Locoid Lipocream

Leaflet attached to the packaging: patient information

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

Locoid Lipocream

1 mg/g, cream

Hydrocortisone butyrate

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a 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 the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform 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 packaging 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 effects.
The medicine relieves symptoms of inflammatory skin conditions often accompanied by itching of the skin.

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 use of 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 tubercular lesions), viral infections (e.g. chickenpox, herpes, shingles), fungal infections, or parasitic infestations;
• on skin ulcers, wounds;
• in eczema around the mouth;
• 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, you should discuss it with your doctor or pharmacist.
You should protect your eyes and mucous membranes from contact with the medicine.
You should avoid contact between the medicine and your eyes, as well as applying it to the eye area, as this may cause glaucoma or subcapsular cataract.
You should avoid applying the medicine to the skin of the face, hairy skin, and the skin in the genital area, as it is particularly sensitive to the effects of corticosteroids. Only weak corticosteroids should be used in these areas.
You should 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 suppression of adrenal cortex function.
The medicine should be used with caution and avoided for prolonged treatment in children, as they may quickly develop suppression of adrenal cortex function, and growth hormone deficiency may also occur.
The medicine should be used with particular caution in patients with psoriasis, as local use of corticosteroids in psoriasis may 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 the systemic and local use of corticosteroids, vision disturbances may occur. If the patient experiences symptoms such as blurred vision or other vision disturbances, they should be referred to an ophthalmologist to determine possible causes, which may include cataract, glaucoma, or rare diseases such as central serous chorioretinopathy (CSCR), which have been reported after systemic and local use of corticosteroids.

Locoid Lipocream and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to use.
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, you should consult your doctor or pharmacist before using this medicine.
During pregnancy, the medicine can only be used if, in the doctor's opinion, there are clear indications for its use.
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. In case of doubts, you should 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-oozing skin lesions.
The dose should not exceed 30-60 g per week.

Using more than the recommended dose of Locoid Lipocream

There are no reports of overdose. With prolonged use, suppression of adrenal cortex function may occur.
In case of any further doubts about the use of this medicine, you should 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;
• dilation of small blood vessels;
• petechiae;
• striae;
• papulopustular acne;
• perioral dermatitis;
• so-called "rebound effect", which may lead to dependence on topical corticosteroids;
• skin discoloration;
• skin inflammation and rash, including contact dermatitis.

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

• suppression of adrenal cortex function.

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 topical use of corticosteroids are rare, but may be severe. Suppression of adrenal cortex function may occur, especially during prolonged use of the medicine.
The risk of systemic side effects of corticosteroids increases during:

• use under occlusive dressings (under a bandage, 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 any side effects not listed in this leaflet, you should inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Locoid Lipocream

The medicine should be stored out of 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 stated.
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. You should ask your pharmacist how to dispose of medicines that are no longer needed.
This will help protect the environment.

6. Contents of the packaging and other information

What Locoid Lipocream contains

• The active substance of the medicine 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 packaging

Locoid Lipocream is a white cream.
The packaging contains 30 g of cream.
For more detailed information, you should contact 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 – Milano, Italy
Astellas Pharma Europe B.V., Hogemaat, 2, 7942 JG Meppel, Netherlands

Parallel importer:

InPharm Sp. z o.o., ul. Strumykowa 28/11, 03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k., ul. Chełmżyńska 249, 04-458 Warsaw
Marketing authorization number in Portugal, the country of export:8640508

Parallel import authorization number: 406/22 Date of approval of the leaflet: 17.11.2022

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