Flucinar

Package Leaflet: Information for the Patient

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Flucinar

0.25 mg/g, ointment

Fluocinolone acetonide

Before using the medicine, carefully read the contents of the leaflet, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet:

• 1. What is Flucinar and what is it 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 packaging and other information

1. What is Flucinar and what is it used for

The active substance of Flucinar is fluocinolone acetonide. Fluocinolone acetonide is a synthetic topical corticosteroid. The medicine has anti-inflammatory, antipruritic, and vasoconstrictive effects.

Indications for Use

Flucinar ointment is indicated for short-term local treatment of acute and severe, non-infected, dry inflammatory skin conditions that respond to corticosteroid therapy and are characterized by persistent itching or excessive scaling, such as seborrheic dermatitis, atopic dermatitis, lichen planus, allergic contact dermatitis, polymorphic erythema, lupus erythematosus, chronic psoriasis.

2. Important Information Before Using Flucinar

When Not to Use Flucinar

• if the patient is allergic to fluocinolone acetonide or other corticosteroids, or any of the other ingredients of this medicine (listed in section 6),
• in bacterial, viral, or fungal skin infections,
• in common or rosacea acne,
• in perioral dermatitis,
• in children under 2 years of age,
• in anal or genital itching,
• in diaper rash.

Warnings and Precautions

Before starting to use Flucinar, consult a doctor, pharmacist, or nurse.
If, after using Flucinar ointment, symptoms of irritation or allergic skin reaction (itching, burning, or redness) occur, inform a doctor immediately. The doctor will decide whether to discontinue the use of the medicine.
Do not use the medicine continuously for more than 2 weeks.
During long-term use of the medicine on a large skin surface, the frequency of general side effects characteristic of corticosteroids, including edema, hypertension, hyperglycemia (elevated blood sugar levels), and decreased immunity, often increases.
Due to the fact that corticosteroids are absorbed through the skin, avoid using the medicine on a large body surface, under occlusive dressings, for prolonged treatment, or in children.
The doctor may order additional tests if adrenal insufficiency is suspected.
If an infection occurs at the site of application, the doctor will apply appropriate antibacterial or antifungal treatment. If the symptoms of the infection do not disappear, consult a doctor. The doctor will decide whether the treatment should be discontinued until the infection is cured.
Avoid contact of the medicine with the eyes, mucous membranes, or wounds.
Do not use the medicine around the eyes, due to the risk of developing glaucoma or cataracts.
If the patient experiences blurred vision or other vision disturbances, consult a doctor.
Avoid applying the medicine to the eyelids or the skin around the eyelids in patients with narrow-angle or wide-angle glaucoma, as well as in patients with cataracts, due to the possibility of exacerbating the disease symptoms.
Avoid applying the medicine to the eyes.
On the facial skin and in the armpits and groin, use only in cases of absolute necessity, due to increased absorption of corticosteroids through delicate skin and a higher risk of side effects such as telangiectasia or perioral dermatitis, even after short-term use.
Telangiectasia or perioral dermatitis may also occur after uncontrolled local steroid use. These symptoms usually disappear on their own after discontinuation of the medicine.
Use with caution in existing atrophic skin conditions, especially in the elderly.

Children and Adolescents

Do not use in children under 2 years of age.
In children over 2 years of age, use with extreme caution, only in cases of absolute necessity - once a day, on a small skin surface.
In children, do not use on the facial skin.
Prolonged corticosteroid treatment may disrupt growth and development in children.
In children, due to a higher ratio of body surface area to body weight than in adults, there is a higher risk of systemic side effects of corticosteroids, including disruption of the hypothalamic-pituitary-adrenal axis and Cushing's syndrome.

Flucinar and Other Medicines

Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
No interactions are known during topical use of corticosteroids with other medicines.
Flucinar may enhance the effects of medicines that affect the immune system or weaken their effects.

Pregnancy, Breastfeeding, and Fertility

If the patient is pregnant, breastfeeding, or thinks they may be pregnant, or is planning to have a child, they should consult a 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.
Do not use in the first trimester of pregnancy.
Breastfeeding
During breastfeeding, the doctor will consider whether to discontinue breastfeeding or stop using the medicine, 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 penetrate into breast milk after topical use.
A risk to newborns/infants cannot be excluded.
Fertility
There are no data on the effect of fluocinolone on human fertility.

Driving and Operating Machines

Flucinar has no influence or negligible influence on the ability to drive and use machines.

What Flucinar Contains

• 50 mg of propylene glycolin 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 as directed by a doctor or pharmacist. In case of doubts, consult a doctor or pharmacist.
The medicine is intended for 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 a day.
Treatment should not be continued without interruption for more than 2 weeks.
On the facial skin, do not use for more than 1 week.
Within one week, no more than 1 tube (15 g) of ointment can be used.
Do not use the ointment under an occlusive dressing (except for psoriasis, where an occlusive dressing can be used, which should be 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, only in cases of absolute necessity - once a day, on a small skin surface.
In children, do not use on the facial skin.

Using a Higher Than Recommended Dose of Flucinar

After prolonged use on large skin surfaces, symptoms of overdose may occur, such as edema, hypertension, elevated blood sugar levels, decreased immunity, and in severe cases, Cushing's syndrome.
If symptoms of overdose occur, consult a doctor.

Missing a Dose of Flucinar

Do not use a double dose to make up for a missed dose.

Stopping the Use of Flucinar

In case of any further doubts about the use of this medicine, consult a doctor, pharmacist, or nurse.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Local Side Effects Occurring Not Very Often (≥1/1,000 to <1>

Secondary infections, skin atrophy, telangiectasia (dilation of blood vessels and capillaries), blurred vision.

Local Side Effects Occurring Rarely (≥1/10,000 to <1>

Hypertrichosis (excessive hair growth).
Local Side Effects of Unknown Frequency(frequency cannot be estimated from available data):
Acne-like changes, perioral dermatitis, inhibition of epidermal growth, burning, itching, irritation, rash, atrophy of subcutaneous tissue, dryness of the skin, hair loss, skin discoloration or hyperpigmentation, skin stretch marks, perioral dermatitis, folliculitis, local skin reactions (e.g., contact dermatitis), secondary eruptions.
Urticaria or papulovesicular eruption may also occur, or existing skin conditions may worsen. When used topically on the eyelids, glaucoma or cataracts may occur.
Systemic Side Effects of Unknown Frequency(frequency cannot be estimated from available data):
Decreased immunity, inhibition of the hypothalamic-pituitary-adrenal axis, Cushing's syndrome, hyperglycemia (elevated blood glucose levels), hypertension, edema, growth retardation.
Due to the absorption of the active substance into the bloodstream, systemic side effects of fluocinolone acetonide may also occur.
These occur mainly in cases of prolonged use of the medicine, use on a large skin surface, under occlusive dressings, or in children.
Systemic side effects of fluocinolone acetonide characteristic of corticosteroids include inhibition of the hypothalamic-pituitary-adrenal axis, Cushing's syndrome, elevated blood sugar levels, glycosuria, edema, hypertension, decreased immunity.

Additional Side Effects in Children and Adolescents

In children, systemic side effects may occur in the form of growth and development retardation.

Reporting Side Effects

If any side effects occur, including any side effects not listed in the leaflet, inform a doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to Store Flucinar

Store at a temperature 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 month.
Shelf life after first opening the tube: 3 months.
Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of unused medicines. This will help protect the environment.

6. Contents of the Packaging and Other Information

What Flucinar Contains

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

What Flucinar Looks Like and What the Packaging Contains

Flucinar is a white or almost white, semi-transparent ointment with a characteristic odor.
The available packaging of the medicine is an aluminum membrane tube, internally lacquered, with a protective membrane and a screw cap, containing 15 g of ointment, placed in a cardboard box.
For more detailed information, consult the marketing authorization holder or parallel importer.

Marketing Authorization Holder in the Czech Republic, the Country of Export:

Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland

Manufacturer:

Pharmaceutical Company JELFA S.A.
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

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing authorization number in the Czech Republic, the country of export: 46/063/74-S/C

Parallel Import Authorization Number: 411/16

Date of Approval of the Leaflet: 03.03.2025

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