Allestin

PATIENT INFORMATION LEAFLET: USER INFORMATION

Allestin, 0.5 mg/ml, eye drops, solution
Azelastine hydrochloride

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any further questions, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same.
• If any of the side effects get worse or if you notice any side effects not listed in the leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Allestin and what is it used for
• 2. Important information before using Allestin
• 3. How to use the medicine Allestin
• 4. Possible side effects
• 5. How to store the medicine Allestin
• 6. Contents of the pack and other information

1. WHAT IS ALLESTIN AND WHAT IS IT USED FOR

Allestin contains azelastine, which belongs to a group of antiallergic and antihistaminic medicines.
The medicine Allestin can be used to treat or prevent symptoms of seasonal, allergic eye disorders (seasonal, allergic conjunctivitis accompanying hay fever) in adults and children over 4 years old.
The medicine Allestin can also be used to treat symptoms of non-seasonal (year-round) allergic eye disorders (year-round, allergic conjunctivitis) in adults and adolescents over 12 years old.
The medicine Allestin is not intended for the treatment of eye infections.

How Allestin works

The medicine Allestin causes rapid relief of symptoms such as burning, itching, tearing, without drowsiness.
Allergy is caused by an excessive response of the body's immune system to external substances.
Allergy is triggered by contact with pollen, house dust mites, mold, or animal hair.
The medicine Allestin inhibits the action of histamine and other inflammatory substances that are easily released in people with allergies. In this way, the medicine Allestin counteracts the symptoms of conjunctivitis.

2. IMPORTANT INFORMATION BEFORE USING ALLESTIN

When not to use Allestin

If the patient is allergic to azelastine hydrochloride, benzalkonium chloride, or any of the other ingredients of this medicine (listed in section 6.1).

Warnings and precautions

Before starting to use the medicine Allestin, consult a doctor or pharmacist:

• if the patient is not sure whether the eye disorder is caused by an allergy. In particular, this applies to situations where the problem affects only one eye; there is a worsening of vision, eye pain, but no nasal symptoms. This may indicate that the cause is an infection, not an allergy
• if the symptoms worsen or persist for more than 48 hours without significant improvement despite the use of the medicine Allestin.

People with conjunctivitis should not wear contact lenses.

Children and adolescents

The medicine Allestin should be used to treat seasonal allergic disorders in children from 4 years old and to treat non-seasonal (year-round) allergic disorders in adolescents from 12 years old.

Other medicines and Allestin

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
The effect of other medicines, food, or drink on the medicine Allestin is not known.

Pregnancy and breastfeeding

In pregnancy and during breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult a doctor or pharmacist before using this medicine.
The medicine Allestin passes into breast milk in small amounts. Therefore, it is not recommended to use the medicine Allestin during breastfeeding.

Driving and using machines

Mild, transient eye irritation may occur due to the administration of the medicine. It is unlikely that the medicine Allestin will significantly impair vision. If transient vision disturbances occur, do not drive or operate machinery until normal vision returns.

Allestin contains benzalkonium chloride

May cause eye irritation. Avoid contact of the medicine with soft contact lenses. Before using the medicine, remove contact lenses from the eyes and wait 15 minutes before reinserting them. It has been shown to cause discoloration of soft contact lenses.

3. HOW TO USE ALLESTIN

This medicine should always be used as directed by your doctor. If you are unsure, consult a doctor or pharmacist.
Seasonal, allergic conjunctivitis
Unless your doctor has told you otherwise, the usual dose for adults and children over 4 years old is one drop into each eye, 2 times a day (morning and evening). If necessary, this dose can be increased to one drop, administered 4 times a day.
The medicine Allestin can be administered prophylactically before expected exposure to an allergen.
Non-seasonal (year-round), allergic conjunctivitis
Unless your doctor has told you otherwise, the usual dose for adults and adolescents over 12 years old is one drop into each eye, 2 times a day (morning and evening). If necessary, this dose can be increased to one drop, administered 4 times a day.

Method of use

Remove the cap. Tilt your head slightly and gently pull down the lower eyelid of the eye. Carefully instill 1 drop onto the inner surface of the lower eyelid. Be careful not to touch the tip of the dropper to the eye or skin. Release the lower eyelid and gently press the corner of the eye towards the nose. Slowly blink several times to spread the drop over the surface of the eyeball. To administer the medicine to the other eye, repeat the above steps.

Duration of treatment

Continue using the medicine Allestin after the symptoms have disappeared, as long as exposure to allergens (e.g., pollen, dust) persists.
Do not use the medicine Allestin for more than 6 weeks.
If you feel that the effect of the medicine Allestin is too strong or too weak, tell your doctor or pharmacist.

Using a higher dose of Allestin than recommended

After administering the medicine to the eyes, no specific overdose reactions are known and are not expected with this route of administration. In case of accidental ingestion of the medicine Allestin, seek medical attention immediately.

Missing a dose of Allestin

No special action is necessary if you miss a dose of the medicine Allestin.
Take the next dose at the usual time. If necessary, the medicine can also be administered between two planned administrations.

Stopping the use of Allestin

Where possible, use the medicine Allestin regularly until the symptoms disappear. If you stop using the medicine Allestin, there is a risk of recurrence of typical disease symptoms.
If you have any further questions about the use of the medicine, consult a doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, the medicine Allestin can cause side effects, although not everybody gets them.
Side effects may occur with varying frequencies, described below:

Very common: occurs in more than 1 in 10 patients

Common: occurs in 1 to 10 patients in 100

Uncommon: occurs in 1 to 10 patients in 1,000

Rare: occurs in 1 to 10 patients in 10,000

Very rare: occurs in less than 1 in 10,000 patients

Not known: frequency cannot be estimated from the available data

Commonly, after administering the medicine Allestin, mild, transient eye irritation (e.g., burning, itching, tearing) occurs. Uncommonly, a bitter taste in the mouth has been reported. In very rare cases, allergic reactions (such as rash and itching) may occur.

Action in case of side effects

Usually, the listed side effects disappear quickly. No special measures are necessary.
A bitter taste in the mouth after using the medicine Allestin can be counteracted by drinking non-alcoholic beverages (juices, water).

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, tell your doctor or pharmacist.
Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, e-mail: ndl@urpl.gov.pl
By reporting side effects, you can help provide more information on the safety of the medicine.

5. HOW TO STORE ALLESTIN

Keep out of the reach and sight of children.
Do not use the medicine Allestin after the expiry date stated on the label and carton. The expiry date refers to the last day of that month.
Do not store above 25°C. Store the bottle in the outer carton to protect from light.
After first opening: do not use the medicine after 4 weeks of first opening the bottle.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Allestin contains

• The active substance is azelastine hydrochloride. 1 ml contains 0.5 mg of azelastine hydrochloride. One drop contains 0.015 mg of azelastine hydrochloride.
• The other ingredients are: benzalkonium chloride; liquid, crystallizing sorbitol; hypromellose; disodium edetate; sodium hydroxide; purified water.

What Allestin looks like and contents of the pack

Allestin is a clear, colorless solution. Allestin is available in a LDPE bottle with a LDPE dropper and an HDPE child-resistant cap. One bottle contains 6 ml of solution.

Marketing Authorization Holder and Manufacturer

Pharma Stulln GmbH
Werksstraße 3
92551 Stulln
Germany

Manufacturer

NOVOCAT FARMA S.A.
Avda de La Flores, 29, Rubí, 08191 Barcelona
Spain
Farma Mediterrània, S.L.
C/Sant Sebastià, s/n Sant Just Desvern, 08960 Barcelona
Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Member State Name of the medicinal product

Germany
Azelastinehydrochlorid Stulln 0,5 mg/ml, Augentropfen
Poland
Allestin

Date of last revision of the leaflet: 05.2015