Novate

Package leaflet: Information for the user

NOVATE, 0.5 mg/g, cream
Clobetasol propionate
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What NOVATE is and what it is 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 NOVATE is and what it is used for

NOVATE is a cream containing clobetasol propionate – a corticosteroid (adrenal cortex hormone) for topical use with very potent activity.
Clobetasol has strong anti-inflammatory, antipruritic (anti-itch), and vasoconstrictive effects.
Indications:
Short-term treatment of the most resistant skin disorders, such as:

• psoriasis (except widespread exudative forms);
• lichen planus;
• chronic lichenoid dermatitis; and other skin diseases which have not responded to treatment with less potent corticosteroids.

2. Important information before using medicine N

When not to use medicine N:

• if the patient is allergic to clobetasol propionate or any of the other ingredients of this medicine (listed in section 6);
• in rosacea;
• in acne vulgaris;
• in perioral dermatitis;
• in primary viral skin infections (e.g. herpes simplex, varicella);
• in anal or genital pruritus;
• in primary fungal (e.g. candidiasis) or bacterial skin infections (e.g. tinea);
• under diapers, because diapers may act like occlusive dressings;
• in children under 1 year of age, including diaper dermatitis and diaper rash;
• long-term use, as skin atrophy may occur.

Warnings and precautions
Before starting treatment with medicine N, discuss with your doctor or pharmacist if:

• during the first use of medicine N, the patient experiences bone pain or worsening of pre-existing bone symptoms, especially if the patient has been using medicine N for a prolonged period or repeatedly.
• the patient is taking orally or topically other medicines containing corticosteroids or medicines intended to regulate immune system function (e.g. in autoimmune diseases or after organ transplantation). Concomitant use of medicine N with these medicines may lead to severe infections.

If skin irritation or allergic reactions occur, treatment should be discontinued and the patient should contact a doctor.
If the patient experiences blurred vision or other visual disturbances, they should contact a doctor.
Avoid:

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

This should be kept in mind especially when initiating treatment for conditions such as: psoriasis, chronic discoid lupus erythematosus, or various types of dermatitis.
Patients with psoriasis should use the medicine with caution due to the risk of disease recurrence caused by development of tolerance, risk of generalized pustular psoriasis, and systemic toxic effects resulting from impaired skin integrity.
In treating infected skin lesions, the doctor may prescribe antibacterial or antifungal treatment. If bacterial or fungal infection occurs during treatment, the doctor will decide whether to discontinue this medicine and initiate systemic antibacterial or antifungal therapy. Bacterial infections may be caused, among other factors, by favorable conditions (warmth and moisture) created by the use of occlusive dressings.

Children and adolescents
Do not use in children under 1 year of age.
In children, during topical corticosteroid treatment, the risk of hypothalamic-pituitary-adrenal axis suppression is higher than in adults, due to a greater skin surface area to body weight ratio and consequently increased absorption of clobetasol through the skin.

Other medicines
Inform your doctor about all medicines currently or recently used, as well as any medicines you plan to use.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
Medicine N must not be used during pregnancy unless absolutely necessary in the opinion of the doctor. The medicine should not be used by women who are planning to become pregnant.

Breastfeeding
Medicine N must not be used during breastfeeding unless absolutely necessary in the opinion of the doctor.
If use is necessary, breastfeeding women should not apply the medicine directly to the breasts immediately before breastfeeding.

Driving and operating machinery
Medicine N has no effect on the ability to drive or operate machinery.

The medicine contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) and propylene glycol.
Medicine N contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216), which may cause allergic reactions (including delayed-type reactions).
The medicine contains 150 mg of propylene glycol in each gram of cream. Propylene glycol may cause skin irritation.

3. How to use medicine N

This medicine should always be used according to the doctor's instructions. In case of doubts, consult
your doctor or pharmacist.
This medicine is intended for topical application on the skin.
Before applying medicine N, thoroughly clean and dry the affected skin area.
A small amount of the medicine is usually applied to the affected skin once daily, until visible
improvement occurs. Treatment should be discontinued after skin symptoms have resolved.
In the most resistant cases, this occurs within a few days.
Treatment should not last longer than 2 weeks, and the amount of medicine used per week must not
exceed 50 g.
If medicine N needs to be applied to the facial skin, do not use dressings, and limit treatment duration
to 5 days.
If the doctor considers continued corticosteroid treatment necessary, a corticosteroid with weaker
activity than clobetasol will be used.
In cases of very resistant lesions, especially when accompanied by excessive keratosis, the doctor
may recommend applying the medicine overnight under an occlusive dressing covered with
polyurethane film. Improvement is usually achieved after such treatment.
In subsequent treatment, applying the medicine without a dressing is usually sufficient.
Use in children and adolescents
Medicine N should not be used in children under 1 year of age.
Use of a higher than recommended dose of medicine N
Prolonged use of the medicine or its application over a large skin surface may lead to symptoms of
overdose, such as edema, hypertension, hyperglycemia (excessively high blood sugar concentration),
glucosuria, decreased immunity, and in severe cases, Cushing's disease.
Prolonged use of the medicine may lead to suppression of adrenal axis function.
Missed dose of medicine N
Do not use a double dose to make up for a missed dose.
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 everybody will experience them.
The adverse reactions observed are:

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

With prolonged local use of the medicine, use in large doses or over large areas of skin, systemic adverse effects of corticosteroids may occur in both children and adults, known as Cushing's syndrome. The use of occlusive dressings (which may also be fulfilled by diapers) may contribute to the occurrence of Cushing's syndrome symptoms, as they enhance absorption of clobetasol from the skin surface. If the weekly dose of the medicine is less than 50 g, suppression of adrenal function is reversible and quickly resolves after discontinuation of treatment.

With prolonged use of the medicine in the treatment of psoriasis, disease relapses may occur more frequently, resistance to further treatment may develop, and pompholyx (dyshidrotic) psoriasis may appear.

Excessive hair growth and skin pigmentation changes may also occur.

During prolonged use, the medicine may cause local atrophic skin changes such as thinning and striae, dilation of superficial blood vessels, particularly when occlusive dressings have been used or skin folds have been treated.

Additional adverse reactions in children:

In children, disturbances in growth and development may additionally occur.

Reporting of adverse reactions

If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions 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

Adverse reactions can also be reported to the marketing authorization holder.

Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store medicine N

Keep this medicine out of sight and reach of children.
Store below 30°C.
Do not use this medicine after the expiry date stated on the tube and the cardboard box.
The expiry date refers to the last day of the stated month.
Medicines must 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 the medicine 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 the medicine looks like and contents of the pack
N is a topical medicine in the form of a white cream.
The container is an aluminium tube with an HDPE cap (for 30 g tubes) or a PP cap (for 45 g and 60 g tubes), packed in a cardboard box.
Pack sizes:
1 tube containing 30 g
1 tube containing 45 g
1 tube containing 60 g
Not all pack sizes may be marketed.

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

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