Oxymetazoline Farline 0.5 mg/ml nasal spray solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Oximetazolina farline 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.

Always follow exactly the instructions for administering this medicine as described in this leaflet or as given 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 adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
• You should consult a doctor if symptoms worsen or do not improve after 3 days of treatment.

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 adverse effects
5. How to store Oximetazolina farline
6. Contents of the pack and other information

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

This medicine belongs to the group of medicines known as 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 local and temporary relief of nasal congestion in adults and children over 6 years of age.

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

2. What you need to know before using Oxymetazoline farline

Do not use Oxymetazoline farline

• if you are allergic to oxymetazoline, to other nasal decongestants, or to any of the other ingredients 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 farline:

• if you are being treated with antidepressant medicines, phenothiazines (tranquilizers), or methyldopa (to lower blood pressure).

• if you have ever 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)

• if you have ever experienced insomnia or dizziness while taking 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.

Insomnia may rarely occur after using the medicine. If this happens to you, avoid using it late in the afternoon or at night.

Do not exceed the recommended dose described in section 3. How to use Oxymetazoline farline.

To prevent transmission of 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 and adolescents

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

Using Oxymetazoline farline 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))
• a medicine to lower blood pressure 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 or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

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

Oxymetazoline farline contains benzalkonium chloride

This medicine contains 0.2 mg of benzalkonium chloride per ml (each 0.07 ml spray contains 14 micrograms of benzalkonium chloride).

Benzalkonium chloride may cause irritation or inflammation inside the nose, especially when used for long treatment periods.

Patients with renal impairment or those on low-potassium diets should be aware that this medicine contains '3.88' mg of potassium per ml.

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

3. How to use Oxymetazoline farline

Follow exactly the instructions for administering this medicine as described in this leaflet or as directed 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 spray into each nostril up to 2 times a day (once in the morning and once at night). If necessary, in adults, a second spray into each nostril may be administered at each dose.

Use in children

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

Use in patients over 65 years of age

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

This medicine is for nasal use.

If this is the first time the spray is being used or if it has not been used for a long time, it is necessary to prime the spray. To do so, hold the container away from the body and press the spray several times until a fine mist is released.

Before administering the medicine, clear any nasal secretions by blowing your nose thoroughly.

For administration, keep your head upright. Insert the nozzle into the nostril in such a way that it does not completely block the opening. While pressing the spray, inhale gently to ensure the medicine is evenly distributed throughout the nasal cavity.

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

If you use more Oxymetazoline farline than you should

Excessive or prolonged use may cause: 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 medicine and the amount ingested.

If you forget to use Oxymetazoline farline

Do not use a double dose to make up for a missed dose.

If necessary, resume use as indicated in section 3. How to use Oxymetazoline farline.

4. Possible adverse effects

Like all medicines, Oxymetazoline nasal may cause adverse effects, although not everyone experiences them.

During the period of use of oxymetazoline, the following adverse effects have been observed, whose frequency cannot be established with accuracy:

The most frequently observed 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 disturbances in children. Tachycardia, palpitations, increased blood pressure. Headache, nausea, exanthema (skin redness).

Excessive or prolonged use of this medicine 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 can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Oxymetazoline farline

No special storage conditions are required.

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

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

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Oxymetazoline Farline

Each ml of solution contains:

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

Appearance of the product and contents of the pack

It is a colorless, transparent liquid solution. The container with the 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,

Alcalá de Henares, 28802, Spain

Date of the most recent review of this leaflet: April 2023

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