Prospect: information for the user

Oximetazoline farline 0.5 mg/ml nasal spray solution

oximetazoline, hydrochloride

Read this prospect 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 prospect or those indicated by your doctor, or pharmacist.

- Keep this prospect, as you may need to read it again.

- If you need advice or more information, consult your pharmacist.

- If you experience adverse effects, consult your doctor or pharmacist even if they are not listed in this prospect. See section 4.

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

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

2. What you need to know before starting to use Oximetazoline farline

3. How to use Oximetazoline farline

4. Possible adverse effects

5. Conservation of Oximetazoline farline

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 oximetazolina as the active ingredient. Oximetazolina 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 over 6 years old.

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

Do not use Oximetazolina farline

-if you are allergic to oximetazolina, other nasal decongestants, or any of the other components of this medication (listed in section 6).

-if you have recently undergone surgery in the head (if you have undergone 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 (tranquilizer), or methyldopa (to lower blood pressure).
• if you have suffered or suffer from, although only once, 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 any prostate disease with difficulty urinating (prostatic hypertrophy)
• if you have any thyroid disease (hyperthyroidism)
• if you have ever suffered from insomnia or dizziness when taking other sympathomimetic medications, such as those used to treat heart disease, to treat low blood pressure, or to treat asthma.

In rare cases, oximetazolina, 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 at night.

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 with a clean, damp cloth after each use.

Children and adolescents

This medication is indicated for children over 6 years old.

Use of Oximetazolina farline 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))
• a medication to lower blood pressure called methyldopa.

It should also not be used while being treated with phenothiazine (tranquilizer) or medications to treat asthma.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

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

Oximetazolina farline contains benzalkonium chloride

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

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

Patients with renal insufficiency or low-potassium 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".

Follow exactly the 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 children over 6 years old: apply 1 spray in each nostril 2 times a day at most (1 time in the morning and another time at night). If necessary, in adults, a second spray can be applied in each nostril with each use.

Use in children

Children under 6 years old:This medication is indicated for children over 6 years old.

Use in people over 65 years old

Consult your doctor or pharmacist as people over 65 years old are more sensitive to the adverse effects of this medication.

This medication is used by nasal spray.

If it is the first time using or has not been used for a long time, the spray must be primed. To do this, keeping the container away from the body, press the spray several times until the liquid spray comes out.

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

To apply the spray, keep your head straight. Place the applicator in the nasal fossa so that it does not completely cover the opening. At the same time as pressing the applicator, breathe gently to ensure that the medication is evenly distributed in the nasal fossa.

To prevent 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 you use more Oximetazolina nasal spray than 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 (Telephone 91 562 04 20) indicating the medication and the amount ingested.

If you forgot to use Oximetazolina nasal spray

Do not use a double dose to compensate for the missed dose.

If necessary, use it again as indicated in section 3. How to use Oximetazolina nasal spray

Like all medications, Oximetazolina farline may produce adverse effects, although not all people may experience them.

During the period of use of oximetazolina, 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 occasions are: anxiety, restlessness, insomnia, hallucinations, tremors, and sleep disorders in children. Tachycardia, palpitations, increased blood pressure. Headache, nausea, exanthema (skin redness).

Excessive or continued use of this medication 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 about possible adverse effects that do 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.

No requires special conservation conditions.

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.

Medications 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.

Oximetazolina Farline Composition

Each milliliter of solution contains:

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

Product appearance and packaging contents

It is a clear and transparent liquid solution. The packaging 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.

Responsible for manufacturing:

Alcalá Farma, S.L.

Avenida de Madrid 82,

Alcala de Henares. 28802. Spain

Last review date of this leaflet:April 2023

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