RINOCUSI VITAMÍNICO 12,500 IU/g NASAL OINTMENT

Introduction

Package Leaflet: Information for the User

Rinocusi Vitamínico 12,500 UI/g Nasal Ointment

retinol acetate

Read the entire package leaflet carefully before starting to use this medication, as it contains important information for you.

Follow the administration instructions exactly as contained in this package leaflet or as indicated by your doctor or pharmacist.

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

Contents of the Package 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 side effects
5. Storage of Rinocusi Vitamínico

Contents of the packaging and additional information

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

This medication belongs to a group of medications 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 orifices, in adults and children over 6 years of age.

2. What you need to know before using Rinocusi Vitamínico

Do not use Rinocusi Vitamínico

• If you are allergic to the active ingredient or any of the other components of this medication (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.

Be careful with Rinocusi Vitamínico

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

Children

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

Other medications and Rinocusi Vitamínico

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

It is recommended to avoid concomitant administration with other nasal preparations.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

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

Driving and using machines

The influence of this medication on the ability to drive and use machines is nil or insignificant.

Rinocusi Vitamínico contains butylhydroxytoluene (E-321)

This medication may cause local skin reactions (such as contact dermatitis) or eye and mucous membrane irritation because it contains butylhydroxytoluene (E-321).

3. How to use Rinocusi Vitamínico

Follow the administration instructions exactly as contained in this package 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 a small amount of nasal ointment 2 or 3 times a day inside the nose or around the nasal openings.

For external use (around the nasal openings):Apply a thin film to the affected area, performing a gentle massage.

For intranasal use:Insert the tube's nozzle deep into the nasal opening and release a small amount of medication. Perform a gentle massage to facilitate the distribution of the nasal ointment throughout the nasal mucosa. Once the ointment is applied, it should remain in contact with the affected area for as long as possible; therefore, the patient should avoid blowing their nose.

To increase its protective action, it is recommended to apply the nasal ointment before bedtime.

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. Phone: 91 562 04 20, indicating the name of the medication and the amount ingested.

If you forget to use Rinocusi Vitamínico

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

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

4. Possible side effects

Like all medications, Rinocusi Vitamínico can cause side effects, although not everyone will experience them.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Rinocusi Vitamínico

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

Do not store at a temperature above 30°C.

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medications at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Contents of the packaging and additional information

Composition of Rinocusi Vitamínico

• The active ingredient is retinol acetate. Each gram of nasal ointment contains 12,500 IU (International Units) of retinol acetate.

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

Appearance of the product and contents of the packaging

Rinocusi Vitamínico is a yellowish-white nasal ointment. Each package contains 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 last revision of this package leaflet:March 2019

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