Leaflet: Information for the user

Bacnas20mg/g nasal ointment

Mupirocin

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

1. What isBacnasand what it is used for

2. What you need to know before you start usingBacnas

3. How to useBacnas

4. Possible side effects

5. Storage ofBacnas

6. Contents of the pack and additional information

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

It is used for:

• destroying a group of bacteria in the nose called «staphylococci».
• This group includes MRSA (Staphylococcus aureusresistant to methicillin).
• This ointment should only be used in the nose.

Do not use Bacnas

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

Newborns should not be treated with Bacnas to avoid aspiration in the trachea.

If you are unsure if this limitation 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 “Special warnings and precautions for use” in section 4.

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

Keep the ointment away from the eyes.

-In case of accidental contact of the ointment with the eyes, wash them thoroughly with water.

Other medications and Bacnas

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

Pregnancy and breastfeeding

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

Driving and operating machines

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

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Dosage

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

Apply Bacnas two or three times a day in both nasal fossae.

Children under one year of age:

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

Patients with renal insufficiency:

No dose adjustment is necessary.

Patients with hepatic insufficiency:

No dose adjustment is necessary.

Use of this medication

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

1. Wash and dry your hands.
2. Place a small amount of Bacnas, approximately the size of a matchstick head, on your little finger.
3. Apply it to the inside of one nasal fossa.
4. Repeat steps 2 and 3 for the other nasal fossa.
5. Press the sides of the nose to distribute the ointment throughout the nasal fossa.
6. Replace the cap on the tube and wash your hands.

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

How long should you use Bacnas

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

In case of Bacnas ingestion

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

If you forgot to use Bacnas

• If you forgot 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 compensate for the missed doses.

If you interrupt the treatment with Bacnas

If you interrupt the treatment with Bacnas before time, it is possible that not all bacteria have been destroyed, or that they continue to reproduce. Consult your doctor, pharmacist, or nurse if you interrupt the use of the ointment.

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

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

Important Considerations

Severe Skin Reactions or Allergies:

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

• Swollen, itchy rash
• Swelling, sometimes on the face or mouth, that makes breathing difficult
• Loss of consciousness or fainting.

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

-If you develop a severe skin reaction or allergy:

• Wash the ointment off
• Stop using it
• Consult a doctor as soon as possible

In rare cases, medications like Bacnas may 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 may cause the following adverse effects:

Infrequent(may affect up to 1 in 100 people)

• Itching, redness, burning, tingling, or stinging 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. Symptoms include rash, itching, redness, or pain.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it's a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: 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 use this medication after the expiration date that appears on the tube and on the box after CAD. The expiration date is the last day of the month indicated.
• Do not store at a temperature above 25°C.
• After the first opening, the contents can be used for 7days.
• Bacnas is a soft, white-colored ointment. Do not use it if its appearance is different from normal.
• Medicines should not be thrown away through drains or in the trash. Dispose of the containers and medicines you no longer need at the Sigre Pointof the pharmacy. Ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition of Bacnas

• The active principle 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 components are white and soft paraffin and bis-diglycerol polyacryl adipate-2.

Appearance of Bacnas and contents of the packaging

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

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

INFECTOPHARM Arzneimittel und Consilium GmbH

Von-Humboldt-Str. 1

64646 Heppenheim

Germany

Local representative

Galenicum Derma, S.L.

Ctra N-1, Km 36

28750, San Agustin de Guadalix (Madrid)

Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

Germany: Mupirocin InfectoPharm 20 mg/g Nasensalbe

France: MupiNa 2 %, pommade nasale

Greece: MupiNa

Italy: PSEROCINA 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

Last review date of this leaflet: 05/2023

For detailed and up-to-date information on this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/