Flucinar

Package Leaflet: Information for the Patient

Warning! Keep the Leaflet! Information on the Immediate Packaging in a Foreign Language.

Flucinar, 0.25 mg/g, Ointment

Fluocinolone Acetonide

Read the Leaflet Carefully Before Using the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medication has been prescribed for a specific person. Do not pass it on to others. The medication may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any 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 medication has anti-inflammatory, anti-itching, 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 treatment 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 medication (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, the patient should discuss it with their doctor, pharmacist, or nurse.
If irritation or allergic skin reaction (itching, burning, or redness) occurs after using Flucinar ointment, the patient should immediately inform their doctor. The doctor will decide whether to discontinue the medication.
The medication should not be used continuously for more than 2 weeks.
During long-term use of the medication on a large skin surface, the frequency of systemic 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, the medication should be avoided on large areas of the body, under occlusive dressings, during prolonged treatment, and 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 prescribe appropriate antibacterial or antifungal treatment. If the symptoms of the infection do not resolve, the patient should contact their doctor. The doctor will decide whether the treatment should be discontinued until the infection is cured.
Contact with the eyes, mucous membranes, or wounds should be avoided.
The medication should not be used around the eyes, due to the risk of glaucoma or cataracts.
If the patient experiences blurred vision or other vision disturbances, they should contact their doctor.
The medication should be avoided on 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.
The medication should not be administered to the eyes.
On the facial skin and in the armpits and groin, the medication should only be used in cases of absolute necessity, due to increased absorption of the corticosteroid 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 resolve on their own after discontinuation of the medication.
The medication should be used with caution in existing atrophic skin conditions, especially in the elderly.

Children and Adolescents

The medication should not be used in children under 2 years of age.
In children over 2 years of age, the medication should be used with extreme caution, only in cases of absolute necessity - once a day, on a small skin surface.
In children, the medication should not be used on the facial skin.
Prolonged treatment with corticosteroids may disrupt growth and development in children.
In children, due to the larger ratio of body surface area to body mass compared to 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 Medications

The patient should inform their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take.
No interactions are known during topical use of corticosteroids with other medications.
Flucinar may enhance the effects of medications that affect the immune system or weaken their effects.

Pregnancy, Breastfeeding, and Fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medication.
Pregnancy
Flucinar may be used in pregnant women only if the benefits to the mother outweigh the risks to the fetus.
Absolute contraindication in the first trimester of pregnancy.
Breastfeeding
During breastfeeding, the doctor will consider whether to discontinue breastfeeding or stop using the medication, 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 effects of fluocinolone on fertility in humans.

Driving and Operating Machinery

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 medication should always be used as directed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
The medication 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, the medication should not be used for more than 1 week.
Within one week, no more than 1 tube (15 g) of ointment should be used.
The ointment should not be used under an occlusive dressing (except for psoriasis, where an occlusive dressing is allowed, which should be changed daily).

Use in Children and Adolescents

The medication should not be used in children under 2 years of age.
In children over 2 years of age, the medication should be used with extreme caution, only in cases of absolute necessity - once a day, on a small skin surface.
In children, the medication should not be used on the facial skin.

Using More than the Recommended Dose of Flucinar

After prolonged use on large areas of the skin, 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, the patient should contact their doctor.

Missing a Dose of Flucinar

A double dose should not be used to make up for a missed dose.

Stopping Use of Flucinar

In case of any further doubts about using this medication, the patient should consult their doctor, pharmacist, or nurse.

4. Possible Side Effects

Like all medications, Flucinar can cause side effects, although not everybody gets them.

Local Side Effects that Occur Not Very Often (≥1/1000 to <1>

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

Local Side Effects that Occur Rarely (≥1/10 000 to <1>

Hypertrichosis (excessive hair growth).
Local Side Effects of Unknown Frequency(frequency cannot be estimated from the 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 papular eruptions 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 the available data):
Decreased immunity, inhibition of the hypothalamic-pituitary-adrenal axis, Cushing's syndrome, hyperglycemia (elevated blood sugar levels), hypertension, edema.
Due to the absorption of the active substance into the blood, systemic side effects of fluocinolone acetonide may also occur.
These occur mainly in cases of prolonged use of the medication, use on large areas of the skin, 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, such as growth and development inhibition.

Reporting Side Effects

If the patient experiences any side effects, including any not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Adverse Reactions to Medicinal Products 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.
By reporting side effects, more information can be collected on the safety of the medication.

5. How to Store Flucinar

Store at a temperature below 25°C.
The medication should be stored out of sight and reach of children.
Do not use this medication 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.
Medications should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the Packaging and Other Information

What Flucinar Contains

The active substance of Flucinar is fluocinolone acetonide.
1 g of ointment contains 0.25 mg of fluocinolone acetonide.
The other ingredients of the medication 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 medication is an aluminum tube with an inner protective layer, a protective membrane, and a puncture cap, containing 15 g of ointment, placed in a cardboard box.
For more detailed information, the patient should contact the marketing authorization holder or the 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 SA
ul. Wincentego Pola 21
58-500 Jelenia Góra, Poland

Parallel Importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorization Number in the Czech Republic, the Country of Export:46/063/74-S/C

Parallel Import Authorization Number: 399/24

Date of Approval of the Leaflet: 19.11.2024

[Information about the Trademark]