Package leaflet: Information for the patient

NOVATE, 0.5 mg/g, ointment
Clobetasol propionate
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

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

Table of contents:

What NOVATE is and what it is used for
Important information before using NOVATE
How to use NOVATE
Possible side effects
How to store NOVATE
Contents of the pack and other information

1. What NOVATE is and what it is used for

NOVATE is an ointment containing clobetasol propionate – a very potent corticosteroid (adrenal cortex hormone) for topical use.
Clobetasol exerts a very strong anti-inflammatory, antipruritic (anti-itch), and vasoconstrictive effect.
Indications:
Short-term treatment of the most resistant skin diseases, such as:

Psoriasis (except widespread exfoliative type);
Lichen planus;
Chronic lichenoid dermatitis;
and other skin disorders which have not responded to treatment with weaker 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 itching;
in primary fungal (e.g. candidiasis) or bacterial skin infections (e.g. tinea);
under diapers, because diapers may act similarly to occlusive dressings;
in children under 1 year of age, including diaper dermatitis and diaper rash;
for prolonged periods, as atrophic skin changes may occur.

Warnings and precautions
Before starting treatment with medicine N, consult a doctor or pharmacist if:

during first-time 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 long time 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:

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

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

Children and adolescents
In children, during topical treatment with corticosteroids, the risk of suppression of the hypothalamic-pituitary-adrenal (HPA) axis is higher than in adults, due to the greater skin surface area to body weight ratio and consequently increased absorption of clobetasol through the skin.

Medicine N and other medicines
Inform the doctor about all medicines currently used or recently used, as well as any medicines the patient plans to use.

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

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

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

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

Medicine N contains propylene glycol.
The medicine contains 50 mg of propylene glycol in each gram of ointment. Propylene glycol may cause skin irritation.

3. How to use medicine N

This medicine should always be used exactly as directed by the physician. In case of doubt, consult
your doctor or pharmacist.
This medicine is intended for topical application to the skin.
Before applying medicine N, the affected skin area should be thoroughly cleaned and dried.
A small amount of the medicine is usually applied to the affected skin once daily until visible
improvement occurs. Treatment should be discontinued once 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 must be used on the facial skin, dressings should not be used, and treatment duration
should be limited to 5 days.
If the physician considers continued corticosteroid treatment necessary, a corticosteroid with weaker
activity than clobetasol should be used.
In cases of very resistant skin lesions, especially those accompanied by excessive keratosis, the
physician may recommend applying the medicine overnight under an occlusive dressing covered
with polyurethane film. Improvement is usually achieved after such treatment.
In subsequent treatment, application of 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 application over large skin areas may lead to overdose symptoms
such as edema, hypertension, hyperglycemia (elevated blood glucose levels), glycosuria, reduced
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 questions concerning the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Observed adverse effects include:

Common (in 1 to 10 people out of 100): burning sensation of the skin at the site of application;
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, i.e. Cushing's syndrome. The use of occlusive dressings (a diaper may also serve this purpose) 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 product is less than 50 g, suppression of adrenal function is reversible and quickly resolves after discontinuation of treatment.
Prolonged use of the medicine in the treatment of psoriasis may lead to more frequent relapses of the disease and resistance to further treatment; pustular psoriasis may also occur.
Excessive hair growth and skin pigmentation changes may occur.
With prolonged use, the medicine may cause local skin atrophy, such as thinning and striae, dilation of superficial blood vessels, particularly when occlusive dressings are used or the medicine is applied in skin folds.

Additional adverse effects in children
In children, additional adverse effects may include disturbances in growth and development.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the 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 cardboard packaging.
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 Novate contains

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

What Novate looks like and contents of the pack
Novate is a topical ointment of white appearance.
The container is an aluminium tube with an HDPE cap (for 30 g tubes) or 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
95-054 Ksawerów
Poland