Lorinden C

Package Leaflet: Information for the Patient

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

LORINDEN C

(0.2 mg + 30 mg)/g, ointment
Flumetasone pivalate+ Clioquinol

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

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

1. What is Lorinden C and what is it used for

Lorinden C ointment is a medicine for use on the skin, containing the active substances flumetasone pivalate and clioquinol.
Flumetasone pivalate is a moderately potent corticosteroid with anti-inflammatory, antipruritic, and vasoconstrictive properties when applied topically to the skin.
Clioquinol has antibacterial effects on some Gram-positive and Gram-negative bacteria.

Indications

Local treatment of dry inflammatory skin conditions, especially those of allergic origin, responding to corticosteroid therapy, complicated by bacterial infections and characterized by excessive scaling and persistent itching.
Lorinden C ointment is used especially in:

• seborrheic dermatitis,
• atopic dermatitis,
• nummular eczema,
• allergic contact dermatitis,
• polymorphic erythema,
• erythema multiforme,
• chronic psoriasis,
• lichen planus.

2. Important information before using Lorinden C

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When not to use Lorinden C

• if the patient is hypersensitive (allergic) to flumetasone pivalate, other corticosteroids, clioquinol, or any of the other ingredients of the medicine (listed in section 6),
• in viral (e.g., chickenpox, herpes simplex), fungal, or bacterial skin infections,
• in skin tumors,
• in acne vulgaris,
• in rosacea,
• in perioral dermatitis,
• in anal itching,
• in diaper rash,
• in venous leg ulcers,
• on extensive skin lesions, especially those with skin loss, e.g., in burns,
• in children under 2 years of age.

Warnings and precautions

Before starting treatment with Lorinden C, discuss it with your doctor, pharmacist, or nurse.

• If symptoms of irritation, hypersensitivity, or excessive dryness of the skin occur during treatment, stop using the medicine and consult a doctor.
• Do not use the medicine on a large skin surface, on wounds, on damaged skin, for a long time, or in large doses, as flumetasone pivalate can be absorbed through the skin, and there is a risk of systemic side effects, including adrenal suppression, decreased cortisol levels in the blood, and Cushing's syndrome.
• In case of skin infection at the treatment site, the doctor will prescribe appropriate antibacterial or antifungal treatment. If symptoms of infection persist, consult a doctor. The doctor will decide whether treatment should be discontinued until the infection is cured.
• If the patient experiences blurred vision or other visual disturbances, consult a doctor.
• Do not use the medicine on the eyelids or on the skin around the eyes, due to the risk of glaucoma or cataracts, and in patients with glaucoma or cataracts, as it may worsen the disease.
• Avoid contact of the medicine with the eyes and mucous membranes.
• On the face and in the axillary and groin areas, use only when absolutely necessary, due to increased absorption of corticosteroids through delicate skin and the associated increased risk of telangiectasia, perioral dermatitis, skin atrophy, even after short-term use.
• The use of the medicine under a tightly occlusive dressing should be limited to exceptional situations, as the dressing increases the absorption of corticosteroids into the body, and may cause skin atrophy, striae, and superinfections.
• Use with caution in atrophic conditions of the subcutaneous tissue, especially in the elderly.
• Use with special caution in patients with psoriasis, as local corticosteroid therapy in psoriasis can be hazardous for several reasons, including the risk of relapse caused by the development of tolerance, the risk of generalized pustular psoriasis, and general toxic effects caused by skin barrier disruption.

Children and adolescents

Use with caution in children over 2 years of age.
In children, due to the larger ratio of body surface area to body mass compared to adults, it is easier for them to experience side effects characteristic of corticosteroids, including growth and development disorders.
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Lorinden C and other medicines

Tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
No interactions are known to be associated with topical corticosteroid use.
During treatment, especially on a large skin surface, do not get vaccinated against smallpox. Do not get other vaccinations either.
Lorinden C may interfere with the effects of medicines that affect the immune system.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
Lorinden C may be used during pregnancy only on the advice of a doctor, for a short period, and on a small skin surface, when the doctor considers that the benefits of using the medicine for the mother outweigh the risks for the fetus.
Do not use the medicine during the first trimester of pregnancy.
Breastfeeding
The doctor will consider, taking into account the possibility of side effects in children and the benefits of treatment for the mother, whether the medicine can be used during breastfeeding.

Driving and using machines

Lorinden C does not affect the ability to drive or use machines.

3. How to use Lorinden C

Always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Do not use the medicine for longer than your doctor has told you.
The medicine is for use on the skin.
Usually, a small amount of the medicine is applied to the affected areas of the skin, no more than once or twice a day.
In cases of excessive lichenification or scaling of the affected skin, an occlusive dressing may be used, which should be changed every 24 hours.
Do not use the medicine for more than 2 weeks.
On the face, do not use the medicine for more than 7 days.
Within one week, no more than 1 tube (15 g) of ointment should be used.

Use in children and adolescents

Do not use in children under 2 years of age.
In children over 2 years of age, unless the doctor has prescribed otherwise, the medicine is usually used only once a day, on a small skin surface.
Do not use on the face.

Using more than the recommended dose of Lorinden C

Prolonged or incorrect use of the medicine, or use on large skin surfaces, may lead to growth and development disorders in children.
Overdose symptoms of flumetasone pivalate may occur, including edema, hypertension, increased blood glucose levels, glucosuria, and decreased immunity, and in severe cases, Cushing's syndrome.
In case of overdose, the doctor will provide appropriate treatment.

Missing a dose of Lorinden C

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Local side effects of unknown frequency (frequency cannot be estimated from available data):
Acne-like symptoms, perioral dermatitis, skin atrophy and subcutaneous tissue atrophy, dryness of the skin, excessive hair growth or hair loss, skin depigmentation or hyperpigmentation, skin atrophy and striae, telangiectasia, perioral dermatitis, folliculitis, secondary infections, skin irritation. Sometimes, urticaria or a papular rash may occur, or existing skin conditions may worsen.
Blurred vision.
When using the medicine on the eyelids, glaucoma or cataracts may occasionally occur.
Systemic side effects of unknown frequency (frequency cannot be estimated from available data):
Due to absorption of the medicine into the blood, systemic side effects may also occur.
These occur mainly in cases of prolonged use of the medicine, use on large skin surfaces, under occlusive dressings, or in children.
Systemic side effects of flumetasone pivalate are characteristic of corticosteroids, including adrenal suppression, Cushing's syndrome, growth and development disorders in children, hyperglycemia, glucosuria, edema, hypertension, and decreased immunity.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Medicinal Product Monitoring 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lorinden C

Do not store above 25°C.
Shelf life after first opening the tube: 30 days.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the month stated.
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 Lorinden C contains

• The active substances are flumetasone pivalate and clioquinol. 1 g of ointment contains 0.2 mg of flumetasone pivalate and 30 mg of clioquinol.
• The other ingredients are white wax and white petrolatum.

What Lorinden C looks like and contents of the pack

Lorinden C is a yellow or gray ointment.
The medicine is available in a 15 g aluminum tube, placed in a cardboard box.
For more detailed information, consult the marketing authorization holder or parallel importer.

Marketing authorization holder in Lithuania, the country of export:

PharmaSwiss Česká republika s.r.o.
Jankovcova 1569/2c
170 00 Prague 7
Czech Republic

Manufacturer:

Przedsiębiorstwo Farmaceutyczne Jelfa SA
ul. Wincentego Pola 21
58-500 Jelenia Góra
Poland

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
Lithuanian, the country of export, license number: LT/1/95/2259/001

Parallel import license number: 63/17 Date of approval of the leaflet: 23.02.2022

[Information about the trademark]
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