Allestin

Allestin, 0.5 mg/ml, eye drops, solution
Azelastini hydrochloridum
Please read the entire leaflet before using the medicine, as it contains important information for the patient.

• Keep this leaflet, as you may need to read it again.
• Consult your doctor or pharmacist if you have any further questions.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If any of the side effects worsen or if you experience any side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet:

1. What Allestin is and what it is used for
2. Important information before using Allestin
3. How to use Allestin
4. Possible side effects
5. How to store 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 medicines known as antiallergic and antihistamine agents.

Allestin may be used to treat or prevent symptoms of seasonal allergic eye disorders (seasonal allergic conjunctivitis associated with hay fever) in adults and children aged above 4 years.

Allestin may also be used to treat symptoms of perennial (year-round) allergic eye disorders (perennial allergic conjunctivitis) in adults and adolescents aged above 12 years.

Allestin is not intended for the treatment of eye infections.

Mechanism of action of Allestin
Allestin rapidly relieves symptoms such as burning, itching, and tearing, without causing drowsiness.

Allergy is an overreaction of the body's immune system to external substances. Allergic reactions are triggered by exposure to pollen, house dust mites, mold, or animal fur.

Allestin inhibits the action of histamine and other inflammatory substances that are more readily released in allergic individuals. Thus, Allestin counteracts the symptoms of conjunctivitis.

2. IMPORTANT INFORMATION BEFORE USING ALLESTIN

When not to use Allestin
Do not 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 treatment with Allestin, consult your doctor or pharmacist:

• if the patient is unsure whether the eye condition is due to allergy. This is particularly important if only one eye is affected, if there is worsening of vision or eye pain, but no nasal symptoms. This may indicate an infection rather than an allergy.
• if symptoms worsen or persist for longer than 48 hours without significant improvement despite using Allestin.

Patients with conjunctivitis should not wear contact lenses.

Children and adolescents
Allestin is indicated for the treatment of seasonal allergic disorders in children aged 4 years and older, and for the treatment of perennial (year-round) allergic disorders in adolescents aged 12 years and older.

Other medicines and Allestin
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned to be used.

There is no known interaction between Allestin and other medicines, food, or drink.

Pregnancy and breastfeeding
During pregnancy or breastfeeding, or if pregnancy is suspected or planned, consult your doctor or pharmacist before using this medicine.

Allestin passes into breast milk in small amounts. Therefore, the use of Allestin during breastfeeding is not recommended.

Driving and operating machinery
Mild, transient eye irritation may occur after instillation of the drops. It is unlikely that Allestin significantly impairs vision. However, if any transient visual disturbance occurs, do not drive or operate machinery until normal visual acuity returns.

Allestin contains benzalkonium chloride
This may cause eye irritation. Avoid contact with soft contact lenses. Remove contact lenses before using the drops and wait 15 minutes before reinserting them. Benzalkonium chloride has been shown to cause discoloration of soft contact lenses.

3. HOW TO USE ALLESTIN

Always use this medicine exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.

Seasonal allergic conjunctivitis
Unless otherwise directed by a doctor, the usual dose for adults and children above 4 years is one drop in each eye twice daily (morning and evening). If necessary, the dose may be increased to one drop administered four times daily.

Allestin may be used prophylactically before anticipated exposure to an allergen.

Perennial (year-round) allergic conjunctivitis
Unless otherwise directed by a doctor, the usual dose for adults and adolescents aged 12 years and older is one drop in each eye twice daily (morning and evening). If necessary, the dose may be increased to one drop administered four times daily.

Instructions for use
Unscrew the cap. Tilt the head slightly backward and gently pull down the lower eyelid. Carefully instill one drop into the inner part of the lower eyelid. Be careful not to touch the dropper tip to the eye or skin. Release the eyelid and gently press the inner corner of the eye toward the nose. Slowly blink several times to spread the drop over the surface of the eyeball. Repeat the procedure for the other eye.

Duration of treatment
Continue using Allestin after symptoms have subsided, for as long as exposure to allergens persists (e.g. pollen, dust).

Do not use Allestin for longer than 6 weeks.

If the patient feels that the effect of Allestin is too strong or too weak, inform the doctor or pharmacist.

Overdose of Allestin
No specific adverse reactions related to overdose are known following ocular administration, and none are expected via this route. In case of accidental ingestion of Allestin, seek immediate medical advice from a doctor or the nearest hospital emergency department.

Missed dose of Allestin
No special actions are required if a dose is missed. Take the next dose at the usual time. If necessary, the medicine may also be administered between two scheduled doses.

Discontinuation of Allestin
As far as possible, use Allestin regularly until symptoms resolve. Premature discontinuation of Allestin may result in recurrence of typical disease symptoms.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, Allestin can cause adverse reactions, although not everyone experiences them.
Adverse reactions may occur with varying frequency, described below:
Very common: occurs in more than 1 in 10 patients
Common: occurs in 1 to 10 in 100 patients
Uncommon: occurs in 1 to 10 in 1,000 patients
Rare: occurs in 1 to 10 in 10,000 patients
Very rare: occurs in fewer than 1 in 10,000 patients
Not known: frequency cannot be estimated from available data

After administration of Allestin, mild, transient eye irritation (e.g. burning, itching, tearing) may commonly occur. Uncommonly, a bitter taste in the mouth has been reported. Allergic reactions (such as rash and itching) may occur very rarely.

Management in case of adverse reactions
The adverse reactions listed above usually resolve quickly. No special preventive measures are usually necessary.
A bitter taste in the mouth after administration of Allestin can be counteracted by drinking non-alcoholic beverages (juices, water).

Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, e-mail: [email protected]
By reporting adverse reactions, additional information on the safety of this medicine can be collected.

5. HOW TO STORE ALLESTIN

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

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What the medicine 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; sorbitol liquid, crystallizing; hypromellose; disodium edetate; sodium hydroxide; purified water.

What Allestin looks like and contents of the pack
Allestin is a clear, colourless solution. Allestin is available in a bottle made of
LDPE with a dropper made of LDPE and a child-resistant cap made of HDPE. One
bottle contains 6 ml of solution.

Marketing Authorisation Holder
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 authorised in the European Economic Area member states under the following names:

| Member State | Name of the medicinal product | |--------------|-------------------------------| | Germany | Azelastinhydrochlorid Stulln 0.5 mg/ml, Augentropfen | | Poland | Allestin |