OXIMETAZOLINE FARLINE 0.5 mg/ml NASAL SPRAY SOLUTION

Introduction

Package Leaflet: Information for the User

Oxymetazoline Farline 0.5 mg/ml Nasal Spray Solution

oxymetazoline, hydrochloride

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

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

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

Package Leaflet Contents:

1. What Oximetazolina Farline is and what it is used for
2. What you need to know before using Oximetazolina Farline
3. How to use Oximetazolina Farline
4. Possible side effects
5. Storage of Oximetazolina Farline
6. Package Contents and Additional Information

1. What Oximetazolina Farline is and what it is used for

This medication belongs to the group of medications called sympathomimetics. It is a nasal decongestant medication 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 over 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 Oximetazolina Farline

Do not use Oximetazolina Farline

-if you are allergic to oxymetazoline, other nasal 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 had any cranial, transnasal, or transoral surgical intervention).

Warnings and Precautions

Consult your doctor or pharmacist before starting to use Oximetazolina Farline:

• if you are being treated with antidepressant medications, phenothiazine (a tranquilizer), or methyldopa (to lower blood pressure).
• if 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 hypertrophy)
• 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, due to its temporary effects and prolonged use, can increase nasal congestion instead of decreasing it; this is known as rebound effect.

Insomnia can rarely occur after using the medication. If this happens, avoid using it in the late afternoon or evening.

Do not exceed the recommended dose in section 3. How to use Oximetazolina Farline.

To avoid contagion, the medication should not be used by more than one person, and the applicator should be cleaned after each use with a clean, damp cloth.

Children and Adolescents

This medication is indicated for children over 6 years of age.

Using Oximetazolina Farline with other medications

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

This medication should not be used by people who are taking or have taken in the last two weeks:

• medications used to treat depression (tricyclic antidepressants or monoamine oxidase inhibitors (MAOIs))
• a medication to lower blood pressure called methyldopa.

It should also not be used in case of treatment with phenothiazine (a tranquilizer) or medications for treating 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 medication.

Driving and Using Machines

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

Oximetazolina Farline contains benzalkonium chloride

This medication contains 0.2 mg of benzalkonium chloride per ml (each 0.07 ml puff contains 14 micrograms of benzalkonium chloride),

Benzalkonium chloride can cause irritation or inflammation inside the nose, especially when used for extended periods.

Patients with renal insufficiency or potassium-poor diets should note that this medication contains 3.88 mg of potassium per ml.

This medication contains less than 23 mg of sodium (1 mmol) per ml; it is essentially "sodium-free".

3. How to use Oximetazolina Farline

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults and children over 6 years of age: apply 1 puff in each nostril 2 times a day, as needed (1 time in the morning and 1 time at night). If necessary, in adults, a second puff can be administered in each nostril at each application.

Use in Children

Children under 6 years of age:this medication is indicated for children over 6 years of age.

Use in People over 65 Years of Age

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

This medication is used nasally.

If it is the first time using it or if it has not been used for a long time, it is necessary to prime the spray pump. To do this, holding the container away from the body, press the spray pump several times until the liquid spray comes out.

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

To apply the puff, keep your head straight. Place the applicator in the nasal cavity so that it does not completely block the nostril. As you press the applicator, breathe in gently to ensure the medication is distributed evenly throughout the nasal cavity.

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

If you use more Oximetazolina Farline 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 (Telephone 91 562 04 20) indicating the medication and the amount ingested.

If you forget to use Oximetazolina Farline

Do not use a double dose to make up for forgotten doses.

If necessary, resume use as indicated in section 3. How to use Oximetazolina Farline.

4. Possible Side Effects

Like all medications, Oximetazolina Farline can cause side effects, although not everyone will experience them.

During the use of oxymetazoline, the following side effects have been observed, whose frequency cannot be established with precision:

The most common side effects are: burning sensation at the application site, dryness, itching of the nasal mucosa, or sneezing.

Rare side effects that can 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 of this medication can lead to nasal congestion.

Reporting Side Effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Oximetazolina Farline

No special storage conditions are required.

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

Do not use this medication after the expiration date stated on the container after CAD. The expiration date is the last day of the month indicated.

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

6. Package Contents and Additional Information

Oximetazolina Farline Composition

Each ml of solution contains:

• The active ingredient is 0.5 mg of oxymetazoline (each 0.07 ml puff contains 35 micrograms)
• The other components (excipients) are: benzalkonium chloride, potassium dihydrogen phosphate, anhydrous disodium hydrogen phosphate, purified water.

Product Appearance and Package Contents

It is a colorless, transparent liquid solution. The container with a dosing pump is white and contains 15 ml of nasal spray solution.

Marketing Authorization Holder

Farline Comercializadora de Productos Farmacéuticos S.A.

C/ Santa Engracia 31

28010 Madrid, Spain.

Manufacturer:

Alcalá Farma, S.L.

Avenida de Madrid 82,

Alcala de Henares. 28802. Spain

Date of the Last Revision of this Package Leaflet:April 2023

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