Mupirocine Galenicumderma 20 mg/g ointment
Spain
Table of Contents
- Package leaflet: Information for the user
- Introduction
- 1. What Mupirocina 20 mg/g Ointment is and what it is used for
- 2. What you need to know before using Mupirocina 20 mg/g ointment
- 3. How to use Mupirocina 20 mg/g ointment
- 4. Possible adverse effects
- 5. Storage of Mupirocin 20 mg/g ointment
- 6. Contents of the pack and other information
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Mupirocina Galenicum Derma 20 mg/g ointment
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, consult your doctor or pharmacist.
- This medicine has been prescribed for you only and should not be given to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents
- What Mupirocina 20 mg/g ointment is and what it is used for
- What you need to know before using Mupirocina 20 mg/g ointment
- How to use Mupirocina 20 mg/g ointment
- Possible side effects
- How to store Mupirocina 20 mg/g ointment
- Contents of the pack and other information
1. What Mupirocina 20 mg/g Ointment is and what it is used for
This medicine contains mupirocina. Mupirocina is an antibiotic capable of stopping the growth of certain microorganisms.
This medicine is used to treat superficial skin infections such as impetigo, folliculitis, and furunculosis, as well as certain skin conditions (atopic dermatitis, eczematous dermatitis, and contact dermatitis) and traumatic lesions that may become secondarily infected, provided the affected area is limited in extent.
2. What you need to know before using Mupirocina 20 mg/g ointment
Do not use Mupirocina 20 mg/g ointment
- if you are allergic to mupirocin or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Consult your doctor or pharmacist before starting to use Mupirocina.
Do not use this ointment in the eyes or nasal passages. If the ointment accidentally gets into the eyes, rinse them thoroughly with water until all traces of the ointment are removed.
Do not use this medicine with cannulas or near intravenous catheters.
This medicine may cause skin irritation and allergic reactions. If during treatment you develop an allergic reaction, or experience burning, itching, redness, dryness, or sensitivity at the site of application, stop treatment, remove any applied ointment, and contact your doctor as soon as possible.
Exercise special caution if you have moderate or severe renal impairment, as this medicine contains a component called polyethylene glycol (macrogol) which, when applied to damaged skin, may be absorbed into the body—especially in cases of extensive lesions or open wounds—and may worsen kidney function.
Avoid prolonged treatment beyond 10 days, as this may lead to the development of resistant microorganisms.
Medicines such as Mupirocina Galenicumderma may cause inflammation of the colon (large intestine), resulting in diarrhea, usually with blood and mucus, stomach pain, and fever (pseudomembranous colitis).
Other medicines and Mupirocina 20 mg/g ointment
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.
Do not use this medicine simultaneously with other products intended for treatment of the same application site.
Pregnancy and breastfeeding
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.
Due to lack of information, Mupirocina 20 mg/g ointment should generally not be administered to pregnant women unless the benefits outweigh the potential risks of treatment.
You should not breastfeed while using Mupirocina 20 mg/g ointment, as it is unknown whether it passes into breast milk and could affect the baby. If Mupirocina 20 mg/g ointment is used to treat nipple fissures, the nipple should be washed thoroughly before breastfeeding.
Driving and using machines
Mupirocin does not affect the ability to drive or operate machinery.
Mupirocina contains Macrogol 400 and Macrogol 3350.
3. How to use Mupirocina 20 mg/g ointment
- Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Cutaneous use. For external use only.
The recommended dose is:
Adults and children:
One application two or three times a day for 5 to 10 days.
Patients with renal impairment
Your doctor will assess the use of this medicine in case there is a risk of polyethylene glycol absorption when applied to damaged skin.
Elderly patients
The dose for patients over 65 years of age is the same as for adults unless they have moderate or severe renal impairment (see section 2 “Warnings and precautions”).
Instructions for use:
Before application, wash your hands and the affected area thoroughly.
Apply a small amount of ointment to the affected area.
You may cover the area with a dressing or gauze, unless your doctor has instructed you to leave the area uncovered.
If there is no improvement after three to five days of treatment, consult your doctor.
If you use more Mupirocina 20 mg/g ointment than you should
If you have used more ointment than you should, consult your doctor or pharmacist.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 915620420, indicating the medicine and the amount ingested.
If you forget to use Mupirocina 20 mg/g ointment
If you forget to apply a dose, apply the next dose as soon as possible and continue treatment as before.
Do not apply a double dose to make up for forgotten doses.
Do not stop treatment earlier than instructed by your doctor, even if you feel better. Otherwise, the infection may recur.
If you have any further questions about the use of this product, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everybody will experience them.
Frequent side effects reported in more than 1 out of 100 patients but in less than 1 out of 10 people using this medicine are:
- Localized burning at the application site.
Uncommon side effects reported in more than 1 out of 1,000 patients but in less than 1 out of 100 are:
- Itching, redness, stinging, and dryness at the application site.
- Skin allergic reactions.
Very rare side effects reported in less than 1 out of 10,000 patients are:
- Systemic allergic reactions (affecting the whole body).
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish System for Pharmacovigilance of Human Medicines at https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Mupirocin 20 mg/g ointment
Keep this medicine out of the sight and reach of children.
Store below 25°C.
After first opening, use within 15 days.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Do not use this medicine if you notice that the ointment is not white or off-white in appearance.
Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE point located at your pharmacy. If you are unsure, ask your pharmacist how to properly 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 Mupirocina 20 mg/g ointment
- The active substance is mupirocina. Each gram of ointment contains 20 mg of mupirocina.
- The other components are macrogol 400 (polyethylene glycol) and macrogol 3350 (polyethylene glycol).
Appearance of the product and contents of the pack
Mupirocina is a white to off-white ointment; it is available in tubes of 15 g or 30 g.
Marketing Authorization Holder and Manufacturer
Galenicum Derma, S.L.
Crta N-1, Km 36,
28750 San Agustin de Guadalix (Madrid)
Spain
Manufacturer
DELPHARM HUNINGUE S.A.S
26 rue de la Chapelle
68330 Huningue
France
VETPROM AD
26 Otez Paissij Str.
Radomir, 2400
Bulgaria
Date of the most recent review of this leaflet: November 2024
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/