Betnovate C

Leaflet attached to the packaging: patient information

Betnovate C (1.22 mg + 30 mg)/g, cream
Betamethasone valerate + Clioquinol

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

1. What is Betnovate C cream and what is it used for

The active substances of Betnovate C cream are:

• betamethasone valerate - a corticosteroid with strong anti-inflammatory action,
• clioquinol - a substance with antibacterial and antifungal action.

Betnovate C cream is indicated for the local treatment of skin diseases that respond to corticosteroid therapy, with accompanying or secondary bacterial and/or fungal infections, such as:

• atopic dermatitis (atopic eczema),
• seborrheic dermatitis,
• nodular prurigo,
• psoriasis (excluding generalized lesions),
• lichen planus, lichen simplex,
• seborrheic dermatitis,
• allergic and non-allergic contact dermatitis,
• inflammation of the anal and genital areas,
• large local reactions to insect bites.

2. Important information before using Betnovate C cream

When not to use Betnovate C cream

• if the patient is allergic to betamethasone valerate, clioquinol, or any of the other ingredients of this medicine (listed in section 6) and iodine,
• in children under 1 year of age,
• if the patient has rosacea,
• if the patient has acne vulgaris,
• if the patient has perioral dermatitis,
• if the patient has itching without inflammation,
• if the patient has itching in the anal and genital areas,
• if the patient has a skin infection caused by viruses, bacteria, or fungi (including yeasts).

Warnings and precautions

Long-term use of the medicine should be avoided,especially in children, as systemic side effects characteristic of corticosteroids, adrenal suppression, and Cushing's syndrome may occur, even without occlusive dressing (see section 4. Possible side effects).
Factors that increase the risk of systemic side effects:

• the potency and form of the corticosteroid product for topical use,
• the duration of treatment,
• application to large areas of the body,
• application to tightly covered areas of the skin (e.g., in inflamed areas or under occlusive dressing, in small children, diapers can act as an occlusive dressing),
• increased hydration of the stratum corneum,
• application to areas where the skin is thin - e.g., on the face,
• application to damaged skin or in situations where the skin barrier may be compromised.

Using corticosteroids on the facial skin 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 facial skin.
Protect the eyes and mucous membranes from contact with the medicine.Avoid applying the medicine to the eyelids, as it may cause glaucoma and cataracts.
If the patient experiences blurred vision or other visual disturbances, they should contact their doctor.
In case of re-infectionwithin the treated lesions, the patient should contact their doctor or pharmacist.
Antimicrobial medicines should not be diluted.
If it is necessary to use the medicinal product under an occlusive dressing(a sealing dressing that protects the treated area from the external environment), 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 psoriasisshould be under close medical supervision. Local use of corticosteroids in psoriasis may be unfavorable due to:

• the risk of developing tolerance to the medicine,
• the risk of exacerbating the disease after stopping treatment,
• 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.

Topical corticosteroids are sometimes used to treat chronic leg ulcers. Using them in such cases may be associated with a higher frequency of local hypersensitivity reactions and an increased risk of local infections.
If signs of irritation or hypersensitivity reactions occur, treatment with Betnovate C cream should be discontinued.
Betnovate C cream may stain hair, skin, and fabrics. After applying the cream, the area should be covered to protect clothing.
There is a risk of neurotoxic action(action that damages the nervous system) of topical clioquinol, especially when Betnovate C cream is used for a long time or under occlusive dressing.

Other medicines and Betnovate C cream

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 some medicines (such as ritonavir, itraconazole) at the same time may increase the effect of Betnovate C cream due to slowed metabolism of corticosteroids.
Medicines containing vigabatrinshould not be used at the same time as Betnovate C cream.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
There are no data or limited data on the safety of using the medicine during pregnancy and breastfeeding, as well as its impact on fertility.
The doctor will assess whether the patient can use Betnovate C cream during pregnancy and breastfeeding.
When using the medicine during breastfeeding, the patient should avoid applying Betnovate C cream to the breast skin to prevent accidental contact with the baby.

Driving and using machines

No studies have been conducted on the effect of the medicinal product Betnovate C cream on driving and using machines, but considering the reported side effects, no such effect is expected.

Betnovate C cream contains cetostearyl alcohol, chlorocresol, and paraffin

Due to the presence of cetostearyl alcohol, the medicine may cause local skin reactions (e.g., contact dermatitis).
Due to the presence of chlorocresol, the medicine may cause allergic reactions.
Betnovate C cream contains paraffin. When using Betnovate C cream, do not smoke or approach open flames due to the risk of serious burns. Materials (clothing, bedding, towels, 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 C cream

This medicine should be used as directed by the doctor. If you have any doubts, consult a doctor or pharmacist.
Betnovate C cream is intended for use on the skin. The medicine is particularly suitable for use on moist, weeping skin lesions.
A thin layer of the medicine should be applied only to the affected areas of the skin 1 or 2 times a day, until improvement is seen, but no longer than 7 days. The cream should be left on the skin until absorbed, and then a moisturizer (emollient) should be applied.
To maintain the therapeutic effect, the doctor may then recommend using the medicine 1 time a day or less oftenor using a less potent medicine.
Do not use Betnovate C cream for more than 7 days.
If there is no improvement after a week of treatment, consult a doctor to determine further treatment, as there is a risk of further asymptomatic spread of the infection due to the anti-inflammatory action of the corticosteroid.
In resistant cases (e.g., psoriatic lesions on the elbows and knees), the doctor may recommend using an occlusive dressing - sealing(e.g., with polyethylene film) only at night. This usually brings significant improvement, which can be maintained by regular use of the medicine without occlusive dressing.
When using the medicine on the facial skin, treatment should be limited to 5 days and 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 time necessary to treat the disease, as they may experience slower elimination of the medicine from the body.

Use in children

Do not use Betnovate C cream in children under 1 year of age.
The medicine can be used in children for up to 5 days.
Do not use occlusive dressingin children.
Make sure the smallest required dose of the cream is used.

Using more than the recommended dose of Betnovate C cream

In case of prolonged or incorrect use of the medicine, consult a doctor, as systemic side effects characteristic of corticosteroids may occur (see sections 2 and 4). Do not stop using the medicine without consulting a doctor, as it may lead to glucocorticoid deficiency in the body.

Missing a dose of Betnovate C cream

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

Stopping treatment with Betnovate C cream

If you have any further doubts about using the medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
To prevent side effects, the doctor should ensure that the patient uses the smallest dose that provides a therapeutic effect.
The following side effects have been observed in patients using the medicine.

Common side effects(in 1 to 10 out of 100 patients using the medicine):

• local burning/pain and itching of the skin.

Very rare side effects(less than 1 in 10,000 patients using the medicine):

• opportunistic infections (infections that occur in people with weakened immunity),
• local hypersensitivity,
• suppression of the hypothalamic-pituitary-adrenal axis,
• Cushing's syndrome (e.g., moon face, central obesity),
• growth retardation in children,
• osteoporosis,
• glaucoma,
• hyperglycemia (high blood sugar) and/or glycosuria (glucose in the urine),
• cataracts,
• hypertension,
• weight gain and/or obesity,
• decreased levels of endogenous (produced in the body) cortisol,
• hair loss,
• hair fragility,
• skin thinning, skin atrophy, skin wrinkling, dry skin,
• striae,
• telangiectasias (dilation of small blood vessels, so-called spider veins),
• discoloration,
• excessive hair growth, hair loss, hair node splitting, hair discoloration,
• worsening of disease symptoms,
• allergic contact dermatitis and/or skin inflammation,
• erythema,
• rash,
• urticaria,
• psoriatic pustulosis (see section 2), irritation, and/or pain at the application site.

Side effects with unknown frequency(frequency cannot be determined from available data):

• blurred vision. If symptoms of hypersensitivity occur, treatment should be discontinued and the doctor contacted immediately.

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 adrenal suppression.
The occurrence of these side effects is more likely in small children and after using occlusive dressings (sealing dressings). In small children, diapers can act as an occlusive dressing (see section 2).

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 Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Betnovate C cream

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 carton and tube after EXP.
The expiry date refers to the last day of the month stated.
The batch number is stated on the carton and tube as "Lot".
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 pack and other information

What Betnovate C cream contains

The active substances are: 1.22 mg of betamethasone valerate and 30 mg of clioquinol per 1 gram of cream;
Other ingredients: chlorocresol, macrogol cetostearyl ether, cetostearyl alcohol, white petrolatum, liquid paraffin, sodium dihydrogen phosphate dihydrate, phosphoric acid or sodium hydroxide, purified water.

What Betnovate C cream looks like and contents of the pack:

Betnovate C is a smooth, pale yellow cream.
An aluminum tube containing 15 g or 30 g of cream, placed in a cardboard box.
Not all pack sizes may be marketed.

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 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