INTERFRIN 0.5 mg/ml NASAL SPRAY SOLUTION

Introduction

Leaflet: Information for the user

INTERFRIN 0.5 mg/ml nasal spray solution

Oxymetazoline, hydrochloride

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

Follow the administration instructions of 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.
• You should consult a doctor if your symptoms worsen or do not improve after 3 days of treatment.

Contents of the leaflet:

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

1. What INTERFRIN 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 using INTERFRIN

Do not use INTERFRIN

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

Warnings and precautions

Inform your doctor or pharmacist before starting to use INTERFRIN if:

• You are being treated with antidepressant medications, phenothiazine (a tranquilizer), or methyldopa (for high blood pressure).
• You have had or currently have any of the following diseases or symptoms: or if you have high blood sugar levels (diabetes mellitus)

• If you have high blood pressure (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 treated with other sympathomimetic medications, such as those used to treat heart disease, hypotension (low blood pressure), or asthma.

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

Insomnia can 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 INTERFRIN

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 the appearance of side effects of this medicine.

Using INTERFRIN 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 in the last 2 weeks: medicines used to treat depression (tricyclic antidepressants or monoamine oxidase inhibitors (MAOIs)), or a medicine to lower blood pressure called methyldopa.

It should not be used in case of treatment with phenothiazine (a tranquilizer) or with medicines for asthma.

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, or 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 no problems are expected, if you experience drowsiness or dizziness, do not drive or operate hazardous tools or machines.

INTERFRIN contains benzalkonium chloride

This medicine can cause inflammation of the nasal mucosa, especially with long-term treatments, because it contains benzalkonium chloride. If you suspect such a reaction (persistent nasal congestion), whenever possible, a nasal medicine that does not contain this component should be used.

3. How to use INTERFRIN

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

The recommended dose is:

Adults and children over 6 years

1 spray in each nostril, no more than 2 times in 24 hours.

Use in children

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

Children may be especially prone to the appearance of side effects of this medicine.

Over 65 years

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

How to use

This medicine is used nasally.

Before applying this medicine, eliminate any existing nasal fluids by blowing your nose.

Insert the end of the bottle into the nasal cavity, perform 1 spray quickly and firmly in each nostril, keeping your head upright and inhaling deeply while pressing the sprayer.

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

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

If you use more INTERFRIN than you should

By applying excessive doses or very continuous doses, 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, phone: 91.5620420, indicating the medicine and the amount ingested.

4. Possible side effects

Like all medicines, INTERFRIN can have 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).

The excessive or continuous use of this medicine can lead to nasal congestion.

If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.

5. Storage of INTERFRIN

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

Do not store above 25°C.

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

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 the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packages and medicines you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of INTERFRIN

The active ingredient is oxymetazoline. Each ml of nasal spray solution contains 0.5 mg of oxymetazoline.

The other components (excipients) are benzalkonium chloride, glycine, povidone, sorbitol (E-420), and purified water.

Appearance of the product and package contents

This medicine is a nasal spray solution.

It is presented in a box containing a 15 ml plastic bottle with a screw cap.

Marketing authorization holder and manufacturer:

INTERPHARMA, S.A.

Santa Rosa, 6. Santa Coloma de Gramanet (Barcelona) - 08921, Spain

Date of the last revision of this leaflet:February - 2013.

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/