PATIENT INFORMATION LEAFLET

Alergical 0.5 mg/ 0.1 mg/ g Cream

Betametasona valerato/ Fluocinolona acetónido

Read this leaflet carefully before you start using the medicine.

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

Alergical Cream is an anti-inflammatory medication (association of two corticosteroids) used on the skin to reduce inflammation, allergic reactions, and excessive multiplication of skin cells (hyperproliferation). Therefore, it reduces redness (erythema), fluid accumulation (edema), and exudate on the 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), substances commonly used such as soap (irritant contact dermatitis), eczema with itchy eruption on hands and feet (dyshidrotic eczema) or common eczema.
• Eczema related to patient factors (endogenous eczema), such as atopic dermatitis or neurodermatitis.
• Eruption on the skin with inflammation and peeling (seborrheic eczema).
• Psoriasis (excluding extensive plaque psoriasis).

No useAllergic Cream

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

Be especially careful with Allergic Cream

• If your doctor diagnoses an additional bacterial or fungal infection; then you must also use the additional treatment prescribed for the infection because, if not, the infection may worsen.
• Allergic Cream should be used at the lowest possible dose, and only for the strictly necessary time to relieve the skin condition.
• Corticosteroid anti-inflammatory drugs have significant effects on the body. Avoid treatment in extensive areas and for long periods of time, as this significantly increases the risk of adverse effects.
• Allergic Cream is contraindicated in children under 1 year and is not recommended for use in children under 12 years as corticosteroids are more likely to pass through the skin and have adverse effects in other parts of the body, such as interfering with growth.
• Avoid contact with the eyes, mouth, open wounds, or mucous membranes (for example, the genital area)
• Do not apply Allergic Cream to skin folds, such as the groin or armpits
• If you have very poor circulation, do not apply corticosteroids as it could cause skin ulceration
• Do not use Allergic Cream under impermeable materials such as bandages, dressings, or diapers.
• If you are being treated for psoriasis, it is recommended to have special medical supervision.
• If you use Allergic Cream for diseases other than those for which it has been prescribed, you may mask symptoms and make it difficult to diagnose and treat correctly.
• Consult your doctor if you experience blurred vision or other visual disturbances.

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription, especially if you are receiving treatment with other steroids. No interactions with Allergic Cream have been described to date.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

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

As a general rule, during the first trimester of pregnancy, corticosteroid-containing medications should not be applied to the skin.

If your doctor prescribes Allergic Cream during pregnancy, do not use it on extensive areas of your body, or for long periods of time, or use occlusive dressings.

Do not apply Allergic Cream to the breasts during breastfeeding; do not put the baby in contact with treated areas.

Driving and operating machinery

The treatment with Allergic Cream does not affect the ability to drive or operate machinery.

Important information about some of the components of Allergic Cream

This medication may cause skin irritation because it contains propylene glycol.

It may cause allergic reactions (possibly delayed) because it contains propylparaben and methylparaben.

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

The normal dose is:

Adults and children over 12 years old

Apply a thin layer of Alergical Cream to the affected area, one to three times a day, gently rubbing it in. When a favorable response is achieved, the frequency can be reduced to the minimum necessary to maintain the effect.

Skin use.

The treatment duration should not exceed 2 weeks. If you use the medication for any condition on the face, do not treat for more than one week. Always make the treatment as short as possible.

Use inchildren

Alergical Cream is contraindicated in children under 1 year and is not recommended for children under 12 years old.

If you use more Alergical Cream than you should

No adverse effects are 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 Toxicological Information Service. Phone 91 562 04 20 (indicating the medication and the amount ingested).

If you forgot to use Alergical Cream

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

If you forget to apply the cream, apply the corresponding dose as soon as possible or, if the next application is near, wait until then.

If you interrupt the treatment with Alergical Cream

Please contact your doctor before interrupting the treatment without completing it until the indicated period.

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

Like all medications, Alergical Cream may produce adverse effects, although not all people may experience them.

The use of corticosteroid medications on the skin may produce adverse effects, especially after prolonged application, in extensive areas, with bandages or occlusive materials, and/or in children.

The use of corticosteroids on the skin may cause the following adverse effects:

?Skin thinning (atrophy)

?Dryness or cracking of the skin

?Itching or burning

• Redness (erythema)
• Appearance of red spots
• Bruises
• Inflammation of hair follicles (folliculitis)
• Striae (stretch marks)
• Acne
• Infections
• Hair loss
• Excessive hair growth
• Contact dermatitis (skin allergy)
• Inflammation of the skin 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 areas of the body. This occurs if the active ingredient passes into the body through the skin.This, for example, may increase eye pressure (glaucoma) or could produce a condition characterized by a rounded face, accumulation of fat, hump, weakness, etc.(Cushing's syndrome); increased blood pressure, fluid retention (edema), osteoporosis, thyroid dysfunction, increased cholesterol, hyperglycemia, gastric ulcers, cataracts.
• With an unknown frequency (cannot be estimated from available data): blurred vision.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaRAM.es/. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Store below 30°C.

Keep out of the reach and sight of children.

Do not use Allergic Cream after the expiration date shown on the packaging, after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of empty containers and unused medicines at theSIGREpoint of the pharmacy. If in doubt, ask your pharmacist how to dispose of empty containers and unused medicines.This will help protect the environment.

Composition of Alergical 0.5 mg/ 0.1 mg/ g Cream:

• The active principles are Betametasona valerato and Fluocinolona acetónido.

1 g of cream contains 0.5 mg of betametasona valerato (0.05 %) and 0.1 mg of fluocinolona acetónido (0.01 %).

• The other components are: stearic acid, sorbitan monoestearate, sorbitan monooleate (polisorbate 80), polisorbate 60, propylene glycol, glycerol (E-422), liquid petrolatum, propylparaben (E-216), methylparaben (E-218), citric acid, distilled water, lavender essence.

Appearance of the product and content of the packaging

Alergical 0.5 mg/ 0.1 mg/ g Cream is a white or off-white cream that is presented in tubes of 30 g.

Holder of the marketing authorization

Faes Farma, S.A.

Autonomia Etorbidea, 10

48940 Leioa (Bizkaia)

Spain

Responsible for manufacturing

Faes Farma Portugal, S.A.

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

PORTUGAL

This leaflet was approved in March/2010.

The detailed and updated information of this medication is available on the webpage of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/