SYNALAR FORTE 2mg/g CREAM

Introduction

Package Leaflet: Information for the User

Synalar Forte 2 mg/g Cream

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 pack:

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

1. What Synalar Forte is and what it is used for

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

Synalar Forte is used in adults and children over 2 years 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 Forte

Do not use Synalar Forte

• 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 infected skin lesions, do not apply this cream 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 the skin that show a vaccination reaction, i.e., redness or inflammation after the administration of a vaccine.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Synalar Forte.

• 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 cream 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.
• Prolonged use, excessive amounts of medication, or in extensive areas can cause the appearance of systemic effects (those that occur when the medication is absorbed and reaches the blood),

especially in children.

• If the medication causes irritation, you should stop applying it and consult your doctor.
• You should avoid contact of the cream 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 in order

to observe any possible worsening.

• Tell 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 medication.

Use in athletes

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

Other medications and Synalar Forte

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

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

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 medication.

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

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

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

Driving and using machines

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

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

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

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

This medication contains 150 mg of propylene glycol (E-1520) per gram of cream.

Propylene glycol may cause skin irritation.

Do not use this medication 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 Synalar Forte

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

Adults and children from 2 years:

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 should not be used for occlusive dressings, for example, bandages.

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 is not recommended in children under 2 years of age.

It should not be used for occlusive dressings, for example, 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 be up to 5 days and generally up to one week maximum in other body areas.

If you use more Synalar Forte than you should

Using excessive amounts of cream 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 hypothalamic-pituitary-adrenal axis.

Accidental ingestion may cause tachycardia (accelerated 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 forget to use Synalar Forte

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

If you forget to apply the cream 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 medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medication 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)
• 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 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, even if it is possible side effects not listed in this leaflet. You can also report them 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 medication.

5. Storing Synalar Forte

Keep below 25°C.

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

Do not use this medication 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 medication in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Contents of the pack and other information

Synalar Forte composition

• The active substance is fluocinolone acetonide. Each gram of cream contains 2 mg of fluocinolone acetonide.
• The other ingredients are: cetyl alcohol, stearyl alcohol, sorbitan stearate, polysorbate 60 (E-435), liquid paraffin, methylparaben (E-218), propylparaben (E-216), propylene glycol (E-1520), anhydrous citric acid (E-330), and purified water.

Appearance of Synalar Forte and pack contents

Homogeneous white cream packaged in aluminum tubes with a polyethylene (HDPE) screw cap. It is available in 15 and 30 gram tubes of cream.

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 the last revision of this leaflet:October 2020

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