BETNOVATE 1 mg/g CREAM

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 because it contains important information for you.

• Keep this leaflet, you may need to read it again. If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

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

1. What is Betnovate cream and what is it 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 problems.

Betnovate cream is indicated for the treatment of inflammatory and pruritic (itchy) manifestations of skin conditions that respond to corticosteroids, such as:

• Atopic dermatitis and neurodermatitis (also called simple lichen, itchy plaques on the skin caused by scratching) (endogenous eczemas, related to patient factors).
• Allergic or irritative 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 skin condition often covered with silver scales). excluding psoriasis with widespread plaques.
• Seborrheic dermatitis (rash with inflammation and scaling).
• Lichen planus (skin condition with itching, with small purple bumps or elevations).
• Discoid lupus erythematosus (disease that affects the skin and usually affects the face or other areas and usually presents with red plaques that can leave scars).

2. What you need to know before you start 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 (skin condition on the face with red/pink inflammation).
• In acne.
• In open ulcers or 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.

• If contact allergic dermatitis occurs, treatment should be discontinued and the doctor consulted.
• If an infection develops during treatment, consult your doctor about your treatment and if the infection spreads, discontinue treatment and initiate appropriate therapy.
• With the use of topical corticosteroids, any of the adverse effects reported with the use of oral corticosteroids may occur, such as changes in the glands located next to the kidneys, which can cause symptoms such as obesity, growth retardation in children, etc. (Cushing's syndrome).

• To minimize the risk of side effects:

• Avoid using large amounts of Betnovate cream and for long periods of time.
• Do not apply this medicine to large areas of skin.
• Do not use an occlusive dressing over the medicine, unless your doctor has indicated it and under their supervision.
• If you need to apply Betnovate cream to the face, the duration of treatment should be as short as possible, up to 1 week, as it can cause skin atrophy (thinning).
• Avoid getting the product in your eyes (see section 4).
• This medicine should not be applied to open wounds or mucous membranes (e.g., the nose or mouth), or to areas with skin thinning (atrophy).

• If you are treating psoriasis, strict medical supervision of your disease is recommended to observe possible worsening.
  • 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 between 12 and 13 years of age, the minimum amount of medicine should be used.

In children, it is more likely that the corticosteroid will pass through the skin and have adverse effects in other areas of the body than in adult patients.

Using Betnovate cream with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Treatments on extensive areas of skin or for long periods with corticosteroids may lead to interactions similar to those that occur with systemic treatment (passing into the body directly), due to their absorption.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

Betnovate cream should not be used during pregnancy unless the benefit to the mother justifies the potential risk to the fetus.

As a general rule, during the first trimester of pregnancy, Betnovate cream should not be applied.

Pregnant women or those planning to become pregnant should not apply Betnovate cream to large areas of skin, or for prolonged periods, or use occlusive dressings.

If you are breastfeeding, tell your doctor before using Betnovate cream. If you use Betnovate cream during breastfeeding, do not apply it to the breast area; this will ensure that the baby does not accidentally ingest it.

Driving and using machines

Treatment with Betnovate cream does not affect the ability to drive or use machines.

Betnovate cream contains chlorocresol and cetearyl 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 cetearyl alcohol.

3. How to use Betnovate cream

Follow the instructions for administration of this medicine exactly as indicated by your doctor. If you are unsure, consult your doctor or pharmacist again.

The recommended dose is:

• Adults from 12 years:

Betnovate 1 mg/g cream is especially indicated for wet or weeping skin conditions.

Apply a thin layer of the cream once or twice a day to the affected area. The number of applications can be reduced as the condition improves, such as with one application per day, and then the treatment can be discontinued.

This medicine should not be used for more than 2 weeks in a row.

If the treatment is on the face, the duration of treatment should be as short as possible, up to 1 week.

If your condition (or eczema) has frequent flare-ups and you have managed to control it, your doctor may advise intermittent treatment (with periods of interruption) with application once a day or 2 times a week in the areas of affected skin or in areas where the lesion is likely to recur. 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 by gentle massage.

Unless you are using it to treat your hands, wash your hands after applying the cream.

If you are using an emollient (moisturizer) at the same time, do not apply it until Betnovate cream has been completely absorbed.

Do not cover the area with a bandage or other non-breathable material, unless your doctor has indicated it 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 you apply more Betnovate cream than you should (repeated overdoses), side effects may occur (see section 4). If you swallow a large amount of Betnovate cream, rinse your mouth with plenty of water and contact your doctor or pharmacist for advice.

If you use the cream more frequently than you should or on large areas of skin, it can be absorbed into the body and cause various disorders; in children, this can affect their growth and development.

In cases of chronic toxicity, it is recommended that corticosteroids be withdrawn gradually. The treatment of overdose is symptomatic. The acute symptoms of excessive use of corticosteroids are generally reversible.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or go to a medical center, or call the Toxicology Information Service. Phone: 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 forgotten doses.

If you forget to apply the cream, apply the corresponding dose when you remember, and continue with the treatment as usual.

If you stop using Betnovate cream

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If enough medicine is absorbed through the skin and into the blood, side effects may occur that affect your skin and other parts of your body.

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.

Side effects that have been reported:

Frequent (may affect up to 1 in 10 people):

• Skin itching
• Burning or local pain in the skin

Very rare (may affect up to 1 in 10,000 people)

• Thinning of the skin
• Stretch marks
• Dryness of the skin

• Wrinkled skin
• Weight gain in the trunk
• Round face
• Fat accumulation in the cervical area
• Psychiatric symptoms
• Appearance of blood vessels under the skin surface

• Hair loss
• Increased body hair

• Changes in skin color
• Allergic skin reaction at the application site
• Worsening of lesions
• Redness
• Rash or hives
• If you have psoriasis, pustular psoriasis (pustules on the skin) may occur, which can happen very rarely 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.

Side effects whose frequency is not known:

• Clouding of the lens (cataracts)
• Increased eye pressure (glaucoma)
• Blurred vision

With the use of topical corticosteroids, the following adverse reactions have also been reported: acne, easy bruising (bruises), inflammation of the hair follicles (folliculitis), appearance of blisters (miliaria) more likely if occlusive dressings or materials are used, perioral dermatitis (inflammation around the mouth), increased cholesterol, low-density lipoproteins, and increased triglycerides.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Health Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing 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 packaging, after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. 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 gram of cream contains 1 mg of betamethasone valerate (0.1%).
• The other ingredients (excipients) are: chlorocresol, cetomacrogol 1000, cetearyl alcohol, white soft paraffin, liquid paraffin, disodium phosphate dihydrate, phosphoric acid, sodium hydroxide, purified water.

Appearance and packaging of the product

Betnovate 1 mg/g cream is a white, smooth 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 last revision of this leaflet:September 2019

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