Package Insert: Information for the User

Synalar forte 2 mg/g Cream

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 to you alone, 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 forte is and what it is used for

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

3. How to use Synalar forte

4. Possible adverse effects

5. Storage of Synalar forte

6. Contents of the pack and additional information

The active ingredient of Synalar forte 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 forte is used in adults and children over 2 years 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 forte

- 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 skin lesions caused by bacteria, viruses, or fungi, do not apply this cream to infected lesions.

-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)

- in a skin inflammation that occurs around the mouth (perioral dermatitis)

-in areas of skin that show a vaccine reaction, i.e., redness or inflammation after 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 infection by fungi or bacteria. If you do not respond to that treatment, your doctor may suspend treatment until the infection is under control.

-This cream should be used at the lowest possible dose, especially in children, and only for the time strictly necessary to relieve skin symptoms.

-The prolonged use of topical corticosteroids, or in skin folds (such as the groin or armpits), as well as application in occlusive dressings (dressings that do not allow air circulation or, for example, in the area covered by a diaper), may cause skin atrophy, mucous membranes, and subcutaneous tissue.

-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, you should suspend its application and consult your doctor.

-You should avoid contact of the cream 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 frequently monitor your condition to observe any possible worsening.

- Inform your doctor if you experience blurred vision or other visual disturbances.

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 the medication.

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 forte

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

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

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, or intend 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 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 should be exercised if this medication needs to be used during lactation. Do not apply the cream to the breasts and avoid contact of the treated areas with the baby.

Driving and operating machinery

This medication does not affect the ability to drive and/or operate machinery.

Synalar forte contains parahydroxybenzoic acid methyl ester (E-218), parahydroxybenzoic acid propyl ester (E-

216), cetyl alcohol, stearyl alcohol, and propylene glycol (E-1520).

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

This medication may cause local skin reactions (such as contact dermatitis) because it contains cetyl alcohol and stearyl 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 infants under 4 weeks with open wounds or large areas of damaged skin (such as burns) without consulting your doctor or pharmacist first.

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

Adults and children 2 years and older:

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

Do not use for occlusive dressings, for example, bandages.

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 there is no improvement within this time period, your doctor should reevaluate the treatment.

Treatment should not exceed 2 months.

Use in children

It is not recommended for use in children under 2 years.

Do not use for occlusive dressings, for example, 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 for up to 5 days and generally no more than one week in other body areas.

If you use more Synalar forte than you should

The use of excessive amounts of cream can cause adrenal suppression (which results in an alteration of normal hormone production). In this case, treatment should be interrupted and your 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, or call the Poison Information Service, phone 91-562 04 20, indicating the medication and the amount used.

If you forgot to use Synalar forte

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

If you forget to apply the cream at the scheduled time, apply 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 everyone will 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.

Store below 25°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 packaging 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. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Synalar forte

-The active ingredient is acetonide of fluocinolone. Each gram of cream contains 2 mg of acetonide of fluocinolone.

- The other components are: cetyl alcohol, stearyl alcohol, sorbitan stearate,

polysorbate 60 (E-435), liquid paraffin, methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), propylene glycol (E-1520), anhydrous citric acid (E-330) and purified water.

Appearance of Synalar forte and content of the packaging

Homogeneous cream of white color packaged in aluminum tubes and HDPE screw cap. It is presented in tubes of 15 and 30 grams of cream.

Only some sizes of packaging 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

Date of the last review of this leaflet:October /2020

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

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