PEITEL 2.5 mg/g CUTANEOUS SOLUTION

2. What you need to know before you start 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 open wounds
• In areas of the skin that show 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, acne vulgaris, or skin diseases with skin thinning (atrophy)
• In inflammation around the mouth (perioral dermatitis).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Peitel.

• It should not be applied to large areas of the body or for a long period, as this significantly increases the risk of effects. This medicine should be used in the lowest possible doses and only for the shortest period necessary to treat the skin condition.
• Avoid getting Peitel in contact with the eyes, open wounds, or mucous membranes.
• In case of skin infections caused by bacteria or fungi, consult your doctor, who will establish additional specific treatment.
• If you use the medicine in skin folds (e.g., armpits or groin), you should be very careful because it can increase the absorption of the active substance.
• This medicine should not be used under airtight and waterproof materials, such as bandages, dressings, or diapers, which are not very breathable.
• The use of topical corticosteroids in large areas or at high doses for a prolonged period increases the risk of side effects significantly.
• 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 discontinued, a rebound effect may occur, which is characterized by intense redness, itching, and burning.
• The non-professional use of topical corticosteroids can mask symptoms and make it difficult to diagnose and treat correctly.
• Contact between Peitel and latex condoms should be avoided, as it may cause them to leak or break.
• 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, the use of topical corticosteroids should be done with caution, limiting the dose to the lowest effective dose.

Using Peitel with other medicines

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

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

Pregnancy, breastfeeding, and fertility

Pregnancy

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

There are no sufficient 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.

Breastfeeding

The safety of Peitel during breastfeeding has not been established, so its use is not recommended. Breastfeeding women should not apply the medicine to their breasts.

Driving and using machines

Peitel has no or negligible influence on the ability to drive and use machines.

Peitel contains Propylene Glycol

This medicine contains 150 mg of propylene glycol in each gram of cutaneous solution. Propylene glycol may cause skin irritation.

3. How to use Peitel

Follow exactly the administration instructions of this medicine given 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

Peitel in bottle with dropper:Apply one or two times a day a few drops of the cutaneous solution with the help of the dropper, well spread over the area of the skin to be treated, gently rubbing.

Or

Peitel in bottle with applicator:Apply a thin layer of cutaneous solution with the help of the applicator over the area of the skin to be treated, gently rubbing.

The treatment can be reduced to one application per day when a noticeable improvement is observed.

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

Method of administration:

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

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

Instructions for the use of

Peitel in bottle with dropper:

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

Peitel in bottle with applicator:

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

Figure: 1

Use in children

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

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

If you use more Peitel than you should

If the recommended doses are significantly exceeded, systemic corticosteroid effects 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. Phone: 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 forgotten doses.

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

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The side effects of prednicarbate topical are generally local, mild, and transient. As 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 occur with the use of this medicine are listed below according to their frequency:

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

Disorders of the skin and subcutaneous tissue:

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

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

Skin disorders:

• striae
• irritation
• hair growth on the skin (hypertrichosis)
• skin discoloration (hypopigmentation)
• skin condition around the mouth (perioral dermatitis)
• skin maceration
• allergic contact dermatitis
• rosacea-like dermatitis (facial skin)
• acne-like reactions
• capillary fragility (ecchymosis)
• red or white bumps on various parts of the body (miliaria)
• dry skin
• inflammation of the hair follicles (folliculitis)
• erythema

Infections:

• secondary infection

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 unknown frequency (cannot be estimated from the available data)

Eyeball disorders:

• blurred vision

Other side effects in children

Children and adolescents may show a greater susceptibility than adult patients to the suppression of the hypothalamic-pituitary-adrenal axis and Cushing's syndrome induced by the administration of topical corticosteroids, due to the greater 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. The manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Health Products Agency's website (www.notificaram.es). By reporting side 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 which is stated on the carton, after EXP. The expiry date is the last day of the month stated.

Once the bottle is opened, it can be used for 3 months if stored in the same conditions indicated.

Store in the refrigerator (between 2°C and 8°C).

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Peitel:

• The active substance is prednicarbate.

Each gram of cutaneous solution contains 2.5 mg of prednicarbate

• The other ingredients (excipients) are: polyethylene glycol glycerol cocoate, propylene glycol, ethanol 96%, citric acid monohydrate, edetic acid, and purified water.

Appearance of the product and pack contents

Peitel 2.5 mg/g cutaneous solution is a clear and colorless solution.

It is presented in a polyethylene bottle with a dropper or applicator, containing 60 ml of cutaneous solution.

Other presentations:

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

Marketing authorization holder:

Galenicum Derma, S.L.U.

Ctra N-1, Km 36

28750 San Agustin del Guadalix (Madrid)

Spain

Manufacturer:

Ferrer Internacional, S.A.

Joan Buscallá, 1-9

08173 - Sant Cugat del Vallés (Barcelona)

Spain

Date of the last revision of this leaflet: October 2024

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).