Flucinar

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Flucinar, 0.25 mg/g, ointment

Fluocinolone acetonide

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

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. 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 possible 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 for skin use. The medicine has anti-inflammatory, antipruritic, and vasoconstrictive properties.

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 accompanied by persistent itching or excessive scaling, such as seborrheic dermatitis, atopic dermatitis, lichen simplex, allergic contact dermatitis, polymorphic erythema, 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 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,
• after vaccinations,
• in children under 2 years of age,
• in anal or genital itching,
• in diaper dermatitis.

Warnings and precautions

Before starting treatment with Flucinar, you should discuss it with your doctor, pharmacist, or nurse.
If symptoms of irritation or skin allergic reaction occur after using Flucinar ointment, you should immediately inform your doctor. The doctor will decide whether to discontinue the treatment.
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 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, you should avoid using the medicine on a large body surface area, under occlusive dressings, for prolonged treatment, or in children.
In children, due to the higher ratio of body surface area to body weight than in adults, there is a greater risk of systemic corticosteroid-induced disorders of the hypothalamic-pituitary-adrenal axis and Cushing's syndrome.
If an infection occurs at the site of application, the doctor will use appropriate antibacterial or antifungal treatment. If the symptoms of the infection do not resolve, you should contact your doctor. The doctor will decide whether the treatment should be discontinued until the infection is cured.
You should avoid contact between the medicine and the eyes, mucous membranes, or wounds.
Do not use the medicine 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.
Use with particular caution in psoriasis, as local corticosteroid treatment in psoriasis can be hazardous for several reasons, including the risk of relapse due to the development of tolerance, the risk of generalized pustular psoriasis, and systemic toxic effects due to skin barrier disruption.
On facial skin and in the axillary and groin areas, use only in cases where it is absolutely necessary, 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.
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.
Prolonged corticosteroid treatment may disrupt growth and development in children.

Flucinar and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
No interactions are known during topical corticosteroid treatment with other medicines.
You should not be vaccinated against smallpox. You should also not receive other vaccinations, especially during prolonged treatment with the medicine or treatment on a large skin surface.
Flucinar may enhance the effects of medicines that affect the immune system.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine.
Pregnancy
Flucinar may be used in pregnant women only if the doctor believes that 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 the treatment, taking into account the risk of side effects in infants and the benefits of treatment for the mother.

Driving and using machines

Flucinar does not affect the ability to drive or use machines.

What Flucinar contains

• 50 mg of propylene glycolin 1 g of ointment (may cause skin irritation),
• lanolin(may cause local skin reactions, e.g., contact dermatitis).

3. How to use Flucinar

This medicine should always be used exactly as your doctor or pharmacist has told you. If you are not sure, you should ask your doctor or pharmacist.
The medicine is for use on the skin.
The recommended dose is a thin layer of ointment applied to the affected areas of skin, initially 2-3 times a day, and then, after the acute inflammatory condition has subsided, no more than once or twice a day.
Treatment should not be continued without interruption for more than 2 weeks.
On facial skin, do not use for more than 1 week.
Within one week, no more than 1 tube (15 g) of ointment should be used.
Do not use the ointment under an occlusive dressing (except in psoriasis, where an occlusive dressing may 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 where it is absolutely necessary - once a day, on a small skin surface area.
In children, do not use on facial skin.

Using more than the 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, you should contact your doctor.

Missing a 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 questions about the use of this medicine, you should ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Flucinar can cause side effects, although not everybody gets them.
Local side effects of unknown frequency (frequency cannot be estimated from the available data):
Acne-like changes, post-steroid pustules, inhibition of epidermal growth, burning, itching, irritation, rash, atrophy of subcutaneous tissue, dryness of the skin, excessive hair growth or hair loss, skin discoloration or hyperpigmentation, skin atrophy and striae, telangiectasia, perioral dermatitis, folliculitis, secondary infections, local skin reactions (e.g., contact dermatitis).
Urticaria or papulovesicular rash may occasionally occur, or existing skin conditions may worsen.
Blurred vision.
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):
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 medicine, use on a large skin surface area, under an occlusive dressing, 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, and decreased immunity.

Additional side effects in children and adolescents

In children, systemic side effects may occur, such as inhibition of growth and development.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, you should inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring 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, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Flucinar

The medicine should be stored out of the sight and reach of children.
Store in a temperature below 25°C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines 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 is fluocinolone acetonide.
1 g of ointment contains 0.25 mg of fluocinolone acetonide.
The other ingredients are: propylene glycol, citric acid monohydrate, lanolin, white petrolatum.

What Flucinar looks like and contents of the packaging

Flucinar is a white or almost white, semi-transparent ointment with a characteristic odor.
The medicine is available in an aluminum tube with a polyethylene screw cap, containing 15 g of ointment, placed in a cardboard box.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Latvia, the country of export:

PharmaSwiss Česká republika s.r.o.
Jankovcova 1569/2c
170 00 Prague 7
Czech Republic

Manufacturer:

Przedsiębiorstwo Farmaceutyczne 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 Latvia, the country of export:97-0468

Parallel import authorization number: 42/22 Date of approval of the leaflet: 18.01.2022

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