Flucinar

Package leaflet: Information for the patient

FLUCINAR, 0.25 mg/g, gel
Fluocinolone acetonide
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• 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 those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

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 pack 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 a strong anti-inflammatory,
anti-pruritic, and vasoconstrictive effect.
Indications
Topical treatment (in the initial phase of treatment, prior to using the medicine in ointment form) of acute and
severe, non-infectious dry inflammatory skin conditions that respond to glucocorticosteroid therapy and are
accompanied by persistent itching or excessive keratinization, such as:

• seborrheic dermatitis,
• atopic dermatitis,
• lichen urticatus,
• allergic contact dermatitis,
• erythema multiforme,
• systemic lupus erythematosus,
• psoriasis of hairy skin,
• chronic psoriasis,
• lichen planus.

The gel formulation allows a smaller dose of the medicine to be spread over a larger skin surface compared to
ointment, and enables application to hairy skin.
Flucinar gel may also be used in patients who poorly tolerate the ointment base.

2. Important information before using Flucinar

When not to use Flucinar:

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

Warnings and precautions
Before starting treatment with Flucinar, consult your doctor or pharmacist.
If irritation symptoms or an allergic skin reaction occur after applying Flucinar, inform your doctor immediately. The doctor will decide whether treatment should be discontinued.
Do not use the medicine continuously for longer than 2 weeks.
With prolonged use over large areas of skin, the frequency of systemic adverse effects typical of corticosteroids increases, including oedema, hypertension, hyperglycaemia, and reduced immunity.
Since corticosteroids are absorbed through the skin, avoid applying the medicine over large body surface areas, under occlusive dressings, or for prolonged periods.
If an infection develops at the site of application, the doctor will initiate appropriate antibacterial or antifungal treatment. If signs of infection persist, contact your doctor. The doctor will decide whether treatment should be interrupted until the infection resolves.
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 cataracts.
Avoid application to the eyelids or skin around the eyes in patients with narrow- or wide-angle glaucoma, as well as in patients with cataracts, due to the possibility of worsening disease symptoms.
Avoid getting the medicine into the eyes.
If the patient experiences blurred vision or other visual disturbances, contact a doctor.
Apply to facial skin, underarms, and groin areas only when absolutely necessary, due to increased absorption of corticosteroids through delicate skin and a higher risk of adverse effects such as telangiectasia or perioral dermatitis, even after short-term use.
Use with caution in pre-existing atrophic conditions of subcutaneous tissue, especially in elderly patients.

Children and adolescents
In children, due to a higher body surface area to body weight ratio compared to adults, there is an increased risk of systemic corticosteroid-related adverse effects and Cushing's syndrome (a cluster of symptoms associated with elevated serum steroid levels, most commonly caused by long-term glucocorticosteroid therapy). Prolonged corticosteroid treatment may impair growth and development in children.

Flucinar and other medicines
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines planned for future use.
No interactions are known during topical use of corticosteroids with other medicines.
Flucinar may enhance or diminish the effects of medicines affecting the immune system.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her 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 foetus.
It is absolutely contraindicated during 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.
Risk to newborns/infants cannot be excluded.

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

Driving and operating machinery
Flucinar gel has no effect or has a negligible effect on the ability to drive and operate machinery.

Flucinar contains propylene glycol, methyl parahydroxybenzoate, propyl parahydroxybenzoate, and ethanol.
The medicine contains 150 mg of propylene glycol in 1 g of gel.
Due to the presence of methyl parahydroxybenzoate and propyl parahydroxybenzoate, the medicine may cause allergic reactions (including delayed-type reactions).
This medicine contains 150 mg of alcohol (ethanol) in 1 g of gel. Due to its ethanol content, the medicine may cause a stinging sensation on damaged skin.
Because the medicine is flammable, do not smoke, stay near open flames, or use certain devices (e.g. hair dryers) during or immediately after application.

3. How to use Flucinar

This medicine should always be used as directed by the physician. If in doubt, consult a doctor or pharmacist.
This medicine is intended for topical use on the skin.
Apply Flucinar gel thinly to the affected areas of the skin initially two to three times daily, then after the acute inflammatory condition subsides, no more than once or twice daily.
Treatment should not be continued continuously for longer than 2 weeks.
Do not use on the facial skin for longer than 1 week.
No more than one tube (15 g) of gel should be used within one week.
If deeper penetration of the medicine is required, the gel may be gently rubbed into the skin at the site of application. Do not use an occlusive dressing. If a dressing is necessary, use one that allows air permeability.

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.
Do not use on the facial skin in children.

Use of a higher than recommended dose of Flucinar
Prolonged use of the medicine over a large skin surface may lead to symptoms of overdose, manifesting as adverse effects such as edema, arterial hypertension, elevated blood glucose levels, reduced immunity, and in severe cases, Cushing's syndrome.
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.

Discontinuation of Flucinar
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

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 frequently (less than in 1 out of 100 patients,
but more often than in 1 out of 1000):
Secondary infections, skin atrophy and striae (stretch marks), telangiectasia (dilation of capillaries and small veins), blurred vision.
Local adverse effects occurring rarely (less than in 1 out of 1000 patients,
but more often than in 1 out of 10,000):
Hypertrichosis (excessive hair growth).
Local adverse effects with unknown frequency (frequency cannot be determined from available data):
Acneiform eruptions, post-steroid purpura, epidermal growth suppression, burning, itching, irritation, rash, subcutaneous tissue atrophy, dry skin, alopecia, skin depigmentation or hyperpigmentation, perioral dermatitis, folliculitis, secondary eruptions. Urticaria or maculopapular rash may occasionally occur, or exacerbation of existing skin lesions.
When applied locally 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 axis, Cushing's syndrome, hyperglycemia (elevated blood glucose levels), hypertension, growth retardation, edema.
Systemic absorption of the active substances may also lead to systemic adverse effects of fluocinolone acetonide.
These occur primarily during prolonged use of the medicine, application over large areas of skin, under occlusive dressings, or when used in children.
Systemic adverse effects of fluocinolone acetonide typical of corticosteroids include growth and development suppression in children, elevated blood sugar levels, and glycosuria.
If any adverse effects occur, including any possible adverse effects not listed in this leaflet, consult a doctor or pharmacist.
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 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
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Flucinar

Store below 25°C. Do not freeze.
Keep out of 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 sewage systems or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Flucinar contains

• The active substance is fluocinolone acetonide. 1 g of gel contains 0.25 mg of fluocinolone acetonide.
• The other ingredients are: propylene glycol, ethanol 96%, disodium edetate, citric acid monohydrate, propyl parahydroxybenzoate (E216), methyl parahydroxybenzoate (E218), carbomer 980, triethanolamine, purified water.

What Flucinar looks like and contents of the pack
Flucinar is a colourless, semi-transparent gel with a slight ethanol odour.
The medicinal product is available in an aluminium tube containing 15 g of gel, packed in a cardboard carton.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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