Product Information for the Patient

DECLOBÁN 500 microgramos/g ointment

Clobetasol propionate

Read this entire product information carefully before starting to use this medication, as it contains important information for you.

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

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

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

Do not use Declobán:

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use Declobán ointment

- If you experience recent bone pain or worsening of previous bone symptoms during treatment with Declobán ointment, especially if you have been using Declobán ointment for a prolonged period of time or repeatedly.

• If you are using another oral or topical medication that contains corticosteroids or immunosuppressive medications (e.g. autoimmune disease or after a transplant). The combination of Declobán ointment with these medications may result in severe infections.
• Continuous treatment in extensive areas and for long periods of time 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. The diaper can act as an occlusive dressing.
• Do not use the cream on the face, unless explicitly indicated by your doctor, as it may 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, be careful not to let the preparation penetrate the eyes, as it may 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 the appropriate treatment.
• Do not exceed the maximum recommended dose (see section 3).
• Contact your doctor if you experience blurred vision or other visual disturbances.

Use of Decloban with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use another medication, including those purchased without a prescription, especially if you are receiving treatment with other steroids.

Pregnancy and lactation:

Consult your doctor or pharmacist before using any medication.

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

Driving and operating machinery:

Declobán treatment does not affect the ability to drive or operate machinery.

Important information about some of the components of Declobán ointment

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

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

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

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

Declobán should be applied to the affected area one or two times a day. The recommended treatment duration should not exceed 4 weeks.

Do not use more than 50 grams of ointment per week in adult patients, or proportional doses in children (see "Warnings and precautions").

Apply the ointment to the clean skin of the affected area.

Perform a gentle 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 instructs you to do so.

Use in children and adolescents:

Declobán 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 Declobán ointment than you should

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

In case of overdose or accidental ingestion, consult the Toxicological Information Service.Telephone 91 562 04 20.

If you forget to use Declobán 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 compensate for the missed doses.

If you interrupt treatment with Declobán ointment

Your doctor will tell you the number of applications and the duration of your treatment with Declobán. Do not stop treatment prematurely, as the expected effects will not be achieved, or abruptly, especially if your doctor tells you to apply the ointment for a prolonged period of time. The cessation of a prolonged treatment should be gradual, spacing out the applications or administering a less active or less concentrated corticosteroid.

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Decloban may cause some adverse effects, such as:

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

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

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

• Hirsutism (changes in hair growth)
• Increased intraocular pressure.
• When used to treat psoriasis, it may worsen, leading to pustular psoriasis (white blisters surrounded by red, irritated skin).
• Decreased levels of adrenal gland hormones, especially with prolonged use of high doses or treatment of extensive areas.

Very rare(affects fewer than 1 of every 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 effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting Adverse Effects

If you experienceany type of adverse effect, consult your doctor or pharmacist, even if it is apossibleadverse effect not listed in this leaflet.You can also report them directly to the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not store at a temperature above 25°C.

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated. Once opened, it can be stored for 2 months.

Medications should not be disposed of through drains or trash. Dispose of packaging and unused medications at the SIGRE drop-off point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

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Composition of Declobán ointment

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

Appearance of the product and content of the packaging

Declobán is presented in the form of a white to yellowish ointment, in containers that contain 15 g and 30 g of ointment.

Holder of the marketing authorization and responsible for manufacturing

Teofarma S.r.l.

Via F.lli Cervi, 8

I-27010 Valle Salimbene

Pavia-Italy

Date of the last review of this leaflet:January 2021