SYNALAR 0.25 mg/g CREAM

1. What Synalar is and what it is used for

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 cell proliferation.

Synalar is used in adults and children over 1 year of age to treat a wide range 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 using Synalar

1.

• 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 skin lesions, do not apply this cream to infected lesions.
• in areas of skin affected by red/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 that occurs around the mouth (perioral dermatitis)
• in areas of skin that show a vaccination reaction, i.e., redness or inflammation after vaccination

Warnings and Precautions

Consult your doctor or pharmacist before starting to use Synalar.

• • If a skin infection occurs, 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.
• The 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 circulation 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 application to large areas can cause systemic effects (those that occur when the medication is absorbed and reaches the bloodstream), especially in children.
• If the medication causes irritation, you should discontinue its application and consult your doctor.
• You should avoid contact of the cream with the eyes or around the eyes, open wounds, or mucous membranes (such as the mouth or genital area).
• If you are being treated for psoriasis, your doctor should frequently monitor your disease to observe any possible worsening.
• Inform 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, which may produce a positive result in doping tests.

Other Medications and Synalar

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 large 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 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 infants 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

Follow your doctor's or pharmacist's instructions for using this medication exactly. If you are unsure, consult your doctor or pharmacist again.

Adults and children over 1 year:

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

It can also be applied as a thin layer to the affected area of the skin, 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 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 1 year of age.

Occlusive dressings (such as in the diaper area) are not recommended.

In children, treatment should be limited to short periods 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 than you should

Using excessive amounts of cream can cause adrenal suppression (which alters the normal production of hormones). In this case, treatment should be discontinued, and your doctor should monitor your adrenal function.

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

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 about using this medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience 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's surface)
• Purpura (presence of red patches 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 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 alters the normal production of hormones.

Frequency not known (cannot be estimated from 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 Side Effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Synalar

Store below 25°C.

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

Do not use this medication after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE collection point. If you are unsure, consult your pharmacist about how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

1.

• The active ingredient is fluocinolone acetonide. Each gram of cream contains 0.25 mg of fluocinolone acetonide.
• The other components 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 and Package Contents

Homogeneous white cream packaged in aluminum tubes with a polyethylene (HDPE) screw cap. It is available in 30 and 60 gram tubes of cream.

Not all package 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 Package Leaflet:May 2020

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