Pollival
Italy
Table of Contents
Package leaflet: Information for the user
POLLIVAL 0.5 mg/ml eye drops, solution
Azelastine hydrochloride
Please read this leaflet carefully before using this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.
- Keep this leaflet. You may need to read it again.
- If you need more advice or information, contact your pharmacist.
- If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
- Contact your doctor if you do not notice any improvement or if your symptoms worsen after 2 days.
Contents of this leaflet:
- What Pollival is and what it is used for
- What you need to know before using Pollival
- How to use Pollival
- Possible side effects
- How to store Pollival
- Contents of the pack and other information
1. What Pollival is and what it is used for
Pollival contains the active substance azelastine hydrochloride, which belongs to a group of medicines called antiallergic agents (antihistamines). Antihistamines work by preventing the effects of substances such as histamine, which the body produces during an allergic reaction. Azelastine has been shown to reduce eye inflammation.
Pollival can be used for the treatment and prevention of eye disorders occurring together with hay fever (seasonal allergic conjunctivitis) in adults and children aged 4 years and older.
Pollival can be used for eye disorders caused by allergies to substances such as house dust mites or animal fur (perennial allergic conjunctivitis) in adults and children aged 12 years and older.
Pollival is not indicated for the treatment of eye infections.
2. What you need to know before using Pollival
Do not use Pollival:
- If you are allergic to azelastine hydrochloride or to any of the other ingredients of this medicine (listed in section 6)
Warnings and precautions
Inform your doctor or pharmacist before using Pollival
- If you are unsure whether your eye symptoms are caused by allergy. In particular, if only one eye is affected; if your vision is impaired; or if you have eye pain without other nasal symptoms, this could be an infection rather than an allergy.
- If symptoms worsen or last for more than 48 hours without significant improvement despite using Pollival.
- If you wear contact lenses.
Children and adolescents
For the treatment of eye symptoms 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 symptoms caused by allergy (non-seasonal (perennial) allergic conjunctivitis):
Do not give this medicine to children under 12 years of age, as safety and efficacy have not been established.
Other medicines and Pollival
Although Pollival is not known to interfere with other medicines, inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Driving and using machines
Your vision may become blurred for a short time after using Pollival. If this occurs, wait until your vision clears before driving or operating machinery.
3. How to use Pollival
Use this medicine exactly as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
Please remember:
POLLIVAL must be applied only in the eyes.
Recommended dose:
Eye disorders caused by hay fever (seasonal allergic conjunctivitis)
- For use in adults and children from 4 years of age onwards
- The usual dose is one drop in each eye in the morning and evening.
If you anticipate exposure to pollen, the usual dose of Pollival may be taken as a preventive measure before going outdoors.
Eye disorders caused by allergy (non-seasonal (perennial) allergic conjunctivitis)
- For use in adults and children from 12 years of age onwards
- The usual dose is one drop in each eye in the morning and evening.
If your symptoms are severe, your doctor may increase the dose to one drop in each eye up to four times a day.
You should notice relief from symptoms of allergic conjunctivitis within 15–30 minutes.
How to use Pollival
Wash your hands.
Take a clean cloth and gently dry the area around the eye to remove moisture.
Step 1:
Remove the cap before use. Before the first application, hold the Pollival bottle with the tip pointing downwards and press the bottom of the bottle until the first drop appears at the nozzle. The bottle is now ready for use.
Step 2:
Hold the bottle upside down with your thumb on the top and the other fingers supporting the bottom of the bottle.
Step 3:
With your free hand, support the hand holding the bottle.
Step 4:
Tilt your head back slightly, gently pull down the lower eyelid and firmly and quickly press the center of the bottom of the bottle. This will activate the release mechanism to dispense one drop. Thanks to the special valve of the COMOD System, the size and speed of each drop are consistent regardless of the pressure applied.
When applying the eye drops, avoid any contact between the tip of the bottle and the eye or skin. Close your eyes slowly to allow the drops to spread evenly over the surface of the eye.
Step 5:
After instilling Pollival, release the lower eyelid and press with your finger at the inner corner of the eye near the nose (see figure). While doing this, blink several times to spread the drop over the surface of the eye. Finally, remove any excess eye drops.
Step 6:
Immediately recap the bottle after use. Make sure the dropper tip is dry.
Treatment duration: if possible, use Pollival regularly until symptoms disappear.
Do not use Pollival for longer than 6 weeks.
If you use more Pollival than you should
If you accidentally apply too much Pollival into your eyes, you are unlikely to have any problems. If you are concerned, contact your doctor.
If you accidentally swallow Pollival, contact your doctor or go immediately to the nearest hospital emergency department.
If you forget to use Pollival
Use the eye drops as soon as you remember, then take the next dose at the usual time. Do not use a double dose to make up for a forgotten dose.
If you stop using Pollival
If you stop treatment with Pollival, your symptoms may return.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody will experience them.
These side effects include:
Common (may affect up to 1 in 10 people): mild eye irritation (burning, itching, tearing) after using Pollival. This condition should not last long.
Uncommon (may affect up to 1 in 100 people): bitter taste in the mouth. This condition disappears quickly, especially if you drink a non-alcoholic beverage.
Very rare (may affect up to 1 in 10,000 people): allergic reactions (such as skin rash and itching).
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following address: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Pollival
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and on the carton (month/year). The expiry date refers to the last day of that month.
After opening: with proper care, Pollival can be used for up to 12 weeks after first opening.
Do not use this medicine if you notice that the carton seal is not intact before first use.
Do not store above 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.
6. Package contents and other information
What Pollival contains
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 ingredients are: Disodium edetate, Hypromellose, Sorbitol, Sodium hydroxide (to adjust pH), and Water for injections.
Description of the appearance of Pollival and contents of the pack
Pollival is a clear, colourless solution in a 10 ml multidose container with a cap and an air-tight system.
Each pack contains 1 multidose container with cap and an air-tight system.
Marketing Authorisation Holder
URSAPHARM S.r.l.
Via Vittor Pisani 16
20124 Milano
Manufacturer
URSAPHARM, Industriestraße 35, 66129 Saarbrücken, Germany
This Patient Information Leaflet was last approved on: MM/YYYY