Hydrocortisone amara

Package leaflet: Information for the patient

HYDROCORTISONUM AMARA, 5 mg/g, cream
Hydrocortisoni acetas
Please read all of this 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 patient leaflet, or as directed by a doctor, pharmacist, or nurse.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 7 days of treatment, or if you feel worse, consult your doctor.

Contents of the leaflet:

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

Hydrocortisonum Amara is a topical cream intended for application to the skin. The medicine contains the active substance hydrocortisoni acetas (hydrocortisone acetate). When applied to the skin, Hydrocortisonum Amara exerts anti-inflammatory, antipruritic (anti-itch), and vasoconstrictive effects.
The medicine suppresses the symptoms of inflammation without affecting its underlying cause.
Indications:
Skin reactions following insect bites or stings.

2. Important information before using Hydrocortisonum Amara

When not to use Hydrocortisonum Amara

• if the patient is 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 simplex, chickenpox), fungi (candidiasis and other fungal infections) or bacteria (e.g. impetigo),
• on damaged skin,
• on mucous membranes,
• in acne vulgaris or rosacea,
• in perioral dermatitis,
• in or around the eyes,
• in the genital and anal areas.

Warnings and precautions
Before starting to use Hydrocortisonum Amara, discuss this with your doctor, pharmacist,
or nurse.

• Do not use the medicine for longer than 7 days without medical advice.
• Prolonged use of the medicine on large areas of skin, or under occlusive dressings (e.g. under a diaper) may lead to systemic adverse effects of hydrocortisone acetate. In children, prolonged use of corticosteroids may cause disturbances in growth and development.
• Use on the facial skin should only be done under medical advice.
• Do not use the medicine on large areas of skin without prior consultation with a doctor.
• If there is no improvement after 7 days of treatment, or if symptoms worsen, consult your doctor.
• Women who are pregnant, planning pregnancy, or breastfeeding should not use the medicine without medical advice.
• If an infection develops at the site of application, appropriate antifungal and antibacterial treatment should be initiated.

Children and adolescents
Do not use in children under 12 years of age without medical advice.
Hydrocortisonum Amara and other medicines
Inform your doctor or pharmacist about all medicines you are currently using,
have recently used, or plan to use.
No interactions with other medicines have been described for topically applied hydrocortisone acetate.
Pregnancy, breastfeeding and fertility
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have
a baby, consult your doctor or pharmacist before using this medicine.
Hydrocortisonum Amara should not be used during pregnancy without medical advice.
Breastfeeding women should not use Hydrocortisonum Amara without consulting
a doctor, as it is unknown whether topically applied corticosteroids pass into human
milk.
If your doctor decides that Hydrocortisonum Amara should be used during breastfeeding,
avoid contact of the medicine with the skin of the breast to prevent accidental ingestion by
the infant or accidental contact with the infant's skin.

Driving and operating machinery
Hydrocortisonum Amara has no effect on the ability to drive
and operate machinery.

Hydrocortisonum Amara contains:

• cetostearyl alcohol – may cause local skin reactions (e.g. contact dermatitis);
• propylene glycol – contains 35 mg of propylene glycol per 1 g of ointment. 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 injured or damaged skin (e.g. burns) without consultation with a doctor or pharmacist;
• propyl parahydroxybenzoate, methyl parahydroxybenzoate – may cause allergic reactions (delayed-type reactions possible). 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 patient information leaflet, or as directed by your doctor, pharmacist, or nurse.
This medicine is intended for topical application to the skin.
Unless otherwise advised by a doctor, a thin layer of the medicine should be applied to the affected areas of skin twice daily. Hands should be washed after applying the medicine.
If there is no improvement after 7 days of treatment, consult a doctor. Use of the medicine without consulting a doctor should not exceed 7 days.
If in doubt, consult a doctor, pharmacist, or nurse.

Use of a higher than recommended dose of Hydrocortisonum Amara
Prolonged use of the medicine over large areas of skin, on damaged skin, under occlusive dressings, or in children may lead to increased systemic absorption of the active substance into the bloodstream, potentially causing general adverse effects of corticosteroids (e.g. suppression of the hypothalamic-pituitary-adrenal axis, Cushing's syndrome).
If a higher than recommended dose has been used, consult a doctor or pharmacist immediately.

Missed dose of Hydrocortisonum Amara
If a dose has been missed, apply it as soon as possible. However, if it is almost time for the next dose, skip the missed dose and apply the next dose at the scheduled time. Do not increase the dose independently.
Do not use a double dose to make up for a missed dose.

Stopping treatment with Hydrocortisonum Amara
If you have any further doubts regarding the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like any medicine, Hydrocortisonum Amara may cause adverse reactions, although not everyone experiences them.
If hypersensitivity reactions occur, the use of the medicine should be discontinued immediately.
When the medicine is used in skin folds, on the facial skin, under occlusive dressing (e.g. diaper) or on large areas of skin, due to increased systemic absorption of hydrocortisone acetate, skin atrophy, striae, superficial dilation of blood vessels, and hypersensitivity reactions may occur.
With prolonged treatment, systemic adverse effects of corticosteroids and suppression of the hypothalamic-pituitary-adrenal axis may occur.
The occurrence of adverse reactions is more likely in children, especially during the use of occlusive dressings.
Changes in skin pigmentation and excessive hair growth have been reported as a result of local corticosteroid use. During treatment, worsening of symptoms and skin reactions may occur.
If any of the above symptoms occur, consult a doctor.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse.
Adverse reactions 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 reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to enhance the knowledge on the safety of the 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 stated month.
Do not store above 25°C. Do not freeze.
Shelf-life after first opening of the tube: 6 months.
Medicines must 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: cetostearyl alcohol polyether, glycerol monostearate 40-55, cetostearyl alcohol, liquid paraffin, white soft paraffin, sorbitan stearate, propylene glycol, methyl parahydroxybenzoate, propyl parahydroxybenzoate, purified water.

What Hydrocortisonum Amara looks like and contents of the pack
Hydrocortisonum Amara is a white or almost white cream.
Pack: aluminium tube with polyethylene (PE) cap containing 10 g, 15 g, 20 g, 25 g or 30 g of cream, placed in a cardboard box with the patient leaflet.

Marketing Authorisation Holder and Manufacturer:
Zakład Farmaceutyczny „Amara” sp. z o.o.
Stacyjna 5 Street
30-851 Kraków
Tel.: 12 657 40 40
[email protected]