Locoid Lipocream

Package Leaflet: Information for the Patient

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language

Locoid Lipocream(Locoid Lipocrème 0.1%)

1 mg/g, cream

Hydrocortisone butyrate
Locoid Lipocream and Locoid Lipocrème 0.1% are different trade names for the same medicine.

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. 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 Locoid Lipocream and what is it used for
• 2. Important information before using Locoid Lipocream
• 3. How to use Locoid Lipocream
• 4. Possible side effects
• 5. How to store Locoid Lipocream
• 6. Contents of the pack and other information

1. What is Locoid Lipocream and what is it 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 often accompanied by itching.

Indications for use of Locoid Lipocream

• inflammatory skin conditions (not caused by microorganisms) that respond to corticosteroid treatment, in cases where treatment with less potent topical corticosteroids does not produce the expected results;
• continuation or maintenance treatment of inflammatory skin diseases, in cases where previous treatment with more potent topical corticosteroids has produced good results.

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, shingles), fungal infections, or parasitic infestations;
• on skin ulcers, wounds;
• in perioral dermatitis;
• in acne vulgaris, rosacea;
• if the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting treatment with Locoid Lipocream, discuss it with your doctor or pharmacist.
Protect your eyes and mucous membranes from contact with the medicine.
Avoid contact between the medicine and your eyes, and do not apply it to the eye area, as this may cause glaucoma or subcapsular cataract.
Avoid applying the medicine to the skin of the face, hairy skin, and the skin of the genital area, as it is particularly sensitive to corticosteroids. Only mild corticosteroids should be used in these areas.
Avoid applying the medicine to large areas of skin, especially under occlusive dressings (under a bandage, diaper), in skin folds and creases. In such cases, the absorption of corticosteroids may be significantly increased, leading to adrenal cortex suppression.
Use with caution and avoid long-term treatment in children, as adrenal cortex suppression can occur quickly, and growth hormone suppression may also occur.
Use with particular caution in patients with psoriasis, as local corticosteroid treatment in psoriasis can lead to relapse of the disease due to the development of tolerance, the risk of generalized pustular psoriasis, and local and systemic toxic effects due to skin barrier disruption.
Due to systemic and local corticosteroid use, vision disturbances may occur. If the patient experiences symptoms such as blurred vision or other vision disturbances, consider referring them to an ophthalmologist to determine possible causes, including cataracts, glaucoma, or rare diseases such as central serous chorioretinopathy (CSCR), which have been reported after systemic and local corticosteroid use.

Locoid Lipocream and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
No interactions with other medicines are known.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.
The medicine can be used during pregnancy only if, in the doctor's opinion, it is clearly necessary.
If the doctor recommends using the medicine during breastfeeding, it can be used on a small area of skin for a short time. In the case of prolonged treatment or application to a large area of skin, breastfeeding should be discontinued.

Driving and using machines

There are no data on the effect of Locoid Lipocream on the ability to drive and use machines.

Locoid Lipocream contains cetostearyl alcohol and propyl parahydroxybenzoate.

Due to the presence of cetostearyl alcohol, the medicine may cause local skin reactions (e.g., contact dermatitis).
Due to the presence of propyl parahydroxybenzoate, the medicine may cause allergic reactions (possible late-type reactions).

3. How to use Locoid Lipocream

This medicine should always be used as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Usually, a thin layer of cream is applied evenly to the affected areas of skin 1 to 3 times a day. The medicine can be lightly massaged in. After improvement, it is usually sufficient to use the medicine once a day or 2-3 times a week.
Locoid Lipocream is used to treat dry and dry-oily skin lesions. Do not use more than 30-60 g of the medicine per week.

Using more than the recommended dose of Locoid Lipocream

There are no reports of overdose. With prolonged use, adrenal cortex suppression may occur.
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Locoid Lipocream can cause side effects, although not everybody gets them.
Rare side effects (may affect up to 1 in 1000 people):

• skin atrophy, often irreversible with thinning of the epidermis;
• telangiectasia;
• petechiae;
• striae;
• acneiform eruptions;
• perioral dermatitis;
• so-called "rebound effect", which can lead to dependence on topical corticosteroids;
• skin depigmentation;
• contact dermatitis and eczema, including contact dermatitis.

Very rare side effects (may affect up to 1 in 10,000 people):

• adrenal cortex suppression.

Frequency not known (frequency cannot be estimated from the 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 (possible late-type reactions) may also occur. Systemic side effects of topical corticosteroids are rare but can be serious. Adrenal cortex suppression may occur, especially with prolonged use of the medicine.
The risk of systemic corticosteroid side effects increases when:

• the medicine is used under occlusive dressings (under a bandage, diaper), in skin folds;
• the medicine is applied to large areas of skin;
• the treatment is prolonged;
• the medicine is used in children (children's skin is thinner, and the skin surface area is larger in relation to body weight).

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Pharmacovigilance of the 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Locoid Lipocream

Keep the 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 month.
Do not store above 25°C. Do not store in the refrigerator.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Locoid Lipocream contains

• The active substance is hydrocortisone 17-butyrate. 1 g of cream contains 1 mg of hydrocortisone 17-butyrate.
• The other ingredients are: cetostearyl alcohol, macrogol 25 cetostearyl ether, light liquid paraffin, white petrolatum, propyl parahydroxybenzoate, 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, consult the marketing authorization holder or the parallel importer.

Marketing authorization holder in Belgium, the 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 by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorization number in Belgium, the country of export: BE129841

Parallel import authorization number: 84/25

Date of leaflet approval: 05.03.2025

[Information about the trademark]