Laticort 0.1%

Package leaflet: Information for the patient

LATICORT 0.1%, 1 mg/g, cream
Hydrocortisoni butyras
Please read the entire leaflet 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, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, even if their symptoms are the same.
• 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% cream is and what it is used for
2. Important information before using Laticort 0.1% cream
3. How to use Laticort 0.1% cream
4. Possible side effects
5. How to store Laticort 0.1% cream
6. Contents of the pack and other information

1. What Laticort 0.1% cream is and what it is used for

Laticort 0.1% cream for topical application 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, and vasoconstrictive effects.
Indications
Subacute and chronic, non-infectious, exuding 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 keratinization.
Laticort 0.1% is indicated in:

• Seborrhoeic dermatitis;
• Atopic dermatitis;
• Lichen urticatus;
• Allergic contact dermatitis;
• Erythema multiforme;
• Systemic lupus erythematosus;
• Psoriasis vulgaris;
• Lichen planus.

Laticort 0.1% cream is usually used in the initial phase of treatment, prior to applying Laticort 0.1% ointment, which is intended for scaly and dry skin lesions.

2. 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 other ingredients of this medicine;
• in viral skin infections (e.g. chickenpox, herpes simplex);
• fungal or bacterial skin infections;
• acne vulgaris;
• rosacea;
• perioral dermatitis;
• anal pruritus;
• 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 are absorbed through the skin; therefore, there is a risk of systemic adverse effects typical of corticosteroids during treatment, including suppression of adrenal cortex function, reduced blood cortisol levels, and Cushing's syndrome (a cluster of symptoms associated with increased steroid levels in blood serum, most commonly caused by long-term administration of glucocorticosteroids). For this reason, avoid using the medicine over large skin areas, open wounds, damaged skin, using high doses, or prolonged treatment.
• If skin infection occurs at the treated site, the doctor will 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 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, which increases the risk of capillary dilation, perioral dermatitis, and skin atrophy, even after short-term use.
• Do not use under an occlusive dressing, 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 may be dangerous for several reasons, including disease rebound due to developing 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 disorders, may occur more easily than in adults.

Laticort 0.1% cream and other medicines
Inform your doctor about all medicines currently used or recently used, 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 smallpox. Other vaccinations should also be avoided.
Laticort 0.1% cream may interfere with the action of medicines affecting the immune system.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans 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 over small skin areas, when the doctor considers that the 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 over small skin areas.

Driving and operating machinery
Laticort 0.1% cream does not affect the ability to drive or operate machinery.

Laticort 0.1% cream contains cetostearyl alcohol and methyl parahydroxybenzoate (E218)
Due to the presence of cetostearyl alcohol, the medicine may cause local skin reactions (e.g. contact dermatitis).
Due to the presence of methyl parahydroxybenzoate, the medicine may cause allergic reactions (delayed-type reactions possible).

3. How to use Laticort 0.1% cream

This medicine should always be used exactly as directed by the physician. If in doubt, consult your
doctor. Do not extend the duration of treatment beyond that recommended by your doctor.
This medicine is intended for topical use on the skin.
Usually, a small amount of the cream should be applied to the affected areas of skin, no more than
once or twice daily. Do not use occlusive dressings (airtight coverings).
Do not use the medicine for longer than 2 weeks.
On the face, do not use for longer than 7 days. No more than one tube (15 g) of cream 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 area of skin. Do not apply to the face.
Use of a higher than recommended dose of Laticort 0.1% cream
Prolonged or improper topical use of the medicine, or use over large areas of skin, may lead to
suppression of growth and development in children.
Symptoms of hydrocortisone 17-butyrate overdose may occur, including edema, arterial
hypertension, increased blood glucose concentration, glycosuria, reduced immunity, and in severe
cases, Cushing's syndrome may develop.
In case of overdose, the physician will initiate appropriate treatment.
Missed dose of Laticort 0.1% cream
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 will experience them.

Local adverse reactions with unknown frequency (frequency cannot be determined from 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 hair loss, skin discoloration or pigmentation changes, 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 existing skin lesions may worsen.

Systemic adverse reactions with unknown frequency (frequency cannot be determined from available data):
Systemic absorption of the medicine may lead to systemic adverse effects of hydrocortisone butyrate, typical of corticosteroids.
These occur primarily after prolonged use, application over large skin areas, use under occlusive dressings, or use in children.

Systemic adverse effects of hydrocortisone butyrate typical of corticosteroids include suppression of the hypothalamic-pituitary-adrenal axis, Cushing's syndrome, growth and development retardation in children, increased blood glucose levels, glycosuria, edema, arterial 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 be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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

Adverse reactions can also be reported to the Marketing Authorisation Holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Laticort 0.1% cream

Store below 25°C. Do not freeze.
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 should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Laticort 0.1% cream contains
The active substance is hydrocortisone 17-butyrate.
1 g of cream contains 1 mg of hydrocortisone 17-butyrate.
The other ingredients are:
White soft paraffin
Liquid paraffin
Cetostearyl alcohol
Cetomacrogol
Citric acid monohydrate
Disodium citrate dihydrate
Methyl 4-hydroxybenzoate (E218)
Purified water

What Laticort 0.1% cream looks like and contents of the pack
Laticort 0.1% is a white, homogeneous, odourless cream.
Available pack:
Aluminium tube containing 15 g of cream, 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
Tel: +48 17 865 51 00

Manufacturer
Przedsiębiorstwo Farmaceutyczne Jelfa SA
ul. Wincentego Pola 21
58-500 Jelenia Góra
Poland