Locoid

Package Leaflet: Information for the Patient

Locoid, 1 mg/ml, skin solution
(Hydrocortisone butyrate)

Read the package 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 any not listed in this leaflet, please tell your 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. Contents of the pack and other information

1. What is Locoid and what is it used for

Locoid solution 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

• inflammatory conditions of the hairy scalp (not caused by microorganisms) that respond to corticosteroid treatment, in cases where treatment with less potent topical corticosteroids has not produced the expected results;
• continuation or maintenance treatment of inflammatory skin conditions, 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 vulgaris, rosacea;
• if you are 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 your eyes and mucous membranes from contact with the medicine.
Avoid contact of the medicine with your eyes and application in the eye area, as getting the solution into the conjunctiva may cause glaucoma or subcapsular cataract.
Avoid applying the medicine to the skin of the face, hairy skin other than the hairy scalp, and the skin in the genital area, as it is particularly sensitive to the effects of corticosteroids. Only weak corticosteroids can be used in these areas.
Avoid applying the medicine to large areas of skin, especially under occlusive dressings (under a patch, diaper), 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 long-term treatment in children, as they may quickly develop suppression of adrenal cortex function, and growth hormone deficiency may also occur.
Use with particular caution in patients with psoriasis, as local treatment with corticosteroids 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.
Contact your doctor if you experience blurred vision or other vision disturbances during treatment.

Locoid 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 use.
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

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

3. How to use Locoid

This medicine should always be used as directed by your doctor. If you are unsure, ask your doctor or pharmacist.
Usually, a small amount of the medicine is applied evenly to the affected areas on the hairy scalp 1 to 3 times a day. The medicine can be gently massaged in. After improvement, it is usually sufficient to use the medicine once a day or 2 to 3 times a week.
Locoid solution is used to treat lesions on the hairy scalp.
Do not use more than 30-60 g per week.

Using more than the 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 questions about the use of this medicine, ask 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 affect up to 1 in 1000 people):

• skin atrophy, often irreversible with thinning of the epidermis;
• telangiectasia;
• petechiae;
• striae;
• papulopustular rash;
• perioral dermatitis;
• so-called "rebound effect", which can lead to dependence on topical corticosteroids;
• skin depigmentation;
• contact dermatitis and eczema

Very rare side effects (may affect up to 1 in 10,000 people):

• suppression of adrenal cortex function

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

• hypersensitivity
• blurred vision

Systemic side effects of topical corticosteroids are rare, but can be severe. Suppression of adrenal cortex function 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 patch, diaper), in skin folds;
• application to 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 not listed in this leaflet, please tell your doctor. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Adverse Reactions to 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
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Locoid

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.
Store below 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 contains

• The active substance is hydrocortisone butyrate.
• The other ingredients are: isopropyl alcohol, glycerol 85%, Povidone K 90, citric acid anhydrous, sodium citrate anhydrous, purified water.

What Locoid looks like and contents of the pack

Locoid is a clear, colorless solution.
The pack contains 30 ml of solution.

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: