Hidrocort Hema

Package Leaflet: Information for the Patient

HYDROCORT CHEMA, 5 mg/g, ointment
(Hydrocortisone acetate)

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If after a few days there is no improvement or the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet

• 1. What is Hydrocort Chema and what is it used for
• 2. Important information before using Hydrocort Chema
• 3. How to use Hydrocort Chema
• 4. Possible side effects
• 5. How to store Hydrocort Chema
• 6. Contents of the pack and other information

1. What is Hydrocort Chema and what is it used for

Hydrocort Chema is an ointment containing the active substance hydrocortisone acetate, which is a mild adrenal cortex hormone. The medicine has anti-inflammatory, anti-itching, and vasoconstrictive effects.

Indications

Hydrocort Chema is used topically on the skin for symptomatic treatment of non-infected skin conditions such as:

• acute allergic inflammatory conditions (atopic dermatitis);
• psoriasis of the scalp;
• chronic psoriasis;
• rosacea;
• erythema multiforme;
• plaque psoriasis with intense itching;
• seborrheic dermatitis;
• eczematous dermatitis;
• acute allergic or inflammatory skin diseases;
• insect bites;
• drug-induced skin reactions;
• first- and second-degree burns;
• neurodermatitis.

2. Important information before using Hydrocort Chema

When not to use Hydrocort Chema

• if the patient is allergic to hydrocortisone acetate or any other ingredient of this medicine (listed in section 6);
• in bacterial, viral, and fungal skin infections;
• in pre-cancerous and cancerous skin conditions;
• in common acne;
• in rosacea;
• in perioral dermatitis;
• after vaccinations;
• on granulomatous vasculitis;
• in patients with Buerger's disease, due to the worsening of trophic (atrophic) disorders and delayed wound healing;
• on ulcers, wounds;
• in children under 12 years of age without consulting a doctor;
• during breastfeeding.

Do not use the medicine on the eyelids or on the skin around the eyes, due to the risk of glaucoma or cataracts, or in patients with glaucoma or cataracts, as it may worsen the symptoms of the disease.

Warnings and precautions

Before starting to use Hydrocort Chema, discuss it with your doctor or pharmacist. If symptoms of skin irritation or allergy occur, discontinue use of the medicine. If after a few days of using the medicine the symptoms of the disease do not subside, contact your doctor. The doctor will prescribe other treatment. Avoid using the medicine on a large area of skin, wounds, damaged skin, using large doses, prolonged treatment with the medicine, using in cases of skin diseases with excessive dryness of the skin and (or) its thinning or elevated body temperature, as well as in acute inflammatory skin conditions. In such cases, the absorption of hydrocortisone acetate may be significantly higher, leading to inhibition of adrenal cortex function. If symptoms of skin infection occur at the treatment site, contact your doctor. The doctor will use antibacterial or antifungal treatment. Protect your eyes and mucous membranes from contact with the medicine. On facial skin and skin of the armpits and groin, the medicine can only be used in absolutely necessary cases, due to increased absorption of hydrocortisone acetate through delicate skin and the associated increased risk of vasodilation, perioral dermatitis, and skin atrophy, even after short-term use. Avoid using the medicine under occlusive dressings (plaster, diaper), as the closed dressing increases the absorption of hydrocortisone acetate into the body. When using Hydrocort Chema, be careful:

• if the medicine is used in patients with tuberculosis;
• if the medicine is used in patients with diabetes;
• if the medicine is used in patients with psoriasis, as local use of corticosteroids in psoriasis may cause the development of tolerance (loss of effect), the risk of generalized pustular psoriasis, and general toxic effects due to skin continuity disorders.

Children

Use with special caution in children, as they are more likely than adults to experience inhibition of the hypothalamic-pituitary-adrenal axis and the occurrence of side effects characteristic of corticosteroids, including growth and development disorders. If hydrocortisone is administered to premature infants, it may be necessary to monitor heart function and cardiac muscle image.

Hydrocort Chema and other medicines

Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine. Hydrocort Chema can be used during pregnancy only if, in the doctor's opinion, the benefits of using the medicine outweigh the possible risk to the fetus. Do not use the medicine during breastfeeding, as its safety has not been established.

Driving and using machines

Hydrocort Chema has no influence or negligible influence on the ability to drive and use machines.

Hydrocort Chema contains propyl parahydroxybenzoate (E 216) and methyl parahydroxybenzoate (E 218)

which may cause allergic reactions (possible late reactions).

3. How to use Hydrocort Chema

This medicine should always be used exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. In case of doubt, consult a doctor or pharmacist. Before starting to use the medicine, pierce the tube membrane with the reverse side of the cap. In the case of a sachet, tear open the packaging; apply the ointment directly after opening the sachet. Apply a thin layer of ointment to the cleaned, affected skin surface 2 or 3 times a day. If improvement occurs, use the medicine 2 or 3 times a week, for no longer than 10 to 14 days. After using the medicine, wash your hands.

Use in children and adolescents

Do not use in children under 12 years of age without consulting a doctor and without medical supervision.

Using a higher dose of Hydrocort Chema than recommended

When using the medicine on large areas of skin, for a long time, under occlusive dressings, or on damaged skin, due to the absorption of hydrocortisone into the blood, systemic side effects of corticosteroids may occur, such as inhibition of the hypothalamic-pituitary-adrenal axis and Cushing's syndrome. If a higher dose of the medicine is used than recommended, contact your doctor.

Missing a dose of Hydrocort Chema

Do not use a double dose to make up for a missed dose. If you have any further doubts about using this medicine, consult a doctor or pharmacist.

Stopping use of Hydrocort Chema

If you have any further doubts about using this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Using the medicine for a period longer than 14 days may cause the occurrence of atrophic dermatitis, skin stretch marks, and delayed wound healing. The medicine used on the facial skin can quite quickly cause perioral dermatitis, atrophic dermatitis, and persistent vasodilation. Redness, symptoms of skin irritation (burning, redness, excessive dryness), skin atrophy, vasodilation, skin discoloration, bacterial, viral, and fungal superinfections - mainly after using occlusive dressings, as well as delayed wound and ulcer healing, may occur. When using the medicine on the eyelid skin, glaucoma or cataracts may occasionally occur. As a result of the absorption of hydrocortisone acetate into the blood, systemic side effects characteristic of corticosteroids may also occur, including inhibition of the hypothalamic-pituitary-adrenal axis and Cushing's syndrome. These occur mainly in the case of long-term use of the medicine, using it on a large area of skin, under occlusive dressings, or in children. In children, growth and development inhibition may also occur. Allergic reactions due to hypersensitivity to excipients may occur. Rarely, exacerbation of existing disease conditions occurs. Frequency not known (cannot be estimated from the available data):
cardiac hypertrophy (hypertrophic cardiomyopathy) in premature infants, weight gain.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, 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 Hydrocort Chema

Do not store above 25°C. Do not store the ointment in an open sachet; apply the ointment directly after opening the sachet. Keep the tube tightly closed. Store the medicine out of the sight and reach of children. Pay attention to the expiry date of the medicine. Do not use this medicine after the expiry date stated on the carton and blister pack (tube or sachet). The expiry date refers to the last day of the month stated. 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 Hydrocort Chema contains

• The active substance of the medicine is hydrocortisone acetate. 1 g of ointment contains 5 mg of hydrocortisone acetate.
• The other ingredients are: white petrolatum, glycerol monostearate, propyl parahydroxybenzoate (E 216), methyl parahydroxybenzoate (E 218), purified water.

What Hydrocort Chema looks like and contents of the pack

Hydrocort Chema is a homogeneous, white ointment. The medicine is available in:

• aluminum tube containing 20 g of ointment, placed together with the leaflet in a cardboard box;
• 10 sachets made of paper/polyethylene/aluminum/surlyn, containing 1 g of ointment, placed in a cardboard box.

Marketing authorization holder and manufacturer

CHEMA-ELEKTROMET
Cooperative
Przemysłowa 9 Street
35-105 Rzeszów
tel. 17 862 05 90

Date of last revision of the leaflet: