Pimafucin

Leaflet attached to the packaging: patient information

Pimafucin, 20 mg/g, cream
(Natamycin)

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Pimafucin and what is it used for
• 2. Important information before using Pimafucin
• 3. How to use Pimafucin
• 4. Possible side effects
• 5. How to store Pimafucin
• 6. Contents of the packaging and other information

1. What is Pimafucin and what is it used for

Pimafucin cream contains natamycin, an antifungal antibiotic from the polyene group for topical use.
Natamycin acts locally and is not absorbed through the skin or mucous membranes.
Pimafucin cream is indicated for the treatment of skin and mucous membrane infections caused by Candida albicansyeast.

2. Important information before using Pimafucin

When not to use Pimafucin

Warnings and precautions

Before starting to use Pimafucin, the patient should discuss it with their doctor or pharmacist.

Pimafucin and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to use.
Interactions with other medicines are not known.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.

Driving and using machines

Pimafucin does not affect the ability to drive or use machines.
Pimafucin containscetyl stearyl alcohol, propylene glycol, and methyl and propyl parahydroxybenzoates.
Due to the presence of cetyl stearyl alcohol, the medicine may cause local skin reactions (e.g., contact dermatitis).
Due to the presence of propylene glycol, the medicine may cause skin irritation.
Due to the presence of methyl and propyl parahydroxybenzoates, the medicine may cause allergic reactions (possible late reactions).

3. How to use Pimafucin

This medicine should always be used as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
Pimafucin cream is usually applied to the affected areas 1 to 4 times a day.
Treatment usually lasts from 2 to 3 weeks.

Using a higher dose of Pimafucin than recommended

There are no reports of overdose with this medicine.
In case of any further doubts about using this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Pimafucin can cause side effects, although not everybody gets them.
Rare side effects (may affect up to 1 in 1000 people):

• hypersensitivity reactions, burning sensation, and irritation

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Pimafucin

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and tube after: {EXP}.
The expiry date refers to the last day of the month.
Do not store above 25°C.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment .

6. Contents of the packaging and other information

What Pimafucin contains

• The active substance of the medicine is natamycin.
• The other ingredients are: decyl oleate, cetyl wax esters, cetyl stearyl alcohol, sodium lauryl sulfate, methyl parahydroxybenzoate, propyl parahydroxybenzoate, propylene glycol, purified water.

What Pimafucin looks like and what the packaging contains

Pimafucin is a white to light yellow cream.
The packaging contains 30 g of cream.

Responsible entity and manufacturer

Responsible entity:
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald
Germany
Manufacturer:
Temmler Italia S.R.L.
Via Delle Industrie 2
20061 Carugate (MI)
Italy

Date of last update of the leaflet: