Azelastine pos 0.5 mg/ml eye drops solution
Spain
Table of Contents
Package Leaflet: Information for the User
Introduction
Package leaflet: information for the patient
Azelastina POS 0.5 mg/ml, eye drops solution
Azelastine hydrochloride
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
- Keep this leaflet as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
Leaflet Contents
- What Azelastina POS is and what it is used for.
- What you need to know before using Azelastina POS.
- How to use Azelastina POS.
- Possible side effects.
- How to store Azelastina POS.
- Contents of the pack and other information.
1. What Azelastina POS is and what it is used for
Azelastina POS contains the active substance azelastine hydrochloride, which belongs to a group of medicines known as antiallergics (antihistamines). Antihistamines prevent the effects of substances such as histamine, which the body produces during an allergic reaction. Azelastine has been shown to reduce ocular inflammation.
Azelastina POS is used for the treatment and prevention of ocular disorders caused by hay fever (seasonal allergic conjunctivitis) in adults and children aged 4 years and older.
Azelastina POS is also used for the treatment of ocular disorders caused by allergies to substances such as house dust mites or animal dander (perennial allergic conjunctivitis) in adults and children aged 12 years and older.
Azelastina POS is not suitable for the treatment of ocular infections.
2. What you need to know before using Azelastina POS
Do not use this medicine:
- If you are allergic to azelastine hydrochloride or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using this medicine:
- If you are unsure whether your eye symptoms are caused by an allergy. In particular, if only one eye is affected; if your vision has worsened; or if you have eye pain without nasal symptoms, you may have an infection rather than an allergy.
- If your symptoms worsen or last longer than 48 hours without significant improvement despite using this medicine.
- If you wear contact lenses.
Children and adolescents
For the treatment of eye disorders caused by hay fever (seasonal allergic conjunctivitis):
Do not give this medicine to children under 4 years of age, as safety and efficacy have not been established.
For the treatment of eye disorders caused by allergy (perennial non-seasonal allergic conjunctivitis):
Do not give this medicine to children under 12 years of age, as safety and efficacy have not been established.
Use of Azelastina POS with other medicines
Although it is not known whether this medicine may be affected by other medicines, tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Driving and using machines
After using this medicine, temporary blurred vision may occur. If this happens, wait until your vision is clear before driving or using machines.
3. How to use Azelastine POS
Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.
Please remember:
- This medicine is for ophthalmic use only.
Recommended dose:
Ocular disorders caused by hay fever (seasonal allergic conjunctivitis)
- For use in adults and children aged 4 years and older.
- The usual dose is one drop in each eye, morning and night.
If you anticipate exposure to pollen, you may administer the usual dose of this medicine before going outdoors as a preventive measure.
Ocular disorders caused by allergy (perennial non-seasonal allergic conjunctivitis)
- For use in adults and children aged 12 years and older.
- The usual dose is one drop in each eye, morning and night.
If your symptoms are severe, your doctor may increase the dose to one drop in each eye up to four times a day.
Relief of allergic conjunctivitis symptoms should occur within 15–30 minutes.
How to use Azelastine POS
Wash your hands.
Take a clean tissue and gently wipe around your eyes to remove any moisture.
Step 1:
Remove the cap before each use. Before the first application of Azelastine POS, hold the container vertically with the tip pointing downward and press the base until the first drop appears at the nozzle. The container is now ready for use.
Step 2:
Hold the container with the dropper pointing downward, so that your thumb presses on the shoulder of the container and the rest of your fingers are placed at the base.
Step 3:
Rest the hand holding the container on your free hand, as shown.
Step 4:
Tilt your head slightly backward, gently pull down the lower eyelid, and firmly and quickly press the base of the container. This activates the mechanism to release one drop. Thanks to the special valve technology of the COMOD system, the size and speed of the drop are identical regardless of the pressure applied. During application, avoid contact between the tip of the container and the eye or skin. Close your eyes slowly to allow the liquid to spread evenly over the surface of the eye.
Step 5:
After applying Azelastine POS, release the lower eyelid and press your finger against the corner of the eye near the nose (see image). While doing this, blink several times to distribute the drop over the entire ocular surface. Then wipe away any excess medicine.
Step 6:
After application, immediately replace the cap. Make sure the dropper tip is dry.
Treatment duration
If possible, you should use this medicine regularly until your symptoms have resolved.
Do not use this medicine for longer than 6 weeks.
If you use more Azelastine POS than you should
If you have administered too much Azelastine POS into your eyes, you are unlikely to experience problems. However, if you are concerned, consult your doctor.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.
If you forget to use Azelastine POS
Use your eye drops as soon as you remember, and then apply the next dose at your usual scheduled time. Do not use a double dose to make up for a missed dose.
If you stop using Azelastine POS
If you stop using this medicine, your symptoms are likely to return.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
These effects include:
Common (may affect up to 1 in 10 people): Mild irritation (stinging, itching, tearing) in the eyes after using this medicine. These effects should not last long.
Uncommon (may affect up to 1 in 100 people): Bitter taste in the mouth. This effect should disappear quickly, especially if you drink a beverage.
Very rare (may affect up to 1 in 10,000 people): Allergic reaction (such as rash and itching).
Reporting of adverse effects:
If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Azelastine POS
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label of the bottle and on the carton, following EXP. The expiry date refers to the last day of the month indicated.
After first opening: With proper care, Azelastine POS can be used for up to 12 weeks after first opening.
Do not use this medicine if the carton seal is broken before first use.
Do not store above 25 °C.
Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at the pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Azelastina POS
The active substance is azelastine hydrochloride 0.05% (0.50 mg/ml). Each drop of approximately 30 µl contains 0.015 mg of azelastine hydrochloride.
The other components are disodium edetate, hypromellose, sorbitol, sodium hydroxide (for pH adjustment), and water for injection.
Appearance of the product and contents of the pack
Azelastina POS is a clear, colourless solution supplied in a 10 ml multidose container with a gas-free pump system and a cap.
Each carton contains 1 multidose container with a gas-free pump system and a cap.
Marketing Authorization Holder
BRILL PHARMA, S.L.
Munner, 8
08022 Barcelona
(Spain)
Manufacturer
URSAPHARM Arzneimittel GmbH,
Industriestraße,
66129 Saarbrücken,
Germany
Date of the most recent review of this leaflet: September 2017
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es