NOVATE 0.5 mg/g Cream

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. NOVATE, 0.5 mg/g, Cream
   1. Read the package 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:
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 methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) and 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. Reporting side effects
7. How to store Novate
8. Contents of the pack and other information
   1. What Novate contains
   2. What Novate looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. Date of last revision of the leaflet: January 2021

Package Leaflet: Information for the Patient

NOVATE, 0.5 mg/g, Cream

Clobetasol Propionate

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your 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. Contents of the pack and other information

1. What is Novate and what is it used for

Novate is a cream containing clobetasol propionate, a corticosteroid (adrenal cortex hormone) for topical use, with very strong effects. Clobetasol has very strong anti-inflammatory, anti-itching, and vasoconstrictive effects.

Indications:

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

• psoriasis (except for widespread pustular form);
• lichen planus;
• chronic discoid lupus erythematosus; and other skin diseases that have not responded to treatment with weaker corticosteroids.

2. Important information before using Novate

When not to use Novate:

• if you are allergic to clobetasol propionate or any of the other ingredients of this medicine (listed in section 6);
• in rosacea;
• in acne;
• in perioral dermatitis;
• in primary viral skin infections (e.g. herpes simplex, chickenpox);
• in anal and 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 under 1 year of age, including diaper rash;
• for a long time, as it may cause skin atrophy.

Warnings and precautions

Before starting treatment with Novate, discuss with your doctor or pharmacist if:

• you experience bone pain or worsening of existing bone symptoms during treatment with Novate, especially if you use it for a long time or repeatedly.
• you are taking other corticosteroid medicines orally or topically, or medicines that affect the immune system (e.g. in autoimmune diseases or after organ transplantation). Using Novate with these medicines may lead to serious infections.

If you experience skin irritation or allergic reactions, stop treatment and consult your doctor. If you experience blurred vision or other vision disturbances, consult your doctor. You should avoid:

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

Remember this, especially when starting treatment for diseases such as psoriasis, chronic discoid lupus erythematosus, or various types of eczema. Patients with psoriasis should use the medicine with caution due to the possible recurrence of the disease caused by the development of tolerance, the risk of generalized pustular psoriasis, and general toxic effects caused by skin barrier disruption. When 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 stop using this medicine and use systemic antibacterial or 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

Do not use in children under 1 year of age. In children, the risk of suppression of 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

Tell your doctor about all medicines you are taking, have recently taken, or plan to take.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before using this medicine. Pregnancy Novate should not be used during pregnancy unless your doctor considers it absolutely necessary. It should not be used by women who are planning to become pregnant. Breastfeeding Novate should not be used during breastfeeding unless your doctor considers it absolutely necessary. If necessary, breastfeeding women should not apply the medicine to the breasts immediately before breastfeeding.

Driving and using machines

Novate has no influence on the ability to drive and use machines.

Novate contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) and propylene glycol.

Novate contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216), which may cause allergic reactions (possible late reactions). The medicine contains 150 mg of propylene glycol in each gram of cream. Propylene glycol may cause skin irritation.

3. How to use Novate

Always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. The medicine is for topical use on the skin. Before applying Novate, wash and dry the affected skin area. A small amount of the medicine is usually applied to the affected skin once a day, until a visible improvement is achieved. Treatment should be stopped when the skin symptoms disappear. In the case of the most resistant skin diseases, this usually 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. When using Novate on the face, do not use occlusive dressings, and limit the treatment to 5 days. If your doctor decides that it is necessary to continue treatment with corticosteroids, a medicine with a weaker corticosteroid will be used. In the case of very resistant skin lesions, especially when accompanied by hyperkeratosis, the doctor may recommend applying the medicine under an occlusive dressing covered with a polyurethane film at night. After using such a dressing, an improvement is usually achieved. In further treatment, it is usually sufficient to use the medicine without a dressing.

Use in children and adolescents

Do not use Novate in children under 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, symptoms of overdose 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

Do not use a double dose to make up for a missed dose. If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

• often (in 1 to 10 people in 100): burning sensation of the skin at the application site;
• frequency not known: itching, skin atrophy (thin skin), 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, known as Cushing's syndrome, may occur in both children and adults. The use of occlusive dressings (which can also be a diaper) may contribute to the occurrence of Cushing's syndrome, as it increases the absorption of clobetasol from the skin surface. If the weekly dose of the medicine is less than 50 g, the suppression of adrenal function is reversible and quickly disappears after stopping treatment. In the case of long-term treatment of psoriasis, relapses of the disease and resistance to further treatment may occur more frequently, as well as the occurrence of pustular psoriasis. Excessive hair growth and skin discoloration may also occur. During long-term use of the medicine, local atrophic skin changes may occur, such as thinning and striae, dilation of superficial blood vessels, especially when using occlusive dressings or treating skin folds. Additional side effects in children: In children, growth and development disorders may also occur.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor. Side effects can be reported directly to the Department of Post-Marketing Surveillance 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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Novate

Keep this medicine out of the sight and reach of children. Store in a temperature below 30°C. Do not use this medicine after the expiry date stated on the tube and carton. The expiry date refers to the last day of the month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Novate contains

• The active substance is clobetasol propionate, 0.5 mg in 1 g of cream.
• The other ingredients are: carbomer 1342, carbomer copolymer (type B), liquid paraffin, propylene glycol, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), disodium edetate, triethanolamine, purified water.

What Novate looks like and contents of the pack

Novate is a white or white with a pink to light gray color cream for external use. The pack consists of an aluminum tube with a PP cap in a carton. Pack sizes: 1 tube of 30 g, 1 tube of 45 g, 1 tube of 60 g. Not all pack sizes may be marketed.

Marketing authorization holder

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

Manufacturer

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

Date of last revision of the leaflet: January 2021