Betnovate

Package leaflet: Information for the patient

Betnovate, 1.22 mg/g, ointment
Betamethasone valerate
Please read all of this leaflet carefully before 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 further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents:

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

1. What Betnovate is and what it is used for

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

• Atopic dermatitis (including infantile atopic dermatitis),
• Discoid eczema,
• Lichen simplex chronicus,
• Psoriasis (excluding generalized forms),
• Chronic lichen planus and planopilaris,
• Seborrhoeic dermatitis,
• Allergic or contact dermatitis,
• Discoid lupus erythematosus,
• Large local reactions to insect bites.

Betnovate may be used topically in erythrodermas (generalized skin disorders characterized by redness and desquamation of large skin areas) as supportive treatment alongside systemic corticosteroid therapy.

2. Important information before using Betnovate

When not to use Betnovate

• if the patient is allergic to the active substance or to 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 inflammatory changes,
• if the patient has itching of the anal or genital area,
• 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 this with your doctor or pharmacist.
Avoid prolonged use of the medicine in high doses, especially in children, as systemic adverse effects characteristic of corticosteroids and suppression of adrenal function may occur.
Factors increasing the risk of systemic effects of the medicine:

• potency and formulation of the topical corticosteroid product,
• prolonged use,
• application over large body surface areas,
• application under occlusive dressings (e.g. in young children, diapers may act as occlusive coverings),
• increased hydration of the stratum corneum,
• application to areas where the skin is thin, such as the face,
• application to damaged skin or in other situations where the skin barrier may be impaired,
• use in children, as children may absorb proportionally larger amounts of topical corticosteroids compared to adults and may therefore be more susceptible to systemic adverse effects.

If it is necessary to use the medicinal product under an occlusive dressing (e.g. plastic film), the skin should be cleaned before applying the dressing, as warmth and moisture associated with occlusive dressings may promote bacterial infections.
Patients with psoriasis should be under close medical supervision. The use of this medicine in psoriasis may be unfavorable due to:

• risk of developing tolerance to the medicine,
• risk of exacerbation of skin lesions,
• risk of generalized pustular psoriasis,
• risk of local or systemic corticosteroid adverse effects due to excessive absorption through damaged skin.

If secondary infection develops in the inflamed areas treated with Betnovate, contact your doctor or pharmacist. The doctor may decide to discontinue treatment immediately and prescribe systemic antimicrobial therapy.
Topical corticosteroids are sometimes used to treat dermatitis associated with 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.
Application of the medicine to the face may lead more frequently than on other body areas to skin atrophy. Therefore, caution is advised when applying the medicine to facial skin, especially in the treatment of psoriasis, lupus erythematosus, and severe eczema.
Protect eyes and mucous membranes from contact with the medicine. Avoid using the medicine on the eyelids, as repeated exposure of the medicine to the conjunctival sac may lead to glaucoma or cataract.
If blurred vision or other visual disturbances occur, contact your doctor.
If irritation symptoms or hypersensitivity reactions occur, consult your doctor as soon as possible.

Betnovate and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to use.
Concomitant use of certain medicines (such as ritonavir, itraconazole) may increase the effect of Betnovate due to inhibition of corticosteroid metabolism.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
There are no data on the safety of using Betnovate during pregnancy and breastfeeding or its effects on fertility.
The use of this medicine is not recommended in pregnant and breastfeeding women, especially in high doses and over large skin areas.
Betnovate may be used during pregnancy and breastfeeding only if decided by a doctor after considering whether the benefits to the mother outweigh the risks to the fetus or infant.
The lowest effective dose for the shortest possible duration should be used.
During breastfeeding, avoid applying Betnovate to the skin of the breasts to prevent accidental exposure of the newborn to the medicine.

Driving and operating machinery
There are no data on the effects of Betnovate ointment on the ability to drive or operate machinery.

Betnovate ointment contains paraffin
Smoking or approaching open flames should be avoided while using Betnovate due to the risk of severe burns. Materials (clothing, bedding, garments, dressings, etc.) that have come into contact with this medicine are more flammable and pose a serious fire hazard. Washing clothes and bedding may reduce the amount of medicine present, but will not completely remove it.

3. How to use Betnovate

This medicine should always be used exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
Betnovate is intended for topical use on the skin. The medicine is particularly indicated for use on dry, lichenified, scaly skin lesions.
Apply a small amount of the medicine to the affected skin areas and gently rub in once or twice daily until improvement occurs. Hands should be washed after each application. To maintain therapeutic effect, your doctor may subsequently recommend using the medicine once daily or less frequently.
If there is no improvement after 2 to 4 weeks of treatment, contact your doctor to determine further management.
In treatment-resistant conditions (e.g. psoriatic lesions on elbows and knees), your doctor may recommend using an occlusive dressing (e.g. plastic film) only at night. This usually leads to noticeable improvement, which can then be maintained by regular use of the medicine without occlusive dressing.
When applying the medicine to the face, treatment should be limited to 5 days and occlusive dressings should not be used.
In elderly patients or patients with renal or hepatic impairment, the smallest possible dose should be used for the shortest possible duration sufficient to control the disease, as elimination of the drug from the body may be slower in these patients.
In atopic eczema, as improvement occurs, your doctor may gradually reduce the dose and replace it with an emollient.

Use in children
Betnovate should not be used in children during the first year of life.
In children over 1 year of age, the medicine may be used for up to 5 days.
Occlusive dressings should not be used in children. Ensure that the smallest necessary dose of the medicine is applied.

Use of a higher than recommended dose of Betnovate
If Betnovate is used for prolonged periods or incorrectly, contact your doctor, as systemic adverse effects characteristic of corticosteroids may occur (see sections 2 and 4).

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

Stopping Betnovate
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist.
To help prevent adverse reactions from occurring, your doctor will prescribe the lowest dose that provides the desired therapeutic effect.

The following adverse reactions have been reported during treatment with Betnovate:

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

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

Very rare (may occur in fewer than 1 in 10,000 patients):

• Local hypersensitivity, opportunistic infections (infections occurring in individuals with weakened immunity), suppression of the hypothalamic-pituitary-adrenal (HPA) axis function, symptoms of Cushing's syndrome (e.g. moon face, central obesity), delayed weight gain and/or delayed skeletal growth in children, osteoporosis, glaucoma, hyperglycaemia (increased blood glucose concentration above the upper limit of normal) and/or glycosuria (presence of glucose in urine), cataract, arterial hypertension, weight gain and/or obesity, decreased concentration of endogenous cortisol, alopecia, hair fragility, allergic contact dermatitis and/or dermatitis, erythema, exanthema (skin lesions resulting from drug use), urticaria, pompholyx, skin atrophy*, skin atrophy*, striae*, wrinkles*, dryness*, depigmentation*, telangiectasia (dilation of small blood vessels, so-called vascular spiders)*, hyperpigmentation*, hirsutism, exacerbation of disease symptoms, irritation and/or pain at the site of application.

Adverse reactions with unknown frequency (frequency cannot be estimated from available data):

• Blurred vision.

Use of the medicine in high doses, for prolonged periods, or over large areas of skin may lead to systemic adverse reactions typical of corticosteroids and may result in adrenal suppression. The occurrence of such reactions is more likely in young children and following use under occlusive dressings. In infants, diapers may act as an occlusive dressing (see section 2).

Prolonged use of this medicine in high doses may lead to local atrophic skin changes such as thinning and striae, particularly when the medicine has been applied in skin folds or under occlusive dressings.

Reporting of adverse reactions

If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse.

Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:

Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl

Reporting adverse reactions helps to provide more information on the safety of this medicine.

Adverse reactions may also be reported to the marketing authorization holder.

5. How to store Betnovate

Store 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 following "EXP".
The expiry date refers to the last day of the stated month.
"Lot" is the batch number of the product.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the package and other information

What Betnovate contains
The active substance is betamethasone valerate micronised.
Other ingredients are: liquid paraffin and white soft paraffin.

What Betnovate looks like and contents of the pack
Betnovate is a white ointment.
Aluminium tube containing 15 g or 30 g of ointment in a cardboard carton.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
GlaxoSmithKline Trading Services Limited
12 Riverwalk
Citywest Business Campus
Dublin 24
D24 YK11
Ireland

Manufacturer
Delpharm Poznań Spółka Akcyjna
ul. Grunwaldzka 189
60-322 Poznań
Poland

Importer
Delpharm Poznań Spółka Akcyjna
ul. Grunwaldzka 189
60-322 Poznań
Poland

For more detailed information, please contact the local representative of the Marketing Authorisation Holder:
GSK Services Sp. z o.o.
ul. Rzymowskiego 53
02-697 Warszawa
tel. (22) 576-90-00