Brand name Peitel 2.5 mg/g ointment

Form ointment

Active substance / Dosage

PREDNICARBATE · 0,250 g

Prescription type Prescription Only Medicine

ATC code

D07A D07AC D07AC18

Registration number 60370

Manufacturer Galenicum Derma S.L.

Table of Contents

Package leaflet: Information for the user
Introduction
1. What Peitel is and what it is used for
2.
3. How to use Peitel
4. Possible adverse effects
5. Storage of Peitel
6. Contents of the pack and other information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Peitel 2.5 mg/g ointment

prednicarbate

Read the entire leaflet carefully before you start using this medicine, because 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, and you should not give it to other people even if they have the same symptoms as you, because it may harm them.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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 prednicarbate as the active substance 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 treatment with corticosteroids, such as atopic dermatitis and psoriasis (excluding extensive plaque psoriasis).

2.

Do not use Peitel:

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use Peitel.

This medicine 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 strictly 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), you must exercise great caution, as this may increase absorption of the active ingredient.
This medicine should not be used under air- and water-impermeable materials, such as non-breathable dressings, bandages, or diapers.
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. When long-term treatment with a potent corticosteroid is stopped, a rebound effect may occur, manifesting as dermatitis with intense redness, itching, and burning.
Non-professional use of topical corticosteroids may mask symptoms and hinder correct diagnosis and treatment.
Avoid contact between Peitel and latex condoms, as it may cause leakage or rupture.
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 the 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, lactation and fertility

Pregnancy

If you are pregnant or breastfeeding, think you may 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, medicines containing corticosteroids should not be applied to the skin.

Lactation

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

Driving and using machines

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

Peitel contains benzyl alcohol

This medicine contains 10 mg of benzyl alcohol in each gram of ointment. 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 ointment to the affected area one or two times a day, gently rubbing it in.

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

The duration of treatment, as a general rule, 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 the hands 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 or 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 dose if it is almost time for it.

If you have any other 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 application site
tingling sensation (paresthesia)
itching (pruritus)
bacterial infections
folliculitis (boils)
local thinning of the skin (local cutaneous atrophy)

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

Skin disorders:

skin striae (stretch marks)
irritation
excessive hair growth on the skin (hypertrichosis)
loss of skin color (hypopigmentation)
skin condition around the mouth (perioral dermatitis)
maceration of the skin
allergic contact dermatitis
papular rosacea-like skin condition (on the face)
acneiform reactions
capillary fragility (bruising)
red or white pimples 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 (HPA) axis and corticosteroid-induced Cushing's syndrome due to the higher skin surface area to body weight ratio. Chronic therapy with corticosteroids may interfere with growth and development in children.

Intracranial hypertension has been reported in children treated with topical corticosteroids. Manifestations of intracranial hypertension include bulging of the fontanelles, headache, 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 Medicines: 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 the sight and reach of children.

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

Store below 25°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are in doubt, 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 ointment contains 2.5 mg of prednicarbate.

The other components (excipients) are: glyceryl monooleate, octyldodecanol, edetic acid, vaseline, benzyl alcohol, magnesium sulfate, and purified water.

Appearance of the product and contents of the container

Peitel 2.5 mg/g ointment is a uniform ointment of almost white color.

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