PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

LATICORT 0.1%, 1 mg/ml, cutaneous solution
Hydrocortisoni butyras
Please read the entire leaflet carefully before using this 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.
This 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:

What Laticort 0.1% cutaneous solution is and what it is used for
Important information before using Laticort 0.1% cutaneous solution
How to use Laticort 0.1% cutaneous solution
Possible side effects
How to store Laticort 0.1% cutaneous solution
Contents of the package and other information

1. WHAT LATICORT 0.1% CUTANEOUS SOLUTION IS AND WHAT IT IS USED FOR

Laticort 0.1% cutaneous solution contains the active substance hydrocortisone 17-butyrate. Hydrocortisone butyrate is a corticosteroid with moderately potent anti-inflammatory activity. When applied topically to the skin, it exerts anti-inflammatory, antipruritic (anti-itch), and vasoconstrictive effects.

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

Laticort 0.1% is indicated for:

Seborrheic dermatitis;
Atopic dermatitis;
Lichen urticatus;
Allergic contact dermatitis;
Erythema multiforme;
Lupus erythematosus;
Chronic psoriasis;
Lichen planus.

Laticort 0.1% cutaneous solution is usually used in the initial phase of treatment, prior to switching to Laticort 0.1% ointment, which is more suitable for scaling and dry skin lesions. Laticort 0.1% cutaneous solution is easier to apply on hairy skin compared to ointment or cream formulations.

2. IMPORTANT INFORMATION BEFORE USING LATICORT 0,1% TOPICAL SOLUTION

FOR THE SKIN
When not to use Laticort 0,1% topical solution

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;
acne vulgaris;
rosacea;
perioral dermatitis;
anal pruritus;
on extensive skin lesions;
in children under 2 years of age;
orally.

Warnings and precautions
Before starting treatment with Laticort 0,1% topical solution, 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 set of disease symptoms related to increased steroid levels in blood serum, most commonly caused by long-term administration of glucocorticosteroids). For this reason, avoid using the medicine on large skin areas, wounds, or damaged skin, using large doses, or prolonged treatment.
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 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 face, underarms, and groin areas only when absolutely necessary, due to increased absorption of corticosteroids through delicate skin and the associated increased risk of capillary dilation, perioral dermatitis, and skin atrophy, even after short-term use.
Do not use 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 corticosteroids in psoriasis may be dangerous for several reasons, including disease rebound due to tolerance development, risk of generalized pustular psoriasis, and general toxic effects due to 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% topical solution
Inform the doctor about all medicines currently used, recently used, or planned for use.
No interactions are known with topical corticosteroids.
During treatment with this medicine, especially when applied to large skin areas, vaccination against smallpox should not be performed. Other vaccinations should also be avoided.
Laticort 0,1% topical solution 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 is planning to become pregnant, she should consult a doctor.

Pregnancy
Laticort 0,1% topical solution 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% topical solution 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% topical solution has no effect on the ability to drive vehicles or operate machinery.

3. HOW TO USE LATICORT 0.1% TOPICAL SOLUTION

This medicine should always be used 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 only.
Usually, a small amount of the solution should be applied to the affected areas of the skin, no more frequently than once or twice daily. Do not use occlusive dressings (airtight and watertight coverings).
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 package should be used per week.

Use in children and adolescents
Do not use in children below 2 years of age.
In children above 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 face.

Use of a higher than recommended dose of Laticort 0.1% topical solution
Prolonged or improper topical use of the medicine, or application 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, glucosuria, reduced immunity, and, in severe cases, Cushing's syndrome.
In case of overdose, the physician will initiate appropriate treatment.
In case of accidental ingestion, contact a doctor immediately.

Missed dose of Laticort 0.1% topical solution
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.
Blurred vision.
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. 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):
As a result of systemic absorption, systemic adverse reactions of hydrocortisone butyrate characteristic of corticosteroids may also occur.
These occur primarily during prolonged use, application over a large skin area, under occlusive dressing, or when used in children.

Systemic adverse effects of hydrocortisone butyrate typical of corticosteroids include, among others: suppression of the hypothalamic–pituitary–adrenal (HPA) axis function, Cushing's syndrome, growth and development retardation in children, hyperglycemia, glycosuria, edema, hypertension, and decreased immunity.

Reporting of adverse reactions
If any adverse reactions occur, including those 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 at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: [email protected]

Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. HOW TO STORE LATICORT 0,1% TOPICAL SOLUTION

Store at a temperature of 2°C - 8°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. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Laticort 0.1% skin solution contains
The active substance is hydrocortisone 17-butyrate.
1 ml of solution contains 1 mg of hydrocortisone 17-butyrate.
The other ingredients are:
Glycerol
Povidone
Citric acid monohydrate
Disodium citrate dihydrate
Isopropyl alcohol
Purified water

What Laticort 0.1% skin solution looks like and contents of the pack
Laticort 0.1% is a colourless, clear solution.
The pack available is:
A polyethylene bottle with dropper and cap containing 20 ml of skin solution, in a cardboard box.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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