Product Information for the User

Gelidina 0.25 mg/g Gel

Fluocinolone Acetonide

Read this entire product information carefully before starting to use this medication, as it contains important information for you.

- Keep this product information, as you may need to refer to it again.

- If you have any questions, consult your doctor or pharmacist.

-This medication has been prescribed to you alone, and you should not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this product information. See section 4.

1. What is Gelidina and how is it used

2. What you need to know before starting to use Gelidina

3. How to use Gelidina

4. Possible adverse effects

5. Storage of Gelidina

6. Contents of the package and additional information

The active ingredient of Gelidina is fluocinolone acetonide. This medication belongs to a group of drugs known as topical corticosteroids (for external use) that act by reducing inflammation, itching, and cell proliferation.

Gelidina is used in adults and children over 1 year old to treat a wide range of inflammatory, pruritic, and allergic skin lesions, such as: eczema, dermatitis, psoriasis, lichen planus, and discoid lupus erythematosus.

This gel is especially intended for use in hairy areas (of difficult accessibility) and visible lesion areas.

No use Gelidina

- if you are allergic to the active ingredient or any of the other components of this medication (listed in section 6).

-in primary skin infections and tuberculosis, syphilis or viral infections (such as herpes or chickenpox).

- if you have infected wounds caused by bacteria, viruses or fungi, do not apply this gel to infected wounds.

-in areas of skin affected by red or pink inflammation on the face (rosacea), ulcers or wounds, inflammation of the sebaceous glands (acne) or skin diseases with skin thinning (atrophy)

- in a skin inflammation that occurs around the mouth (perioral dermatitis)

-in areas of skin that show a vaccine reaction, i.e., redness or inflammation after administration of a vaccine

Warnings and precautions

Consult your doctor or pharmacist before starting to use Gelidina.

-If a skin infection appears, your doctor will prescribe the appropriate treatment for that fungal or bacterial infection. If you do not respond to that treatment, your doctor may suspend treatment until the infection is under control.

-This gel should be used at the lowest possible dose, especially in children, and only for the strictly necessary time to relieve skin symptoms.

-The prolonged use of topical corticosteroids, or in skin folds (such as the groin or armpits), as well as application in occlusive dressings (dressings that do not allow air circulation or, for example, in the area covered by a diaper), may cause skin atrophy, mucous membranes and subcutaneous tissue.

-The prolonged use, excessive amounts of medication or in extensive areas may cause systemic effects (those that occur when the medication is absorbed and reaches the blood), especially in children.

- If the medication causes irritation, discontinue its application and consult your doctor.

-Avoid contact of the gel with the eyes or around the eyes, in open wounds or with mucous membranes (such as the mouth or genital area).

-If you are being treated for psoriasis, your doctor should frequently monitor your condition to observe any possible worsening.

- Inform your doctor if you experience blurred vision or other visual disturbances.

Pediatric population

The chronic administration in children may interfere with growth and development, so it should be limited to short periods of time and the minimum effective amount of medication.

Use in athletes

Warning to athletes: this medication contains a component, fluocinolone, which may produce a positive result in doping control tests.

Other medications and Gelidina

Inform your doctor or pharmacist if you are using, have used recently or may need to use any other medication.

Do not apply other topical preparations to the treated area along with this gel.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, or think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

As a general rule, this gel should not be applied during the first trimester of pregnancy.

Do not use this medication for a prolonged period, in extensive areas or with occlusive dressings if you are pregnant. Its use should be reserved for cases where the therapeutic benefit is greater than the possible risk.

Similarly, caution is advised if this medication needs to be used during breastfeeding. Do not apply the gel to the breasts and avoid contact of the treated areas with the child.

Driving and operating machinery

This medication does not affect the ability to drive and/or operate machinery.

Gelidina contains phenoxyethanol (E-216), phenoxyethanol (E-218), ethanol (alcohol) and propylene glycol (E-1520).

This medication may cause allergic reactions (possibly delayed) because it contains phenoxyethanol (E-216) and phenoxyethanol (E-218).

This medication contains 150 mg of alcohol (ethanol) in each gram of gel, which is equivalent to 0.176 ml of ethanol. Containing ethanol, it may cause a burning sensation on damaged skin.

This medication contains 150 mg of propylene glycol (E-1520) in each gram of gel. Propylene glycol may cause skin irritation.

Do not use this medication in infants under 4 weeks with open wounds or large areas of damaged skin (such as burns) without consulting your doctor or pharmacist first.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The use of gel is best suited for the scalp, other hairy body areas, and visible skin lesions.

Adults and children over 1 year:

It can be applied in open dressing, as a thin layer on the affected skin area, 2 to 3 times a day, gently rubbing until completely absorbed.

It can also be applied in occlusive dressing, as a thin layer on the affected skin area, once a day, covering it with a non-porous plastic bandage.

Your doctor will indicate the duration of your treatment; usually one week.

Depending on the severity of the condition, treatment may be prolonged from 1 to 4 weeks. If there is no improvement within this time period, your doctor should reevaluate the treatment.

Treatment should not exceed 2 months.

Use in children

It is not recommended for use in children under 1 year.

It is not recommended to use occlusive dressings (such as in the diaper area).

In children, treatment should be limited to short periods of time and the minimum effective amount of medication should be used. If used on the face, treatment should not exceed 5 days, and generally not more than one week in other body areas.

If you use more Gelidina than you should

Using excessive amounts of gel can cause adrenal suppression (which results in an alteration of normal hormone production). In this case, treatment should be interrupted and your doctor should monitor your adrenal hormonal axis function.

Accidental ingestion may cause tachycardia (rapid heart rate) and occasional elevations in blood pressure, which resolve without the need for medical treatment.

If you have used this medication more than you should, consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91-562 04 20, indicating the medication and the amount used.

If you forgot to use Gelidina

Do not apply a double dose to compensate for the missed doses.

If you forget to apply the gel at the scheduled time, do it as soon as you remember and then continue as before.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

Rare Adverse Effects (may affect up to 1 in 1,000 people):

- Skin atrophy with thinning of the epidermis (often irreversible)

- Telangiectasia (dilation of small blood vessels on the skin surface)

- Purpura (presence of red patches and spots on the skin)

- Striae on the skin

- Acneiform eruptions (acne-like eruptions)

- Perioral dermatitis (small red papules around the mouth)

- Depigmentation of the skin (loss of skin coloration)

- Dermatitis and eczema, including contact dermatitis

- Burning sensation

- Rebound effect.

Very Rare Adverse Effects (may affect up to 1 in 10,000 people):

- Adrenal suppression, which causes an alteration in normal hormone production.

Unknown Frequency (cannot be estimated from available data):

- Hypersensitivity (allergic reactions)

- Pruritus (itching)

- Dry skin

-Miliaria (alteration caused by obstruction of sweat glands, resulting in the appearance of white or red grains on various parts of the body) or prickly heat

- Skin maceration

- Hirsutism (excessive hair growth)

- Folliculitis (inflammation of one or more hair follicles)

- Secondary infection.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if

it is possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:

www.notificaRAM.es.MReporting adverse effects can help provide more information about the safety of this medication.

Store below 25°C.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Gelidina

-The active ingredient is acetonic fluocinolone. Each gram of gel contains 0.25 mg of acetonic fluocinolone.

-The other components are: anhydrous citric acid E330, carbomer 940, propylene glycol E1520, ethanol 17.6% v/v (alcohol), this small amount corresponds to 150 mg, methyl parahydroxybenzoate E218, propyl parahydroxybenzoate E216, sodium edetate, triethanolamine, purified water.

Appearance of Gelidina and content of the packaging

Homogeneous transparent colorless gel packaged in aluminum tubes and polyethylene screw cap (HDPE).

It is presented in tubes of 30 and 60 grams of gel.

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization

Laboratorios ERN, S.A.

C/Perú, 228

08020 Barcelona, Spain

Responsible for manufacturing

Temmler Italia S.R.L.

Via delle Industrie, 2 - 280061 Carugate – Milan - Italy

Date of the last review of this leaflet: October/2020

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/