Oxymetazoline Tecnimed 0.5 mg/ml nasal spray solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Oxymetazoline Tecnimede 0.5 mg/ml nasal spray solution

Oxymetazoline hydrochloride

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

Follow exactly the instructions for administration of the medicine contained in this leaflet or those 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 adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
• You must consult a doctor if your condition worsens or if there is no improvement after 3 days of treatment.

Leaflet contents

1. What Oxymetazoline Tecnimede is and what it is used for
2. What you need to know before using Oxymetazoline Tecnimede
3. How to use Oxymetazoline Tecnimede
4. Possible side effects
5. How to store Oxymetazoline Tecnimede
6. Contents of the pack and other information

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

This medicine belongs to a group of medicines called sympathomimetics. It is a nasal decongestant containing oxymetazoline as the active substance. When administered through the nose, oxymetazoline produces 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 children aged 6 years and older.

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

2. What you need to know before starting to use Oxymetazoline Tecnimede

Do not use Oxymetazoline Tecnimede

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

Warnings and precautions

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

• • You are being treated with antidepressant medicines, phenothiazines (tranquilizers), or methyldopa (for lowering blood pressure).
• • You have had or currently have, even if only once, any of the following conditions or symptoms:

• If you have high blood sugar levels (diabetes mellitus)

• If you have high blood pressure (hypertension)

• If you have any heart or circulatory system disease

• If you have prostate disease with difficulty urinating (prostatic hypertrophy)

• If you have any thyroid disease (hyperthyroidism)

• You have previously experienced insomnia or dizziness while being treated with other sympathomimetic medicines, such as those used to treat heart conditions, hypotension (low blood pressure), or asthma.

In rare cases, oxymetazoline, due to its temporary effects and prolonged use, may increase nasal congestion rather than reduce it; this is known as rebound effect.

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

Do not exceed the recommended dose stated in section 3. How to use Oxymetazoline Tecnimede.

To prevent infection, this medicine must not be used by more than one person, and the applicator should always be cleaned after each use with a clean, damp cloth.

Children

Do not use in children under 6 years of age.

Children may be particularly susceptible to adverse effects of this medicine.

Using Oxymetazoline Tecnimede with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

This medicine must not be used by people who are taking or have taken, within the last two weeks, medicines used to treat depression (tricyclic antidepressants or monoamine oxidase inhibitors (MAOIs)), or the blood pressure-lowering medicine called methyldopa.

It should also not be used if you are being treated with phenothiazines (tranquilizers) or medicines for treating asthma.

Pregnancy and breastfeeding

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

This medicine must not be used during pregnancy or while breastfeeding.

Driving and use of machines

Although problems in this regard are not expected, if you experience drowsiness or dizziness, do not drive or operate dangerous tools or machines.

Oxymetazoline Tecnimede contains benzalkonium chloride.

This medicinal product may cause inflammation of the nasal mucosa, particularly with prolonged treatment, due to the presence of benzalkonium chloride. If such a reaction is suspected (persistent nasal congestion), a nasal medication not containing this excipient should be used whenever possible.

3. How to use Oxymetazoline Tecnimede

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults and children aged 6 years and older: 1 spray into each nostril, no more than 2 times in 24 hours. If necessary, a second spray into each nostril per application may be administered in adults.

Use in children

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

How to use

This medicine is for nasal use.

Before administering this medicine, clear any existing nasal discharge by blowing your nose thoroughly.

To prevent infection, after each use and before closing the container, clean the applicator tip with a clean, damp cloth. In addition, each container must be used by only one person.

If this product is being used for the first time or has not been used for some time, it is necessary to prime the spray. To do this, holding the container away from the body, press the spray pump several times until a fine mist is released.

For administration of the spray, keep your head upright.

If your condition worsens or does not improve after 3 days of treatment, stop the treatment and consult your doctor.

Elderly patients

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

If you use more Oxymetazoline Tecnimed than you should

If excessive or very frequent doses are applied, 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 (telephone: 91.5620420), indicating the medicine and the amount ingested.

4. Possible adverse effects

Like all medicines, this medicine may produce adverse effects, although not everyone will experience them.

The following adverse effects have been observed during the period of use of oxymetazoline, although their frequency cannot be precisely determined.

The most frequently occurring adverse effects are:

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

Adverse effects that may occur rarely are:

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

Tachycardia, palpitations, increased blood pressure.

Headache, nausea, rash (skin redness).

Excessive or prolonged use may lead to nasal congestion.

Reporting of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Oxymetazoline Tecnimede

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging, after EXP. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Oxymetazoline Tecnimede

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

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 contents of the pack

It is presented as a clear, colourless solution in a nasal spray pump container.

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

Marketing Authorisation Holder and Manufacturer:

Marketing Authorisation 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 most recent review of this leaflet: April 2017

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.