Plasimine 20 mg/g ointment
Spain
Table of Contents
Package Leaflet: Information for the User
Introduction
Package Leaflet: Information for the Patient
Plasimine 20 mg/g 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 others, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
Contents of the leaflet
- What Plasimine is and what it is used for
- What you need to know before using Plasimine
- How to use Plasimine
- Possible adverse effects
- How to store Plasimine
- Contents of the pack and other information
1. What Plasimine is and what it is used for
Plasimine contains mupirocin, an antibiotic that works by eliminating bacteria causing infections.
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 dosage, 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 to treat superficial skin infections, provided their extent is limited.
2. What you need to know before using Plasimine
Do not use Plasimine:
- If you are allergic to mupirocin or to any of the other components of this medicine (listed in section 6)
- Do not use intranasally or ophthalmically
- Do not use with cannulas or near intravenous catheters
Warnings and precautions
Consult your doctor or pharmacist before starting to use Plasimine.
Plasimine may cause skin irritation and allergic reactions. See section 4.
- Keep the ointment away from the eyes. If the ointment accidentally comes into contact with the eyes, rinse thoroughly with water.
Plasimine contains an excipient called polyethylene glycol, which when applied to damaged skin may be absorbed into the body, especially in cases of extensive lesions or open wounds, potentially worsening kidney function.
Use of Plasimine with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes medicines obtained without a prescription.
You should 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.
Information on the safety of this medicine in pregnant women is limited.
Plasimine should not be administered to pregnant women unless the benefits outweigh the potential risks of treatment.
It is unknown whether mupirocin passes into breast milk. If you are breastfeeding, you should consult your doctor before using this medicine.
If this medicine is ultimately used to treat cracked nipples, the breast should be thoroughly washed to remove any residue of the product before breastfeeding.
Driving and using machines
This medicine does not affect the ability to drive or operate machinery.
3. How to use Plasimine
Follow exactly the administration instructions for this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.
For topical use only. Exclusively for external use.
Adults and children
Apply the ointment 2–3 times daily, for up to a maximum of 10 days. Your doctor will assess the treatment after 5 days to review its progress.
Patients with renal impairment
Your doctor will evaluate the use of this medicine if there is a risk of polyethylene glycol absorption when applied to damaged skin.
Elderly patients
Dosage adjustment is not necessary unless moderate or severe renal impairment is present.
Instructions for use:
- Before application, wash your hands and the area to be treated.
- Using a cotton ball or swab, apply a small amount of ointment to the entire affected area.
- After applying the ointment, you may cover the treated area with a bandage or gauze, unless your doctor instructs you to leave it uncovered.
If there is no improvement after five days of treatment, consult your doctor.
If you use more Plasimine than you should
If you have applied more ointment than recommended, carefully remove the excess.
If you accidentally ingest this medicine, 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: 91 562 04 20, indicating the medicine and the amount ingested.
If you forget to use Plasimine
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 missed doses.
Do not stop treatment earlier than instructed by your doctor, even if you feel better. If you do, the infection may recur.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Situations you should monitor:
Severe allergic reactions
These reactions occur very rarely in people using Plasimine. Signs include:
-
itchy skin 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 Plasimine.
Plasimine may cause skin irritation.
- If you experience skin irritation, stop using Plasimine. Remove any remaining medicine and consult your doctor as soon as possible.
Occasionally, medicines such as Plasimine (because they contain an antibiotic) may cause inflammation of the colon (large intestine), resulting in 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.
Frequent adverse effects
May affect up to 1 in 10 people:
- burning sensation at the application site.
Uncommon adverse effects
May affect up to 1 in 100 people:
- itching, redness, stinging, and/or local dryness at the application site.
Very rare adverse effects
May affect up to 1 in 10,000 people:
- allergic reactions.
Reporting of adverse effects
If you experience any 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. Plasimine Storage
Keep this medicine out of the sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date stated on the packaging and tube. The expiry date refers to the last day of the month indicated.
After opening, this medicine remains valid for 10 days.
Do not use this medicine if you notice that the ointment is not white or almost white.
Discard any remaining product.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point located at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of the pack and other information
Composition of Plasimine
- The active substance is mupirocin. Each gram of ointment contains 20 mg of mupirocin.
- The other components are polyethylene glycol 400 and polyethylene glycol 3350.
Appearance of the medicinal product and contents of the pack
Plasimine is presented in an aluminum tube with nozzle and plastic cap, containing 15 or 30 grams of ointment.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
GlaxoSmithKline, S.A.
P.T.M. C/ Severo Ochoa, 2
28760 Tres Cantos (Madrid)
Tel: +34 900 202 700
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 package leaflet: March 2020.
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es