Package leaflet: Information for the patient

Hydrocortisonum Aflofarm
5 mg/g, cream
Hydrocortisoni acetas
Please read this 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
instructed by the doctor or pharmacist.

Keep this leaflet, so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 7 days, or if you feel worse, consult your doctor.

Leaflet contents

What is Hydrocortisonum Aflofarm and what is it used for
Important information before using Hydrocortisonum Aflofarm
How to use Hydrocortisonum Aflofarm
Possible side effects
How to store Hydrocortisonum Aflofarm
Contents of the pack 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
Topical treatment of:

Atopic dermatitis;
Lichen planus;
Erythema multiforme;
Lichen planus with severe pruritus;
Seborrhoeic dermatitis;
Various forms of eczema, especially eczema with lichenification;
Scalp psoriasis, chronic psoriasis;
Prurigo;
First- and second-degree burns (including sunburn);
Relief of discomfort following insect bites.

Hydrocortisonum Aflofarm is recommended for topical use following treatment with potent glucocorticosteroids (as continuation therapy).
If there is no improvement after 7 days, or if you feel worse, consult your doctor.

2. Important information before using Hydrocortisonum Aflofarm

When not to use Hydrocortisonum Aflofarm

if the patient is allergic to hydrocortisone acetate or to 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 around the mouth);
if the patient has tuberculosis skin lesions;
if the patient has open wounds or damaged skin.

Warnings and precautions
Before starting treatment with Hydrocortisonum Aflofarm, consult 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 around the eyelids or on the skin near the eyes may worsen symptoms;
if the patient has psoriasis, as topical corticosteroids may trigger a relapse.

While using Hydrocortisonum Aflofarm, observe the following warnings:

Do not use large amounts of the medicine over a large skin area or for prolonged periods, as corticosteroids may be absorbed into the bloodstream and may 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 the eyes and mucous membranes.
The medicine may be applied to the facial skin and to the skin of the armpits and groin only when absolutely necessary, as absorption is greater in these areas and there is an increased risk of adverse effects. In such cases, consult your doctor.
After applying Hydrocortisonum Aflofarm, do not cover the treated area with any dressing (especially plastic film or adhesive bandages), as this increases absorption of the medicine.
Children
Do not use in children under 12 years of age without consulting a doctor. There is a risk of impaired growth and development in children.

Hydrocortisonum Aflofarm and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently using,
has recently used, or plans to use.
No interactions of Hydrocortisonum Aflofarm cream with other medicines are known.

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

Pregnancy
The medicine may be used during pregnancy only for short periods 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
This medicine has no effect or has negligible effect on the ability to drive and operate machinery.

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 (delayed-type hypersensitivity reactions possible).

3. How to use Hydrocortisonum Aflofarm

This medicine should always be used exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Recommended dose
This medicine is intended for topical use only.
Apply a thin layer of the cream to the affected skin area 2 or 3 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 observed after 7 days of treatment, consult a doctor.
Do not use this medicine for longer than 14 days without consulting a doctor.
Use in children
Do not use in children under 12 years of age without prior consultation with a doctor.
Use of a higher than recommended dose of Hydrocortisonum Aflofarm
If more than the recommended amount of Hydrocortisonum Aflofarm has been used, contact a doctor immediately.
Hydrocortisonum Aflofarm used in large amounts and over large skin areas may cause growth and developmental disorders in children and suppression of the hypothalamic–pituitary–adrenal axis (this is the name of the interdependent 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 Aflofarm
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 regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

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

atrophic dermatitis, skin striae;
recurrence of infection;
post-steroidal purpura (skin pigmentation and depigmentation);
superficial dilation of blood vessels;
steroid-induced acne;
perioral dermatitis;
periorbital dermatitis;
folliculitis, hypertrichosis;
delayed wound and ulcer healing;
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 eyelid skin;
suppression of hypothalamic-pituitary-adrenal (HPA) axis function;
Cushing's syndrome;
growth and development retardation in children;
hyperglycemia, glycosuria.

If any of the above symptoms occur, discontinue use of the medicine and contact your doctor.
Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor or pharmacist.
Adverse effects 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 effects may also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Hydrocortisonum Aflofarm

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

6. Contents of the pack and other information

What Hydrocortisonum Aflofarm contains

The active substance is hydrocortisone acetate. 1 g of cream contains 5 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 Aflofarm looks like and contents of the pack
Hydrocortisonum Aflofarm is a white cream.
The medicine is packed in an aluminium tube with a protective membrane internally coated with epoxy-phenolic lacquer, 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