Locoid Lipocream

Package Leaflet: Information for the Patient

Locoid Lipocream, 1 mg/g, cream
(Hydrocortisone butyrate)

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your 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 butyrate, a corticosteroid with anti-inflammatory and vasoconstrictive properties. 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 treatment with more potent topical corticosteroids 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, parasitic infestations;
• on skin ulcers, wounds;
• in eczema around the mouth;
• in acne, 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 of the medicine with your eyes and application in the eye area, as getting the cream on the conjunctiva may cause glaucoma or subcapsular cataract.
Avoid applying the medicine to the skin of the face, hairy skin, and skin in the genital area, as it is particularly sensitive to the effects of corticosteroids. Only weak 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 flexures. 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 they may quickly develop adrenal cortex suppression, and growth hormone suppression may also occur.
Use with particular caution in patients with psoriasis, as local corticosteroid treatment in psoriasis may lead to relapse of the disease due to the development of tolerance, risk of generalized pustular psoriasis, and local and systemic toxic effects due to skin barrier disruption.
Due to systemic and local use of corticosteroids, 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 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

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might 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 your doctor considers it necessary.
If your doctor recommends using the medicine during breastfeeding, it can be used on a small area of skin for a short time. In case of prolonged treatment or application to a large area of skin, breastfeeding should be discontinued.

Driving and using machines

No data are available on the effects of Locoid Lipocream on the ability to drive or use machines.
Locoid Lipocream containscetyl alcohol and propyl parahydroxybenzoate.
Due to the presence of cetyl 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-oozing skin lesions.
Do not use more than 30-60 g of the medicine per week.

Using more than the recommended dose of Locoid Lipocream

No reports of overdose are available. Prolonged use may lead to adrenal cortex suppression.
If you have any further questions about the use of this medicine, ask 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;
• purpura;
• striae;
• acne;
• perioral dermatitis;
• so-called "rebound effect", which may lead to dependence on local corticosteroid treatment;
• skin discoloration;
• 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 - cetyl 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 corticosteroids after local use are rare but may be severe. Adrenal cortex suppression 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 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, please inform your doctor. 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, 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 carton and tube after: {EXP}.
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 no longer required. 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: cetyl alcohol, macrogol 25 cetostearyl ether, liquid paraffin, white petrolatum, propyl parahydroxybenzoate, benzyl alcohol, anhydrous citric acid, anhydrous sodium citrate, purified water.

What Locoid Lipocream looks like and contents of the pack

Locoid Lipocream is a white cream.
The pack contains 15 or 30 g of cream.

Marketing Authorisation Holder and Manufacturer

CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald
Germany
Manufacturer:
Temmler Italia S.R.L.
Via Delle Industrie 2
20061 Carugate (MI)
Italy

Date of last revision of the leaflet: