Label: information for the user

Peitel 2.5 mg/g topical solution

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 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, 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 applied to the skin to reduce inflammation, allergic reactions, redness, and exudate on inflamed skin.

Peitel is indicated for the symptomatic treatment of hairy skin areas (with hair) of the body (for example, scalp, beard, armpits, and pubic area) that respond to treatment with topical corticosteroids such as psoriasis, atopic eczema, and seborrheic eczema.

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 effective 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 such as bandages, dressings, or diapers.
• 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, it is recommended to have strict medical supervision.
• It is recommended to avoid sudden interruption of treatment. When a long-term treatment with a potent corticosteroid is interrupted, a rebound effect may occur, which is manifested by 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.

There are no sufficient data 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 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 Propilenglicol.

This medication contains 150 mg of propilenglicol in each gram of topical solution. Propilenglicol may cause skin 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.

The recommended dose is:

Adults and children over 2 years old

Topical solution in a bottle with a dosifier:Apply one or two times a day a fewdrops of the topical solution with the help of the dosifier, well distributed over the area of the skin to be treated, gently rubbing.

Or

Topical solution in a bottle with an applicator: apply a thin layer of topical solution with the help of the applicator over the area of the skin to be treated, gently rubbing.

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

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

Administration form:

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

After each application, hands should be washed unless they are the treatment area.

Instructions for the use of

Topical solution in a bottle with a dosifier:

To use Peitel in a bottle with a dosifier, the patient should open the screw cap, tilt the bottle downwards and press the bottle walls to facilitate the release of the drops of the topical solution through the hole of the dosifier.

Topical solution in a bottle with an applicator:

To use Peitel with an applicator, the patient should remove the screw cap and attach the applicator that is included in the box and acts as a closure (see Figure 1).

Figure: 1

Use in children

It is not recommended to use Peitel in children under 2 years old due to the scarcity of data on safety.

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

If you use more Peitel than you should

If significantly higher doses than recommended are exceeded, adverse effects typical of systemic corticosteroids cannot be ruled out.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or go to 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 doubts 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 prednicarbato topical 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,
• tingling sensation (paresthesia),
• itching (pruritus),
• bacterial infections
• folliculitis
• local skin thinning (cutaneous atrophy).

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

Skin disorders:

• skin striations
• irritation
• hair growth on the skin (hypertrichosis)
• skin color loss (hypopigmentation)
• skin around the mouth affected (perioral dermatitis)
• skin maceration
• contact allergic 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
• inflammation of hair follicles (folliculitis).
• erythema

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 area 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 fontanelle bulging, 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 in refrigerator (between 2°C and 8°C).

Medicines should not be thrown down the drains or in the trash.Deposit the containers 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 containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Peitel:

-The active principle is prednicarbato.

Each gram of topical solution contains 2.5 mg of prednicarbato

-The other components (excipients) are: polietilenglicol gliceril cocoato, propilenglicol, ethanol at 96%, citric acid monohydrate, edetic acid, and purified water.

Appearance of the product and contents of the packaging

Peitel 2.5 mg/g topical solution is a transparent and colorless solution.

It is presented in a polyethylene bottle with a dosifier or applicator, with 60 ml of topical solution.

Other presentations:

Peitel 2.5 mg/g ointment and Peitel 2.5 mg/g cream.

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: March 2021

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