Betnovate N

Leaflet attached to the packaging: patient information

Betnovate N

(1.22 mg + 5 mg)/g, ointment
Betamethasone valerate + Neomycin sulfate

Please read the contents of the leaflet carefully before using the medicine, as it contains important information for the patient.

• Please keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should 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 inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Betnovate N ointment and what is it 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. Package contents and other information

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

The active substances of Betnovate N ointment are:

• betamethasone valerate - a corticosteroid with strong anti-inflammatory action,
• neomycin sulfate - an antibiotic that acts on most bacteria that cause inflammatory skin changes.

Betnovate N ointment is indicated for the local treatment of skin diseases that respond to corticosteroid therapy with accompanying or secondary bacterial infection, such as:

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

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,
• if the patient has anal or genital itching,
• if the patient has itching without inflammation,
• if the patient has viral skin infections,
• if the patient has skin lesions primarily infected with bacteria or fungi,
• if the patient has primary or secondary skin infections caused by yeast,
• if the patient has secondary infections caused by bacteria of the Pseudomonas and Proteus families,
• if the patient has otitis externa with perforation of the eardrum (risk of hearing damage in case of using neomycin-containing medications),
• long-term, in large doses, or on large skin surfaces due to the risk of hearing damage and kidney damage by neomycin, if significant absorption of the medicine into the body occurs.

Warnings and precautions

Before starting treatment with Betnovate N ointment, you should discuss it with your doctor or pharmacist.
The medicine should be used with caution in patients with hypersensitivity to topical corticosteroids, neomycin, and any excipients of Betnovate N ointment
(listed in section 6.). Local symptoms of hypersensitivity may resemble the symptoms of the treated
disease (see section 4.).
If symptoms of irritation or hypersensitivity reactions occur, you should stop using Betnovate N ointment and contact your doctor immediately.
In rare cases, medications like Betnovate N ointment may cause colitis (inflammation of the colon) – characterized by
diarrhea, usually bloody and containing mucus, abdominal pain, and elevated temperature (pseudomembranous colitis).

• In case of the above symptoms, you should inform your doctor as soon as possible.

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

• the potency and form of the corticosteroid for topical use,
• long-term use of the medicine,
• use on large body surfaces,
• use on tightly covered skin areas (e.g., in irritated areas or under an occlusive dressing), in small children, a diaper may act as an occlusive dressing,
• increased hydration of the stratum corneum,
• use on areas where the skin is thin - e.g., on the face,
• use on damaged skin or when the skin may be damaged.

The medicine should be used with caution in children, as children may absorb proportionally more topical corticosteroids than adults and may be more susceptible to systemic side effects.
Using corticosteroid medications on the face may lead (more often than when using them on other parts of the body) to skin atrophy. Therefore, you should use the medicine with caution on the face, especially in the case of psoriasis, lupus, and severe eczema.
Due to the neomycin content, the medicine may damage hearing (including hearing loss) and kidneys.
The medicine should be used with particular caution in elderly patients and patients with kidney function disorders.
Protect your eyes and mucous membranes from contact with the medicine. Avoid using the medicine on the eyelids, as getting the medicine into the conjunctival sac may lead to the development of glaucoma or cataracts.
If the patient experiences blurred vision or other vision disturbances, they should contact their doctor.
In case of persistent infection symptoms in the treated lesions, the doctor may decide to discontinue treatment and prescribe systemic antimicrobial medications.
If it is necessary to use the medicine under an occlusive dressing, the skin should be thoroughly cleaned before applying the dressing, as heat and moisture promote the development of bacterial infections.
Long-term or frequent use of Betnovate N ointment may lead to the development of hypersensitivity symptoms at the application site. In this case, you should contact your doctor or pharmacist.
Patient with psoriasis should be treated 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 symptoms,
• the risk of developing generalized pustular psoriasis,
• toxic effects resulting from excessive absorption of the medicine through damaged skin.

Corticosteroids are sometimes used topically in the treatment of skin inflammation in chronic leg ulcers. Using Betnovate N ointment in such cases is associated with a higher frequency of local hypersensitivity reactions and an increased risk of local infections.
Betnovate N ointment, like other antimicrobial medications, should not be diluted.

Betnovate N ointment and other medications

You should tell your doctor or pharmacist about all medications you are currently taking or have recently taken, as well as any medications you plan to take.
Concomitant use of certain medications, such as ritonavir, itraconazole, may enhance the effect of Betnovate N ointment.
Betnovate N ointment, due to its neomycin sulfate content, may enhance and prolong the depressant effect on the respiratory system of depolarizing muscle relaxants.
There is a risk of cumulative toxicity during concomitant use of Betnovate N ointment with systemically acting aminoglycosides.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine.
Using Betnovate N ointment during pregnancy or breastfeeding is not recommended.
Betnovate N ointment may be used during pregnancy and breastfeeding only if decided by your doctor.
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.

Driving and using machines

No effects of Betnovate N ointment on the ability to drive and use machines have been observed.

Betnovate N ointment contains paraffin

When using Betnovate N ointment, you should not smoke or approach an open flame 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 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 N ointment

This medicine should always be used as directed by your doctor. In case of doubts, you should consult your doctor or pharmacist.
You should be cautious when using the medicine in elderly patients and patients with kidney function disorders (see section 2) .
Betnovate N ointment is intended for use on the skin. The medicine is particularly suitable for use on dry, scaly, or flaky skin lesions.
A small amount of the medicine should be used to cover only the affected areas on the skin once or twice a day until improvement occurs, but no longer than for 7 days.
The ointment should be left on the skin to be absorbed, and then an emollient should be applied.
In resistant cases (e.g., psoriatic lesions on the elbows and knees), the doctor may recommend using an occlusive dressing (e.g., with polyethylene foil) only at night.
This usually brings about significant improvement, which can be maintained by regular use of the medicine without an occlusive dressing during the day.
If there is no improvement after 7 days of treatment, you should contact your doctor to determine further actions.
When using the medicine on the face, treatment should be limited to 5 days, and an occlusive dressing should not be used.
In elderly patients or those with kidney or liver failure, the medicine may be eliminated from the body more slowly, so the doctor will determine the smallest possible dose and the shortest possible treatment duration that allows the disease to be cured.

Use in children

Do not use in children under 2 years of age.
In children over 2 years of age, Betnovate N ointment can be used for up to 5 days.
In children, an occlusive dressing should not be used. You should ensure that the smallest required dose of the medicine is used.

Using more than the recommended dose of Betnovate N ointment

In case of prolonged or incorrect use of the medicine, you should contact your doctor, as systemic side effects characteristic of corticosteroids (see sections 2 and 4) may occur, including acute adrenal insufficiency.

Missing a dose of Betnovate N ointment

You should not use a double dose to make up for a missed dose. You should use the medicine as soon as possible, according to the recommended dosing schedule.

Stopping treatment with Betnovate N ointment

In case of any further doubts about using the medicine, you should consult your 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, your doctor should ensure that you use 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 or pain in the skin and itching.

Very rare side effects(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,
• Cushing's syndrome (e.g., moon face, central obesity),
• growth retardation in children,
• osteoporosis,
• glaucoma,
• hyperglycemia/glycosuria (elevated blood sugar or sugar in the urine),
• cataract,
• hypertension,
• weight gain or obesity,
• decreased endogenous cortisol levels,
• thinning or atrophy of the skin,
• wrinkling of the skin,
• dryness of the skin,
• stretch marks,
• telangiectasias (dilation of small blood vessels, so-called spider veins),
• discoloration,
• excessive hair growth,
• hair loss,
• hair shaft split,
• worsening of the symptoms of the treated disease,
• contact allergic dermatitis/skin inflammation,
• redness,
• rash,
• urticaria,
• psoriatic erythroderma (see section 2),
• pain or irritation at the injection site.

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

• blurred vision.

Due to the fact that the medicine contains a potent corticosteroid, long-term treatment may lead to local atrophic changes in the skin, such as thinning, stretch marks, and dilation of superficial blood vessels, especially when the medicine is used in skin folds or under an occlusive dressing.
If symptoms of hypersensitivity to the medicine occur, you should stop using the medicine and contact your doctor immediately.
In rare cases, during treatment of psoriasis, there is a risk of generalized pustular psoriasis.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products of 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
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 N ointment

Store at a temperature below 30°C.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after “EXP” and on the tube after “EXP”. The expiry date refers to the last day of the month.
The abbreviation “Lot” means the batch number of the product.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Betnovate N ointment contains

The active substances are betamethasone valerate and neomycin sulfate.
1 g of ointment contains 1.22 mg of betamethasone valerate and 5 mg of neomycin sulfate.
The other ingredients are: liquid paraffin, white petrolatum

What Betnovate N ointment looks like and contents of the pack

Betnovate N ointment is a smooth, transparent ointment with a broken white color.
An aluminum tube containing 15 g or 30 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, you should contact the representative of the marketing authorization holder:
GSK Services Sp. z o.o.
ul. Rzymowskiego 53
02-697 Warsaw
tel. (22) 576-90-00
Date of last revision of the leaflet:January 2025