Locoid Crelo

Leaflet attached to the packaging: patient information

Locoid Crelo, 1 mg/g, emulsion
(Hydrocortisone butyrate)

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Locoid Crelo and what is it used for

Locoid Crelo 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 of the skin.

Indications for use of Locoid Crelo

• 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 of treatment 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 Crelo

When not to use Locoid Crelo:

• on skin lesions caused by bacterial infections (e.g. syphilitic or tubercular lesions), viral infections (e.g. chickenpox, herpes, shingles), fungal infections, parasitic infestations;
• on skin ulcers, wounds;
• in eczema around the mouth;
• in acne, 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 Crelo, discuss it with your doctor or pharmacist.
Protect your eyes and mucous membranes from contact with the medicine.
Avoid contact between the medicine and your eyes, and do not apply it to the eye area, as getting the emulsion on the conjunctiva may cause simple glaucoma or subcapsular cataract.
Avoid applying the medicine to the skin of the face and genital area, as it is particularly sensitive to the effects of corticosteroids. Only mild corticosteroids can be used in these areas.
Avoid applying the medicine to large areas of skin, especially under occlusive dressings (under a plaster, diaper), in skin folds and creases. In such cases, the absorption of corticosteroids may be significantly increased, leading to adrenal cortex suppression.
Use with caution and avoid prolonged treatment in children, as they may quickly develop adrenal cortex suppression, and growth hormone suppression may also occur.
Use with particular caution in patients with psoriasis, as local corticosteroid treatment in psoriasis may lead to 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 barrier disruption.
If you experience blurred vision or other vision disturbances during treatment, contact your doctor.

Locoid Crelo and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about 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 are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
The medicine can be used during pregnancy only if your doctor considers it necessary.
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, breastfeeding should be discontinued.

Driving and using machines

No data are available on the effects of Locoid Crelo on the ability to drive or use machines.
Locoid Crelo containscetyl alcohol, propylene glycol, butylhydroxytoluene, propyl parahydroxybenzoate, and butyl parahydroxybenzoate.
Due to the presence of cetyl alcohol, butylhydroxytoluene, and propylene glycol, the medicine may cause local skin reactions (e.g. contact dermatitis), eye and mucous membrane irritation, skin irritation.
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 Crelo

This medicine should always be used as directed by your doctor. If you are unsure, ask your doctor or pharmacist.
Usually, a thin layer of emulsion 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 Crelo is used to treat weeping skin lesions, also on hairy skin.
Do not use more than 30-60 g of the medicine per week.

Using more than the recommended dose of Locoid Crelo

No cases of overdose have been reported. Prolonged use may lead to adrenal cortex suppression.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Locoid Crelo can cause side effects, although not everybody gets them.
Uncommon side effects (may affect up to 1 in 100 people):

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

Rare side effects (may affect up to 1 in 1,000 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, butylhydroxytoluene, propylene glycol, propyl parahydroxybenzoate, and butyl parahydroxybenzoate, local skin reactions (e.g. contact dermatitis), eye and mucous membrane irritation, skin irritation, 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:

• when the medicine is used under occlusive dressings (under a plaster, diaper), in skin folds;
• when applied to large areas of skin;
• during prolonged treatment;
• when used 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 those not listed in this leaflet, please tell your 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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Locoid Crelo

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle after: {EXP}. The expiry date refers to the last day of the month.
Do not store above 25°C.
Medicines should 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 pack and other information

What Locoid Crelo contains

• The active substance is hydrocortisone butyrate.
• The other ingredients are: cetyl alcohol, macrogol 25 cetostearyl ether, white petrolatum, white wax, ogre seed oil, butylhydroxytoluene, propylene glycol, anhydrous sodium citrate, anhydrous citric acid, propyl parahydroxybenzoate, butyl parahydroxybenzoate, purified water.

What Locoid Crelo looks like and contents of the pack

Locoid Crelo is a white emulsion.
The pack contains 30 g of emulsion.

Marketing authorisation holder and manufacturer

Marketing authorisation 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: