Package leaflet: Information for the patient

Warning! Keep the leaflet, information on the immediate packaging in a foreign language
Locoid Lipocream (Locoid Lipocrème 0.1%)
1 mg/g, cream
Hydrocortisoni butyras
Locoid Lipocream and Locoid Lipocrème 0.1% are different trade names of the same medicine.
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet so that you can read it again if necessary.
If you have any doubts, 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 the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

What Locoid Lipocream is and what it is used for
Important information before using Locoid Lipocream
How to use Locoid Lipocream
Possible side effects
How to store Locoid Lipocream
Contents of the pack and other information

1. What Locoid Lipocream is and what it is used for

Locoid Lipocream contains the active substance hydrocortisone 17-butyrate, a corticosteroid with anti-inflammatory and vasoconstrictive properties. The medicine relieves symptoms of inflammatory skin conditions, which are often accompanied by itching.
Indications for use of Locoid Lipocream

Inflammatory skin conditions (not caused by microorganisms) responsive to corticosteroid treatment, when topical treatment with less potent corticosteroids does not provide the expected results;
Continuation of treatment or maintenance therapy of inflammatory skin diseases, when previous use of more potent topical corticosteroids has been effective.

2. Important information before using Locoid Lipocream

When not to use Locoid Lipocream

on skin lesions caused by bacterial infections (e.g. syphilitic or tuberculous lesions), viral infections (e.g. chickenpox, herpes simplex, shingles), fungal infections, or parasitic infestations;
on skin ulcers or wounds;
in perioral dermatitis;
in acne vulgaris, rosacea;
if the patient is hypersensitive to the active substance or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Locoid Lipocream, discuss this with your doctor or pharmacist.
Protect the eyes and mucous membranes from contact with the medicine.
Avoid contact of the medicine with the eyes and avoid applying it around the eye area, as contact with the conjunctiva may lead to the development of glaucoma or subcapsular cataract.
Avoid applying the medicine to the facial skin, hairy skin, and genital areas, as these areas are particularly sensitive to corticosteroids. Only weakly acting corticosteroids should be used in these areas.
Avoid applying the medicine over large areas of skin, especially under occlusive dressings (e.g. plastic film, diapers), and in skin folds and creases. In such cases, absorption of corticosteroids may be significantly increased, leading to suppression of adrenal cortex function.
Use with caution and avoid prolonged treatment in children, as adrenal suppression may occur rapidly; growth hormone secretion may also be suppressed.
Extreme caution is required in patients with psoriasis, as topical use of corticosteroids in psoriasis may lead to disease recurrence due to development of tolerance, risk of generalized pustular psoriasis, and local or systemic toxic effects resulting from impaired skin barrier integrity.
Visual disturbances may occur following systemic or topical use of corticosteroids. If the patient experiences symptoms such as blurred vision or other visual disturbances, consider referring the patient to an ophthalmologist to determine possible causes, including cataract, glaucoma, or rare conditions such as central serous chorioretinopathy (CSCR), which has been reported following both systemic and topical corticosteroid use.

Locoid Lipocream and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to use.
Interactions with other medicines are not known.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
During pregnancy, this medicine should be used only if clearly indicated by the physician.
If your doctor prescribes this medicine during breastfeeding, it may be used on a small skin area for a short duration. In case of prolonged treatment or application over a large skin area, breastfeeding should be discontinued.

Driving and operating machinery
There is no data available regarding the effect of Locoid Lipocream on the ability to drive vehicles or operate machinery.

Locoid Lipocream contains cetostearyl alcohol and propyl parahydroxybenzoate.
Due to the presence of cetostearyl alcohol, this medicine may cause local skin reactions (e.g. contact dermatitis).
Due to the presence of propyl parahydroxybenzoate, this medicine may cause allergic reactions (including delayed-type reactions).

3. How to use Locoid Lipocream

This medicine should always be used according to the instructions given by your doctor. If in doubt, consult your doctor or pharmacist.
Usually, a thin layer of the cream should be applied evenly to the affected areas of skin 1 to 3 times daily. The cream may be gently massaged in. Once improvement occurs, application once daily or 2–3 times per week is usually sufficient.
Locoid Lipocream is used in the treatment of dry and dry-exudative skin lesions. The dose should not exceed 30–60 g per week.
Use of a higher than recommended dose of Locoid Lipocream
There are no reports of overdose. With prolonged use, suppression of adrenal cortex function may occur.
If you have any further doubts regarding 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 will experience them.

Rare adverse reactions (may occur in less than 1 in 1,000 people):

Skin atrophy, often irreversible, with thinning of the epidermis;
Dilation of small blood vessels;
Purpura;
Striae (stretch marks);
Acneiform eruptions;
Perioral dermatitis;
So-called "rebound effect", which may lead to dependence on topical corticosteroids;
Skin depigmentation;
Dermatitis and rash, including contact dermatitis.

Very rare adverse reactions (may occur in less than 1 in 10,000 people):

Suppression of adrenal cortex function.

Frequency not known (frequency cannot be estimated from available data):

Hypersensitivity;
Blurred vision.

Due to the presence of excipients – cetostearyl alcohol and propyl parahydroxybenzoate – local skin reactions (e.g. contact dermatitis) and allergic reactions (including delayed-type reactions) may also occur. Systemic adverse reactions following topical application of corticosteroids are rare, but can be severe. Suppression of adrenal cortex function may occur particularly during prolonged use of the medicine.

The risk of systemic corticosteroid adverse reactions increases under the following conditions:

Use under occlusive dressing (e.g. under plastic film, under diapers), or in skin folds;
Application over large areas of skin;
Prolonged treatment;
Use in children (children's skin is thinner and the skin surface area relative to body weight is greater).

Reporting of adverse reactions

If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can also be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, PL-02 222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl

Reporting adverse reactions enables continuous monitoring of the benefit-risk balance of the medicine and contributes to improved safety information.

5. How to store Locoid Lipocream

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Do not store above 25°C. Do not store in the refrigerator.
Medicines must not be disposed of via the sewage system 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 Locoid Lipocream contains

The active substance is hydrocortisone butyrate (hydrocortisone 17-butyrate). 1 g of cream contains 1 mg of hydrocortisone butyrate.
Other ingredients are: cetostearyl alcohol, cetostearyl alcohol macrogol 25 ether, light liquid paraffin, white soft paraffin, propyl p-hydroxybenzoate, benzyl alcohol, citric acid, sodium citrate, purified water.

What Locoid Lipocream looks like and contents of the pack
Locoid Lipocream is a white cream.
The pack contains 30 g of cream.
For more detailed information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in Belgium, country of export:
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald
Germany
Manufacturer:
Temmler Italia S.R.L.
Via Delle Industrie 2
20061 Carugate (MI)
Italy
Parallel importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Belgium, country of export, Marketing Authorisation number: BE129841
Parallel import licence number: 84/25