Betnovate c

Package leaflet: Information for the patient

Betnovate C,
(1.22 mg + 30 mg)/g, ointment
Betamethasone valerate + Clioquinol
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, 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 the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist immediately. See section 4.

Table of contents of the leaflet:

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

The active substances in Betnovate C ointment are:

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

Betnovate C ointment is indicated for the local treatment of skin disorders responsive to corticosteroid therapy, accompanied by or complicated with bacterial and/or fungal infection, such as:

• atopic dermatitis (atopic eczema),
• nummular eczema,
• prurigo nodularis,
• psoriasis (excluding generalized forms),
• lichen planus, lichen simplex,
• seborrheic dermatitis,
• allergic and non-allergic contact dermatitis,
• perianal and genital pruritus,
• extensive 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 to 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 non-inflammatory skin itching,
• if the patient has itching of the anogenital area,
• if the patient has a skin infection caused by viruses, bacteria, or fungi (including yeasts).

Warnings and precautions
Prolonged use of the medicine should be avoided, especially in children, as it may lead to
systemic adverse effects typical of corticosteroids, suppression of adrenal function, and symptoms of
Cushing's syndrome, even without the use of occlusive dressings (see section 4. Possible side effects).
Factors increasing the risk of systemic effects:

• potency and formulation of the topical corticosteroid product,
• duration of treatment,
• application over large body surface areas,
• application to tightly covered areas of skin (e.g. intertriginous areas or under occlusive dressings; in young children, diapers may act as occlusive dressings),
• increased hydration of the stratum corneum,
• application to areas where the skin is thin—e.g. facial skin,
• application to damaged skin or in other situations where the skin barrier may be impaired.

Topical application of corticosteroids to facial skin may lead more frequently than on other body areas
to skin atrophy. For this reason, the medicine should be used cautiously on facial skin.
Protect eyes and mucous membranes from contact with the medicine. Avoid applying the medicine to
the eyelids, as entry of the medicine into the conjunctival sac may lead to the development of glaucoma and cataracts.
If the patient experiences blurred vision or any other visual disturbances, medical advice should be sought.
If re-infection occurs within the inflamed lesions being treated with Betnovate C ointment, consult a
doctor or pharmacist.
Antimicrobial agents should not be diluted.
If it is necessary to apply the medicinal product under an occlusive dressing (a sealed dressing that protects the treated area from the external environment), the skin should be cleaned before applying the dressing, as the warmth and moisture associated with occlusive dressings may promote bacterial infections.
Patients with psoriasis should be under strict medical supervision. Topical use of corticosteroids in psoriasis may be disadvantageous due to:

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

Topically applied corticosteroids are sometimes used to treat skin inflammation in the form of chronic
ulcerative lesions of the lower limbs. In such cases, their use may be associated with a higher incidence of local hypersensitivity reactions and an increased risk of local infections.
If irritation symptoms 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) from topically applied clioquinol, particularly when Betnovate C ointment is used for prolonged periods or under occlusive dressings.

Other medicines and Betnovate C ointment
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use.
Concomitant use of certain medicines (such as ritonavir, itraconazole) may increase the effect of Betnovate C ointment due to inhibition of corticosteroid metabolism.
Medicines containing vigabatrin should not be used simultaneously with Betnovate C ointment.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
There are no data or limited data on the safety of using this medicine during pregnancy and breastfeeding, and its effects 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 skin of the breasts to prevent accidental exposure of the newborn to the medicine.

Driving and operating machinery
No studies have been conducted on the effects of Betnovate C ointment on driving or operating machinery. However, considering the reported adverse effects, such effects are not expected.

Betnovate C ointment contains paraffin
Smoking or approaching open flames should be avoided during treatment with Betnovate C ointment 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 C ointment

This medicine should be used as directed by the doctor. If in doubt, consult a doctor or pharmacist.
Betnovate C ointment is intended for topical use on the skin. The medicine is particularly indicated for dry, lichenified, scaly skin lesions.
Apply a thin layer of the ointment once or twice daily to the affected areas only, until improvement occurs, but not for longer than 7 days. Leave the ointment on the skin until absorbed, then apply a skin-softening agent (emollient).
To maintain the therapeutic effect, the doctor may subsequently recommend using the medicine once daily or less frequently, or switching to a less potent preparation.
Do not use Betnovate C ointment for longer than 7 days.
If there is no improvement after one week of treatment, consult a doctor to determine further management, as there is a risk of asymptomatic spread of infection due to the anti-inflammatory effect of the corticosteroid.
In treatment-resistant conditions (e.g. psoriatic lesions on elbows and knees), the doctor may recommend using an occlusive dressing (e.g. polyethylene film) only at night. This usually results in noticeable improvement, which can be maintained by regular use of the medicine without occlusive dressing.
When using the medicine on facial skin, treatment should be limited to 5 days, and occlusive dressings must not be used.
In elderly patients or those with renal or hepatic impairment, the smallest possible dose should be used for the shortest duration necessary to achieve treatment response, as elimination of the drug may be slower in these patients.

Use in children
Betnovate C ointment should not be used in children under 1 year of age.
In children, the medicine may be used for up to 5 days.
Occlusive dressings (occlusive coverings) must not be used in children.
Ensure that the smallest effective dose of ointment is applied.

Use of a higher than recommended dose of Betnovate C ointment
If the medicine is used for prolonged periods or incorrectly, consult a doctor, as systemic adverse effects characteristic of corticosteroids may occur (see sections 2 and 4). Do not stop using the medicine abruptly, as this may lead to glucocorticoid deficiency in the body.

Missed dose of Betnovate C ointment
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.

Discontinuation of Betnovate C ointment
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 everybody will experience them.
To help prevent adverse reactions from occurring, the doctor should ensure that the patient uses the lowest dose that provides therapeutic benefit.
The adverse reactions listed below have been observed in patients using this medicine.

Common adverse reactions (occur in 1 to 10 out of 100 patients using the medicine):

• Local burning and (or) skin pain and itching.

Very rare adverse reactions (occur in less than 1 out of 10,000 patients using the medicine):

• Opportunistic infections (infections occurring in people with weakened immunity),
• Local hypersensitivity,
• Suppression of the hypothalamic-pituitary-adrenal (HPA) axis,
• Cushing's syndrome symptoms (e.g. moon face, central obesity),
• Delayed bone growth in children,
• Osteoporosis,
• Glaucoma,
• Hyperglycaemia (excess glucose in the blood) and (or) glycosuria (glucose in urine),
• Cataract,
• Hypertension,
• Weight gain and (or) obesity,
• Decreased concentration of endogenous (internally produced) cortisol,
• Alopecia,
• Hair fragility,
• Skin thinning, skin atrophy, wrinkling of the skin, dry skin,
• Striae,
• Telangiectasia (dilation of small blood vessels, so-called vascular spiders),
• Discoloration,
• Excessive hair growth, alopecia, pili torti (twisted hair), hair decoloration,
• Worsening of disease symptoms,
• Allergic contact dermatitis and (or) dermatitis,
• Erythema,
• Rash,
• Urticaria,
• Pustular psoriasis (see section 2), irritation and (or) pain at the site of application.

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

• Blurred vision.

If symptoms of hypersensitivity occur, treatment should be discontinued immediately and the doctor should be contacted without delay.
Prolonged, high-dose or extensive application of the medicine over large skin areas may lead to systemic adverse reactions typical of corticosteroids and adrenal suppression.
These reactions are more likely in young children and after use of occlusive dressings. In young children, diapers may act as occlusive dressings (see section 2).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions 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 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide 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 cardboard packaging after
"Exp." and on the tube after: EXP. The expiry date refers to the last day of the stated month.
The abbreviation "Lot" refers to 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 required. Such measures 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 micronized betamethasone valerate and 30 mg of clioquinol per 1 g of ointment.
Other ingredients: liquid paraffin, white soft paraffin.

What Betnovate C ointment looks like and contents of the pack:
Betnovate C is a straw-coloured to yellow ointment.
Aluminium tube containing 15 g of ointment, placed in a cardboard box.

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 representative of the Marketing Authorisation Holder:
GSK Services Sp. z o.o.
ul. Rzymowskiego 53
02-697 Warszawa
tel. (22) 576-90-00