Package Insert: Information for the User

Synalar 0.25 mg/g Topical Foam

Fluocinolone Acetonide

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

- Keep this package insert, as you may need to refer to it again.

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

-This medication has been prescribed only for you, 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 package insert. See section 4.

1. What Synalar is and how it is used

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

3. How to use Synalar

4. Possible adverse effects

5. Storage of Synalar

6. Contents of the package and additional information

The active ingredient of Synalar 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 cellular proliferation.

Synalar 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.

No use Synalar

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

- 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 foam 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)

- Around the mouth (perioral dermatitis)

- In areas of skin showing a vaccine reaction, i.e., redness or inflammation after receiving a vaccine.

Warnings and Precautions

Consult your doctor or pharmacist before starting to use Synalar:

- 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 medication 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 the application in occlusive dressings (dressings that do not allow air circulation or, for example, in the area covered by a diaper), may cause skin, mucous membrane, and subcutaneous tissue atrophy.

- 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 foam 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 regularly monitor your condition to observe any possible worsening.

- Inform your doctor if you experience blurred vision or other visual disturbances. This preparation is not indicated for ophthalmic use.

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.

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.

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 Synalar

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 medication.

Pregnancy, Lactation, and Fertility

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

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

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 foam 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.

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

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

This medication may cause local skin reactions (such as contact dermatitis) because it contains cetearyl alcohol.

This medication contains 30 mg of propylene glycol (E-1520) per gram of foam. Propylene glycol may cause skin irritation.

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

Shake before each use

Keep the container in a vertical position during application, press the nozzle at a distance greater than

one centimeter to dispense the foam over the affected area and extend with your fingers until its total absorption.

Wash your hands thoroughly after applying the medication (unless you are using the foam to treat your

hands).

Adults and children over 1 year:

It can be applied in open treatment, as a thin layer on the affected skin area, two to three times a day gently rubbing until its total absorption.

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; usually one week.

Depending on the severity of the condition, treatment may be prolonged from 1 to 4 weeks. If in this

period of time there is no improvement, 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 in general, one week at most in other body areas.

If you use more Synalar than you should

The use of excessive amounts of foam may cause adrenal suppression (which causes an alteration of the

normal production of hormones). In this case, treatment should be interrupted and the doctor should monitor your adrenal hormonal axis function.

An accidental ingestion may cause tachycardia (acceleration of 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 immediately, or call the Toxicology Information Service, phone 91-562 04 20 indicating the medication and the amount used.

If you forgot to use Synalar foam

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

If you forget to apply the foam 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 epidermal thinning (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 a possible adverse effect not listed 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.

Danger: Extremely flammable aerosol. Pressurized container: May rupture if heated. Keep away from heat sources, sparks, open flames, or hot surfaces and other ignition sources. – Do not smoke. Do not spray onto an open flame or other ignition source. Do not pierce or burn, even after use. Protect from sunlight, and store the container in its box. Do not expose to temperatures above 50°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 container after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Deposit the containers and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Synalar

-The active ingredient is acetonide of fluocinolone. Each gram of foam contains 0.25 mg of acetonide of fluocinolone.

-The other components are: anhydrous citric acid (E330), propylene glycol (E1520), decyl oleate, cetostearyl alcohol and cetostearyl sodium sulfate, β-phenylethyl alcohol, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), purified water, tetrafluoroethane, and dimethyl ether.

Appearance of Synalar and content of the packaging

White pressure emulsion in an aluminum aerosol container. It is presented in containers of 15 and 60 grams of foam.

Only some sizes of containers may be commercially available.

Marketing authorization holder

Tora Laboratories, S.L.U.

Avenida de Oporto, 60

28019 Madrid, Spain

Responsible for manufacturing

Temmler Italia S.R.L.

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

Last review date of this leaflet: February 2021

The detailed and updated information on this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)

http://www.aemps.gob.es/