Locoid lipocream

Package leaflet: Information for the patient

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

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, 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 another person, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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) responsive to corticosteroid treatment, when topical treatment with less potent corticosteroids does not provide the expected results;
• Continuation of treatment or maintenance therapy of inflammatory skin diseases, in cases where 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 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 avoid applying it around the eye area, as exposure to the conjunctiva may lead to the development of primary glaucoma or subcapsular cataract.
Avoid applying the medicine to the facial skin, 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 (e.g. plastic film, diapers), and in skin folds and creases. In such cases, absorption of corticosteroids may be significantly increased, potentially leading to suppression of adrenal cortex function.
Use with caution and avoid prolonged treatment in children, as adrenal suppression may develop rapidly. Suppression of growth hormone secretion may also occur.
Particular caution is required in patients with psoriasis, as topical use of corticosteroids in psoriasis may lead to disease 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 following 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 may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Locoid Lipocream 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 (delayed-type reactions possible).

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 applied evenly to the affected areas of skin
1 to 3 times daily. The cream may be gently massaged in. Once improvement is achieved,
treatment with the medicine once daily or 2–3 times weekly is usually sufficient.
Locoid Lipocream is used to treat dry and dry-exuding 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. 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 everybody will experience them.

Rarely occurring adverse reactions (may occur in less than 1 in 1,000 people):

• Skin atrophy, often irreversible, with epidermal thinning;
• Telangiectasia (dilation of small blood vessels);
• Purpura;
• Striae (skin stretch marks);
• 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 rarely occurring adverse reactions (may occur in less 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 reactions 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 reactions increases during:

• Application under occlusive dressings (e.g. under plaster, under diapers), or in skin folds;
• Application over large skin surface areas;
• Prolonged treatment;
• Use in children (children's skin is thinner and has a larger 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 or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Poland, Tel: +48 22 4921301, Fax: +48 22 4921309, Website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store the medicine 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.
Store below 25°C in the original packaging.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This helps 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 responsible party or the parallel importer.
Responsible party in Romania, 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:
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 authorisation number in Romania, country of export: 8684/2016/01
Parallel import authorisation number: 149/21