Pimafucort

Leaflet attached to the packaging: patient information

Pimafucort, (10 mg + 10 mg + 3500 I.U.)/g, ointment
(Natamycin + Hydrocortisone + Neomycin)

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 you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Pimafucort and what is it used for

Pimafucort ointment contains hydrocortisone, natamycin, and neomycin.
Hydrocortisone is a mildly acting corticosteroid with anti-inflammatory and vasoconstrictive effects.
It inhibits inflammatory reactions and alleviates symptoms of skin inflammation, often accompanied by skin itching, without treating the underlying disease.
The medicine also contains neomycin, an antibiotic with a broad spectrum of antibacterial activity against Gram-positive (e.g., Staphylococcus spp., Enterococcus spp.) and Gram-negative (e.g., Klebsiella spp., Proteus spp., Escherichia coli) bacteria.
In addition to hydrocortisone and neomycin, Pimafucort ointment contains natamycin, an antifungal antibiotic, particularly effective against yeast of the genus Candida spp.
Pimafucort is indicated for short-term treatment of superficial skin diseases that respond to corticosteroid therapy, but are not caused by primary microbial infections, with concomitant secondary infections caused by bacteria and fungi sensitive to neomycin or natamycin.

2. Important information before using Pimafucort

When not to use Pimafucort

• if the patient has skin diseases caused by primary bacterial, viral, fungal, or parasitic infections;
• if the patient has ulcerative skin diseases, wounds, leg ulcers, burn wounds; adverse reactions after local use of corticosteroids (post-steroid perioral dermatitis, skin striae);
• if the patient has: ichthyosis, juvenile plantar dermatosis, acne vulgaris, rosacea, skin fragility, skin atrophy;
• if the patient is hypersensitive to the active substances or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting to use Pimafucort, discuss it with your doctor or pharmacist.
Avoid contact of the medicine with the eyes and application in the eye area, as getting the ointment on the conjunctiva may cause glaucoma or subcapsular cataract.
When using Pimafucort on large skin areas, in children, or under occlusive dressings, consider the possibility of adrenal cortex suppression.
In individuals sensitive to neomycin, cross-sensitivity to other antibiotics with a similar chemical structure, such as kanamycin, paromomycin, gentamicin, and other aminoglycoside antibiotics, is possible.
Avoid prolonged use of the medicine and application to wounds or damaged skin, due to the theoretical risk of ototoxic and nephrotoxic effects of neomycin after its absorption into the general circulation.
In case of superinfection or excessive fungal growth, discontinue the use of the medicine and implement another treatment method.
If the patient experiences blurred vision or other vision disturbances during treatment, contact a doctor.

Pimafucort and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about 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.
Due to the theoretical risk that topical neomycin-containing medicines may have an ototoxic effect on the fetus, Pimafucort should not be used on large skin areas, for a long time, or under occlusive dressings in pregnant women.

Driving and using machines

There are no data on the effect of Pimafucort on the ability to drive and use machines. However, it does not seem that the medicine could affect this ability.

3. How to use Pimafucort

This medicine should always be used as directed by your doctor. If you are unsure, consult your doctor or pharmacist.
A small amount of ointment is usually applied to the affected skin area 2 to 4 times a day. Pimafucort should not be used for more than 14 days.
Pimafucort ointment is recommended for the treatment of skin lesions with accompanying dryness, scaling, or cracking of the skin, especially in seborrheic dermatitis.

Using a higher dose of Pimafucort ointment than recommended

There are no reports of overdose. It does not seem possible to absorb a toxic dose of neomycin through the skin.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

• adrenal cortex suppression;
• skin atrophy with skin thinning;
• expansion of small blood vessels;
• petechiae;
• skin striae;
• dermatitis with symptoms similar to rosacea;
• perioral dermatitis with or without skin atrophy;
• “rebound effect”, i.e., exacerbation of disease symptoms after discontinuation of treatment, which may lead to dependence on topical steroid use;
• delayed healing process;
• skin discoloration;
• excessive hair growth;
• contact allergy to neomycin

Very rare side effects (may affect up to 1 in 10,000 people):

• increased intraocular pressure;
• increased risk of cataract

Side effects of unknown frequency (frequency cannot be estimated from available data):

• blurred vision

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor. Side effects can be reported directly to the Department of Drug Monitoring, 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, e-mail: [email protected]. Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Pimafucort

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 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. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Pimafucort contains

• The active substances are natamycin, hydrocortisone, and neomycin in the form of neomycin sulfate. One gram of ointment contains 10 mg of natamycin, 10 mg of hydrocortisone, and 3500 I.U. of neomycin in the form of neomycin sulfate.
• The other ingredients are ointment base (containing liquid paraffin and 5% polyethylene).

What Pimafucort looks like and contents of the pack

Pimafucort ointment is white to light yellow in color.
The pack contains 15 g of ointment.

Marketing authorization holder and manufacturer

Marketing authorization holder:
LEO Pharma A/S
Industriparken 55
DK-2750 Ballerup
Denmark
Manufacturer:

• 1. Astellas Pharma Europe B.V. Sylviusweg 62 2333 BE Leiden Netherlands
• 2. Temmler Italia S.R.L. Via Delle Industrie 2 20061 Carugate (MI) Italy
• 3. Prodlekpol Sp. z o.o. ul. Chełmżyńska 249 04-458 Warsaw

For more detailed information, please contact the representative of the marketing authorization holder:
LEO Pharma Sp. z o.o.
Ul. Marynarska 15
02-674 Warsaw
Tel: 22 244 18 40
Date of last revision of the leaflet:August 2018