Laticort 0.1%

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet. The information on the immediate packaging is in a foreign language!
Laticort 0.1%
1 mg/g, ointment
Hydrocortisoni butyras
Please read the entire leaflet before using the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any doubts, consult your doctor or pharmacist. This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm another person, even if their symptoms are similar.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

1. What Laticort 0.1% ointment is and what it is 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 pack and other information

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

Laticort 0.1% ointment for topical application contains the active substance hydrocortisone butyrate. Hydrocortisone butyrate is a corticosteroid medicine with moderately strong anti-inflammatory activity. When applied locally to the skin, it exerts anti-inflammatory, antipruritic, and vasoconstrictive effects.

Indications
Subacute and chronic, non-infectious, dry inflammatory skin conditions of various origins, particularly those of allergic origin, of moderate to severe intensity, which respond to treatment with glucocorticosteroids and are accompanied by persistent itching or excessive keratinization.

Laticort 0.1% is indicated for:

• Seborrhoeic dermatitis;
• Atopic dermatitis;
• Lichen urticatus;
• Allergic contact dermatitis;
• Erythema multiforme;
• Systemic lupus erythematosus;
• 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 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;
• common acne;
• rosacea;
• perioral dermatitis;
• anal pruritus;
• 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 longer than 2 weeks.
• Corticosteroids are absorbed through the skin; therefore, there is a risk of systemic adverse effects typical of corticosteroids, including suppression of adrenal cortex function, decreased blood cortisol levels, and Cushing's syndrome (a group of symptoms caused by increased steroid levels in blood serum, most commonly due to long-term administration of glucocorticosteroids). For this reason, avoid using the medicine over large skin areas, open wounds, damaged skin, in high doses, or for prolonged periods.
• If a skin infection develops at the treated site, the doctor should initiate appropriate antibacterial or antifungal treatment. If signs of infection persist, contact a doctor. The doctor will decide whether treatment should be discontinued until the infection resolves.
• Do not apply the medicine to the eyelids or skin around the eyes due to the risk of glaucoma or cataract, and avoid use in patients with glaucoma or cataract, as symptoms may worsen.
• If the patient experiences blurred vision or other visual disturbances, contact a doctor.
• Avoid contact of the medicine with eyes and mucous membranes.
• Use on the face, armpits, and groin areas only when absolutely necessary, due to increased absorption of corticosteroids through delicate skin, which may lead to increased risk of telangiectasia, perioral dermatitis, skin atrophy—even after short-term use.
• Avoid using the medicine under occlusive dressings, as such dressings enhance corticosteroid absorption into the body and may lead to epidermal atrophy, striae, and secondary infections.
• Use with caution in conditions involving atrophy of subcutaneous tissue, especially in elderly patients.
• Use with particular caution in patients with psoriasis, as topical use of corticosteroids in psoriasis may be dangerous for several reasons, including disease rebound due to development of tolerance, risk of generalized pustular psoriasis, and systemic toxic effects caused by impaired skin integrity.

Children and adolescents
Use with caution and avoid prolonged use in children over 2 years of age.
In children, due to a higher body surface area to body weight ratio compared to adults, adverse effects typical of corticosteroids—including growth and developmental disturbances—may occur more easily than in adults.

Other medicines and Laticort 0,1% ointment
Inform your doctor about all medicines currently taken or recently used, as well as any medicines the patient plans to take.
No interactions are known associated with topical use of corticosteroids.
During treatment with this medicine, especially when applied to large skin areas, vaccination against smallpox should be avoided. Other vaccinations should also not be performed.
Laticort 0,1% ointment may interfere with the action of drugs affecting the immune system.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
Laticort 0,1% ointment may be used during pregnancy only on a doctor's prescription, for short periods and on small skin areas, when the doctor considers that benefits to the mother outweigh the risks to the fetus.
The medicine must not be used during the first trimester of pregnancy.

Breastfeeding
Laticort 0,1% ointment may be used during breastfeeding only on a doctor's prescription—short-term and on small skin areas.

Driving and operating machinery
Laticort 0,1% ointment has no effect on the ability to drive or operate machinery.

3. HOW TO USE LATICORT 0.1% OINTMENT

This medicine should always be used as directed by the physician. If in doubt, consult your doctor.
Do not extend the duration of treatment beyond that recommended by the physician.
This medicine is intended for topical use only.
Usually, a small amount of the ointment should be applied to the affected skin areas no more than once or twice daily.
In cases of marked lichenification or excessive keratosis of the diseased skin, use of an occlusive dressing is permitted, which should be changed every 24 hours.
Do not use the medicine for longer than 2 weeks.
On the facial skin, do not use for longer than 7 days. No more than 1 tube (15 g) of ointment should be used per week.

Use in children and adolescents
Do not use in children under 2 years of age.
In children over 2 years of age, unless otherwise directed by a physician, the medicine is usually applied once daily and only to a small skin area. Do not apply to the face.

Use of a dose higher than recommended of Laticort 0.1% ointment
Prolonged or improper topical use of the medicine, or use over large skin areas, may lead to suppression of growth and development in children.
Symptoms of hydrocortisone acetate overdose may occur, including edema, hypertension, increased blood glucose, glycosuria, reduced immunity, and in severe cases, Cushing's syndrome.
In case of overdose, the physician will initiate appropriate treatment.

Missed dose of Laticort 0.1% ointment
Do not use a double dose to make up for a missed dose.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Local adverse reactions of unknown frequency (frequency cannot be determined from the available data):
When the medicine is applied to the eyelids, glaucoma or cataract may occasionally occur.
Visual disturbances may occur.
Acneiform eruptions, steroid-induced purpura, epidermal and subcutaneous tissue atrophy, dry skin, excessive hair growth or alopecia, skin depigmentation or hyperpigmentation, skin atrophy and striae, dilation of small blood vessels, perioral dermatitis, folliculitis, secondary infections, skin irritation may occur. Urticaria or maculopapular rash may occasionally occur, or exacerbation of existing skin lesions.
Systemic adverse reactions of unknown frequency (frequency cannot be determined from the available data):
As a result of systemic absorption of the medicine into the bloodstream, systemic adverse reactions of hydrocortisone butyrate characteristic of corticosteroids may also occur.
These occur primarily during prolonged use of the medicine, application over a large skin surface area, under occlusive dressing, or use in children.
Systemic adverse effects of hydrocortisone butyrate characteristic of corticosteroids include, among others, suppression of the hypothalamic–pituitary–adrenal (HPA) axis function, Cushing's syndrome, growth and developmental retardation in children, increased blood glucose levels, glycosuria, edema, hypertension, and reduced immunity.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 492 1301
Fax: +48 22 492 1309
Website: https://smz.ezdrowie.gov.pl
Reporting of adverse reactions allows the collection of further information on the safety of the 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. PACK CONTENTS AND OTHER INFORMATION

What Laticort 0.1% ointment contains
The active substance is hydrocortisone 17-butyrate.
1 g of ointment contains 1 mg of hydrocortisone 17-butyrate.
The other ingredient is:
White vaseline.

What Laticort 0.1% ointment looks like and contents of the pack
Laticort 0.1% is a white or almost white, semi-transparent ointment.
Available pack:
Aluminum tube containing 15 g of ointment, in a cardboard box.
For more detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.

Marketing Authorisation Holder in Hungary, the 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:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warszawa
Poland
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warszawa
Poland
Laboratorium Galenowe Olsztyn Sp. z o.o.
ul. Spółdzielcza 25A
11-001 Dywity
Poland
Synoptis Industrial Sp. z o.o.
ul. Szosa Bydgoska 58
87-100 Toruń
Poland

Hungarian Marketing Authorisation Number (country of export): OGYI-T-1317/01
Parallel Import Licence Number: 321/19