Package leaflet: Information for the patient

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

Keep this leaflet, as you may need to read it again.
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 another person, even if their symptoms are similar.
If the patient experiences any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents:

What Locoid is and what it is used for
Important information before using Locoid
How to use Locoid
Possible side effects
How to store Locoid
Contents of the pack and other information

1. What Locoid is and what it is used for

Locoid 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

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 treatment of inflammatory skin diseases, when previous treatment with more potent topical corticosteroids has been effective.

2. Important information before using Locoid

When not to use Locoid

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 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, discuss it with 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 the cream coming into contact with the conjunctiva may cause 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 weakly acting corticosteroids should be used in these areas.
Avoid applying the medicine to large areas of skin, especially under occlusive dressings (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 develop rapidly; growth hormone secretion may also be suppressed.
Use with particular caution in patients with psoriasis, as topical application of corticosteroids in psoriasis may lead to relapse due to development of tolerance, risk of generalized pustular psoriasis, and local and systemic toxic effects resulting from impaired skin integrity.
Contact your doctor if blurred vision or other visual disturbances occur during treatment.

Locoid and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans 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 baby, she should consult her doctor or pharmacist before using this medicine.
Locoid may be used during pregnancy only if there are clear medical indications, as determined by the physician.
If the doctor prescribes Locoid 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 are no data available regarding the effect of Locoid on the ability to drive vehicles or operate machinery.

Locoid contains cetostearyl alcohol, propyl parahydroxybenzoate, and butyl 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 and butyl parahydroxybenzoate, this medicine may cause allergic reactions (including delayed-type reactions).

3. How to use Locoid

This medicine should always be used as directed by a physician. In case of doubts, consult a
physician or pharmacist.
Usually, a thin layer of cream should be applied evenly to the affected areas of skin 1 to 3 times daily. The medicine may be gently massaged in. Once improvement occurs, treatment with the medicine once daily or 2–3 times weekly is usually sufficient.
Locoid is used in the treatment of dry, dry-exudative, and exudative skin lesions.
The dose should not exceed 30–60 g per week.
Use of a higher than recommended dose of Locoid
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 a physician or pharmacist.

4. Possible adverse effects

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

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

Skin atrophy, often irreversible, with thinning of the epidermis;
Dilation of small blood vessels;
Purpura;
Striae;
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 effects 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, propyl parahydroxybenzoate, and butyl 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 have thinner skin and a larger skin 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, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions 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 effects helps to provide more information on the safety of the medicine.

5. How to store the medicine Locoid

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.
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 no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Locoid contains

The active substance is hydrocortisone 17-butyrate.
The other ingredients are: cetostearyl alcohol, macrogol 25 cetostearyl ether, light liquid paraffin, white soft paraffin, propyl parahydroxybenzoate, butyl parahydroxybenzoate, citric acid, sodium citrate, purified water.

What Locoid looks like and contents of the pack
Locoid 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:
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
Romania, country of export, marketing authorization number: 8683/2016/01
Parallel import authorization number: 172/24