Allergical 0,5 mg/ 0,1 mg/ g Cream
Betamethasone valerate/ Fluocinolone acetГіnide
Read the entire package insert carefully before you start using the 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 you should not give it to other people, even if they have the same symptoms, as it may harm them.
- If you think that any of the side effects you are experiencing are serious or if you notice any side effects not mentioned in this leaflet, please tell your doctor or pharmacist.
Package Insert Contents:
What is Alergical Crema and what is it used for 2.
- Before using Alergical Crema
- How to use Alergical Cream
- Possible side effects
- Storage of Alergical Cream
- Additional information
What is alergical cream and what is it used for?
Alergical Crema is an anti-inflammatory drug (association of two corticosteroids) used on the skin to decrease inflammation, allergic reactions and reactions with excessive multiplication of skin cells (hyperproliferation). Therefore, it decreases redness (erythema), fluid accumulation (edema) and exudate in inflamed skin. It also relieves itching, burning or pain. Alergical Cream is indicated in 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 commonly used substances such as, for example, soap (irritant contact dermatitis), eczema with itchy rash on hands and feet (dyshydratic eczema) or eczema vulgaris.
- Eczema related to patient factors (endogenous eczema), such as atГіpical dermatitis or neurodermatitis.
- Skin rash with inflammation and scaling (seborrheic eczema).
- Psoriasis (excluding psoriasis with widespread plaques).
Before using allergical cream
Do not use Alergical Cream
- if you are allergic (hypersensitive) to betamethasone, fluocinolone, other corticosteroids or any of the other ingredients of Alergical Crema (see also section 6. Additional information).
- if you have tuberculosis, sГГyphilis, or virus infections (e.g. chickenpox or shingles)
- in areas of skin affected by red/pink inflammation on the face (rosacea), ulcers, acne or skin diseases with thinning of the skin (atrophy)
- in an inflammation of the skin around the mouth (perioral dermatitis)
- in areas of the skin showing a vaccination reaction, i.e. redness or inflammation after vaccination
- in the eyes, on mucous membranes (e.g. in the mouth) or in open wounds
- in children under 1 year of age.
- on skin infections caused by bacteria or fungi (unless additionally treated with a specific treatment).
Take special care with Alergical Cream
- If your doctor additionally diagnoses a bacterial or fungal infection; then you should also use the additional treatment prescribed for the infection because otherwise the infection may worsen.
- Alergical Crema should be used at the lowest possible dose, and only for the time strictly necessary to relieve the skin condition.
- Corticosteroid anti-inflammatory drugs have important effects on the body. Treatment should be avoided in large areas and for long periods of time, because this significantly increases the risk of adverse effects.
- Alergical Cream estГЎ contraindicated in children under 1 year of age and not estГЎ recommended for use in children under 12 years of age since in growing children and adolescents it is more likely that corticosteroids will pass into the body through the skin and have adverse effects in other areas of the body, such as interfering with their growth.
- Contact with eyes, 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, you should not apply corticosteroids as skin ulceration may occur.
- Alergical Cream should not be used under materials impermeable to air and water, such as bandages, dressings or diapers, which are not very breathable.
- If you are being treated for psoriasis, special medical supervision is recommended.
- If you use Alergical Cream for conditions other than those for which it has been prescribed, it may mask the symptoms and make correct diagnosis and treatment difficult.
Use of other medications
Inform your doctor or pharmacist if you are using or have recently used other drugs, including those purchased without a prescription, especially if you are being treated with other steroids. No interactions of Alergical Crema have been described so far.
Pregnancy and lactation
Consult your physician or pharmacist before using any medication. If you are pregnant or breastfeeding you should not use Alergical Crema unless your doctor considers it advisable.
As a general rule, medications 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 on large areas of your body, or for long periods of time, or use occlusive dressings.
Driving and use of machines.
Treatment with Alergical Cream does not affect the ability to drive or use machines.
Important information about some of the ingredients of Alergical Crema.
This medicine may cause skin irritation because it contains propylene glycol. It may produce allergic reactions (possibly delayed) because it contains propyl parahydroxybenzoate and methyl parahydroxybenzoate.
How to use alergical cream
Follow the directions for administration of Allergical Cream exactly as directed by your doctor.
Consult your doctor if you have any questions.
Normal dosage is:
Adults and children over 12 years of age: apply a thin layer of Alergical Crema to the affected area one to three times daily, rubbing gently. When a favorable response is achieved, the frequency can be reduced to the minimum necessary to maintain the effect.
Cutaneous use. The duration of treatment should not exceed 2 weeks. If you use the medicine for any 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 for children under 12 years of age.
If you use more Alergical Cream than you should.
No risk is to be 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 Servicio de InformaciГГіn InformaciГіn ToxicolГіgica. TelГ©fono 91 562 04 20 (indicating the medicine and the quantity 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 discontinue treatment with Alergical Cream.
Please contact your doctor before discontinuing 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.
Possible side effects
Like all medicines, Alergical Crema can produce adverse effects, although not all people suffer from them. The use of corticosteroid drugs on the skin may produce adverse effects, especially after prolonged application, on extensive areas, with bandages or occlusive materials and/or on children. The use of corticosteroids on the skin may cause the following adverse effects:
- Thinning of the skin (atrophy)
- Dryness or cracking of the skin
- Itching or burning
- Redness (erythema)
- Appearance of red spots
- Inflammation of hair follicles (folliculitis)
- Skin striae
- Hair loss
- Hair growth
- allergic skin reaction (contact dermatitis)
- Specific inflammation of the skin around the upper lip and on the 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 substance passes into the body through the skin. Г‰sto, for example, may increase the pressure in the eye (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 disorders, increased cholesterol, hyperglycemia, gastric ulcer, cataracts.
If you consider any of the side effects you experience to be serious or if you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
Storage of alergical cream
Store below 30Вє C. Keep out of the reach and sight of children.
Do not use Alergical Crema after the expiration date which is stated on the container, after EXP.
The expiration date is the last day of the month indicated.
Medicines should not be thrown down the drain or in the trash. Ask your pharmacist how to dispose of containers and unneeded medicines. This will help protect the environment.
Composition of Alergical 0.5 mg/ 0.1 mg/ g Cream:
- The active ingredients are Betamethasone valerate and Fluocinolone acetГіnide. 1 g of cream contains 0.5 mg betamethasone valerate (0.05 %) and 0.1 mg fluocinolone acetГіnide (0.01 %).
- The other ingredients are: stearic acid, sorbitan monostearate, sorbitan monostearate (polysorbate 80), polysorbate 60, propylene glycol, glycerol (E-422), petrolatum liquid, propyl parahydroxybenzoate (E-216), methyl parahydroxybenzoate (E-218), citric acid, distilled water, lavender essence.
Appearance of the product and contents of the container.
Alergical 0.5 mg/ 0.1 mg/ g Cream is a white, shiny cream, which comes in 30 g tubes.
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