Azel-drop free
Poland
Table of Contents
Azel-Drop Free, 0.5 mg/ml, eye drops, solution
Azelastini hydrochloridum
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist.
- Keep this leaflet for future reference.
- If advice or additional information is needed, please consult a pharmacist.
- If the patient experiences any adverse reactions, including those not listed in this leaflet, inform a doctor or pharmacist. See section 4.
- If there is no improvement after 2 days of treatment, or if the patient feels worse, consult a doctor.
Table of contents:
- What Azel-Drop Free is and what it is used for
- Important information before using Azel-Drop Free
- How to use Azel-Drop Free
- Possible side effects
- How to store Azel-Drop Free
- Contents of the package and other information
1. What Azel-Drop Free is and what it is used for
Azel-Drop Free contains azelastine hydrochloride as the active substance, which belongs to a group of medicines known as antiallergic (antihistamine) agents. Antihistamines work by blocking the action of substances such as histamine, which are released by the body during an allergic reaction. Azelastine has been shown to reduce ocular inflammation.
Azel-Drop Free may be used for the treatment or prevention of eye disorders associated with hay fever (seasonal allergic conjunctivitis characterized by redness, itching, or watering of the eyes) in adults and children aged 4 years and older.
Azel-Drop Free may also be used for the treatment of eye disorders caused by allergy to house dust mites or animal dander (perennial allergic conjunctivitis) in adults and children aged 12 years and older.
Azel-Drop Free is a preservative-free solution.
2. Important information before using Azel-Drop Free
When not to use Azel-Drop Free
Do not use this medicine if the patient is allergic to azelastine hydrochloride or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Before using Azel-Drop Free, consult a doctor or pharmacist:
- if the patient is unsure whether the eye condition is due to allergy. This is particularly important if the problem affects only one eye, if there is worsening of vision or eye pain, but no nasal symptoms. These may indicate an infection rather than an allergic reaction.
- if symptoms worsen or persist for longer than 48 hours without significant improvement, despite using Azel-Drop Free.
- if the patient wears contact lenses.
Azel-Drop Free is not intended for the treatment of eye infections.
Children and adolescents
Treatment of eye disorders caused by hay fever (seasonal allergic conjunctivitis):
This medicine should not be used in children under 4 years of age, as its safety and efficacy have not been established in this age group.
Treatment of eye disorders caused by allergy (perennial allergic conjunctivitis):
This medicine should not be used in children under 12 years of age, as its safety and efficacy have not been established in this age group.
Azel-Drop Free with other medicines
Although no interactions with other medicines are known, inform the doctor or pharmacist about all medicines currently or recently taken, as well as any medicines planned for use.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor before using this medicine.
Driving and operating machinery
Blurred vision may occur shortly after instillation of Azel-Drop Free. If this occurs, do not drive or operate machinery until vision returns to normal.
Contact lenses must be removed before instillation, and at least 15 minutes should elapse before reinserting them.
3. How to use Azel-Drop Free
This medicine should always be used exactly as described in this leaflet or as directed by a doctor or pharmacist.
If further advice or information is needed, consult a doctor or pharmacist.
The patient should remember that Azel-Drop Free is for ocular use only.
Recommended dose:
Eye disorders caused by hay fever (seasonal allergic conjunctivitis):
- For use in adults and children aged 4 years and above. The usual dose is one drop into each eye in the morning and evening.
If exposure to pollen is expected, Azel-Drop Free may be used preventively at the usual dose before going outdoors.
Eye disorders caused by allergy (perennial [year-round] allergic conjunctivitis):
- For use in adults and children aged 12 years and above. The usual dose is one drop into each eye in the morning and evening.
If symptoms are severe, the doctor may increase the dose to one drop into each eye up to four times daily.
Relief of symptoms of allergic conjunctivitis should occur within 15–30 minutes.
Instillation of Azel-Drop Free eye drops
To properly instill eye drops, the patient may sit in front of a mirror to observe the procedure during the first few applications.
If the patient wears contact lenses, they should be removed before instilling Azel-Drop Free. Wait 15 minutes before reinserting the lenses.
Before using these eye drops, hands should be thoroughly washed prior to opening the bottle, and the following steps should be performed:
A. Before the first instillation into the eye
- Remove the tamper-evident ring.
- Remove the protective cap.
B. To instill the eye drops, solution
- Hold the bottle upside down. Press the middle of the bottle firmly enough to release 1–2 drops. If a drop does not appear, repeat steps A2 and B1.
Gently pull the lower eyelid downwards while looking upwards. Hold the bottle above the eye and gradually press the middle of the bottle until a drop appears.
Avoid touching the eye or eyelids with the tip of the bottle.
- Blink once gently to help spread the drop over the entire surface of the eye. With eyes closed, carefully wipe away any excess drops. To reduce possible systemic absorption of the drops, it is recommended to press the finger against the inner corner of the eye for 2 minutes after each instillation, with the eye closed.
C. After each instillation
To remove residual drops:
- Hold the bottle in the middle, keeping the tip upwards.
- Quickly turn the bottle upside down, squeezing firmly to remove the remaining drop.
- After use, replace the protective cap.
Duration of treatment
Azel-Drop Free should be used, if possible, until symptoms resolve.
Azel-Drop Free should not be used for longer than 6 weeks without medical advice.
If the patient does not experience improvement or feels worse after 2 days of using the medicine, inform the doctor.
Use of a higher than recommended dose of Azel-Drop Free
Instilling a larger amount of the medicine into the eyes should not cause any problems. If concerned, contact a doctor. In case of accidental ingestion of Azel-Drop Free, seek immediate medical attention from a doctor or the nearest hospital emergency department.
Missed dose of Azel-Drop Free
Take the missed dose as soon as remembered, then take the next dose at the usual time.
Do not take a double dose to make up for a missed dose.
If there are any further questions about the use of this medicine, consult a doctor or pharmacist.
4. Possible adverse reactions
Like all medicines, Azel-Drop Free can cause adverse reactions, although not everybody experiences them.
Possible adverse reactions include:
Common (may affect up to 1 in 10 people):
Mild eye irritation (burning, itching, tearing) occurring after administration of Azel-Drop Free. These symptoms should not last long.
Uncommon (may affect up to 1 in 100 people):
Bitter taste in the mouth. This symptom should resolve quickly, especially after drinking a non-alcoholic beverage.
Very rare (may affect up to 1 in 10,000 people):
Allergic reactions (such as rash and itching).
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in the 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
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the Marketing Authorization Holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.
5. How to store Azel-Drop Free
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated after EXP on the label of the bottle and
on the packaging. The expiry date refers to the last day of the stated month.
Do not store above 25°C. Do not freeze.
After first opening: do not use the medicine more than 3 months after first opening the bottle.
This medicine should not be stored at temperatures above 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will help
protect the environment.
6. Contents of the package and other information
What Azel-Drop Free contains
- The active substance is azelastine hydrochloride. Each ml contains 0.5 mg of azelastine hydrochloride. One drop contains 0.0216 mg of azelastine hydrochloride.
- Other ingredients are: sorbitol; hypromellose (2663 - 4970 mPa*s); disodium edetate; sodium hydroxide (for pH adjustment); purified water.
What Azel-Drop Free looks like and contents of the pack
Azel-Drop Free is a clear solution.
Azel-Drop Free is available in a plastic bottle with a dropper and cap. Each bottle contains 10 ml of solution. Outer packaging: cardboard carton.
Marketing Authorisation Holder
Bausch+Lomb Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland
[email protected]
Manufacturer
Laboratoire Chauvin
Zone Industrielle De Ripotier
50 Avenue Jean Monnet
07200 Aubenas,
France
This medicinal product is authorised in the European Economic Area member states under the following names:
Member State Name of the medicinal product
Germany Vividrin Azelastin MDO 0.5 mg/ml eye drops, solution
Austria Vividrin Azelastin MDO 0.5 mg/ml eye drops, solution
Czech Republic Ocuazel
Spain Vividrin 0.5 mg/ml eye drops, solution
Croatia Vivialle 0.5 mg/ml eye drops, solution
Hungary Vivialle 0.5 mg/ml eye drops, solution
Italy Vividrin occhi 0.5 mg/ml eye drops, solution
Poland Azel-Drop Free
Portugal Vivilin, 0.5 mg/ml eye drops, solution
Slovakia Ocuazel
