AFLUON SUCRALOSE 1.5 mg/mL NASAL SPRAY SOLUTION

Introduction

Package Leaflet: Information for the User

Afluon Sucralose1.5 mg/mlNasal Spray Solution

Azelastine Hydrochloride

Read the entire package leaflet carefully before starting touse this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again
• If you have any questions, consult your doctor or pharmacist
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet.
• In this package leaflet, Afluon Sucralose 1.5 mg/ml Nasal Spray Solution is referred to as Afluon Sucralose.

Contents of the Package Leaflet

1. What is Afluon Sucralose and what is it used for
2. What you need to know before starting to use Afluon Sucralose
3. How to use Afluon Sucralose
4. Possible side effects
5. Storage of Afluon Sucralose
6. Package Contents and Additional Information

1. What is Afluon Sucralose and what is it used for

Afluon Sucralose contains azelastine, which belongs to a group of medications called antihistamines. Antihistamines work by preventing the effects of histamine, which is produced by the body as part of an allergic reaction.

Afluon Sucralose is used to treat allergic rhinitis in adults, adolescents, and children over 6 years old. Allergic rhinitis is an allergic reaction to substances such as pollen, dust mites, or animal hair.

It usually causes runny nose, sneezing, itching, or nasal congestion. Afluon Sucralose can help control these symptoms.

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

Do not use Afluon Sucralose

• If you are allergic (hypersensitive) to azelastine hydrochloride or 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 Sucralose.

Children

Afluon Sucralose is not recommended for children under 6 years old.

Using Afluon Sucralose with other medications

Although it is not known that Afluon Sucralose is affected by the use of other medications, inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

Pregnancy, Breastfeeding, and Fertility

There is limited information on the effects of Afluon Sucralose on the fetus or breastfed infant.

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

Driving and Using Machines

The influence of Afluon Sucralose on the ability to drive and use machines is negligible.

Rarely, you may experience fatigue or dizziness due to the underlying disease or when using Afluon Sucralose. In these cases, do not drive or use machines. Consuming alcohol may intensify these effects.

3. How to use Afluon Sucralose

Follow the administration instructions for Afluon Sucralose exactly as indicated by your doctor. Afluon Sucralose is for nasal use.

Important:

If you are unsure of the correct dose or how to use this medication, consult your doctor or pharmacist.

Adults and adolescents over 12 years old:

• The recommended dose is two applications in each nostril once a day. In some cases, two applications in each nostril twice a day may be required.
• The maximum daily dose is two applications in each nostril twice a day.

Children from 6 to 11 years old:

• The recommended dose is one application in each nostril twice a day.

Clinical experience over 4 weeks showed good efficacy and safety in children. There is no long-term experience in children; however, clinical trials of up to one year's duration using twice the daily dose showed good safety in adults and adolescents.

Afluon Sucralose is not recommended for use in children under 6 years old due to the lack of safety and/or efficacy data.

If possible, use Afluon Sucralose regularly until your symptoms have disappeared. If you stop using Afluon Sucralose, it is likely that your symptoms will return.

Afluon Sucralose is suitable for long-term use.

It is not recommended to use it for more than 4 weeks in children from 6-11 years old due to the lack of clinical data.

How to use the spray

1. First, blow your nose.
2. Remove the protective cap (Figure 1).
3. Before using for the first time, press the pump six times until a constant spray is produced (Figure 2). When Afluon Sucralose has not been used for three or more days, press the pump a sufficient number of times until a fine spray appears.
4. Spray once in each nostril, keeping your head upright. Do not tilt your head back (Figure 3).
5. Clean and replace the protective cap.

Figure 1. Figure 2. Figure 3.

If you use more Afluon Sucralose than you should

If you apply too much Afluon Sucralose to your nose, you will probably not have any problems. If you are concerned, consult your doctor.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to use Afluon Sucralose

If you forget to use your medication, use it as soon as you remember, then apply the next dose at your usual time. Do not use a double dose to make up for forgotten doses.

If you have any questions about the use of this medication, consult your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

These effects include:

Frequent (may affect up to 1 in 10 people):

• Unpleasant taste in your mouth (especially if you tilt your head too far back during nasal spray administration).

Uncommon (may affect up to 1 in 100 people):

• Mild irritation inside the nose (itching, pruritus), sneezing, and nosebleeds.

Rare (may affect up to 1 in 1,000 people):

• The unpleasant taste may make you feel unwell. Fatigue (tiredness, exhaustion), dizziness, weakness, or a feeling of drowsiness that may appear may also be caused by the underlying disease.

Very rare (may affect up to 1 in 10,000 people):

• An allergic reaction, skin rash, itching, or hives.

Reporting side effects:

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Afluon Sucralose

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

Do not use your nasal spray after the expiration date indicated on the packaging and carton. The expiration date is the last day of the month indicated.

Discard any remaining medication 6 months after the first opening of the nasal spray.

Do not refrigerate or freeze.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging of medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Afluon Sucralose

The active ingredient is azelastine hydrochloride.

1 ml of solution contains 1.5 mg of azelastine hydrochloride. Each application (0.14 ml) contains 0.21 mg of azelastine hydrochloride, equivalent to 0.19 mg of azelastine.

The other ingredients are: hypromellose, sucralose, liquid sorbitol (crystallizable), disodium edetate, sodium citrate, purified water.

Appearance of the Product and Package Contents

Afluon Sucralose is a clear and colorless solution.

It is presented in a brown glass bottle with a dosing pump. The 10 ml bottle contains 5 or 10 ml of nasal solution. The 20 ml bottle contains 17, 20, or 22 ml of nasal solution. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Cooper Consumer Health B.V.

Verrijn Stuartweg 60,

1112 AX Diemen,

Netherlands

Manufacturer

Madaus GmbH

Lütticher Straße 5

53842 Troisdorf

Germany

You can request more information about this medication from the local representative of the Marketing Authorization Holder:

Vemedia Pharma Hispania, S.A.

C/ Aragón, 182, 5th floor

08011 - Barcelona

Spain

This medication is authorized in the EEA Member States with the following names:

Austria: Allergodil 1.5 mg/ml Nasenspray

Denmark: Allergodil

Finland: Rhinolast 0.19 mg/annos nenäsumute, liuos

Germany: Rhinolast 1.5 mg/ml Nasenspray, Lösung

Ireland: Rhinolast S 1.5 mg/ml Nasal Spray, Solution

Spain: Afluon sucralosa 1.5 mg/ml solución para pulverización nasal

Italy: Allergodil

Netherlands: Rhinolast 0.15 %

Sweden: Rhinolast S 0.19 mg/dos nässpray, lösning

United Kingdom: Rhinolast S 0.15 % Nasal Spray

Date of the last revision of this package leaflet:March 2018

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) https://www.aemps.gob.es