OXIMETAZOLINE TECNIMEDE 0.5 mg/ml NASAL SPRAY SOLUTION

Introduction

Leaflet: information for the user

Oxymetazoline Tecnimede 0.5 mg/ml nasal spray solution

Oxymetazoline hydrochloride

Read the entire leaflet carefully before starting to use this medicine, as it contains important information for you.

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

• Keep this 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 leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 3 days of treatment.

Contents of the leaflet

1. What Oxymetazoline Tecnimede is and what it is used for
2. What you need to know before taking Oxymetazoline Tecnimede
3. How to use Oxymetazoline Tecnimede
4. Possible side effects
5. Storage of Oxymetazoline Tecnimede
6. Package contents and additional information

1. What Oxymetazoline Tecnimede is and what it is used for

This medicine belongs to the group of medicines called sympathomimetics. It is a nasal decongestant that contains oxymetazoline as the active ingredient. Oxymetazoline, when administered nasally, produces local vasoconstriction, decongesting the nasal mucosa.

It is indicated for the local and temporary relief of nasal congestion in adults and children from 6 years of age.

You should consult a doctor if your symptoms worsen or do not improve after 3 days of treatment.

2. What you need to know before taking Oxymetazoline Tecnimede

Do not use Oxymetazoline Tecnimede

• If you are allergic to oxymetazoline, other decongestants, or any of the other components of this medicine (listed in section 6).
• If you have recently undergone surgery on your head (if you have had any cranial, transnasal, or transoral surgical intervention).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Oxymetazoline Tecnimede if:

• - You are being treated with antidepressant medications, phenothiazine (a tranquilizer), or methyldopa (to lower 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 or circulatory disease
• If you have any prostate disease with difficulty urinating (prostatic hyperplasia)
• If you have any thyroid disease (hyperthyroidism)

• If you have ever experienced 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, oxymetazoline may increase nasal congestion instead of reducing it due to its temporary effects and prolonged use; this is known as rebound effect.

Insomnia may 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 section 3. How to use Oxymetazoline Tecnimede.

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 6 years of age.

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

Using Oxymetazoline Tecnimede with other medicines

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

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

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

Pregnancy and breastfeeding

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

This medicine should not be used during pregnancy or breastfeeding.

Driving and using machines

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

Oxymetazoline Tecnimede 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 Oxymetazoline Tecnimede

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

The recommended dose is:

Adults and children from 6 years of age: 1 spray in each nostril, no more than 2 times in 24 hours. If necessary, a second spray can be administered in each nostril in each application, in the case of adults.

Use in children

This medicine should not be used in children under 6 years of age.

How to use

This medicine is used nasally.

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

To avoid contagion, after each use and before closing the package, the applicator tip should be cleaned with a clean, damp cloth. Additionally, each package should be used by only 1 person.

If it is the first time using this product or it has not been used for a long time, the sprayer needs to be loaded. To do this, holding the package away from the body, press the sprayer several times until a finally pulverized liquid comes out.

For the application of the spray, the head should be held upright.

If your symptoms worsen or do not improve after 3 days of treatment, discontinue treatment and consult your doctor.

Elderly patients

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

If you use more Oxymetazoline Tecnimede than you should

Due to excessive or continuous dosing, you may experience: headache, tremors, insomnia, excessive sweating, palpitations, tachycardia, increased blood pressure, or sleep disturbances.

In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service (phone: 91.5620420), indicating the medicine and the amount ingested.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

During the use of oxymetazoline, the following side effects have been observed, whose frequency could not be established with precision.

The most common side effects are:

Irritation at the application site, dryness, itching of the nasal mucosa, or sneezing.

Rare side effects that may occur are:

Anxiety, restlessness, insomnia, hallucinations, tremors, and sleep disorders in children.

Tachycardia, palpitations, increased blood pressure.

Headache, nausea, skin rash (redness of the skin).

Excessive or prolonged use may lead to nasal congestion.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this 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 contribute to providing more information on the safety of this medicine.

5. Storage of Oxymetazoline Tecnimede

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

Do not use this medicine after the expiration date stated on the package, after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

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

6. Package contents and additional information

Composition of Oxymetazoline Tecnimede

The active ingredient is: oxymetazoline hydrochloride. Each ml contains 0.5 mg of oxymetazoline hydrochloride (35 micrograms per 0.07 spray).

The other components (excipients) are: benzalkonium chloride 0.2 mg/ml, potassium dihydrogen phosphate, anhydrous disodium hydrogen phosphate, purified water.

Appearance of the product and package contents

It is presented as a clear, colorless solution in a package with a dosing pump for nasal application.

The package is white and contains 15 ml of solution for nasal spray.

Marketing authorization holder and manufacturer:

Marketing authorization holder

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3º D.

28108 Alcobendas (Madrid)

Spain

Manufacturer

Laboratorios Alcalá Farma, S.L.

Avenida de Madrid, 82

28802 Alcalá de Henares, Madrid - Spain

Date of the last revision of this leaflet:April 2017

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/.