Pimafucin

Leaflet attached to the packaging: patient information

Pimafucin, 100 mg, vaginal tablets
(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.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for 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 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. Package contents and other information

1. What is Pimafucin and what is it used for

Pimafucin vaginal tablets contain natamycin, an antifungal antibiotic from the polyene group for local use.
Natamycin acts locally and is not absorbed through the skin or mucous membranes.
Pimafucin vaginal tablets are indicated for the treatment of vaginal infections caused by Candida albicansyeast.

2. Important information before using Pimafucin

When not to use Pimafucin

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

Warnings and precautions

Before starting to use Pimafucin, discuss it with your doctor or pharmacist.
Some of the ingredients of Pimafucin vaginal tablets may damage latex products, such as condoms or diaphragms.

Pimafucin and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to use.
No interactions with other medicines are known.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or plan to have a child, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Pimafucin does not affect the ability to drive and use machines.

3. How to use Pimafucin

Always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Use one vaginal tablet once a day, at bedtime. The treatment lasts from 3 to 6 days.
Insert the vaginal tablet as deeply as possible into the vagina, preferably in a lying position, before sleep.

Using more than the recommended dose of Pimafucin

No overdose of the medicine has been reported so far.
Since natamycin acts locally and is not absorbed through the skin or mucous membranes, even accidental ingestion of the contents of the entire package does not usually cause any symptoms.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Pimafucin can cause side effects, although not everybody gets them.
Sometimes the following may occur:

• hypersensitivity reaction to the excipient - cetyl alcohol;
• mild burning sensation in the genital area after inserting the vaginal tablet.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, ul. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Pimafucin

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister 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. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Pimafucin contains

• The active substance is natamycin.
• The other ingredients are: cetyl alcohol, solid fat, sorbitan trioleate, polysorbate 80, sodium bicarbonate, adipic acid.

What Pimafucin looks like and contents of the pack

Pimafucin is a vaginal tablet with a color from light yellow to pale yellow.
The blister pack contains 3 vaginal tablets. The package contains 3 vaginal tablets (1 blister) or 6 vaginal tablets (2 blisters).

Marketing authorization holder and manufacturer

Marketing authorization holder:
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 revision of the leaflet