Betnovate

Leaflet attached to the packaging: patient information

Betnovate, 1.22 mg/g, ointment

Betamethasone valerate

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Betnovate and what is it used for
• 2. Important information before using Betnovate
• 3. How to use Betnovate
• 4. Possible side effects
• 5. How to store Betnovate
• 6. Contents of the packaging and other information

1. What is Betnovate and what is it used for

The active substance of Betnovate is micronized betamethasone valerate, a corticosteroid with strong anti-inflammatory action.
Betnovate is indicated for adults (including the elderly), adolescents, and children over 1 year of age, for the local treatment of skin diseases that respond to corticosteroid therapy, such as:

• atopic dermatitis (including childhood atopic dermatitis),
• seborrhoeic dermatitis,
• discoid lupus erythematosus,
• psoriasis (excluding generalized lesions),
• chronic lichen simplex and lichen planus,
• seborrhoeic dermatitis,
• allergic or contact dermatitis,
• discoid lupus erythematosus,
• large insect bite reactions.

Betnovate may be used locally in erythroderma (generalized skin diseases characterized by redness and peeling of large skin areas) as an adjunct to systemic corticosteroid therapy.

2. Important information before using Betnovate

When not to use Betnovate

• if the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6),
• if the patient has untreated skin infections,
• if the patient has rosacea,
• if the patient has acne vulgaris,
• if the patient has itching without inflammation,
• if the patient has itching in the anal and genital areas,
• if the patient has perioral dermatitis,
• in children under 1 year of age for the treatment of skin diseases, including those with inflammatory skin changes.

Warnings and precautions

Before starting treatment, discuss it with your doctor or pharmacist.
Long-term use of the medicine in large doses, especially in children, may lead to systemic side effects characteristic of corticosteroids and adrenal suppression.
Factors that increase the risk of systemic effects of the medicine:

• the potency and form of the corticosteroid product for local use,
• long-term use,
• use on large areas of the body,
• use on tightly covered areas of the skin (e.g., in small children, diapers may act as a tight dressing),
• increased hydration of the stratum corneum,
• use on areas where the skin is thin, e.g., on the face,
• use on damaged skin or in situations where the skin barrier may be compromised,
• use in children, as children may absorb proportionally larger amounts of locally applied corticosteroids and may be more susceptible to systemic side effects.

In case of necessity to use the medicinal product under an occlusive dressing (e.g., airtight dressing, e.g., with foil), the skin should be cleaned before applying the dressing, as the heat and moisture associated with the use of occlusive dressings promote the development of bacterial infections.
Patients with psoriasis should be under close medical supervision. The use of this medicine in psoriasis may be disadvantageous due to:

• the risk of developing tolerance to the medicine,
• the risk of exacerbating the disease,
• the risk of developing generalized pustular psoriasis,
• the risk of local or systemic side effects of corticosteroids resulting from excessive absorption of the medicine through damaged skin.

In case of secondary infection within the inflammatory lesions treated with Betnovate, contact your doctor or pharmacist. The doctor may decide to discontinue treatment and prescribe systemic antimicrobial drugs.
Locally applied corticosteroids are sometimes used to treat skin inflammation in the form of chronic leg ulcers. The use of Betnovate in such cases is associated with a higher frequency of local hypersensitivity reactions and an increased risk of local infections.
Using the medicine on the face may lead to skin atrophy more frequently than when used on other areas of the body. Therefore, the medicine should be used with caution on the face, especially in the treatment of psoriasis, lupus, and severe eczema.
Protect your eyes and mucous membranes from contact with the medicine. Avoid applying the medicine to the eyelids, as repeated exposure to the medicine can lead to glaucoma or cataracts.
If the patient experiences blurred vision or other visual disturbances, they should contact their doctor.
If symptoms of irritation or hypersensitivity reactions occur, the patient should consult their doctor as soon as possible.

Betnovate and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
Concomitant use of certain medicines (such as ritonavir, itraconazole) may increase the effect of Betnovate due to slowed metabolism of corticosteroids.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.
There is no data on the safety of using the medicine during pregnancy and breastfeeding, as well as its impact on fertility.
The medicine is not recommended for use in pregnant and breastfeeding women, especially in large doses and on large areas of the skin.
The medicine can be used during pregnancy and breastfeeding only if the doctor decides that the benefits to the mother outweigh the risks to the fetus and child.
Use the smallest dose of the medicine for the shortest possible time.
During breastfeeding, avoid applying the medicine to the breast skin to prevent accidental contact with the infant.

Driving and using machines

There is no data on the effect of Betnovate ointment on the ability to drive and use machines.

Betnovate ointment contains paraffin

Do not smoke or approach open flames while using Betnovate, as there is a risk of severe burns. Materials (clothing, bedding, dressings, etc.) that have come into contact with this medicine are more flammable and pose a significant fire hazard. Washing clothing and bedding may reduce the amount of medicine in them, but not completely remove it.

3. How to use Betnovate

Always use this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.
Betnovate is for use on the skin. The medicine is especially suitable for use on dry, lichenified, scaly skin lesions.
Apply a small amount of the medicine to the affected areas of the skin and gently rub it in once or twice a day until improvement occurs. After each application of the medicine, wash your hands. To maintain the therapeutic effect, your doctor may then recommend using the medicine once a day or less frequently.
If there is no improvement after 2 to 4 weeks of treatment, consult your doctor to determine further action.
In resistant cases (e.g., psoriatic lesions on elbows and knees), your doctor may recommend using an occlusive dressing (e.g., with foil) only at night. This usually results in significant improvement, which can be maintained by regular use of the medicine without an occlusive dressing.
When using the medicine on the face, limit treatment to 5 days and do not use an occlusive dressing.
In elderly patients or those with renal and hepatic impairment, use the smallest possible dose of the medicine for the shortest possible time, allowing for the treatment of the disease, as they may experience slower elimination of the medicine from the body.
In the case of atopic eczema, as improvement occurs, your doctor may gradually reduce the dose of the medicine and replace it with an emollient.

Use in children

Do not use Betnovate in children under 1 year of age.

In children over 1 year of age, the medicine can be used for up to 5 days.

In children, do not use an occlusive dressing. Ensure that the smallest necessary dose of the medicine is used.

Using more than the recommended dose of Betnovate

In case of prolonged or improper use of the medicine, consult your doctor, as systemic side effects characteristic of corticosteroids may occur (see sections 2 and 4).

Missing a dose of Betnovate

Do not use a double dose to make up for a missed dose. Use the medicine as soon as possible, following the recommended dosing schedule.

Stopping use of Betnovate

If you have any further questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Betnovate can cause side effects, although not everybody gets them.
If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist.
To prevent side effects, your doctor will prescribe the smallest dose that will provide a therapeutic effect.
The following side effects have been reported during use of Betnovate:
Common(may affect up to 1 in 10 people):

• local burning sensation of the skin, itching, and pain,

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

• local hypersensitivity, opportunistic infections (infections that occur in people with weakened immunity), suppression of the hypothalamic-pituitary-adrenal axis, symptoms of Cushing's syndrome (e.g., moon face, central obesity), delayed weight gain and/or growth retardation in children, osteoporosis, glaucoma, hyperglycemia (elevated blood glucose levels) and/or glycosuria (glucose in the urine), cataracts, hypertension, weight gain and/or obesity, decreased endogenous cortisol levels, hair loss, hair fragility, allergic contact dermatitis and/or skin inflammation, erythema, eczema (skin changes resulting from the use of the medicine), urticaria, pustular psoriasis, skin thinning*, skin atrophy*, stretch marks*, wrinkles*, dryness*, discoloration*, telangiectasias (dilation of small blood vessels, so-called spider veins)*, hyperpigmentation*, excessive hair growth, worsening of disease symptoms, irritation, and/or pain at the application site.
  Side effects with unknown frequency(frequency cannot be estimated from available data):
  • blurred vision.

  Using the medicine in large doses, for a long time, or on large areas of the skin may lead to systemic side effects characteristic of corticosteroids and may cause adrenal suppression. The occurrence of these side effects is more likely in small children and after using occlusive dressings. In small children, diapers may act as an occlusive dressing (see section 2).
  Prolonged use of this medicine in large doses may lead to local atrophic changes in the skin, such as thinning and stretch marks, especially when the medicine is used in skin folds or under an occlusive dressing.

  Reporting side effects

  If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse.
  Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products:
  Jerozolimskie Avenue 181C
  02-222 Warsaw
  Phone: +48 22 49 21 301
  Fax: +48 22 49 21 309
  Website: https://smz.ezdrowie.gov.pl
  Reporting side effects will help gather more information on the safety of the medicine.
  Side effects can also be reported to the marketing authorization holder.

  5. How to store Betnovate

  Store in a temperature below 30°C.
  Keep the medicine out of the sight and reach of children.
  Do not use this medicine after the expiry date stated on the packaging after: "EXP".
  The expiry date refers to the last day of the month.
  The abbreviation "Lot" means the batch number of the product.
  Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

  6. Contents of the packaging and other information

  What Betnovate contains

  The active substance of Betnovate is micronized betamethasone valerate.
  The other ingredients of the medicine are liquid paraffin and white petrolatum.

  What Betnovate looks like and contents of the pack

  Betnovate is a white ointment.
  An aluminum tube containing 15 g or 30 g of ointment in a cardboard box.

  Marketing authorization holder and manufacturer

  Marketing authorization holder

  GlaxoSmithKline Trading Services Limited
  12 Riverwalk
  Citywest Business Campus
  Dublin 24
  D24 YK11
  Ireland

  Manufacturer

  Delpharm Poznań Spółka Akcyjna
  Grunwaldzka Street 189
  60-322 Poznań
  Poland

  Importer

  Delpharm Poznań Spółka Akcyjna
  Grunwaldzka Street 189
  60-322 Poznań
  Poland
  To obtain more detailed information, contact the local representative of the marketing authorization holder:
  GSK Services Sp. z o. o.
  Rzymowskiego Street 53
  02-697 Warsaw
  phone: (22) 576-90-00
  Date of last revision of the leaflet:January 2025