Betnovate Ointment and Cream 0.1% 30 G

1. What BETNOVATE is and what it is used for

BETNOVATE contains a medicine called betamethasone valerate and is available in ointment form, in tubes of 5 g, 15 g and 30 g.

BETNOVATE belongs to a group of drugs called steroids. It helps to relieve swelling and irritation on the skin.

BETNOVATE is used in the treatment of the following diseases:

Eczema (an inflammatory skin disease)

Prurigo nodularis (a skin disease that causes severe itching, rash and blisters), Psoriasis (except for types with widespread plaques)

Neurodermatitis, including lichen planus and lichen simplex (benign skin disease affecting the skin, skin appendages, and mucous membranes)

Seborrheic dermatitis (an inflammatory and itchy skin disease usually seen in oily parts of the skin)

contact sensitivity reactions

Discoid lupus erythematosus (a skin disease that usually causes plaque formation on the face) Diffuse erythroderma (severe rash) in addition to systemic steroid therapy

Insect bites and rash.

2.How to use BETNOVATE?

Instructions for proper use and dose/frequency of administration

Unless recommended otherwise by the physician;

BETNOVATE is applied in a thin layer, in an amount to softly cover the affected area, once or twice a day for 4 weeks until improvement is achieved. Then the frequency of administration is reduced or the treatment is changed to a less potent drug. Adequate time should be allowed for absorption before applying an emollient after each application. BETNOVATE ointment is suitable for dry, hard and flaking lesions.

Application route and method

BETNOVATE, if necessary, can increase the effect of the cream by applying occlusion (covering the skin with a dressing) to the treatment area in more resistant injuries such as thick psoriasis plaques on the elbows and knees. In these cases, it is usually sufficient to cover the skin with a bandage at night. Afterwards, healing is maintained with normal application without closing the skin.

If the condition worsens or does not improve in 2-4 weeks, treatment and diagnosis should be reassessed.

Atopic dermatitis (allergic skin reactions)

Once control is achieved, treatment should be tapered off and an emollient should be used as maintenance therapy. Sudden discontinuation of treatment may lead to worsening of the skin event.

Treatment-resistant skin disorders

With frequent use in recurrent events, treatment can be continued intermittently (once a day, twice a week, without closed therapy) after symptoms have been treated.

Application should be continued to previously affected areas or areas with potential for recurrence. This regimen should be applied in conjunction with a routine daily emollient. The condition and the benefits and risks of continued treatment should be reassessed regularly.

Use in children

Use in the elderly

It should not be used for more than 5 days and the skin should not be closed after the application. It should be administered in the smallest amount that provides benefit in children.

Use in the elderly

It should be used in the lowest amount and for the shortest time to achieve the desired clinical effect.

Special use cases

Kidney/liver failure:

It should be used in the lowest amount and for the shortest time to achieve the desired clinical effect.

If you have the impression that the effect of BETNOVATE is too strong or too weak, talk to your doctor or pharmacist.

3. What are the possible side effects?

Like all medicines, there may be side effects in people who are sensitive to the substances contained in BETNOVATE.

Stop using BETNOVATE and IMMEDIATELY tell your doctor:

If there is worsening or swelling of the skin at the treatment site. You may be allergic to BETNOVATE, have an infection, or require other treatment.

If you have psoriasis, swelling may develop under the skin with inflammation. This is very rare.

Side effects are classified as shown in the following categories:

It can be seen in at least one of 10 patients.

Very common: Common:

Uncommon: Rare:

Very rare: Not known:

It can be seen less than one in 10 patients, but more than one in 100 patients. It can be seen less than one in 100 patients, but more than one in 1,000 patients.

It can be seen in less than one in 1,000 patients.

It can be seen in less than one in 10,000 patients.

It cannot be estimated from the available data.

Common side effects

• Itching, burning and pain on the skin

Very rare side effects

weight gain
Lunar grandfather face / rounding of the face
Obesity
skin thinning
skin wrinkle
dry skin

• Appearance of blood vessels under the skin surface
change in skin color
increase in body hair

• Hair loss/non-growth/thinning of hair
Allergic reaction at the application site
worsening of skin condition
Irritation at the application site
redness
rash, itching
Inflammatory bumps if you have psoriasis
skin infection