BACNAS 20 mg/g NASAL PASTE

Introduction

Package Leaflet: Information for the User

Bacnas20mg/g nasal ointment

Mupirocin

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

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed to you only, 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 side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What Bacnas is and what it is used for
2. What you need to know before using Bacnas
3. How to use Bacnas
4. Possible side effects
5. Storage of Bacnas
6. Package Contents and Additional Information

1. What Bacnas is and what it is used for

Bacnas 20 mg/g nasal ointment (referred to as Bacnas in this package leaflet) contains the active substance mupirocin calcium. Bacnas is a nasal antibiotic ointment.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as the flu or common cold.

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

Do not store or reuse this medication. If you have any leftover antibiotic after completing treatment, return it to the pharmacy for proper disposal. Do not dispose of medications down the drain or in the trash.

It is used to:

• destroy a group of bacteria in the nose called "staphylococci".
• This group includes MRSA (Methicillin-resistant Staphylococcus aureus).
• This ointment should only be used in the nose.

2. What you need to know before using Bacnas

Do not use Bacnas

if you are allergic (hypersensitive) to mupirocin calcium, mupirocin, or any of the other ingredients of this medication (listed in section 6).

Infants should not be treated with Bacnas to avoid aspiration into the trachea.

If you are unsure whether this restriction applies to you, do not use this medication. Consult your doctor, pharmacist, or nurse before starting to use Bacnas.

Warnings and Precautions

Consult your doctor or pharmacist before starting to use Bacnas.

Bacnas may cause severe skin reactions or allergies. See "Situations to Consider" in section 4.

Prolonged use of Bacnas may lead to the development of infections with non-susceptible organisms. If this occurs, inform your doctor, pharmacist, or nurse.

Keep the ointment away from the eyes.

• In case of accidental contact of the ointment with the eyes, rinse them thoroughly with water.

Other Medications and Bacnas

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

Pregnancy and Breastfeeding

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

Driving and Using Machines

Bacnas is unlikely to affect your ability to drive or operate machines.

3. How to Use Bacnas

Follow your doctor's instructions for administering this medication exactly. If you are unsure, consult your doctor or pharmacist again.

Dosage

Adults (including elderly) and children over 1 year of age:

Apply Bacnas 2 to 3 times a day to both nostrils.

Children under 1 year of age:

Bacnas should not be used in children under 1 year of age.

Patients with Renal Impairment:

No dose adjustment is necessary.

Patients with Hepatic Impairment:

No dose adjustment is necessary.

Using this Medication

Apply Bacnas 2 to 3 times a day to the nose.

1. Wash and dry your hands.
2. Place a small amount of Bacnas, about the size of a match head, on your pinky finger.
3. Apply it to the inside of one nostril.
4. Repeat steps 2 and 3 for the other nostril.
5. Press the sides of the nose to spread the ointment throughout the nostril.
6. Replace the cap on the tube and wash your hands.

Instead of using your pinky finger, you can also use a cotton swab to apply the ointment, especially in small children or severely ill individuals.

How Long to Use Bacnas

Use Bacnas for the duration indicated by your doctor. If you are unsure, consult your doctor, pharmacist, or nurse. Generally, the bacteria disappear from the nose between 5 to 7 days after starting treatment.

In Case of Ingestion of Bacnas

If you ingest any amount of the ointment, consult your doctor, pharmacist, or nurse, or call the Toxicology Information Service at phone number: 91 562 04 20, indicating the medication and the amount ingested.

If You Forget to Use Bacnas

• If you forget to apply Bacnas, apply the ointment as soon as you remember.
• If the next dose is due in less than an hour, do not apply the missed dose.
• Do not take a double dose to make up for missed doses.

If You Interrupt Treatment with Bacnas

If you interrupt treatment with Bacnas prematurely, it is possible that not all bacteria will be destroyed, or they may continue to multiply. Consult your doctor, pharmacist, or nurse if you interrupt use of the ointment.

If you have any further questions about using this medication, ask your doctor, pharmacist, or nurse.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Situations to Consider

Severe Skin Reactions or Allergies:

These are very rare in people using Bacnas. The signs include:

• Bumpy rash with itching
• swelling, sometimes in the face or mouth, which can make breathing difficult
• fainting or loss of consciousness.

• Immediately contact a doctorif you experience any of these symptoms. Interrupt treatment with Bacnas.

• If you develop a severe skin reaction or allergy:
  • wash off the ointment to remove it
  • interrupt its use
  • consult a doctor as soon as possible

On rare occasions, medications like Bacnas can cause inflammation of the colon (large intestine), leading to diarrhea, usually with blood and mucus, stomach pain, and fever (pseudomembranous colitis).

• Inform your doctor as soon as possibleif you experience any of these symptoms.

This medication can cause the following side effects:

Uncommon(may affect up to 1 in 100 people)

• Itching, redness, burning, tingling, or prickling sensation in the nose.

Very Rare(may affect up to 1 in 10,000 people)

• Some people may develop a skin reaction or allergy that can be severe. The signs include rash, itching, redness, or pain.

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines Agency's website: www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Bacnas

• Keep this medication out of sight and reach of children.
• Do not use this medication after the expiration date stated on the tube and carton after EXP. The expiration date is the last day of the month indicated.
• Do not store above 25°C.
• After the first opening, the contents can be used for 7 days.
• Bacnas is a white, soft ointment. Do not use it if its appearance is different from normal.
• Medications should not be disposed of down the drain or in the trash. Return the packaging and any unused medication to the pharmacy's SIGRE point. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Bacnas

• The active ingredient is mupirocin in the form of mupirocin calcium. 100 g of nasal ointment contains 2.00 g of mupirocin in the form of mupirocin calcium. 1 g of nasal ointment contains 20 mg of mupirocin in the form of mupirocin calcium.
• The other ingredients are white and soft paraffin and bis-diglycerol polyacryladipate-2.

Appearance of Bacnas and Package Contents

• Bacnas is a white, soft nasal ointment.
• Bacnas is available in 3 g or 5 g tubes. Each tube is presented in a carton.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

INFECTOPHARM Arzneimittel und Consilium GmbH

Von-Humboldt-Str. 1

64646 Heppenheim

Germany

Local Representative

Galenicum Derma, S.L.U.

Ctra N-1, Km 36

28750, San Agustin del Guadalix (Madrid)

Spain

This medication is authorized in the Member States of the European Economic Area under the following names:

Germany: Mupirocin InfectoPharm 20 mg/g Nasensalbe

France: MupiNa 2%, pommade nasale

Greece: MupiNa

Italy: MUPIDER NASALE

Netherlands: Mupirocine InfectoPharm, 20 mg/g, neuszalf

Austria: Mupirocin InfectoPharm 20 mg/g Nasensalbe

Poland: Mupina

Portugal: Mupirocina Infectopharm Nasal

Slovakia: Mupina 20 mg/g nosová mast

Spain: Bacnas 20 mg/g pomada nasal

Czech Republic: Mupina

Hungary: Mupirocin InfectoPharm 20 mg/g orrkenocs

United Kingdom: Mupirocin 20 mg/g Nasal Ointment

Date of the Last Revision of this Package Leaflet:05/2023

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