Locoid lipocream

Package leaflet: Information for the patient

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.
Locoid Lipocream (Locoid Lipocrème 0.1%), 1 mg/g, cream
Hydrocortisoni butyras
Locoid Lipocream and Locoid Lipocrème 0.1% are different trade names for the same medicinal product.
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, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including those 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. What you need to know 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 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 of treatment or maintenance therapy of inflammatory skin diseases, when 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, wounds;
• in perioral dermatitis;
• in acne vulgaris, rosacea;
• if the patient is hypersensitive to the active substance or to any of the other ingredients of this medicinal product (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 the cream coming into contact with the conjunctiva may cause open-angle glaucoma or subcapsular cataracts.
Avoid applying the medicine to the facial skin, hairy skin, and genital areas, as these are particularly sensitive to corticosteroids. Only weakly-acting corticosteroids should be used in these areas.
Avoid using the medicine on extensive skin areas, especially under occlusive dressings (e.g. under 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 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 referring the patient to an ophthalmologist to determine possible causes, including cataract, glaucoma, or rare conditions such as central serous chorioretinopathy (CSCR), which has been reported following both systemic and topical corticosteroid use.

Locoid Lipocream and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines you plan to use.
Interactions with other medicinal products 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 a doctor or pharmacist before using this medicine.
During pregnancy, the medicine should only be used 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 surface, breastfeeding should be discontinued.

Driving and operating machinery
There are no data regarding the effect of Locoid Lipocream on the ability to drive or operate machinery.

Locoid Lipocream contains cetostearyl alcohol, propyl parahydroxybenzoate, and benzyl alcohol
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).
Due to the presence of benzyl alcohol, this medicine may cause allergic reactions.

3. How to use Locoid Lipocream

This medicine should always be used according to the doctor's instructions. If in doubt, consult your doctor or pharmacist.
Usually, a thin layer of the cream should be evenly applied to the affected areas of skin 1 to 3 times daily. The cream may be gently massaged in. Once improvement occurs, application once daily or 2–3 times per week is usually sufficient.
Locoid Lipocream is used to treat 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 have been 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 reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.

Adverse reactions occurring rarely (may occur in fewer than 1 in 1,000 people):

• skin atrophy, often irreversible with epidermal thinning;
• dilation of small blood vessels;
• purpura;
• striae (stretch marks);
• acneiform eruptions;
• perioral dermatitis;
• so-called "rebound effect", which may lead to dependence on topical corticosteroids;
• skin depigmentation;
• dermatitis and rash, including contact dermatitis.

Adverse reactions occurring very rarely (may occur in fewer than 1 in 10,000 people):

• suppression of adrenal cortex function.

Frequency unknown (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 reactions following topical application of corticosteroids are rare, but may be severe. Suppression of adrenal cortex function may occur, particularly during prolonged treatment.

The risk of systemic corticosteroid adverse reactions increases under the following conditions:

• use under occlusive dressing (e.g. under plastic film, diaper);
• application in skin folds;
• application over large skin surface areas;
• prolonged treatment;
• use in children (children have thinner skin and a larger skin surface area relative to body weight).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at 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 reactions helps to provide more information on the safety of the medicine.

5. How to store Locoid Lipocream

Keep this medicine 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 stated month.
Do not store above 25°C.
Do not store in the refrigerator.
Medicines must 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 package and other information

What Locoid Lipocream contains

• The active substance is hydrocortisone 17-butyrate. 1 g of cream contains 1 mg of hydrocortisone 17-butyrate.
• Other ingredients are: cetostearyl alcohol, macrogol 25 cetostearyl ether, light 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 responsible party or the parallel importer.
Responsible party in Belgium, 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
Belgium, country of export, marketing authorisation number: BE129841
Parallel import authorisation number: 36/26