Maxicortan

Package Leaflet: Information for the Patient

Maxicortan

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 the package leaflet for the patient, or as directed by a doctor or pharmacist.

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

Table of Contents of the Leaflet

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

1. What is Maxicortan and what is it used for

Maxicortan cream is intended for topical use on the skin. It contains the active substance hydrocortisone acetate, which has anti-inflammatory, anti-itching, and vasoconstrictive effects. This medicine belongs to a group of medicines called corticosteroids.

Indications for Use

Maxicortan is used topically in inflammatory skin conditions of various origins, primarily of allergic origin, of moderate severity, which respond to glucocorticosteroids. Local treatment:

• atopic dermatitis;
• allergic contact dermatitis, urticaria;
• reactions occurring after insect bites or stings (such as itching and irritation).

Do not use for more than 7 days without a doctor's recommendation.

2. Important Information Before Using Maxicortan

When Not to Use Maxicortan:

• on the face;
• in children under 12 years of age without a doctor's recommendation.

Warnings and Precautions

Before starting to use Maxicortan, discuss it with your doctor or pharmacist. Tell your doctor:

While using Maxicortan, follow these warnings.

• Do not apply the medicine to healthy skin.
• Do not use large doses of the medicine, on a large skin surface, and for a long time, as corticosteroids are absorbed into the blood and may cause side effects (listed in section 4: Possible side effects).
• If a skin infection occurs at the site of application of Maxicortan, contact a doctor.
• Avoid contact of the medicine with the eyes and mucous membranes. If the medicine gets into the eyes or nose, rinse them immediately with water.
• The medicine may be used on the skin of the armpits and groin only in absolutely necessary cases, as the medicine is absorbed faster in these areas and there is a risk of increased side effects. In such cases, consult a doctor.
• After applying Maxicortan to the skin, do not cover the area with any dressing (especially foil or cerate), as this increases the absorption of the medicine.

Children

Do not use in children under 12 years of age without a doctor's recommendation. There is a risk of growth and development disorders in children.

Maxicortan and Other Medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take. There are no known interactions between Maxicortan cream and other medicines.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult a doctor or pharmacist before using this medicine. Do not use Maxicortan during pregnancy and breastfeeding without a doctor's recommendation. If a doctor recommends using the medicine during pregnancy or breastfeeding, use it with caution, for a short time, and on a small skin surface.

Driving and Using Machines

The effect of Maxicortan on driving and using machines is not known.

Maxicortan Contains Cetostearyl Alcohol, Stearyl Alcohol, Propylene Glycol, Methyl Parahydroxybenzoate, and Propyl Parahydroxybenzoate

• Cetostearyl alcohol and stearyl alcohol may cause local skin reactions (e.g., contact dermatitis).
• The medicine contains 30 mg of propylene glycol in each gram of cream.
• Methyl parahydroxybenzoate and propyl parahydroxybenzoate may cause allergic reactions (possible late reactions).

3. How to Use Maxicortan

This medicine should always be used exactly as described in the package leaflet for the patient, or as directed by a doctor. In case of doubts, consult a doctor or pharmacist. Recommended dose The medicine is intended for topical use on the skin. Apply a thin layer of cream to the affected skin 1 or 2 times a day. Maxicortan should be used according to the FTU (Fingertip Unit) measure. 1 FTU defines the amount of cream squeezed from the tube in a line from the tip to the first fold of the finger of an adult (~ 2.5 cm), which corresponds to 0.5 g of cream. Smaller areas will require smaller amounts of cream. One FTU of the medicine is intended to cover the surface of both hands of an adult. Do not use on large skin surfaces without a doctor's recommendation. Duration of treatment Do not use for more than 7 days without a doctor's recommendation. If symptoms worsen or do not improve after 7 days of using the medicine, consult a doctor.

Use in Children

Maxicortan is not intended for use in children under 12 years of age.

Using More Than the Recommended Dose of Maxicortan

In case of using more than the recommended dose of Maxicortan, contact a doctor immediately. Maxicortan used in large doses and on large skin surfaces may cause growth and development disorders in children and suppression of the hypothalamic-pituitary-adrenal axis (this is the name of the system of interdependent endocrine glands that produce hormones). The following overdose symptoms may occur:

• increased blood sugar levels:
• glucosuria (glucose in the urine);
• Cushing's syndrome (characteristic silhouette: moon face, rounded torso, and thin limbs).

Missing a Dose of Maxicortan

Continue using the medicine, without increasing the next dose. Do not use a double dose to make up for a missed dose. If you have any further doubts about using this medicine, consult a doctor or pharmacist.

4. Possible Side Effects

Like all medicines, Maxicortan can cause side effects, although not everybody gets them. Prolonged use of the medicine (for more than 14 days), use on large skin surfaces, or under a dressing, and in children may cause the following side effects:

• atrophic dermatitis, skin striae;
• relapse of infection;
• post-steroid purpura (skin discoloration and depigmentation);
• superficial vasodilation;
• acne;
• perioral dermatitis;
• periorbital dermatitis;
• folliculitis, hypertrichosis;
• delayed wound healing and ulceration;
• 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 used on the skin of the eyelids;
• suppression of the hypothalamic-pituitary-adrenal axis;
• Cushing's syndrome:
• growth and development disorders in children;
• excess sugar in the blood or urine.

If you experience any of the above symptoms, contact a doctor.

Reporting Side Effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance 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 Maxicortan

Keep the medicine out of the sight and reach of children. Store in a temperature below 25°C. Do not freeze. Do not use this medicine after the expiry date stated on the tube and carton. The expiry date refers to the last day of the month. Shelf life after first opening: 28 days. 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 Maxicortan Contains

• The active substance of the medicine is hydrocortisone acetate. 1 g of cream contains 10 mg of hydrocortisone acetate.
• The other ingredients are: cetostearyl alcohol, stearyl alcohol, propylene glycol, methyl parahydroxybenzoate, propyl parahydroxybenzoate, cetomacrogol emulsifying wax, liquid paraffin, sorbitan stearate, white petrolatum, purified water.

What Maxicortan Looks Like and What the Pack Contains

Maxicortan is a white cream. Packaging: aluminum tube with a protective membrane, internally coated with epoxy-phenolic lacquer, with a white polyethylene HDPE cap, containing 15 g of cream, placed in a cardboard box.

Marketing Authorization Holder and Manufacturer

Aflofarm Farmacja Polska Sp. z o.o. ul. Partyzancka 133/151 95-200 Pabianice Tel.: + 48 42 22-53-100

Date of Last Revision of the Leaflet: