Package leaflet: Information for the patient

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Flucinar, 0.25 mg/g, ointment
Fluocinolone acetonide
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet for future reference.
If you have any doubts, consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are identical.
If you experience any adverse effects, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents:

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,
antipruritic, and vasoconstrictive properties.
Indications
Flucinar ointment is indicated for short-term local treatment of acute and severe, non-infectious, dry
inflammatory skin conditions responsive to glucocorticosteroid therapy and associated with persistent
itching or excessive keratosis, such as seborrheic dermatitis, atopic dermatitis, lichen urticatus, allergic
contact dermatitis, erythema multiforme, lupus erythematosus, chronic psoriasis, and lichen planus.

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,
in children under 2 years of age,
in anal and genital itching,
in diaper dermatitis.

Warnings and precautions
Before starting treatment with Flucinar ointment, discuss this with your doctor, pharmacist or
nurse.
If irritation symptoms or allergic skin reactions (itching, burning or redness) 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 over large areas of skin 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 using the medicine over large body surface areas, under occlusive dressings, prolonged treatment, and use in children.
Your doctor may order additional tests if adrenal insufficiency is suspected.
If an infection develops at the site of application, your doctor will initiate appropriate antibacterial or antifungal treatment. If signs of infection do not resolve, contact your doctor. The doctor will decide whether treatment should be interrupted until the infection is resolved.
Avoid contact of the medicine with eyes, mucous membranes or open wounds.
Do not use the medicine around the eyes due to the risk of developing glaucoma or cataracts.
If blurred vision or other visual disturbances occur, contact your doctor.
Avoid application to the eyelids or skin around the eyelids in patients with narrow-angle or wide-angle glaucoma, and in patients with cataracts, due to the possibility of worsening symptoms.
Avoid getting the medicine into the eyes.
On facial skin, and in the axillary or groin areas, use 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.
Telangiectasia or perioral dermatitis may also occur after uncontrolled local use of steroids. These symptoms usually resolve spontaneously after discontinuation of the medicine.
Use with caution in pre-existing atrophic conditions of subcutaneous tissue, especially in elderly patients.

Children and adolescents
Do not use in children under 2 years of age.
In children aged 2 years and older, use with extreme caution and only when absolutely necessary – once daily on a small area of skin.
Do not use on the face in children.
Prolonged corticosteroid treatment may impair growth and development in children.
Due to a higher body surface area to body weight ratio compared to adults, children are at greater risk of systemic corticosteroid effects, including hypothalamic-pituitary-adrenal (HPA) axis suppression and Cushing's syndrome.

Flucinar and other medicines
Tell your doctor or pharmacist about any medicines you are currently taking, have recently taken, or plan to take.
No interactions are known during topical use of corticosteroids with other medicines.
Flucinar may enhance the effects of immunosuppressive medicines or reduce their efficacy.

Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.

Pregnancy
Flucinar may be used during pregnancy only if, in the opinion of the doctor, the benefits to the mother outweigh the risks to the foetus.
It is absolutely contraindicated during the first trimester of pregnancy.

Breastfeeding
During breastfeeding, the doctor will weigh the benefits of breastfeeding for the child against the benefits of treatment for the mother when deciding whether to discontinue breastfeeding or interrupt treatment.
It is not known to what extent fluocinolone acetonide and its metabolites, after topical application, may pass into human breast milk.
Risk to newborns/infants cannot be excluded.

Fertility
There are no data available on the effect of fluocinolone on fertility in humans.

Driving and operating machinery
Flucinar has no effect or has a negligible effect on the ability to drive and operate machinery.

Flucinar contains:

50 mg of propylene glycol in 1 g of ointment,
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 your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
This medicine is for topical use on the skin.
The recommended dose is a thin layer of ointment applied to the affected areas of the skin,
no more frequently than once or twice daily.
Treatment should not be continued continuously for longer than 2 weeks.
On the facial skin, 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 aged 2 years and older, use with extreme caution and only when absolutely necessary –
once daily and only on a small area of skin.
Do not use on the facial skin of children.
Use of more than the recommended dose of Flucinar
Prolonged use over large areas of skin may lead to symptoms of overdose such as oedema,
arterial hypertension, elevated blood glucose levels, reduced immunity, and in severe cases,
Cushing's syndrome.
If symptoms of overdose occur, consult your doctor.
Missed dose of Flucinar
Do not apply a double dose to make up for a missed dose.
Stopping treatment with Flucinar
If you have any further doubts regarding the use of this medicine, consult your doctor,
pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this product may cause adverse reactions, although not everyone experiences them.

Local adverse reactions occurring uncommonly (≥1/1,000 to <1/100):
Secondary infections, skin atrophy, telangiectasia (dilation of arterioles and venules), blurred vision.

Local adverse reactions occurring rarely (≥1/10,000 to <1/1,000):
Hypertrichosis (excessive hair growth).

Local adverse reactions with unknown frequency (frequency cannot be estimated from available data):
Acneiform eruptions, steroid-induced purpura, epidermal growth suppression, burning sensation, pruritus, irritation, rash, atrophy of subcutaneous tissue, dry skin, alopecia, hypopigmentation or hyperpigmentation, striae, perioral dermatitis, folliculitis, local skin reactions (e.g. contact dermatitis), secondary eruptions.

Urticaria, maculopapular rash, or exacerbation of pre-existing skin lesions may occasionally occur. When applied locally to the eyelid skin, glaucoma or cataract may develop.

Systemic adverse reactions with unknown frequency (frequency cannot be estimated from available data):
Reduced immunity, suppression of the hypothalamic-pituitary-adrenal (HPA) axis, Cushing's syndrome, hyperglycaemia (elevated blood glucose levels), arterial hypertension, growth retardation, oedema.

Systemic adverse reactions of fluocinolone acetonide may occur due to absorption of the active substance into the bloodstream. These are particularly likely with prolonged use, application over large areas of skin, use under occlusive dressings, or use in children.

Systemic adverse reactions of fluocinolone acetonide typical of corticosteroids include suppression of the hypothalamic–pituitary–adrenal axis, Cushing's syndrome, increased blood glucose, glycosuria, oedema, arterial hypertension, and reduced immunity.

Additional adverse reactions in children and adolescents
In children, systemic adverse reactions may manifest as growth and developmental retardation.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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 reactions helps provide more information on the safety of this medicine.

5. How to store Flucinar medicine

Store below 25°C.
Keep the medicine out of sight and reach of children.
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.
Period of validity after first opening of the tube: 3 months.
Medicines must 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 packaging and other information

What Flucinar contains
The active substance is fluocinonide.
0.25 mg of fluocinonide is contained in 1 g of ointment.
Other ingredients are: propylene glycol, citric acid monohydrate, lanolin, white petroleum jelly.

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 packed in an aluminium tube with an internal protective layer, a tamper-evident membrane and a perforating cap, containing 15 g of ointment, placed in a cardboard box.

For further information, please contact the Marketing Authorisation Holder or the Parallel Importer.

Marketing Authorisation Holder in the Czech Republic, the country of export:
Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3, Ireland

Manufacturer:
Jelfa Pharmaceutical Company S.A.
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 by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland

Marketing Authorisation Number in the Czech Republic, the country of export: 46/063/74-S/C
Parallel Import Authorisation Number: 399/24