Flucinar

Leaflet attached to the packaging: patient information

Flucinar, 0.25 mg/g, ointment

Fluocinolone acetonide

Read the leaflet carefully before using the medicine, 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 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 not listed in this leaflet, they should tell 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 glucocorticosteroid. The medicine 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 glucocorticosteroid treatment and are accompanied 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 glucocorticosteroids, or any of the other ingredients of this medicine (listed in section 6),
• in bacterial, viral, or fungal skin infections,
• in common and rosacea acne,
• in perioral dermatitis,
• in children under 2 years of age,
• in anal and genital itching,
• in diaper dermatitis.

Warnings and precautions

Before starting treatment with Flucinar, discuss it with your doctor, pharmacist, or nurse.
If symptoms of irritation or skin allergic reaction (itching, burning, or redness) occur after applying Flucinar ointment, inform your doctor immediately. The doctor will decide whether to stop using 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, 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 use appropriate antibacterial or antifungal treatment. If the symptoms of the infection do not disappear, consult a doctor. The doctor will decide whether to discontinue treatment 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 glaucoma or cataracts.
If the patient experiences blurred vision or other vision disturbances, consult a doctor.
Avoid applying the medicine to the eyelids or 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 worsening the symptoms of the disease.
Avoid applying the medicine to the eyes.
On the face skin and in the armpits and groin, use only in absolutely necessary cases, 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 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 caution, only if absolutely necessary - once a day, on a small skin surface.
Do not use on the face skin in children.
Prolonged treatment with corticosteroids may disrupt growth and development in children.
In children, due to the larger 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 your doctor or pharmacist about all medicines you are taking, have recently taken, or plan 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 you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, 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 stop breastfeeding or discontinue the medicine, taking into account the benefits of breastfeeding for the baby and the benefits of treatment for the mother.
It is not known to what extent fluocinolone acetonide and its metabolites may pass 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 fertility in humans.

Driving and using 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

Always use this medicine exactly as your doctor or pharmacist has told you. If you are not sure, 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, no more than once or twice a day.
Treatment should not be continued without interruption for more than 2 weeks.
On the face 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 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 caution, only if absolutely necessary - once a day, on a small skin surface.
Do not use on the face skin in children.

Using more than the recommended dose of Flucinar

After long-term 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 treatment with Flucinar

If you have any further questions on the use of this medicine, ask your 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 that occur not very often (≥1/1,000 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 skin growth, burning, itching, irritation, rash, atrophy of subcutaneous tissue, dry 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 rash 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, growth retardation, 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 the case of long-term use of the medicine, use on a large skin surface, 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, 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 you experience any side effects, including any not listed in the leaflet, tell 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
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Flucinar

Store below 25°C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after: Expiry date. The expiry date refers to the last day of the month stated.
Shelf life after first opening the tube: 3 months.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. 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 pack

Flucinar is a white or almost white, semi-transparent ointment with a characteristic odor.
The medicine is available in an aluminum tube containing 15 g of ointment, placed in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder

Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland
Tel: +48 17 865 51 00

Manufacturer

Przedsiębiorstwo Farmaceutyczne Jelfa SA
ul. Wincentego Pola 21
58–500 Jelenia Góra
Poland
Date of last revision of the leaflet: