Locoid

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Locoid, 1 mg/g, cream

(Hydrocortisone butyrate)

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. 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. Contents of the packaging 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 inflammatory skin conditions often accompanied by itching.

Indications for use of Locoid

• inflammatory skin conditions (not caused by microorganisms) that respond 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 treatment with 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 tuberculous lesions), viral infections (e.g., chickenpox, herpes, shingles), fungal infections, or parasitic infestations;
• on skin ulcers, wounds;
• in eczema around the mouth;
• in acne or 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, you should discuss it with your doctor or pharmacist.
You should protect your eyes and mucous membranes from contact with the medicine.
You should avoid contact between the medicine and your eyes, as well as applying it to the eye area, as getting the cream into the conjunctiva may cause glaucoma or subcapsular cataract.
You should avoid applying the medicine to the skin of the face, hairy skin, and the skin around the genital area, as it is particularly sensitive to the effects of corticosteroids. Only weak corticosteroids can be used in these areas.
You should avoid applying the medicine to large areas of skin, especially under occlusive dressings (under a bandage, diaper), in skin folds, and flexures. 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 they may quickly develop adrenal cortex suppression, and growth hormone suppression may also occur.
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.
You should contact your doctor if you experience blurred vision or other vision disturbances during treatment.

Locoid and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
No interactions with other medicines are known.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine.
The medicine can be used during pregnancy only if, in the doctor's opinion, there are clear indications for its use.
If your doctor recommends using the medicine during breastfeeding, it can be used on a small area of skin for a short time. In the case of prolonged treatment or application to a large area of skin, you should stop breastfeeding.

Driving and using machines

There are no data on the effect of Locoid on the ability to drive and use machines.

Locoid contains cetostearyl alcohol, propyl parahydroxybenzoate, and butyl parahydroxybenzoate.

Due to the presence of cetostearyl alcohol, the medicine may cause local skin reactions (e.g., contact dermatitis).
Due to the presence of propyl parahydroxybenzoate 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 your doctor. In case of doubts, you should consult your doctor or pharmacist.
Usually, a thin layer of cream is applied evenly to the affected areas of skin 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-oozing, and oozing skin lesions.
The dose should not exceed 30-60 g per week.

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 any further doubts about the use of this medicine, you should consult your 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;
• vasodilation;
• petechiae;
• striae;
• pustular acne;
• perioral dermatitis;
• so-called "rebound effect", which may lead to dependence on topical corticosteroids;
• skin discoloration;
• dermatitis and eczema, 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 - cetostearyl 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 may 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 areas of skin;
• 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 you experience any side effects, including any side effects not listed in this leaflet, you should inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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
By reporting side effects, you can help gather more information on the safety of this 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 packaging. The expiry date refers to the last day of the month stated.
Store in a temperature below 25°C, in the original packaging.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Locoid contains

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

What Locoid looks like and contents of the packaging

Locoid is a white cream.
The packaging contains 30 g of cream.
For more detailed information, you should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Romania, the 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 by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Romania export authorization number: 8683/2016/01

Parallel import authorization number: 172/24

Date of leaflet approval: 25.04.2024

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