Laticort 0,1%

LEAFLET INCLUDED IN THE PACKAGE: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Laticort 0.1% (Laticort), 1 mg/g, ointment

Hydrocortisone butyrate
Laticort 0.1% and Laticort are different trade names for the same medicine.

You should read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a 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.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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% ointment for topical use contains the active substance hydrocortisone butyrate. Hydrocortisone butyrate is a moderately potent anti-inflammatory corticosteroid. When applied topically to the skin, it has anti-inflammatory, antipruritic, and vasoconstrictive effects.

Indications for use

Subacute and chronic, non-infected, dry inflammatory skin conditions of various origins, especially those 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% ointment 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:

• in viral skin infections (e.g., chickenpox, herpes simplex);
• in fungal or bacterial (e.g., tuberculosis) skin infections;
• in acne vulgaris;
• in rosacea;
• in perioral dermatitis;
• in anal itching;
• on extensive skin lesions;
• in children under 2 years of age.

Warnings and precautions

Before starting to use Laticort 0.1% ointment, you should 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 suppression, decreased cortisol levels in the blood, and Cushing's syndrome. Therefore, you should avoid using the medicine on a large skin surface, wounds, damaged skin, in large doses, and for prolonged treatment.
• In the event of a skin infection at the treatment site, the doctor will prescribe appropriate antibacterial or antifungal treatment. If the symptoms of the infection persist, you should contact your 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 eyes, 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 vision disturbances, they should contact their 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 the increased absorption of corticosteroids through delicate skin and the associated increased risk of telangiectasia, perioral dermatitis, skin atrophy, even after short-term use.
• Avoid using the medicine under a tightly occlusive dressing, as it increases the absorption of corticosteroids into the body, and may cause skin atrophy, striae, and superinfections.
• Use with caution in atrophic conditions of the subcutaneous tissue, especially in the elderly.
• Use with special caution in patients with psoriasis, as local use of corticosteroids in psoriasis can be dangerous for several reasons, including the risk of relapse due to the development of tolerance, the risk of generalized pustular psoriasis, and general toxic effects due to skin barrier disruption.

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 side effects characteristic of corticosteroids to occur, 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.
No interactions are known to be associated with topical use of corticosteroids.
During treatment, especially on a large skin surface, do not get vaccinated against smallpox. Do not get other vaccinations either.
Laticort 0.1% ointment may interfere with the effects 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 or pharmacist before using this medicine.
Pregnancy
Laticort 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 risks for the fetus.
Do not use the medicine during the first trimester of pregnancy.
Breastfeeding
Laticort 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 on 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 higher dose of Laticort 0.1% ointment than recommended

Prolonged or incorrect topical use of the medicine or use on large skin surfaces may lead to growth and development disorders in children.
Overdose symptoms of hydrocortisone butyrate may occur, including edema, hypertension, increased blood glucose levels, glucosuria, and decreased immunity, and in severe cases, Cushing's syndrome.
In the event of an overdose, the doctor will provide 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):

When using the medicine on the eyelids, glaucoma or cataracts may occasionally occur.
Visual disturbances may occur.
Acne-like symptoms, perioral dermatitis, skin atrophy and subcutaneous tissue atrophy, dry skin, excessive hair growth or hair loss, skin discoloration or hyperpigmentation, skin atrophy and striae, telangiectasia, perioral dermatitis, folliculitis, secondary infections, skin irritation may occur. Occasionally, urticaria or a papular rash may occur, or existing skin lesions may worsen.

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

Due to the absorption of the medicine into the blood, systemic side effects of hydrocortisone butyrate characteristic of corticosteroids may also occur.
These 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 butyrate characteristic of corticosteroids include adrenal suppression, Cushing's syndrome, growth and development disorders in children, increased blood glucose levels, glucosuria, edema, hypertension, and decreased immunity.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell 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, website: https://smz.ezdrowie.gov.pl.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE LATICORT 0.1% OINTMENT

Do not store above 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 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 butyrate.
1 g of ointment contains 1 mg of hydrocortisone butyrate.
The other ingredient is:
White petrolatum

What Laticort 0.1% ointment looks like and contents of the package

Laticort 0.1% is a white or almost white, semi-transparent ointment.
The medicine is available in:
An aluminum tube, internally lacquered, with a protective membrane and a PE cap, containing 15 g of ointment, in a cardboard box.
For more detailed information, please contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Lithuania, country of export:

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

Manufacturer:

Przedsiębiorstwo Farmaceutyczne Jelfa S.A.
ul. Wincentego Pola 21
58-500 Jelenia Góra
Poland

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Lithuanian, country of export marketing authorization number: LT/1/97/0510/002

Parallel import authorization number: 336/22 Date of leaflet approval: 13.09.2022

[Information about the trademark]