Lorinden N

Leaflet attached to the packaging: patient information

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

Lorinden N (Лоринден N), (0.2 mg + 5 mg)/g, cream

Flumetasoni pivalas + Neomycini sulfas
Lorinden N and Лоринден N are the same trade names of the same drug written in Polish and Bulgarian.

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• The leaflet should be kept so that it can be read again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for one person. It should not be given to others. The medicine may harm another person, even if the symptoms of their disease are the same.
• If the patient experiences any side effects, including any side effects 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 N and what is it used for
• 2. Important information before using Lorinden N
• 3. How to use Lorinden N
• 4. Possible side effects
• 5. How to store Lorinden N
• 6. Contents of the packaging and other information

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

Lorinden N cream is a medicine for use on the skin, containing the active substances flumetazoni pivalas and neomycini sulfas.
Flumetazoni pivalas is a synthetic corticosteroid with moderate anti-inflammatory activity. When applied topically to the skin, it has anti-inflammatory, antipruritic, and vasoconstrictive effects.
Neomycini sulfas is an aminoglycoside antibiotic, which, due to its toxicity, is mainly intended for topical use. The drug acts on aerobic Gram-negative bacteria and some Gram-positive bacteria. Neomycini sulfas from the cream base may penetrate into the deeper layers of the skin. During prolonged use on large areas of skin, especially damaged skin, neomycini sulfas may be absorbed into the blood.

Indications for use

Lorinden N cream is used topically in weeping inflammatory skin conditions (especially of allergic origin), which respond to glucocorticosteroids and are complicated by secondary bacterial infections sensitive to neomycin, as well as those with excessive keratinization and persistent itching.
Lorinden N is used especially in: seborrheic dermatitis, atopic dermatitis, lichen planus, allergic contact dermatitis, polymorphic erythema, lupus erythematosus, chronic psoriasis.

2. Important information before using Lorinden N

When not to use Lorinden N

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• if the patient is allergic to the active substances (flumetazoni pivalas, other corticosteroids, neomycini sulfas, or other aminoglycoside antibiotics), or any of the other ingredients of this medicine (listed in section 6),
• in viral (e.g., chickenpox, herpes simplex), fungal, or bacterial (e.g., tuberculosis) skin infections,
• in skin tumors,
• in acne vulgaris,
• in rosacea,
• in perioral dermatitis,
• in anal itching,
• 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 to use Lorinden N, you should discuss it with your doctor or pharmacist.
If the patient experiences blurred vision or other visual disturbances, they should contact their doctor.
The medicine should not be used continuously for more than 2 weeks.
If signs of irritation or hypersensitivity reactions occur, the use of the medicine should be stopped immediately and a doctor consulted.
Corticosteroids are absorbed through the skin. Therefore, during the use of the medicine, there is a risk of systemic side effects of corticosteroids, including adrenal gland suppression, decreased cortisol levels in the blood, and Cushing's syndrome. For this reason, the medicine should be avoided on large areas of skin, wounds, damaged skin, and high doses, as well as long-term treatment with the medicine.
In the event of worsening skin infection or if the symptoms of infection do not subside, the patient should contact their doctor. The doctor will decide whether to discontinue the use of the medicine and apply appropriate antimicrobial treatment.
The medicine should be avoided on the eyelids or the skin around the eyelids, due to the risk of glaucoma or cataracts, and in patients with glaucoma or cataracts, as it may exacerbate the symptoms of the disease.
Contact with the medicine and mucous membranes should be avoided.
On the facial skin and the skin of the armpits and groin, the medicine should only be used in cases of absolute necessity, due to the increased absorption of corticosteroids through delicate skin and the associated increased risk of telangiectasia (dilation of blood vessels and capillaries), perioral dermatitis, and skin atrophy, even after short-term use.
The medicine should not be used under occlusive dressings (e.g., bandages, diapers), as the dressing increases the absorption of corticosteroids into the body, and skin atrophy, striae, and superinfections may occur.
The medicine should be used with caution in atrophic conditions of the subcutaneous tissue, especially in the elderly.
A cross-allergy to aminoglycoside antibiotics may occur.
Particular caution should be exercised in patients with psoriasis, as local use of corticosteroids in psoriasis can be hazardous for several 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 caused by skin barrier disruption.
Due to the risk of neomycin absorption into the blood, the use of the medicine on large areas of skin, on damaged skin, or for a long time may cause hearing damage, including hearing loss, and kidney damage. Patients with kidney function disorders or hearing impairment should be particularly cautious when using the medicine.
The risk of neomycin-induced hearing and kidney damage is higher in patients with kidney function disorders.
The medicine may enhance the effect of concurrently used medicines that are harmful to the kidneys and hearing.
Prolonged use of the medicine may lead to the proliferation of neomycin-resistant bacterial strains and allergy to neomycin.

Children and adolescents

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Lorinden N should be used with caution in children over 2 years of age.
In children, due to the greater ratio of body surface area to body mass compared to adults, it is easier for them to experience suppression of the hypothalamic-pituitary-adrenal axis and the occurrence of side effects characteristic of corticosteroids, including growth and development disorders.

Lorinden N and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
No interactions are known to be associated with topical use of corticosteroids.
During the use of the medicine, especially on large areas of skin, the patient should not be vaccinated against smallpox. Other vaccinations should not be performed either.
Lorinden N may interfere with the action of medicines that affect the immune system.
The medicine should not be used concurrently with medicines that are toxic to the kidneys and hearing, such as furosemide, ethacrynic acid, as these medicines increase the concentration of aminoglycoside antibiotics in the blood, increasing the risk of hearing damage.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Pregnancy
Lorinden N may be used during pregnancy only on the advice of a doctor, for a short period, and on a small area of skin, when the doctor considers that the benefits of using the medicine for the mother outweigh the risk to the fetus.
The medicine should not be used in the first trimester of pregnancy.
Breastfeeding
During breastfeeding, the doctor will consider whether to stop breastfeeding or using the medicine, taking into account the risk of side effects in children and the benefits of treatment for the mother.
When using the medicine during breastfeeding, particular caution should be exercised.

Driving and using machines

Lorinden N does not affect or has a negligible effect on the ability to drive and use machines.

What Lorinden N contains

• cetostearyl alcohol, may cause local skin reactions, e.g., contact dermatitis,
• methyl parahydroxybenzoate and propyl parahydroxybenzoate, may cause allergic reactions, including possible late-type reactions.

3. How to use Lorinden N

This medicine should always be used as directed by a doctor or pharmacist. In case of doubts, the patient should consult a doctor or pharmacist.
The medicine is intended for use on the skin.
The recommended dose is a small amount of medicine applied to the affected areas of skin, no more than once or twice a day.
The cream should not be used under occlusive dressings (e.g., bandages, diapers).
Treatment should not be continued without interruption for more than 2 weeks.
On the facial skin, the medicine should not be used for more than 7 days.
Within one week, no more than 1 tube (15 g) of cream should be used.
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Use in children and adolescents

The medicine should not be used in children under 2 years of age.
In children over 2 years of age, the medicine should be used with extreme caution, only in cases of absolute necessity. The medicine is used only once a day, on a small area of skin. The medicine should not be used on the facial skin.

Use of a higher than recommended dose of Lorinden N

If symptoms of overdose occur, the patient should contact their doctor.
Prolonged or improper topical use of the medicine or use on large areas of skin may lead to suppression of the hypothalamic-pituitary-adrenal axis, growth inhibition, and development disorders in children.
Overdose symptoms of flumetazoni pivalas may occur, including edema, hypertension, increased blood glucose levels, glucosuria, decreased immunity, and in severe cases, Cushing's syndrome.
Excessive or prolonged topical use of the medicine due to the presence of neomycin may lead to the development of resistant bacterial strains and damage to hearing and kidneys.

Missing a dose of Lorinden N

A double dose should not be used to make up for a missed dose.

Stopping the use of Lorinden N

In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

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 the available data):
Acne-like symptoms, perioral dermatitis, skin atrophy, and subcutaneous tissue atrophy, dryness of the skin, excessive hair growth or hair loss, skin discoloration or hyperpigmentation, skin atrophy, and striae, expansion of small blood vessels, perioral dermatitis, folliculitis, striae, secondary infections, skin irritation, local skin reactions (e.g., contact dermatitis), allergic reactions (including possible late-type reactions).
Urticaria or papulovesicular rash may occur, or existing skin lesions may worsen.
Blurred vision.
In the case of using the medicine on the eyelid skin, glaucoma or cataracts may occur.
Systemic side effects of unknown frequency (frequency cannot be estimated from the available data):
Due to the absorption of the medicine into the blood, systemic side effects of flumetazoni pivalas may also occur. These occur mainly in the case of prolonged use of the medicine, use on large areas of skin, under occlusive dressings, or in children.
Systemic side effects of flumetazoni pivalas characteristic of corticosteroids include adrenal gland suppression, Cushing's syndrome, increased blood glucose levels, glucosuria, edema, hypertension, decreased immunity, and growth inhibition in children.
Due to the presence of neomycin in the medicine, local skin irritation and allergic reactions may occur. The medicine used on large areas of skin, on damaged skin, or under occlusive dressings may cause hearing damage, including hearing loss, and kidney damage.
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Additional side effects in children and adolescents of unknown frequency (frequency cannot be estimated from the available data):

As systemic side effects in children, growth inhibition may occur.
If any side effects occur, including any side effects not listed in the leaflet, the patient should consult their doctor, pharmacist, or nurse.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
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, more information can be collected on the safety of the medicine.

5. How to store Lorinden N

Store in a temperature below 25°C. Do not freeze.
The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Shelf life after first opening the tube: 30 days.
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 packaging and other information

What Lorinden N contains

• The active substances of the medicine are flumetazoni pivalas and neomycini sulfas. 1 g of cream contains 0.2 mg of flumetazoni pivalas and 5 mg of neomycini sulfas.
• The other ingredients of the medicine are: sorbitan stearate, polysorbate 60, cetostearyl alcohol, stearic acid, liquid paraffin, isopropyl palmitate, sorbitol liquid crystallizing, methyl parahydroxybenzoate, propyl parahydroxybenzoate, purified water.

What Lorinden N looks like and what the packaging contains

Lorinden N is a white or almost white, uniform emulsion mass.
The available packaging of the medicine is an aluminum tube with a membrane, coated with a lacquer from the inside, with a HDPE cap, containing 15 g of cream, placed in a cardboard box.
For additional information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Bulgaria, the country of export:

Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
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Dublin 24, D24PPT3
Ireland

Manufacturer:

Przedsiębiorstwo Farmaceutyczne Jelfa S.A.
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
Marketing authorization number in Bulgaria, the country of export: 20000025

Parallel import authorization number: 144/25

Date of leaflet approval: 15.04.2025

[Information about the trademark]
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