Label: information for the user

Peitel 2.5 mg/g cream

prednicarbate

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

• Keep this label, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed for you only, and you should not give it to others, 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 label. See section 4.

Peitel contains prednicarbato as its active ingredient, and it belongs to a group of medications known as topical corticosteroids. This medication is used on the skin to reduce inflammation, allergic reactions, redness, and exudate on inflamed skin.

Peitel is indicated for the treatment of symptoms (redness and itching) caused by certain inflammatory skin disorders that respond to topical treatment with corticosteroids, such as atopic dermatitis and psoriasis (excluding extensive plaque psoriasis).

Do not use Peitel:

• If you are allergic to prednicarbate or any of the other components of this medication (listed in section 6)
• In the eyes, or in deep open wounds
• In areas of the skin that show a vaccination reaction, that is, redness or inflammation after the vaccine
• If you have tuberculosis, syphilis, or viral infections (for example, chickenpox or herpes)
• In rosacea, acne vulgar, or skin diseases with skin thinning (atrophy)
• In a inflammation around the mouth (perioral dermatitis).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Peitel.

• Do not apply it to large areas of the body or for a long period of time, as this significantly increases the risk of side effects. This medication should be used in the lowest possible doses and only for the time strictly necessary to treat the skin condition.
• Avoid letting Peitel come into contact with the eyes, open wounds, or mucous membranes.
• If skin infections caused by bacteria or fungi develop, consult your doctor who will establish a specific additional treatment.
• If you use the medication in skin folds areas (for example, armpits or groin), you must be very careful because it may increase the absorption of the active ingredient.
• This medication should not be used under impermeable materials to air and water, such as bandages, dressings, or diapers, that are poorly breathable.
• The use of topical corticosteroids in large areas or at high doses for a prolonged period significantly increases the risk of adverse effects.
• If you are being treated for psoriasis, a strict medical supervision is recommended.
• It is recommended to avoid sudden treatment interruption. When a long-term treatment with a potent corticosteroid is interrupted, a rebound effect may develop, which manifests as a dermatitis with intense redness, itching, and burning.
• The non-professional use of topical corticosteroids may mask symptoms and make it difficult to diagnose and treat correctly.
• Avoid contact between Peitel and latex condoms, as it may cause leaks or breaks.
• Contact your doctor if you experience blurred vision or other visual disturbances.

Children

This medication is not recommended for use in children under 2 years of age, due to the absence of clinical data in this population.

In children, the use of topical corticosteroids should be done with caution, limiting it to the lowest effective dose.

Use of Peitel with other medications

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

No interactions with Peitel are known; however, do not apply other preparations to the treated area.

Pregnancy,Lactation, and Fertility

Pregnancy

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

No sufficient data are available on the use of Peitel in pregnant women.

Generally, during the first trimester of pregnancy, corticosteroid-containing medications should not be applied to the skin.

Lactation

The safety of Peitel during breastfeeding has not been established, so its use is not recommended. Women who are breastfeeding should not apply the medication to the breasts.

Driving and operating machinery

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

Peitel contains cetomacrogol, cetearyl alcohol, and benzyl alcohol

This medication may cause local skin reactions (such as contact dermatitis) because it contains cetomacrogol and cetearyl alcohol.

This medication contains 10 mg of benzyl alcohol per gram of cream. Benzyl alcohol may cause allergic reactions and moderate local irritation.

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.

This medication is for exclusive topical use (to apply on the skin).

The recommended dose is:

Adults and children over 2 years old

Apply a thin layer of cream to the affected area one or two times a day, gently rubbing it in.

The treatment may be reduced to a daily application when a noticeable improvement is observed.

The treatment duration, as a general rule, should not exceed 4 weeks.

If you use the medication for any condition on the face, the treatment duration should be as short as possible and no more than 1 week.

After each application, wash your hands unless they are the treatment area.

Use in children

Peitel is not recommended for use in children under 2 years old due to a lack of safety data.

In children, the use of topical corticosteroids should be done with caution, limiting it to the lowest dose compatible with effective treatment.

If you use more Peitel than you should

Exceeding the recommended doses significantly cannot be ruled out, and systemic corticosteroid effects may occur.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or visit a medical center, or call the Toxicological Information Service. Tel.: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use Peitel

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

Apply the corresponding dose when you remember, or wait until the next application if it is close.

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.

The side effects of topical prednicarbato are generally local, mild, and transient. Like with other topical corticosteroids, prolonged use of large quantities or treatment of extensive areas may lead to systemic corticosteroid effects due to absorption. If this occurs, topical treatment should be discontinued.

The possible side effects that may be observed with the use of this medicine are detailed below in accordance with their frequency:

Frequent side effects (may affect up to 1 in 10 people)

Skin and subcutaneous tissue disorders:

• Mild to moderate burning sensation at the application site
• Prickling sensation (paresthesia),
• Itching (pruritus),
• Bacterial infections
• Furunculosis
• Local skin thinning (cutaneous atrophy).

Rare side effects (may affect up to 1 in 100 people)

Skin disorders:

• Striae
• Irritation
• Excessive hair growth on the skin (hypertrichosis)
• Pigmentation loss in the skin (hypopigmentation)
• Perioral dermatitis
• Skin maceration
• Contact dermatitis
• Rosacea-like papular dermatitis (facial skin)
• Acneiform reactions
• Capillary fragility (ecchymosis)
• Red or white papules in various parts of the body (miliaria)
• Skin dryness
• Folliculitis.

Infections:

• Secondary infection

Very rare side effects (may affect up to 1 in 10,000 people)

Vascular disorders:

• Dilation of skin blood vessels or spider veins (telangiectasia).

Side effects with an unknown frequency (cannot be estimated from available data)

Eye disorders:

• Blurred vision

Other side effects in children

Children and adolescents may demonstrate a greater susceptibility than adult patients to suppression of the hypothalamic-pituitary-adrenal axis function and to corticosteroid-induced Cushing's syndrome due to the higher skin surface-to-body weight ratio. Chronic corticosteroid therapy could interfere with infant growth and development.

Increased intracranial pressure has been reported in children treated with topical corticosteroids. Manifestations of increased intracranial pressure include bulging fontanelles, headaches, and bilateral papilledema.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaram.es.By reporting side 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 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.

Store below 25°C.

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. In case of doubtask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Peitel:

-The active ingredient is prednicarbato.

Each gram of cream contains 2.5 mg of prednicarbato

-The other components (excipients) are:octildodecanol, paraffin liquid, stearic alcohol, cetyl alcohol, myristic alcohol, sorbitan stearate, polisorbate 60 (E-435), benzyl alcohol, disodium edetate, and purified water.

Appearance of the product and contents of the packaging

Peitel is a uniform cream with a creamy consistency and white color.

It is presented in aluminum tubes containing 30 and 60 grams of cream.

Other presentations:

Peitel 2.5 mg /g ointment and Peitel 2.5 mg /g topical solution.

Holder of the marketing authorization:

Galenicum Derma, S.L.U.

Ctra N-1, Km 36

28750 San Agustin del Guadalix (Madrid)

Spain

Responsible for manufacturing:

Ferrer Internacional, S.A.

Joan Buscallá, 1-9

08173 - Sant Cugat del Vallés (Barcelona)

Spain

Last review date of this leaflet: January 2021

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).