Locoid Lipocream

Package Leaflet: Information for the Patient

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.

Locoid Lipocream (Locoid Lipocreme), 1 mg/g, cream

(Hydrocortisone butyrate)
Locoid Lipocream and Locoid Lipocreme 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 you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. 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 butyrate, a corticosteroid with anti-inflammatory and vasoconstrictive properties. The medicine relieves symptoms of inflammatory skin conditions often accompanied by skin 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 you are 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 getting the cream on the conjunctiva may cause glaucoma or subcapsular cataract.
Avoid applying the medicine to the face, hairy skin, and skin in the genital area, as it is particularly sensitive to corticosteroids. Only mild corticosteroids can be used in these areas.
Avoid applying the medicine to large areas of skin, especially under occlusive dressings (under a plaster, 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 prolonged 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 continuity disorders.
Due to systemic and local corticosteroid use, vision disturbances may occur. If you experience symptoms such as blurred vision or other vision disturbances, consider consulting an ophthalmologist to determine possible causes, which may include cataracts, glaucoma, or rare diseases such as central serous chorioretinopathy (CSCR), which has 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, there are clear indications for it.
If your doctor recommends using the medicine during breastfeeding, you can use it on a small area of skin for a short time. In the case of prolonged treatment or application to a large area of skin, you should stop breastfeeding.

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 are unsure, 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, this medicine 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;
• purpura;
• striae;
• acneiform eruptions;
• perioral dermatitis;
• so-called "rebound effect", which can lead to dependence on local corticosteroid treatment;
• skin depigmentation;
• 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 after local corticosteroid use are rare but can be severe. Adrenal cortex suppression may occur, especially during prolonged use of the medicine.
The risk of systemic corticosteroid side effects increases during:

• use under occlusive dressings (under a plaster, diaper), in skin folds;
• use on large areas of skin;
• prolonged treatment;
• use 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 those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181 C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help gather 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 or freeze.
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 butyrate.
• The other ingredients are cetostearyl alcohol, macrogol 25 cetostearyl ether, 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 parallel importer.

Marketing authorization holder in Portugal, 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:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Portuguese export authorization number: 8640508

Parallel import authorization number: 204/23

Date of leaflet approval: 27.09.2023

[Information about the trademark]