Laticort 0,1%

LEAFLET INCLUDED IN THE PACKAGE: INFORMATION FOR THE PATIENT

LATICORT 0.1%, 1 mg/ml, liquid for the skin

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 specifically for you. Do not pass it on to others.
• -The medicine may harm another person, even if their symptoms are the same as yours.
• -If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. WHAT IS LATICORT 0.1% LIQUID FOR THE SKIN AND WHAT IS IT USED FOR

Laticort 0.1% in the form of a liquid for application to the skin contains the active substance hydrocortisone 17-butyrate. Hydrocortisone 17-butyrate is a medicine from the group of corticosteroids with moderate anti-inflammatory action. The medicine used locally on the skin has anti-inflammatory, anti-itching and vasoconstrictive effects.

Indications for use

Subacute and chronic, non-infected 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 keratinization. Laticort 0.1% is indicated in:

• seborrheic dermatitis;
• atopic dermatitis;
• prurigo;
• allergic contact dermatitis;
• polymorphic erythema;
• erythema multiforme;
• psoriasis;
• lichen planus. Usually, Laticort 0.1% in the form of a liquid for the skin is used in the first phase of treatment, before using Laticort 0.1% in the form of an ointment, which is used for scaly and dry skin changes. Laticort 0.1% in the form of a liquid for the skin is easier to apply to hairy skin than in the form of an ointment or cream.

2. IMPORTANT INFORMATION BEFORE USING LATICORT 0.1% LIQUID FOR THE SKIN

When not to use Laticort 0.1% liquid for the skin

• 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 changes;
• in children under 2 years of age;
• orally.

Warnings and precautions

Before starting treatment with Laticort 0.1% liquid for the skin, consult a doctor or pharmacist.

• Do not use continuously for more than 2 weeks.
• Corticosteroids are absorbed through the skin, so during treatment, there is a risk of systemic side effects characteristic of corticosteroids, including adrenal cortex suppression, decreased cortisol levels in the blood, Cushing's syndrome (a syndrome of disease symptoms associated with increased steroid levels in the blood, most often caused by prolonged administration of glucocorticosteroids). Therefore, avoid using the medicine on a large skin surface, wounds, damaged skin, using high doses, as well as long-term 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 people with glaucoma or cataracts, as it may worsen the symptoms of the disease.
• If the patient experiences blurred vision or other vision disturbances, consult a doctor.
• Avoid contact of the medicine with the eyes and mucous membranes.
• On the skin of the face and in the skin of the armpits and groin, use only in cases where it is absolutely necessary, due to the increased absorption of corticosteroids through delicate skin and the associated increased risk of widening of small blood vessels and perioral dermatitis, skin atrophy, even after short-term use.
• Do not use the medicine under a tightly sealing dressing, as the dressing increases the absorption of corticosteroids into the body, and skin atrophy, stretch marks, and superinfections may occur.
• Use with caution in cases of atrophic skin changes, 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 than in adults, it is easier for side effects characteristic of corticosteroids to occur, including growth and development disorders.

Other medicines and Laticort 0.1% liquid for the skin

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 local use of corticosteroids. During treatment, especially on a large skin surface, do not get vaccinated against smallpox. Do not undergo other vaccinations. Laticort 0.1% liquid for the skin 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 child, consult your doctor. PregnancyLaticort 0.1% liquid for the skin may be used during pregnancy only on the doctor's prescription, 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 in the first trimester of pregnancy. BreastfeedingLaticort 0.1% liquid for the skin may be used during breastfeeding only on the doctor's prescription, for a short period and on a small skin surface.

• for a short period and on a small skin surface.

Driving and using machines

Laticort 0.1% liquid for the skin does not affect the ability to drive and use machines.

3. HOW TO USE LATICORT 0.1% LIQUID FOR THE SKIN

Always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor. Do not extend the treatment period beyond the period prescribed by your doctor. The medicine is for use on the skin only. Usually, a small amount of liquid is applied to the affected areas of the skin, no more than once or twice a day. Do not use an occlusive dressing. Do not use the medicine for more than 2 weeks. On the skin of the face, do not use for more than 7 days. Within a week, no more than 1 package of the medicine 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 has prescribed 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 higher dose of Laticort 0.1% liquid for the skin than recommended

Prolonged or improper local 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, glucosuria, decreased immunity, and in severe cases, Cushing's syndrome. In case of overdose, the doctor will use appropriate treatment. If the medicine is ingested, consult a doctor immediately.

Missing a dose of Laticort 0.1% liquid for the skin

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 skin of the eyelids, glaucoma or cataracts may occasionally occur. Blurred vision. 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 existing skin changes may worsen.

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, using it on a large skin surface, under an occlusive dressing, or in the case of using it in children. Systemic side effects of hydrocortisone 17-butyrate, characteristic of corticosteroids, include adrenal cortex suppression, Cushing's syndrome, growth and development disorders in children, increased blood sugar levels, glucosuria, edema, hypertension, decreased immunity.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety 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% LIQUID FOR THE SKIN

Store in a temperature of 2°C - 8°C. The medicine should be stored out of the sight and reach of children. Do not use this medicine after the expiry date stated on the package. 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 does Laticort 0.1% liquid for the skin contain

The active substance of the medicine is hydrocortisone 17-butyrate, 1 ml of liquid contains 1 mg of hydrocortisone 17-butyrate. The other ingredients are: Glycerol Povidone Citric acid monohydrate Sodium citrate dihydrate Isopropyl alcohol Purified water

What does Laticort 0.1% liquid for the skin look like and what does the package contain

Laticort 0.1% is a colorless, transparent liquid. The available package of the medicine is: A polyethylene bottle with a dropper and a stopper containing 20 ml of liquid for the skin, 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 Bausch Health Poland sp. z o.o. ul. Przemysłowa 2 35-959 Rzeszów Poland

Date of last revision of the leaflet: