Betnovate n

Package leaflet: Information for the patient

Betnovate N
(1.22 mg + 5 mg)/g, ointment
Betamethasone valerate + Neomycin sulfate
Please read all of this leaflet carefully before using the medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any 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 not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet:

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

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

The active substances in Betnovate N ointment are:

• betamethasone valerate – a corticosteroid with strong anti-inflammatory action,
• neomycin sulfate – an antibiotic effective against most bacteria causing skin infections.

Betnovate N ointment is indicated for the topical treatment of skin diseases responsive to corticosteroids, complicated by associated or secondary bacterial infection, such as:

• atopic dermatitis (atopic eczema),
• nummular eczema,
• lichen simplex chronicus,
• psoriasis (excluding generalized forms),
• lichen planus,
• seborrheic dermatitis,
• allergic and non-allergic contact dermatitis,
• extensive reactions to insect bites,
• perianal and genital pruritus.

2. Important information before using Betnovate N ointment

When not to use Betnovate N ointment:

• in children under 2 years of age,
• if the patient has rosacea,
• if the patient has acne vulgaris,
• if the patient has perioral dermatitis (inflammation of the skin around the mouth),
• if the patient has anal or genital itching without inflammatory changes,
• if the patient has pruritus without inflammation,
• if the patient has viral skin infections,
• if the patient has primary bacterial or fungal skin infections,
• if the patient has primary or secondary skin infections caused by yeasts,
• if the patient has secondary infections caused by bacteria of the Pseudomonas and Proteus families,
• if the patient has external otitis with perforation of the eardrum (risk of hearing damage when using drugs containing neomycin),
• long-term, in high doses, or over large skin areas due to the risk of hearing and kidney damage from neomycin if significant systemic absorption occurs.

Warnings and precautions
Before starting treatment with Betnovate N ointment, discuss this with your doctor or pharmacist.
The medicine should be used with caution in patients with hypersensitivity to topical corticosteroids, neomycin, or any excipients of Betnovate N ointment (listed in section 6.). Local hypersensitivity reactions may resemble symptoms of the disease being treated (see section 4.).
If irritation or hypersensitivity reactions occur, discontinue use of Betnovate N ointment and contact your doctor immediately.
In rare cases, medicines such as Betnovate N ointment may cause colitis (inflammation of the large intestine) – symptoms include diarrhoea, usually bloody and containing mucus, abdominal pain, and elevated temperature (pseudomembranous colitis).

• If any of the above symptoms occur, inform your doctor as soon as possible.

Avoid prolonged use of the medicine, especially in children, as systemic adverse effects typical of corticosteroids, adrenal suppression, and Cushing's syndrome may occur, even without using occlusive dressings (see section 4).
Factors increasing the risk of systemic effects:

• potency and formulation of the topical corticosteroid,
• prolonged duration of treatment,
• application over large body surface areas,
• application to tightly covered skin areas (e.g. skin folds or under occlusive dressings; in small 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 where skin may become damaged.

The medicine should be used cautiously in children, as children may absorb proportionally larger amounts of topical corticosteroids compared to adults, making them more susceptible to systemic adverse effects.
Applying corticosteroid-containing medicines to facial skin may lead (more frequently than when applied to other body areas) to skin atrophy. Therefore, use Betnovate N ointment cautiously on facial skin, especially in cases of psoriasis, lupus, or severe eczema.
Due to its neomycin content, the medicine may damage hearing (including hearing loss) and kidneys.
The medicine should be used with particular caution in elderly patients and in patients with impaired kidney function.
Protect eyes and mucous membranes from contact with the medicine. Avoid applying the medicine to eyelids, as entry into the conjunctival sac may lead to glaucoma or cataract.
If the patient experiences blurred vision or other visual disturbances, contact a doctor.
If signs of infection persist within inflammatory lesions treated with Betnovate N ointment, the doctor may decide to immediately discontinue treatment and administer systemic antimicrobial therapy.
If it is necessary to use the medicine under an occlusive dressing, the skin should be thoroughly cleaned before application, as heat and moisture promote bacterial infections.
Prolonged or frequent use of Betnovate N ointment may lead to hypersensitivity reactions at the application site. In such cases, contact your doctor or pharmacist.
Patients with psoriasis should be treated under strict medical supervision. Topical use of corticosteroids in psoriasis may be disadvantageous due to:

• risk of developing tolerance to the medicine,
• risk of exacerbating skin lesions,
• risk of generalized pustular psoriasis,
• toxic effects resulting from excessive absorption of the medicine through damaged skin.

Corticosteroids are sometimes used topically in the treatment of dermatitis associated with chronic leg ulcers. Use of Betnovate N ointment in such cases is associated with a higher incidence of local hypersensitivity reactions and increased risk of local infections.
Betnovate N ointment, like other antimicrobial agents, should not be diluted.

Betnovate N ointment and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use.
Concomitant use of certain medicines, such as ritonavir and itraconazole, may enhance the effect of Betnovate N ointment.
Due to its neomycin sulfate content, Betnovate N ointment may intensify and prolong the respiratory depressant effect of depolarizing muscle relaxants.
There is a risk of cumulative toxicity when Betnovate N ointment is used concomitantly with systemically acting aminoglycosides.

Pregnancy, breastfeeding, and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Use of Betnovate N ointment during pregnancy or breastfeeding is not recommended.
Betnovate N ointment may be used during pregnancy or breastfeeding only if decided by a doctor.
There are no data or limited data on the safety of using this medicine during pregnancy and breastfeeding, and its effects on fertility.

Driving and operating machinery
No effects of Betnovate N ointment on the ability to drive or operate machinery have been demonstrated.

Betnovate N ointment contains paraffin
Do not smoke or go near open flames while using Betnovate N ointment due to the risk of severe burns. Materials (clothing, bedding, clothing, dressings, etc.) that have come into contact with this medicine ignite more easily 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 N ointment

This medicine should always be used as directed by the doctor. If in doubt, consult a doctor or pharmacist.
Exercise caution when using this medicine in elderly patients and in patients with impaired kidney function (see section 2).
Betnovate N ointment is intended for topical use on the skin. The medicine is particularly indicated for dry, lichenified, scaly skin lesions.
Apply a small amount of the ointment only to the affected areas of skin once or twice daily until improvement occurs, but not for longer than 7 days.
Leave the ointment on the skin to be absorbed, then apply an emollient.
In treatment-resistant conditions (e.g. psoriatic lesions on elbows and knees), the doctor may recommend the use of an occlusive dressing (sealed, e.g. with polyethylene film) only at night.
This usually results in noticeable improvement, which can be maintained by regular daytime application of the medicine without an occlusive dressing.
If no improvement is observed after 7 days of treatment, consult the doctor for further management.
When applying the medicine to the facial skin, limit treatment to 5 days and do not use an occlusive (sealed) dressing.
In elderly patients or in patients with renal or hepatic impairment, elimination of the medicine from the body may be slower; therefore, the doctor will determine the lowest possible dose and the shortest possible duration of treatment necessary to achieve cure.
Use in children
Do not use in children under 2 years of age.
In children aged 2 years and older, Betnovate N ointment may be used for up to 5 days.
Do not use an occlusive (sealed) dressing in children. Ensure that the smallest required dose of the medicine is applied.
Use of a larger than recommended dose of Betnovate N ointment
In case of prolonged or improper use of the medicine, consult a doctor, as systemic adverse effects characteristic of corticosteroids (see sections 2 and 4) may occur, including acute adrenal insufficiency.
Missed dose of Betnovate N 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.
Stopping use of Betnovate N ointment
If you have any further doubts regarding 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 everyone experiences them.
To help prevent adverse reactions from occurring, the physician should ensure that the patient uses the lowest dose that provides therapeutic benefit.
Below are the adverse reactions observed in patients using this medicine.

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

• Local burning or skin pain and itching.

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

• Opportunistic infections (infections occurring in individuals with weakened immunity),
• Local hypersensitivity,
• Suppression of hypothalamic-pituitary-adrenal (HPA) axis function,
• Cushing's syndrome symptoms (e.g. moon face, central obesity),
• Delayed bone growth in children,
• Osteoporosis,
• Glaucoma,
• Hyperglycemia/glycosuria (excessively high blood sugar or sugar in urine),
• Cataract,
• Hypertension,
• Increased body weight or obesity,
• Decreased concentration of endogenous cortisol,
• Skin thinning or atrophy,
• Skin wrinkling,
• Dry skin,
• Striae (stretch marks),
• Telangiectasias (dilation of small blood vessels, so-called spider veins),
• Discoloration,
• Hirsutism (excessive hair growth),
• Alopecia (hair loss),
• Pseudofolliculitis,
• Worsening of symptoms of the treated condition,
• Allergic contact dermatitis/dermatitis,
• Erythema,
• Rash,
• Urticaria,
• Pustular psoriasis (see section 2),
• Pain or irritation at the application site.

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

• Blurred vision.

Because this medicine contains a potent corticosteroid, prolonged treatment may lead to local skin atrophic changes such as thinning, striae, and dilation of superficial blood vessels, particularly when the medicine is used in skin folds or under occlusive dressings.
If signs of hypersensitivity to the medicine occur, treatment should be discontinued immediately and the physician should be contacted without delay.
In rare cases, when used in the treatment of psoriasis, there is a risk of generalized pustular psoriasis.

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 Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warszawa
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions may also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Betnovate N ointment

Store below 30°C.
Keep the medicine in a place out of 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" means 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 N ointment contains
The active substances are micronized betamethasone valerate and neomycin sulfate.
1 g of ointment contains 1.22 mg of micronized betamethasone valerate and 5 mg of neomycin sulfate.
The other ingredients are: liquid paraffin, white soft paraffin.

What the medicine looks like and contents of the pack
Betnovate N is a smooth, transparent ointment of off-white colour.
Aluminium tube containing 15 g or 30 g of ointment, packed in a cardboard carton.

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