PROSPECTO : INFORMATION FOR THE USER

AFLUON 1 mg/ml nasal spray solution

Azelastina hydrochloride

Read this prospect carefully before starting to use this medication, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect.

1.What is Afluon and what is it used for

2.What you need to know before starting to use Afluon

3.How to use Afluon

4.Possible adverse effects

5Storage of Afluon

6.Contents of the package and additional information

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, itching, or nasal obstruction. 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.

Do not use Afluon

-if you are allergic to azelastine or to any of the other ingredients of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Afluon

Use of AFLUON with other medications.

Inform your doctor or pharmacist that you are using, have used recently, or may have to use any other medication.

No specific interactions have been studied.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Due to the nasal administration route and the low doses administered, minimal systemic (general) exposure is expected. However, as with all medications, precautions should be taken during use in pregnancy and breastfeeding.

Driving and operating machinery

No effects on the ability to drive or operate machinery have been described due to the use of Afluon.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose in adults is a spray (0.14 ml) in each nasal passage, twice a day (0.56 mg of azelastine hydrochloride).

Use in children over 6 years old: a spray (0.14 ml) in each nasal passage, twice a day (0.56 mg of azelastine hydrochloride).

Use in elderly people: No specific studies have been conducted.

Instructions for correct administration of the medication

4. 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.

No overdose reactions are anticipated with nasal administration.

Animal studies show that toxic doses can produce symptoms on the Central Nervous System (excitement, tremor, convulsions). If this occurs in humans, symptomatic and supportive treatment will be initiated. If the overdose is recent, a gastric lavage is recommended.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone: (91) 562 04 20.

If you forget to use AFLUON

Do not use a double dose to compensate for the missed doses.

If you forget to use your medication, use it as soon as you remember and put the next dose 12 hours later, if necessary.

If you interrupt treatment with AFLUON

Do not stop treatment abruptly.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, Afluon can produce adverse effects, although not all people may experience them.

Frequent effects (affect between 1 and 10 out of 100 people): After administration, a bitter taste may appear due to incorrect application, for example, with the head too far back. On occasion, this bitter taste may cause nausea.

Rare effects (affect between 1 and 10 out of 1000 people):nasal mucosa irritation, for example, itching, prickling, sneezing.

In isolated cases: epistaxis (small nasal hemorrhages).

If you experience any effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this prospectus.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the label of the bottle and on the box after CAD. The expiration date is the last day of the month indicated.

Do not store below 8° C. Do not refrigerate.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition ofAfluon

• The active ingredient is hydrochloride of azelastine 1 mg per ml.
• The other components are:sodium edetate, hypromellose, citric acid, sodium phosphate, sodium chloride, and purified water.

Appearance of the product and contents of the packaging

Afluon is an colorless and transparent solution.

Afluon is presented in 10 ml and 20 ml bottles, provided with a dosing valve, containing a nasal spray solution.

Holder of the marketing authorization

Cooper Consumer Health B.V.

Verrijn Stuartweg 60,

1112 AX Diemen,

Netherlands

Responsible for manufacturing

Madaus GmbH

Lütticher Str. 5

53842 Troisdorf

Germany

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Vemedia Pharma Hispania, S.A.

C/ Aragón, 182, 5th floor

08011 - Barcelona

Spain

Last review date of this leaflet: February 2021

The detailed and updated information about this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es