Decloban 500 microgramos/g ointment

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

DECLOBAN 500 micrograms/g ointment

Clobetasol propionate

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Decloban ointment is and what it is used for
2. What you need to know before using Decloban ointment
3. How to use Decloban ointment
4. Possible adverse effects
5. Storage of Decloban ointment
6. Contents of the pack and other information

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

Declobán belongs to a group of medicines called potent topical corticosteroids.

Declobán is a medicine indicated for the 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 using Declobán ointment

Do not use Declobán:

• if you are allergic to clobetasol propionate, to other corticosteroids, or to any of the other ingredients of this medicine (listed in section 6).
• if you have rosacea (a chronic skin condition affecting the nose or surrounding areas, characterized by redness), acne, or perioral dermatitis (inflammation of the skin around the mouth).
• if you have itching (pruritus) 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 cases of dermatoses in children under 1 year of age, including diaper rash and skin inflammation or rashes caused by diapers.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Declobán ointment:

• If you experience new-onset bone pain or worsening of pre-existing bone symptoms during treatment with Declobán ointment, especially if you have been using Declobán ointment for a prolonged or repeated period.
  • If you are taking any other oral or topical medication containing corticosteroids, or medications to suppress your immune system (e.g. for autoimmune disease or after organ transplant). Combining Declobán ointment with these medicines may lead to serious infections.
  • Continuous treatment over large skin areas and for long periods should be avoided, especially in infants and children. When used in children, strict weekly medical supervision is required, and the treated area should not be covered. Bear in mind that diapers may act as an occlusive dressing.
  • This ointment should not be used on the face unless explicitly directed by your doctor, as it may alter the thickness of your skin.
  • Special caution is advised if you are being treated for psoriasis; strict medical supervision is recommended.
  • When applying near the eyelids, care must be taken to avoid contact with the eyes, as this may increase intraocular pressure. If contact occurs, rinse the eyes thoroughly with plenty of water. If irritation persists, consult your doctor.
  • If the skin lesions become infected, inform your doctor so appropriate treatment can be provided.
  • The recommended maximum dose must not be exceeded (see section 3).
  • Contact your doctor if you experience blurred vision or any other visual disturbances.

Using Declobán with other medicines

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines, including those obtained without a prescription, especially if you are being treated with other steroids.

Pregnancy and breastfeeding:

Consult your doctor or pharmacist before using any medicine.

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

Driving and using machines:

Treatment with Declobán does not affect your ability to drive or operate machinery.

Important information about some of the ingredients of Declobán ointment

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

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

3. How to use Declobán ointment

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will determine the number of applications and the duration of your treatment with Declobán.

Declobán should be applied to the affected area once or twice daily. The recommended duration of treatment should not exceed 4 weeks.

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

Apply the ointment to the clean affected skin area.

Gently massage until the ointment is completely absorbed. Wash your hands after applying the ointment, unless the hands themselves are being treated.

Do not cover the area with occlusive dressings unless instructed to do so by your doctor.

Use in children and adolescents:

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

If you use more Declobán ointment than you should

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

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

If you forget to use Declobán ointment

If you forget to apply the ointment, apply the missed dose as soon as possible. However, if it is almost time for the next dose, wait and apply the next dose at the scheduled time.

Do not use a double dose to make up for a missed dose.

If you stop using Declobán ointment

Your doctor will determine the number of applications and the duration of your treatment with Declobán. Do not stop the treatment prematurely, as the expected effects will not be achieved, nor stop abruptly, especially if your doctor has instructed you to use the ointment for a prolonged period. Discontinuation after long-term treatment should be gradual, by increasing the intervals between applications or by switching to a less potent or less concentrated corticosteroid.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

Declobán may cause some adverse effects, such as:

Uncommon (affects between 1 and 10 out of 1,000 patients):

• Atrophic skin changes such as thinning, striae, and dilation of superficial blood vessels, especially when occlusive dressings are used or skin folds are affected.
• Changes in skin color at the application site.
• Hypersensitivity reactions. If signs of allergy occur, treatment must be stopped immediately.

Rare (affects between 1 and 10 out of 10,000 patients):

• 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, irritated skin).
• Decrease in hormone levels from the adrenal glands, especially with prolonged use of high doses or treatment over extensive areas.

Very rare (affects fewer than 1 out of 10,000 patients):

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

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

• Blurred vision.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Declobán 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 refers to the last day of the month indicated. Once opened, the medicine can be kept for 2 months.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Declobán ointment

• The active substance is clobetasol propionate, 500 micrograms per gram. Each 100 grams of ointment contain 50 mg of clobetasol propionate.
• The other components are propylene glycol, sorbitan sesquioleate, and white soft paraffin.

Appearance of the product and contents of the container

Declobán is presented as a white to yellowish ointment in tubes 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 most recent revision of this leaflet: January 2021