AMIDRIN 1 mg/ml NASAL SPRAY SOLUTION

Introduction

Package Leaflet: Information for the Patient

AMIDRIN 1 mg/ml Nasal Spray Solution

Xylometazoline Hydrochloride

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

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

Siga exactamente las instrucciones de administración del medicamento contenidas en este prospecto o las indicadas por su médico, o farmacéutico.

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 it is a side effect not listed in this package leaflet. See section 4.

• Conserve este prospecto, ya que puede tener que volver a leerlo.
• Si necesita consejo o más información, consulte a su farmacéutico.
• Si experimenta efectos adversos, consulte a su médico, o farmacéutico incluso si se trata de efectos adversos que no aparecen en este prospecto. Ver sección 4.

Contents of the Package Leaflet:

1. What is Amidrin and what is it used for
2. What you need to know before you start using Amidrin
3. How to use Amidrin
4. Possible side effects
5. Storage of Amidrin
6. Contents of the pack and further information

1. What is Amidrin and what is it used for

This medicine belongs to the group of medicines called sympathomimetics. It is a nasal decongestant.

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 you start using Amidrin

Do not use Amidrin

• 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 high blood pressure).
• You have had or have any of the following diseases or symptoms:

Si tiene niveles de azúcar en sangre elevados (diabetes mellitus).

Si tiene la tensión arterial alta (hipertensión arterial).

Si tiene alguna enfermedad del corazón o del aparato circulatorio.

Si tiene alguna enfermedad de la próstata con dificultad al orinar (hipertrofia prostática).

Si tiene alguna enfermedad del tiroides (hipertiroidismo).

Si alguna vez ha padecido insomnio o vértigo cuando ha estado en tratamiento con otros medicamentos simpaticomiméticos, como por ejemplo pueden ser, entre otros, algunos de los utilizados para tratar enfermedades del corazón, hipotensión (tensión arterial baja) o para tratar el asma.

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.

Rarely, insomnia can 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 Amidrin".

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.

Older adults

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

Using Amidrin with other medicines

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

This medicine should not be used by people who are taking or have taken in the last 2 weeks the following medicines, as it may cause an increase in blood pressure:

• Medicines used to treat depression (tricyclic antidepressants or monoamine oxidase inhibitors (MAOIs))
• A medicine used to lower blood pressure called methyldopa.

It should also not be used in case of treatment with phenothiazine (a tranquilizer) or with medicines for 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 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 feel drowsy or dizzy, do not drive or operate hazardous tools or machines.

Amidrin 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 Amidrin

Follow exactly the administration instructions 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:

1-2 applications 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.

Older adults

They should consult their doctor or pharmacist, as older adults are more sensitive to the adverse effects of this medicine.

How to use

This medicine is used nasally.

Before application, existing nasal fluids should be eliminated by blowing your nose well.

The solution is applied with the head held upright.

Remove the protective cap from the container.

Insert the upper end of the container in a vertical position into the nostril. Press the container walls briefly and firmly while inhaling through the nose. Remove the container without stopping the pressure. Repeat the operation in the other nostril. To avoid contagion, after each use and before closing the container, the applicator end should be cleaned with a clean, damp cloth. Also, each container should only be used by one person. If it worsens or does not improve after 3 days of treatment, stop and consult your doctor.

If you use more Amidrin than you should

In case of excessive dose administration or very continuous use, or in case of accidental ingestion, you may notice: headache, tremors, insomnia, excessive sweating, palpitations, tachycardia, increased blood pressure, or sleep disturbances.

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

4. Possible side effects

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

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

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

The rare side effects that may affect up to 1 in 1,000 patients are: anxiety, restlessness, transient visual disturbances, sleep disorders, tachycardia, palpitations, increased blood pressure, and skin rash.

Like other nasal decongestants, excessive or continued 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 it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medicines Monitoring System: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Amidrin

This medicine does not require special storage conditions.

Keep out of sight and reach of children.

Do not use Amidrin after the expiration date stated on the container after CAD. The expiration 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 pharmacy's SIGRE point. In case of doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. This will help protect the environment.

6. Further information

Composition of Amidrin

• The active ingredient is Xylometazoline Hydrochloride 1 mg/ml.
• The other components (excipients) are: glycerol (E422), benzalkonium chloride, Niauli essence, disodium phosphate, monosodium phosphate, and purified water.

Appearance and container contents

Amidrin is presented in a box containing a 10 ml polyethylene spray container for nasal spray solution.

Marketing authorization holder and manufacturer

Laboratorio de Aplicaciones Farmacodinámicas, S.A.

Grassot, 16 - 08025 Barcelona (Spain)

Logo FARDI

Date of last revision of this package leaflet: July 2021

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