BETNOVATE 1 mg/g CUTANEOUS SOLUTION

Introduction

Package Leaflet: Information for the User

Betnovate 1 mg/g Cutaneous Solution

Betamethasone 17-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 Package Leaflet

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

1. What is Betnovate 1mg/g Cutaneous Solution and what is it used for

It is a medicine that contains the active ingredient betamethasone valerate, 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 Cutaneous Solution is indicated for the treatment of inflammatory and pruritic (itchy) manifestations of scalp conditions that respond to corticosteroids, such as a scaly red condition often covered by silver scales (psoriasis) and an eruption with inflammation and scaling (seborrheic dermatitis).

Betnovate 1 mg/g Cutaneous Solution is indicated in adults and children over 12 years of age.

2. What you need to know before you start using Betnovate 1 mg/g Cutaneous Solution

Do not use Betnovate Cutaneous Solution:

• If you are allergic to betamethasone or any of the other ingredients of this medicine (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 (such as herpes or chickenpox).
• In skin diseases with thinning of the skin (atrophy).
• In ulcers, eyes, or deep wounds, or in acne.
• In children under 12 years of age.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Betnovate Cutaneous Solution.

• If you experience local irritation or sensitivity with the use of the medicine, you should discontinue treatment and consult your doctor.
• If you develop an infection during treatment, you should consult your doctor about your treatment.
• With the use of topical corticosteroids, any of the side effects that have been reported with the use of corticosteroids by other routes may occur, such as changes in glands located near the kidneys that produce symptoms such as obesity, growth retardation, etc. (Cushing's syndrome), especially in children.
• Corticosteroids, like the active ingredient of this medicine, have significant effects on the body. Betnovate should not be used on large areas of the body or for prolonged periods, as this significantly increases the risk of side effects.
• This medicine should not come into contact with the eyes, open wounds, or mucous membranes (e.g., the nose or mouth).
• If you are being treated for psoriasis, you should be under strict medical supervision to monitor any possible worsening of your disease.
• The treated scalp area should not be bandaged or covered unless your doctor tells you to, as this can increase the absorption of the active ingredient through the skin and increase the risk of infection.
• Betnovate Cutaneous Solution is flammable (can catch fire). Keep away from heat, fire, flames, and do not smoke while applying the medicine or after application. Do not use a hair dryer after applying Betnovate Cutaneous Solution.
• Contact your doctor if you experience blurred vision or other visual disturbances.

Children and adolescents

This medicine is contraindicated in children under 12 years of age.

Using Betnovate Cutaneous Solution with other medicines

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

No interactions with other medicines are known for Betnovate Cutaneous Solution. However, long-term treatments with corticosteroids could lead to interactions similar to those that occur with systemic treatment, due to 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 using this medicine.

Pregnancy

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

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

Pregnant or breastfeeding women should not use Betnovate Cutaneous Solution on large areas of the skin, in large amounts, or for prolonged periods, nor should they use occlusive dressings.

Breastfeeding

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

Driving and using machines

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

3. How to use Betnovate 1 mg/g Cutaneous Solution

Follow exactly the instructions of administration of this medicine indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

• Adults and children over 12 years:

Use Betnovate Cutaneous Solution once or twice a day on the affected area of the scalp, in the morning and at night. The number of applications can be reduced as the condition improves.

Then, treatment can be maintained by applying once a day.

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

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

Instructions for application:

• Open the bottle of solution and place the nozzle on the part of the scalp to be treated.
• Gently press the bottle, applying the product directly to the scalp to cover the entire area to be treated with a thin layer of liquid. You can spread it or not with a light massage.
• You will feel a slight sensation of cold until the liquid dries.

If you wash your hair, apply Betnovate Cutaneous Solution after drying it.

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

Use in children and adolescents

Betnovate Cutaneous Solution is contraindicated in children under 12 years of age.

If you use more Betnovate Cutaneous Solution than you should

Excessive use of topical corticosteroids (repeated overdoses) can produce side effects (see section 4). If you apply more Betnovate Cutaneous Solution than you should or ingest it in excess, you may experience side effects.

If you use the solution more frequently than you should or on large areas of the 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 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 Cutaneous Solution

Do not apply a double dose to make up for forgotten doses.

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

If you stop using Betnovate Cutaneous Solution

If you have any further questions on 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 that affect your skin and other parts of your body can occur.

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

Side effects that have been reported:

• Frequent (may affect up to 1 in 10 people):
  • Skin itching
  • Local burning sensation on the skin

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

The use of Betnovate Cutaneous Solution for long periods of time, or under occlusive dressings, may cause the following effects:

• Thinning of the skin (atrophy)
• Stretch marks
• Dryness of the skin
• Allergic skin reaction at the application site (contact dermatitis)
• Appearance of blood vessels under the skin surface (telangiectasias)
• Acne
• Hair loss
• Increased body hair
• Changes in skin color
• Pain or irritation at the application site
• Worsening of lesions
• Redness
• Rash or hives
• Skin infection

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

• In children, the following very rare symptoms have also been observed:
  • Delayed weight gain and growth
  • Increased pressure inside the skull

• Side effects that have been observed in blood tests or when the doctor requests an examination:

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

• Other side effects whose frequency is not known:

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any 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. Storage of Betnovate 1 mg/g Cutaneous Solution

Do not store above 25°C. Keep in the outer packaging to protect from light.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Betnovate Cutaneous Solution

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

Appearance of the product and pack contents

Betnovate 1 mg/g Cutaneous Solution is presented in a bottle with a stopper and cap.

Packs of 30 and 60 g.

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 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.gob.es/.