DECLOBAN 500 micrograms/g OINTMENT

Introduction

Package Leaflet: Information for the Patient

DECLOBAN 500 micrograms/g ointment

Clobetasol propionate

Read this package leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this package 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet:

1. What is Decloban ointment and what is it used for
2. What you need to know before you start using Decloban ointment
3. How to use Decloban ointment
4. Possible side effects
5. Storage of Decloban ointment
6. Package contents and further information

1. What is Decloban ointment and what is it used for

Decloban belongs to a group of medicines called very potent topical corticosteroids.

Decloban is a medicine indicated for short-term topical treatment of dermatoses (skin conditions) such as psoriasis (excluding generalized plaque psoriasis), eczemas resistant to other topical corticosteroids, lichen planus, discoid lupus erythematosus, and other skin conditions that do not respond satisfactorily to less potent topical corticosteroids.

2. What you need to know before you start using Decloban ointment

Do not use Decloban:

• if you are allergic to clobetasol propionate, other corticosteroids, or any of the other ingredients of this medicine (listed in section 6).
• if you have rosacea (a chronic skin condition of the nose or surrounding area characterized by redness), acne, dermatitis (inflammation of the skin) around the mouth.
• if you have pruritus (itching) in the perianal or genital area.
• if you have a skin infection caused by bacteria (e.g., impetigo), fungi (e.g., candidiasis, ringworm), or viruses (e.g., herpes simplex, chickenpox).
• in case of dermatoses in children under 1 year, including dermatitis (inflammation of the skin) and diaper rash.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Decloban ointment.

• If you experience recent onset bone pain or worsening of previous bone symptoms during treatment with Decloban ointment, especially if you have been using Decloban ointment for a prolonged period or repeatedly.
• If you are using another medicine orally or topically that contains corticosteroids or medicines for controlling your immune system (e.g., autoimmune disease or after a transplant). The combination of Decloban ointment with these medicines may result in serious infections.
• Continuous treatment, in large areas, and for long periods should be avoided, especially in infants and children. If administered to children, strict medical supervision should be performed every week, and the affected area should not be covered. It should be taken into account that the diaper can act as an occlusive dressing.
• The cream should not be used on the face, unless explicitly indicated by your doctor, as it can alter the thickness of your skin.
• Special care should be taken if you are being treated for psoriasis, and strict medical supervision is recommended.
• When applied to the eyelids, care should be taken to ensure that the preparation does not penetrate the eyes, as it has been seen to increase intraocular pressure. If this occurs, rinse your eyes with plenty of water. If irritation persists, consult your doctor.
• If the lesions become infected, inform your doctor to receive appropriate treatment.
• Do not exceed the maximum recommended dose (see section 3).
• Contact your doctor if you experience blurred vision or other visual disturbances.

Using Decloban with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might use another medicine, including those obtained without a prescription, especially if you are receiving treatment with other steroids.

Pregnancy and breastfeeding:

Consult your doctor or pharmacist before using any medicine.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines:

Treatment with Decloban does not affect your ability to drive or use machines.

Important information about some of the ingredients of Decloban ointment

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

Do not use this medicine in babies under 4 weeks with open wounds or large areas of damaged skin (such as burns) without consulting your doctor or pharmacist first.

3. How to use Decloban ointment

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Your doctor will indicate the number of applications and the duration of your treatment with Decloban.

Decloban should be applied to the affected area once or twice a day. The recommended treatment duration should not exceed 4 weeks.

No more than 50 grams of ointment should be used per week in adult patients, or proportional doses in children (see "Warnings and precautions").

Apply the ointment to the previously cleaned skin of the affected area.

Gently massage until the ointment is fully absorbed. Wash your hands after applying the ointment, unless you are treating your hands.

Do not cover the area with occlusive dressings unless your doctor indicates otherwise.

Use in children and adolescents:

Decloban is contraindicated in children under 1 year (see section 2). Long-term treatment should be avoided, especially in infants and children.

If you use more Decloban ointment than you should

If you have applied more Decloban than you should, consult your doctor or pharmacist.

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Phone 91 562 04 20.

If you forget to use Decloban ointment

If you forget to apply the ointment, apply the corresponding dose as soon as possible, or if the next application is near, wait until then.

Do not use a double dose to make up for forgotten doses.

If you stop using Decloban ointment

Your doctor will indicate the number of applications and the duration of your treatment with Decloban. Do not stop treatment before, as the expected effects will not be achieved, nor abruptly, especially if your doctor indicates that the ointment should be applied for a prolonged period. The cessation of prolonged treatment should be gradual, spacing out applications or administering a less active or less concentrated corticosteroid.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Decloban can cause some side effects, such as:

Uncommon (affects 1 to 10 users in 1,000):

• Atrophic changes in the skin, such as thinning, stretch marks, and dilation of superficial blood vessels, especially when using occlusive dressings or when skin folds are affected.
• Changes in skin color at the application site.
• Hypersensitivity reactions. If signs of allergy appear, treatment should be discontinued immediately.

Rare (affects 1 to 10 users in 10,000):

• Hypertrichosis (changes in hair growth).
• Increased intraocular pressure.
• When used for the treatment of psoriasis, it may worsen, leading to pustular psoriasis (white blisters surrounded by red and irritated skin).
• Decreased levels of hormones from the adrenal glands, especially with prolonged use of high amounts or treatment of extensive areas.

Very rare (affects less than 1 user in 10,000):

• Hypercorticism (hormonal disorder due to prolonged exposure to high levels of corticosteroids).
• Glaucoma.

Frequency not known (cannot be estimated from the available data):

• Blurred vision.

If you experience any side effect, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Decloban ointment

Keep this medicine out of the sight and reach of children.

Do not store above 25°C.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Once opened, it can be stored for 2 months.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

.

6. Package contents and further information

Composition of Decloban ointment

• The active ingredient is clobetasol propionate, 500 micrograms per gram. Each 100 grams of ointment contains 50 mg of clobetasol propionate.
• The other ingredients are propylene glycol, sorbitan sesquioleate, and petrolatum.

Appearance of the product and package contents

Decloban is presented as a white to yellowish ointment, in containers containing 15 g and 30 g of ointment.

Marketing authorization holder and manufacturer

Teofarma S.r.l.

Via F.lli Cervi, 8

I-27010 Valle Salimbene

Pavia-Italy

Date of the last revision of this package leaflet:January 2021