended during breast feeding.

4.7. Effects on ability to drive and use machines

The mild, transient irritation which can be experienced after application of Azelastine OmniVisionis unlikely to affect vision to any greater extent. However, if there are any transient effects on vision, the patient should be advised to wait until this clears before driving or operating machinery.

4.8. Undesirable effects

Assessment of undesirable effects is based on the following frequencies: very common (1/10), common (1/100 to <1/10), uncommon (1/1,000 to <1/100), rare (1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).

The following adverse events have been reported during Azelastine hydrochloride therapy:

Eye disorders

Common: mild, transient irritation in the eye.

Nervous system disorders

Uncommon: bitter taste.

Immune system disorders

Very rare: allergic reactions.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions viathe national reporting system listed in

[To be completed nationally]

No specific reactions after ocular overdose are known, and with the ocular route of administration, overdose reactions are not anticipated.

There is no experience with the administration of toxic doses of azelastine hydrochloride in humans. In the case of overdose or intoxication, disturbances of the central nervous system are to be expected based on the results of animal experiments. Treatment of these disorders must be symptomatic. There is no known antidote.

5.1 Pharmacodynamics properties

Pharmacotherapeutic Group: Antiallergic, ATC code: S01G X07.

Azelastine, a phthalazinone derivative is classified as a potent long-acting anti-allergic compound with selective H1 antagonist properties. An additional anti-inflammatory effect could be detected after topical ocular administration.

Data from in vivo (pre-clinical) and in vitro studies show that azelastine inhibits the synthesis or release of the chemical mediators known to be involved in early and late stage allergic reactions e.g. leukotriene, histamine, PAF and serotonin.

To date, long term therapy ECG evaluations of patients treated with high oral doses of azelastine, have shown that in multiple dose studies, there is no clinically significant effect of azelastine on the corrected QT (QTc) interval.

No association of azelastine with ventricular arrhythmia or torsade de pointes was observed in over 3700 patients treated with oral azelastine.

General characteristics (systemic pharmacokinetics)

Following oral administration azelastine is rapidly absorbed showing an absolute bioavailability of 81%. Food has no influence on absorption. The volume of distribution is high indicating distribution predominantly into the periphery. The level of protein binding is relatively low (80 - 90%, a level too low to give concern over drug displacement reactions).

Plasma elimination half-lives after a single dose of azelastine are approximately 20 hours for azelastine and about 45 hours for the therapeutically active metabolite N-Desmethyl azelastine. Excretion occurs mainly via the faeces. The sustained excretion of small amounts of the dose in the faeces suggests that some entero-hepatic circulation may take place.

Characteristics in patients (ocular pharmacokinetics)

After repeated ocular application of azelastine ophthalmic solution (up to one drop in each eye, four times daily), Cmax steady state plasma levels of azelastine hydrochloride were very low and were detected at or below the limit of quantification.

Azelastine hydrochloride displayed no sensitising potential in the guinea pig. Azelastine demonstrated no genotoxic potential in a battery of in vitro and in vivo tests, nor any carcinogenic potential in rats or mice.

In male and female rats, azelastine at oral doses greater than 30 mg/kg/day caused a dose-related decrease in the fertility index; no substance-related alterations were found in the reproductive organs of males or females during chronic toxicity studies, however.

Embryotoxic and teratogenic effects in rats, mice and rabbits occurred only at maternal toxic doses (for example, skeletal malformations were observed in rats and rabbits at doses of 50 mg/kg/day).

6. PHARMACEUTICAL PARTICULARS

6.1. List of excipients

Sorbitol liquid

Hypromellose

Disodium edetate

Sodium hydroxide

Purified water

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

2 years.

After first opening of the container: 12 weeks.

6.4. Special precautions for storage

This medicinal product does not require any special storage conditions

6.5. Nature and contents of container

6 mL white HDPE bottle and white dropper with HDPE cap.

6.6 Special precautions for disposal and other handling

No special requirements for disposal.

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

OmniVision GmbH. Lindberghstrasse 7, 82178 D-Puchheim, Germany

Tel. +49 89 840 792 30

Fax. +49 89 840 792 40

E-mail: info@omnivision.de

8. MARKETING AUTHORISATION NUMBER(S)

To be completed nationally

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

2013-09-25

2015-11-27