Locoid

Leaflet attached to the packaging: patient information

Locoid, 1 mg/g, cream
(Hydrocortisone butyrate)

Please read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Please keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. 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 side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Locoid and what is it used for
• 2. Important information before using Locoid
• 3. How to use Locoid
• 4. Possible side effects
• 5. How to store Locoid
• 6. Package contents and other information

1. What is Locoid and what is it used for

Locoid contains the active substance hydrocortisone butyrate, a corticosteroid with anti-inflammatory and vasoconstrictive properties. The medicine relieves symptoms of skin inflammation, often accompanied by skin itching.

Indications for use of Locoid

• skin inflammation (not caused by microorganisms) that responds to corticosteroid treatment, in cases where treatment with less potent topical corticosteroids does not produce the expected results;
• continuation or maintenance treatment of inflammatory skin diseases, in cases where previous use of more potent topical corticosteroids has produced good results.

2. Important information before using Locoid

When not to use Locoid

• on skin lesions caused by bacterial infections (e.g., syphilitic or tubercular lesions), viral infections (e.g., chickenpox, herpes, shingles), fungal infections, or parasitic infestations;
• on skin ulcers, wounds;
• in eczema around the mouth;
• in common or rosacea acne;
• 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, the patient should discuss it with their doctor or pharmacist.
The eyes and mucous membranes should be protected from contact with the medicine.
Contact between the medicine and the eyes, as well as application in the eye area, should be avoided, as it may cause glaucoma or subcapsular cataract.
The medicine should not be applied to the skin of the face, hairy skin, or skin in the genital area, as it is particularly sensitive to corticosteroids. Only weak corticosteroids can be used in these areas.
The medicine should not be applied to large areas of skin, especially under occlusive dressings (under a bandage, diaper), in skin folds and creases. In such cases, the absorption of corticosteroids may be significantly increased, leading to adrenal cortex suppression.
The medicine should be used with caution and avoided for prolonged treatment in children, as adrenal cortex suppression may occur quickly, and growth hormone secretion may be inhibited.
The medicine should be used with particular caution in patients with psoriasis, as local corticosteroid treatment in psoriasis may cause relapse of the disease due to the development of tolerance, the risk of generalized pustular psoriasis, and local and systemic toxic effects due to skin continuity disorders.
If the patient experiences blurred vision or other vision disturbances during treatment, they should contact their doctor.

Locoid and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
No interactions with other medicines are known.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
The medicine can be used during pregnancy only if the doctor considers it necessary.
If the doctor recommends using the medicine during breastfeeding, it can be used on a small skin area for a short time. In the case of prolonged treatment or application to a large skin area, breastfeeding should be discontinued.

Driving and using machines

There is no data on the effect of Locoid on the ability to drive and use machines.
Locoid containscetyl alcohol, propyl parahydroxybenzoate, and butyl parahydroxybenzoate.
Due to the presence of cetyl alcohol, the medicine may cause local skin reactions (e.g., contact dermatitis).
Due to the presence of propyl and butyl parahydroxybenzoate, the medicine may cause allergic reactions (possible late-type reactions).

3. How to use Locoid

This medicine should always be used as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
Usually, a thin layer of cream is applied evenly to the affected skin areas 1 to 3 times a day. The medicine can be lightly massaged in. After improvement, it is usually sufficient to use the medicine once a day or 2-3 times a week.
Locoid is used to treat dry, dry-wet, and wet skin lesions.
A dose greater than 30-60 g per week should not be used.

Using more than the recommended dose of Locoid

There are no reports of overdose. Prolonged use may lead to adrenal cortex suppression.
In case of further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Locoid can cause side effects, although not everybody gets them.
Rare side effects (may occur in less than 1 in 1000 people):

• skin atrophy, often irreversible with thinning of the epidermis;
• dilation of small blood vessels;
• purpura;
• skin striae;
• pustular acne;
• perioral dermatitis;
• so-called "rebound effect", which may lead to dependence on local corticosteroid treatment;
• skin discoloration;
• skin inflammation and rash, including contact dermatitis

Very rare side effects (may occur in less than 1 in 10,000 people):

• adrenal cortex suppression

Frequency not known (frequency cannot be estimated from the available data):

• hypersensitivity
• blurred vision

Due to the presence of excipients - cetyl alcohol, propyl parahydroxybenzoate, and butyl parahydroxybenzoate, local skin reactions (e.g., contact dermatitis) and allergic reactions (possible late-type reactions) may also occur.
Systemic side effects of topical corticosteroids are rare but can be severe. Adrenal cortex suppression may occur, especially during prolonged use of the medicine.
The risk of systemic side effects of corticosteroids increases during:

• use under occlusive dressings (under a bandage, diaper), in skin folds;
• use on large skin areas;
• prolonged treatment;
• use in children (children's skin is thinner, and the skin surface area is larger in relation to body weight).

Reporting side effects

If side effects occur, including those not listed in the leaflet, the patient should inform their doctor. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, PL-02 222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Locoid

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the carton and tube after: {EXP}.
The expiry date refers to the last day of the specified month.
The medicine should not be stored at a temperature above 25°C, nor should it be refrigerated or frozen.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of unused medicines. This will help protect the environment .

6. Package contents and other information

What Locoid contains

• The active substance of the medicine is hydrocortisone butyrate.
• The other ingredients are: cetyl alcohol, macrogol 25 cetostearyl ether, liquid paraffin, white petrolatum, propyl parahydroxybenzoate, butyl parahydroxybenzoate, anhydrous citric acid, anhydrous sodium citrate, purified water.

What Locoid looks like and what the package contains

Locoid is a white cream.
The package contains 15 or 30 g of cream.

Marketing authorization holder and manufacturer

Marketing authorization holder:
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald
Germany
Manufacturer:
Temmler Italia S.R.L.
Via Delle Industrie 2
20061 Carugate (MI)
Italy

Date of last revision of the leaflet: