Hidrocortisonum Amara

Package Leaflet: Information for the Patient

HYDROCORTISONUM AMARA,5 mg/g, cream
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, pharmacist, or nurse.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, ask your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.
• If after 7 days there is no improvement or you feel worse, contact your doctor.

Table of Contents of the Leaflet:

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

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

Hydrocortisonum Amara is a cream for topical use on the skin. The active substance is hydrocortisone acetate. After application to the skin, the medicine has anti-inflammatory, antipruritic, and vasoconstrictive effects.
The medicine suppresses the development of inflammation symptoms without affecting their cause.

Indications:

Skin reactions after insect bites or stings.

2. Important information before using Hydrocortisonum Amara

When not to use Hydrocortisonum Amara

• if you are allergic to hydrocortisone acetate or any of the other ingredients of this medicine listed in section 6,
• in skin infections caused by viruses (e.g., herpes, chickenpox), fungi (candidiasis and other mycoses), or bacteria (e.g., impetigo),
• on damaged skin,
• on mucous membranes,
• in common or rosacea acne,
• in perioral dermatitis,
• in the eyes or around the eyes,
• in the genital or anal area.

Warnings and precautions

Before starting to use Hydrocortisonum Amara, discuss it with your doctor, pharmacist, or nurse.

• Do not use the medicine for more than 7 days without a doctor's recommendation.
• Long-term use of the medicine on large areas of skin or under occlusive dressings (e.g., under a diaper) may cause systemic side effects of hydrocortisone acetate. In children, long-term use of corticosteroids may cause growth and development disorders.
• Use on the face should only be done on the recommendation of a doctor.
• Do not use the medicine on a large area of skin without prior consultation with a doctor.
• If there is no improvement after 7 days of using the medicine or the symptoms worsen, contact your doctor.
• Pregnant or breastfeeding women should not use the medicine without a doctor's recommendation.
• If an infection occurs at the site of application, appropriate antifungal and antibacterial treatment should be used.

Children and adolescents

Do not use in children under 12 years of age without a doctor's recommendation.

Hydrocortisonum Amara and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
No interactions with other medicines have been reported for topical hydrocortisone acetate.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before using this medicine.
Hydrocortisonum Amara should not be used in pregnant women without a doctor's recommendation.
Breastfeeding women should not use Hydrocortisonum Amara without consulting a doctor, as it is not known whether topical corticosteroids pass into breast milk.
If the doctor decides to use Hydrocortisonum Amara during breastfeeding, do not allow the medicine to come into contact with the breast skin to avoid accidental ingestion by the infant or accidental contact with the infant's skin.

Driving and using machines

Hydrocortisonum Amara does not affect the ability to drive and use machines.

What Hydrocortisonum Amara contains

• cetostearyl alcohol - the medicine may cause local skin reactions (e.g., contact dermatitis);
• propylene glycol - the medicine contains 35 mg of propylene glycol in 1 g of cream. Propylene glycol may cause skin irritation. Do not use this medicine in children under 4 weeks of age on open wounds or large areas of damaged or broken skin (e.g., burned) without consulting a doctor or pharmacist;
• methyl parahydroxybenzoate, propyl parahydroxybenzoate - the medicine may cause allergic reactions (possible late reactions). If skin reactions occur, discontinue use of Hydrocortisonum Amara.

3. How to use Hydrocortisonum Amara

This medicine should always be used exactly as described in this package leaflet for the patient, or as directed by a doctor, pharmacist, or nurse.
The medicine is intended for topical use on the skin.
Unless otherwise recommended by a doctor, apply a thin layer of the medicine to the affected areas of skin twice a day. After using the medicine, wash your hands.
If there is no improvement after 7 days of using the medicine, contact your doctor. Do not use the medicine without consulting a doctor for more than 7 days.
In case of doubts, consult a doctor, pharmacist, or nurse.

Using more than the recommended dose of Hydrocortisonum Amara

During long-term use of the medicine on large areas of skin or on damaged skin or under occlusive dressings (e.g., under a diaper), as well as in children, due to increased absorption of the active substance into the bloodstream, systemic side effects of corticosteroids may occur (e.g., suppression of the hypothalamic-pituitary-adrenal axis, Cushing's syndrome).
In case of using a higher dose of the medicine than recommended, contact a doctor or pharmacist immediately.

Missing a dose of Hydrocortisonum Amara

If you miss a dose, use it as soon as possible. However, if it is close to the time for the next dose, use the next scheduled dose. Do not use a double dose to make up for a missed dose.

Stopping use of Hydrocortisonum Amara

In case of further doubts about using this medicine, consult a doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Hydrocortisonum Amara can cause side effects, although not everybody gets them.
In case of hypersensitivity reactions, discontinue use of the medicine immediately.
When using the medicine in skin folds, on the face, under occlusive dressings (e.g., under a diaper), or on large areas of skin, due to increased absorption of hydrocortisone acetate into the body, skin atrophy, striae, superficial vasodilation, or hypersensitivity reactions may occur. After long-term treatment, systemic side effects of corticosteroids and suppression of the hypothalamic-pituitary-adrenal axis may occur.
The occurrence of side effects is more likely in children, especially when using occlusive dressings.
Changes in skin pigmentation and excessive hair growth have been reported with the use of topical corticosteroids. During treatment, worsening of disease symptoms and skin reactions may occur.
If you experience any of the above symptoms, consult a doctor.
Reporting side effects
If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products 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 Hydrocortisonum Amara

Keep the medicine out of the sight and reach of children.
Do not use Hydrocortisonum Amara after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Do not store above 25°C. Do not freeze.
Shelf life after first opening the tube: 6 months.
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 Amara contains

The active substance is hydrocortisone acetate.
1 g of cream contains 5 mg of hydrocortisone acetate.
The other ingredients are: macrogol cetostearyl ether, glycerol monostearate 40-55, cetostearyl alcohol, liquid paraffin, white petrolatum, sorbitan stearate, propylene glycol, methyl parahydroxybenzoate, propyl parahydroxybenzoate, purified water.

What Hydrocortisonum Amara looks like and contents of the pack

The medicine is a white or almost white cream.
Packaging: aluminum tube with a polyethylene (PE) screw cap, containing 10 g, 15 g, 20 g, 25 g, or 30 g of cream, placed in a cardboard box with a patient leaflet.

Marketing authorization holder and manufacturer:

Zakład Farmaceutyczny „Amara” sp. z o.o.
ul. Stacyjna 5
30-851 Kraków
Tel.: 12 657 40 40
[email protected]

Date of last revision of the leaflet: