Product Information for the User

Clovate 0.5 mg/g Cream

Clobetasol (propionate)

Read this entire product information carefully before starting to use this medication, because 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 to you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this product information. See section 4.

1. What is Clovate Cream and for what it is used

2. What you need to know before starting to use Clovate Cream

3. How to use Clovate Cream

4. Possible adverse effects

5. Storage of Clovate Cream

6. Contents of the package and additional information

Clovate belongs to a group of medicines called topical steroids. "Topical" means it is applied to the skin. Topical steroids reduce redness and itching of certain skin problems.

Clovate cream reduces the effects of inflammation in skin conditions such as:

• Difficult-to-treat eczemas
• Psoriasis, a skin inflammation that produces redness, itching, and scales on the skin

(excluding generalized pustular psoriasis)

• Lichen planus (a skin and mucous membrane disorder that causes inflammation and itching)
• Lupus erythematosus discoid (a rash that appears on the cheeks and nose).

Do not use Clovate

• If you are allergic to clobetasol (propionate) or any of the other components of this medication (listed in section 6).
• If you have any primary skin lesions infected by fungi (for example: candidiasis, ringworm) or bacteria (for example impetigo).

• If you have a primary viral infection (simple herpes, chickenpox).
• If you have acne or a condition called rosacea (severe redness of the skin of the nose and around it) or perioral dermatitis (red rash with crusts around the mouth).
• In skin lesions of children under 1 year, including dermatitis (skin inflammation) and diaper rash.

• If you have pruritus (itching) in the perianal or genital area.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Clovate cream if:

• You experience recent bone pain or worsening of previous bone symptoms during treatment with Clovate, especially if you have been using Clovate for a prolonged period of time or repeatedly.
• You are using another oral or topical medication that contains corticosteroids or immunosuppressive medications (for example, autoimmune disease or after a transplant). The combination of Clovate with these medications may result in severe infections.

Clovate should not be used for long periods of time, especially in children. If administered to children, strict medical supervision should be performed every week. It should be taken into account that the use of occlusive dressings (including diapers) may favor a greater absorption of Clovate.

If you do not notice improvement after 4 weeks of treatment, consult your doctor.

Clovate cream should not be used on the face, unless explicitly indicated by your doctor, as it may modify the thickness of your skin.

Avoid Clovate from entering your eyes, as it may increase intraocular pressure. If it comes into contact with your eyes, wash the affected area with plenty of water.

Special care should be taken if you are being treated for psoriasis, with strict medical supervision recommended.

Clovate should not be used on wounds and ulcers.

Contact your doctor if you experience blurred vision or other visual disturbances.

Children

Do not use in children under 1 year; it is contraindicated in this population.

Other medications and Clovate cream

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

No interactions of Clovate with other medications are known.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

Do not use Clovate during pregnancy, unless your doctor considers it absolutely necessary.

Breastfeeding

Do not use Clovate during breastfeeding, unless your doctor considers it absolutely necessary.

Driving and operating machinery

The influence of Clovate on the ability to drive or operate machinery is negligible or insignificant.

Clovate 0.5 mg/g cream contains propylene glycol, chlorocresol, and cetyl ester alcohol

This medication contains 475 mg of propylene glycol in each gram of cream.

Propylene glycol may cause skin irritation.

This medication may cause local skin reactions (such as contact dermatitis) because it contains cetyl ester alcohol.

This medication may cause allergic reactions because it contains chlorocresol.

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

Cutaneous use.

The recommended dose is:

Apply the cream moderately to the affected skin areas one or two times a day. If you estimate that the action of Clovate is too strong or too weak, inform your doctor or pharmacist. If prolonged corticosteroid therapy is necessary, use a less potent corticosteroid cream.

Wash your hands after applying Clovate, unless you are treating your hands.

Unless your doctor tells you otherwise, do not use larger quantities or use the cream on large areas of the body for a long time (such as every day for many weeks or months).

The skin should be cleaned before applying a new occlusive dressing (closed) or diaper over the affected area.

Clovate is for use on the skin only.

Use in children

Clovate is contraindicated in children under 1 year (see section 2 “What you need to know before starting to use Clovate cream”). Long-term treatment should be avoided, especially in children.

If you use more Clovate than you should

If you have used Clovate in excess of the prescribed dose, in quantities greater than the prescribed dose or for a longer period than indicated, consult your doctor or pharmacist immediately.

It is unlikely that using a larger quantity will be hazardous, unless it is used all at once.

In case of overdose or accidental ingestion, consult your doctor or pharmacist, orcall the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amountingested.

If you forgot to use Clovate cream

Do not use a double dose to compensate for the missed doses.

If you forgot to use Clovate cream, apply the normal amount when you remember, or wait until the next application if it is close.

If you interrupt treatment with Clovate cream

Do not stop treatment abruptly.

The cessation of 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 medicines, this medicine may cause side effects, although not everyone will experience them.

Local allergic reactions such as skin redness, rash, itching, urticaria, local skin burning, and allergic contact dermatitis at the application site may occur, which may be similar to the symptoms of the skin condition being treated. If symptoms persist, discontinue treatment immediately and consult your doctor.

If you experience swelling of the eyelids, face, or lips, discontinue treatment immediately and consult your doctor, as it may be an allergic reaction.

Clovate may be absorbed through the skin into the bloodstream. This is not a problem if you use the correct amount of medicine for the correct period. If you use too much medicine or for a long time, you may experience skin changes in the area where you use the medicine, such as striae, thinning, appearance of blood vessels (especially when using bandages or when it affects skin folds), changes in hair color or quantity, and pustular psoriasis (white blisters surrounded by red and irritated skin).

If large amounts of Clovate are used for long periods of time, signs of adrenal insufficiency may be observed, including delayed growth in children, unexplained weight gain, and acne. If you notice any of these symptoms, consult your doctor.

The frequencies of adverse effects are defined as follows: very common (may affect more than 1 in 10 people), common (may affect up to 1 in 10 people), uncommon (may affect up to 1 in 100 people), rare (may affect up to 1 in 1,000 people), very rare (may affect up to 1 in 10,000 people), unknown frequency (cannot be estimated from available data).

Uncommon

Superficial skin blood vessel dilation.

Local skin atrophy, striae.

Very rare

Allergy (hypersensitivity).

Hypercortisolism (increased cortisol) or Cushing's syndrome (round face, fat accumulation, and weakness) anddecreased levels of adrenal gland hormones.

Redness of the skin, rash, itching, urticaria, local skin burning, swelling of the face, eyelids, or lips, and allergic contact dermatitis, pustular psoriasis (white blisters surrounded by red and irritated skin), worsening of initial symptoms, skin thinning, acne, changes in pigmentation, increased hair growth (hypertrichosis).

Unknown frequency

Blurred vision.

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 that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

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

Do not store at a temperature above30 °C.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

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

Clovate Cream Composition

• The active ingredient is clobetasol propionate. Each gram of cream contains 0.5 mg of clobetasol propionate, which is equivalent to 0.44 mg of clobetasol.
• The other components are: propylene glycol (E-1520), monoesterarate of glycerol, cetoestearic alcohol, monoesterate of glyceryl autoemulsifying (Arlacel 165), white beeswax, chlorocresol, sodium citrate dihydrate, citric acid monohydrate, and purified water.

Product Appearance and Packaging Content

Clovate is a white cream, presented in a 30-gram tube.

Marketing Authorization Holder and Responsible Manufacturer

INDUSTRIAL FARMACÉUTICA CANTABRIA, S.A.

Barrio Solía 30

La Concha de Villaescusa

39690 Cantabria (Spain)

Last Review Date of this Leaflet:November 2021.

Detailed information about this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es