Azelastin-URSAPHARM 0,5 mg/ml oogdruppel, oplossing

Azelastin-URSAPHARM contains azelastine which belongs to a group of medicines called antihistamines. Antihistamines work by preventing the effects of substances such as histamine that the body produces as part of an allergic reaction. Azelastine has been shown to reduce inflammation of the eye.

Azelastin-URSAPHARM can be used to treat and prevent eye disorders which you get with hayfever (seasonal allergic conjunctivitis) in adults and children age 4 years and above. Azelastin-URSAPHARM can be used for eye disorders caused by an allergy to substances such as house dust mites or animal hair (perennial allergic conjunctivitis) in adults and children age 12 years and above.

Azelastin-URSAPHARM is not suitable for treating eye infections.

Edition 03/2012

1.3.1 SPC, Labelling and Package leaflet

Do not use Azelastin-URSAPHARM

if you are allergic (hypersensitive) to azelastine hydrochloride or any of the other ingredients of Azelastin-URSAPHARM (See section 6 “What Azelastin-URSAPHARM contains”).

If this applies to you, talk to your doctor.

Take special care with Azelastin-URSAPHARM

Please talk to your doctor or pharmacist

• if you are not sure whether your eye disorders are caused by an allergy. In particular if only one eye is affected; if your vision is impaired; or the eye hurts and you do not have any symptoms in your nose, you may have an infection rather than an allergy
• if the complaints worsen or last longer than 48 hours without remarkable improvement despite the use of Azelastin-URSAPHARM

Check with your doctor before using Azelastin-URSAPHARM if:

• you are taking any other medicines obtained without a prescription.
• you wear contact lenses. If wearing contact lenses applies for you, please see also the section “Important information about some of the ingredients of Azelastin- URSAPHARM” at the end of this section.

Using other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken or plan to use medicines, including other eye drops or medicines, including medicines obtained without prescription.

Interactions with other medicines or food are not known until now.

Pregnancy and breast-feeding

If you are pregnant, trying to become pregnant or breast-feeding ask your doctor or pharmacists for advice before using Azelastin-URSAPHARM.

As the active substance passes in small amounts into breast milk Azelastin-URSAPHARM should not be used during breast-feeding.

Driving and using machines

It is unlikely that the mild transient irritation occurring after application of Azelastin- URSAPHARM affects vision to a greater extent. However, if there are transient effects on vision, your sight may become blurred for a short time after you use Azelastin- URSAPHARM. Please wait until this clears before driving or operating machines.

Important information about some of the ingredients of Azelastin-URSAPHARM

Azelastin-URSAPHARM contains benzalkonium chloride. May cause eye irritation. Avoid contact with soft contact lenses. Remove contact lenses prior to application and wait at least 15 minutes before reinsertion. Known to discolour soft contact lenses.

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1.3.1 SPC, Labelling and Package leaflet

Always use Azelastin-URSAPHARM exactly as your doctor has told you. If you are not sure of the correct dose or how to use this medicine, ask your doctor or pharmacist.

Eye disorders caused by hayfever (Seasonal allergic conjunctivitis)

If not otherwise prescribed adults and children aged 4 years and older apply twice daily (in the morning and in the evening) one drop Azelastin-URSAPHARM to each eye. If necessary, that can be increased to four times daily.

Eye disorders caused by an allergy (Non seasonal (Perennial) allergic conjunctivitis)

If not otherwise prescribed adults and children aged 12 years and older apply twice daily one drop Azelastin-URSAPHARM to each eye. If necessary, that can be increased to four times daily.

Remember:

• Do not use Azelastin-URSAPHARM for more than 6 weeks.
• Azelastin-URSAPHARM should only be applied to the eyes.

How to use Azelastin-URSAPHARM

1. Wash your hands.
2. Take a clean tissue and gently wipe around your eyes to remove any moisture (diagram 1).
3. Unscrew the bottle and check that the dropper is clean.
4. Tilt your head slightly back, gently pull your lower eye lid down (diagram 2)
5. and place one drop inside the middle of your lower eye lid (diagram 3). Take care not to let the dropper touch your eye.
6. Release your lower eye lid and gently press on the inner corner of your eye against the bridge of your nose (diagram 4). Then keeping your finger pressed against your nose, slowly blink your eye a few times to spread the drop across the surface of your eye.
7. Blot away any excess medication.
8. Repeat this procedure for your other eye.

How long to use Azelastin-URSAPHARM

You should continue the treatment with Azelastin-URSAPHARM as long as you stay in contact with the allergen(s) (e.g. house dust, pollen) even if your symptoms have improved.

The treatment of perennial allergic conjunctivitis should be limited to a continuous application of 6 weeks duration. Also in seasonal allergic conjunctivitis a treatment for longer than 6 weeks should only be done under control of a doctor.

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1.3.1 SPC, Labelling and Package leaflet

Please ask your doctor or pharmacist if you have the impression that the effect of Azelastin- URSAPHARM is too strong or too weak.

If you use more Azelastin-URSAPHARM than you should

No particular action has to be taken. No cases of overdose became known by now. If you are worried, contact your doctor.

If you accidentally swallow Azelastin-URSAPHARM contact your doctor or nearest hospital casualty department as soon as possible.

If you forget to use Azelastin-URSAPHARM

Do not use a double dose to make up for a missed dose. Use your eye drops as soon as possible and apply the same amount and in the same frequency as described above or prescribed by your doctor.

If you stop using Azelastin-URSAPHARM

The treatment with Azelastin-URSAPHARM should be done regularly if possible until a relief of symptoms is reached. If you stop using Azelastin-URSAPHARM although you are in contact with the allergen(s) you have to expect that the typical allergic symptoms return.

If you have further questions on the use of this product please ask your doctor or pharmacist.

Like all medicines, Azelastin-URSAPHARM can cause side effects, although not everybody gets them.

For the assessment of side effects the following frequencies of occurrence are defined: Very common: affects more than 1 user in 10

Common: affects 1 to 10 users in 100 Uncommon: affects 1 to 10 users in 1,000 Rare: affects 1 to 10 users in 10,000 Very rare: affects less than 1 user of 10,000

Not known: Frequency cannot be estimated from available data

Immune system disorders

Very rare: Allergic reactions (such as rash and pruritus)

Nervous system disorders

Uncommon: Bitter taste

Eye disorders

Common: mild, transient irritation in the eye

In case one of the above described side-effects occur please stop using Azelastin- URSAPHARM and consult your doctor directly. The side-effects mentioned usually disappear quickly. Therefore no specific measures are required. If you recognize a bitter taste after using Azelastin-URSAPHARM this can be eliminated with a soft drink (e.g. juice, milk).

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1.3.1 SPC, Labelling and Package leaflet

If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children!

Do not use Azelastin-URSAPHARM after the expiry date which is stated on the label and outer carton (mm/yyyy). The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

With proper care Azelastin-URSAPHARM can be used up to 4 weeks after the first opening.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. The measures will help to protect the environment.

What Azelastin-URSAPHARM contains

The active substance is Azelastine hydrochloride 0.50 mg/ml. One drop of about 30 µl contains 0.015 mg Azelastine hydrochloride.

The other ingredients are Benzalkonium chloride (preservative), Disodium edetate, Hypromellose, Sorbitol, Sodium hydroxide (for pH-adjustment) and Water for injections.

What Azelastin-URSAPHARM looks like and contents of the pack

Azelastin-URSAPHARM are clear, colourless eye drops filled into a 10 ml plastic bottle with dropper applicator and screw cap.

Each pack contains 1 plastic bottle with dropper applicator and screw cap.

In het register ingeschreven onder nummer:

RVG 111896

Marketing Authorisation Holder and Manufacturer

Vergunninghouder

URSAPHARM Benelux B.V.

Steenovenweg 5

5708 HN Helmond

Nederland

Fabrikant

URSAPHARM

Industriestraße 35

66129 Saarbrücken

Edition 03/2012

1.3.1 SPC, Labelling and Package leaflet

Duitsland

This leaflet was last approved in oktober 2012.

Edition 03/2012