Ficha técnica de Rinobanedif pomada nasal – Espanha

Como usar Rinobanedif pomada nasal

Introduction

Label: Information for the User

Rinobanedif Nasal Ointment

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

Keep this label, as you may need to refer to it again.
If you have any questions, consult your doctor or pharmacist.
This medication has been prescribed to you alone, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.

If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

6. Contents of the container and additional information

1. What is Rinobanedif and what is it used for

It is a nasal ointment that contains as active ingredients two antibiotics (bacitracin and neomycin), a corticosteroid, prednisolone (anti-inflammatory), phenylephrine (nasal decongestant), chlorobutanol (antiseptic) and two components with aromatic properties (eucalyptus oil and niaulí essence); upon application to the nasal mucosaRinobanedifprovides antiseptic, anti-inflammatory and vasoconstrictor activity.

The antibiotics are used to treat bacterial infections and do not serve to treat viral infections such as the flu or the common cold.

It is essential to follow the instructions regarding the dose, administration interval and treatment duration indicated by your doctor.

Do not store or re-use this medication. If once the treatment is finished you have leftover antibiotic, return it to the pharmacy for proper disposal. Do not dispose of the medication through the drain or in the trash.

Rinobanedif is indicatedfor the local treatment ofaffections of the nasal mucosa that are accompanied by congestion, inflammation (such as some symptoms of rhinitis) and/or small wounds, with or without the formation of crusts, in adults and children over 6 years old.

2. What you need to know before starting to use Rinobanedif

No use Rinobanedif:

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

- If you have tuberculosis, syphilis, fungal or viral infections (e.g., herpes or varicella), including those in the respiratory tract.

- In the eyes or open wounds.

- In children under 6 years old.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Rinobanedif.

- Administer with caution in the following situations: coronary artery disease or heart disease, hypertension, irregular heartbeats (arrhythmias), thyroid disease, diabetes mellitus, difficulty urinating due to prostate problems, glaucoma (increased eye pressure), recent nasal ulcers, recent nasal surgery, or recent nasal trauma.

- Due to the corticosteroid content (prednisolone) via nasal spray, any of the adverse effects reported with oral corticosteroids may occur, especially at high doses and with prolonged treatment, such as the alteration of adrenal glands located near the kidneys, resulting in symptoms like obesity, delayed growth in children, etc. (Cushing's syndrome).

- Do not use the medication for an extended period.

- If you are hypersensitive to certain antibiotics (aminoglycosides), you may be sensitive to neomycin and, if sensitive to this, you may be sensitive to bacitracin, a component of this medication.

Children

Do not administer to children under 6 years old, as the safety and efficacy of this medication have not been established in this age group.

Children are more prone to adverse effects from corticosteroids than adults.

Other medications and Rinobanedif

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription.

Some medications may increase the effects of Rinobanedif, so your doctor will perform thorough checks if you are taking these medications (including some for HIV: ritonavir, cobicistat).

If sufficient internal absorption occurs, it may lead to hypertensive crises and cardiac arrhythmias, especially when administered with MAOIs (antidepressants and other uses), tricyclic antidepressants, and beta-blockers (for the heart). Interactions may also occur with maprotiline (antidepressant) and other aminoglycosides (antibiotics).

Pregnancy, breastfeeding, and fertility

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

Since one of the components of Rinobanedif may be absorbed into the circulation, especially with high-dose and prolonged administration, do not administer during pregnancy, unless your doctor considers that the benefit to the mother outweighs the potential risks to the fetus or baby.

Do not apply Rinobanedif during breastfeeding.

Driving and operating machines

No effects have been described on the ability to drive and operate machines.

3. How to use Rinobanedif

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:Perform 1 to 3 applications per day.

The average duration of treatment will be 5 days.

Use in children

Do not administer to children under 6 years old.

Nasal route.

Instructions for the correct use of the ointment

Opening the tube and mode of use: To open the tube, unscrew the cap-needle assembly and remove the safety washer (Fig. A). Place the needle back in, screwing it to the bottom, to thus pierce the aluminum seal of the tube.

Apply a small amount of Rinobanedif to both nasal openings (Fig. B), ensuring a uniform distribution of the ointment, for which a gentle external massage is recommended (Fig. C).

After application, clean the tube tip with a clean and damp cloth. Do not use the container for more than one person.

You should consult your doctor if you worsen or do not improve after 7 days of treatment.

If you use more Rinobanedif than you should

Given the administration method, it is very difficult to experience an overdose.

In case of overdose, the effects that may occur would be primarily local irritation, and in case of sufficient absorption of phenylephrine, the appearance of cardiovascular alterations (cardiac arrhythmias, hypertension).

In the case of accidental ingestion, a container, there would be gastric irritation and there would be no reason to have cardiovascular alterations initially.

The treatment, in case of overdose or accidental ingestion, should include blood pressure control and electrocardiogram. Additionally, in case of ingestion (equal to or greater than a container), induce vomiting or perform gastric lavage and administer a mucous protector.

In case of overdose or accidental ingestion,consultyour doctor or pharmacist immediately, orvisit a medical center, or call the Toxicology Information Service, Tel. 91 562 04 20 indicating the medication and the amount ingested.

If you forgot to use Rinobanedif

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

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

4. Possible Adverse Effects

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The assessment of side effects is based on the following frequencies:

Very common:may affect more than 1 in 10 people

Common:may affect up to 1 in 10 people

Uncommon:may affect up to 1 in 100 people

Rare:may affect up to 1 in 1,000 people

Very rare:may affect up to 1 in 10,000 people.

Unknown frequency (cannot be estimated from available data).

During the use of Rinobanedif ointment, the following side effects may appear:

- Common: contact allergic dermatitis (inflammation in the application area) may occur; after prolonged or excessive use, rebound nasal congestion may occur.

- Rarely: cutaneous allergic reactions have been observed: redness, itching, dryness, or burning sensation of the nasal mucosa. In rare cases, also: sneezing and signs of internal absorption such as: headache, dizziness, or nervousness, irregular heartbeat, hypertension, and anaphylactic reaction (exaggerated allergic reaction), in general if the ointment is applied to deep wounds.

- In very rare cases: ototoxicity (hearing loss), nephrotoxicity (kidney damage), especially if renal dysfunction exists, slight nasal bleeding, nasal dryness, and irritation.

The side effects of corticosteroids increase with factors that increase absorption, such as prolonged use, extensive areas, or occlusive materials.

With the use of topical corticosteroids, particularly through the nasal route, the following side effects may also occur:

Nasal and gustatory disorders; rarely, nasal septum ulceration or perforation.

Other side effects of corticosteroids are: skin atrophy, skin color changes, propensity to bruise, appearance of blood vessels under the skin surface, folliculitis (inflammation of hair follicles), increased hair growth, striae, acne, secondary infections such as fungal infections.

Side effects due to corticosteroid absorption: a condition characterized by obesity, rounded face, accumulation of fat in the cervical area, delayed wound healing, psychiatric symptoms, etc. (Cushing's syndrome); cataracts, glaucoma.

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 System of Pharmacovigilance of Medicines for Human Use: https://www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Rinobanedif

No requires special conservation conditions.

This medication must be used within 6 months after its opening.

Keep this medication out of sight and reach of children.

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

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. In this way, you will help protect the environment.

6. Contents of the packaging and additional information

Composition of Rinobanedif

- The active principles are: bacitracin-zinc, neomycin sulfate, prednisolone, phenylephrine hydrochloride, chlorobutanol hemihydrate, eucalyptus oil, and niaouli essential oil. Each gram of ointment contains: 500 IU of bacitracin zinc, 5 mg of neomycin sulfate (equivalent to 3.5 mg of neomycin base), 3 mg of prednisolone (0.3%), 2.5 mg of phenylephrine hydrochloride (0.25%), 8 mg of chlorobutanol hemihydrate, 2.00 mg - 2.86 mg of eucalyptus oil (equivalent to 2 mg of 1,8 cineole) and1.54 mg - 2.22 mgof niaouli essential oil (equivalent to 1 mg of 1,8 cineole).

- The other components (excipients) are: cholesterol, plastibase, white flowing vaseline, and liquid vaseline.

Appearance of the product and contents of the packaging

Rinobanedif is a nasal ointment; it is greasy, white-yellowish in color.

Each package contains an aluminum tube with 10 g of nasal ointment.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

TEOFARMA S.R.L.

Via F.lli Cervi, 8

27010 Valle Salimbene (PV) - Italy

Responsible for manufacturing:

DOPPEL FARMACEUTICI, S.R.L.

Via Martiri delle Foibe, 1.Cortemaggiore

(Piacenza)- 29016- Italy

Last review date of this leaflet:February 2020

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