GELIDINA 0.25 mg/g GEL

Introduction

Package Leaflet: Information for the User

Gelidina 0.25 mg/g gel

Fluocinolone, acetate

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What is Gelidina and what is it used for
2. What you need to know before you use Gelidina
3. How to use Gelidina
4. Possible side effects
5. Storage of Gelidina
6. Contents of the pack and other information

1. What is Gelidina and what is it used for

The active substance of Gelidina is fluocinolone acetate. This medicine belongs to a group of medicines known as topical corticosteroids (for external use) that act by reducing inflammation, itching, as well as cell proliferation.

Gelidina is used in adults and children over 1 year of age to treat a wide variety 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 (difficult to access) and lesions in visible areas.

2. What you need to know before you use Gelidina

Do not use Gelidina

• if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
• in primary skin infections and tuberculosis, syphilis, or viral infections (such as herpes or chickenpox).
• if you have infected lesions caused by bacteria, viruses, or fungi, do not apply this gel to infected lesions.
• in areas of skin affected by red/pink inflammation on the face (rosacea), ulcers, or wounds, inflammation of the sebaceous glands (acne), or skin diseases with skin thinning (atrophy)
• in skin inflammation that occurs around the mouth (perioral dermatitis)
• in areas of skin that show a vaccination reaction, i.e., redness or inflammation after vaccination

Warnings and precautions

Consult your doctor or pharmacist before starting to use Gelidina.

• If a skin infection occurs, your doctor will prescribe the appropriate treatment for that fungal or bacterial infection. If it does not respond to that treatment, your doctor may suspend treatment until the infection is controlled.
• This gel should be used at the lowest possible dose, especially in children, and only for the strictly necessary time to relieve the skin condition.
• Prolonged use of topical corticosteroids, or in skin folds (such as the groin or armpits), as well as application under occlusive dressings (dressings that do not allow air to circulate or, for example, in the area covered by a diaper), can produce skin atrophy, mucous membranes, and subcutaneous tissue.

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

• If the medicine causes irritation, you should stop applying it and consult your doctor.
• You should avoid contact of the gel with the eyes or around the eyes, on 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 disease to observe any possible worsening.
• Inform your doctor if you experience blurred vision or other visual disturbances.

Pediatric population

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

Use in athletes

Athletes are warned that this medicine contains a component, fluocinolone, which may produce a positive result in doping tests.

Other medicines and Gelidina

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

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

Pregnancy, breastfeeding, and fertility

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

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

Do not use this medicine 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 medicine is to be used during breastfeeding. Do not apply the gel to the breasts and avoid contact between the child and the treated areas.

Driving and using machines

This medicine does not affect the ability to drive and/or use machines.

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

This medicine may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate (E-218) and propyl parahydroxybenzoate (E-216).

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

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

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

3. How to use Gelidina

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

Adults and children from 1 year:

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

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

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

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

Treatment should not exceed 2 months.

Use in children

Use in children under 1 year of age is not recommended.

Use of occlusive dressings (such as in the diaper area) is not recommended.

In children, treatment should be limited to short periods of time and the minimum effective amount of medicine should be used. If used on the face, treatment should be up to 5 days and generally up to 1 week maximum in other body areas.

If you use more Gelidina than you should

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

Accidental ingestion may cause tachycardia (acceleration of heart rate) and occasional elevations of blood pressure, which subside without the need for medical treatment.

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

If you forget to use Gelidina

Do not apply a double dose to make up for forgotten doses.

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

If you have any further questions on 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.

Rare side 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)
• Skin depigmentation (loss of skin pigmentation)
• Dermatitis and eczema, including contact dermatitis
• Burning sensation
• Rebound effect.

Very rare side effects (may affect up to 1 in 10,000 people):

• Adrenal suppression, which causes an alteration of normal hormone production.

Frequency not known (cannot be estimated from the available data):

• Hypersensitivity (allergic reactions)
• Pruritus (itching)
• Skin dryness
• Miliaria (alteration produced by the obstruction of the sweat secretion ducts, which generates the appearance of white or red grains in various parts of the body) or rash
• Skin maceration
• Hypertrichosis (excessive hair growth)
• Folliculitis (inflammation of one or more hair follicles)
• Secondary infection.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Gelidina

Store below 25°C.

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Gelidina

• The active substance is fluocinolone acetate. Each gram of gel contains 0.25 mg of fluocinolone acetate.
• The other ingredients 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 pack contents

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

It is available in 30 and 60 gram tubes of gel.

Not all pack sizes may be marketed.

Marketing authorization holder

Laboratorios ERN, S.A.

C/Perú, 228

08020 Barcelona, Spain

Manufacturer

Temmler Italia S.R.L.

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

Date of last revision of this leaflet:October 2020

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/