Package leaflet: information for the patient

Pimafucin, 100 mg, globules
(Natamycinum)
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any 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 others, even if their symptoms are the same.
If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

What Pimafucin is and what it is used for
Important information before using Pimafucin
How to use Pimafucin
Possible side effects
How to store Pimafucin
Contents of the pack and other information

1. What Pimafucin is and what it is used for

Pimafucin globules contain natamycin, a polyene antifungal antibiotic intended for topical use.
Natamycin acts locally and is not absorbed through the skin or mucous membranes.
Pimafucin globules are indicated for the treatment of vaginal 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);
during menstruation.

Warnings and precautions
Before starting treatment with Pimafucin, discuss this with your doctor or pharmacist.
Some of the ingredients in Pimafucin globules may damage latex products, such as condoms or diaphragms (vaginal caps).
Pimafucin with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.
Interactions with other medicines are not known.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Driving and operating machinery
Pimafucin has no effect on the ability to drive or operate machinery.

3. How to use Pimafucin

This medicine should always be used as directed by the physician. In case of doubt, consult
your doctor or pharmacist.
One suppository should be used once daily at night. The treatment lasts from 3 to 6 days.
The suppository should be inserted as deeply as possible into the vagina, preferably while lying down, before bedtime.
Use of a higher than recommended dose of Pimafucin
Overdose has not been reported to date.
Since natamycin acts locally and is not absorbed through the skin or mucous membranes, even
accidental ingestion of the entire contents of the package usually does not cause any symptoms.
If you have any further doubts regarding 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.
The following may occur occasionally:

allergic reaction to the excipient - cetyl alcohol;
slight burning sensation in the genital area after insertion of the suppository.

Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor. Adverse reactions can also 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 helps provide more information on the safety of this medicine.

5. How to store Pimafucin

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following:
{EXP}. The expiry date refers to the last day of the stated month.
Do not store above 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Proper disposal helps protect the environment.

6. Contents of the pack and other information

What Pimafucin contains

The active substance is natamycin.
The other ingredients are: cetyl alcohol, hard fat, sorbitan trioleate, polysorbate 80, sodium hydrogen carbonate, adipic acid.

What Pimafucin looks like and contents of the pack
Pimafucin is globules ranging in colour from pale yellow to light yellow. The blister contains 3 globules. The pack contains either 3 globules (1 blister) or 6 globules (2 blisters).

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