Hidrokortizon Allefin Max

Package Leaflet: Information for the Patient

Hydrocortisone Allefin Max, 10 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 package leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including those not listed in this package leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If after 7 days there is no improvement or the patient feels worse, they should contact a doctor.

Table of Contents of the Package Leaflet

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

1. What is Hydrocortisone Allefin Max and what is it used for

Hydrocortisone Allefin Max is a cream for topical use on the skin.
The cream Hydrocortisone Allefin Max contains hydrocortisone (in the form of acetate) - a corticosteroid with mild action, which, when applied topically, has anti-inflammatory, antipruritic, and vasoconstrictive effects.

Indications for Use

Hydrocortisone Allefin Max is used topically in inflammatory skin conditions of various origins, primarily of allergic origin, of moderate severity, which respond to glucocorticosteroids.
The drug is used topically in the following indications:

• atopic dermatitis, allergic eczema, urticaria,
• seborrheic dermatitis,
• relief of insect bite reactions.

2. Important information before using Hydrocortisone Allefin Max

When not to use Hydrocortisone Allefin Max

• if the patient is hypersensitive to hydrocortisone, other corticosteroids, or any of the other ingredients of this medicine (listed in section 6);
• in the case of bacterial, viral, fungal, or systemic fungal infections;
• in common or rosacea acne;
• if skin atrophy (thinning) occurs;
• in the case of skin cancer or precancerous skin conditions;
• in perioral dermatitis (dermatitis perioralis);

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• in tuberculous skin lesions;
• on open wounds and damaged skin.

Warnings and precautions

Before starting treatment with Hydrocortisone Allefin Max, the patient should discuss it with their doctor or pharmacist:

• if the patient has diabetes - the medicine should not be used for a long time;
• if the patient has glaucoma or cataracts, as the medicine used on the eyelids or on the skin around the eyes may worsen the symptoms of the disease. The medicine should not be used on the eyelids or on the skin around the eyes due to the risk of glaucoma or cataracts.

During treatment with Hydrocortisone Allefin Max, the following warnings should be observed:

• The medicine should not be used in large doses, on large areas of skin, or for a long time, as corticosteroids are absorbed into the bloodstream and may cause side effects (see section 4).
• If a skin infection occurs at the site of application of Hydrocortisone Allefin Max, the patient should contact their doctor.
• If the patient experiences blurred vision or other vision disturbances, they should contact their doctor.
• Avoid contact of the medicine with the eyes and mucous membranes.
• The medicine may be used on the skin of the face and in the axillary and groin areas only in cases where it is absolutely necessary. Due to the significantly greater absorption of the medicine in these areas, there is a risk of side effects, even after short-term use of the medicine. In such cases, the patient should consult their doctor.
• The use of the medicine on the skin of the face is allowed only for a short period (up to 3 days).
• After applying Hydrocortisone Allefin Max to the skin, the area should not be covered with any dressing (especially foil or cerate), as this increases the absorption of the medicine.

Children

The medicine should not be used in children under 12 years of age without consulting a doctor. In children, the medicine should be used with caution and long-term use should be avoided due to the greater risk of systemic side effects, including growth and development disorders.

Hydrocortisone Allefin Max and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
No interactions of Hydrocortisone Allefin Max cream with other medicines are known.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Pregnancy
In pregnancy, the medicine may be used only in consultation with a doctor, only when absolutely necessary, for a short period, and on small areas of skin. Particular caution should be exercised during the first 3 months of pregnancy.
Breastfeeding
In breastfeeding, the medicine may be used only in consultation with a doctor. It is not known whether topically applied corticosteroids pass into breast milk, so the medicine should be used with caution, for a short period, and on a small area of skin. The medicine should not be applied to the skin of the breast immediately before breastfeeding.
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Driving and using machines

The medicine has no influence or negligible influence on the ability to drive and use machines.

Hydrocortisone Allefin Max 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, the medicine may cause allergic reactions (possible late reactions).
Due to the presence of cetyl alcohol and stearyl alcohol, the medicine may cause local skin reactions (e.g., contact dermatitis).
The medicine contains 30 mg of propylene glycol in 1 g of cream. Propylene glycol may cause skin irritation.

3. How to use Hydrocortisone Allefin Max

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.
In case of doubt, the patient should consult their doctor, pharmacist, or nurse.
The medicine is intended for topical use on the skin.
Recommended dose
A thin layer of cream should be applied to the affected skin 2 or 3 times a day.
After applying the medicine, the patient should wash their hands, unless they are being treated.
The medicine should not be used on large areas of skin without prior consultation with a doctor.
Duration of treatment
Without consulting a doctor, the medicine should not be used for more than 7 days. On the skin of the face, it should not be used for more than 3 days.
If after 7 days there is no improvement or the patient feels worse, they should contact their doctor.
Children
In children under 12 years of age, the medicine should not be used without a doctor's recommendation.

Using a higher dose of Hydrocortisone Allefin Max than recommended

Hydrocortisone Allefin Max used in large doses and on large areas of skin or for a long time may cause growth and development disorders in children and suppression of the hypothalamic-pituitary-adrenal axis (a system of interdependent endocrine glands that produce hormones). Overdose symptoms may occur, such as:
increased blood sugar levels, glucose in the urine, Cushing's syndrome.
In case of overdose, the patient should contact their doctor immediately.

Missing a dose of Hydrocortisone Allefin Max

The patient should use the medicine as soon as possible. They should not use a double dose to make up for the missed application.
In case of any further doubts about using this medicine, the patient should consult their doctor, pharmacist, or nurse.
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4. Possible side effects

Like all medicines, Hydrocortisone Allefin Max can cause side effects, although not everybody gets them.
Long-term use of hydrocortisone cream (for more than 14 days), use on large areas of skin, under a dressing, and in children, may cause side effects, such as:

• atrophic dermatitis, skin stretch marks;
• infection recurrence;
• so-called post-steroid purpura (skin discoloration and depigmentation);
• superficial vasodilation;
• 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 cataracts - when the medicine is used on the skin of the eyelids;
• blurred vision (may occur in up to 1 in 100 patients);
• suppression of the hypothalamic-pituitary-adrenal axis (a system of interdependent endocrine glands that produce hormones);
• increased blood sugar levels (hyperglycemia);
• glucose in the urine (glycosuria);
• growth and development disorders in children;
• so-called Cushing's syndrome (growth and development disorder associated with the occurrence of characteristic silhouette changes: moon face, rounded torso, and thin limbs).

If any of the above symptoms occur, the patient should stop using the medicine and contact their doctor.

Reporting side effects

If any side effects occur, including those not listed in the package leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Pharmacovigilance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C, 02-222 Warsaw
phone: +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.
Reporting side effects will allow for the collection of more information on the safety of the medicine.

5. How to store Hydrocortisone Allefin Max

The medicine should be stored out of sight and reach of children.
Store at a temperature below 25°C. Do not store in the refrigerator or freeze.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
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Shelf life after first opening the tube: 6 months.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Hydrocortisone Allefin Max contains

• The active substance of the medicine is hydrocortisone acetate. 1 g of cream contains 10 mg of hydrocortisone acetate.
• The other ingredients (excipients) are: macrogol cetostearyl ether, cetyl alcohol, stearyl alcohol, liquid paraffin, white petrolatum, sorbitan stearate, propylene glycol (E 1520), methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), and purified water.

What Hydrocortisone Allefin Max looks like and contents of the pack

Hydrocortisone Allefin Max is a homogeneous cream with a white to slightly yellowish color.
One pack of the medicine contains 15 g of cream in an aluminum tube with an internal membrane coated with epoxy-phenolic lacquer, with a polyethylene (HDPE) cap and a piercer, in a cardboard box.

Marketing authorization holder and manufacturer

“PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK” S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E

Medicine information

phone: (22) 742 00 22
e-mail: [email protected]

Date of last revision of the package leaflet:

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