Package Insert: Information for the Patient

Idasal 1 mg/ml Nasal Spray

Xylometazoline Hydrochloride

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

Follow exactly the administration instructions for the medication contained in this package insert or those indicated by your doctor, or pharmacist.

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

This medication belongs to the group of medications known as sympathomimetics.

It is a nasal decongestant medication.

It contains xylometazoline as the active ingredient. Xylometazoline administered in the form of a nasal spray, produces a local constriction of blood vessels, thereby decongesting the nasal mucosa.

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

Consult a doctor if symptoms worsen or do not improve after 3 days of treatment.

No use Idasal

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

Advertencias and precautions

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

• You are being treated with antidepressant medications, phenothiazine (tranquilizer), or methyldopa (to lower blood pressure).
• You have had or have, although it only occurred once, any of the following diseases or symptoms:
• • If you have high blood sugar levels (diabetes mellitus).
  • If you have high blood pressure (hypertension).
  • If you have any heart disease (for example, long QT syndrome) or circulatory system disease.
  • If you have any prostate disease with difficulty urinating (prostatic hypertrophy).
  • If you have any thyroid disease (hyperthyroidism).
• If you have ever had insomnia or dizziness when taking other sympathomimetic medications, such as those used to treat heart disease, hypotension (low blood pressure), or asthma.

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

Rarely, insomnia may occur after using the medication. If this happens, avoid using it in the late afternoon or at night.

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

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

Children

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

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

People over 65 years old

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

Use of Idasal with other medications

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

This medication should not be used by people taking or having taken during the last two weeks: medications used to treat depression (tricyclic antidepressants or monoamine oxidase inhibitors (MAOIs), or a medication to lower blood pressure called methyldopa.

It should also not be used in case of being treated with phenothiazine (tranquilizer) or medications to treat asthma.

Pregnancy and breastfeeding

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

This medication should not be used during pregnancy or breastfeeding.

Driving and operating machines

Although problems are not expected, if you notice drowsiness or dizziness, do not drive or operate hazardous tools or machines.

Idasal contains Benzalkonium Chloride

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

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults and adolescents 12 years of age and older:

1 puff in each nasal passage every 8-10 hours (up to 3 times a day).

Use in children

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

Individuals 65 years of age and older

Consult your doctor or pharmacist as individuals over 65 years of age are more sensitive to the adverse effects of this medication.

How to use

This medication is used via the nasal route.

Before applying this medication, you must remove any existing nasal secretions by blowing your nose well.

Remove the protective cap.

Before the first application, hold the container with the applicator facing upwards and press several times until the liquid is released. 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 nasal opening. The push button is pressed briefly and firmly while inhaling through the nose. Remove the container without releasing the pressure. The procedure is repeated in the other nasal opening.

To prevent contagion, after each use and before closing the container, the applicator tip should be cleaned with a clean, damp cloth. Additionally, each container should only be used 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

Following excessive or very frequent dosing, you may experience: Headache, tremors, insomnia, excessive sweating, palpitations, tachycardia, increased blood pressure, or sleep disturbances.

In case of overdose or accidental ingestion, seek medical attention or consult the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

The adverse effects that may affect up to 1 in 100 patients are:

Itching, dryness, and tickling in the nose and throat, sneezing, nausea, headache, and nasal bleeding.

The adverse effects that may affect up to 1 in 1,000 patients are:

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

Like other nasal decongestants, excessive or prolonged use of this medication may lead to nasal congestion due to rebound effect.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

No special storage conditions are required.

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

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Idasal

• The active principle 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 phosphate dihydrate, sorbitol, purified water.

Appearance of the product and contents of the packaging

Idasal is a solution presented in a 15ml glass vial with a dosing pump for 150 pulses.

Holder of the marketing authorization:

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Responsible for manufacturing:

Laboratorios Alcalá Farma S. L.

Avenida de Madrid, 8228002 Alcalá de Henares (Madrid)

Spain

Date of the last review of this leaflet: May 2021

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