Package leaflet: Information for the patient

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.
LORINDEN C
(0.2 mg + 30 mg)/g, ointment
Flumetasone pivalate + Clioquinol
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any questions, please consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

What Lorinden C is and what it is used for
Important information before using Lorinden C
How to use Lorinden C
Possible side effects
How to store Lorinden C
Contents of the pack and other information

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

Lorinden C ointment is a topical medicine containing the active substances flumetasone pivalate and cliоquinol.
Flumetasone pivalate is a corticosteroid with moderately potent anti-inflammatory activity. When applied locally to the skin, it exerts anti-inflammatory, antipruritic, and vasoconstrictive effects.
Clioquinol is an agent with antibacterial activity against certain Gram-positive and Gram-negative bacteria.
Indications
Local treatment of dry inflammatory skin conditions, particularly those of allergic origin, responsive to corticosteroid therapy, complicated by bacterial infections, and associated with excessive keratinization and persistent pruritus.
Lorinden C ointment is particularly indicated in:

Seborrheic dermatitis,
Atopic dermatitis,
Lichen urticatus,
Allergic contact dermatitis,
Erythema multiforme,
Discoid lupus erythematosus,
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 allergic (hypersensitive) to flumetasone pivalate, other corticosteroids, clioquinol, or any of the other ingredients of the medicine (listed in section 6),
in viral (e.g. chickenpox, cold sores), fungal, or bacterial skin infections,
in skin tumours,
in acne vulgaris,
in rosacea,
in perioral dermatitis,
in perianal pruritus,
in diaper dermatitis,
in venous inflammation or ulceration,
on extensive skin lesions, especially those associated with skin loss, e.g. burns,
in children under 2 years of age.

Warnings and precautions
Before starting to use Lorinden C, discuss it with your doctor, pharmacist, or nurse.

If irritation, allergy, or excessive skin dryness occurs during treatment, discontinue use immediately and contact your doctor.
Do not use the medicine on large areas of skin, on wounds, on damaged skin, for prolonged periods, or in high doses, because flumetasone pivalate is absorbed through the skin and there is a risk of systemic adverse effects: including suppression of adrenal cortex function, reduced blood cortisol levels, and Cushing's syndrome.
If a skin infection develops at the treated site, the doctor will initiate appropriate antibacterial or antifungal treatment. If signs of infection persist, contact your doctor. The doctor will decide whether treatment should be discontinued until the infection resolves.
If the patient experiences blurred vision or other visual disturbances, contact your doctor.
Do not apply the medicine to the eyelids or to the skin around the eyes due to the risk of glaucoma or cataract, and avoid use in patients with glaucoma or cataract, as symptoms may worsen.
Avoid contact of the medicine with eyes and mucous membranes.
Use on the facial skin and on skin of the armpits and groin only when absolutely necessary, due to increased absorption of corticosteroid through delicate skin and the associated increased risk of telangiectasia, perioral dermatitis, and skin atrophy, even after short-term use.
Use under an occlusive dressing should be limited to exceptional circumstances, as such dressings enhance systemic absorption of the corticosteroid, and may additionally lead to epidermal atrophy, striae, and secondary infections.
Use with caution in conditions involving atrophy of subcutaneous tissue, especially in elderly patients.
Use with particular caution in patients with psoriasis, as topical corticosteroids in psoriasis may be hazardous for several reasons, including disease rebound due to development of tolerance, risk of generalized pustular psoriasis, and systemic toxic effects resulting from impaired skin integrity.

Children and adolescents
Use 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, adverse effects typical of corticosteroids, including disturbances in growth and development, may occur more easily than in adults.
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Lorinden C and other medicines
Inform your doctor about all medicines currently or recently taken, as well as any medicines the patient plans to take.
No interactions are known related to the topical use of corticosteroids.
During treatment with this medicine, especially when applied to large skin areas, do not get vaccinated against smallpox. Do not undergo other vaccinations either.
Lorinden C may interfere with the action of medicines affecting the immune system.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
Lorinden C may be used during pregnancy only on a doctor's prescription, for short periods and on small skin areas, when the doctor considers that benefits to the mother outweigh risks to the fetus.
The medicine must not be used during the first trimester of pregnancy.
Breastfeeding
The doctor will assess, considering the possibility of adverse effects in infants and the benefits of treatment for the mother, whether the medicine can be used during breastfeeding.
Driving and operating machinery
Lorinden C does not affect the ability to drive or operate machinery.

3. How to use Lorinden C

This medicine should always be used exactly as directed by the doctor. If in doubt, consult
your doctor or pharmacist.
Do not use the medicine for longer than recommended by the doctor.
This medicine is intended for topical use only.
Usually, a small amount of the medicine should be applied to the affected areas of the skin, no more than
once or twice daily.
In cases of marked lichenification or marked hyperkeratosis of the affected skin,
the use of an occlusive dressing may be permitted, which should be changed every 24 hours.
Do not use the medicine for longer than 2 weeks.
On the facial skin, do not use for longer than 7 days.
No more than 1 tube (15 g) of ointment should be used within one week.
Use in children and adolescents
Do not use in children under 2 years of age.
In children over 2 years of age, unless otherwise directed by a doctor, the medicine is usually applied
once daily and only to a small skin surface.
Do not apply to the facial skin.
Use of a higher than recommended dose of Lorinden C
Prolonged or improper topical use of the medicine, or use over large skin areas,
may lead to suppression of growth and development in children.
Symptoms of overdose with flumetasone pivalate may occur, such as edema,
hypertension, increased blood glucose concentration, glycosuria, decreased immunity,
and in severe cases, Cushing's syndrome.
In case of overdose, the doctor will initiate appropriate treatment.
Missed dose of Lorinden C
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Do not use a double dose to make up for a missed dose.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Local adverse effects of unknown frequency (frequency cannot be determined from available data):
Acne-like symptoms, steroid-induced purpura, epidermal and subcutaneous tissue atrophy, dry skin, excessive hair growth or hair loss, skin depigmentation or hyperpigmentation, skin atrophy and striae, dilation of small blood vessels, perioral dermatitis, folliculitis, secondary infections, skin irritation. Occasionally, urticaria or maculopapular rash may occur, or existing skin lesions may worsen.
Blurred vision.
When the medicine is applied to the eyelid skin, glaucoma or cataract may occasionally occur.

Systemic adverse effects of unknown frequency (frequency cannot be determined from available data):
As a result of systemic absorption, systemic adverse effects may also occur. These occur primarily with prolonged use, application over a large skin surface area, use under occlusive dressing, or use in children.
Systemic adverse effects of flumetasone pivalate are typical of corticosteroids and include suppression of the hypothalamic–pituitary–adrenal axis, Cushing's syndrome, growth and development suppression in children, increased blood glucose levels, glycosuria, oedema, hypertension, and decreased immunity.

If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse.
Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Lorinden C

Do not store above 25°C.
Period of use after first opening of the tube – 30 days.
Keep the medicine out of 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.
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.
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6. Contents of the package and other information

What Lorinden C contains

The active substances in the medicine are flumetasone pivalate and clioquinol. 1 g of the ointment contains 0.2 mg flumetasone pivalate and 30 mg clioquinol.
Other ingredients: white wax, white vaseline.

What Lorinden C looks like and contents of the pack
Lorinden C is a yellow or greyish ointment.
The medicine is available in an aluminum tube containing 15 g of ointment, packed in a cardboard box.
For more detailed information, please contact the responsible entity or parallel importer.
Responsible entity in Lithuania, country of export:
PharmaSwiss Česká republika s.r.o.
Jankovcova 1569/2c
170 00 Prague 7
Czech Republic
Manufacturer:
Jelfa Pharmaceutical Company 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 in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing authorization number in Lithuania, country of export: LT/1/95/2259/001
Parallel import authorization number: 63/17
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