IDASAL 1mg/ml NASAL SPRAY SOLUTION

Introduction

Package Leaflet: Information for the Patient

Idasal 1 mg/ml Nasal Spray Solution

Xylometazoline Hydrochloride

Read this package leaflet carefully before you start using this medicine, because it contains important information for you.

Follow the instructions for administration of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 3 days.

Contents of the Package Leaflet

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

1. What Idasal is and what it is used for

This medicine belongs to the group of medicines called sympathomimetics.

It is a nasal decongestant medicine.

It contains xylometazoline as the active ingredient. Xylometazoline, when administered as a nasal spray, produces local vasoconstriction, decongesting the nasal mucosa.

It is indicated for the local and temporary relief of nasal congestion in adults and adolescents from 12 years of age.

You should consult a doctor if it worsens or does not improve after 3 days of treatment.

2. What you need to know before using Idasal

Do not use Idasal

• If you are allergic to xylometazoline, other nasal decongestants, or any of the other components of this medicine (listed in section 6).
• If you have recently undergone any surgery in the brain through the nose or mouth.

Warnings and Precautions

Consult your doctor or pharmacist before starting to use this medicine if:

• You are being treated with antidepressant medicines, phenothiazine (a tranquilizer), or methyldopa (for lowering blood pressure).
• You have had or currently have any of the following diseases or symptoms:
• • If you have high blood sugar levels (diabetes mellitus).
  • If you have high blood pressure (arterial hypertension).
  • If you have any heart disease (e.g., long QT syndrome) or circulatory disorders.
  • If you have any prostate disease with difficulty urinating (prostatic hypertrophy).
  • If you have any thyroid disease (hyperthyroidism).
• If you have ever experienced insomnia or dizziness when treated with other sympathomimetic medicines, such as those used to treat heart diseases, hypotension (low blood pressure), or asthma.

In rare cases, xylometazoline, due to its temporary effects and prolonged use, can increase nasal congestion instead of reducing it; this is known as rebound effect.

Insomnia can rarely occur after using the medicine. If this happens, avoid using it in the late afternoon or evening.

Do not exceed the recommended dose in the section "3. How to use Idasal".

To avoid contagion, the medicine should not be used by more than one person, and the applicator should be cleaned after each use with a clean, damp cloth.

Children

Do not use in children under 12 years of age without consulting a doctor.

Children may be especially prone to the adverse effects of this medicine.

Elderly (over 65 years)

Consult your doctor or pharmacist, as older people are more sensitive to the adverse effects of this medicine.

Using Idasal with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

This medicine should not be used by people who are taking or have taken in the last 2 weeks: medicines used to treat depression (tricyclic antidepressants or monoamine oxidase inhibitors (MAOIs)), or a medicine to lower blood pressure called methyldopa.

It should also not be used in case of treatment with phenothiazine (a tranquilizer) or with medicines for treating asthma.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using a medicine.

This medicine should not be used during pregnancy or breastfeeding.

Driving and Using Machines

Although it is not expected to cause problems, if you notice drowsiness or dizziness, do not drive or operate hazardous tools or machines.

Idasal contains Benzalkonium Chloride

This medicine may cause inflammation of the nasal mucosa, especially with long-term treatments, because it contains benzalkonium chloride. If such a reaction is suspected (persistent nasal congestion), whenever possible, a nasal medicine that does not contain this excipient should be used.

3. How to use Idasal

Follow the instructions for administration of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults and adolescents from 12 years of age:

1 spray in each nostril every 8-10 hours (up to 3 times a day).

Use in Children

This medicine should not be used in children under 12 years of age without consulting a doctor.

Elderly (over 65 years)

Consult your doctor or pharmacist, as older people are more sensitive to the adverse effects of this medicine.

How to use

This medicine is used nasally.

Before applying this medicine, existing nasal fluids should be eliminated by blowing your nose well.

Remove the protective cap.

Before the first application, hold the container with the applicator upwards and actuate several times until the liquid comes out. In subsequent applications, the dosing pump will be ready for immediate use.

The solution is applied while keeping the head straight. The applicator is inserted vertically into the nostril. The actuator is pressed briefly and firmly while inhaling through the nose. Remove the container without stopping pressing. Repeat the operation in the other nostril.

To avoid contagion, after each use and before closing the container, the tip of the applicator should be cleaned with a clean, damp cloth. Also, each container should be used only by one person.

If it worsens or does not improve after 3 days of treatment, discontinue treatment and consult your doctor.

If you use more Idasal than you should

By applying excessive doses or very continuous doses, you may notice: headache, tremors, insomnia, excessive sweating, palpitations, tachycardia, increased blood pressure, or sleep disturbances.

In case of overdose or accidental ingestion, go to a medical center or consult the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The side effects that can affect up to 1 in 100 patients are:

Irritation, dryness, and itching in the nose and throat, sneezing, nausea, headache, and nasal bleeding.

The side effects that can affect up to 1 in 1,000 patients are:

Anxiety, restlessness, hallucinations, sleep disorders, tachycardia, palpitations, increased blood pressure, and skin rash.

Like other nasal decongestants, excessive or continuous use of this medicine can lead to nasal congestion due to rebound effect.

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Idasal

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 container after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the containers and medicines you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Idasal

• The active ingredient is xylometazoline hydrochloride. Each milliliter of solution contains 1 mg of xylometazoline hydrochloride.
• The other components (excipients) are: benzalkonium chloride, sodium edetate, sodium chloride, disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate, sorbitol, purified water.

Appearance of the Product and Package Contents

Idasal is a solution presented in a 15ml glass bottle with a dosing pump for 150 sprays.

Marketing Authorization Holder:

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer:

Laboratorios Alcalá Farma S. L.

Avenida de Madrid, 82 28002 Alcalá de Henares (Madrid)

Spain

Date of the Last Revision of this Package Leaflet: May 2021

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es