Flucinar N

Package Leaflet: Information for the Patient

Flucinar N, (0.25 mg + 5 mg)/g, Ointment

(Fluocinolone Acetonide + Neomycin Sulfate)

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Flucinar N ointment and what is it used for
• 2. Important information before using Flucinar N ointment
• 3. How to use Flucinar N ointment
• 4. Possible side effects
• 5. How to store Flucinar N ointment
• 6. Contents of the pack and other information

1. What is Flucinar N ointment and what is it used for

Flucinar N ointment is a medicine for use on the skin, containing the active substances fluocinolone acetonide and neomycin sulfate.
Fluocinolone acetonide is a synthetic glucocorticosteroid with strong anti-inflammatory action.
When applied to the skin, it has anti-inflammatory, anti-itching, anti-allergic, and vasoconstrictive effects.
Neomycin sulfate is an antibiotic with a broad spectrum of action. It acts on aerobic Gram-negative and some Gram-positive bacteria.

Indications for use

Flucinar N ointment is indicated for local treatment of dry inflammatory skin conditions responding to corticosteroid therapy, especially those with an allergic background, complicated by secondary bacterial infections sensitive to neomycin, and characterized by excessive scaling and persistent itching, especially in:
seborrheic dermatitis, atopic dermatitis, lichen planus, allergic contact dermatitis, polymorphic erythema, lupus erythematosus, chronic psoriasis.

2. Important information before using Flucinar N ointment

When not to use Flucinar N ointment

• if you are allergic to fluocinolone acetonide or other glucocorticosteroids, neomycin sulfate, or other aminoglycoside antibiotics, or any of the other ingredients of this medicine (listed in section 6),
• in viral (e.g., chickenpox, herpes simplex), fungal, or bacterial (e.g., tuberculosis) skin infections,
• in common and rosacea acne,
• in skin inflammation around the mouth,
• in venous leg ulcers or eczema,
• on extensive skin lesions, especially those with skin loss, e.g., in burns,
• in skin tumors,
• in children under 2 years of age,
• in diaper dermatitis,
• during the first trimester of pregnancy.

Warnings and precautions

Before starting treatment with Flucinar N, discuss it with your doctor, pharmacist, or nurse.
If symptoms of irritation or skin allergic reaction occur after using Flucinar N ointment, discontinue use and contact your doctor.
Do not use the medicine continuously for more than 2 weeks without consulting a doctor.
During prolonged use of the medicine or use on a large skin surface, the frequency of systemic side effects characteristic of corticosteroids, including edema, hypertension, hyperglycemia, and decreased immunity, increases. Therefore, avoid using the medicine on a large body surface area, prolonged treatment, and use in children.
If symptoms of infection at the site of application worsen or do not improve, contact your doctor. The doctor will decide whether to discontinue use and apply appropriate antimicrobial treatment.
Avoid contact of the medicine with the eyes, mucous membranes, or wounds.
Do not use around the eyes due to the risk of glaucoma or cataracts.
If you experience blurred vision or other vision disturbances, contact your doctor.
On facial skin and skin of 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 (dilation of blood vessels), perioral dermatitis, even after short-term use.
Do not use the ointment under occlusive dressings. Use with caution in existing atrophic conditions of subcutaneous tissue, especially in the elderly.
There is a possibility of cross-allergy to aminoglycoside antibiotics.
Due to the risk of neomycin absorption into the blood, using the medicine on large skin surfaces, damaged skin, or for a long time, may cause hearing damage, including hearing loss, and kidney damage.
Patients with kidney function disorders or hearing impairment should be particularly cautious when using the medicine.
The risk of kidney and hearing damage is higher in patients with kidney function disorders.
The medicine may enhance the effect of concurrently used medicines that damage the kidneys and hearing.
Prolonged use of the medicine may lead to the development of neomycin-resistant bacterial strains and the development of an allergy to neomycin.

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, due to the larger body surface area to body mass ratio compared to adults, it is easier for systemic side effects characteristic of corticosteroids to occur, including growth and development disorders.

Flucinar N ointment 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 glucocorticosteroids with other medicines.
Flucinar N ointment may enhance or weaken the effect of medicines that affect the immune system.
Do not use the medicine concurrently with medicines that are toxic to the kidneys and hearing organ, such as furosemide, ethacrynic acid, as these medicines increase the concentration of aminoglycoside antibiotics in the blood, increasing the risk of hearing damage.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
Before using any medicine, consult your doctor. Flucinar N may be used in pregnant women only if the doctor considers that the benefits to the mother outweigh the risks to the fetus.
Do not use in the first trimester of pregnancy (see section 2, "When not to use Flucinar N ointment").
Animal studies have shown teratogenic effects of glucocorticosteroids even at low doses. Teratogenic effects have also been observed in animals after topical application of strong glucocorticosteroids.
No studies have been conducted on the risk of teratogenic effects of fluocinolone acetonide after topical application in pregnant women.
There is a risk of neomycin absorption into the fetus.
Breastfeeding
Flucinar N may be used in breastfeeding women only if the doctor considers that the benefits to the mother outweigh the risks to the child.
It is not known to what extent fluocinolone acetonide and neomycin in the ointment may pass into breast milk after topical application.
Fertility
The effect of fluocinolone acetonide on fertility has not been studied, but other glucocorticosteroids have been reported to affect fertility.

Driving and using machines

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

What Flucinar N ointment 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 N ointment

Always use this medicine exactly as your doctor or pharmacist has told you.
In case of doubt, consult 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 skin surface, not more than once or twice a day.
Treatment should not be continued without interruption for more than 2 weeks.
Do not use the ointment under occlusive dressings.
On facial skin, do not use for more than 1 week.
Within one week, do not use more than 1 tube (15 g) of ointment.
Patients with kidney function disorders
Do not use the ointment for prolonged treatment or on a large skin surface in patients with severe kidney function disorders.
Patients with liver function disorders
Do not use the ointment for prolonged treatment or on a large skin surface in patients with severe liver function disorders.

Use in children and adolescents

Do not use in children under 2 years of age (see section 2, "When not to use Flucinar N ointment").
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 facial skin.

Using more than the recommended dose of Flucinar N ointment

Due to the content of fluocinolone acetonide, prolonged use of the medicine or use on large skin surfaces may cause symptoms of overdose, such as edema, hypertension, hyperglycemia, decreased immunity, and in severe cases, Cushing's syndrome.
Prolonged use of the medicine or use on large skin surfaces may cause enhanced side effects. In such cases, gradually discontinue the medicine or use a less potent glucocorticosteroid.
If symptoms of overdose occur, contact your doctor.
Excessive or prolonged topical use of the medicine, due to the content of neomycin, may lead to the development of resistant bacterial strains and damage to hearing and kidneys.

Missing a dose of Flucinar N ointment

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

Stopping use of Flucinar N ointment

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 (may occur in up to 1 in 100 patients ):
Blurred vision.
Local side effects of unknown frequency(frequency cannot be estimated from available data):
May cause acne, acne-like changes, perioral dermatitis, inhibition of skin growth, burning, itching, irritation, rash, subcutaneous tissue atrophy, dry skin, excessive hair growth or hair loss, skin discoloration or hyperpigmentation, skin atrophy and striae, telangiectasia (dilation of blood vessels), perioral dermatitis, folliculitis, secondary infections, local skin reactions (e.g., contact dermatitis).
Sometimes, urticaria or papular-pustular rash may occur, or existing skin conditions may worsen. When used topically on the eyelids, glaucoma or cataracts may occur.
Due to the content of neomycin in the medicine, local skin irritation and allergic reactions (including delayed reactions) may occur.

Systemic side effects of unknown frequency (frequency cannot be estimated from available data):

Decreased immunity*, Cushing's syndrome*, inhibition of the hypothalamic-pituitary-adrenal axis*, hyperglycemia* (elevated blood sugar), glucosuria*, hypertension*, growth retardation*, edema*, inhibition of development (in children)*.
*Due to the absorption of fluocinolone acetonide through the skin, systemic side effects may occur during prolonged use, application on large skin surfaces, or under occlusive dressings, as well as in children.
*Systemic side effects characteristic of fluocinolone acetonide.
Due to the content of neomycin, the medicine used on large skin surfaces, damaged skin, or under occlusive dressings may cause hearing damage (including hearing loss) or kidney damage.

Additional side effects in children and adolescents

In children, systemic side effects may occur, such as growth and development disorders.
If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Drug Safety Monitoring 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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Flucinar N ointment

Store 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 carton after: Expiry date. The expiry date refers to the last day of the month stated.
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 pack and other information

What Flucinar N ointment contains

The active substances of the medicine are fluocinolone acetonide and neomycin sulfate.
1 g of ointment contains 0.25 mg of fluocinolone acetonide and 5 mg of neomycin sulfate.
The other ingredients are propylene glycol, liquid paraffin, lanolin, white petrolatum.

What Flucinar N ointment looks like and contents of the pack

Flucinar N is a light yellow, 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: