Peitel 2.5 mg/g cream: detailed information

Brand name Peitel 2.5 mg/g cream

Form cream

Active substance / Dosage

PREDNICARBATE · 0,250 g

Prescription type Prescription Only Medicine

ATC code

D07A D07AC D07AC18

Registration number 60372

Manufacturer Galenicum Derma S.L.

Table of Contents

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

Patient Information Leaflet

Introduction

Patient Information Leaflet

Peitel 2.5 mg/g cream

prednicarbate

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. Do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
If you experience any side effects, talk to your doctor or pharmacist, even if the side effects are not listed in this leaflet. See section 4.

Contents of the leaflet

What Peitel is and what it is used for
What you need to know before using Peitel
How to use Peitel
Possible side effects
How to store Peitel
Contents of the pack and other information

1. What Peitel is and what it is used for

Peitel contains the active substance prednicarbate and belongs to a group of medicines called topical corticosteroids. This medicine is applied to the skin to reduce inflammation, allergic reactions, redness, and exudation in inflamed skin.

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

2. What you need to know before using Peitel

Do not use Peitel:

If you are allergic to prednicarbate or any of the other ingredients of this medicine (listed in section 6)
In the eyes, or on deep open wounds
On areas of skin showing a vaccination reaction, i.e., redness or inflammation after vaccination
If you have tuberculosis, syphilis, or viral infections (e.g., chickenpox or herpes)
In rosacea, vulgar acne, or skin conditions associated with skin thinning (atrophy)
In inflammation around the mouth (perioral dermatitis).

Warnings and precautions

Talk to your doctor or pharmacist before starting to use Peitel.

Peitel should not be applied over large areas of the body or for prolonged periods, as this significantly increases the risk of side effects. This medicine should be used at the lowest possible dose and only for the minimum time necessary to treat the skin condition.
Avoid contact of Peitel with the eyes, open wounds, or mucous membranes.
If bacterial or fungal skin infections develop, consult your doctor, who will determine an appropriate additional treatment.
If you apply the medicine to skin areas with folds (e.g., armpits or groin), exercise great caution, as absorption of the active ingredient may increase.
This medicine should not be used under occlusive dressings, such as non-breathable bandages, dressings, or diapers, which are impermeable to air and water.
The use of topical corticosteroids over extensive areas or at high doses for prolonged periods significantly increases the risk of adverse effects.
If you are being treated for psoriasis, strict medical supervision is recommended.
Sudden discontinuation of treatment should be avoided. Abruptly stopping long-term treatment with a potent corticosteroid may lead to a rebound effect, characterized by dermatitis with intense redness, itching, and burning.
Non-professional use of topical corticosteroids may mask symptoms and complicate correct diagnosis and treatment.
Avoid contact between Peitel and latex condoms, as it may cause leakage or breakage.
Contact your doctor if you experience blurred vision or other visual disturbances.

Children

The use of this medicine is not recommended in children under 2 years of age due to lack of clinical data in this population.

In children, topical corticosteroids should be used with caution and limited to the lowest effective dose.

Use of Peitel with other medicines

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

No interactions with Peitel are known; however, other preparations should not be applied to the treated area.

Pregnancy, breastfeeding, and fertility

Pregnancy

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

There are insufficient data on the use of Peitel in pregnant women.

In general, during the first trimester of pregnancy, medications containing corticosteroids should not be applied to the skin.

Breastfeeding

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

Driving and using machines

The effect of Peitel on the ability to drive and use machines is none or negligible.

Peitel contains cetyl alcohol, stearyl alcohol, and benzyl alcohol

This medicine may cause local skin reactions (such as contact dermatitis) because it contains cetyl alcohol and stearyl alcohol.

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

3. How to use Peitel

Follow exactly the administration instructions for this medicine as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

This medicine is for topical use only (to be applied to the skin).

The recommended dose is:

Adults and children over 2 years of age

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

The treatment may be reduced to once daily when a clear improvement is observed.

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

If you are using the medicine for a condition affecting the face, treatment duration should be as short as possible and no longer than one week.

Hands should be washed after each application unless they are the area being treated.

Use in children

The use of Peitel is not recommended in children under 2 years of age due to limited safety data.

In children, topical corticosteroids should be used with caution and limited to the lowest dose compatible with effective treatment.

If you use more Peitel than you should

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

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

If you forget to use Peitel

Do not apply a double dose to make up for missed doses.

Apply the missed dose as soon as you remember, or wait until the next scheduled application if it is almost time for it.

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 can cause adverse effects, although not everyone experiences them.

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

The possible adverse effects that may occur with the use of this medicine are listed below according to their frequency:

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

Skin and subcutaneous tissue disorders:

mild to moderate burning sensation at the site of application
tingling sensation (paresthesia)
itching (pruritus)
bacterial infections
furunculosis
local thinning of the skin (local cutaneous atrophy)

Uncommon adverse effects (may affect up to 1 in 100 people)

Skin disorders:

cutaneous striae
irritation
excessive hair growth on the skin (hypertrichosis)
loss of skin color (hypopigmentation)
skin condition around the mouth (perioral dermatitis)
skin maceration
allergic contact dermatitis
papular rosacea-like dermatitis (facial skin)
acneiform reactions
capillary fragility (bruising)
red or white bumps in various parts of the body (miliaria)
dry skin
inflammation of hair follicles (folliculitis)

Infections:

secondary infection

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

Vascular disorders:

dilation of blood vessels in the skin or spider veins (telangiectasia)

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

Eye disorders:

blurred vision

Other adverse effects in children

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

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

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 via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Peitel

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging, after EXP. The expiry date is the last day of the month indicated.

Store below 25°C.

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

6. Contents of the pack and other information

Composition of Peitel:

The active substance is prednicarbate.

Each gram of cream contains 2.5 mg of prednicarbate.

The other components (excipients) are: octyldodecanol, liquid paraffin, stearyl alcohol, cetyl alcohol, myristyl alcohol, sorbitan stearate, polysorbate 60 (E-435), benzyl alcohol, disodium edetate, and purified water.

Appearance of the product and contents of the container

Peitel is a cream with a uniform, creamy consistency and white colour.

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