ALERGICAL 0.5 mg / 0.1 mg/g CREAM

Introduction

PROSPECTUS: INFORMATION FOR THE USER

Alergical 0.5 mg/ 0.1 mg/ g Cream

Betamethasone valerate/ Fluocinolone acetonide

Read the entire prospectus carefully before starting to use the medication.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication 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 adverse effects you are suffering from is serious or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Contents of the prospectus:

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

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

Alergical Cream is an anti-inflammatory medication (an association of two corticosteroids) used on the skin to reduce inflammation, allergic reactions, and reactions with excessive cell multiplication (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 due to causes such as allergy to a substance that has come into contact with the skin (allergic contact dermatitis), to substances of habitual use such as soap (irritant contact dermatitis), eczema with eruption and itching on hands and feet (dyshidrotic eczema), or common eczema.
• Eczema related to patient factors (endogenous eczema), such as atopic dermatitis or neurodermatitis.
• Skin eruption with inflammation and scaling (seborrheic eczema).
• Psoriasis (excluding psoriasis with widespread plaques).

2. What you need to know before starting to use Alergical Cream

Do not useAlergical Cream

• if you are allergic (hypersensitive) to betamethasone, fluocinolone, other corticosteroids, or any of the other components of Alergical Cream (see also section 6. Additional information)
• if you have tuberculosis, syphilis, or viral infections (e.g., chickenpox or herpes)
• in areas of skin affected by a red/pink inflammation on the face (rosacea), ulcers, acne, or skin diseases with skin thinning (atrophy)
• in a skin inflammation around the mouth (perioral dermatitis)
• in areas of skin showing a vaccination 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 also treated with specific treatment)

Be careful with Alergical Cream

• If your doctor diagnoses a bacterial or fungal infection, you should also use the prescribed additional treatment for the infection, as otherwise, the infection may worsen.
• Alergical 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. Treatment should be avoided in extensive areas and for long periods, 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 the growth period, it is more likely that corticosteroids will pass through the skin and have adverse effects on other areas of the body, such as interfering with growth.
• Eye contact, mouth, open wounds, or mucous membranes (e.g., genital area) should be avoided.
• 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 skin ulcers may occur.
• Alergical Cream should not be used under impermeable materials to air and water, such as bandages, dressings, or diapers, which are not very breathable.
• If you are being treated for psoriasis, medical supervision is recommended.
• If you use Alergical Cream for conditions other than those for which it has been prescribed, you may mask symptoms and make diagnosis and correct treatment difficult.
• Contact 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. To date, no interactions with Alergical Cream have been described.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

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

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

If your doctor prescribes Alergical Cream during pregnancy, you should not use it on extensive areas of your body, nor for long periods, nor use occlusive dressings.

Do not apply Alergical Cream to the breasts during breastfeeding; do not let the child come into contact with treated areas.

Driving and using machines

Treatment with Alergical Cream does not affect the ability to drive or use machines.

Important information about some components of Alergical 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.

3. How to use Alergical Cream

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

The normal dose is:

Adults and children over 12 years

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

Topical use.

The duration of treatment should not exceed 2 weeks. If you use the medication for a condition on the face, do not treat for more than one week. Always make 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 produce 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. Phone 91 562 04 20 (indicating the medication and the amount ingested).

If you forget to use Alergical Cream

Do not apply a double dose to make up for forgotten 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 treatment with Alergical Cream

Please contact your doctor before interrupting treatment without having completed the indicated period.

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

4. Possible side effects

Like all medications, Alergical Cream can produce side effects, although not all people experience them.

The use of corticosteroid drugs on the skin can produce side effects, especially after prolonged application, in extensive areas, with dressings or occlusive materials, and/or in children.

The use of corticosteroids on the skin can cause the following side effects:

? Skin thinning (atrophy)

? Dryness or cracking of the skin

? Itching or burning

• Redness (erythema)
• Appearance of red spots
• Bruises
• Inflammation of the hair follicles (folliculitis)
• Stretch marks
• Acne
• Infections
• Hair loss
• Increased hair growth
• Allergic skin reaction (contact dermatitis)
• Inflammation of the skin around the upper lip and chin (perioral dermatitis)
• Changes in skin color
• Side 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 through the skin into the body. This, for example, can increase eye pressure (glaucoma) or could produce 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.
• With an unknown frequency (cannot be estimated from available data): blurred vision.

Reporting side effects

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

5. Storage of Alergical Cream

Keep below 30°C.

Keep out of the reach and sight of children.

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

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Contents of the package and additional information

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

• The active ingredients are Betamethasone valerate and Fluocinolone acetonide.

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

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

Appearance of the product and contents of the package

Alergical 0.5 mg/ 0.1 mg/ g Cream is a white or off-white cream presented 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 prospectus was approved in March/2010.

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