CUVENAX 35 micrograms/PUFF NASAL SPRAY SOLUTION

2. What you need to know before you start using Cuvenax

Do not use Cuvenax

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

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If you have recently undergone an operation on the head.

Warnings and precautions

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

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

• If you have had or have 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 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 vertigo 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 may 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 Cuvenax.

To avoid contagion, the medicine should not be used by more than one person and the applicator should be cleaned after each use with a clean, damp cloth.

Children and adolescents

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

Use in people over 65 years

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

Other medicines and Cuvenax

Tell your doctor or pharmacist if you are using, have recently used or may need to use any other medicine.

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

It should not be used in case of being treated with phenothiazine (tranquilizer) or with medicines to treat asthma.

Use of Cuvenax with food, drinks and alcohol

Food consumption does not affect the efficacy of this medicine.

Pregnancy and breastfeeding

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

This medicine should not be administered during pregnancy or breastfeeding.

Consult your doctor or pharmacist before using a medicine.

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.

Cuvenax contains benzalkonium chloride

This medicine contains 0.014 mg of benzalkonium chloride per spray.

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

3. How to use Cuvenax

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

The recommended dose is:

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

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

This medicine 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 load the spray pump. To do this, keeping the container away from the body, press the spray pump several times until the sprayed liquid comes out.

Before application, eliminate 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 pressing the applicator, breathe in gently to ensure that the medicine is distributed evenly throughout the nasal cavity.

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

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

If you use more Cuvenax than you should

By applying excessive doses or very continuous ones, 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 medicine and the amount ingested.

If you forget to use Cuvenax

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 Cuvenax.

If you stop treatment with Cuvenax

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

During the period of use of oxymetazoline, the following side effects have been observed, whose frequency has not been 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).

Excessive or continued use of this medicine may lead to an increase in nasal congestion.

Reporting of side effects

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

5. Storage of Cuvenax

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

This medicine does not require special storage conditions.

Do not use this medicine after the expiry date that appears on the box after {CAD.}. The expiry date is the last day of the month indicated.

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

6. Contents of the pack and further information

Composition of CUVENAX

The active ingredient is: oxymetazoline, hydrochloride.

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

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

Appearance of the product and contents of the pack

It is a colorless and transparent liquid solution.

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

Marketing Authorization Holder:

PHARMEX ADVANCED LABORATORIES, S.L.

Ctra. A-431 Km.19

14720 Almodóvar del Río (Córdoba)

Manufacturer:

PHARMEX ADVANCED LABORATORIES, S.L.

Ctra. A-431 Km.19

14720 Almodóvar del Río (Córdoba)

Spain

This leaflet was approved in August 2009