FLUCINAR N

Package leaflet: Information for the patient

Flucinar N, (0.25 mg + 5 mg)/g, ointment
(Fluocinoloni acetonidum + Neomycini sulfas)
Please read this 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, pharmacist, or nurse.
• 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 any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents:

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

Flucinar N ointment is a topical medicine containing the active substances fluocinolone acetonide and neomycin sulfate.
Fluocinolone acetonide is a synthetic glucocorticosteroid with strong anti-inflammatory activity.
When applied to the skin, it exerts anti-inflammatory, antipruritic (anti-itching), antiallergic, and vasoconstrictive effects.
Neomycin sulfate is a broad-spectrum antibiotic active against aerobic Gram-negative bacteria and some Gram-positive bacteria.

Indications
Flucinar N ointment is indicated for the local treatment of corticosteroid-responsive dry inflammatory skin conditions, particularly those of allergic origin, complicated by secondary infection with microorganisms sensitive to neomycin, and associated with excessive keratosis and persistent itching, especially in:
seborrheic dermatitis, atopic dermatitis, lichen urticatus, allergic contact dermatitis, erythema multiforme, discoid lupus erythematosus, chronic psoriasis, and lichen planus.

2. Important information before using Flucinar N ointment

When not to use Flucinar N ointment

• if the patient is allergic to fluocinonide acetonide or other glucocorticosteroids, neomycin sulfate or other aminoglycoside antibiotics, or to 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 acne vulgaris and rosacea,
• in perioral dermatitis,
• in inflammatory or ulcerative conditions associated with varicose veins,
• for extensive skin lesions, especially those involving skin loss, such as burns,
• in skin cancers,
• 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 this with your doctor, pharmacist, or nurse. If signs of irritation or an allergic skin reaction occur after applying Flucinar N ointment, discontinue use immediately and contact your doctor.

Do not use the medicine continuously for longer than 2 weeks. With prolonged use or application over large skin areas, the frequency of systemic adverse effects typical of corticosteroids increases, including edema, arterial hypertension, hyperglycemia, and decreased immunity. Therefore, avoid using the medicine over large body surface areas, for prolonged periods, and especially in children.

If signs of infection at the site of application worsen or do not resolve, contact your doctor. The doctor will decide whether to discontinue treatment and initiate appropriate antimicrobial therapy.

Avoid contact of the medicine with eyes, mucous membranes, or open wounds. Do not apply around the eyes due to the risk of glaucoma or cataract development. 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 (dilation of small blood vessels), and perioral dermatitis, even after short-term use.

Do not use the ointment under occlusive dressings. Use with caution in pre-existing atrophic conditions of subcutaneous tissue, especially in elderly patients.

Cross-allergy to aminoglycoside antibiotics may occur. Due to the risk of systemic absorption of neomycin, prolonged use or application over large skin areas or damaged skin may lead to ototoxicity, including hearing loss, and nephrotoxicity. Patients with impaired renal function or hearing impairment should use the medicine with particular caution. The risk of kidney and hearing damage is higher in patients with renal impairment. The medicine may potentiate the toxic effects on kidneys and hearing of other concurrently used drugs with such adverse effects.

Prolonged use of the medicine may lead to overgrowth of neomycin-resistant bacterial strains and development of neomycin allergy.

Children and adolescents

Do not use in children under 2 years of age.

In children aged 2 years and older, use with extreme caution, only when absolutely necessary – once daily, on a small skin area.

Due to children's higher body surface area to body weight ratio compared to adults, suppression of the hypothalamic-pituitary-adrenal axis, Cushing's syndrome, and other corticosteroid-related adverse effects, including disturbances in growth and development, may occur more easily than in adults.

Flucinar N ointment and other medicines

Inform your doctor or pharmacist about all medicines currently or recently used, as well as any medicines you plan to use.

No interactions are known during topical application of glucocorticosteroids with other medicines.

Flucinar N ointment may enhance or diminish the effects of medicines affecting the immune system.

Do not use this medicine simultaneously with drugs that are toxic to the kidneys and auditory system, such as furosemide or ethacrynic acid, as these drugs increase blood concentrations of aminoglycoside antibiotics, thereby increasing the risk of hearing damage.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.

Pregnancy

Consult a doctor before using any medicine. Flucinar N may be used in pregnant women only if, in the doctor's opinion, the benefits to the mother outweigh the risks to the fetus.

Its use is absolutely contraindicated during the first trimester of pregnancy (see section 2 "When not to use Flucinar N ointment").

Animal studies have shown teratogenic effects of glucocorticosteroids even after oral administration of low doses. Teratogenic effects have also been observed in animals after topical application of potent glucocorticosteroids.

No studies have been conducted on the risk of teratogenic effects of fluocinonide acetonide after topical skin application in pregnant women.

There is a risk of neomycin crossing the placental barrier and reaching the fetus.

Breastfeeding

Flucinar N may be used in breastfeeding women only if, in the doctor's opinion, the benefits to the mother outweigh the risks to the infant.

It is not known to what extent fluocinonide acetonide and neomycin from the ointment, after topical skin application, may pass into human breast milk.

Fertility

The effect of fluocinonide acetonide on fertility has not been studied; however, effects on fertility have been reported for other glucocorticosteroids.

Driving and operating machinery

Flucinar N ointment has no effect or a negligible effect on the ability to drive vehicles or operate machinery.

Flucinar N ointment contains:

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

3. How to use Flucinar N ointment

This medicine should always be used according to the recommendations of your doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.
This medicine is intended for topical application on the skin.
The recommended dose is a thin layer of ointment applied to the affected area of skin, no more frequently than once or twice daily.
Treatment should not be continued continuously for longer than 2 weeks.
Do not use the ointment under occlusive dressings (sealed coverings).
Do not apply to the facial skin for longer than 1 week.
No more than 1 tube (15 g) of ointment should be used within one week.

Patients with renal function disorders
Do not use the ointment for long-term treatment or over large areas of skin in patients with severe renal function disorders.

Patients with hepatic function disorders
Do not use the ointment for long-term treatment or over large areas of skin in patients with severe hepatic 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 aged 2 years and older, use with great caution and only when absolutely necessary – once daily on a small area of skin. Do not apply to the face in children.

Use of a higher than recommended dose of Flucinar N ointment
Due to the presence of fluocinolone acetonide, prolonged use of the medicine or application over large areas of skin may lead to symptoms of overdose such as oedema, hypertension, increased blood glucose levels, reduced immunity, and in severe cases, Cushing's syndrome.
Prolonged use or application over large skin areas may result in intensified adverse effects. In such cases, the medicine should be gradually withdrawn or weaker-acting glucocorticosteroids should be used.
If symptoms of overdose occur, consult your doctor.
Excessive or prolonged local use of the medicine, due to the presence of neomycin, may lead to the development of resistant bacterial strains and to ototoxicity and nephrotoxicity.

Missed dose of Flucinar N ointment
Do not use a double dose to make up for a missed dose.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.

**Local adverse reactions occurring not very commonly (**may occur in no more than 1 in 1000 patients):
Blurred vision.

**Local adverse reactions of unknown frequency (**frequency cannot be estimated from the available data):
Acne, acneiform eruptions, perioral dermatitis, epidermal atrophy, burning sensation, itching, irritation, rash, subcutaneous tissue atrophy, dryness of the skin, hypertrichosis or alopecia, skin depigmentation or discoloration, skin atrophy and striae, telangiectasia (dilation of capillaries and small arteries), perioral inflammatory dermatitis, folliculitis, secondary infections, local skin reactions (e.g. contact dermatitis).
Urticaria or maculopapular rash may occasionally occur, or exacerbation of pre-existing skin lesions. When applied locally to the eyelids, glaucoma or cataract may occur.

Due to the presence of neomycin in the medicine, local skin irritation and allergic reactions (including delayed-type reactions) may occur.

**Systemic adverse reactions of unknown frequency (**frequency cannot be estimated from the available data):
Reduced immunity*, Cushing's syndrome*, suppression of the hypothalamic-pituitary-adrenal axis*, hyperglycaemia* (excessively high blood sugar levels), glycosuria*, arterial hypertension*, growth retardation*, oedema*, developmental delay (in children)*.
*Due to skin absorption of fluocinolone acetonide, systemic adverse reactions may occur during prolonged use, application over large skin areas, or under occlusive dressing, particularly in children.
*Systemic adverse reactions characteristic of fluocinolone acetonide.

Due to the presence of neomycin, the medicine, when applied over large skin areas, on damaged skin, or under occlusive dressing, may cause ototoxicity (including hearing loss) or nephrotoxicity.

Additional adverse reactions in children and adolescents
In children, systemic adverse reactions may occur in the form of growth and developmental retardation.

If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, consult a doctor, pharmacist, or nurse.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse.

Adverse reactions 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 reactions may also be reported to the marketing authorisation holder.

Reporting adverse reactions helps provide more information on the safety of the 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 stated month.
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 in this medicine are fluocinolone acetonide and neomycin sulfate.
Each 1 g of ointment contains 0.25 mg of fluocinolone acetonide and 5 mg of neomycin sulfate.
The other components are propylene glycol, liquid paraffin, lanolin, and white vaseline.

What Flucinar N ointment looks like and contents of the pack
Flucinar N is a slightly yellow, semi-transparent ointment with a characteristic odour.
The medicine is available in an aluminium tube containing 15 g of ointment, packed in a cardboard box.

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