Package Leaflet: Information for the User

Betnovate 1mg/g Cream

Betamethasone valerate

Read this leaflet carefully before you start using this medicine because it contains important information for you.

• 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 only. Do not pass it on to others even if they have similar symptoms to you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Betnovate cream is and what it is used for

2. What you need to know before using Betnovate cream

3. How to use Betnovate cream

4. Possible side effects

5. Storage of Betnovate cream

6. Contents of the pack and additional information

Betnovate creamcontains betamethasone valerate as its active ingredient, 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 manifestations of skin conditions that respond to corticosteroids, such as:

• Atopic dermatitis and neurodermatitis (also known as simple lichen, itchy patches on the skin caused by scratching) (endogenous eczemas, related to patient factors).
• Contact allergic or irritative dermatitis (skin eruption due to allergy or substances that irritate the skin).
• Nummular dermatitis (discoid eczema) (eruption in the shape of a coin).
• Dyshidrotic eczema (eruption with itching on hands and feet).
• Poriasis (scaly, red skin condition often covered with silver scales). excluding widespread plaque psoriasis.
• Seborrheic dermatitis (eruption with inflammation and desquamation).
• Plaque lichen (skin condition with itching, with small, violaceous papules or elevations).
• Discoid lupus erythematosus (disease that affects the skin and often affects the face or other areas and often presents red plaques that may leave scars).

Do not use Betnovate cream

• If you are allergic to betamethasone, other corticosteroids, or any of the other components of this medication (listed in section 6).
• If you have skin infections (bacterial or viral).
• If you have rosacea (a skin condition of the face with red/inflamed skin).
• In acne.
• In open wounds.
• Around the anus or genitals if you have itching.
• Do not use this medication in children under 1 year.

Warnings and precautions

Consult your doctor or pharmacist before starting to useBetnovate cream.

• If contact dermatitis occurs, discontinue treatment and consult a doctor.
• If an infection develops during treatment, consult a doctor about treatment and if the infection spreads, discontinue treatment and initiate appropriate therapy.
• With the use of topical corticosteroids, any of the adverse effects that have been reported with the use of oral corticosteroids, such as the alteration of glands located near the kidneys that produce symptoms such as obesity, delayed growth in children, etc. (Cushing's syndrome), may occur.

• To reduce the risk of adverse effects:

• Avoid usinglarge doses of Betnovate cream and for long periods of time.
• Do not apply this medication to large areas of skin.
• Do not use a occlusive dressing on the medication, except if your doctor has instructed you to do so and under their supervision.
• If you have to applyBetnovatecream to the face, the duration of treatment should be the shortest possible, one week at most, as it may cause skin atrophy.
• Avoid the product coming into contact with the eyes (see section 4).
• This medication should not be applied to open wounds or mucous membranes (e.g., the nose or mouth), or to areas with skin atrophy.

- If you are being treated for psoriasis, it is recommended to have strict medical supervision of your condition to observe any possible worsening.

• Contact your doctor if you experience blurred vision or other visual disturbances.

Children and adolescents

This medication is contraindicated in children under 1 year and is not indicated in children under 12years. In adolescents between 12 and 13 years, the smallest possible amount of the medication should be used.

In children, it is morelikely that the corticosteroid will pass through the skin and have adverse effects in other areas of the bodythan in adult patients.

Use of Betnovate cream with other medications

Inform your doctor or pharmacist if you are using, have used recently, or mayneed to use

any other medication.

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

Pregnancy, breastfeeding, and fertility

If you are pregnantorbreastfeeding, believe you may be pregnant, or intend tobecome pregnant,consult your doctor before using this medication.

Betnovate cream should not be used during pregnancy except if 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 the skin, or for prolonged periods, or use occlusive dressings.

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

Driving and operating machinery

The treatment withBetnovatecream does not affectthe ability to drive or operate machinery.

Betnovate cream contains chlorocresol and cetyl esters alcohol

This medication may cause allergic reactions because it contains chlorocresol.

This medication may cause local skin reactions (such as contact dermatitis) because it contains cetyl esters alcohol.

Follow exactly the administration instructions of this medication indicated by your doctor.In case of doubt,consultagainyour doctoror pharmacist.

The recommended dose is:

-Adults 12 years and older:

Betnovate 1 mg/g cream is especially indicated for moist conditions or those that secrete liquid.

Apply a thin layer of cream one or two times a day to the affected area. The number of applications may be reduced according to improvement, such as one application per day, to subsequently interrupt treatment.

This medication should not be used for more than 2 consecutive weeks.

If treatment is on the face, the treatment duration should be the shortest possible, 1 week at most.

If your condition (or eczema) has frequent outbreaks and you have managed to control it, your doctor may advise you on an intermittent treatment (with periods of interruption) with one application per day or 2 times a week on the affected skin areas or those where the lesion is likely to reappear. This could reduce the frequency of relapses.

The medication should be applied in a thin layer using only the amount necessary to cover the affected area and extending it with a gentle massage.

Unless it is used to treat the hands, wash them after applying the cream.

If you are using a moisturizer (humectant) at the same time, do not apply it until Betnovate cream has been fully absorbed.

Do not cover the area with a bandage or other non-breathable material, except as indicated by your doctor under their supervision.

Use in children and adolescents

Do not applyBetnovate cream to children under 12years of age.

If you use more Betnovate cream than you should

If a larger amount of Betnovate cream is applied (repeated overdose), adverse effects may occur (see section4). If a large amount of Betnovate cream is ingested, 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 the skin, it may be absorbed into the body and cause various disorders; in children, this may 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, orgo to a medical center, or callthe Toxicological Information Service. Tel.: 91 562 04 20(indicating the medication and the amount ingested).

If you forgot to use Betnovate cream

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

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

If you interrupt treatment with Betnovate cream

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

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.Although not everyone will experience them.

If you absorb a sufficient amount of the medicine through your skin and it passes into your blood, you may experience side effects 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 reported:

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

• Itching of the skin
• Burning or pain in the skin

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

• Skin thinning
• Stretch marks
• Dry skin

• Wrinkled skin
• Weight gain in the trunk
• Rounded face
• Accumulation of fat in the cervical area
• Psychiatric symptoms
• Appearance of blood vessels under the skin's surface

• Hair loss
• Increased body hair

• Changes in skin color
• Skin reaction in the application area
• Worsening of lesions
• Redness
• Rash or urticaria
• If you have psoriasis, you may experience pus-filled skin bumps (psoriasis pustular). This can occur very rarely before or during treatment.
• Skin infection, including fungal infections
• High blood pressure

The following symptoms have also been observed in children:

Very rare:

• Delayed weight gain and growth.

Very rare side effects that have been observed in blood tests or when the doctor requests an examination:

• Decreased cortisol hormone level in the blood
• Increased blood sugar or urine

Side effects whose frequency is not known exactly:

• Cataracts (clouding of the lens)
• Increased eye pressure (glaucoma)
• Blurred vision

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

Reporting side effects

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

Do not store at a temperature above 30°C.

Keepthis medicationout of the sight and reach of children.

Do not use Betnovate cream after the expiration date that appears 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 the packaging and medicines you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Betnovate 1 mg/g cream

• The active ingredient is Betamethasone 17-valerate. Eachg of cream contains 1mg of betamethasone valerate (0.1%).
• The other components (excipients) are: chlorocresol, cetomacrogol 1000, cetoestearic alcohol, white soft vaseline, liquid vaseline, monosodium dihydrogen phosphate, phosphoric acid, sodium hydroxide, purified water.

Appearance of the product and contents of the packaging

Betnovate 1 mg/g cream is a white, smooth cream.

It is presented in tubes of30 g.

Holder of the marketing authorization and responsible for manufacturing

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 last review ofthis leaflet:September 2019

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