Synalar 0.25 mg/g cream

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Synalar 0.25 mg/g cream

Fluocinolone acetonide

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

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

Leaflet contents:

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

1. What Synalar is and what it is used for

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

Synalar is used in adults and children over 1 year 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 using Synalar

1. Do not use Synalar

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
• in primary skin infections and tuberculosis, syphilis, or viral infections (e.g., herpes or varicella).
• if you have lesions infected by bacteria, viruses, or fungi, do not apply this cream to infected areas.
• on areas of skin affected by facial red/rosy inflammation (rosacea), ulcers or wounds, sebaceous gland inflammation (acne), or skin disorders with thinning of the skin (atrophy).
• in skin inflammation occurring around the mouth (perioral dermatitis).
• on areas of skin showing 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.

• • If a skin infection develops, your doctor will prescribe appropriate treatment for the fungal or bacterial infection. If the infection does not respond to treatment, your doctor may discontinue the treatment until the infection is under control.
  • This cream should be used at the lowest possible dose, especially in children, and only for the minimum time necessary to relieve the skin condition.
• Prolonged use of topical corticosteroids, or use 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, areas covered by a diaper), may cause atrophy of the skin, mucous membranes, and subcutaneous tissue.
• Prolonged use, excessive amounts of medication, or application over large areas may lead to systemic effects (those occurring when the medicine is absorbed into the bloodstream), especially in children.
• If the medicine causes irritation, you should stop using it and consult your doctor.
• 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 monitor your condition frequently to detect any possible worsening.
• Inform your doctor if you experience blurred vision or other visual disturbances.

Paediatric population

Chronic administration in children may interfere with growth and development; therefore, treatment should be limited to short periods and to the minimum effective amount of the medicine.

Use in athletes

Athletes are advised that this medicine contains a component, fluocinolone, which may result in a positive outcome in doping control tests.

Other medicines and Synalar

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

You should 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 are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

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

Do not use this medicine for prolonged periods, over large areas, or under occlusive dressings if you are pregnant. Its use should be reserved for cases where the therapeutic benefit outweighs the potential risk.

Similarly, caution is advised if this medicine must be used during breastfeeding. Do not apply the cream to the breasts and avoid contact of the infant with treated areas.

Driving and use of machines

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

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

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

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

This medicine contains 150 mg of propylene glycol (E-1520) in each gram of cream.

Propylene glycol may cause skin irritation.

Do not use this medicine in infants under 4 weeks of age with open wounds or large areas of damaged skin (such as burns) without first consulting your doctor or pharmacist.

3. How to use Synalar

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Adults and children aged 1 year and older:

It may be applied under open treatment, as a thin layer on the affected area of skin, two to three times daily, gently rubbing until fully absorbed.

It may also be applied under occlusive treatment, as a thin layer on the affected area of skin, once daily, covering the area 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 for 1 to 4 weeks. If there is no improvement during this time, your doctor should re-evaluate 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 smallest effective amount of the medicine should be used. If used on the face, treatment should last up to 5 days, and generally no more than one week on other body areas.

If you use more Synalar than you should

Excessive use of the cream may cause adrenal suppression (leading to disruption of normal hormone production). In such a case, treatment must be discontinued and your doctor should monitor your adrenal hormonal axis function.

Accidental ingestion may cause episodes of tachycardia (increased heart rate) and occasional elevations in blood pressure, which resolve without requiring medical treatment.

If you have used more of this medicine than you should, contact your doctor, pharmacist, or call the Toxicology Information Service, telephone 91-562 04 20, indicating the medicine and the amount used.

If you forget to use Synalar

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

If you forget to apply the cream at the scheduled time, apply it as soon as you remember, then continue as before.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Rare adverse effects (may affect up to 1 in 1,000 people):

• Cutaneous atrophy with thinning of the epidermis (often irreversible)
• Telangiectasia (dilation of small blood vessels on the skin surface)
• Purpura (appearance of red patches and spots on the skin)
• Skin striae (stretch marks)
• Acneiform eruptions (acne-like rashes)
• Perioral dermatitis (small red papules around the mouth)
• Skin depigmentation (loss of skin color)
• 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, leading to disruption of normal hormone production.

Frequency not known (cannot be estimated from available data):

• Hypersensitivity (allergic reactions)
• Pruritus (itching)
• Dry skin
• Miliaria (a condition caused by blockage of sweat ducts, resulting in the appearance of white or red bumps 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 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Synalar

Store below 25°C.

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

1. Composition of Synalar

• The active substance is fluocinolone acetonide. Each gram of cream contains 0.25 mg of fluocinolone acetonide.
• The other components are: cetyl alcohol, stearic alcohol, sorbitan stearate,

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

Appearance of Synalar and pack contents

Homogeneous white cream packed in aluminum tubes with a polyethylene screw cap (HDPE). Available in tubes containing 30 and 60 grams of cream.

Only certain pack sizes may be commercially available.

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 latest revision of this leaflet: May 2020

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/