Patient Information Leaflet

Keep this leaflet! The packaging contains information in a foreign language.
Locoid Lipocream
1 mg/g, cream
Hydrocortisoni butyras
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

Keep this leaflet for future reference.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are identical.
If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

What is Locoid Lipocream and what is it 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 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 Locoid Lipocream

Inflammatory skin conditions (not caused by microorganisms) responsive to corticosteroid treatment, when topical treatment with less potent corticosteroids has not provided the expected results;
Continuation or maintenance therapy of inflammatory skin diseases, in cases where previous treatment with 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 or 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, consult your doctor or pharmacist.
Protect the eyes and mucous membranes from contact with the medicine.
Avoid contact of the medicine with the eyes and its use around the eye area, as exposure of the conjunctiva to the cream may lead to the development of primary glaucoma or subcapsular cataract.
Avoid using the medicine on the face, hairy skin, and genital areas, as these areas are particularly sensitive to corticosteroids. Only weak 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 relapse 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 a patient experiences symptoms such as blurred vision or other visual disturbances, referral to an ophthalmologist should be considered to determine possible causes, including cataract, glaucoma, or rare conditions such as central serous chorioretinopathy (CSCR), which has been reported after both systemic and topical corticosteroid use.

Locoid Lipocream and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient intends 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 have a child, she should consult her doctor or pharmacist before using this medicine.
This medicine should be used during pregnancy only if clearly indicated by the physician.
If the doctor prescribes the use of 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 on the effect of Locoid Lipocream on the ability to drive 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 as directed by the physician. 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,
treatment once daily or 2–3 times weekly is usually sufficient.
Locoid Lipocream is used in the treatment of dry and dry-exudative skin lesions.
Do not use more than 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 effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Rare adverse effects (may occur in fewer than 1 in 1,000 people):

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

Very rare adverse effects (may occur in fewer 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 effects following topical application of corticosteroids are rare, but may be severe. Suppression of adrenal cortex function may occur, particularly during prolonged use of the medicine.

The risk of systemic corticosteroid adverse effects increases during:

Use under occlusive dressing (e.g. under plaster, under diaper), or in skin folds;
Application over large skin areas;
Long-term treatment;
Use in children (children's skin is thinner and has a larger surface area relative to body weight).

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel: +48 22 4921 301, Fax: +48 22 4921 309, Website: https://smz.ezdrowie.gov.pl.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store the medicine Locoid Lipocream

The medicine should be stored in a place inaccessible and not visible to 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 a refrigerator or freeze.
Medicines must not be disposed of via sewage systems 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 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 soft paraffin, 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, please contact the responsible party or the parallel importer.
Responsible party in Portugal, 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 in:
InPharm Sp. z o.o. Services sp. k., ul. Chełmżyńska 249, 04-458 Warsaw
Marketing authorization number in Portugal, country of export: 8640508
Parallel import authorization number: 406/22