Azelastine Mabo 0.5 mg/ml eye drops solution
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Azelastina MABO 0,5 mg/ml, eye drops, solution
Azelastine hydrochloride 0.05% (0.5 mg/ml)
Read this entire leaflet carefully before you start using this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to refer to it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only; do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any side effects, talk to your doctor or pharmacist, even if the side effects are not listed in this leaflet. See section 4.
Leaflet Contents
- What Azelastina MABO is and what it is used for
- What you need to know before using Azelastina MABO
- How to use Azelastina MABO
- Possible side effects
- How to store Azelastina MABO
- Contents of the pack and other information
1. What Azelastina MABO is and what it is used for
Azelastina MABO contains azelastine, which belongs to a group of medicines known as antihistamines.
Antihistamines prevent the effects of substances such as histamine that the body produces as part of an allergic reaction. Azelastine has been shown to reduce ocular inflammation.
Azelastina MABO is used for the treatment and prevention of eye disorders caused by hay fever (seasonal allergic conjunctivitis) in adults and children from 4 years of age.
Azelastina MABO is also used for the treatment of eye disorders caused by allergies to substances such as house dust mites or animal hair (perennial allergic conjunctivitis) in adults and children from 12 years of age.
Azelastina MABO is not suitable for the treatment of ocular infections.
2. What you need to know before using Azelastina MABO
Do not use Azelastina MABO:
- If you are allergic to azelastine hydrochloride or to any of the other ingredients of this medicine (listed in section 6).
If this applies to you, inform your doctor or pharmacist.
Warnings and precautions
Talk to your doctor or pharmacist before starting to use Azelastina MABO if:
- You are unsure whether your eye symptoms are due to 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.
- Your symptoms worsen or last longer than 48 hours without significant improvement despite using Azelastina MABO.
- You are taking other medicines without a prescription.
- You wear contact lenses.
It is recommended not to wear contact lenses until the signs and symptoms of allergic conjunctivitis have disappeared.
Using Azelastina MABO with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
It is unknown whether Azelastina MABO may be affected by other medicines.
Pregnancy, breastfeeding, and fertility
If you are pregnant or 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
You may experience blurred vision immediately after applying Azelastina MABO. Do not drive or operate machinery until this effect has disappeared.
Azelastina MABO contains Benzalkonium chloride
This medicine contains 0.75 mg of benzalkonium chloride per bottle.
Benzalkonium chloride can be absorbed by soft contact lenses and may change the color of contact lenses. Remove contact lenses before using this medicine and wait 15 minutes before reinserting them.
Benzalkonium chloride may cause eye irritation, particularly if you have dry eye or other corneal conditions (the transparent layer at the front of the eye). Consult your doctor if you experience a foreign body sensation, stinging, or eye pain after using this medicine.
3. How to use Azelastine MABO
Follow exactly the instructions for administration of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Important: if you are unsure about the correct dose or how to use this medicine, consult your doctor or pharmacist.
Ocular disorders caused by hay fever (seasonal allergic conjunctivitis)
- For use in adults and children aged 4 years and older.
- The recommended dose is one drop in each eye, in the morning and at night.
If you anticipate exposure to pollen, you may administer the normal dose of Azelastine MABO before going outdoors as a preventive measure.
Ocular disorders caused by allergy (allergic (perennial) non-seasonal conjunctivitis)
- For use in adults and children aged 12 years and older.
- The recommended dose is one drop in each eye, in the morning and at night.
If your symptoms are severe, your doctor may increase the dose to one drop in each eye up to four times a day.
If possible, you should use Azelastine MABO regularly until your symptoms have disappeared.
If you stop using Azelastine MABO, your symptoms are likely to return.
Please remember:
- Do not use Azelastine MABO for longer than 6 weeks.
- Azelastine MABO should only be applied to the eyes.
Instructions for the proper use of Azelastine MABO
To make it easier to administer the eye drops, it may be helpful to sit in front of a mirror the first few times, so you can see what you are doing.
- Wash your hands.
- Gently clean around your eyes to remove any moisture (Scheme 1).
- Unscrew the cap of the bottle and check that the dropper is clean.
- Gently pull down your lower eyelid (Scheme 2).
- Carefully place one drop into the middle part of the lower eyelid (Scheme 3). Make sure the dropper does not touch the eye.
- Release your lower eyelid and gently press the inner corner of your eye against the bridge of your nose (Scheme 4). While keeping your finger pressed against the nose, blink slowly several times to spread the drop over the entire surface of the eye.
- Wipe away any excess medicine with a tissue.
- Repeat this procedure in the other eye.
Scheme 1 Scheme 2 Scheme 3 Scheme 4
If you use more Azelastine MABO than you should
If you have administered too much Azelastine MABO into your eyes, you are unlikely to have problems. Overdosing generally does not cause adverse effects. However, if you have applied an excessive amount of the product and are concerned, consult your doctor.
In case of accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount taken, or go to the nearest hospital emergency department.
If you forget to use Azelastine MABO
Use your eye drops as soon as you remember, and then take the next dose at your usual time. Do not use a double dose to make up for forgotten doses.
If you have any further questions about the use of this product, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Azelastina MABO may produce adverse effects, although not everyone experiences them. These side effects are usually not serious.
These effects include:
- Common (may affect up to 1 in 10 people): Mild eye irritation (stinging, itching, tearing) after using Azelastina MABO. 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 (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 Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Azelastine MABO
Keep this medicine out of the sight and reach of children.
No special storage conditions are required.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
After opening: Do not use Azelastine MABO more than 4 weeks after the bottle has been opened.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Azelastine MABO
- The active substance is azelastine hydrochloride 0.05% (0.5 mg/mL). Each drop contains 0.015 mg of azelastine hydrochloride.
- The other components are benzalkonium chloride, disodium edetate, hypromellose (E-464), liquid sorbitol (crystallizable) (E-420i), sodium hydroxide (E-524) for pH adjustment, and water for injections.
Appearance of the product and contents of the container
Azelastine MABO is a clear, colourless solution.
Azelastine MABO is supplied in a plastic bottle with a dropper. One bottle contains 6 mL.
Marketing Authorization Holder
MABO-FARMA, S.A.
Calle Vía de los Poblados 3,
Edificio 6, 28033, Madrid,
Spain
Manufacturer
MEIJI PHARMA SPAIN, S.A.
Avda. de Madrid, 94,
28802 Alcalá de Henares (Madrid)
Spain
Date of the most recent review of this leaflet: June 2015
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/