PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Laticort 0.1% (Laticort), 1 mg/g, ointment
Hydrocortisoni butyras
Laticort 0.1% and Laticort are different trade names for the same medicinal product.
Please read this leaflet before using the medicine, as it contains important information for the patient.

Keep this leaflet for future reference.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

What Laticort 0.1% ointment is and what it is used for
Important information before using Laticort 0.1% ointment
How to use Laticort 0.1% ointment
Possible side effects
How to store Laticort 0.1% ointment
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 with moderately potent anti-inflammatory activity. When applied locally to the skin, the drug exerts anti-inflammatory, antipruritic, and vasoconstrictive effects.

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

Laticort 0.1% ointment is indicated in:

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% CREAM

When not to use Laticort 0.1% cream:

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

Warnings and precautions
Before starting treatment with Laticort 0.1% cream, consult a doctor or pharmacist.

Do not use continuously for longer than 2 weeks.
Corticosteroids can be 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 set of symptoms caused by increased steroid concentration in blood serum, most commonly due to long-term administration of glucocorticosteroids). For this reason, avoid using the medicine on large skin areas, wounds, or damaged skin, using high doses, or prolonged treatment.
If skin infection occurs 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 the 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 facial skin, as well as in the axillary and groin areas, only when absolutely necessary, due to increased absorption of corticosteroids through delicate skin and the associated increased risk of telangiectasia, perioral dermatitis, and skin atrophy, even after short-term use.
Avoid using the medicine under an occlusive dressing, as such dressings enhance systemic absorption of corticosteroids and may additionally 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 corticosteroids may be dangerous in psoriasis for several reasons, including disease rebound due to development of tolerance, risk of generalized pustular psoriasis, and general 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 the 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% cream
Inform the doctor about all medicines currently used, recently used, or planned to be used.
No interactions are known related to topical use of corticosteroids.
During treatment with this medicine, especially when applied to large skin areas, do not get vaccinated against chickenpox. Other vaccinations should also be avoided.
Laticort 0.1% cream may interfere with the action of drugs affecting the immune system.

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

Pregnancy
Laticort 0.1% cream 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% cream may be used during breastfeeding only on a doctor's prescription, for short periods and on small skin areas.

Driving and operating machinery
Laticort 0.1% cream has no effect on the ability to drive vehicles or operate machinery.

3. HOW TO USE THE MEDICINAL PRODUCT LATICORT 0,1% OINTMENT

This medicine should always be used as directed by a physician. In case of doubt, consult your doctor. Do not extend the duration of treatment beyond that recommended by the doctor.
This medicine is intended for topical use on the skin.
Usually, a small amount of the ointment should be applied to the affected areas of the skin no more than once or twice daily. In cases of marked lichenification or excessive keratosis of the diseased skin, application under an occlusive dressing may be 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 one 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 surface area. Do not apply to the facial skin.

Use of a higher than recommended dose of Laticort 0,1% ointment
Prolonged or improper topical use of the medicine, or use over large skin surface areas, may lead to suppression of growth and development in children.
Symptoms of hydrocortisone 17-butyrate overdose may occur, including edema, hypertension, increased blood glucose concentration, 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 everybody will experience them.
Local adverse reactions with unknown frequency (frequency cannot be determined from the available data):
When the medicine is applied to the eyelid skin, glaucoma or cataract may occasionally occur.
Visual disturbances may occur.
Acneiform eruptions, steroid-induced purpura, epidermal and subcutaneous tissue atrophy, dry skin, hypertrichosis 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 or exacerbation of existing skin lesions may occasionally occur.
Systemic adverse reactions with unknown frequency (frequency cannot be determined from the available data):
Systemic adverse reactions of hydrocortisone butyrate characteristic of corticosteroids may also occur due to absorption of the medicine into the bloodstream.
These occur primarily with prolonged use, 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, Cushing's syndrome, growth and development suppression in children, increased blood glucose levels, glycosuria, edema, hypertension, and reduced immunity.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions 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 4921301, fax: +48 22 4921309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions allows further information on the safety of the medicine to be collected.

5. HOW TO STORE LATICORT 0.1% OINTMENT

Do not store above 25°C.
Keep the medicine in a place inaccessible and out of sight 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 in use. This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Laticort 0,1% ointment contains
The active substance is hydrocortisone acetate.
1 g of ointment contains 1 mg of hydrocortisone acetate.
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.
The available pack is:
An aluminium tube, internally lacquered, with a protective membrane and a PE cap, containing 15 g of ointment, in a cardboard box.

For further information, please contact the responsible party or the parallel importer.

Responsible party 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
Poland

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

Marketing authorisation number in Lithuania, country of export: LT/1/97/0510/002
Parallel import authorisation number: 336/22