Flucinar

Package leaflet: Information for the user

Warning! Keep the leaflet, information on the outer packaging in a foreign language!
Flucinar
0.25 mg/g, ointment
Fluocinoloni acetonidum
Please read carefully the entire leaflet before using this medicine, because 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. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

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 for topical application to the skin. The medicine has anti-inflammatory,
antipruritic 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. Information before using Flucinar

When not to use Flucinar

• if the patient is allergic to fluocinolone acetonide or other corticosteroids, 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 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 an allergic skin reaction (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, arterial hypertension, hyperglycaemia (increased blood sugar concentration), 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 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 has 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 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 cataract, due to the possibility of worsening disease symptoms.
Avoid getting the medicine into the eyes.
On the facial skin and in the axillary or groin areas, use only when absolutely necessary, due to increased absorption of corticosteroids through thin and sensitive 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 skin surface area.
Do not apply to the face in children.
Long-term treatment with corticosteroids 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 suppression of the hypothalamic-pituitary-adrenal (HPA) axis and Cushing's syndrome.

Flucinar and other medicines
Tell your doctor or pharmacist about any medicines the patient is currently taking, has recently taken, or plans to use.
No interactions are known during topical use of corticosteroids with other medicines.
Flucinar may enhance or reduce 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 have a child, she should consult her 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 consider whether to discontinue breastfeeding or interrupt treatment, 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 after topical application.
Risk to newborns/infants cannot be excluded.

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

Driving and using machines
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 recommended 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 the affected areas of the skin, no more
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 1 tube (15 g) of ointyment 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 great caution and only when absolutely necessary –
once daily and on a small skin surface area.
Do not use on the facial skin of 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,
hypertension, elevated blood glucose levels, reduced immunity, and in severe cases, Cushing's disease.
If symptoms of overdose occur, consult a doctor.
Missed dose of Flucinar
Do not use 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 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 occurring not very commonly (≥1/1,000 to <1/100):
Secondary infections, skin atrophy, telangiectasia (dilation of small arteries and veins), blurred vision.
Local adverse effects occurring rarely (≥1/10,000 to <1/1,000):
Hypertrichosis (excessive hair growth).
Local adverse effects with unknown frequency (frequency cannot be determined from available data):
Acneiform eruptions, steroid-induced purpura, epidermal atrophy, burning sensation, pruritus, irritation, rash, subcutaneous tissue atrophy, dry skin, alopecia, hypopigmentation or hyperpigmentation, striae, perioral dermatitis, folliculitis, local skin reactions (e.g. contact dermatitis), secondary eruptions.
Urticaria or maculopapular rash may occasionally occur, or exacerbation of pre-existing skin lesions. When applied topically to the eyelids, glaucoma or cataract may occur.
Systemic adverse effects 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.
Systemic adverse effects of fluocinolone acetonide may also 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 effects 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 effects in children and adolescents
In children, systemic adverse effects may manifest as growth and developmental retardation.
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 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 effects helps to provide more information on the safety of the medicine.

5. How to store Flucinar

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.
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 package and other information

What Flucinar contains
The active substance is fluocinolone acetonide.
1 g of ointment contains 0.25 mg of fluocinolone acetonide.
The other ingredients are propylene glycol (E 1520), citric acid monohydrate, lanolin,
and white soft paraffin.

What Flucinar looks like and contents of the pack
Flucinar is a white or almost white, semi-transparent ointment with a characteristic odour.
The medicine is available in an aluminium tube with an internal protective layer, a safety membrane,
and a cap with a piercing device, packed in a cardboard box.
For more detailed 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 S.A. Pharmaceutical Company
ul. Wincentego Pola 21
58-500 Jelenia Góra
Poland

Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Marketing Authorisation Number in the Czech Republic, the country of export: 46/063/74-S/C
Parallel Import Licence Number: 330/24