PATIENT INFORMATION LEAFLET

CUVENAX 35 micrograms/actuation nasal spray solution

Oxymetazoline hydrochloride

Read this leaflet carefully before you start using this medicine because it contains important information for you.

Follow exactly the administration instructions contained in this leaflet or those given by your doctor, pharmacist or nurse.

• 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 side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 3 days.

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 Cuvenax

If you are allergic (hypersensitive) to oxymetazoline or to any of the other components of this medication (listed in section 6).

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If you have recently undergone surgery on the head.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Cuvenax:

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

• If 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 vertigo 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 Cuvenax.

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

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

Use in people over 65 years old

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

Other medications and Cuvenax

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: 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 while being treated with phenothiazine (tranquilizer) or medications to treat asthma.

Use of Cuvenax with food, drinks, and alcohol

The consumption of food does not affect the efficacy of this medication.

Pregnancy and breastfeeding

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

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.

Cuvenax contains benzalkonium chloride

This medication contains0.014 mgof benzalkonium chloride in each spray.

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

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended doseis:

Adults and children over 6 years old: Apply 1 pulse in each nasal orifice 2 times a day at most, 1 time in the morning and another time at night. If necessary, in adults, in each application, a second pulse could be performed in each nasal orifice.

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, it is necessary to load the sprayer. To do this, keeping the container away from the body, the sprayer is pressed several times until the liquid spray comes out.

Before its application, the existing nasal fluids must be eliminated, blowing the nose well.

To apply the pulse, the head must be kept straight.

Place the applicator in the nasal fossa so that it does not cover the orifice completely. At the same time as pressing the applicator, breathe softly to ensure that the medication is distributed uniformly in the nasal fossa.

To avoid contagions, after each use and before closing the container, the end of the applicator must be cleaned with a clean and damp cloth. In addition, each container must be used only by one person.

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

If you use more Cuvenax than you should

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

If you forgot to use Cuvenax

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 Cuvenax.

If you interrupt the treatment with Cuvenax

If you have any other doubt about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce 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 more frequently are:

Itching at the site of application, 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.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the box 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.Deposit the containers and medications you no longer need at the SIGRE Pointof the pharmacy.If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of CUVENAX

The active ingredient is: oxymetazoline hydrochloride.

• The other excipients are benzalkonium chloride (0.014 mg per pump), potassium dihydrogen phosphate, anhydrous sodium hydrogen phosphate, purified water.

Each pump contains 35 micrograms of oxymetazoline hydrochloride in 0.07 ml of nasal spray solution.

Appearance of the product and contents of the packaging

It is a clear and transparent liquid solution.

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

Holder of the Marketing Authorization:

PHARMEX ADVANCED LABORATORIES, S.L.

Ctra. A-431 Km.19

14720 Almodóvar del Río (Córdoba)

Responsible for manufacturing:

PHARMEX ADVANCED LABORATORIES, S.L.

Ctra. A-431 Km.19

14720 Almodóvar del Río (Córdoba)

Spain

This leaflet was approved in August 2009