Package leaflet: Information for the user

Hydrocortisonum Ziaja, 5 mg/g, cream
Hydrocortisoni acetas
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
the doctor or pharmacist.

Keep this leaflet so that you can read it again if necessary.
If you need advice or further information, consult your pharmacist.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 7 days of treatment, or if your condition worsens, consult your doctor.

Table of contents of the leaflet

What Hydrocortisonum Ziaja is and what it is used for
Important information before using Hydrocortisonum Ziaja
How to use Hydrocortisonum Ziaja
Possible side effects
How to store Hydrocortisonum Ziaja
Contents of the pack and other information

1. What Hydrocortisonum Ziaja is and what it is used for

Hydrocortisonum Ziaja is a topical cream intended for skin application and belongs to a group of medicines called corticosteroids. The active substance, hydrocortisone acetate, has anti-inflammatory, antipruritic, and vasoconstrictive effects.
Indications
Adults and children over 12 years of age
Local treatment of inflammatory skin conditions of various origins, particularly those of allergic origin, which respond to glucocorticosteroids.
Hydrocortisonum Ziaja is indicated for the local treatment of atopic dermatitis, contact dermatitis (allergic or irritant), seborrheic dermatitis, and reactions following insect bites or stings.
If there is no improvement after 7 days of treatment, or if your condition worsens, consult your doctor.

2. Important information before using Hydrocortisonum Ziaja

When not to use Hydrocortisonum Ziaja

if the patient is allergic to hydrocortisone acetate or any of the other ingredients of this medicine (listed in section 6),
if the patient has bacterial skin infections (e.g. impetigo), viral infections (e.g. herpes simplex, chickenpox), fungal infections (e.g. candidiasis) or systemic fungal infection,
if the patient has acne vulgaris or rosacea (redness, flushing and acne-like eruptions),
if the patient has skin atrophy (thinning of the skin),
if the patient has skin cancer or a pre-cancerous skin condition,
if the patient has perioral dermatitis (inflammation around the mouth),
if the patient has tuberculosis skin lesions,
if the patient has open wounds or damaged skin,
in the genital and anal areas,
in children under 12 years of age without medical advice.

Warnings and precautions
Before starting treatment with Hydrocortisonum Ziaja, discuss with your doctor:

if the patient has diabetes.
if the patient has glaucoma or cataracts, as use of the medicine on the eyelids or skin around the eyes may worsen symptoms. The medicine should not be applied to the eyelids or skin around the eyes due to the risk of developing glaucoma or cataracts.
if the patient has psoriasis, as topical use of the medicine may lead to development of tolerance (loss of effectiveness), disease relapse, risk of generalized pustular psoriasis, and systemic toxic effects due to impaired skin integrity.
if the patient intends to apply the medicine to facial skin.
if the patient experiences blurred vision or other visual disturbances, medical advice should be sought.

While using Hydrocortisonum Ziaja, observe the following warnings:

Do not use on healthy skin.
Do not use large doses, over large skin areas, or for prolonged periods, as corticosteroids may be absorbed into the bloodstream and cause systemic adverse effects (listed in section 4: Possible side effects).
If a skin infection (e.g. sores, pustules) develops at the site of application, consult a doctor.
Avoid contact with eyes and mucous membranes.
The medicine may be used on the face, armpits, and groin areas only with caution and only when absolutely necessary. Due to significantly increased absorption in these areas, there is a risk of occurrence or worsening of adverse effects, even after short-term use. In such cases, consult a doctor.
After applying Hydrocortisonum Ziaja to the skin, do not cover the area with any dressing (e.g. plaster, diaper), as this increases drug absorption.

Children and adolescents
Hydrocortisonum Ziaja is indicated for use in children over 12 years of age.
Do not use in children under 12 years of age without medical advice. In children, the medicine should be used with caution and prolonged use should be avoided due to increased risk of systemic adverse effects, including disturbances in growth and development, compared to adults.

Hydrocortisonum Ziaja with other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use.
No interactions have been reported between topically applied hydrocortisone acetate and other medicines.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Do not use Hydrocortisonum Ziaja during pregnancy or breastfeeding without medical advice.

Pregnancy
There are no data or only limited data on the use of hydrocortisone acetate in pregnant women. If a doctor prescribes Hydrocortisonum Ziaja during pregnancy, it should be used for short periods, on small skin areas, and with particular caution during the first three months of pregnancy.

Breastfeeding
If a doctor decides to prescribe Hydrocortisonum Ziaja during breastfeeding, avoid contact of the medicine with the skin of the breasts to prevent accidental ingestion by the infant or accidental contact with the infant's skin.
During breastfeeding, the medicine should be used cautiously, for short periods, and on small skin areas, as it is unknown whether topically applied corticosteroids pass into human milk.

Driving and operating machinery
Hydrocortisonum Ziaja has no influence on the ability to drive or operate machinery.

Hydrocortisonum Ziaja contains:

cetyl alcohol and stearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis);
80 mg of propylene glycol (E 1520) in each gram of cream, which may cause skin irritation;
methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216), which may cause allergic reactions (delayed-type hypersensitivity reactions possible).

3. How to use Hydrocortisonum Ziaja

This medicine should always be used exactly as described in this patient information leaflet, or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
This medicine is intended for topical application to the skin.
Recommended dose
Adults and children over 12 years of age
Apply a small amount of cream to the affected skin areas once or twice daily. Wash hands after application.
Do not use on the facial skin for longer than 3 days.
The maximum treatment duration without consulting a doctor is one week. If there is no improvement after 7 days, or if the patient feels worse, medical advice should be sought.
Children
Do not use Hydrocortisonum Ziaja in children under 12 years of age without consulting a doctor.
Use of a higher than recommended dose of Hydrocortisonum Ziaja
In case of overdose, seek immediate medical advice.
Missed dose of Hydrocortisonum Ziaja
Do not use a double dose to make up for a missed dose.
Continue treatment as prescribed, without increasing the next dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If allergic reactions occur, discontinue use of the medicine immediately.
To minimize the number of adverse effects, Hydrocortisonum Ziaja should be used for the shortest possible duration.

Adverse effects occurring not very commonly (may occur in up to 1 in 100 patients):

blurred vision.

Adverse effects with unknown frequency (frequency cannot be estimated from available data):

skin atrophy, striae (stretch marks),
recurrence of skin infection,
post-steroidal pigmentation (skin discoloration),
superficial dilation of blood vessels,
steroid-induced acne,
perioral dermatitis,
periorbital dermatitis,
folliculitis, hypertrichosis,
delayed wound and ulcer healing,
secondary bacterial, fungal, or viral skin infections,
petechiae (small red or purple spots on the skin),
skin irritation such as burning, redness, excessive dryness, contact allergy,
glaucoma or cataract – when the medicine is applied to the skin of the eyelids,
systemic adverse effects (suppression of the hypothalamic-pituitary-adrenal axis, Cushing's syndrome (elevated serum cortisol concentration), growth and development suppression in children, hyperglycemia (increased blood sugar concentration), glycosuria (presence of sugar in urine)).

Systemic adverse effects may occur during prolonged use of the medicine over a large skin surface area, under occlusive dressing, or when used in children, due to enhanced absorption of the active substance into the systemic circulation.
If any of the above symptoms occur, discontinue the medicine and contact a doctor.

Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of 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
Website: https://smz.ezdrowie.gov.pl

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

5. How to store Hydrocortisonum Ziaja

Keep this medicine out of sight and reach of children.
Do not freeze.
Use-by period after first opening the immediate packaging: 3 years, but not beyond the expiry date stated on the packaging after "EXP".
Do not use this medicine after the expiry date stated on the packaging after "EXP".
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 in use. This will help protect the environment.

6. Contents of the package and other information

What Hydrocortisonum Ziaja contains

The active substance is hydrocortisone acetate. 1 gram of cream contains 5 mg of hydrocortisone acetate.
Other ingredients are: cetyl alcohol, stearyl alcohol, propylene glycol (E 1520), methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), macrogol cetostearyl ether 20, liquid paraffin, sorbitan stearate (type I), white soft paraffin, purified water.

What Hydrocortisonum Ziaja looks like and contents of the pack
Hydrocortisonum Ziaja is a white or almost white, homogeneous cream.
Packaging: an aluminium tube with an internal epoxy-phenolic varnish coating, fitted with a HDPE cap with a piercing device, containing 15 g of cream, placed with a leaflet in a cardboard box.
Marketing Authorisation Holder
ZIAJA Ltd Zakład Produkcji Leków sp. z o.o.
Jesienna 9 Street
80-298 Gdańsk
Phone: +48 58 521 34 00
(logo of the marketing authorisation holder)
Manufacturer
ZIAJA Ltd Zakład Produkcji Leków sp. z o.o.
Przemysłowa 12 Street
83-050 Kolbudy