Flucinar

Package leaflet: Information for the patient

Caution! Keep this leaflet. Information on the immediate packaging in a foreign language.
Flucinar
0.25 mg/g, ointment
Fluocinoloni acetonidum
Please read the entire leaflet carefully before using this 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, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are identical.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

1. What Flucinar is and what it is used for
2. Important information before using Flucinar
3. How to use Flucinar
4. Possible side effects
5. How to store Flucinar
6. Contents of the package 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 intended for topical application to the skin. The medicine exerts anti-inflammatory,
antipruritic, and vasoconstrictive effects.
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 accompanied by persistent
itching or excessive keratosis, such as seborrheic dermatitis, atopic dermatitis, lichen planus, allergic
contact dermatitis, erythema multiforme, discoid lupus erythematosus, psoriasis vulgaris, 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 or rosacea,
• in perioral dermatitis,
• in children under 2 years of age,
• in anal or genital itching,
• in diaper dermatitis.

Warnings and precautions
Before starting treatment with Flucinar ointment, discuss this with your doctor, pharmacist, or nurse.
If irritation or an allergic skin reaction (itching, burning, or redness) occurs 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.
With prolonged use of the medicine over large areas of skin, the frequency of systemic adverse effects typical of corticosteroids increases, including edema, hypertension, hyperglycemia (increased blood sugar levels), and reduced immunity.
Since corticosteroids are absorbed through the skin, avoid use 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, the doctor will initiate appropriate antibacterial or antifungal treatment. If infection symptoms do not resolve, 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 use the medicine around the eyes due to the risk of glaucoma or cataract.
If the patient experiences blurred vision or other visual disturbances, contact a doctor.
Avoid application to the eyelids or periorbital skin in patients with narrow-angle or wide-angle glaucoma, as well as in patients with cataracts, due to the possibility of worsening disease symptoms.
Avoid contact with the eyes.
Use on the face, underarms, or groin 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 following uncontrolled topical steroid use. These symptoms usually resolve spontaneously after discontinuation of the medicine.
Use with caution in pre-existing conditions involving atrophy 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 and on a small skin surface area.
Do not use on the face in children.
Prolonged corticosteroid treatment may impair growth and development in children.
In children, due to a higher body surface area to body weight ratio compared to adults, there is an increased risk of systemic corticosteroid effects, including suppression of the hypothalamic-pituitary-adrenal axis and Cushing's syndrome.

Flucinar with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently using or has recently used, as well as any medicines the patient plans to use.
No interactions are known during topical use of corticosteroids with other medicines.
Flucinar may enhance the effects of medicines affecting the immune system or may reduce their efficacy.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.

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

Breastfeeding
During breastfeeding, the doctor will consider whether breastfeeding should be discontinued or treatment interrupted, taking into account the benefits of breastfeeding for the child and the benefits of treatment for the mother.
It is not known to what extent fluocinolone acetonide and its metabolites may pass into human milk following topical application.
A risk to newborns/infants cannot be excluded.

Fertility
There are no data 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 per 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 a physician or pharmacist. If in doubt,
consult a physician or pharmacist.
This medicine is intended 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 apply 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 skin surface area.
Do not use on the face in children.
Use of a higher than recommended dose of Flucinar
Prolonged use over large skin surface areas may lead to symptoms of overdose, such as edema,
arterial hypertension, elevated blood glucose levels, reduced immunity, and in severe cases,
Cushing's syndrome.
If symptoms of overdose occur, consult a physician.
Missed dose of Flucinar
Do not use a double dose to make up for a missed dose.
Discontinuation of Flucinar
If you have any further doubts regarding the use of this medicine, consult your physician,
pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.

Local adverse reactions occurring not very frequently (≥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 determined from available data):
Acneiform eruptions, steroid-induced purpura, epidermal growth suppression, burning sensation, pruritus, irritation, rash, atrophy of subcutaneous tissue, dry skin, alopecia, skin discoloration or hyperpigmentation, striae, perioral dermatitis, folliculitis, local skin reactions (e.g. contact dermatitis), secondary eruptions.

Occasionally, urticaria or maculopapular rash may occur, or exacerbation of pre-existing skin lesions. With topical application to the eyelid skin, glaucoma or cataract may occur.

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

As a result of systemic absorption of the active substance, systemic adverse reactions of fluocinolone acetonide may also occur. These are mainly observed during prolonged use, application over large skin areas, use under occlusive dressings, or use in children.

Systemic adverse reactions of fluocinolone acetonide typical of corticosteroids include suppression of the hypothalamic-pituitary-adrenal (HPA) axis, Cushing's syndrome, elevated blood glucose levels, glycosuria, edema, 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 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 to provide more information on the safety of this medicine.

5. How to store Flucinar medicine

Store below 25°C.
Keep the medicine out of the 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 use after first opening 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 in use. This will help protect the environment.

6. Contents of the pack and other information

What Flucinar contains
The active substance is fluocinolone acetonide.
Each 1 g of ointment contains 0.25 mg of fluocinolone acetonide.
The other ingredients are propylene glycol, citric acid monohydrate, lanolin, and white petrolatum.

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 membrane tube, internally lacquered, with a protective membrane and cap, containing 15 g of ointment, packed in a cardboard box.

For further detailed information, please contact the responsible entity 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 S.A. Pharmaceutical Company
ul. Wincentego Pola 21
58-500 Jelenia Góra
Poland

Parallel importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

Marketing Authorisation number in the Czech Republic, the country of export: 46/063/74-S/C
Parallel import authorisation number: 411/16