Package Insert: Information for the User

Synalar 0.25 mg/g Cream

Fluocinolone, Acetonide

Read this entire package insert carefully before you start using this medicine because it contains important information for you.

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

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

1.No use Synalar

• 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 (such as herpes or chickenpox).
• If you have infected wounds caused by bacteria, viruses, or fungi, do not apply this cream to infected wounds.
• 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 skin inflammation around the mouth (perioral dermatitis)
• In areas of skin showing a vaccination reaction, i.e., redness or inflammation after receiving 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 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 strictly necessary time 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, 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 changes.

Pediatric population

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

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, breastfeeding, and fertility

If you are pregnant or breastfeeding, 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 is advised 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 contains phenoxyethanol (E-216), phenoxyethanol (E-218), cetyl alcohol, stearyl alcohol, and propylene glycol (E-1520).

This medication may cause allergic reactions (possibly delayed) because it contains phenoxyethanol (E-218) and phenoxyethanol (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) in each 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 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, treatment may be prolonged from 1 to 4 weeks. If there is no improvement in this period of time, 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 be for up to 5 days and generally no more than a week in other body areas.

If you use more Synalar 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

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

If you forget to apply the cream at the scheduled time, do 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 may experience them.

Rare Adverse Effects (may affect up to 1 in 1,000 people):

Very Rare Adverse Effects (may affect up to 1 in 10,000 people):

Unknown Frequency (cannot be estimated from available data):

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.By reporting adverse effects, you can contribute to providing more information on 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 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 packaging and medications you no longer need. By doing so, you will help protect the environment.

1.Composition of Synalar

• The active ingredient is acetonide of fluocinolone. Each gram of cream contains 0.25 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 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:May 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/