Locoid lipocream

Patient Information Leaflet

Warning! Please keep this leaflet. The packaging information is in a foreign language.
Locoid Lipocream (Locoid Lipocreme), 1 mg/g, cream
(Hydrocortisoni butyras)
Locoid Lipocream and Locoid Lipocreme are different trade names for the same medicine.
Please read this leaflet carefully before using the 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. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents:

1. What Locoid Lipocream is and what it is 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 Locoid Lipocream is and what it is 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.
Indications for Locoid Lipocream

• Inflammatory skin conditions (not caused by microorganisms) that respond to corticosteroid treatment, when topical treatment with less potent corticosteroids has not provided the desired results;
• Continuation of treatment or maintenance therapy of inflammatory skin diseases, when previous use of 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 allergic 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 to the conjunctiva may lead to the development of open-angle 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-acting corticosteroids should be used in these areas.
Avoid applying the medicine over large skin areas, especially under occlusive dressings (such as plastic film or 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 develop rapidly; inhibition of growth hormone secretion may also occur.
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 the patient experiences symptoms such as blurred vision or other visual disturbances, consider referral to an ophthalmologist 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 planned for future use.
Interactions with other medicines are not known.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to become pregnant, 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 your doctor prescribes 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 regarding the effect of Locoid Lipocream on the ability to drive vehicles 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 (delayed-type reactions possible).

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 the skin
1 to 3 times daily. The cream may be gently massaged in. Once improvement occurs,
application once daily or 2–3 times weekly is usually sufficient.
Locoid Lipocream is used for the treatment of dry and dry-exudative skin lesions.
The weekly dose should not exceed 30–60 g.
Use of a higher than recommended dose of Locoid Lipocream
There are no reports of overdose. However, prolonged use may lead to suppression of adrenal
cortical function.
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 experiences them.

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

• Skin atrophy, often irreversible with epidermal thinning;
• Dilatation 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 side 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), in skin folds;
• Application over large skin surface areas;
• Long-term treatment;
• Use in children (children's skin is thinner and the skin surface area relative to body weight is larger).

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration 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
Reporting adverse effects helps to provide more information on the safety of the 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 stated month.
Do not store above 25°C. Do not store in a refrigerator or freeze.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Locoid Lipocream contains

• The active substance is hydrocortisone 17-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 further information, please contact the marketing authorisation holder or parallel importer.
Marketing authorisation holder 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 (MI)
Italy
Parallel importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing authorisation number in Portugal, country of export: 8640508
Parallel import licence number: 204/23