Locatop

Package Leaflet: Information for the Patient

Locatop, 1 mg/g, Cream

Desonidum

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.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• 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 Locatop and what is it used for
• 2. Important information before using Locatop
• 3. How to use Locatop
• 4. Possible side effects
• 5. How to store Locatop
• 6. Contents of the pack and other information

1. What is Locatop and what is it used for

Locatop is a cream that contains the active substance desonide. Desonide is a synthetic corticosteroid for topical use. According to the results of skin vasoconstrictor tests, desonide is a moderately to highly potent corticosteroid. When applied topically to the skin, it has anti-inflammatory, anti-pruritic (reducing itching) and vasoconstrictive effects.

Indications

The medicine is indicated for use in infants, children, adolescents, and adults to relieve inflammatory and pruritic symptoms in the following skin diseases:

• contact dermatitis,
• atopic dermatitis,
• psoriasis, except for very severe lesions,
• lichen planus,
• limited neurodermatitis,
• lichen sclerosus et atrophicus,
• granuloma annulare,
• chronic discoid lupus erythematosus,
• psoriatic erythroderma of the hands and feet,
• seborrhoeic dermatitis, except for facial skin,
• symptomatic treatment of pruritus in mycosis fungoides,
• large insect bites.

2. Important information before using Locatop

When not to use Locatop:

• if the patient is allergic to desonide or any of the other ingredients of this medicine (listed in section 6),
• in primary bacterial, viral, fungal, or parasitic skin infections,
• on ulcers,
• in acne vulgaris,
• in rosacea (a skin disease of the face, in which redness affects mainly the nose and the cheeks adjacent to the nose),
• in perioral dermatitis (rash around the mouth) .

Warnings and precautions

Before starting to use Locatop, the patient should discuss it with their doctor or pharmacist.

• This medicine should be used as directed by the doctor:
• The medicine should not be used on the facial skin, especially for a long time. On the facial skin, the medicine should only be used under strict medical supervision.
• Avoid using the medicine on large areas of skin or under occlusive dressings (sealing dressings), as the medicine may penetrate into the bloodstream. This may cause, especially in children, the occurrence of systemic side effects (including adrenal suppression, Cushing's syndrome, growth retardation) - see section 4.
• Repeated or prolonged use may cause significant amounts of the medicine to penetrate into the bloodstream.
• If the patient experiences blurred vision or other vision disturbances, they should contact their doctor.
• Repeated or prolonged use of this medicine in the eye area may cause the occurrence of increased intraocular pressure or cataracts. In the case of prolonged use on the eyelids, ophthalmological monitoring is necessary. Patients at risk of glaucoma, in the case of using the medicine for more than a week, should be under ophthalmological supervision.
• In the case of bacterial or fungal infections in the treated skin disease, the doctor will use specific anti-infective treatment before administering this medicine.
• Any signs of irritation or infection should be reported to the doctor.
• The medicine should be used with particular caution in psoriasis, as local use of corticosteroids can be dangerous for many reasons, including the risk of relapse of the disease caused by the development of tolerance, the risk of generalized pustular psoriasis, and general toxic effects due to skin disorders and damage.
• In the case of sudden cessation of treatment after prolonged use of the medicine, a "rebound effect" may occur, i.e., worsening of symptoms. This effect can be minimized by gradual withdrawal of the medicine under medical supervision. If the symptoms of the disease worsen during treatment, the patient should consult their doctor, as this may indicate the development of an allergic reaction, infection, or the need for alternative therapy. If the disease recurs within a short time (within 2 weeks) after the end of treatment, the cream Locatop should not be used again without prior consultation with the doctor, unless the doctor has previously recommended it. If the patient's disease has resolved, and after recurrence, the redness of the skin exceeds the previously treated area, and the patient feels burning of the skin, before resuming treatment, they should consult their doctor. A "rebound effect" may be suspected.
• If signs of intolerance occur, the use of Locatop cream should be discontinued and the doctor should be contacted immediately.

Infants and children

The decision to use the medicine in a child is made by the doctor. It is recommended to avoid using the medicine in infants and children, due to the possibility of systemic side effects of corticosteroids, including growth disorders.

Locatop and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Locatop with food and drink

Not applicable.

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 before using this medicine.
Pregnancy
There are insufficient data on the use of desonide in pregnant women. The use of this medicine is not recommended during pregnancy, unless the doctor considers it absolutely necessary.
Breastfeeding
There is insufficient information on the penetration of desonide into breast milk; the risk to the breastfed child cannot be excluded. Locatop should not be used during breastfeeding.

Driving and using machines

Locatop has no influence or negligible influence on the ability to drive and use machines.
Locatop contains sorbic acid and cetomacrogol emulsifying wax,which may cause local skin reactions (e.g., contact dermatitis).

3. How to use Locatop

This medicine should always be used as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
Do not extend the treatment period beyond the period prescribed by the doctor.
Recommended dose
The medicine is used, in infants, children, adolescents, and adults, 1 or a maximum of 2 times a day on the affected skin. More frequent use of the medicine increases the risk of side effects and does not improve the effectiveness of treatment.
Using the medicine on large areas of skin requires monitoring of the number of used packages.

Method of administration

Topical application.
A small amount of the medicine should be gently rubbed into the affected skin, then spread and gently massaged into the skin until completely absorbed. The use of a plastic glove is recommended.

Using a higher dose of Locatop than recommended

This medicine should always be used as directed by the doctor or pharmacist. Acute overdose is rare. However, the medicine used in excessive amounts or for a long time may penetrate into the bloodstream and cause systemic side effects due to the effect on certain hormones, such as moon face, increased fat on the upper back and neck ("buffalo hump"), central obesity (Cushing's syndrome), growth retardation in children.

The patient should immediately inform their doctor in the following cases:

• using the medicine in higher doses than prescribed,
• using the medicine for a longer period than indicated by the doctor.

In the case of overdose (too much corticosteroid in the blood leading to side effects), the doctor will use appropriate treatment.

Missing a dose of Locatop

Do not use a double dose to make up for a missed dose.

Stopping the use of Locatop

Treatment should not be stopped abruptly. The treatment should be gradually discontinued under medical supervision.
In case of any further doubts regarding the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Locatop can cause side effects, although not everybody gets them.
Side effects may include:

Side effects of unknown frequency (frequency cannot be estimated from the available data)

• secondary infections (infection that occurs during or immediately after treatment)
• folliculitis
• allergic reaction (hypersensitivity reaction)
• skin rash (contact allergy)
• systemic side effects, such as changes in body appearance, moon face, central obesity (Cushing's syndrome), growth retardation in children - see section 2
• blurred vision
• skin thinning, skin atrophy, skin fragility
• telangiectasias (dilated and reddened blood vessels)
• petechiae
• striae (white streaks on the skin)
• perioral dermatitis (rash around the mouth)
• acne-like dermatitis
• pustular rash
• skin discoloration
• contact dermatitis (contact eczema)
• worsening of rosacea (a skin disease of the face, where the nose and cheeks are highly reddened)
• ulcers and (or) eschars
• leg ulcers
• urticaria
• excessive hair growth (hypertrichosis)
• delayed wound healing
• withdrawal reaction of topical corticosteroids (rebound effect). If the medicine is used for a long time, in some patients during treatment, as well as within days to weeks after stopping the use of the medicine, a withdrawal reaction may occur, i.e., recurrence of the disease, with some or all of the following symptoms: redness of the skin in an area larger than initially treated, burning or stinging sensation, intense itching, skin peeling, and weeping open sores.

If any of the side effects get worse or if the patient experiences any side effects not listed in the leaflet, they should inform their doctor.

Reporting side effects

If side effects occur, including those not listed in the leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Pharmacovigilance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Locatop

The medicine should be stored at a temperature below 30°C.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after: EXP.
The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Locatop contains

• The active substance of the medicine is desonide. 1 g of cream contains 1 mg of desonide (Desonidum).
• The other ingredients are: liquid paraffin, solid paraffin, cetomacrogol emulsifying wax, sorbic acid (E 200), propyl gallate, disodium edetate, purified water.

What Locatop looks like and contents of the pack

Locatop is a white, odorless cream.
The tube contains 30 g of cream, placed in a cardboard box.

Marketing authorization holder

Pierre Fabre Medicament
Les Cauquillous
81500 Lavaur
France
{logo of the marketing authorization holder}

Manufacturer

Pierre Fabre Médicament Production
Site Progipharm
Rue du Lycée
45500 Gien
France
To obtain more detailed information about this medicine, the patient should contact the representative of the marketing authorization holder:
Pierre Fabre Dermo-Cosmetique Polska Sp. z o.o.
ul. Belwederska 20/22
00-762 Warsaw
tel.: 22 559 63 60

Date of last revision of the leaflet: