Locoid crelo

Package leaflet: Information for the user

Locoid Crelo, 1 mg/g, emulsion
(Hydrocortisoni butyras)
Please read this leaflet carefully before using this medicine because it contains important information for you.

• 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 any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

1. What Locoid Crelo is and what it is used for
2. What you need to know 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 Locoid Crelo is and what it is used for

Locoid Crelo contains the active substance hydrocortisone 17-butyrate, a corticosteroid with anti-inflammatory and vasoconstrictive properties. The medicine relieves symptoms of inflammatory skin conditions, often accompanied by itching.

Indications for Locoid Crelo

• Inflammatory skin conditions (not caused by microorganisms), such as eczema and psoriasis;
• Maintenance treatment of inflammatory skin diseases previously treated with more potent corticosteroids.

Locoid Crelo is indicated for use in adults, children, and infants above 3 months of age.

2. Information before using Locoid Crelo

When not to use Locoid Crelo:

• for 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 allergic to the active substance or to 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.
Avoid contact of the medicine with eyes and mucous membranes.
Avoid contact with the eyes and application around the eye area, as exposure of the emulsion to the conjunctiva may lead to the development of open-angle glaucoma or subcapsular cataracts.
Locoid Crelo should be used with caution on facial skin and on genital areas, as these are particularly sensitive to corticosteroids. Hands should be washed after each application, unless Locoid Crelo is being used to treat the hands.
There is an increased risk of systemic and local adverse effects when the medicine is used over long periods, over large skin areas, especially under occlusive dressings (e.g. under plastic film, diapers), or in skin folds and creases. Suppression of adrenal cortex function should be considered. In children, this may occur rapidly and may lead to suppression of growth hormone secretion.
In some patients with psoriasis, the use of topical corticosteroids may lead to relapse due to development of tolerance, generalized pustular psoriasis, or local and systemic toxic effects resulting from impaired skin barrier integrity.
After discontinuation of the medicine, a rebound effect may occur. This is a transient condition characterized by recurrence or worsening of symptoms that originally required treatment.
Contact your doctor if the patient develops blurred vision or other visual disturbances during treatment.
Due to the higher body surface area to body weight ratio in children, Locoid Crelo should be used with caution and strictly according to the doctor's instructions.
Particular caution is also required in infantile dermatoses, including diaper dermatitis.

Locoid Crelo with other medicines
Inform 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 become pregnant, she should consult a doctor or pharmacist before using this medicine.
During pregnancy, this medicine should be used only if, in the opinion of the doctor, the potential benefit justifies the potential risk to the fetus.
If the doctor prescribes 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 are no data available regarding the effect of Locoid Crelo on the ability to drive or operate machinery.

Locoid Crelo contains cetostearyl alcohol, propylene glycol, butylhydroxytoluene, propyl parahydroxybenzoate and butyl parahydroxybenzoate.
Due to the presence of cetostearyl alcohol, butylhydroxytoluene and propylene glycol, this medicine may cause local skin reactions (e.g. contact dermatitis), eye and mucous membrane irritation, and skin irritation.
Due to the presence of propyl parahydroxybenzoate and butyl parahydroxybenzoate, this medicine may cause allergic reactions (delayed-type reactions possible).

3. How to use Locoid Crelo

This medicine should always be used as directed by a physician. If in doubt, consult a doctor or pharmacist.
Typically, a thin layer of the emulsion should be applied evenly to the affected skin areas once or twice daily.
Once improvement is achieved, usually once-daily application or application two to three times per week is sufficient.
Locoid Crelo is used in the treatment of weeping skin lesions, including on hairy skin.
The dose should not exceed 30 to 60 g per week.
In children and infants, large doses, occlusion, and prolonged treatment should be avoided. In infants, treatment duration should usually not exceed 7 days.
Use of a higher than recommended dose of Locoid Crelo
Overdose has not been reported. With long-term use, adrenal cortex function suppression may occur.
If you have any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Cases of skin irritation and hypersensitivity have been reported in clinical trials.
The most commonly reported adverse reactions after marketing are hypersensitivity and
skin reactions such as erythema, pruritus, and skin infection.

Adverse reactions occurring rarely (may affect fewer than 1 in 1,000 people):

• skin atrophy, often irreversible, with thinning of the epidermis
• telangiectasia (dilation of small blood vessels)
• purpura
• striae (stretch marks)
• acne
• perioral dermatitis
• so-called "rebound effect", which may lead to dependence on topical corticosteroids
• skin depigmentation
• dermatitis and rash, including contact dermatitis

Adverse reactions occurring very rarely (may affect fewer than 1 in 10,000 people):

• suppression of adrenal cortex function

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

• skin infection
• hypersensitivity
• blurred vision
• pruritus, erythema, rash
• pain at the application site

Due to the presence of excipients—cetostearyl 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 (including delayed-type reactions) may also occur.

Systemic adverse reactions following topical application of corticosteroids are rare but can be severe. Suppression of adrenal cortex function may occur, particularly during prolonged use of the medicine.

The risk of systemic adverse reactions from corticosteroids increases:

• when the medicine is used under occlusive dressing (e.g. plastic film, diaper), or in skin folds;
• when applied over large areas of skin;
• during long-term treatment;
• in children (children have thinner skin and a larger skin surface area relative to body mass).

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse reactions not listed in this leaflet, inform your doctor. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Locoid Crelo

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle:
{EXP}. The expiry date refers to the last day of the stated month.
Do not store above 25°C.
Medicines should not be disposed of via the sewage system or in 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-17-butyrate.
• The other ingredients are: cetostearyl alcohol, cetostearyl alcohol macrogol ether 25, white soft paraffin, white petroleum jelly, cucumber 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