Rinocusi Vitamínico 12.500 UI/g nasal ointment

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the User

Rinocusi Vitamínico 12,500 IU/g nasal ointment

retinol acetate

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

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
  • If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
  • You should consult a doctor if your condition worsens or if you do not improve after 10 days.

Contents of the leaflet

1. What Rinocusi Vitamínico is and what it is used for
2. What you need to know before using Rinocusi Vitamínico
3. How to use Rinocusi Vitamínico
4. Possible adverse effects
5. How to store Rinocusi Vitamínico

Contents of the container and additional information

1. What Rinocusi Vitamínico is and what it is used for

This medicine belongs to a group of medicines called nasal preparations. This nasal ointment contains retinol (vitamin A), a substance with a protective effect on irritated nasal mucosa.

Rinocusi Vitamínico is indicated for the local symptomatic relief of nasal mucosa irritation in dry nasal colds, with or without crust formation in the nasal passages, in adults and children over 6 years of age.

2. What you need to know before starting to use Rinocusi Vitamínico

Do not use Rinocusi Vitamínico

• If you are allergic to the active substance or to any of the other components of this medicine (listed in section 6).
• In children under 6 years of age.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Rinocusi Vitamínico.

Take special care with Rinocusi Vitamínico

• Must be used externally on the skin only. It must not be ingested.
• Do not exceed the recommended dosage.
• If symptoms worsen or persist after 10 days of treatment, stop using the medicine and consult your doctor or pharmacist.

Children

Do not use in children under 6 years of age due to lack of safety and efficacy data.

Other medicines and Rinocusi Vitamínico

Inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

Concomitant use with other nasal preparations is not recommended.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

The use of Rinocusi Vitamínico is not recommended during pregnancy or breastfeeding. If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using Rinocusi Vitamínico.

Driving and using machines

The effect of this medicine on the ability to drive and operate machinery is none or negligible.

Rinocusi Vitamínico contains butylhydroxytoluene (E-321)

This medicine may cause local skin reactions (such as contact dermatitis) or irritation of the eyes and mucous membranes because it contains butylhydroxytoluene (E-321).

3. How to Use Rinocusi Vitamínico

Follow exactly the instructions for use provided in this leaflet or those 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 of age: apply a small amount of nasal ointment 2 or 3 times a day inside the nose or around the nasal passages.

For external use (around the nasal passages): apply a thin film to the affected area and gently massage.

For intranasal use: insert the tube's cannula deeply into the nostril and release a small amount of the medication. Gently massage to help distribute the nasal ointment over the entire nasal mucosa. After applying the nasal ointment, it should remain in contact with the affected area for as long as possible; therefore, the patient should avoid blowing the nose.

To enhance its protective effect, it is advisable to apply the nasal ointment before going to bed.

If you use more Rinocusi Vitamínico than you should

In cases of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service immediately. Telephone: 91 562 04 20, indicating the name of the medicine and the amount ingested.

If you forget to use Rinocusi Vitamínico

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

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

4. Possible adverse effects

Like all medicines, Rinocusi Vitamínico may produce adverse effects, although not all people will experience them.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Rinocusi Vitamínico

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

Do not store above 30°C.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the container and other information

Composition of Rinocusi Vitamínico

• The active substance is retinol acetate. Each gram of nasal ointment contains 12,500 IU (international units) of retinol acetate.

• The other components (excipients) are: tocopheryl acetate, butylhydroxytoluene (E-321), cholesterol, liquid paraffin and white soft paraffin.

Appearance of the product and contents of the container

Rinocusi Vitamínico is a yellowish-white nasal ointment. Each container holds 10 grams of nasal ointment.

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Laboratoris Feltor, S.A.U.

Polígono Industrial Molí de les Planes

c/ Roques Blanques, 3-5

08470 Sant Celoni (Barcelona)

Spain

Date of the most recent revision of this leaflet: March 2019

Detailed information about this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/