Laticort 0,1%

Leaflet attached to the packaging: patient information

LATICORT 0.1%, 1 mg/g, cream

Hydrocortisone butyrate

Table of contents of the leaflet:

You should read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• -You should keep this leaflet, so you can read it again if you need to.
• -If you have any doubts, you should consult a doctor or pharmacist.
• -This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• -If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

• 1. What is Laticort 0.1% cream and what is it 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 packaging and other information

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

Laticort 0.1% in the form of a cream for topical use, contains the active substance hydrocortisone 17-butyrate. Hydrocortisone 17-butyrate is a medicine from the group of corticosteroids with moderate anti-inflammatory action; used locally on the skin, it has anti-inflammatory, anti-itching and vasoconstrictive effects.

Indications for use

Subacute and chronic, non-infected, weeping skin conditions of various origins, especially of allergic origin, of moderate or severe intensity, which respond to treatment with glucocorticosteroids and are accompanied by persistent itching or excessive keratinization. Laticort 0.1% is indicated in:

• seborrheic dermatitis;
• atopic dermatitis;
• nummular eczema;
• allergic contact dermatitis;
• polymorphic erythema;
• erythema multiforme;
• chronic psoriasis;
• psoriasis vulgaris. Usually, Laticort 0.1% in the form of a cream is used in the first phase of treatment, before using Laticort 0.1% in the form of an ointment, which is used on scaly and dry skin lesions.

2. Important information before using Laticort 0.1% cream

When not to use Laticort 0.1% cream

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

Warnings and precautions

Before starting to use Laticort 0.1% cream, you should consult a doctor or pharmacist.

• Do not use continuously for more than 2 weeks.
• Corticosteroids are absorbed through the skin, so during the use of the medicine, there is a risk of systemic side effects characteristic of corticosteroids, including adrenal suppression, decreased cortisol levels in the blood, Cushing's syndrome (a syndrome of disease symptoms associated with increased steroid levels in the blood, most often caused by prolonged administration of glucocorticosteroids). Therefore, you should avoid using the medicine on a large skin surface, wounds, damaged skin, using it in large doses, as well as long-term treatment with the medicine.
• In the case of skin infection at the treatment site, the doctor will use appropriate antibacterial or antifungal treatment. If the symptoms of infection persist, you should contact a doctor. The doctor will decide whether the treatment should be discontinued until the infection is cured.
• The medicine should not be used on the eyelids or on the skin around the eyelids, due to the risk of glaucoma or cataracts, and in people with glaucoma or cataracts, as it may exacerbate the symptoms of the disease.
• If the patient experiences blurred vision or other vision disturbances, they should contact a doctor.
• Avoid contact of the medicine with the eyes and mucous membranes.
• On the skin of the face and in the axillary and groin areas, use only in cases where it is absolutely necessary, due to the increased absorption of corticosteroids through delicate skin and the associated increased risk of telangiectasia and perioral dermatitis, even after short-term use.
• Do not use the medicine under a tightly occlusive dressing, as the dressing increases the absorption of corticosteroids into the body, and atrophy of the epidermis, striae and superinfections may occur.
• Use with caution in atrophic conditions of the subcutaneous tissue, especially in the elderly.
• Use with special caution in patients with psoriasis, as local use of corticosteroids in psoriasis can be dangerous for several reasons, including the risk of relapse of the disease caused by the development of tolerance, the risk of generalized pustular psoriasis and general toxic effects caused by skin barrier disruption.

Children and adolescents

Use with caution and avoid long-term use in children over 2 years of age. In children, due to the greater ratio of body surface area to body mass than in adults, it is easier for side effects characteristic of corticosteroids to occur, including growth and development disorders.

Laticort 0.1% cream and other medicines

You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. There are no known interactions related to the topical use of corticosteroids. During the use of the medicine, especially on a large skin surface, you should not be vaccinated against smallpox. You should not undergo other vaccinations either. Laticort 0.1% cream may interfere with the action of medicines that affect the immune system.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or plan to have a child, you should consult a doctor or pharmacist before using this medicine. PregnancyLaticort 0.1% cream may be used during pregnancy only on the doctor's prescription, for a short period and on a small skin surface, when the doctor considers that the benefits of using the medicine for the mother outweigh the risk to the fetus. Do not use the medicine during the first trimester of pregnancy. BreastfeedingLaticort 0.1% cream may be used during breastfeeding only on the doctor's prescription - for a short period and on a small skin surface.

Driving and using machines

Laticort 0.1% cream does not affect the ability to drive and use machines.

Laticort 0.1% cream contains cetostearyl alcohol and methyl parahydroxybenzoate (E218)

Due to the content of cetostearyl alcohol, the medicine may cause local skin reactions (e.g. contact dermatitis). Due to the content of methyl parahydroxybenzoate, the medicine may cause allergic reactions (possible late-type reactions).

3. How to use Laticort 0.1% cream

This medicine should always be used as directed by your doctor. If you are unsure, you should consult a doctor. Do not extend the treatment period beyond what is recommended by your doctor. The medicine is intended for use on the skin. Usually, a small amount of the medicine is applied to the affected areas of the skin, no more than once or twice a day. Do not use an occlusive dressing. Do not use the medicine for more than 2 weeks. On the skin of the face, do not use for more than 7 days. During the week, you can use no more than 1 tube (15 g) of cream.

Use in children and adolescents

Do not use in children under 2 years of age. In children over 2 years of age, unless the doctor recommends otherwise, the medicine is usually used only once a day, on a small skin surface. Do not use on the skin of the face.

Using a higher dose of Laticort 0.1% cream than recommended

Prolonged or improper topical use of the medicine or use on large skin surfaces may lead to growth and development disorders in children. Symptoms of hydrocortisone 17-butyrate overdose may occur, including edema, hypertension, increased blood glucose levels, glucosuria, decreased immunity, and in severe cases, Cushing's syndrome. In the event of an overdose, the doctor will use appropriate treatment.

Missing a dose of Laticort 0.1% cream

Do not use a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Local side effects with unknown frequency (frequency cannot be determined from available data):

When using the medicine on the skin of the eyelids, glaucoma or cataracts may occasionally occur. Blurred vision. Symptoms similar to acne, perioral dermatitis, atrophy of the epidermis and subcutaneous tissue, dryness of the skin, excessive hair growth or hair loss, skin discoloration or hyperpigmentation, atrophy and striae of the skin, telangiectasia, perioral dermatitis, folliculitis, secondary infections, skin irritation may occur. Occasionally, urticaria or a papular rash may occur, or existing skin lesions may worsen.

Systemic side effects with unknown frequency (frequency cannot be determined from available data):

As a result of the absorption of the medicine into the blood, systemic side effects of hydrocortisone 17-butyrate, characteristic of corticosteroids, may also occur. They occur mainly in the case of long-term use of the medicine, use on a large skin surface, under an occlusive dressing, or in the case of use in children. Systemic side effects of hydrocortisone 17-butyrate, characteristic of corticosteroids, include adrenal suppression, Cushing's syndrome, growth and development disorders in children, increased blood glucose levels, glucosuria, edema, hypertension, decreased immunity.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Al. Jerozolimskie 181C 02-222 Warsaw Tel: +48 22 49 21 301 Fax: +48 22 49 21 309 Website: https://smz.ezdrowie.gov.pl Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Laticort 0.1% cream

Store at a temperature below 25°C. Do not freeze. The medicine should be stored in a place that is 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 should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Laticort 0.1% cream contains

The active substance of the medicine is hydrocortisone 17-butyrate. 1 g of cream contains 1 mg of hydrocortisone 17-butyrate. The other ingredients are: White petrolatum Liquid paraffin Cetostearyl alcohol Macrogol cetostearyl ether Citric acid monohydrate Sodium citrate dihydrate Methyl parahydroxybenzoate (E218) Purified water

What Laticort 0.1% cream looks like and what the packaging contains

Laticort 0.1% is a white, uniform cream without a smell. The available packaging of the medicine is: An aluminum tube containing 15 g of cream, in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization 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

Date of last revision of the leaflet: