Afluon 1 mg/ml nasal spray solution
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
AFLUON 1 mg/ml nasal spray 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 adverse effects not listed in this leaflet.
Contents of the leaflet:
- What Afluon is and what it is used for
- What you need to know before using Afluon
- How to use Afluon
- Possible side effects
- How to store Afluon
- Contents of the pack and other information
1. What AFLUON is and what it is used for
AFLUON contains azelastine, which belongs to a group of medicines that prevent the effects of histamine (antihistamines) and other substances the body produces as part of an allergic reaction, which cause symptoms such as sneezing, runny nose, nasal itching, or nasal congestion. Azelastine also has an additional anti-inflammatory effect.
AFLUON is used for the treatment of symptoms of seasonal allergic rhinitis and acute exacerbations (attacks) of perennial allergic rhinitis.
2. What you need to know before starting to use AFLUON
Do not use AFLUON
- if you are allergic to azelastine or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Consult your doctor or pharmacist before starting to use AFLUON.
Use of AFLUON with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Specific interactions have not been studied.
Pregnancy and breastfeeding
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.
Due to the nasal route of administration and the low doses used, minimal systemic (general) exposure is expected. However, as with all medicines, precautions should be taken when using this medicine during pregnancy and breastfeeding.
Driving and using machines
No effects on the ability to drive or operate machinery have been reported with the use of AFLUON.
3. How to use AFLUON
Follow exactly the administration instructions for this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
The recommended dose for adults is one spray (0.14 ml) into each nostril, twice daily (0.56 mg of azelastine hydrochloride).
Use in children over 6 years of age: one spray (0.14 ml) into each nostril, twice daily (0.56 mg of azelastine hydrochloride).
Use in elderly people: No specific studies have been conducted.
Instructions for correct administration of the medicine
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- Clean and replace the protective cap.
If you use more Afluon than you should
If you have administered too much Afluon, consult your doctor or pharmacist.
With nasal administration, overdose reactions are not expected.
Animal studies show that toxic doses may cause symptoms affecting the Central Nervous System (excitation, tremor, convulsions). If this occurs in humans, symptomatic and supportive treatment will be initiated. If the overdose is recent, gastric lavage is recommended.
In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone: (91) 562 04 20.
If you forget to use Afluon
Do not use a double dose to make up for missed doses.
If you forget to use your medicine, use it as soon as you remember, and then take the next dose 12 hours after, if necessary.
If you stop using Afluon
Do not stop the treatment abruptly.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Afluon may produce adverse effects, although not everyone experiences them.
Frequent effects (affect between 1 and 10 out of every 100 people): A bitter taste may occur after administration, due to incorrect application, for example, tilting the head too far backwards. Occasionally, this bitter taste may cause nausea.
Uncommon effects (affect between 1 and 10 out of every 1000 people): nasal mucosa irritation, for example, burning sensation, itching, sneezing.
In isolated cases: epistaxis (minor nosebleeds).
If you experience any effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.
5. Storage of AFLUON
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label of the vial and on the carton after EXP. The expiry date refers to the last day of the month indicated.
Do not store below 8°C. Do not refrigerate.
Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.
6. Contents of the pack and other information
Composition of Afluon
- The active substance is azelastine hydrochloride 1 mg per ml.
- The other components are: disodium edetate, hypromellose, citric acid, sodium phosphate, sodium chloride and purified water.
Appearance of the product and contents of the container
Afluon is a colourless and clear solution.
Afluon is available in 10 ml and 20 ml bottles, equipped with a metering valve, containing a solution for nasal spray.
Marketing Authorisation Holder
Cooper Consumer Health B.V.
Verrijn Stuartweg 60,
1112 AX Diemen,
The Netherlands
Manufacturer
Madaus GmbH
Lütticher Str. 5
53842 Troisdorf
Germany
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Vemedia Pharma Hispania, S.A.
C/ Aragón, 182, 5th floor
08011 - Barcelona
Spain
Date of the most recent revision of this leaflet: February 2021
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