Lorinden N

Package Leaflet: Information for the Patient

LORINDEN N, (0.2 mg + 5 mg)/g, cream
Flumetasoni pivalas + Neomycini sulfas

• This leaflet should be kept in case it needs to be read again.
• In case of any doubts, the doctor or pharmacist or nurse should be consulted.
• This medicine has been prescribed specifically for one person. It should not be given to others. The medicine may harm another person, even if their symptoms are the same.
• 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 Lorinden N cream and what is it used for
• 2. Important information before using Lorinden N cream
• 3. How to use Lorinden N cream
• 4. Possible side effects
• 5. How to store Lorinden N cream
• 6. Contents of the pack and other information

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

Lorinden N cream is a medicine for use on the skin, containing the active substances flumetasoni pivalas and neomycini sulfas.
Flumetasoni pivalas is a synthetic corticosteroid with moderate anti-inflammatory action.
When applied locally to the skin, it exhibits anti-inflammatory, antipruritic, and vasoconstrictive effects.
Neomycini sulfas is an aminoglycoside antibiotic, mainly intended for local use due to its toxicity.
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 skin surfaces, especially damaged skin, neomycini sulfas may be absorbed into the blood.

Indications for Use

Lorinden N cream is used locally in weeping inflammatory skin conditions (especially those with an allergic background), 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, papular urticaria, allergic contact dermatitis, erythema multiforme, lupus erythematosus, chronic psoriasis.

2. Important Information Before Using Lorinden N Cream

When Not to Use Lorinden N Cream

• if the patient is allergic to the active substances (flumetasoni pivalas, other corticosteroids, neomycini sulfas, or other aminoglycoside antibiotics), or to any of the other ingredients of this medicine (listed in section 6),
• in viral (e.g., chickenpox, common herpes), fungal, or bacterial (e.g., tuberculosis) skin infections,
• in skin tumors,
• in common acne,
• in rosacea,
• in dermatitis around the mouth,
• 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 cream, the doctor or pharmacist should be consulted.
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 the doctor should be 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 suppression, decreased cortisol levels in the blood, and Cushing's syndrome.
For this reason, the medicine should be avoided on large skin surfaces, wounds, damaged skin, and high doses, as well as long-term treatment with the medicine.
In case of worsening skin infection or if the symptoms of infection do not resolve, the doctor should be consulted.
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 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 symptoms of the disease.
Contact between the medicine and the eyes and mucous membranes should be avoided.
On the face skin and in the armpits and groin area, the medicine should be used only in cases of absolute necessity, due to increased absorption of corticosteroids through delicate skin and the associated increased risk of telangiectasia (enlargement of capillaries and arterioles), perioral dermatitis (skin inflammation around the mouth), and skin atrophy, even after short-term use.
The medicine should not be used under occlusive dressings (e.g., cerate, diaper), 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 elderly patients.
There may be cross-allergy to aminoglycoside antibiotics.
The medicine should be used with special caution in patients with psoriasis, as local use of corticosteroids in psoriasis 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 caused by skin discontinuity.
Due to the risk of neomycin absorption into the blood, the use of the medicine on large skin surfaces, 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 use the medicine with special caution.
The risk of neomycin-induced hearing and kidney damage is higher in patients with kidney function disorders.
The medicine may enhance the effect of concomitantly used nephrotoxic and ototoxic drugs.
Long-term use of the medicine may lead to the proliferation of neomycin-resistant bacterial strains and allergy to neomycin.

Children and Adolescents

Lorinden N should be used with caution in children over 2 years of age.
In children, due to the larger body surface area to body mass ratio compared to adults, it is easier to cause 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 doctor or pharmacist should be informed about all medicines currently or recently used by the patient, as well as any planned medicines.
No interactions are known to be associated with the local use of corticosteroids.
During the use of the medicine, especially on large skin surfaces, the patient should not be vaccinated against smallpox.
Lorinden N cream may interfere with the action of medicines that affect the immune system.
The medicine should not be used concomitantly with medicines that are toxic to the kidneys and hearing organ, 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, or 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 cream may be used during pregnancy only on the doctor's prescription, 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 risk to the fetus.
The medicine should not be used during 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, special caution should be exercised.

Driving and Using Machines

Lorinden N cream does not affect or has a negligible effect on the ability to drive vehicles or operate 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 Cream

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

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 caution, only in cases of absolute necessity.
The medicine is used only once a day, on a small skin surface.
The medicine should not be used on the face skin.

Use of a Larger Than Recommended Dose of Lorinden N Cream

If symptoms of overdose occur, the doctor should be consulted.
Prolonged or improper local use of the medicine or use on large skin surfaces may lead to suppression of the hypothalamic-pituitary-adrenal axis and growth and development disorders in children.
Overdose symptoms of flumetasoni pivalas may occur, including edema, hypertension, increased blood glucose levels, glucosuria, decreased immunity, and in severe cases, Cushing's syndrome.
Excessive or prolonged local 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.

Missed Use of Lorinden N Cream

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

Discontinuation of Lorinden N Cream

In case of any further doubts related to the use of this medicine, the doctor or pharmacist should be consulted.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Local side effects with unknown frequency (frequency cannot be determined 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 discoloration or hyperpigmentation, skin atrophy and striae, expansion of small blood vessels, perioral dermatitis, folliculitis, striae, secondary infection, skin irritation, local skin reaction (e.g., contact dermatitis), allergic reactions (including possible late-type reactions).
Sometimes, urticaria or papular rash may occur, or existing skin lesions may worsen.
Blurred vision.
When using the medicine on the eyelid skin, glaucoma or cataracts may occasionally occur.
Systemic side effects with unknown frequency (frequency cannot be determined from available data):
Due to the absorption of the medicine into the blood, systemic side effects of flumetasoni pivalas may also occur.
These occur mainly in the case of prolonged use of the medicine, use on large skin surfaces, under occlusive dressings, or in children.
Systemic side effects of flumetasoni pivalas characteristic of corticosteroids include suppression of the hypothalamic-pituitary-adrenal axis, Cushing's syndrome, increased blood glucose levels, glucosuria, edema, hypertension, decreased immunity, and growth and development disorders in children.
Due to the presence of neomycin in the medicine, local skin irritation and allergic reactions may occur.
The medicine used on large skin surfaces, on damaged skin, or under occlusive dressings may cause hearing damage, including hearing loss, and kidney damage.

Additional Side Effects in Children and Adolescents with Unknown Frequency (Frequency Cannot Be Determined from Available Data):

As systemic side effects in children, growth and development disorders may occur.
If any side effects occur, including those not listed in this leaflet, the doctor or pharmacist or nurse should be consulted.

Reporting Side Effects

If any side effects occur, including those not listed in this leaflet, the doctor or pharmacist or nurse should be informed.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jankovcova 1569/2c
170 00 Prague 7
Czech Republic
Phone: + 420 224 414 111
Fax: + 420 224 414 112
e-mail: [info@sukl.cz](mailto:info@sukl.cz)
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will allow for the collection of more information on the safety of the medicine.

5. How to Store Lorinden N Cream

Store 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 carton after "Expiry Date".
The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste.
The pharmacist should be asked how to dispose of unused medicines.
This will help protect the environment.

6. Contents of the Pack and Other Information

What Lorinden N Cream Contains

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

What Lorinden N Cream Looks Like and What the Pack Contains

Lorinden N is a white or almost white, uniform emulsion mass.
The medicine is available in a 15 g aluminum tube, placed in a cardboard box.

Marketing Authorization Holder:

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

Manufacturer:

Jelfa Pharmaceutical Works SA
ul. Wincentego Pola 21
58-500 Jelenia Góra

Date of Last Revision of the Leaflet: