Betnovate

Package leaflet: information for the patient

Betnovate, 1.22 mg/g, cream
Betamethasone valerate
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.
˗ Keep this leaflet, so that you can read it again if necessary.
˗ If you have any further questions, please consult your doctor or pharmacist.
˗ This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
˗ If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
Contents of the leaflet:

1. What Betnovate is and what it is 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 pack and other information

1. What Betnovate is and what it is used for

The active substance in Betnovate is micronized betamethasone valerate, a corticosteroid with strong anti-inflammatory activity.
Betnovate is indicated for adults (including elderly), adolescents, and children over 1 year of age, for the topical treatment of skin diseases 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 flat lichen,
• seborrhoeic dermatitis,
• allergic or contact dermatitis,
• discoid lupus erythematosus,
• large local reactions following insect bites.

Betnovate may be used topically in erythrodermas (generalized skin disorders characterized by redness and desquamation of extensive skin areas), as an adjunctive treatment 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 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 around the anus 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 lesions.

Warnings and precautions
Before starting treatment with this medicine, discuss it with your doctor or pharmacist.
Avoid prolonged use of the medicine in high doses, especially in children, as this may lead to systemic adverse effects typical of corticosteroids and suppression of adrenal function.
Factors increasing the risk of systemic effects of the medicine:

• potency and formulation of the corticosteroid-containing product for topical use,
• prolonged use,
• application over large areas of the body,
• use on tightly covered areas of skin (e.g. diapers in young children may act as an occlusive dressing),
• 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 topically applied corticosteroids compared to adults, making them more susceptible to systemic adverse effects.

If it is necessary to use the medicinal product under an occlusive dressing (an airtight covering, 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 disadvantageous 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 resulting from 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.
Topically applied corticosteroids are sometimes used to treat dermatitis associated with chronic leg ulcers. The use of Betnovate in such cases may be associated with a higher incidence of local hypersensitivity reactions and an increased risk of local infections.
Application of the medicine to facial skin may lead more frequently than on other body areas to skin atrophy. Therefore, Betnovate should be used cautiously on the face, especially in the treatment of psoriasis, lupus, and severe eczema.
Protect eyes and mucous membranes from contact with the medicine. Avoid applying the medicine to the eyelids, as repeated entry of the medicine into the conjunctival sac may lead to glaucoma or cataract.
If the patient experiences blurred vision or any other visual disturbance, contact a doctor.
If irritation symptoms or hypersensitivity reactions occur, seek medical advice immediately.

Betnovate and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.
Concomitant use of certain medicines (e.g. 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 a doctor or pharmacist before using this medicine.
There are no data on the safety of using this medicine during pregnancy and breastfeeding or its effect on fertility.
The use of Betnovate 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 a doctor decides that 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 breast skin to prevent accidental exposure of the newborn to the medicine.

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

Betnovate contains chlorocresol, cetostearyl alcohol and paraffin.
Due to the presence of chlorocresol, this medicine may cause allergic reactions.
Due to the presence of cetostearyl alcohol, this medicine may cause local skin reactions (e.g. contact dermatitis).
While using Betnovate, do not smoke or go near open flames due to the risk of severe burns. Materials (clothing, bedding, clothing, dressings, etc.) that have been in 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 your doctor has instructed. 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 moist, weeping skin lesions.
Apply a small amount of the medicine to the affected areas of skin 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 then recommend continuing treatment once daily or less frequently.
If there is no improvement after 2 to 4 weeks of treatment, consult your doctor to determine further management.
In treatment-resistant conditions (e.g. psoriatic lesions on elbows and knees), your doctor may recommend the use of an occlusive dressing (e.g. plastic film) applied only at night. This usually leads to clear 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 must not be used.
In elderly patients or in patients with renal or hepatic impairment, the smallest possible dose should be used for the shortest possible duration necessary to achieve treatment response, as elimination of the medicine from the body may be slower in these individuals.
In atopic eczema, as improvement occurs, your doctor may gradually reduce the dose and replace the medicine with an emollient.

Use in children
Betnovate must 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 must not be used in children.
Ensure that the smallest necessary dose of the medicine is applied.

Use of more Betnovate than recommended
If the medicine is used for prolonged periods or incorrectly, consult 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 effects

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

The following adverse effects have been reported during the use of Betnovate:

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

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

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

• Local hypersensitivity, opportunistic infections (infections occurring in people with weakened immunity), suppression of the hypothalamic-pituitary-adrenal (HPA) axis function, Cushing's syndrome symptoms (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 sugar 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 the use of the medicine), urticaria, pustular psoriasis, skin thinning*, skin atrophy*, striae*, wrinkles*, dryness*, depigmentation*, telangiectasia (dilation of small blood vessels, so-called vascular spiders)*, hyperpigmentation*, hirsutism, worsening of disease symptoms, irritation and/or pain at the site of application.
  * Skin reactions secondary to local and/or systemic suppression of the hypothalamic-pituitary-adrenal (HPA) axis function.

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

• Blurred vision.

Prolonged use of this medicine in high doses or over large skin areas may lead to systemic adverse effects typical of corticosteroids and may result in adrenal suppression. The occurrence of such effects is more likely in young children and when occlusive dressings are used. In young children, 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 effects

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

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

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

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

Adverse effects can also be reported to the marketing authorization holder.

5. How to store Betnovate medicine

Store 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 stated month.
The abbreviation "Lot" indicates the product batch number.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Betnovate contains
The active substance is micronized betamethasone valerate.
The other ingredients are: chlorocresol, macrogol cetostearyl ether, cetostearyl alcohol,
white soft paraffin, liquid paraffin, sodium dihydrogen phosphate dihydrate, phosphoric acid or sodium
hydroxide, purified water.

What Betnovate looks like and contents of the pack
Betnovate is a white, smooth, water-soluble cream.
Aluminium tube containing 15 g or 30 g of cream, packed 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
Grunwaldzka Street 189
60-322 Poznań
Poland

Importer
Delpharm Poznań Spółka Akcyjna
Grunwaldzka Street 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.
Rzymowskiego Street 53
02-697 Warsaw
tel. (22) 576-90-00