Label: Information for the User

Betnovate 1 mg/g Topical Solution

Betamethasone 17-valerate

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to refer to it again.
  If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

It is a medication that contains betamethasone valerate as its active ingredient, which is a corticosteroid (anti-inflammatory), that when applied to the scalp helps to reduce redness, inflammation, and itching caused by certain scalp problems.

Betnovate topical solution is indicated for the treatment of inflammatory and pruritic manifestations (with itching) of scalp conditions that respond to corticosteroids, such as a scaly, red, and frequently scaly condition (psoriasis) and an inflammatory eruption with scaling (seborrheic dermatitis).

Betnovate 1mg/g topical solution is indicated for use in adults and children over 12 years old.

Do not use Betnovate topical solution:

• If you are allergic to betamethasone or any of the other components of this medication (listed in section 6).
• If you have a fungal infection on any part of your body or scalp (see next section).
• If you have bacterial or viral infections (for example: herpes or chickenpox).
• In skin conditions with skin thinning (atrophy).
• In ulcers, or in the eyes or deep wounds, or in acne.
• In children under 12 years old.

Warnings and precautions

Consult your doctor or pharmacist before starting to useBetnovate topical solution.

• If irritation or local sensitivity occurs with the use of the medication, discontinue treatment and consult a doctor.
• If you develop an infection during treatment, consult a doctor about your treatment.
• With the use of topical corticosteroids, any of the adverse effects reported with the use of corticosteroids by other routes may occur, such as alteration of glands located near the kidneys that cause symptoms such as obesity, growth delay, etc. (Cushing's syndrome), especially in children.
• Topical corticosteroids, like the active ingredient in this medication, have significant effects on the body. Do not use Betnovate on large areas of the body or for prolonged periods, as this significantly increases the risk of adverse effects.
• This medication should not enter the eyes, open wounds, or mucous membranes (e.g., the nose or mouth).
• If you are being treated for psoriasis, it is recommended to have strict medical supervision of your condition to observe any possible worsening.
• The treated scalp area should not be bandaged or covered unless instructed by your doctor, as it is easier for the active ingredient to penetrate the skin and increase the risk of infection.
• Betnovate topical solution is flammable (may burn). Keep away from heat, fire, flames, and do not smoke while applying the medication or after application. Do not use a hair dryer after applying Betnovate topical solution.
• Contact your doctor if you experience blurred vision or other visual disturbances.

Children and adolescents

This medication is contraindicated in children under 12 years old.

Use ofBetnovate topical solution withother medications

Inform your doctor or pharmacist if you are using, have used recentlyor may need to use any other medication.

No interactions ofBetnovate topical solutionwith other medications are known. However, long-term treatments with corticosteroids may lead to interactions similar to those that occur with systemic treatment, due to absorption.

Pregnancy, breastfeeding, and fertility

If you are pregnantorbreastfeeding, believe you may be pregnant, or plan tobecome pregnant,consult your doctorbefore using this medication.

Pregnancy

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

This medication will not be used during pregnancy unless your doctor considers that the potential benefit of its use justifies the potential risk to the fetus.

Pregnant women or women planning to become pregnant should not useBetnovate topical solutionon large areas of the skin, in large quantities, or for prolonged periods, or use occlusive dressings.

Breastfeeding

During breastfeeding, the use of Betnovate may be considered when the expected benefit for the mother outweighs the potential risk to the baby.

Driving and operating machinery

The treatment with Betnovate does not affect the ability to drive or operate machinery.

Followexactlythe administration instructionsfor this medication as indicatedby your doctor.In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

• Adults and children over 12 years old:

Use Betnovate topical solution one or two times a day on the affected area of the scalp, in the morning and at night. The number of applications may be reduced according to improvement.

The treatment can then be maintained by applying once a day.

Or less frequently (on separate days, for example).

The duration of treatment should not exceed 2weeks with the maximum dose (2 times a day).

Application instructions:

• Open the solution bottle and place the nozzle on the scalp area to be treated.
• Press the bottle lightly and apply the product directly to the scalp to cover the entire area to be treated with a thin layer of liquid. You can extend it or not with a light massage.
• You will feel a slight cold sensation until the liquid dries.

If you wash your hair, apply Betnovate topical solution after drying it.

Betnovate topical solution is flammable. Keep away from heat, fire, or flames and do not smoke while applying the product or after its application.Do not dry your hair with a hair dryer after using Betnovate topical solution.

Use in children and adolescents

Betnovate topical solution is contraindicated in children under 12years of age.

If you use more Betnovate topical solution than you should

Excessive use of topical corticosteroids (repeated overdoses) may cause adverse effects (see section4). If you apply more Betnovate topical solution or ingest it in excess, you may experience adverse effects.

If you use the solution 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 to withdraw corticosteroids gradually. The treatment of overdose is symptomatic. The acute symptoms of excessive corticosteroid use are usually reversible.

In case of overdose or accidental ingestion, consult your doctor or pharmacist 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 topical solution

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

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

If you interrupt the treatment with Betnovate topical solution

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

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

If a sufficient amount of the medicine is absorbed through the skin and enters the bloodstream, it may cause side effects that affect the skin and other parts of the body.

If skin lesions worsen or become inflamed during treatment, you may be allergic to the medicine, have an infection, or need another treatment. Stop the treatment and consult your doctor.

Reported side effects:

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

• Itching of the skin
• Local burning sensation on the skin

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

The use of Betnovate topical solution for long periods of time, or under occlusive dressings may cause the following side effects:

• Skin thinning (atrophy)
• Striae
• Skin dryness
• Contact dermatitis (skin allergic reaction at the application site)
• Appearance of blood vessels under the skin surface (telangiectasias)
• Acne
• Hair loss
• Excessive body hair
• Changes in skin color
• Pain or irritation at the application site
• Worsening of skin lesions
• Redness
• Rash or urticaria
• Skin infection

• Rounded face
• Accumulation of fat in the cervical area
• Delayed healing
• Psychiatric symptoms
• Obesity
• High blood pressure

- In children, the following rare symptoms have also been observed:

• Delayed weight gain and growth
• Increased intracranial pressure

- Side effects observed in blood tests or when the doctor requests an examination:

• Increased blood sugar levels or urine or increased cholesterol and other fats.

• Other side effects whose frequency is not exactly known:

• Cataracts (clouding of the lens)
• Glaucoma (increased intraocular pressure)
• Fungal infection of the skin or mucous membranes
• Inflammation of the skin around the upper lip and chin (perioral dermatitis)
• Folliculitis (inflammation of hair follicles)
• Haematomas
• Blurred vision

Reporting of 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 to 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 on the safety of this medicine.

Do not store at a temperature above 25°C. Store in the outer packaging to protect it from light.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter 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 unused medicines at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Betnovate topical solution

• The active ingredient is betamethasone 17-valerate. Eachg of topical solution contains 1mg of betamethasone 17-valerate (0.1%).
• The other components (excipients) are: Carbomer, isopropyl alcohol, sodium hydroxide, and purified water.

Appearance of the product and contents of the packaging

Betnovate 1mg/g topical solution is presented in a bottle with a stopper and cap.

Containers with 30 and 60 g.

Holder of the marketing authorization and responsible 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 last review ofthis leaflet:September 2019

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