NOVATE 0.5 mg/g Ointment

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. NOVATE, 0.5 mg/g, ointment
   1. Read the leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
3. What is Novate and what is it used for
   1. Indications for use:
4. Important information before using Novate
   1. When not to use Novate:
   2. Warnings and precautions
   3. Children and adolescents
   4. Novate and other medicines
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
   7. Novate contains propylene glycol.
5. How to use Novate
   1. Use in children and adolescents
   2. Using more than the recommended dose of Novate
   3. Missing a dose of Novate
6. Possible side effects
   1. Additional side effects in children
   2. Reporting side effects
7. How to store Novate
8. Package contents and other information
   1. What Novate contains
   2. What Novate looks like and what the package contains
   3. Marketing authorization holder
   4. Manufacturer
   5. Date of the last update of the leaflet: January 2021

Leaflet attached to the packaging: patient information

NOVATE, 0.5 mg/g, ointment

Clobetasol propionate

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your 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 tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Novate and what is it used for
• 2. Important information before using Novate
• 3. How to use Novate
• 4. Possible side effects
• 5. How to store Novate
• 6. Package contents and other information

1. What is Novate and what is it used for

Novate is a medicine in the form of an ointment, containing clobetasol propionate - a corticosteroid (adrenal cortex hormone) for topical use with very strong effects.
Clobetasol has a very strong anti-inflammatory, anti-itching, and vasoconstrictive effect.

Indications for use:

Short-term treatment of the most resistant skin diseases, such as:

• psoriasis (except for widespread pustular form);
• lichen planus;
• chronic eczema; and other skin diseases, whose treatment with weaker corticosteroids has been ineffective.

2. Important information before using Novate

When not to use Novate:

• if the patient is allergic to clobetasol propionate or any other component of this medicine (listed in section 6);
• in rosacea;
• in common acne;
• in perioral dermatitis;
• in primary viral skin infections (e.g., herpes simplex, chickenpox);
• in anal or genital itching;
• in primary fungal (e.g., candidiasis) or bacterial skin infections (e.g., impetigo);
• on skin under a diaper, as the diaper may act like an occlusive dressing;
• in children up to 1 year of age, including diaper rash and skin eruptions;
• for a long time, as atrophy may occur on the skin.

Warnings and precautions

Before starting to use Novate, discuss it with your doctor or pharmacist if:

• when using Novate for the first time, the patient experiences bone pain or worsening of pre-existing bone symptoms, especially if the patient uses Novate for a long time or repeatedly.
• the patient is taking other corticosteroid medicines orally or topically, or medicines to regulate the immune system (e.g., in autoimmune diseases or after organ transplantation). The combined use of Novate with these medicines may lead to severe infections.

If signs of skin irritation or allergic reaction occur, treatment should be discontinued and the doctor consulted.
If the patient experiences blurred vision or other vision disturbances, they should consult their doctor.
The following should be avoided:

• long-term use: topically used corticosteroids may be absorbed into the body and cause suppression of the hypothalamic-pituitary-adrenal axis and the occurrence of Cushing's syndrome symptoms (especially in children), see also section 4;
• use on large areas of skin;
• use under an occlusive dressing;
• contact with mucous membranes;
• contact with the eyes, as it may cause glaucoma or exacerbate its symptoms;
• use on damaged skin;
• use on the skin of the face, as atrophy may occur, especially during prolonged treatment.

This should be remembered, especially when starting treatment for diseases such as psoriasis, chronic eczema, or various types of eruptions.
Patients with psoriasis should use the medicine with caution due to the risk of disease relapse caused by the development of tolerance, the risk of generalized pustular psoriasis, and general toxic effects caused by skin continuity disorders.
In the case of treating infected skin lesions, the doctor will use antibacterial or antifungal treatment. If a bacterial or fungal infection occurs during treatment, the doctor will decide whether to discontinue the use of this medicine and use systemic antibacterial and antifungal medicines. The cause of bacterial infections is, among other things, the favorable conditions (heat and humidity) created by the use of occlusive dressings.

Children and adolescents

In children, the risk of suppressing the hypothalamic-pituitary-adrenal axis is greater than in adults, due to the larger ratio of skin surface to body weight and the associated increased absorption of clobetasol through the skin.

Novate and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Pregnancy
Novate should not be used during pregnancy unless the doctor considers it absolutely necessary. The medicine should not be used by women who plan to become pregnant.
Breastfeeding
Novate should not be used during breastfeeding unless the doctor considers it absolutely necessary. If necessary, breastfeeding women should not apply the medicine to their breasts immediately before breastfeeding.

Driving and using machines

Novate has no effect on the ability to drive or operate machines.

Novate contains propylene glycol.

The medicine contains 50 mg of propylene glycol per gram of ointment. Propylene glycol may cause skin irritation.

3. How to use Novate

This medicine should always be used as directed by the doctor. If in doubt, consult the doctor or pharmacist.
The medicine is intended for topical use on the skin.
Before applying Novate, the affected skin area should be thoroughly cleaned and dried.
A small amount of the medicine is usually applied to the affected skin once a day until visible improvement is achieved. Treatment should be discontinued after the skin symptoms have resolved.
In the case of the most resistant skin diseases, this occurs within a few days.
Treatment should not last longer than 2 weeks, and the amount of medicine used in a week should not exceed 50 g.
If Novate needs to be used on the skin of the face, dressings should not be used, and the treatment time should be limited to 5 days.
If the doctor considers it necessary to continue corticosteroid treatment, they will prescribe a medicine containing a corticosteroid with a weaker effect than clobetasol.
In the case of very resistant skin lesions, especially when accompanied by excessive hyperkeratosis, the doctor may recommend applying the medicine under an occlusive dressing covered with a polyurethane film at night. After using such a dressing, improvement is usually achieved.
In further treatment, it is usually sufficient to use the medicine without a dressing.

Use in children and adolescents

Novate should not be used in children up to 1 year of age.

Using more than the recommended dose of Novate

After long-term use of the medicine or using it on a large skin area, overdose symptoms may occur, such as edema, hypertension, hyperglycemia (excessive blood sugar levels), glycosuria, decreased immunity, and in severe cases, Cushing's syndrome.
Long-term use of the medicine may lead to suppression of adrenal function.

Missing a dose of Novate

A double dose should not be used to make up for a missed dose.
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Novate can cause side effects, although not everybody gets them.
The observed side effects include:

• often (in 1 to 10 people out of 100): burning sensation of the skin at the application site;
• frequency not known: itching, skin atrophy (thinning), skin cracking and striae, secondary infections, rash, contact dermatitis, folliculitis, worsening of disease symptoms, blurred vision.

In the case of long-term topical use of the medicine, using it in large doses or on large skin areas, systemic side effects of corticosteroids may occur, known as Cushing's syndrome. The use of occlusive dressings (which can also be a diaper) may contribute to the occurrence of Cushing's syndrome symptoms, as they increase the absorption of clobetasol from the skin surface. If the weekly dose of the product is less than 50 g, the suppression of adrenal function is reversible and quickly resolves after treatment is discontinued.
In the case of long-term use of the medicine in the treatment of psoriasis, more frequent relapses of the disease and resistance to further treatment may occur, and pustular psoriasis may also occur.
Excessive hair growth and skin discoloration may occur.
During long-term use, the medicine may cause local atrophic skin changes, such as thinning and striae, dilation of superficial blood vessels, especially when occlusive dressings or skin folds are used.

Additional side effects in children

In children, additional side effects may include growth and development disorders.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor should be informed. Side effects can be reported directly to the Department of Pharmacovigilance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw
Phone: +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 gather more information on the safety of the medicine.

5. How to store Novate

The medicine should be stored out of sight and reach of children.
Store at a temperature below 30°C.
Do not use this medicine after the expiry date stated on the tube and carton.
The expiry date is the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be consulted on how to dispose of unused medicines. This will help protect the environment.

6. Package contents and other information

What Novate contains

• The active substance of the medicine is clobetasol propionate in an amount of 0.5 mg per 1 g of ointment.
• The other ingredients are: sorbitan sesquioleate, propylene glycol, white petrolatum.

What Novate looks like and what the package contains

Novate is a medicine for external use in the form of a white ointment.
The packaging consists of an aluminum tube with a PP cap in a carton.
Package sizes:
1 tube of 30 g
1 tube of 45 g
1 tube of 60 g
Not all package sizes may be available.

Marketing authorization holder

Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland

Manufacturer

EMO-FARM Sp. z o.o.
Łódzka Street 52
95-054 Ksawerów

Date of the last update of the leaflet: January 2021