Package Leaflet: Information for the User

Synalar gamma 0.1 mg/g cream

Fluocinolone, acetate

Read this 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. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.

- If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before you start using Synalar gamma

3. How to use Synalar gamma

4. Possible side effects

5. Storage of Synalar gamma

6. Contents of the pack and additional information

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

Synalar gamma is used in adults and children over 1 year old to treat a wide variety of inflammatory, pruritic, and allergic skin lesions, such as: eczema, dermatitis, psoriasis, lichen planus, and discoid lupus erythematosus.

Do not use Synalar gamma

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

- in primary skin infections and tuberculosis, syphilis or viral infections (for example, herpes or varicella).

- if you have skin lesions infected with 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 inflammation of the skin around the mouth (perioral dermatitis)

- in areas of skin showing a vaccination reaction, that is, redness or inflammation after administration of a vaccine

Warnings and precautions

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

-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 under control.

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

-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, 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 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 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 gamma

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 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, this cream should not be applied during the first trimester of pregnancy.

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 is greater than the possible risk.

Similarly, caution should be exercised if this medication needs to be used during breastfeeding. Do not apply the cream 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 gamma contains phenoxyethanol (E-216), phenoxyisopropanol (E-218), cetyl alcohol, stearyl alcohol and propylene glycol (E-1520).

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

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 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 completely 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; 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 must 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, not more than one week in other body areas.

If you use more Synalar gamma 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 Toxicology Information Service, phone 91-562 04 20, indicating the medication and the amount used.

If you forgot to use Synalar gamma

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

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 all people 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)

- Skin depigmentation (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 on the safety of this medication.

Conserve 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 thrown down the drains or in the trash. Dispose of the packaging and themedications that you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask yourpharmacist how to dispose of the packaging and the medications that you no longer need. By doing so, you will help protect the environment.

Composition of Synalar gamma

-The active ingredient is acetonide of fluocinolone. Each gram of cream contains 0.1 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 gamma and content of the packaging

Homogeneous cream of white color packaged in aluminum tubes and HDPE screw cap. It is presented in tubes of 30 and 60 grams of cream.

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization

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/