Betnovate

Leaflet accompanying the packaging: patient information

Betnovate, 1.22 mg/g, cream

Betamethasone valerate

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

• Keep this leaflet, so you can read it again if you need to.
• If you have 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 you experience any side effects, including those not listed in this leaflet, tell your 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 infantile atopic dermatitis),
• seborrheic dermatitis,
• nodular prurigo,
• psoriasis (excluding generalized lesions),
• chronic eczema and lichen planus,
• seborrheic eczema,
• 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 you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6),
• if you have untreated skin infections,
• if you have rosacea,
• if you have acne vulgaris,
• if you have itching without inflammation,
• if you have itching in the anal and genital areas,
• if you have dermatitis around the mouth,
• 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 high doses, especially in children, should be avoided, as systemic side effects characteristic of corticosteroids and adrenal suppression may occur.
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 can 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.

If it is necessary 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 occlusive dressings can 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 the event of a secondary infection within the treated inflammatory lesions, you should 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 eczema 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 seborrheic dermatitis.
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 the development of glaucoma or cataracts.
If you experience blurred vision or other visual disturbances, contact your doctor.
If you experience signs of irritation or hypersensitivity reactions, seek medical attention as soon as possible.

Betnovate and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Taking certain medicines (such as ritonavir, itraconazole) at the same time can 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 high 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. The smallest dose of the medicine should be used for the shortest possible time.
During breastfeeding, avoid applying Betnovate to the breast skin to prevent accidental contact with the infant.

Driving and using machines

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

Betnovate contains chlorocresol, cetyl alcohol, and paraffin.

Due to the presence of chlorocresol, the medicine may cause allergic reactions.
Due to the presence of cetyl alcohol, the medicine may cause local skin reactions (e.g., contact dermatitis).
When using Betnovate, do not smoke or approach open flames, as there is a risk of serious burns. Materials (clothing, bedding, clothing, 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

This medicine should always be used as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Betnovate is intended for use on the skin. The medicine is particularly suitable for use on wet, weeping skin lesions.
A small amount of the medicine should be applied to the affected areas of the skin and gently rubbed in once or twice a day until improvement occurs. After each use of the medicine, wash your hands. To maintain the therapeutic effect, the 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 the elbows and knees), the 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, treatment should be limited to 5 days, and an occlusive dressing should not be used.
In elderly patients or those with renal and hepatic impairment, the smallest possible dose of the medicine should be used 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 dermatitis, as improvement occurs, the doctor may gradually reduce the dose of the medicine and replace it with an emollient.

Use in children

Betnovate should not be used 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, an occlusive dressing should not be used.
Ensure that the smallest necessary dose of the medicine is used.

Using a higher dose of Betnovate than recommended

In the event 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 Betnovate treatment

If you have any further doubts 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 those not listed in this leaflet, tell your doctor or pharmacist.
To prevent side effects, the doctor will prescribe the smallest dose that provides a therapeutic effect.
The following side effects have been reported during the use of Betnovate:

• Frequent(may occur in 1 to 10 out of 100 patients):

local burning of the skin, itching, and pain.

• Very rare(may occur less frequently than 1 in 10,000 patients):

local hypersensitivity, opportunistic infections (infections that occur in people with reduced immunity), suppression of the hypothalamic-pituitary-adrenal axis, symptoms of Cushing's syndrome (e.g., moon face, central obesity), delayed weight gain and/or delayed bone growth in children, osteoporosis, glaucoma, hyperglycemia (elevated blood glucose levels) and/or glycosuria (presence of sugar 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, redness, exanthema (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)*, pigmentation changes*, excessive hair growth, worsening of disease symptoms, irritation, and/or pain at the application site.
*skin symptoms secondary to local and/or systemic suppression of the hypothalamic-pituitary-adrenal axis.
Side effects with unknown frequency(frequency cannot be estimated from available data):

• blurred vision. Using the medicine in high 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 can act as an occlusive dressing (see section 2).

Prolonged use of this medicine in high doses may lead to local atrophic changes in the skin, such as thinning and stretch marks, especially when used in skin folds or under an occlusive dressing.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration 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
By reporting side effects, you can 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 at a temperature below 25°C.
Keep the medicine out of 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 "Lot" abbreviation means the product batch number.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of unused medicines. This will help protect the environment.

6. Contents of the packaging and other information

What Betnovate contains

The active substance of the medicine is micronized betamethasone valerate.
The other ingredients of the medicine are: chlorocresol, macrogol cetostearyl ether, cetyl alcohol, white petrolatum, liquid paraffin, sodium dihydrogen phosphate dihydrate, phosphoric acid or sodium hydroxide, purified water.

What Betnovate looks like and contents of the packaging

The medicine is a white cream with a smooth consistency, soluble in water.
An aluminum tube containing 15 g or 30 g of cream, 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 update of the leaflet:January 2025