Hydrocortisone allefin

Package leaflet: Information for the patient

Hydrokortyzon Allefin, 5 mg/g, cream
Hydrocortisoni acetas
Please read 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 for future reference.
• If advice or additional information is needed, consult a pharmacist.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform a doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 7 days of treatment, or if the patient feels worse, contact a doctor.

Table of contents

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

1. What Hydrokortyzon Allefin is and what it is used for

Hydrokortyzon Allefin is a cream intended for topical application to the skin.
Hydrokortyzon Allefin cream contains hydrocortisone (as acetate), a corticosteroid with mild activity, which, when applied topically, exerts anti-inflammatory, antipruritic, and vasoconstrictive effects.
Indications
Hydrokortyzon Allefin cream is used topically in the following conditions:

• Atopic dermatitis, allergic eczema, urticaria,
• Lichen planus,
• Erythema multiforme,
• Pruritic lichen planus,
• Seborrhoeic dermatitis,
• Various forms of eczema, especially eczema with lichenification,
• Psoriasis of the hairy scalp, chronic psoriasis,
• Prurigo,
• Continuation of treatment after potent glucocorticosteroids,
• Relief of symptoms following insect bites.

2. Important information before using Hydrokortyzon Allefin

When not to use Hydrokortyzon Allefin

• if the patient is allergic to hydrocortisone, other corticosteroids, or any of the other ingredients of this medicine (listed in section 6);
• in bacterial, viral, fungal infections, or systemic mycosis;
• in acne vulgaris or rosacea;

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• in case of skin atrophy (thinning of the skin);
• in skin tumours or pre-malignant skin conditions;
• in perioral dermatitis;
• in cutaneous tuberculosis;
• on open wounds or damaged skin.

Warnings and precautions
Before starting to use Hydrokortyzon Allefin, discuss with your doctor or
pharmacist:

• if the patient has diabetes – the medicine should not be used long-term;
• if the patient has glaucoma or cataracts, as use around the eyelids or periorbital skin may worsen symptoms. The medicine should not be applied to the eyelids or skin around the eyes due to the risk of glaucoma or cataracts;
• if the patient has psoriasis, as topical corticosteroids may lead to tachyphylaxis (loss of drug efficacy), disease relapse, risk of generalized pustular psoriasis, and systemic toxic effects due to impaired skin barrier.

While using Hydrokortyzon Allefin, observe the following warnings:

• Do not use large doses, over large skin areas, or for prolonged periods, as corticosteroids may be absorbed into the bloodstream and cause adverse effects (see section 4).
• If a skin infection develops at the site of application, contact your doctor.
• If blurred vision or other visual disturbances occur, contact your doctor.
• Avoid contact of the medicine with eyes and mucous membranes.
• The medicine may be used on facial skin and on skin of the armpits and groin only when absolutely necessary. Due to significantly increased absorption in these areas, there is a risk of developing or worsening adverse effects, even after short-term use. In such cases, consult your doctor.
• Use on facial skin is permitted only for a short period (up to 3 days).
• After applying Hydrokortyzon Allefin, do not cover the treated area with any dressing (especially plastic film or occlusive dressings), as this increases drug absorption.

Children
Do not use in children under 12 years of age without consulting a doctor. In children, the medicine should be used cautiously and prolonged use should be avoided due to a higher risk of systemic adverse effects, including disturbances in growth and development, compared to adults.

Hydrokortyzon Allefin and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use.
No interactions are known between Hydrokortyzon Allefin cream and other medicines.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she might be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
During pregnancy, the medicine should only be used under medical supervision, solely when clearly necessary, for short durations, and on small skin areas. Particular caution is advised during the first three months of pregnancy.

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Breastfeeding
During breastfeeding, the medicine should only be used under medical supervision. It is not known whether topically applied corticosteroids pass into breast milk; therefore, the medicine should be used cautiously, for short durations, and on small skin areas. The medicine should not be applied to the breast skin immediately before breastfeeding.

Driving and operating machinery
This medicine has no effect or negligible effect on the ability to drive and operate machinery.

Hydrokortyzon Allefin contains methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), cetyl alcohol, stearyl alcohol, and propylene glycol (E 1520)

Due to the presence of methyl parahydroxybenzoate and propyl parahydroxybenzoate, this medicine may cause allergic reactions (including delayed-type reactions).

Due to the presence of cetyl alcohol and stearyl alcohol, this medicine may cause local skin reactions (e.g. contact dermatitis).

The medicine contains 30 mg of propylene glycol per 1 g of cream. Propylene glycol may cause skin irritation.

3. How to use Hydrokortyzon Allefin

This medicine should always be used exactly as described in this patient information leaflet or as directed by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse.
This medicine is intended for topical application to the skin.
Recommended dose
Apply a thin layer of cream to the affected area of skin 2 or 3 times daily.
After applying the medicine, wash your hands unless the hands are the area being treated.
Do not use on large areas of skin without prior consultation with your doctor.
Duration of treatment
Without prior consultation with your doctor, do not use this medicine for longer than 14 days. On the face, do not use for longer than 3 days.
If there is no improvement after 7 days, or if the patient feels worse, consult your doctor.
Children
In children under 12 years of age, do not use without medical advice.
Use of a higher than recommended dose of Hydrokortyzon Allefin
Hydrokortyzon Allefin used in high doses, over large skin areas, or for prolonged periods may cause disturbances in growth and development in children and suppression of the hypothalamic-pituitary-adrenal (HPA) axis (this refers to the interdependent endocrine glands producing hormones). Symptoms of overdose may include: increased blood glucose levels, glucose in urine, and Cushing's syndrome.
In case of overdose, contact your doctor immediately.
Missed dose of Hydrokortyzon Allefin
Apply the medicine as soon as possible. Do not use a double dose to make up for a missed application.
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If you have any further questions regarding the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, Hydrokortyzon Allefin can cause adverse reactions, although not everyone experiences them.

Prolonged use of hydrocortisone cream (for longer than 14 days), application over large areas of skin, use under occlusive dressings, and use in children may lead to the occurrence of adverse reactions such as:

• atrophic skin changes, striae (stretch marks);
• recurrence of infection;
• post-steroidal pigmentation (skin discoloration and hypopigmentation);
• superficial dilation of blood vessels;
• acne;
• perioral dermatitis;
• periorbital dermatitis;
• folliculitis, hypertrichosis;
• delayed wound and ulcer healing;
• bacterial, fungal, and viral superinfections;
• 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;
• blurred vision (may occur in no more than 1 in 100 patients);
• suppression of the hypothalamic-pituitary-adrenal axis (a term referring to the interdependent endocrine glands producing hormones);
• increased blood glucose levels (hyperglycemia);
• glucose in urine (glycosuria);
• growth and development suppression in children;
• so-called Cushing's syndrome (growth and developmental disorder associated with characteristic body changes: moon face, rounded trunk, and thin limbs).

If any of the above symptoms occur, treatment with the medicine should be discontinued and medical advice should be sought.

Reporting of adverse reactions

If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:

Aleje Jerozolimskie 181C, 02-222 Warsaw
Tel: +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 provide more information on the safety of the medicine.

5. How to store Hydrokortyzon Allefin

Keep the medicine out of the sight and reach of children.
Store below 25°C. Do not store in the refrigerator or freeze.
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Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the stated month.
Use-by period after first opening of the tube: 6 months.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Hydrokortyzon Allefin contains

• The active substance is hydrocortisone acetate. 1 g of cream contains 5 mg of hydrocortisone acetate.
• The other ingredients (excipients) are: cetostearyl alcohol polyether, cetyl alcohol, stearyl alcohol, liquid paraffin, white soft paraffin, sorbitan stearate, propylene glycol (E 1520), methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), and purified water.

What Hydrokortyzon Allefin looks like and contents of the pack
Hydrokortyzon Allefin is a homogeneous cream, white to slightly yellowish in colour.
One pack of the medicine contains 15 g of cream in an aluminium tube with a sealing membrane internally coated with epoxy-phenolic varnish, fitted with a polyethylene (HDPE) cap with a piercing device, packed in a cardboard box.
Marketing Authorisation Holder and Manufacturer
„PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK” S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Medicine Information
tel.: (22) 742 00 22
e-mail: [email protected]
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