Hidrocortisonum Afp

Leaflet attached to the packaging: patient information

Hydrocortisonum AFP

10 mg/g, cream
Hydrocortisone acetate

You should read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

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

Hydrocortisonum AFP cream is intended for topical use.
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

Local treatment:

• atopic dermatitis;
• rosacea;
• polymorphic erythema;
• psoriasis with intense itching;
• seborrheic dermatitis;
• various forms of eczema, especially eczema herpeticum;
• psoriasis of the scalp, chronic psoriasis;
• pruritus.

Hydrocortisonum AFP is recommended for topical use after completing treatment with potent corticosteroids (as a continuation of this treatment).

2. Important information before using Hydrocortisonum AFP

When not to use Hydrocortisonum AFP

Warnings and precautions

Before starting to use Hydrocortisonum AFP, you should discuss it with your doctor or
pharmacist:

While using Hydrocortisonum AFP, you should follow the warnings below.

• 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 Hydrocortisonum AFP, you should contact your 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 absolutely necessary cases. Because the medicine is absorbed faster in these areas and there is a risk of increased side effects. In such cases, you should consult your doctor.
• After applying Hydrocortisonum AFP to the skin, do not cover the area with any dressing (especially foil or plastic), as this increases the absorption of the medicine.

Children

The medicine should be used as directed by the doctor.
There is a risk of growth and development disorders in children.

Hydrocortisonum AFP and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking
or have recently taken, as well as any medicines you plan to take.
No interactions between Hydrocortisonum AFP cream and other medicines are known.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child,
you should consult your 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 recommended during the first 3 months of pregnancy.
Breastfeeding
During breastfeeding, the medicine should be used with caution, for a short period, and on a small skin surface. 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 in each gram of cream. Propylene glycol may
cause skin irritation.

Methyl parahydroxybenzoate and propyl parahydroxybenzoate

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

3. How to use Hydrocortisonum AFP

This medicine should always be used as directed by the doctor. If you have any doubts, you should consult your doctor or pharmacist.
Method of administration:
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 your doctor first.
Duration of treatment:
If the symptoms worsen or do not improve after 7 days of using the medicine, you should contact your doctor.
Use in children
The medicine should be used as directed by the doctor.

Using a higher dose of Hydrocortisonum AFP than recommended

If you use a higher dose of Hydrocortisonum AFP than recommended, you should contact your doctor immediately.
Hydrocortisonum AFP 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 (this is the name of the 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 (characteristic silhouette: moon face, rounded torso, and thin limbs).

Missing a dose of Hydrocortisonum AFP

You should 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, you should consult your 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, 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;
• 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 you experience any of the above side effects, you should stop using the medicine and consult your doctor.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 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 Hydrocortisonum AFP

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C. Do not freeze.
Do not use the medicine after the expiry date stated on the tube and carton. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. You should ask your 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 AFP contains

• The active substance of the medicine is hydrocortisone acetate.

1 g of cream contains 10 mg of hydrocortisone acetate.

• The other ingredients are: cetyl alcohol, stearyl alcohol, propylene glycol, methyl parahydroxybenzoate, propyl parahydroxybenzoate, cetostearyl ether of macrogol, liquid paraffin, stearyl sorbitan, white petrolatum, purified water.

What Hydrocortisonum AFP looks like and what the package contains

Hydrocortisonum AFP is a white cream.
The package contains: an 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.
Partyzancka 133/151
95-200 Pabianice
Tel.: +48 42 22-53-100

Date of last revision of the leaflet: