Bactroban Nasal 20 mg/g nasal ointment
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: Information for the user
Bactroban nasal 20 mg/g nasal ointment
mupirocin
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
Leaflet contents
- What Bactroban nasal is and what it is used for
- What you need to know before using Bactroban nasal
- How to use Bactroban nasal
- Possible side effects
- How to store Bactroban nasal
- Contents of the pack and other information
1. What Bactroban nasal is and what it is used for
Bactroban nasal is an antibiotic that contains mupirocin as the active substance.
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 the instructions regarding dose, dosing interval, and duration of treatment as directed by your doctor.
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. Medicines must not be disposed of via the sewage system or with household waste.
This medicine is used in the treatment of bacterial infections of the nose.
2. What you need to know before using Bactroban nasal
Do not use Bactroban nasal:
- if you are allergic to mupirocin or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before starting to use this medicine.
Do not use this ointment if you have had an allergic reaction (a rash) to another ointment containing mupirocin.
If you develop an allergic reaction (such as a rash, local pain, or swelling) while using this medicine, stop treatment and contact your doctor as soon as possible.
Rarely, antibiotics can cause inflammation of the colon (large intestine), leading to diarrhoea, usually with blood and mucus, stomach pain, and fever (pseudomembranous colitis).
- If you experience any of these symptoms, consult your doctor as soon as possible and stop treatment immediately.
Do not use this ointment in the eyes. If the ointment gets into the eyes accidentally, rinse thoroughly with plenty of water until all traces of the ointment are removed.
Children and adolescents
Same dose as adults; see section 3.
Using Bactroban nasal with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Pregnancy and breastfeeding
Information on the safety of mupirocin in pregnant women is limited. Therefore, if you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
It is not known whether mupirocin is excreted in human breast milk. If you are breastfeeding, you should consult your doctor before using this medicine.
Driving and using machines
No effects on the ability to drive or operate machinery have been observed.
3. How to use Bactroban nasal
Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.
Remember to use your medicine. Your doctor will tell you how long your treatment should last.
Adults (including elderly patients) and paediatric population (children and adolescents)
Route of administration: nasal.
Apply a small amount of Bactroban nasal ointment into each nostril two or three times a day.
Instructions for use:
Wash your hands before and after applying the ointment.
Using the little finger or a cotton-tipped applicator (swab or pledget), apply a small amount of ointment, about the size of the head of a matchstick (approximately 30 mg of ointment), onto the inner surface of each nostril.
Using the index finger and thumb, press both sides of the nose and gently massage to spread the ointment inside the nose.
Use 2 - 3 times a day for a period of 5 to 7 days.
If you use more Bactroban nasal than you should
If you apply more ointment than you should, carefully remove the excess ointment.
Experience with overdose cases of mupirocin is currently limited.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.
Information for healthcare professionals:
There is no specific treatment for mupirocin overdose.
If you forget to use Bactroban nasal
Do not apply a double dose to make up for missed doses.
If you forget to apply a dose, apply the next dose as soon as possible and continue using it as before.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.
Situations you need to monitor:
Severe allergic reactions
These reactions occur very rarely in people using Bactroban nasal. Signs include:
-
raised, itchy rash
-
swelling, sometimes of the face or mouth, causing difficulty in breathing
-
collapse or loss of consciousness.
-
If you experience any of these symptoms, contact your doctor immediately. Stop using this medicine.
This medicine may cause skin irritation and allergic reactions.
- If you experience skin irritation, stop using this medicine. Remove any remaining ointment and consult your doctor as soon as possible.
Uncommon adverse effects
May affect up to 1 in 100 people:
- runny nose
- itching, redness, burning sensation, tingling, and/or stinging in the nose.
Very rare adverse effects
May affect up to 1 in 10,000 people:
- itching, redness, and stinging of the skin.
Reporting of 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 may 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 Bactroban nasal
Keep this medicine out of sight and reach of children.
Store below 25 °C. Dispose of any unused product.
Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the month indicated.
Medicines should not be disposed of via wastewater drains or household waste. Return unused medicines and their containers to the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Bactroban nasal
-
The active substance is mupirocin (as mupirocin calcium). Each gram of ointment contains 20 mg of mupirocin (as mupirocin calcium).
-
The other components are: white soft paraffin and Softisan 649 (a mixture of glycerol esters).
Appearance of the medicine and contents of the pack
This medicine is an almost white ointment.
It is supplied in an aluminium tube with a nozzle and plastic cap containing 3 g of ointment. It is packaged in a cardboard carton.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
GlaxoSmithKline, S.A.P.T.M.
C/ Severo Ochoa, 2
28760 Tres Cantos (Madrid)
Manufacturer:
GlaxoSmithKline Trading Services Limited
12 Riverwalk
Citywest Business Campus
Dublin 24
Ireland
or
Delpharm Poznan Spólka Akcyjna
ul. Grunwaldzka 189
60-322 Poznan
Poland
Date of the most recent revision of this summary: January 2019.
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es