Alergical 0.5 mg/0.1 mg/g cream

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Alergical 0.5 mg/0.1 mg/g Cream

Betamethasone valerate/Fluocinolone acetonide

Read the entire leaflet carefully before you start using this medicine.

• 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 and should not be given to other people, even if they have the same symptoms, as it may harm them.
• If you consider any of the side effects you experience to be serious, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

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

1. What Alergical Cream is and what it is used for

Alergical Cream is an anti-inflammatory medication (a combination of two corticosteroids) used on the skin to reduce inflammation, allergic reactions, and skin conditions involving excessive skin cell proliferation (hyperproliferation). Therefore, it reduces redness (erythema), fluid accumulation (edema), and exudate in inflamed skin. It also relieves itching, burning, or pain.

Alergical Cream is indicated for the treatment of acute forms of:

• Exogenous eczema caused by factors such as allergy to a substance that has come into contact with the skin (allergic contact dermatitis), or to commonly used substances such as soap (irritant contact dermatitis), eczema with itchy rash on hands and feet (dyshidrotic eczema), or common eczema (atopic eczema).
• Eczema related to patient-specific factors (endogenous eczema), such as atopic dermatitis or neurodermatitis.
• Skin eruptions with inflammation and scaling (seborrheic eczema).
• Psoriasis (excluding psoriasis with widespread plaques).

2. What you need to know before using Alergical Cream

Do not use Alergical Cream

• if you are allergic (hypersensitive) to betamethasone, fluocinolone, other corticosteroids, or to any of the other components of Alergical Cream (see also section 6. Additional information)
• if you have tuberculosis, syphilis, or viral infections (for example, chickenpox or herpes)
• on areas of skin affected by red/rosy facial inflammation (rosacea), ulcers, acne, or skin diseases with skin thinning (atrophy)
• in skin inflammation around the mouth (perioral dermatitis)
• in areas of skin showing a vaccine reaction, i.e., redness or inflammation after vaccination
• in the eyes, on mucous membranes (e.g., in the mouth), or on open wounds
• in children under 1 year of age
• in skin infections caused by bacteria or fungi (unless additionally treated with specific therapy)

Take special care with Alergical Cream

• If your doctor also diagnoses a bacterial or fungal infection, you must use the additional prescribed treatment for the infection, otherwise the infection may worsen.
• Alergical Cream should be used at the lowest possible dose and only for the minimum time necessary to relieve the skin condition.
• Anti-inflammatory corticosteroid medicines have significant effects on the body. Treatment over large areas and for prolonged periods should be avoided, as this significantly increases the risk of adverse effects.
• Alergical Cream is contraindicated in children under 1 year of age and is not recommended for use in children under 12 years of age, as in children and adolescents during growth, corticosteroids are more likely to be absorbed into the body through the skin and may cause adverse effects in other parts of the body, such as interfering with growth.
• Avoid contact with the eyes, mouth, open wounds, or mucous membranes (e.g., genital area).
• Alergical Cream should not be applied to skin folds, such as the groin or armpits.
• If you have severely impaired circulation, corticosteroids should not be applied, as this could lead to skin ulceration.
• Alergical Cream should not be used under air- and water-impermeable materials, such as non-breathable dressings, bandages, or diapers.
• If you are being treated for psoriasis, medical supervision is recommended.
• If you use Alergical Cream for conditions other than those for which it was prescribed, it may mask symptoms and make correct diagnosis and treatment more difficult.
• Contact your doctor if you experience blurred vision or other visual disturbances.

Using other medicines

Inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription, especially if you are receiving treatment with other steroids. No interactions with Alergical Cream have been reported to date.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

If you are pregnant or breastfeeding, do not use Alergical Cream unless your doctor considers it appropriate.

As a general rule, medicines containing corticosteroids should not be applied to the skin during the first trimester of pregnancy.

If your doctor prescribes Alergical Cream during pregnancy, you should not use it over large areas of the body, for prolonged periods, or with occlusive dressings.

Do not apply Alergical Cream to the breasts during breastfeeding; avoid contact of the child with treated areas.

Driving and using machines

Treatment with Alergical Cream does not affect the ability to drive or operate machinery.

Important information about some of the components of Alergical Cream

This medicine may cause skin irritation as it contains propylene glycol.

It may cause allergic reactions (possibly delayed) as it contains propyl parahydroxybenzoate and methyl parahydroxybenzoate.

Polysorbates may cause allergic reactions.

3. How to use Alergical Cream

Follow exactly the administration instructions for Alergical Cream provided by your doctor. Consult your doctor if you have any doubts.

The usual dose is:

Adults and children over 12 years of age

Apply a thin layer of Alergical Cream to the affected area one to three times daily, gently rubbing it in. Once a favorable response has been achieved, the frequency may be reduced to the minimum necessary to maintain the effect.

For topical use only.

The duration of treatment should not exceed 2 weeks. If you are using the medicine for a condition affecting the face, do not treat for longer than one week. Always keep the treatment as short as possible.

Use in children

Alergical Cream is contraindicated in children under 1 year of age and is not recommended in children under 12 years of age.

If you use more Alergical Cream than you should

No risk is expected after a single overdose of Alergical Cream. Repeated overdoses may cause adverse effects (see section 4).

In case of overdose or accidental ingestion, consult your doctor or pharmacist or go to a medical center, or call the Toxicology Information Service at telephone number 91 562 04 20 (indicating the medicine and the amount ingested).

If you forget to use Alergical Cream

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

If you forget to apply the cream, apply the missed dose as soon as possible. However, if it is almost time for the next dose, wait until then and continue your regular dosing schedule.

If you stop using Alergical Cream

Please contact your doctor before stopping treatment before the recommended period has ended.

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

4. Possible adverse effects

Like all medicines, Alergical Cream may cause adverse effects, although not everyone will experience them.

The use of topical corticosteroid medicines may cause adverse effects, especially after prolonged application, over large skin areas, when using dressings or occlusive materials, and/or in children.

Topical corticosteroids may cause the following adverse effects:

? Skin thinning (atrophy)
? Dryness or cracking of the skin
? Itching or burning sensation

• Redness (erythema)

• Appearance of red spots

• Bruising

• Inflammation of hair follicles (folliculitis)

• Stretch marks (striae)

• Acne

• Infections

• Hair loss

• Increased hair growth

• Allergic skin reaction (contact dermatitis)

• Specific skin inflammation around the upper lip and chin (perioral dermatitis)

• Changes in skin color

• Adverse effects may occur not only in the treated area but also in completely different parts of the body. This may happen if the active substance passes through the skin into the body. For example, this could increase eye pressure (glaucoma) or cause a condition characterized by a rounded face, fat accumulation, hump, weakness, etc. (Cushing's syndrome); increased blood pressure, fluid retention (edema), osteoporosis, thyroid disorders, increased cholesterol, hyperglycemia, gastric ulcer, cataracts.

• Frequency not known (cannot be estimated from available data): blurred vision.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaRAM.es/. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Alergical Cream

Store below 30°C.

Keep out of the reach and sight of children.

Do not use Alergical Cream after the expiry date stated on the container, 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 Point in your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the container and other information

Composition of Alergical 0,5 mg/0.1 mg/g Cream:

• The active substances are Betamethasone valerate and Fluocinolone acetonide.

Each gram of cream contains 0.5 mg of betamethasone valerate (0.05%) and 0.1 mg of fluocinolone acetonide (0.01%).

• The other components are: cetostearyl alcohol, sorbitan monostearate, polysorbate 60, propylene glycol, glycerol (E-422), liquid paraffin, propylparaben (E-216), methylparaben (E-218), citric acid, distilled water, lavender essence.

Appearance of the medicinal product and contents of the container

Alergical 0.5 mg/0.1 mg/g Cream is a white or almost white cream supplied in 30 g tubes.

Marketing Authorization Holder

Faes Farma, S.A.

Autonomia Etorbidea, 10

48940 Leioa (Bizkaia)

Spain

Manufacturer

Faes Farma Portugal, S.A.

Av. Elias Garcia nº 28, Amadora, 2700-327,

PORTUGAL

This patient information leaflet was last approved in March 2010.

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/