Laticort 0.1%

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, 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 the patient experiences any adverse reactions, including any not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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 is an ointment for topical application on the skin and contains the active substance hydrocortisone butyrate. Hydrocortisone butyrate is a corticosteroid with moderately potent 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, especially those of allergic origin, with moderate to severe intensity, which respond to treatment with glucocorticosteroids and are associated with persistent itching or excessive keratosis. Laticort 0.1% ointment is indicated in:

• seborrheic dermatitis;
• atopic dermatitis;
• lichen urticatus;
• allergic contact dermatitis;
• erythema multiforme;
• 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 is allergic (hypersensitive) to hydrocortisone butyrate, other corticosteroids, or any of the other ingredients of the medicine;
• in viral skin infections (e.g. chickenpox, herpes simplex);
• fungal or bacterial skin infections (e.g. tuberculosis);
• acne vulgaris;
• rosacea;
• perioral dermatitis;
• anal pruritus;
• over extensive skin areas;
• in children under 2 years of age.

Warnings and precautions
Before starting treatment with Laticort 0.1% ointment, consult your 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, reduced blood cortisol levels, and Cushing's syndrome (a clinical condition caused by elevated steroid levels in blood serum, most commonly due to prolonged glucocorticosteroid therapy). Therefore, avoid using the medicine over large skin areas, wounds, or damaged skin, using large doses, or prolonged treatment.
• If a skin infection develops in the treated area, the doctor should initiate appropriate antibacterial or antifungal treatment. If signs of infection persist, contact your 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 especially 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, axillae, or groin areas only when absolutely necessary, due to increased absorption of corticosteroids through thin skin and the associated higher 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 additionally cause 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 corticosteroid use in psoriasis may be dangerous for several reasons, including disease relapse 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 treatment 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 disturbances in growth and development, may occur more easily than in adults.

Other medicines and Laticort 0.1% ointment
Inform your doctor about all medicines currently or recently taken, as well as any medicines you plan to take.
No interactions are known with topical corticosteroids.
During treatment, especially when applied over large skin areas, do not get vaccinated against chickenpox. Other vaccinations should also be avoided.
Laticort 0.1% ointment may interfere with the action of medicines affecting the immune system.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her 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 over small skin areas, when the doctor considers that the benefits to the mother outweigh the risks to 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 a doctor's prescription, for short periods and over small skin areas.

Driving and using machines
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 exactly as directed by the physician. In case of doubt, consult
your doctor. Do not extend the duration of treatment beyond that recommended by the physician. 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, an occlusive dressing may be used, 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 to a small skin area. Do not apply to the face.
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 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
disease.
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 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 also 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 with unknown frequency (frequency cannot be determined from the available data):
Systemic adverse reactions of hydrocortisone 17-butyrate characteristic of corticosteroids may also occur due to absorption of the medicine into the bloodstream.
These occur primarily during prolonged use, application over a large skin surface area, under occlusive dressing, or when used in children.

Systemic adverse effects of hydrocortisone 17-butyrate characteristic of corticosteroids include, among others: suppression of the hypothalamic-pituitary-adrenal axis, Cushing's syndrome, growth and development suppression in children, increased blood glucose levels, glycosuria, edema, hypertension, and decreased 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 also be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warszawa
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl

Reporting adverse reactions helps to provide more information on the safety of using this medicine.

5. How to store Laticort 0.1% ointment

Do not store above 25°C.
Keep the medicine out of 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 specified 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. Contents of the pack 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 soft paraffin.

What Laticort 0.1% ointment looks like and contents of the pack
Laticort 0.1% is a white or almost white, semi-transparent ointment.
Pack size available:
Aluminium tube containing 15 g of ointment, packed in a cardboard box.

For further information, please contact the Marketing Authorisation Holder or the Parallel Importer.

Marketing Authorisation 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:
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

SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
Poland

Marketing Authorisation number in Lithuania, country of export: LT/1/97/0510/002
Parallel Import authorisation number: 216/23