Hidrocortisonum Aflofarm

Leaflet attached to the packaging: patient information

Hydrocortisonum Aflofarm

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 or pharmacist.

• Keep this leaflet, so you can read it again if you need to.
• 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 or pharmacist. See section 4.
• If there is no improvement after 7 days or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Hydrocortisonum Aflofarm and what is it used for
• 2. Important information before using Hydrocortisonum Aflofarm
• 3. How to use Hydrocortisonum Aflofarm
• 4. Possible side effects
• 5. How to store Hydrocortisonum Aflofarm
• 6. Package contents and other information

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

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

Indications for use

Local treatment:

• atopic dermatitis;
• psoriasis;
• polymorphic erythema;
• flat lichen with intense itching;
• seborrheic dermatitis;
• various forms of eczema, especially eczematous eczema;
• psoriasis of the scalp, chronic psoriasis;
• pruritus;
• first- and second-degree burns (including sunburns);
• relieving symptoms after insect bites.

Hydrocortisonum Aflofarm is recommended for topical use after completing treatment with potent glucocorticosteroids (as a continuation of this treatment).
If there is no improvement after 7 days or the patient feels worse, they should consult their doctor.

2. Important information before using Hydrocortisonum Aflofarm

When not to use Hydrocortisonum Aflofarm

• if the patient is allergic to hydrocortisone acetate or any other component of this medicine (listed in section 6);
• if the patient has a bacterial, viral, fungal, or systemic fungal infection;
• if the patient has common or rosacea acne;
• if the patient has skin atrophy;
• if the patient has skin cancer or a precancerous skin condition;
• if the patient has perioral dermatitis;
• if the patient has cutaneous tuberculosis;
• if the patient has open wounds and damaged skin.

Warnings and precautions

Before starting treatment with Hydrocortisonum Aflofarm, the patient should discuss it with their doctor or pharmacist:

• if the patient has diabetes - the medicine should not be used for a long period;
• if the patient has glaucoma or cataracts, as the medicine used on the eyelids or skin around the eyes may worsen the symptoms of the disease;
• if the patient has psoriasis, as local use of corticosteroids may cause a relapse of the disease.

During treatment with Hydrocortisonum Aflofarm, the following warnings should be observed.

• Do not use large doses of the medicine, on a large skin surface, or 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 Hydrocortisonum Aflofarm, the patient 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, as the medicine is absorbed more quickly in these areas and there is a risk of increased side effects. In such cases, the patient should consult their doctor.
• After applying Hydrocortisonum Aflofarm 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

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

Hydrocortisonum Aflofarm 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 between Hydrocortisonum Aflofarm cream and 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
The medicine may be used during pregnancy for a short period and on small skin surfaces only if necessary, when the benefit to the mother outweighs the potential risk to the fetus. Particular caution is advised during the first 3 months of pregnancy.
Breastfeeding
The medicine should be used with caution, for a short period, and on a small skin surface during breastfeeding. It is not known whether topical corticosteroids pass into breast milk.

Driving and using machines

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

The medicine contains cetyl alcohol, stearyl alcohol, propylene glycol, methyl parahydroxybenzoate, and propyl parahydroxybenzoate

Cetyl alcohol and stearyl alcohol

The medicine may cause local skin reactions (e.g., contact dermatitis).

Propylene glycol

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

Methyl parahydroxybenzoate and propyl parahydroxybenzoate

The medicine may cause allergic reactions (possible late-type reactions).

3. How to use Hydrocortisonum Aflofarm

This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.
Recommended dose
The medicine is intended for topical use.
A thin layer of cream should be applied to the affected skin 2 or 3 times a day.
On the skin of the face, do not use for more than 3 days.
Do not use on healthy skin.
Do not use on large skin surfaces without consulting a doctor first.
Duration of treatment
If symptoms worsen or there is no improvement after 7 days of using the medicine, the patient should consult their doctor.
Do not use the medicine without consulting a doctor for more than 14 days.

Use in children

Do not use in children under 12 years of age without consulting a doctor.

Using a higher dose of Hydrocortisonum Aflofarm than recommended

In case of using a higher dose of Hydrocortisonum Aflofarm than recommended, the patient should immediately contact their doctor.
Hydrocortisonum Aflofarm used in high doses and on large skin surfaces 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).
The following overdose symptoms may occur:

• increased blood sugar levels (hyperglycemia);
• glucosuria (glucose in the urine);
• Cushing's syndrome (characterized by a moon-shaped face, rounded torso, and thin limbs).

Missing a dose of Hydrocortisonum Aflofarm

The patient should continue using the medicine, without increasing the next dose.
Do not use a double dose to make up for a missed dose.
If the patient has any further doubts about using this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine 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, as well as in children, may cause the following side effects:

• atrophic dermatitis, skin stretch marks;
• relapse of infection;
• post-steroid purpura (skin discoloration and depigmentation);
• superficial vasodilation;
• post-steroid 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 the medicine is used on the skin of the eyelids;
• suppression of the hypothalamic-pituitary-adrenal axis;
• Cushing's syndrome;
• growth and development disorders in children;
• hyperglycemia, glucosuria.

If any of the above side effects occur, the patient should stop using the medicine and consult their doctor.

Reporting side effects

If any side effects occur, including those not listed in this leaflet, the patient should inform their doctor or pharmacist.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to 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.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Hydrocortisonum Aflofarm

The medicine should be stored out of sight and reach of children.
Store at a temperature below 25°C. Do not freeze.
Do not use the medicine after the expiration date stated on the tube and carton. The expiration date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste containers. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Hydrocortisonum Aflofarm contains

• The active substance of the medicine is hydrocortisone acetate. 1 g of cream contains 5 mg of hydrocortisone acetate.
• Other ingredients are: cetyl alcohol, stearyl alcohol, propylene glycol, methyl parahydroxybenzoate, propyl parahydroxybenzoate, cetostearyl ether of macrogol, liquid paraffin, sorbitan stearate, white petrolatum, purified water.

What Hydrocortisonum Aflofarm looks like and what the package contains

Hydrocortisonum Aflofarm is a white cream.
The packaging of the medicine is: an aluminum tube with a protective membrane, internally coated with epoxy-phenolic varnish, 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 the last update of the leaflet: