Laticort 0,1%

LEAFLET INCLUDED IN THE PACKAGE: INFORMATION FOR THE PATIENT

LATICORT 0.1%, 1 MG/G, OINTMENT

Hydrocortisone butyrate

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• -Keep this leaflet, you may need to read it again.
• -If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• -If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Laticort 0.1% ointment and what is it used for
• 2. Important information before using Laticort 0.1% ointment
• 3. How to use Laticort 0.1% ointment
• 4. Possible side effects
• 5. How to store Laticort 0.1% ointment
• 6. Contents of the package and other information

1. WHAT IS LATICORT 0.1% OINTMENT AND WHAT IS IT USED FOR

Laticort 0.1% in the form of an ointment for topical use, contains the active substance hydrocortisone 17-butyrate. Hydrocortisone 17-butyrate is a moderately potent anti-inflammatory corticosteroid. The drug used topically on the skin has anti-inflammatory, antipruritic, and vasoconstrictive effects.

Indications for use

Subacute and chronic, non-infected, dry inflammatory skin conditions of various origins, especially of allergic origin, of moderate or severe intensity, which respond to treatment with glucocorticosteroids and are accompanied by persistent itching or excessive scaling. Laticort 0.1% is indicated in:

• seborrheic dermatitis;
• atopic dermatitis;
• nummular eczema;
• allergic contact dermatitis;
• polymorphic erythema;
• erythema multiforme;
• chronic psoriasis;
• lichen planus.

2. IMPORTANT INFORMATION BEFORE USING LATICORT 0.1% OINTMENT

When not to use Laticort 0.1% ointment

• if the patient has been diagnosed with hypersensitivity (allergy) to hydrocortisone 17-butyrate, other corticosteroids, or any of the other ingredients of the medicine;
• in viral skin infections (e.g., chickenpox, herpes simplex);
• fungal or bacterial (e.g., tuberculosis) skin infections;
• acne vulgaris;
• rosacea;
• perioral dermatitis;
• pruritus ani;
• on extensive skin lesions;
• in children under 2 years of age.

Warnings and precautions

Before starting to use Laticort 0.1% ointment, consult a doctor or pharmacist.

• Do not use continuously for more than 2 weeks.
• Corticosteroids are absorbed through the skin, so during the use of the medicine, there is a risk of systemic side effects characteristic of corticosteroids, including adrenal suppression, decreased cortisol levels in the blood, and Cushing's syndrome (a syndrome of disease symptoms associated with increased steroid levels in the blood, most commonly caused by prolonged administration of glucocorticosteroids). Therefore, avoid using the medicine on a large skin surface, wounds, damaged skin, using it in large doses, and prolonged treatment with the medicine.
• In the case of skin infection at the treatment site, the doctor will use appropriate antibacterial or antifungal treatment. If the symptoms of infection persist, consult a doctor. The doctor will decide whether the treatment should be discontinued until the infection is cured.
• Do not use the medicine on the eyelids or on the skin around the eyelids, due to the risk of glaucoma or cataracts, and in patients with glaucoma or cataracts, as it may worsen the symptoms of the disease.
• If the patient experiences blurred vision or other visual disturbances, consult a doctor.
• Avoid contact of the medicine with the eyes and mucous membranes.
• On the skin of the face and in the axillary and groin areas, use only in cases where it is absolutely necessary, due to increased absorption of the corticosteroid through delicate skin and the associated increased risk of widening of small blood vessels and perioral dermatitis, skin atrophy, even after short-term use.
• Avoid using the medicine under a tightly sealing dressing, as the dressing increases the absorption of the corticosteroid into the body, and may cause skin atrophy, stretch marks, and superinfections.
• Use with caution in conditions of skin atrophy, especially in the elderly.
• Use with special caution in patients with psoriasis, as local use of corticosteroids in psoriasis can be dangerous for many reasons, including the risk of relapse of the disease caused by the development of tolerance, the risk of generalized pustular psoriasis, and general toxic effects caused by skin discontinuity.

Children and adolescents

Use with caution and avoid long-term use in children over 2 years of age. In children, due to the larger ratio of body surface area to body mass compared to adults, it is easier for them to experience side effects characteristic of corticosteroids, including growth and development disorders.

Other medicines and Laticort 0.1% ointment

Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. There are no known interactions associated with the topical use of corticosteroids. During the use of the medicine, especially on a large skin surface, do not get vaccinated against smallpox. Do not get other vaccinations. Laticort 0.1% ointment may interfere with the action of medicines that affect the immune system.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before using this medicine. PregnancyLaticort 0.1% ointment may be used during pregnancy only on the advice of a doctor, for a short period, and on a small skin surface, when the doctor considers that the benefits of using the medicine for the mother outweigh the risk to the fetus. Do not use the medicine during the first trimester of pregnancy. BreastfeedingLaticort 0.1% ointment may be used during breastfeeding only on the advice of a doctor - for a short period and on a small skin surface.

Driving and using machines

Laticort 0.1% ointment has no effect on the ability to drive and use machines.

3. HOW TO USE LATICORT 0.1% OINTMENT

This medicine should always be used as directed by your doctor. If you are unsure, consult your doctor. Do not extend the treatment period beyond the period prescribed by your doctor. The medicine is intended for use on the skin. Usually, a small amount of the medicine is applied to the affected areas of the skin, no more than once or twice a day. In cases of excessive lichenification or scaling of the affected skin, an occlusive dressing may be used, which should be changed every 24 hours. Do not use the medicine for more than 2 weeks. On the skin of the face, do not use for more than 7 days. During the week, no more than 1 tube (15 g) of ointment can be used.

Use in children and adolescents

Do not use in children under 2 years of age. In children over 2 years of age, unless the doctor advises otherwise, the medicine is usually used only once a day, on a small skin surface. Do not use on the skin of the face.

Using a larger dose of Laticort 0.1% ointment than recommended

Prolonged or improper topical use of the medicine or use on large skin surfaces may lead to growth and development disorders in children. Symptoms of hydrocortisone 17-butyrate overdose may occur, including edema, hypertension, increased blood glucose levels, glycosuria, decreased immunity, and in severe cases, Cushing's syndrome. In case of overdose, the doctor will use appropriate treatment.

Missing a dose of Laticort 0.1% ointment

Do not use a double dose to make up for a missed dose.

4. POSSIBLE SIDE EFFECTS

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

Local side effects of unknown frequency (frequency cannot be estimated from available data):

In the case of using the medicine on the eyelid skin, glaucoma or cataracts may occasionally occur. Visual disturbances may occur. Symptoms similar to acne, perioral dermatitis, skin atrophy, and subcutaneous tissue, dry skin, excessive hair growth or hair loss, skin discoloration or hyperpigmentation, skin atrophy, and stretch marks, widening of small blood vessels, perioral dermatitis, folliculitis, secondary infections, skin irritation may occur. Occasionally, urticaria or a papular rash may occur, or worsening of existing skin lesions.

Systemic side effects of unknown frequency (frequency cannot be estimated from available data):

As a result of the absorption of the medicine into the blood, systemic side effects of hydrocortisone 17-butyrate, characteristic of corticosteroids, may also occur. They occur mainly in the case of prolonged use of the medicine, use on a large skin surface, under an occlusive dressing, or in the case of use in children. Systemic side effects of hydrocortisone 17-butyrate, characteristic of corticosteroids, include adrenal suppression, Cushing's syndrome, growth and development disorders in children, increased blood glucose levels, glycosuria, edema, hypertension, decreased immunity.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Medicinal Product Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, e-mail: [email protected]. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE LATICORT 0.1% OINTMENT

Store below 25°C. Keep the medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the given month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Laticort 0.1% ointment contains

The active substance of the medicine is hydrocortisone 17-butyrate. 1 g of ointment contains 1 mg of hydrocortisone 17-butyrate. The other ingredient is white petrolatum.

What Laticort 0.1% ointment looks like and what the package contains

Laticort 0.1% is a white or almost white, semi-transparent ointment. The available packaging of the medicine is: an aluminum tube containing 15 g of ointment, in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder

Bausch Health Ireland Limited, 3013 Lake Drive, Citywest Business Campus, Dublin 24, D24PPT3, Ireland

Manufacturer

Przedsiębiorstwo Farmaceutyczne Jelfa SA, ul. Wincentego Pola 21, 58-500 Jelenia Góra, Poland

Date of the last update of the leaflet: