Label: Information for the User

Rinocusi Vitamínico 12.500 UI/g Nasal Ointment

retinol acetate

Read this label carefully before starting to use this medication, as it contains important information for you.

Follow exactly the administration instructions contained in this label or those indicated by your doctor or pharmacist.

-Keep this label, as you may need to refer to it again.

-If you need advice or more information, consult your pharmacist.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 10 days.

Contents of the package and additional information

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 openings, in adults and children over 6 years old.

Do not use Rinocusi Vitamínico

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

Warnings and precautions

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

Be especially careful with Rinocusi Vitamínico

• It must be used exclusively on the skin. Do not ingest.
• 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 old due to the absence of safety and efficacy data.

Other medications and Rinocusi Vitamínico

Inform 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 concurrent administration with other nasal preparations.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

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

Driving and operating machinery

The influence of this medication on the ability to drive and operate machinery is negligible or insignificant.

Rinocusi Vitamínico contains butylhydroxytoluene (E-321)

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

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 dose is:

Adults and children over 6 years old: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 over the affected area, performing a gentle massage.

For intranasal use:Insert the tube cannula deeply into the nasal passage 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 nasal ointment is applied, it should remain in contact with the affected area for as long as possible, so the patient should avoid blowing their nose.

To increase its protective action, it is recommended 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 immediately or call the Toxicological Information Service. Phone: 91 562 04 20, indicating the name of the medication and the amount ingested.

If you forgot to use Rinocusi Vitamínico

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

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

Like all medications, Rinocusi Vitamínico may cause adverse effects, although not everyone will experience them.

Reporting 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 can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://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.

Do not store at a temperature above 86°F (30°C).

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

Unused medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Rinocusi Vitamínico

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

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

Appearance of the product and contents of the packaging

Rinocusi Vitamínico is a yellowish white nasal ointment. Each package contains10 gramsof nasal ointment.

Holder of the marketing authorization

STADA Laboratory, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing

Feltor Laboratories, S.A.U.

Molí de les Planes Industrial Estate

c/ Roques Blanques, 3-5

08470 Sant Celoni (Barcelona)

Spain

Last review date of this leaflet:March 2019

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/