Pimafucin

Package leaflet: Information for the patient

Pimafucin, 20 mg/g, cream
(Natamycinum)
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

1. What Pimafucin is and what it is 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 pack and other information

1. What Pimafucin is and what it is used for
Pimafucin cream contains natamycin, a polyene antifungal antibiotic 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 the yeast Candida albicans.

2. Important information before using Pimafucin

When not to use Pimafucin

• if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Pimafucin, please consult your doctor or pharmacist.
Pimafucin and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Interactions with other medicines are not known.
Pregnancy and breastfeeding
If you are pregnant, breastfeeding, suspect you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.
Driving and operating machinery
Pimafucin has no influence on the ability to drive or operate machinery.
Pimafucin contains cetostearyl alcohol, propylene glycol, and methyl and propyl parahydroxybenzoates.
Due to the presence of cetostearyl 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 (including delayed-type reactions).

3. How to use Pimafucin medicine

This medicine should always be used as directed by the physician. In case of doubt, consult
your doctor or pharmacist.
Pimafucin cream is usually applied to affected areas from 1 to 4 times daily.
Treatment typically lasts from 2 to 3 weeks.
Use of a higher than recommended dose of Pimafucin
There are no reports regarding overdose of this medicine.
If you have any further doubts concerning the use of this medicine,
consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Adverse reactions occurring rarely (may occur in less than 1 in 1,000 people):

• hypersensitivity reactions, burning sensation and irritation

Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions enables further information on the safety of the medicine to be collected.

5. How to store Pimafucin

Keep the medicine 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 stated month.
Do not store above 25°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This helps protect the environment.

6. Contents of the packaging and other information

What Pimafucin contains

• The active substance is natamycin.
• The other ingredients are: oleyl decylate, cetostearyl alcohol esters, cetostearyl alcohol, sodium lauryl sulfate, methyl parahydroxybenzoate, propyl parahydroxybenzoate, propylene glycol, purified water.

What Pimafucin looks like and contents of the pack
Pimafucin is a cream of white to slightly yellow colour.
The pack contains 30 g of cream.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald
Germany

Manufacturer:
Temmler Italia S.R.L.
Via Delle Industrie 2
20061 Carugate (MI)
Italy