SYNALAR 0.25 mg/g CUTANEOUS FOAM

Introduction

Package Leaflet: Information for the User

Synalar 0.25 mg/g Cutaneous Foam

Fluocinolone, Acetonide

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 Package Leaflet:

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

1. What is Synalar and what is it used for

The active substance of Synalar is fluocinolone acetonide. 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.

Synalar 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.

2. What you need to know before you use Synalar

Do not use Synalar

• If you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
• Primary skin infections and tuberculosis, syphilis, or viral infections (such as herpes or chickenpox).
• If you have bacterial, viral, or fungal infected lesions. Do not apply this foam to infected lesions.
• In areas of skin affected by a red/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 showing a vaccination reaction, i.e., redness or inflammation after administration of 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 it does not respond to that treatment, your doctor may suspend treatment until the infection is controlled.
• This medicine 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, of excessive amounts of medicine or in extensive areas can 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 foam 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 check your disease 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

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.

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.

Use in athletes

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

Other medicines and Synalar

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

You should not apply other skin preparations to the treated area along with this medicine.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

As a general rule, during the first trimester of pregnancy, this foam 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 foam 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.

Synalar contains methylparaben (E-218), propylparaben (E-216), cetearyl alcohol, and propylene glycol (E-1520).

This medicine may cause allergic reactions (possibly delayed) because it contains methylparaben (E-218) and propylparaben (E-216).

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

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

3. How to use Synalar foam

Follow exactly the administration instructions of this medicine 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 of more than one centimeter to dose the foam onto the affected area and spread with your fingers until fully absorbed.

Wash your hands well after spreading the medicine (unless you are using the foam to treat your hands).

Adults and children from 1 year:

It can be applied in open treatment, as a thin layer on the affected skin area, two to three times a day, rubbing gently 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, the treatment may be extended from 1 to 4 weeks. If it does not improve within this period, your doctor should reevaluate the treatment. The treatment should not exceed 2 months.

Use in children

It is not recommended to use in children under 1 year of age.

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

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

If you use more Synalar than you should

The use of excessive amounts of foam 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 Synalar foam

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

If you forget to apply the foam 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 epidermal thinning (often irreversible)
• Telangiectasia (dilation of small blood vessels on the skin surface)
• Purpura (presence of red patches and spots on the skin)
• Skin striae
• 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 ducts through which sweat is secreted, which generates the appearance of white or red grains in various parts of the body) or rash

Maceration of the skin

• 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 Synalar

Danger: extremely flammable aerosol. Pressurized container: May burst if heated. Keep away from heat sources, sparks, open flames, or hot surfaces, and other ignition sources. – No smoking. Do not spray onto an open flame or other ignition source. Do not pierce or burn, even after use. Protect from sunlight and keep the container in its box. Do not expose to temperatures above 50°C.

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

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Synalar

• The active substance is fluocinolone acetonide. Each gram of foam contains 0.25 mg of fluocinolone acetonide.
• The other ingredients are: anhydrous citric acid (E330), propylene glycol (E1520), decyl oleate, cetearyl alcohol, and sodium cetearyl sulfate, beta-phenylethyl alcohol, methylparaben (E218), propylparaben (E216), purified water, tetrafluoroethane, and dimethyl ether.

Appearance of Synalar and contents of the pack

White to off-white pressurized emulsion in an aluminum spray container. It is available in 15 and 60 gram foam containers.

Not all pack sizes may be marketed.

Marketing authorization holder

Tora Laboratories, S.L.U.

Avenida de Oporto, 60

28019 Madrid, Spain

Manufacturer

Temmler Italia S.R.L.

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

Date of last revision of this leaflet:February 2021

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/