NOVAG RINO 35 micrograms/PUFF NASAL SPRAY SOLUTION

Introduction

Package Leaflet: Information for the User

NOVAG RINO 35 micrograms/spray nasal spray solution

Oxymetazoline, hydrochloride

Read this leaflet carefully because it contains important information for you.

This medication can be obtained without a prescription. Nevertheless, to obtain the best results, it should be used properly.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If your symptoms worsen or persist after 3 days of treatment, you should consult your doctor.
• If you consider that any of the adverse effects you are suffering from is serious, or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

Contents of the package leaflet:

1. What is NOVAG RINO and what is it used for
2. Before using NOVAG RINO
3. How to use NOVAG RINO
4. Possible side effects
5. Storage of NOVAG RINO
6. Additional information

1. What is NOVAG RINO and what is it used for

This medication belongs to the group called Sympathomimetics. It is a medication that contains oxymetazoline as the active ingredient, which is a nasal decongestant. When administered in the nose, it produces decongestion and improvement of nasal ventilation.

This medication is indicated for the local symptomatic relief of nasal congestion, such as in the case of colds and rhinitis.

2. BEFORE USING NOVAG RINO

Do not use NOVAG RINO

If you are allergic (hypersensitive) to oxymetazoline, to other nasal decongestants, or to any of the other components of the medication.

If you have recently undergone an operation on the head.

Be careful with NOVAG RINO

Be careful with NOVAG RINO and consult your doctor before using this medication if:

• You are being treated with antidepressant medications, phenothiazine (tranquilizer), or methyldopa (to lower blood pressure).

• You have had or have, even if it only happened once, 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 hyperplasia)
• If you have any thyroid disease (hyperthyroidism)
• If you have ever suffered from insomnia or dizziness when being treated with other sympathomimetic medications, such as those used to treat heart diseases, to treat hypotension (low blood pressure) or to treat asthma.

In rare cases, oxymetazoline can increase the symptoms of nasal congestion instead of decreasing them; this is because its effects are temporary and prolonged use can cause this result, known as rebound effect.

Do not exceed the recommended dose in section 3. How to use NOVAG RINO.

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.

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, even those purchased without a prescription.

This medication should not be used by people who are taking or have taken during the last two weeks: tricyclic antidepressants or monoamine oxidase inhibitors (MAOIs) (medications used to treat depression) or methyldopa (medication to lower blood pressure).

It should not be used in case of treatment with phenothiazine (tranquilizer) or with medications to treat asthma.

Use of NOVAG RINO with food and beverages

The use of NOVAG RINO does not affect the efficacy of this medication.

Use in children

Do not use in children under 6 years old without consulting a doctor.

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

Use in people over 65 years old

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

Pregnancy and breastfeeding

This medication should not be administered during pregnancy or breastfeeding.

Consult your doctor or pharmacist before using a medication.

Driving and using machines

Observe your response to the medication because in some cases, drowsiness has occurred at usual doses. In this case, do not drive or operate hazardous machinery.

Important information about some of the components of NOVAG RINO

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

3. HOW TO USE NOVAG RINO

Follow these instructions unless your doctor has given you different ones.

Consult your doctor or pharmacist if you have doubts.

The normal dose is:

Adults and children over 6 years old: Apply 1 spray in each nostril 2 times a day, maximum, 1 time in the morning and another time at night. If necessary, in adults, a second spray can be applied in each nostril at each application.

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

This medication is used nasally.

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

Before application, eliminate any existing nasal fluids by blowing your nose well.

For the application of the spray, keep your head straight.

Place the applicator in the nasal cavity so that it does not completely cover the nostril. At the same time as you press the applicator, breathe in gently to ensure that the medication is distributed evenly throughout the nasal cavity.

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

If your symptoms worsen or persist after 3 days of treatment, interrupt the treatment and consult your doctor.

If you use more NOVAG RINO than you should

Due to excessive or very continuous application, you may feel headache, tremors, insomnia, excessive sweating, sleep disturbances, palpitations, nervousness.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91.5620420, indicating the medication and the amount ingested.

If you forget to use NOVAG RINO

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

If necessary, use it again as indicated in section 3. How to use NOVAG RINO.

4. Possible side effects

Like all medications, NOVAG RINO can have side effects, although not everyone will experience them.

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

The side effects that can occur most frequently are:

Irritation at the site of application, dryness, itching of the nasal mucosa, or sneezing.

The side effects that can occur very rarely are:

Anxiety, restlessness, insomnia, hallucinations, tremors, and sleep disorders in children. Tachycardia, palpitations, increased blood pressure. Headache, nausea, exanthema (redness of the skin).

The excessive or continued use of this medication can lead to an increase in nasal congestion.

If you consider that any of the side effects you are suffering from is serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

5. Storage of NOVAG RINO

Keep out of the reach and sight of children.

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the container after: EXP. The expiration date is the last day of the month indicated.

Medications should not be thrown away through the sewers or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This way, you will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of NOVAG RINO

The active ingredient is: oxymetazoline hydrochloride. Each spray contains 35 micrograms of oxymetazoline hydrochloride in 0.07 ml of nasal spray solution.

The other components (excipients) are: benzalkonium chloride (0.014 mg per spray), potassium dihydrogen phosphate (to adjust the pH), anhydrous disodium hydrogen phosphate (to adjust the pH), purified water.

Appearance of the product and container contents

It is a colorless and transparent liquid solution.

The container with a dosing pump is white and contains 15 ml of the nasal spray solution.

Marketing authorization holder:

Tarbis Farma, S.L.U.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturer:

Laboratorios Alcalá Farma, S.L.

Avenida de Madrid 82

28802 Alcalá de Henares (Madrid)

Spain

This leaflet was approved in August 2009