Bacnas 20 mg/g nasal ointment
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: Information for the user
Bacnas 20 mg/g nasal ointment
Mupirocin
Read this entire leaflet carefully before you start using this medicine, because it contains important information for you.
- Keep this leaflet; you may need to read it again.
- If you have any questions, ask your doctor, pharmacist or nurse.
- This medicine has been prescribed for you only; do not give it to others, even if they have the same symptoms as you, because it could harm them.
- If you experience any side effects, talk to your doctor, pharmacist or nurse, even if it is a side effect not listed in this leaflet. See section 4.
Contents of the leaflet
- What Bacnas is and what it is used for
- What you need to know before using Bacnas
- How to use Bacnas
- Possible side effects
- How to store Bacnas
- Contents of the pack and other information
1. What Bacnas is and what it is used for
Bacnas 20 mg/g nasal ointment (referred to as Bacnas in this leaflet) contains the active substance called calcium mupirocin. Bacnas is an antibiotic nasal ointment.
Antibiotics are used to treat bacterial infections and are not effective against viral infections such as influenza or the common cold.
It is important that you follow your doctor's instructions regarding dose, dosing interval, and duration of treatment.
Do not store or reuse this medicine. If you have any antibiotic left over after completing treatment, return it to the pharmacy for proper disposal. Do not dispose of medicines via wastewater or household waste.
It is used for:
- destroying a group of bacteria in the nose called "staphylococci".
- This group includes MRSA (Staphylococcus aureus resistant to methicillin).
- 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 calcium mupirocin, mupirocin, or to any of the other components of this medicine (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 medicine. Consult your doctor, pharmacist, or nurse before starting to use Bacnas.
Warnings and precautions
Talk to your doctor or pharmacist before starting to use Bacnas.
Bacnas may cause serious skin reactions or allergies. See "Situations to be aware of" in section 4.
Prolonged use of Bacnas may lead to the development of infections caused by organisms that are not sensitive to it. 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 medicines and Bacnas
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
Driving and using machines
Bacnas is unlikely to affect your ability to drive or operate machinery.
3. How to use Bacnas
Follow exactly the administration instructions for this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again.
Dosage
Adults (including elderly patients) and children aged one year and older:
Apply Bacnas two or three times daily into both nostrils.
Children under one year of age:
Bacnas must not be used in children under one year of age.
Patients with renal impairment:
Dose adjustment is not required.
Patients with hepatic impairment:
Dose adjustment is not required.
How to use this medicine
Apply Bacnas 2 to 3 times daily into the nose.
- Wash and dry your hands.
- Place a small amount of Bacnas, approximately the size of a match head, on your little finger.
- Apply it inside one nostril.
- Repeat steps 2 and 3 for the other nostril.
- Press the sides of the nose to spread the ointment throughout the nasal cavity.
- Replace the cap on the tube and wash your hands.
Instead of using the little finger, you may also use a cotton swab to apply the ointment, especially in young children or severely ill patients.
How long to use Bacnas
Use Bacnas for as long as your doctor has instructed. If you are unsure, consult your doctor, pharmacist, or nurse. Generally, bacteria disappear from the nose within 5 to 7 days after starting treatment.
In case of ingestion of Bacnas
If you swallow any amount of the ointment, consult your doctor, pharmacist, or nurse, or call the Toxicology Information Service at telephone number: 91 562 04 20, stating the medicine 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 within less than one hour, do not apply the missed dose.
- Do not use a double dose to make up for forgotten doses.
If you stop using Bacnas
If you stop treatment with Bacnas prematurely, it is possible that not all bacteria have been destroyed or that they continue to multiply. Consult your doctor, pharmacist, or nurse if you discontinue use of the ointment.
If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.
Situations to be aware of
Severe skin reactions or allergies:
These are very rare in people using Bacnas. Signs include:
-
Raised rash with itching
-
Swelling, sometimes in the face or mouth, causing difficulty in breathing
-
Fainting or loss of consciousness.
-
Contact a doctor immediately if you experience any of these symptoms. Discontinue treatment with Bacnas.
-
If you develop a severe skin reaction or allergy:
- Wash off the ointment to remove it
- Stop using it
- Consult your doctor as soon as possible
Rarely, medicines such as Bacnas may cause inflammation of the colon (large intestine), leading to diarrhoea, usually with blood and mucus, stomach pain, and fever (pseudomembranous colitis).
- Inform your doctor as soon as possible if you experience any of these symptoms.
This medicine may cause the following adverse effects:
Uncommon (may affect up to 1 in 100 people)
- Itching, redness, burning, tingling, or prickling in the nose.
Very rare (may affect up to 1 in 10,000 people)
- Some people may develop a skin reaction or allergy which can be severe. Signs include rash, itching, redness, or pain.
Reporting of adverse effects
If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es.
By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Bacnas
- Keep this medicine out of the sight and reach of children.
- Do not use this medicine after the expiry date stated on the tube and the carton after EXP. The expiry date refers to the last day of the month indicated.
- Do not store above 25 °C.
- After first opening, the contents may be used for up to 7 days.
- Bacnas is a soft, white to off-white ointment. Do not use if it appears different from normal.
- Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the Punto Sigre collection point in your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Bacnas
- The active substance 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 soft paraffin and bis-diglycerol polyacyladipate-2.
Appearance of Bacnas and contents of the pack
- Bacnas is a soft, whitish nasal ointment.
- Bacnas is available in tubes of 3 g or 5 g. Each tube is packaged in a carton.
Only certain 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 medicinal product 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 most recent revision of this leaflet: 05/2023
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/