Lorinden n
Poland
Table of Contents
Package leaflet: Information for the patient
Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Lorinden N (Лоринден N), (0.2 mg + 5 mg)/g, cream
Flumetasone pivalate + Neomycin sulfate
Lorinden N and Лоринден N are the same brand names of the same medicinal product written in Polish and Bulgarian languages.
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.
- Keep this leaflet for possible future reference.
- If you have any doubts, consult your doctor, pharmacist, or nurse.
- This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are similar.
- If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
Table of contents
- What Lorinden N is and what it is used for
- Important information before using Lorinden N
- How to use Lorinden N
- Possible side effects
- How to store Lorinden N
- Contents of the pack and other information
1. What Lorinden N is and what it is used for
Lorinden N cream is a topical medicine containing the active substances flumetasone pivalate and neomycin sulfate.
Flumetasone pivalate is a synthetic corticosteroid with moderately potent anti-inflammatory activity. When applied locally to the skin, it exerts anti-inflammatory, antipruritic (anti-itch), and vasoconstrictive effects.
Neomycin sulfate is an aminoglycoside antibiotic; due to its toxicity, it is primarily intended for topical use. The drug is active against aerobic Gram-negative bacteria and some Gram-positive bacteria. Neomycin sulfate from the cream base may penetrate into deeper skin layers. With prolonged use over large skin areas, especially if the skin is damaged by disease, neomycin sulfate may be absorbed into the bloodstream.
Indications
Lorinden N cream is indicated for topical treatment of exuding inflammatory skin conditions (particularly of allergic origin) that respond to glucocorticoids and are complicated by secondary infection with bacteria sensitive to neomycin, as well as those associated with excessive keratinization and persistent itching.
Lorinden N is especially used in: seborrheic dermatitis, atopic dermatitis, lichen urticatus, allergic contact dermatitis, erythema multiforme, systemic lupus erythematosus, chronic psoriasis, and flat lichen (lichen planus).
2. Important information before using Lorinden N
When not to use Lorinden N
Page 1 of 6
- if the patient is allergic to the active substances (flumetasone pivalate, other corticosteroids, neomycin sulfate or other aminoglycoside antibiotics), or to any of the other ingredients of this medicine (listed in section 6),
- in viral (e.g. chickenpox, cold sores), fungal or bacterial (e.g. tuberculosis) skin infections,
- in skin tumours,
- in acne vulgaris,
- in rosacea,
- in perioral dermatitis,
- in anal pruritus,
- in phlebitis or varicose ulcers,
- on extensive skin lesions, especially those associated with skin loss, such as burns,
- in children under 2 years of age.
Warnings and precautions
Before starting treatment with Lorinden N, discuss this with your doctor or pharmacist.
If the patient experiences blurred vision or other visual disturbances, contact your doctor.
Do not use continuously for longer than 2 weeks.
If irritation symptoms or hypersensitivity reactions occur, discontinue use immediately and contact your doctor.
Corticosteroids are absorbed through the skin. Therefore, when using this medicine, there is a risk of systemic adverse effects of corticosteroids, including suppression of adrenal cortex function, reduced blood cortisol levels, and Cushing's syndrome. For this reason, avoid applying the medicine to large skin areas, wounds, or damaged skin, using high doses, or prolonged treatment.
If skin infection worsens or symptoms do not resolve, contact your doctor. The doctor will decide whether to discontinue the medicine and initiate appropriate antimicrobial treatment.
Avoid using the medicine on eyelids or skin around the eyes due to the risk of glaucoma or cataract, especially in patients with glaucoma or cataract, as symptoms may worsen.
Avoid contact of the medicine with eyes and mucous membranes.
Use on facial skin, underarms, and groin areas only when absolutely necessary, due to increased absorption of corticosteroids through delicate skin, which increases the risk of telangiectasia (dilation of small blood vessels), perioral dermatitis, and skin atrophy, even after short-term use.
Do not use under occlusive dressings (e.g. plaster, diaper), as occlusion enhances corticosteroid absorption into the body, and may lead to epidermal atrophy, striae, and superinfections.
Use with caution in conditions involving atrophy of subcutaneous tissue, especially in elderly patients.
Cross-allergy to aminoglycoside antibiotics may occur.
Use with particular caution in patients with psoriasis, as topical corticosteroids in psoriasis may be dangerous for several reasons, including disease relapse due to tolerance development, risk of generalized pustular psoriasis, and general toxic effects resulting from impaired skin integrity.
Due to the risk of neomycin absorption into the bloodstream, using the medicine on large skin areas, on damaged skin, or for prolonged periods may cause hearing damage, including hearing loss, and kidney damage. Patients with impaired kidney function or hearing impairment should use this medicine with particular caution.
The risk of neomycin-induced ototoxicity and nephrotoxicity is higher in patients with impaired kidney function.
The medicine may enhance the toxic effects on kidneys and hearing of other medicines taken simultaneously.
Prolonged use of the medicine may lead to proliferation of bacterial strains resistant to neomycin and to neomycin allergy.
Children and adolescents
Page 2 of 6
Lorinden N should be used with caution in children over 2 years of age.
In children, due to the higher body surface area to body weight ratio compared to adults, suppression of the hypothalamic-pituitary-adrenal axis and corticosteroid-related adverse effects, including growth and developmental disorders, may occur more easily than in adults.
Lorinden N 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 take.
No interactions are known related to topical corticosteroid use.
During treatment with this medicine, especially when applied to large skin areas, vaccination against smallpox should be avoided. Other vaccinations should also be avoided.
Lorinden N may interfere with the action of medicines affecting the immune system.
Do not use this medicine simultaneously with medicines that are toxic to the kidneys and hearing, such as furosemide or ethacrynic acid, as these drugs increase aminoglycoside antibiotic concentrations in the blood, thereby increasing the risk of hearing damage.
Pregnancy and breastfeeding and effect on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
Lorinden N may be used during pregnancy only on a doctor's prescription, for short periods and on small skin areas, when the doctor considers that the benefits to the mother outweigh the risks to the fetus.
The medicine must not be used during the first trimester of pregnancy.
Breastfeeding
During breastfeeding, the doctor will consider whether to discontinue breastfeeding or the use of the medicine, taking into account the risk of adverse effects in infants and the benefits of treatment for the mother.
If the medicine is used during breastfeeding, particular caution is required.
Driving and operating machinery
Lorinden N has no effect or negligible effect on the ability to drive motor vehicles and operate machinery.
Lorinden N contains:
- cetyl alcohol, which may cause local skin reactions, e.g. contact dermatitis,
- methyl parahydroxybenzoate and propyl parahydroxybenzoate, which may cause allergic reactions, including delayed-type reactions.
3. How to use Lorinden N
This medicine should always be used exactly as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
This medicine is for topical use on the skin.
The recommended dose is a small amount of the medicine applied to the affected areas of the skin,
no more frequently than once or twice daily.
Do not use the cream under occlusive dressings (sealed coverings such as plastic film or diapers).
Treatment should not be continued continuously for longer than 2 weeks.
On the face, do not use for longer than 7 days.
No more than 1 tube (15 g) of cream should be used in one week.
Page 3 of 6
Use in children and adolescents
Do not use in children under 2 years of age.
In children over 2 years of age, use with extreme caution and only when absolutely necessary. The medicine should be applied once daily to a small area of skin only. Do not use on the face.
Use of a higher than recommended dose of Lorinden N
If symptoms of overdose occur, contact a doctor.
Prolonged or improper topical use of the medicine, or use over large areas of skin, may lead to suppression of the hypothalamic-pituitary-adrenal (HPA) axis, growth retardation, and impaired development in children.
Symptoms of flumetasone pivalate overdose may occur, including edema, hypertension, increased blood glucose, glucosuria, reduced immunity, and in severe cases, Cushing's syndrome.
Excessive or prolonged topical use of the medicine due to its neomycin content may lead to the development of resistant bacterial strains, as well as hearing and kidney damage.
Missed dose of Lorinden N
Do not use a double dose to make up for a missed dose.
Stopping treatment with Lorinden N
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Local adverse effects with unknown frequency (frequency cannot be determined from the available data):
Acneiform eruptions, steroid-induced purpura, epidermal and subcutaneous tissue atrophy, dry skin, excessive hair growth or alopecia, skin depigmentation or hyperpigmentation, skin atrophy and striae, telangiectasia, perioral dermatitis, folliculitis, striae, secondary infection, skin irritation, local skin reactions (e.g. contact dermatitis), allergic reactions (including delayed-type reactions) may occur.
Occasionally, urticaria or maculopapular rash may occur, or existing skin lesions may worsen.
Blurred vision.
When the medicine is applied to the eyelids, glaucoma or cataract may occasionally occur.
Systemic adverse effects with unknown frequency (frequency cannot be determined from the available data):
Due to absorption of the medicine into the bloodstream, systemic adverse effects of flumetasone pivalate may also occur. These occur primarily with prolonged use of the medicine, application over a large skin surface area, use under occlusive dressings, or use in children.
Systemic adverse effects of flumetasone pivalate typical of corticosteroids include, among others, suppression of the hypothalamic-pituitary-adrenal axis, Cushing's syndrome, hyperglycemia, glycosuria, edema, hypertension, decreased resistance to infections, and growth and development suppression in children.
Due to the presence of neomycin in the medicine, local skin irritation and allergic reactions may occur. When the medicine is applied over large skin surface areas, on damaged skin, or under occlusive dressings, it may cause ototoxic effects, including hearing loss, and may lead to kidney damage.
Page 4 of 6
Additional adverse effects in children and adolescents with unknown frequency (frequency cannot be determined from the available data):
Systemic adverse effects in children may include suppression of growth and development.
If any adverse effects occur, including any possible adverse effects not listed in this leaflet, consult a doctor, pharmacist, or nurse.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse effects helps to provide more information on the safety of the medicine.
5. How to store Lorinden N
Store below 25°C. Do not freeze.
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 stated month.
Period of use after first opening of the tube: 30 days.
Medicines should not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such practices help protect the environment.
6. Contents of the pack and other information
What Lorinden N contains
- The active substances in this medicine are flumetasone pivalate and neomycin sulfate. Each 1 g of cream contains 0.2 mg flumetasone pivalate and 5 mg neomycin sulfate.
- The other ingredients of the medicine are: sorbitan stearate, polysorbate 60, cetyl alcohol, stearic acid, liquid paraffin, isopropyl palmitate, liquid sorbitol, crystallizing, methyl parahydroxybenzoate, propyl parahydroxybenzoate, purified water.
What Lorinden N looks like and contents of the pack
Lorinden N is a white or almost white, homogeneous emulsion mass.
The medicine is available in an aluminium tube with a membrane, internally coated with lacquer, fitted with a cap made of HDPE, containing 15 g of cream, placed in a cardboard box.
For additional information, please contact the responsible party or parallel importer.
Marketing Authorization Holder in Bulgaria, country of export:
Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Page 5 of 6
Dublin 24, D24PPT3
Ireland
Manufacturer:
Jelfa Pharmaceutical Company 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
Repacked in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing Authorization number in Bulgaria, country of export: 20000025
Parallel import license number: 144/25
Page 6 of 6