Hidrokortizon Allefin

Leaflet attached to the packaging: patient information

Hydrocortisone Allefin, 5 mg/g, cream

Hydrocortisone acetate

Read the 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, 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 leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 7 days or the patient feels worse, they should contact a doctor.

Table of contents of the leaflet

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

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

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

Indications for use

Hydrocortisone Allefin cream is used topically for the following indications:

• atopic dermatitis, allergic eczema, urticaria,
• rosacea,
• erythema multiforme,
• psoriasis with intense itching,
• seborrheic dermatitis,
• various forms of eczema, especially eczema herpeticum,
• psoriasis of the scalp, chronic psoriasis,
• pruritus,
• continuation of treatment with potent glucocorticosteroids,
• relief of post-insect bite reactions.

2. Important information before using Hydrocortisone Allefin

When not to use Hydrocortisone Allefin

• if the patient is allergic 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;

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• if skin atrophy (thinning) occurs;
• in the case of skin cancer or precancerous skin conditions;
• in perioral dermatitis;
• in tuberculous skin lesions;
• on open wounds and damaged skin.

Warnings and precautions

Before starting treatment with Hydrocortisone Allefin, 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;
• if the patient has psoriasis, as local use of corticosteroids may lead to the development of tolerance (loss of drug effect) and recurrence of the disease, the risk of generalized pustular psoriasis, and general toxic effects due to skin barrier disruption.

While using Hydrocortisone Allefin, the patient should follow the warnings below:

• 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, the patient should contact their doctor.
• If the patient experiences blurred vision or other vision disturbances, they should contact their doctor.
• Eye contact and contact with mucous membranes should be avoided.
• The medicine may be used on the face and in the armpits and groin areas only when 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. In such cases, the patient should consult their doctor.
• Use on the face is allowed for a short period only (up to 3 days).
• After applying the medicine to the skin, the area should not be covered with any dressing (especially foil or plastic), 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 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. There are no known interactions between Hydrocortisone Allefin cream and other medicines.

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 The medicine may be used during pregnancy only in consultation with a doctor, only when necessary, for a short period, and on small areas of skin. Particular caution is advised during the first 3 months of pregnancy. Breastfeeding The medicine may be used during breastfeeding only in consultation with a doctor. It is not known whether topical 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 breast skin immediately before breastfeeding.

Driving and using machines

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

Hydrocortisone 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, 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

This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor, pharmacist, or nurse. If in 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 hands should be washed, unless they are being treated. The medicine should not be used on large areas of skin without consulting a doctor. Duration of treatment Without consulting a doctor, the medicine should not be used for more than 14 days. On the face, it should not be used for more than 3 days. If there is no improvement after 7 days 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 than recommended

Hydrocortisone Allefin 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 include: 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

The patient should apply the medicine as soon as possible. They should not apply a double dose to make up for the missed application. If the patient has any further doubts about using this medicine, they should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Hydrocortisone Allefin 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;
• recurrence of infection;
• so-called post-steroid pustular dermatitis (skin discoloration and depigmentation);
• superficial vasodilation;
• acne;
• perioral dermatitis;
• periorbital dermatitis;
• folliculitis, hypertrichosis;
• delayed wound 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;
• Cushing's syndrome (growth and development disorder associated with characteristic changes in silhouette: 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 the patient experiences any side effects, including those not listed in the leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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 Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Hydrocortisone Allefin

The medicine should be stored out of sight and reach of children. Store in a temperature below 25°C. Do not store in the refrigerator or freeze. 4/5 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. 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 contains

• The active substance of the medicine is hydrocortisone acetate. 1 g of cream contains 5 mg of hydrocortisone acetate.
• The other ingredients (excipients) are: cetostearyl alcohol, 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 looks like and contents of the pack

Hydrocortisone Allefin 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 a membrane seal, internally 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

Information about the medicine

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

Date of last revision of the leaflet:

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