Betnovate C

Leaflet attached to the packaging: patient information

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

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

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

The active substances of Betnovate C ointment are:

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

Betnovate C ointment 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,
• nummular eczema,
• psoriasis (excluding generalized lesions),
• lichen planus, lichen simplex,
• seborrheic eczema,
• 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 ointment

When not to use Betnovate C ointment

• if the patient is allergic to betamethasone valerate, clioquinol or any of the other ingredients of this medicine (listed in section 6) or 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 of the skin without inflammation,
• if the patient has itching of 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 - a dressing that seals the treated area from the external environment (see section 4. Possible side effects).
Factors that increase the risk of systemic 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. facial skin,
• 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 vision disturbances, they should contact their doctor.
In case of recurrence of infection within 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 dressing that seals 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 promote the development of bacterial infections.
Patients with psoriasisshould be under close medical supervision. Local use of corticosteroids in psoriasis may be disadvantageous due to:

• the risk of developing tolerance to the medicine,
• the risk of worsening of the disease after stopping the 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 ulcerative lesions of the lower limbs. Using them in this case 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 ointment should be discontinued.
Betnovate C ointment may stain hair, skin, and fabrics. After application, the area should be covered to protect clothing.
There is a risk of neurotoxic effects (effects involving damage to the nervous system) of topical clioquinol, especially when Betnovate C ointment is used for a long time or under occlusive dressing.

Other medicines and Betnovate C ointment

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

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 ointment during pregnancy and breastfeeding.
When using the medicine during breastfeeding, avoid applying Betnovate C ointment to the breast skin to prevent accidental contact with the infant.

Driving and using machines

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

Betnovate C ointment contains paraffin

When using Betnovate C ointment, do not smoke or approach an open flame due to the 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 C ointment

This medicine should be used as directed by the doctor. In case of doubts, consult a doctor or pharmacist.
Betnovate C ointment is intended for use on the skin. The medicine is particularly suitable for use on dry, scaly, or crusted skin lesions.
A thin layer of the medicine should be applied only to the affected areas of the skin 1 or 2 times
daily, until improvement is achieved, but not for more than 7 days. The ointment should be left on the skin until absorbed, and then a skin moisturizer (emollient) should be applied.
To maintain the therapeutic effect, the doctor may then recommend using the medicine 1 time a dayor less frequently, or using a less potent medicine.
Do not use Betnovate C ointment for more than 7 days.
If there is no improvement after a week of treatment, consult a doctor to determine further action, 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(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 daysand occlusive dressing should not be used.
In elderly patients or those with renal or 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 ointment in children under 1 year of age.
In children, the medicine can be used for up to 5 days.
In children, occlusive dressing (sealing dressing) should not be used.
Ensure that the smallest required dose of the ointment has been used.

Using more than the recommended dose of Betnovate C ointment

In case of prolonged or improper 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 this may lead to glucocorticoid deficiency in the body.

Missing a dose of Betnovate C ointment

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 treatment with Betnovate C ointment

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

4. Possible side effects

Like all medicines, Betnovate C ointment 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 Betnovate C ointment.

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

• local burning and/or pain and/or itching of the skin.

Rare side effects(occurring in 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,
• symptoms of Cushing's syndrome (e.g. moon face, central obesity),
• delayed growth in children,
• osteoporosis,
• glaucoma,
• hyperglycemia (elevated blood glucose levels) and/or glycosuria (glucose in the urine),
• cataracts,
• hypertension,
• weight gain and/or obesity,
• decreased levels of endogenous 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 shaft splitting, hair discoloration,
• worsening of disease symptoms,
• contact allergic dermatitis and/or eczema,
• erythema,
• rash,
• urticaria,
• psoriatic pustules (see section 2), irritation and/or pain at the application site.

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

• blurred vision.

If signs of hypersensitivity occur, treatment should be discontinued and a doctor should be consulted 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. 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 Drug Safety Monitoring of 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
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 ointment

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 ointment contains:

The active substances are: 1.22 mg of betamethasone valerate and 30 mg of clioquinol in 1 gram of ointment.
Other ingredients: liquid paraffin, white petrolatum.

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

Betnovate C is a straw-colored to yellow ointment.
An aluminum tube containing 15 g of ointment, placed in a cardboard box.

Marketing authorization 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
To obtain more detailed information, contact the representative of the marketing authorization holder:
GSK Services Sp. z o.o.
ul. Rzymowskiego 53
02-697 Warsaw
phone: (22) 576-90-00
Date of last revision of the leaflet:January 2025