Hydrocortisone afp

Package leaflet: Information for the patient

Hydrocortisonum AFP
10 mg/g, cream
Hydrocortisoni acetas
Please read the entire leaflet before using the medicine, as it contains important information
for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your 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. Contents of the pack 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, antipruritic (anti-itch), and vasoconstrictive effects. This medicine belongs to a group of medicines called corticosteroids.

Indications
Topical treatment of:

• Atopic dermatitis;
• Lichen planus;
• Erythema multiforme;
• Pruritic lichen planus;
• Seborrheic dermatitis;
• Various forms of eczema, particularly eczema with lichenification;
• Scalp psoriasis, chronic psoriasis;
• Pruritus (itching).

Hydrocortisonum AFP is recommended for topical use following treatment with potent glucocorticosteroids (as continuation therapy).

2. Important information before using Hydrocortisonum AFP

When not to use Hydrocortisonum AFP

• if the patient is allergic to hydrocortisone acetate or any of the other ingredients of this medicine (listed in section 6);
• if the patient has a bacterial, viral, fungal or systemic fungal infection;
• if the patient has acne vulgaris or rosacea;
• if the patient has skin atrophy (skin thinning);
• if the patient has skin cancer or a pre-cancerous skin condition;
• if the patient has perioral dermatitis (inflammation of the skin around the mouth);
• if the patient has cutaneous tuberculosis;
• if the patient has open wounds or damaged skin.

Warnings and precautions
Before starting to use Hydrocortisonum AFP, discuss the following with your doctor or
pharmacist:

• if the patient has diabetes – the medicine should not be used for prolonged periods;
• if the patient has glaucoma or cataracts, as use on the eyelids or skin around the eyes may worsen symptoms of the disease;
• if the patient has psoriasis, as topical corticosteroids may cause recurrence of the disease.

While using Hydrocortisonum AFP, observe the following warnings:

• Do not use large doses, over large skin areas, or for prolonged periods, because corticosteroids may be absorbed into the bloodstream and cause adverse effects (listed in section 4: Possible side effects).
• If a skin infection develops at the site of application, contact your doctor.
• Avoid contact of the medicine with eyes and mucous membranes.
• The medicine may be applied to the facial skin and to the armpits and groin only when absolutely necessary, as absorption is greater in these areas and there is a risk of increased adverse effects. In such cases, consult your doctor.
• After applying Hydrocortisonum AFP to the skin, do not cover the area with any dressing (especially plastic film or occlusive dressings), as this increases absorption of the medicine.

Children
The medicine should be used according to the doctor's instructions.
There is a risk of impaired growth and development in children.

Hydrocortisonum AFP and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
No interactions between Hydrocortisonum AFP cream and other medicines are known.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a
child, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
The medicine may be used during pregnancy only briefly and on small skin areas, and only if clearly necessary, when the benefit to the mother outweighs the potential risk to the fetus. Particular caution is advised during the first three months of pregnancy.

Breastfeeding
During breastfeeding, the medicine should be used cautiously, for short periods and on small skin areas. It is not known whether topically applied corticosteroids pass into human milk.

Driving and operating machinery
Hydrocortisonum AFP has no effect or has a negligible effect on the ability to drive and operate machinery.

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

Cetostearyl 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 (including delayed-type reactions).

3. How to use Hydrocortisonum AFP

This medicine should always be used exactly as directed by the doctor. In case of doubt, consult
your doctor or pharmacist.
Method of administration:
This medicine is intended for topical use only.
Apply a thin layer of cream to the affected skin area two or three times daily.
Do not use on the facial skin for longer than 3 days.
Do not apply to healthy skin.
Do not use on large areas of skin without prior consultation with a doctor.
Duration of treatment:
If symptoms worsen or no improvement is seen after 7 days of treatment, consult your doctor.
Use in children
This medicine should be used according to the doctor's instructions.
Use of a higher than recommended dose of Hydrocortisonum AFP
If more than the recommended amount of Hydrocortisonum AFP has been used, contact your doctor immediately.
Hydrocortisonum AFP used in high doses and over large skin areas may cause disturbances in children's growth and development, as well as suppression of the hypothalamic–pituitary–adrenal axis (this is the name of the interconnected endocrine glands producing hormones).
Symptoms of overdose may include:

• increased blood glucose levels (hyperglycaemia);
• presence of glucose in urine (glucosuria);
• Cushing's syndrome (characteristic appearance: moon-shaped face, rounded trunk and thin limbs).

Missed dose of Hydrocortisonum AFP
Continue using the medicine as prescribed, without increasing the next dose.
Do not use a double dose to make up for a missed dose.
If you have any further doubts concerning the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Prolonged use of the medicine (for longer than 14 days), application over large skin areas,
use under occlusive dressing, or use in children may result in the following adverse effects:

• cutaneous atrophy, striae;
• recurrence of infection;
• post-steroidal pigmentation (skin discoloration and depigmentation);
• superficial dilation of blood vessels;
• steroid acne;
• perioral dermatitis;
• periorbital dermatitis;
• folliculitis, hypertrichosis;
• delayed healing of wounds and ulcers;
• bacterial, fungal, and viral superinfections;
• petechiae (small red or purple spots on the skin);
• skin irritation such as burning, erythema, excessive dryness, contact allergy;
• glaucoma or cataract – when the medicine is applied to the skin of the eyelids;
• suppression of hypothalamic-pituitary-adrenal (HPA) axis function;
• Cushing's syndrome;
• growth and development retardation in children;
• hyperglycaemia, glycosuria.

If any of the above symptoms occur, discontinue use of the medicine and consult a doctor.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Hydrocortisonum AFP

Keep the medicine out of the sight and reach of children.
Store 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What Hydrocortisonum AFP contains

• The active substance 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, macrogol cetostearyl ether, liquid paraffin, sorbitan stearate, white soft paraffin, purified water.

What Hydrocortisonum AFP looks like and contents of the pack
Hydrocortisonum AFP is a white cream.
The medicine is packaged in an aluminium tube with a protective membrane internally coated with epoxy-phenolic varnish, fitted with a white cap made of HDPE polyethylene, containing 15 g of cream, placed in a cardboard box.
Marketing Authorisation Holder and Manufacturer
Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
Tel.: + 48 42 22-53-100