Betnovate 1 mg/g cream
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Betnovate 1mg/g cream
Betamethasone valerate
Read all of this 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 may 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.
Contents of the leaflet
- What Betnovate cream is and what it is used for
- What you need to know before using Betnovate cream
- How to use Betnovate cream
- Possible side effects
- How to store Betnovate cream
- Contents of the pack and other information
1. What Betnovate cream is and what it is used for
Betnovate cream contains the active substance betamethasone valerate, which is a corticosteroid (anti-inflammatory) that, when applied to the skin, reduces redness, inflammation and itching caused by certain skin conditions.
Betnovate cream is indicated for the treatment of inflammatory and pruritic (itchy) manifestations of skin disorders that respond to corticosteroids, such as:
- Atopic dermatitis and neurodermatitis (also called lichen simplex, itchy skin patches caused by scratching) (endogenous eczema, related to patient factors).
- Allergic or irritant contact dermatitis (skin rash due to allergy or substances that irritate the skin).
- Nummular dermatitis (discoid eczema) (coin-shaped rash).
- Dyshidrotic eczema (itchy rash on hands and feet).
- Psoriasis (scaly red condition, often covered with silvery scales), excluding widespread plaque psoriasis.
- Seborrheic dermatitis (rash with inflammation and scaling).
- Lichen planus (skin condition with itching, small purplish papules or elevations).
- Discoid lupus erythematosus (disease affecting the skin, usually on the face or other areas, typically presenting red patches that may leave scarring).
2. What you need to know before using Betnovate cream
Do not use Betnovate cream
- If you are allergic to betamethasone, other corticosteroids, or any of the other ingredients of this medicine (listed in section 6).
- If you have skin infections (bacterial or viral).
- If you have rosacea (a facial skin condition with red, inflamed skin).
- In acne.
- In ulcers or open wounds.
- In itching around the anus or genitals.
- Do not use this medicine in children under 1 year of age.
Warnings and precautions
Consult your doctor or pharmacist before starting to use Betnovate cream.
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If allergic contact dermatitis occurs, treatment must be discontinued and you should consult your doctor.
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If you develop a skin infection during treatment, consult your doctor about your treatment; if the infection spreads, treatment must be stopped and appropriate therapy initiated.
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Topical corticosteroids may produce any of the adverse effects reported with oral corticosteroids, for example, affecting glands located near the kidneys, leading to symptoms such as obesity, growth retardation in children, etc. (Cushing's syndrome).
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To reduce the risk of adverse effects:
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Avoid using large doses of Betnovate cream and for prolonged periods.
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Do not apply this medicine over large areas of skin.
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Do not use an occlusive dressing over the medicine, unless specifically instructed by your doctor and under medical supervision.
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If Betnovate cream must be applied to the face, treatment duration should be as short as possible—maximum one week—because it may cause skin atrophy (thinning).
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Avoid contact of the product with the eyes (see section 4).
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This medicine should not be applied to open wounds or mucous membranes (e.g., nose or mouth), or to areas with thinning skin (atrophy).
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If you are being treated for psoriasis, strict medical supervision is recommended to monitor for possible worsening of the condition.
- Contact your doctor if you experience blurred vision or other visual disturbances.
Children and adolescents
This medicine is contraindicated in children under 1 year of age and is not indicated in children under 12 years of age. In adolescents aged 12 to 13 years, the smallest possible amount of the medicine should be used.
In children, corticosteroids are more likely to be absorbed through the skin into the body, increasing the risk of adverse effects in other parts of the body compared to adult patients.
Using Betnovate cream with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Treatments over large areas of skin or for long durations with corticosteroids may lead to interactions similar to those seen with systemic treatment (when absorbed into the body), due to their absorption.
Pregnancy, breastfeeding and fertility
If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.
Betnovate cream should not be used during pregnancy unless the benefit to the mother outweighs the potential risk to the fetus.
As a general rule, Betnovate cream should not be used during the first trimester of pregnancy.
Pregnant women or those planning pregnancy should not apply Betnovate cream over large skin areas, for prolonged periods, or under occlusive dressings.
If you are breastfeeding, inform your doctor before using Betnovate cream. If you use Betnovate cream while breastfeeding, do not apply it to the breast area to avoid accidental ingestion by the infant.
Driving and using machines
Treatment with Betnovate cream does not affect the ability to drive or operate machinery.
Betnovate cream contains chlorocresol and cetyl alcohol
This medicine may cause allergic reactions because it contains chlorocresol.
This medicine may cause local skin reactions (such as contact dermatitis) because it contains cetyl alcohol.
3. How to use Betnovate cream
Follow exactly the instructions for administration of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.
The recommended dose is:
- Adults from 12 years of age:
Betnovate 1 mg/g cream is especially indicated for moist or exuding conditions.
Apply a thin layer of the cream once or twice daily to the affected area. The frequency of application may be reduced as improvement occurs, for example to once daily, before eventually discontinuing treatment.
This medicine should not be used for longer than 2 weeks continuously.
If treatment involves the face, the duration should be as short as possible, with a maximum of 1 week.
If your condition (or eczema) has frequent flare-ups and you have managed to control it, your doctor may advise an intermittent treatment (with treatment-free periods), applying once daily or twice weekly to the areas of skin affected by eczema or to areas where lesions are likely to reappear. This may help reduce the frequency of relapses.
The medicine should be applied in a thin layer, using only the amount necessary to cover the affected area, and spread gently with light massage.
Unless the hands are the area being treated, wash them after applying the cream.
If you are also using an emollient (moisturiser), do not apply it until Betnovate cream has been completely absorbed.
Do not cover the area with a dressing or any occlusive material unless specifically instructed by your doctor and under their supervision.
Use in children and adolescents
Do not apply Betnovate cream to children under 12 years of age.
If you use more Betnovate cream than you should
If excessive amounts of Betnovate cream are applied (repeated overdose), adverse effects may occur (see section 4). If a large amount of Betnovate cream is ingested, rinse your mouth thoroughly with plenty of water and contact your doctor or pharmacist for advice.
If the cream is used more frequently than recommended or over large areas of skin, it may be absorbed into the body and cause various disorders; in children, this may affect growth and development.
In cases of chronic toxicity, corticosteroids should be withdrawn gradually. Treatment of overdose is symptomatic. Acute symptoms due to excessive use of corticosteroids are generally reversible.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, go to a medical centre, or call the Toxicology Information Service. Tel.: 91 562 04 20 (indicating the medicine and the amount ingested).
If you forget to use Betnovate 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 you remember, and then continue with your treatment as usual.
If you stop using Betnovate 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 medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If a sufficient amount of the medicine is absorbed through the skin and enters the bloodstream, adverse effects affecting your skin and other parts of the body may occur.
If your skin lesions worsen or become inflamed during treatment, you may be allergic to the medicine. Stop using Betnovate cream and consult your doctor as soon as possible.
Adverse effects that have been reported:
Frequent (may affect up to 1 in 10 people):
- Itching of the skin
- Burning or local skin pain
Very rare (may affect up to 1 in 10,000 people):
- Thinning of the skin
- Stretch marks
- Dry skin
- Wrinkled skin
- Weight gain in the trunk
- Rounded face
- Accumulation of fat in the neck area
- Psychiatric symptoms
- Appearance of blood vessels under the skin surface
- Hair loss
- Increased body hair
- Changes in skin colour
- Allergic skin reaction at the application site
- Worsening of skin lesions
- Redness
- Rash or hives
- If you have psoriasis, pus-filled papules may appear on the skin (pustular psoriasis). This may very rarely occur before or during treatment.
- Skin infection, including fungal infections
- High blood pressure
In children, the following symptoms have also been observed:
Very rare:
- Delayed weight gain and growth retardation
Very rare adverse effects observed in blood tests or when the doctor orders an examination:
- Decreased level of cortisol hormone in the blood
- Increased blood sugar or sugar in urine
Adverse effects with unknown frequency:
- Clouding of the lens (cataracts)
- Increased intraocular pressure (glaucoma)
- Blurred vision
With the use of topical corticosteroids, the following adverse reactions have also been reported: acne, easy bruising, inflammation of hair follicles (folliculitis), development of blisters (miliaria), particularly if dressings or occlusive materials are used, perioral dermatitis (inflammation around the mouth), increased cholesterol, increased low-density lipoproteins, and increased triglycerides.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Betnovate cream
Do not store above 30°C.
Keep this medicine out of the sight and reach of children.
Do not use Betnovate 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 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 dispose of unused medicines and their containers. This will help protect the environment.
6. Contents of the pack and other information
Composition of Betnovate 1 mg/g cream
- The active substance is Betamethasone 17-valerate. Each g of cream contains 1 mg of betamethasone valerate (0.1%).
- The other components (excipients) are: chlorocresol, cetomacrogol 1000, cetyl alcohol and stearyl alcohol, white soft paraffin, liquid paraffin, monosodium phosphate dihydrate, phosphoric acid, sodium hydroxide, purified water.
Appearance of the product and contents of the pack
Betnovate 1 mg/g cream is a soft, white cream.
It is available in 30 g tubes.
Marketing Authorization Holder and Manufacturer
INDUSTRIAL FARMACÉUTICA CANTABRIA, S.A.
Barrio Solía 30
La Concha de Villaescusa
39690 Cantabria (Spain)
Local representative
NUTRICIÓN MÉDICA, S.L.
C/ Arequipa, 1
28043 Madrid
Date of the most recent revision of this leaflet: September 2019
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.es/