Hidrocortisonum Ziaia

Package Leaflet: Information for the Patient

Hydrocortisonum Ziaja, 5 mg/g, Cream

Hydrocortisone Acetate

Read the Package Leaflet Carefully Before Using the Medication, as it Contains Important Information for the Patient.

This medication should always be used exactly as described in this patient information leaflet 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 you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after 7 days there is no improvement or you feel worse, you should contact a doctor.

Table of Contents of the Leaflet

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

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

Hydrocortisonum Ziaja is a cream for topical use on the skin and belongs to a group of medicines called corticosteroids. The active substance is hydrocortisone acetate, which has anti-inflammatory, anti-itching, and vasoconstrictive effects.

Indications for Use

Adults and Children Over 12 Years Old

Local treatment of inflammatory skin conditions of various origins, primarily of allergic origin, which respond to glucocorticosteroids. Hydrocortisonum Ziaja is indicated for the local treatment of atopic dermatitis, contact dermatitis (allergic or irritant), seborrhoeic dermatitis, and reactions to insect bites or stings. If after 7 days there is no improvement or you feel worse, you should contact a doctor.

2. Important Information Before Using Hydrocortisonum Ziaja

When Not to Use Hydrocortisonum Ziaja

• in the genital and anal areas,
• in children under 12 years old without a doctor's recommendation.

Warnings and Precautions

Before starting treatment with Hydrocortisonum Ziaja, discuss with your doctor:

During treatment with Hydrocortisonum Ziaja, follow these warnings:

• Do not use on healthy skin.
• Do not use large amounts of the medication, on a large skin surface, or for a long time, as corticosteroids are absorbed into the bloodstream and may cause systemic side effects (listed in section 4: Possible side effects).
• If a skin infection occurs at the site of application of Hydrocortisonum Ziaja (e.g., ulcers, pustules), contact a doctor.
• Avoid contact of the medication with the eyes and mucous membranes.
• The medication may be used on the facial skin and in the armpits and groin area with caution and only in cases where it is absolutely necessary. Due to significantly greater absorption of the medication in these areas, there is a risk of side 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., bandage, diaper), as this increases the absorption of the medication.

Children and Adolescents

Hydrocortisonum Ziaja is indicated for use in children over 12 years old. Do not use in children under 12 years old without consulting a doctor. In children, the medication should be used with caution and avoid long-term use, due to a greater risk of systemic side effects, including growth and development disorders.

Hydrocortisonum Ziaja and Other Medications

Tell your doctor or pharmacist about all medications you are currently taking, have recently taken, or plan to take. No interactions have been described between topically applied hydrocortisone acetate and other medications.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult a doctor or pharmacist before using this medication. Do not use Hydrocortisonum Ziaja during pregnancy and breastfeeding without a doctor's recommendation. Pregnancy: There are no data or only limited data on the use of hydrocortisone acetate in pregnant women. If a doctor recommends using Hydrocortisonum Ziaja during pregnancy, the medication should be used for a short period and on small skin areas, and with special caution in the first 3 months of pregnancy. Breastfeeding: If a doctor decides to use Hydrocortisonum Ziaja during breastfeeding, avoid contact of the medication with the breast skin to prevent accidental ingestion by the infant or accidental contact of the medication with the infant's skin. During breastfeeding, the medication should be used with caution, for a short period, and on a small skin area, as it is not known whether topically applied corticosteroids pass into human milk.

Driving and Operating Machinery

Hydrocortisonum Ziaja does not affect the ability to drive and operate machinery.

Hydrocortisonum Ziaja Contains:

• cetyl alcohol and stearyl alcohol, so the medication may cause local skin reactions (e.g., contact dermatitis);
• 80 mg of propylene glycol (E 1520) per gram of cream, so the medication may cause skin irritation;
• methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216), so the medication may cause allergic reactions (possible late-type reactions).

3. How to Use Hydrocortisonum Ziaja

This medication should always be used exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If you are unsure, consult a doctor or pharmacist. The medication is intended for topical use on the skin. Recommended dose

Adults and Children Over 12 Years Old

Apply a small amount of cream to the affected areas of the skin 1 or 2 times a day. After use, wash your hands. Do not use on the facial skin for more than 3 days. The maximum treatment duration without consulting a doctor is one week. If after 7 days there is no improvement or you feel worse, you should contact a doctor.

Children

Do not use Hydrocortisonum Ziaja in children under 12 years old without consulting a doctor.

Using More Than the Recommended Dose of Hydrocortisonum Ziaja

In case of using more than the recommended dose, contact a doctor immediately.

Missing a Dose of Hydrocortisonum Ziaja

Do not use a double dose to make up for a missed dose. Continue using the medication without increasing the next dose. If you have any further doubts about using this medication, consult a doctor or pharmacist.

4. Possible Side Effects

Like all medicines, Hydrocortisonum Ziaja can cause side effects, although not everybody gets them. If you experience an allergic reaction, stop using the medication immediately. To minimize the number of side effects, Hydrocortisonum Ziaja should be used for the shortest possible time. Uncommon side effects (may affect up to 1 in 100 people):

• blurred vision.

Side effects of unknown frequency (frequency cannot be estimated from the available data):

• atrophic dermatitis, skin striae,
• recurrence of skin infection,
• perioral dermatitis (skin discoloration and depigmentation),
• superficial vasodilation,
• perioral dermatitis-like acne,
• perioral dermatitis,
• ocular dermatitis,
• folliculitis, hypertrichosis,
• delayed wound healing and ulceration,
• bacterial, fungal, and viral skin superinfections,
• petechiae (small, red, or purple spots on the skin),
• skin irritation, such as burning, redness, excessive dryness, contact allergy,
• glaucoma or cataracts - when the medication is used on the skin of the eyelids,
• systemic side effects (suppression of the hypothalamic-pituitary-adrenal axis, Cushing's syndrome (elevated cortisol levels in the blood), growth and development disorders in children, hyperglycemia (elevated blood sugar levels), glycosuria (glucose in the urine)).

Systemic side effects may occur with prolonged use of the medication on a large skin surface, under occlusive dressing, or in children, due to increased absorption of the active substance into the bloodstream. If you experience any of the above symptoms, stop using the medication and contact a doctor.

Reporting Side Effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Medicinal Product Monitoring, 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 medication.

5. How to Store Hydrocortisonum Ziaja

Keep the medication out of the sight and reach of children. Do not freeze. Shelf life after first opening the immediate packaging: 3 years, but no longer than the expiry date stated on the packaging. Do not use this medication after the expiry date stated on the packaging after "EXP". 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 Hydrocortisonum Ziaja Contains

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

What Hydrocortisonum Ziaja Looks Like and Contents of the Pack

Hydrocortisonum Ziaja is a white or almost white, homogeneous cream. Packaging: aluminum tube with a membrane, internally coated with epoxy-phenolic lacquer, with an HDPE cap with a piercer, containing 15 g of cream, placed with a leaflet in a cardboard box.

Marketing Authorization Holder

ZIAJA Ltd Pharmaceutical Works sp. z o.o., ul. Jesienna 9, 80-298 Gdańsk, tel.: +48 58 521 34 00, (logo of the marketing authorization holder)

Manufacturer

ZIAJA Ltd Pharmaceutical Works sp. z o.o., ul. Przemysłowa 12, 83-050 Kolbudy

Date of Last Revision of the Leaflet: