Label: information for the user

INTERFRIN 0.5 mg/ml nasal spray solution

Oxymetazoline hydrochloride

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

Follow exactly the administration instructions of the medicine contained in this label or those indicated by your doctor or pharmacist.

• Keep this label, as you may need to read it again.
• For advice or more information, consult your pharmacist.
• Report any adverse effects to your doctor or pharmacist, even if they are not listed in this label.
• You should consult a doctor if your condition worsens or does not improve after 3 days of treatment.

1. What is INTERFRIN and what it is used for

2. What you need to know before using INTERFRIN

3. How to use INTERFRIN

4. Possible adverse effects

5. Storage of INTERFRIN

6. Contents of the package 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. Oxymetazoline administered through the nose, 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 INTERFRIN

• If you are allergic to oxymetazoline, other nasal decongestants, or any of the other ingredients in this medication (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

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

• You are being treated with antidepressant medications, phenothiazine (tranquilizer), or methyldopa (to lower blood pressure).
• You have had or have, although it may have only occurred once, 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 system disease
• If you have any prostate disease with difficulty urinating (prostatic hypertrophy)
• If you have any thyroid disease (hyperthyroidism)

• If you have ever had 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, 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 USE INTERFRIN

To prevent 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 the appearance of adverse effects of this medication

Use of INTERFRIN 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 cases of treatment 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 a medication

This medication should not be used during pregnancy or breastfeeding.

Driving and operating machines

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

INTERFRIN contains benzalkonium chloride

This medication may cause nasal mucosa inflammation, especially with long-term treatments, because it contains benzalkonium chloride. If you suspect such a reaction (persistent nasal congestion), it is recommended to use a nasal medication that does not contain this component whenever possible.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.

The recommended dose is:

Adults and children over 6 years old

1 puff in each nasal opening no more than 2 times in 24 hours.

Use in children

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

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

Over 65 years old

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

How to use

This medication is used by nasal route.

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

Insert the end of the bottle into the nasal cavity, perform 1 quick and firm puff, in each nasal opening, keeping your head raised and inhaling deeply while pressing the spray.

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

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

If you use more INTERFRIN than you should

By excessive or very frequent dose application, 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 Toxicological Information Service, phone: 91.5620420, indicating the medication and the amount ingested.

Like all medications, INTERFRIN may have adverse effects, although not everyone will 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 disorders in children. Tachycardia, palpitations, increased blood pressure. Headache, nausea, exanthema (skin redness).

Excessive or prolonged use of this medication may lead to nasal congestion.

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

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

Do not store at a temperature above 25°C.

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.

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

Composition of INTERFRIN

The active principle is Oximetazolina. Each ml of nasal spray solution contains 0.5 mg of oximetazolina.

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

Appearance of the product and contents of the packaging

This medication is a nasal spray solution.

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

Holder of the marketing authorization and responsible for manufacturing:

INTERPHARMA, S.A.

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

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

Detailed and updated information about this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/