Synalar 0.25 mg/g cutaneous foam

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Synalar 0,25 mg/g cutaneous foam

Fluocinolone acetonide

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Synalar is and what it is used for

The active substance of Synalar is fluocinolone acetonide. This medicine belongs to a group of drugs known as topical corticosteroids (for external use) which work by reducing inflammation, itching, and cellular 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 starting to use Synalar

Do not use Synalar

• If you are allergic to the active substance or to any of the other components of this medicine (listed in section 6).
• In primary skin infections and in tuberculosis, syphilis, or viral infections (e.g., herpes or varicella).
• If you have lesions infected by bacteria, viruses, or fungi. Do not apply this foam to infected lesions.
• On areas of skin affected by facial red/pink inflammation (rosacea), ulcers or wounds, inflammation of sebaceous glands (acne), or skin disorders associated with skin thinning (atrophy).
• In skin inflammation occurring around the mouth (perioral dermatitis).
• On areas of skin showing a vaccine reaction, i.e., redness or inflammation following vaccine administration.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Synalar:

• If a skin infection develops, your doctor will prescribe appropriate treatment for the fungal or bacterial infection. If the infection does not respond to treatment, your doctor may discontinue Synalar until the infection is under control.
• This medicine should be used at the lowest possible dose, especially in children, and only for the minimum time necessary to relieve the skin condition.
• Prolonged use of topical corticosteroids, particularly in skin folds (such as the groin or armpits), and application under occlusive dressings (dressings that do not allow air circulation, or, for example, areas covered by a diaper) may lead to atrophy of the skin, mucous membranes, and subcutaneous tissue.
• Prolonged use, excessive amounts of the medicine, or application over large areas may result in systemic effects (effects occurring when the medicine is absorbed into the bloodstream), especially in children.
• If the medicine causes irritation, you should stop using it and consult your doctor.
• 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 monitor your condition regularly to detect any possible worsening.
• Inform your doctor if you experience blurred vision or other visual disturbances. This preparation is not intended for ophthalmic use.

Paediatric population

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

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

Use in athletes

Athletes are advised that this medicine contains a component, fluocinolone acetonide, which may cause a positive result in doping control tests.

Other medicines and Synalar

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

You should not apply other topical preparations to the treated area while using this medicine.

Pregnancy, breastfeeding, and fertility

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

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

Do not use this medicine for prolonged periods, over large areas, or under occlusive dressings if you are pregnant. Its use should be reserved for cases where the therapeutic benefit outweighs the potential risk.

Similarly, caution is advised if this medicine must be used during breastfeeding. Do not apply the foam to the breasts and avoid contact between the treated areas and the infant.

Driving and use of machines

This medicine has no effect on the ability to drive and/or operate machinery.

Synalar contains methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), cetostearyl 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 may cause local skin reactions (such as contact dermatitis) because it contains cetostearyl 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 for this medicine as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Shake before each use.

Keep the container in an upright position during application. Press the nozzle to dispense the foam onto the affected area from a distance of more than one centimeter, and spread it with your fingers until completely absorbed.

Wash your hands thoroughly after applying the medicine (unless you are treating your hands with the foam).

Adults and children aged 1 year and older:

It may be applied under open treatment, as a thin layer on the affected skin area, two to three times daily, gently rubbing until completely absorbed.

It may also be applied under occlusive treatment, as a thin layer on the affected skin area, once daily, covering the area with a non-porous plastic dressing.

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

Depending on the severity of the condition, treatment may be extended from 1 to 4 weeks. If there is no improvement within this time period, your doctor should re-evaluate the treatment. Treatment should not exceed 2 months.

Use in children

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

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

In children, treatment should be limited to short periods, and the smallest effective amount of medicine should be used. If applied to the face, treatment should not exceed 5 days, and generally one week at most in other body areas.

If you use more Synalar than you should

Excessive use of the foam may cause adrenal suppression (leading to disruption of normal hormone production). In such cases, treatment should be discontinued and your doctor should monitor your hypothalamic-pituitary-adrenal (HPA) axis function.

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

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

If you forget to use Synalar foam

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

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Rare adverse effects (may affect up to 1 in 1,000 people):

• Cutaneous atrophy with thinning of the epidermis (often irreversible)
• Telangiectasia (dilation of small blood vessels on the skin surface)
• Purpura (appearance of red patches and spots on the skin)
• Skin striae (stretch marks)
• Acneiform eruptions (acne-like rashes)
• 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 adverse effects (may affect up to 1 in 10,000 people):

• Adrenal suppression, leading to disruption of normal hormone production

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

• Hypersensitivity (allergic reactions)
• Pruritus (itching)
• Dry skin
• Miliaria (a condition caused by blockage of the ducts through which sweat is secreted, resulting in the appearance of white or red bumps 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 adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines:

www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Synalar

Warning: Extremely flammable aerosol. Pressurized container: May burst if heated. Keep away from heat sources, sparks, open flame or hot surfaces, and other sources of ignition. – Do not smoke. Do not spray on 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 medicine out of the sight and reach of children.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Synalar

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

Appearance of Synalar and contents of the container

White emulsion under pressure in an aluminum spray container. Available in containers containing 15 and 60 grams of foam.

Only certain container 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 the most recent revision of this leaflet: February 2021

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/