Betnovate c

Package leaflet: Information for the user

Betnovate C, (1.22 mg + 30 mg)/g, cream
Betamethasone valerate + Clioquinol
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.

• Keep this leaflet. 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.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

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

The active substances in Betnovate C cream are:

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

Betnovate C cream is indicated for the local treatment of skin disorders responsive to corticosteroids, associated with or complicated by secondary bacterial and/or fungal infection, such as:

• Atopic dermatitis (atopic eczema),
• Discoid eczema,
• Prurigo nodularis,
• Psoriasis (excluding generalized forms),
• Lichen planus, lichen simplex,
• Seborrhoeic dermatitis,
• Allergic and non-allergic contact dermatitis,
• Perianal and genital pruritus,
• Large insect bite reactions.

2. Important information before using Betnovate C cream

When not to use Betnovate C cream

• If you are 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 you have rosacea,
• If you have acne vulgaris,
• If you have perioral dermatitis,
• If you have non-inflammatory pruritus (itching without inflammation),
• If you have perianal or genital itching,
• If you have skin infections caused by viruses, bacteria, or fungi (including yeast-like fungi).

Warnings and precautions
Prolonged use should be avoided, especially in children, as systemic adverse effects typical of corticosteroids may occur, including suppression of adrenal function and 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,
• Use on tightly covered areas of skin (e.g. in intertriginous areas or under occlusive dressings; in young children, diapers may act as occlusive dressings),
• Increased hydration of the stratum corneum,
• Application to areas with thin skin – e.g. facial skin,
• Application to damaged skin or in other situations where the skin barrier may be impaired.

Topical corticosteroid use on the face may more frequently lead to skin atrophy than when applied to other body areas. Therefore, caution is advised when applying the cream to facial skin.
Protect eyes and mucous membranes from contact with the medicine. Avoid applying the cream to the eyelids, as entry of the medicine into the conjunctival sac may lead to the development of glaucoma and cataracts.
If you experience blurred vision or any other visual disturbance, consult your doctor.
If re-infection occurs in the treated inflammatory lesions, contact your doctor or pharmacist.
Antimicrobial agents should not be diluted.
If it is necessary to use the medicinal product under an occlusive dressing (a sealed dressing that protects the treated area from the external environment), clean the skin before applying the dressing, as the heat and moisture associated with occlusive dressings may promote bacterial infections.
Patients with psoriasis should be under strict medical supervision. Local use of corticosteroids in psoriasis may be disadvantageous due to:

• Risk of developing tolerance to the drug,
• Risk of exacerbation of skin lesions upon discontinuation of treatment,
• Risk of generalized pustular psoriasis,
• Risk of local or systemic adverse effects of corticosteroids due to excessive absorption through damaged skin.

Topically applied corticosteroids are sometimes used in the treatment of dermatitis associated with chronic leg ulcers. In such cases, there may be an increased frequency of local hypersensitivity reactions and a higher 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 application, the area should be covered to protect clothing.
There is a risk of neurotoxic effects (damage to the nervous system) from topically applied clioquinol, particularly when Betnovate C cream is used for prolonged periods or under occlusive dressings.

Other medicines and Betnovate C cream
Tell your doctor or pharmacist if you are taking, have recently taken, or plan to take any other medicines.
Concomitant use of certain medicines (such as ritonavir, itraconazole) may increase the effect of Betnovate C cream due to inhibition of corticosteroid metabolism.
Medicines containing vigabatrin should not be used simultaneously with Betnovate C cream.

Pregnancy, breastfeeding, and fertility
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.
There are no data or limited data on the safety of this medicine during pregnancy and breastfeeding, and its effects on fertility.
Your doctor will decide whether you may use Betnovate C cream during pregnancy or breastfeeding.
If used during breastfeeding, avoid applying Betnovate C cream to the skin of the breasts to prevent accidental exposure of the newborn to the medicine.

Driving and using machines
No studies on the effect of Betnovate C cream on driving and operating machinery have been conducted. However, considering the reported side effects, no such influence is expected.

Betnovate C cream contains cetostearyl alcohol, chlorocresol, and paraffin
Due to the presence of cetostearyl alcohol, this medicine may cause local skin reactions (e.g. contact dermatitis).
Due to the presence of chlorocresol, this medicine may cause allergic reactions.
Betnovate C cream contains paraffin. Smoking or approaching open flames should be avoided during use 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 cream

This medicine should be used as directed by the doctor. If in doubt, consult your doctor or pharmacist.
Betnovate C cream is intended for topical use on the skin. The medicine is particularly indicated for moist, weeping skin lesions.
A thin layer of the cream should be applied only to the affected areas of the skin once or twice daily until improvement occurs, but not for longer than 7 days. The cream should be left on the skin until absorbed, after which an emollient should be applied.
To maintain therapeutic effect, the doctor may subsequently recommend using the medicine once daily or less frequently, or switching to a less potent medicine.
Do not use Betnovate C cream for longer than 7 days.
If there is no improvement after one week of treatment, consult your 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) applied only overnight. This usually results in clear 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 patients with renal or hepatic impairment, the smallest effective dose should be used for the shortest duration possible to achieve healing, as slower elimination of the drug from the body may occur in these individuals.
Use in children
Do not use Betnovate C cream in children under 1 year of age.
In children, the medicine may be used for up to 5 days.
Do not use occlusive dressings in children.
Ensure that the smallest required dose of cream is applied.
Use of a higher than recommended dose of Betnovate C cream
If the medicine is used for prolonged periods or incorrectly, contact your 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.
Missed dose of Betnovate C cream
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 C cream
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
To help prevent adverse effects from occurring, the doctor should ensure that the patient uses the lowest dose that provides therapeutic benefit.
The adverse effects observed in patients taking this medicine are listed below.

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

• Local burning/stinging or pain and itching of the skin.

Very rare adverse effects (occur in fewer than 1 out of 10,000 patients taking the medicine):

• Opportunistic infections (infections occurring in people with weakened immunity),
• Local hypersensitivity,
• Suppression of the hypothalamic-pituitary-adrenal (HPA) axis function,
• Cushing's syndrome symptoms (e.g. moon face, central obesity),
• Delayed bone growth in children,
• Osteoporosis,
• Glaucoma,
• Hyperglycaemia (high blood glucose levels) and (or) glycosuria (glucose in urine),
• Cataract,
• Hypertension (high blood pressure),
• 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 (stretch marks),
• Telangiectasia (dilation of small blood vessels, so-called spider veins),
• Pigmentation disorders,
• Excessive hair growth, alopecia, pili torti (twisted hair), hair discoloration,
• Worsening of disease symptoms,
• Allergic contact dermatitis and (or) dermatitis,
• Erythema,
• Rash,
• Urticaria (hives),
• Pompholyx (see section 2), irritation and (or) pain at the application site.

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

• Blurred vision.

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

Prolonged, high-dose or extensive application of the medicine over large skin areas may lead to systemic adverse effects typical of corticosteroids and to adrenal suppression.
The occurrence of such effects is more likely in infants and young children, and after using occlusive dressings.
In infants and young children, diapers may act as occlusive dressings (see section 2).

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
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps provide more information on the safety of this 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 cardboard box after the abbreviation "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 cream contains
The active substances are: 1.22 mg micronized betamethasone valerate and 30 mg
clioquinol per 1 gram of cream.
Other ingredients: chlorocresol, cetostearyl macrogol ether, cetostearyl alcohol,
white soft paraffin, liquid paraffin, disodium 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.
Aluminium tube containing 15 g or 30 g of cream, placed in a cardboard box.
Not all pack sizes may be marketed.

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 further 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