FLUCINAR 0.25 mg/g Gel

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. FLUCINAR, 0.25 mg/g, gel
   1. Read the package leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet:
3. What is Flucinar and what is it used for
   1. Indications for Use
4. Important Information Before Using Flucinar
   1. When Not to Use Flucinar:
   2. Warnings and Precautions
   3. Children and Adolescents
   4. Flucinar and Other Medicines
   5. Pregnancy and Breastfeeding
   6. Driving and Using Machines
   7. Flucinar Contains Propylene Glycol, Methyl Parahydroxybenzoate, Propyl Parahydroxybenzoate, and Ethanol.
5. How to Use Flucinar
   1. Use in Children and Adolescents
   2. Using More Than the Recommended Dose of Flucinar
   3. Missing a Dose of Flucinar
   4. Stopping Treatment with Flucinar
6. Possible Side Effects
   1. Local Side Effects that Occur Not Very Often (Less Than 1 in 100, but More Than 1 in 1000):
   2. Local Side Effects that Occur Rarely (Less Than 1 in 1000, but More Than 1 in 10,000):
   3. Local Side Effects with Unknown Frequency (Frequency Cannot Be Estimated from Available Data):
   4. Systemic Side Effects with Unknown Frequency (Frequency Cannot Be Estimated from Available Data):
   5. Reporting Side Effects
7. How to Store Flucinar
8. Contents of the Pack and Other Information
   1. What Flucinar Contains
   2. What Flucinar Looks Like and Contents of the Pack
   3. Marketing Authorization Holder and Manufacturer
   4. Marketing Authorization Holder
   5. Manufacturer
   6. Date of Last Revision of the Leaflet:

Package Leaflet: Information for the Patient

FLUCINAR, 0.25 mg/g, gel

Fluocinolone acetonide

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 or pharmacist.
• -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, please tell your doctor or pharmacist. 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 pack 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 strong anti-inflammatory, anti-pruritic, and vasoconstrictive effects.

Indications for Use

Local treatment (in the first phase of treatment before using the medicine in the form of an ointment) 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:

• seborrhoeic dermatitis,
• atopic dermatitis,
• urticaria,
• allergic contact dermatitis,
• erythema multiforme,
• discoid lupus erythematosus,
• psoriasis of the scalp,
• chronic psoriasis,
• lichen planus.

The gel form of the medicine allows for the application of a smaller dose of the medicine to a larger skin surface than when using an ointment, and for the application of the medicine to hairy skin. Flucinar in the form of a gel can also be used in patients who poorly tolerate the base of the ointment.

2. Important Information Before Using Flucinar

When Not to Use Flucinar:

• if you are 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,
• in children under 2 years of age.

Warnings and Precautions

Before starting treatment with Flucinar, discuss it with your doctor or pharmacist. If irritation or allergic skin reaction occurs after using Flucinar, 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 on a large skin surface, the frequency of general side effects characteristic of corticosteroids, including edema, hypertension, hyperglycemia, 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, under closed dressings, or for prolonged treatment with the medicine. 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, contact your doctor. The doctor will decide whether the treatment should be discontinued 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. You should avoid applying the medicine to the eyelids or the skin around the eyelids in patients with narrow- or wide-angle glaucoma, as well as in patients with cataracts, due to the possibility of exacerbating the symptoms of the disease. Avoid getting the medicine in the eyes. If the patient experiences blurred vision or other vision disturbances, they should contact their doctor. On the face skin and in the armpits and groin, use only in cases where it is absolutely necessary, 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. Use with caution in existing atrophic skin conditions, especially in the elderly.

Children and Adolescents

In children, due to the greater ratio of body surface area to body mass compared to adults, there is a higher risk of side effects caused by the systemic action of corticosteroids and Cushing's syndrome (a syndrome of disease symptoms associated with elevated steroid levels in the blood, the most common cause of which is prolonged administration of glucocorticosteroids). Long-term treatment with corticosteroids may disrupt growth and development in children.

Flucinar and Other Medicines

Tell your doctor or pharmacist about all medicines you are currently taking, or have recently taken, and about medicines you plan to take. There are no known interactions during topical use of corticosteroids with other medicines. Flucinar may enhance or weaken the effect of medicines that affect the immune system.

Pregnancy and Breastfeeding

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. PregnancyFlucinar may be used in pregnant women only if, in the doctor's opinion, the benefits to the mother outweigh the risk to the fetus. Do not use in the first trimester of pregnancy. BreastfeedingThe doctor will consider whether to stop breastfeeding or using the medicine, taking into account the benefits of breastfeeding for the baby and the benefits of treatment for the mother. The risk to newborns/children cannot be excluded. FertilityThere is no data on the effect of fluocinolone on fertility in humans.

Driving and Using Machines

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

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 (possible late reactions). This medicine contains 150 mg of alcohol (ethanol) in 1 g of gel. Due to the presence of ethanol, the medicine may cause burning of damaged skin. Due to the flammability of the medicine, do not smoke, stay near open fire, or use certain devices (e.g., hair dryers) while applying the medicine or immediately after its application.

3. How to Use Flucinar

Always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. The medicine is for use on the skin. Flucinar gel is applied in a thin layer to the affected areas of the 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 the face skin, do not use for more than 1 week. Within one week, no more than 1 tube (15 g) of gel can be used. If deeper penetration of the medicine is necessary, the gel can be gently rubbed into the skin at the site of application. Do not use a closed dressing. If it is necessary to apply a dressing, use a breathable dressing.

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 when absolutely necessary - once a day, on a small skin surface. In children, do not use on the face skin.

Using More Than the Recommended Dose of Flucinar

After long-term use of the medicine on a large skin surface, symptoms of overdose may occur, such as side effects: edema, hypertension, hyperglycemia, decreased immunity, and in severe cases, Cushing's syndrome. If symptoms of overdose occur, 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, ask your doctor or pharmacist.

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 (Less Than 1 in 100, but More Than 1 in 1000):

Secondary infections, skin atrophy and striae, telangiectasias (dilation of blood vessels and capillaries), blurred vision.

Local Side Effects that Occur Rarely (Less Than 1 in 1000, but More Than 1 in 10,000):

Hypertrichosis (excessive hair growth).

Local Side Effects with Unknown Frequency (Frequency Cannot Be Estimated from Available Data):

Acne-like changes, perioral dermatitis, inhibition of epidermal growth, burning, itching, irritation, rash, subcutaneous tissue atrophy, skin dryness, hair loss, skin discoloration or hyperpigmentation, perioral dermatitis, folliculitis, secondary eruptions. Sometimes, urticaria or a papular rash may occur, or existing disease symptoms may worsen. When used topically on the eyelids, glaucoma or cataracts may occur.

Systemic Side Effects with Unknown Frequency (Frequency Cannot Be Estimated from Available Data):

Decreased immunity, inhibition of the hypothalamic-pituitary-adrenal axis, Cushing's syndrome, hyperglycemia (elevated blood glucose 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. They occur mainly in the case of long-term use of the medicine, use on a large skin surface, under a closed dressing, or in the case of use in children. Systemic side effects of fluocinolone acetonide characteristic of corticosteroids include growth and development inhibition in children, elevated blood sugar levels, glycosuria. If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist.

Reporting Side Effects

If you experience any side effects, including any not listed in this leaflet, please 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. Do not freeze. Store in a place 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 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 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, tromethamine, purified water.

What Flucinar Looks Like and Contents of the Pack

Flucinar is a colorless, semi-transparent gel with a slight smell of ethanol. The medicine is available in an aluminum tube containing 15 g of gel, 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: