Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Flucinar, 0.25 mg/g, ointment
Fluocinoloni acetonidum
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 questions, please consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm another person, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

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

1. What Flucinar is and what it is used for

The active substance in Flucinar is fluocinolone acetonide. Fluocinolone acetonide is a synthetic
glucocorticosteroid for topical application to the skin. The medicine has anti-inflammatory,
anti-pruritic, and vasoconstrictive properties.
Indications
Flucinar ointment is indicated for short-term topical treatment of acute and severe, non-infectious, dry
inflammatory skin conditions that respond to glucocorticosteroid therapy and are accompanied by persistent itching or excessive keratosis, such as seborrheic dermatitis, atopic dermatitis, lichen planus, allergic contact dermatitis, erythema multiforme, discoid lupus erythematosus, chronic psoriasis, and flat lichen.

2. Important information before using Flucinar

When not to use Flucinar

if the patient is allergic to fluocinolone acetonide or other glucocorticosteroids, or to any of the other ingredients of this medicine (listed in section 6),
in bacterial, viral, or fungal skin infections,
in acne vulgaris and rosacea,
in perioral dermatitis,
following vaccination,
in children under 2 years of age,
in anal or genital pruritus,
in diaper dermatitis.

Warnings and precautions
Before starting treatment with Flucinar ointment, discuss this with your doctor, pharmacist, or nurse.
If irritation symptoms or a skin allergic reaction occur after applying Flucinar ointment, inform your doctor immediately. The doctor will decide whether treatment should be discontinued.
Do not use the medicine continuously for longer than 2 weeks.
Prolonged use of the medicine over large skin areas increases the frequency of systemic adverse effects typical of corticosteroids, including oedema, hypertension, hyperglycaemia (increased blood sugar levels), and reduced immunity.
Since corticosteroids are absorbed through the skin, avoid applying the medicine over large body surface areas, under occlusive dressings, prolonged treatment, and use in children.
In children, due to the higher body surface area to body weight ratio compared to adults, there is an increased risk of systemic corticosteroid effects, including hypothalamic-pituitary-adrenal axis suppression and Cushing's syndrome.
If an infection develops at the site of application, the doctor will initiate appropriate antibacterial or antifungal treatment. If infection symptoms persist, contact your doctor. The doctor will decide whether treatment should be interrupted until the infection resolves.
Avoid contact of the medicine with eyes, mucous membranes, or open wounds.
Do not apply the medicine around the eyes due to the risk of glaucoma or cataract development.
If the patient experiences blurred vision or other visual disturbances, contact a doctor.
Use with particular caution in psoriasis, as topical corticosteroids may be hazardous for several reasons, including disease relapse due to development of tolerance, risk of generalized pustular psoriasis, and systemic toxic effects due to impaired skin integrity.
Apply to the face, axillae, and groin areas only when absolutely necessary, due to increased absorption of corticosteroids through delicate skin and a higher risk of adverse effects such as telangiectasia or perioral dermatitis, even after short-term use.
Use with caution in pre-existing atrophic skin conditions, especially in elderly patients.

Children and adolescents
Do not use in children under 2 years of age.
Prolonged corticosteroid treatment may impair growth and development in children.

Flucinar and other medicines
Inform 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.
No interactions are known during topical use of corticosteroids with other medicines.
Do not get vaccinated against smallpox. Other vaccinations should also be avoided, particularly during prolonged treatment or when applied over large skin areas.
Flucinar may enhance the effects of medicines affecting the immune system.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
Flucinar may be used during pregnancy only if, in the doctor's opinion, the benefits to the mother outweigh the potential risks to the fetus.
The medicine must not be used during the first trimester of pregnancy.

Breastfeeding
During breastfeeding, the doctor will assess whether to discontinue breastfeeding or stop using the medicine, taking into account the risk of adverse effects in the infant and the benefits of treatment for the mother.

Driving and operating machinery
Flucinar does not affect the ability to drive or operate machinery.

Flucinar contains:

50 mg of propylene glycol per 1 g of ointment (may cause skin irritation),
lanolin (may cause local skin reactions, e.g. contact dermatitis).

3. How to use Flucinar

This medicine should always be used exactly as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
This medicine is intended for topical use on the skin.
The recommended dose is a thin layer of ointment applied to affected skin areas
initially two to three times daily, and then, after the acute inflammatory condition has subsided,
no more frequently than once or twice daily.
Treatment should not be continued continuously for longer than 2 weeks.
On the face, do not use for longer than 1 week.
No more than one tube (15 g) of ointment should be used within one week.
Do not use the ointment under occlusive dressings, except in psoriasis,
where occlusive dressings are permitted provided they are changed daily.
Use in children and adolescents
Do not use in children under 2 years of age.
In children over 2 years of age, use with extreme caution and only when absolutely necessary –
once daily and only on a small skin surface area.
Do not use on the facial skin in children.
Use of a higher than recommended dose of Flucinar
Prolonged use over large skin surface areas may result in symptoms of overdose,
such as edema, hypertension, elevated blood glucose levels, reduced immunity,
and in severe cases, Cushing's syndrome.
If symptoms of overdose occur, consult a doctor.
Missed dose of Flucinar
Do not apply a double dose to make up for a missed dose.
Discontinuation of Flucinar treatment
If you have any further doubts regarding the use of this medicine, consult
a doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Local adverse effects of unknown frequency (frequency cannot be determined from available data):
Acne-like changes, steroid-induced purpura, inhibition of epidermal growth, burning, itching, irritation, rash, subcutaneous tissue atrophy, dry skin, excessive hair growth or hair loss, skin depigmentation or discoloration, skin atrophy and striae, dilation of arterioles and capillaries, perioral dermatitis, bacterial folliculitis, secondary infections, local skin reactions (e.g. contact dermatitis).
Occasionally, urticaria or maculopapular rash may occur, or exacerbation of pre-existing skin lesions.
Blurred vision.
With topical application to the eyelids, glaucoma or cataract may occur.

Systemic adverse effects of unknown frequency (frequency cannot be determined from available data):
Due to systemic absorption of the active substances into the bloodstream, systemic adverse effects of fluocinolone acetonide may also occur.
These occur primarily during prolonged use of the medicine, application over a large skin surface area, use under occlusive dressing, or use in children.
Systemic adverse effects of fluocinolone acetonide typical of corticosteroids include, among others, suppression of the hypothalamic–pituitary–adrenal (HPA) axis function, Cushing's syndrome, elevated blood glucose levels, glycosuria, edema, hypertension, and decreased immunity.

Additional adverse effects in children and adolescents
In children, systemic adverse effects may manifest as inhibition of growth and development.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects 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, 02-222 Warsaw, Tel: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting adverse effects helps to gather further information on the safety of the medicine.

5. How to store Flucinar

Keep this medicine out of sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures help protect the environment.

6. Contents of the package and other information

What Flucinar contains
The active substance is fluocinolone acetonide.
1 g of the ointment contains 0.25 mg of fluocinolone acetonide.
Other components are: propylene glycol, citric acid monohydrate, lanolin, white vaseline.

What Flucinar looks like and contents of the pack
Flucinar is a white or almost white, semi-transparent ointment with a characteristic odour.
The medicinal product is available in an aluminium tube internally lacquered with a polyethylene cap, containing 15 g of ointment, placed in a cardboard box.

For more detailed information, please contact the responsible party or the parallel importer.

Marketing Authorisation Holder in Latvia, country of export:
PharmaSwiss Česká republika s.r.o.
Jankovcova 1569/2c
170 00 Prague 7
Czech Republic

Manufacturer:
Jelfa SA Pharmaceutical Company
ul. Wincentego Pola 21
58-500 Jelenia Góra
Poland

Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

Marketing Authorisation Number in Latvia, country of export: 97-0468
Parallel Import Licence Number: 42/22