Leaflet: information for the user

NOVAG RINO 35 micrograms/pulse nasal spray solution

Oxymetazoline hydrochloride

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

This medicine can be purchased without a prescription. However, for 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 symptoms worsen or persist after 3 days of treatment, you should consult a doctor.
• If you consider any of the adverse effects you are experiencing to be severe, or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

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

2. Before using NOVAG RINO

3. How to use NOVAG RINO

4. Possible adverse effects

5. Storage of NOVAG RINO

6. Additional information

This medication belongs to the group known as 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 local symptomatic relief of nasal congestion, such as in cases of colds and rhinitis.

No use NOVAG RINO

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

If you have recently undergone surgery on the head.

Be especially careful with NOVAG RINO

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

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

• You have suffered or suffer, 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 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, oxymetazoline may increase nasal congestion symptoms instead of reducing them; this is due to its temporary effects and the fact that 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 with a clean, damp cloth after each use.

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 taking or having 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 also not be used in cases of treatment with phenothiazine (tranquilizer) or 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 without consulting a doctor.

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

Use in people over 65 years

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 operating machinery

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

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

Consult your doctor or pharmacist if you have any doubts.

The normal dose is:

Adults and children over 6 years old: Apply 1 pulse in each nasal passage 2 times a day at most, once in the morning and once at night. If necessary, in adults, a second pulse can be applied in each nasal passage per application.

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

This medication is used by nasal route.

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

Before its application, you must remove existing nasal secretions, blowing your nose well.

To apply the pulse, you must keep your head straight.

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

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 symptoms worsen or persist after 3 days of treatment, discontinue treatment and consult your doctor.

If you use more NOVAG RINO than you should

Due to excessive or very frequent dose applications, 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 Toxicological Information Service, phone: 91.5620420, indicating the medication and the amount ingested.

If you forgot to use NOVAG RINO

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

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

Like all medications, NOVAG RINO may have adverse effects, although not all people may 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 may occur with greater frequency are:

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

The adverse effects that may occur in very few cases are:

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

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

If you consider that any of the adverse effects you are experiencing is severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Keep out of reach and sight of children.

No special storage conditions are required.

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

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and unused medicines. By doing so, you will help protect the environment.

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 pH), anhydrous sodium hydrogen phosphate (to adjust pH), purified water.

Appearance of the product and contents of the package

It is a clear and transparent liquid solution.

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

Holder of the marketing authorization:

Tarbis Farma, S.L.U.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Responsible for manufacturing:

Laboratorios Alcalá Farma, S.L.

Avenida de Madrid 82

28802 Alcalá de Henares (Madrid)

Spain

This leaflet was approved in August 2009