Leaflet: information for the user

Oximetazoline Tecnimede 0.5 mg/ml nasal spray solution

Oximetazoline hydrochloride

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

Follow exactly the administration instructions 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 any 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.

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

2. What you need to know before using Oximetazoline Tecnimede

3. How to use Oximetazoline Tecnimede

4. Possible side effects

5. Storage of Oximetazoline Tecnimede

6. Contents of the pack and additional information

This medication belongs to the group of medications known as Sympathomimetics. It is a nasal decongestant medication that contains oxymetazoline as the active ingredient. When administered through the nose, oxymetazoline produces local vasoconstriction, 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 above.

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

Do not use Oximetazolina Tecnimede

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

Warnings and precautions

Consult your doctor or pharmacist before starting to useOximetazolina Tecnimedeif:

• -You are being treated with antidepressant medications, phenothiazine (tranquilizer), or methyldopa (for lowering blood pressure).
• - You have experienced or are experiencing 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 or circulatory system disease
• If you have an enlarged prostate with difficulty urinating (prostatic hypertrophy)
• If you have any thyroid disease (hyperthyroidism)

• You have ever experienced insomnia or dizziness when taking other sympathomimetic medications, such as those used to treat heart disease, low blood pressure, or asthma.

In rare cases, oxymetazoline, 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 evening.

Do not exceed the recommended dose in the section 3. How to useOximetazolina Tecnimede.

To avoid 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 6 years old.

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

Use of Oximetazolina Tecnimede 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, consult your doctor or pharmacist before using this medication.

This medication should not be used during pregnancy or breastfeeding.

Driving and operating machinery

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

Oximetazolina Tecnimede 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. If in doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults and childrenaged 6 years and above:1 puff in each nostril, no more than 2 times in 24 hours. In case of need, a second puff in each nostril can be administered in each application, in the case of adults.

Use in children

This medication should not be used in children under 6 years.

How to use

This medication is used via the nose.

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

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

If it is the first time this product is used or has not been used for a long time, it is necessary to prime the pump. To do this, holding the container away from the body, the pump is pressed several times until a final liquid is sprayed.

To apply the puff, you must keep your head straight.

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

Older patients

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

If you use moreOximetazolina Tecnimedethan you should

By excessive or very frequent dose application, you may experience: headache, tremors, insomnia, excessive sweating, palpitations, tachycardia, increased blood pressure, or sleep disturbances.

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

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

During the period of use of oxymetazoline, the following adverse effects have been observed, whose frequency has not been established with precision.

The adverse effects that have occurred most frequently are:

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

The adverse effects that may occur in rare cases are:

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

Tachycardia, palpitations, increased blood pressure.

Headache, nausea, exanthema (skin redness).

Excessive or continued use may lead to nasal congestion.

Reporting Adverse Effects

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

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

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.

No special storage conditions are required.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE point of your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Oximetazolina Tecnimede Composition

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

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

Product appearance and packaging contents

It is presented as a transparent and colorless solution in a packaging with a nasal pump dosifier.

The packaging is white and contains 15 ml with nasal spray solution.

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

LaboratoriosAlcalá Farma, S.L.

Avenida de Madrid, 82

28802 Alcalá de Henares, Madrid- Spain

Last review date of this leaflet:April 2017

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