Package leaflet: Information for the user

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

Keep this leaflet, as you may need to read it again.
If you have any doubts, please consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm another person, even if their symptoms are the same.
If you experience any adverse effects, 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 clioquinol.
Flumetasone pivalate is a corticosteroid with moderately potent anti-inflammatory action. 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 of allergic origin, responsive to corticosteroid therapy, complicated by bacterial infections and associated with excessive keratosis and persistent itching.
Lorinden C ointment is especially used in:

Seborrheic dermatitis,
Atopic dermatitis,
Lichen urticatus,
Allergic contact dermatitis,
Erythema multiforme,
Lupus erythematosus,
Chronic psoriasis,
Lichen planus.

2. Important information before using Lorinden C

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 this medicine (listed in section 6),
in viral (e.g. chickenpox, herpes simplex), fungal or bacterial skin infections,
in skin tumours,
in acne vulgaris,
in rosacea,
in perioral dermatitis,
in perianal pruritus,
in diaper dermatitis,
in venous inflammatory conditions or venous 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 C, discuss it with your doctor, pharmacist, or nurse.

If symptoms of irritation, allergy, or excessive skin dryness occur during treatment, discontinue use immediately and contact your doctor.
Do not apply the medicine over large areas of skin, on wounds, or on damaged skin, nor for prolonged periods or in high doses, because flumetasone pivalate may be absorbed through the skin and there is a risk of systemic adverse effects, including suppression of adrenal cortex function, decreased blood cortisol levels, and Cushing's syndrome.
If a skin infection develops at the treated site, your 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 has resolved.
If the patient experiences blurred vision or other visual disturbances, contact your doctor.
Do not apply the medicine to the eyelids or 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 facial skin, as well as in the axillary and groin areas, only when absolutely necessary, due to increased absorption of corticosteroid through delicate skin, which increases the risk of capillary dilation, perioral dermatitis, and skin atrophy, even after short-term use.
Use under occlusive dressings should be limited to exceptional circumstances, as occlusion enhances corticosteroid absorption into the body. In addition, epidermal atrophy, striae, and secondary infections may occur.
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 may be hazardous in psoriasis 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 may occur more easily than in adults, including disturbances in growth and development.

Lorinden C and other medicines
Inform your doctor 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 with topical corticosteroids.
During treatment with this medicine, especially when applied to large skin areas, do not get vaccinated against smallpox. Other vaccinations should also be avoided.
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 advice, for short periods and on small skin areas, when the doctor considers that benefits to the mother outweigh the risks to the fetus.
The medicine must not be used during the first trimester of pregnancy.

Breastfeeding
The doctor will consider the potential for adverse effects in infants and the benefits of treatment for the mother when deciding whether Lorinden C can be used during breastfeeding.

Driving and operating machinery
Lorinden C has no effect on the ability to drive or operate machinery.

3. How to use Lorinden C

This medicine should always be used exactly as directed by the physician. In case of doubt, consult
your doctor or pharmacist.
Do not use the medicine longer than prescribed by your doctor.
This medicine is intended for topical use only.
Usually, a small amount of the medicine should be applied to the affected skin areas no more than
once or twice daily.
In cases of extensive lichenification or excessive keratosis of the diseased skin, use of an occlusive
dressing is permitted, which should be changed every 24 hours.
Do not use the medicine for longer than 2 weeks.
Do not use on the facial skin 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 physician, the medicine is usually
applied once daily to a small skin area only.
Do not use on the face.
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
inhibition of growth and development in children.
Symptoms of flumetasone pivalate overdose may occur, including edema, hypertension, increased
blood glucose concentration, glycosuria, reduced immunity, and in severe cases, Cushing's syndrome.
In case of overdose, the physician will initiate appropriate treatment.
Missed dose of Lorinden C
Do not apply 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 with unknown frequency (frequency cannot be determined from available data):
Acneiform eruptions, steroid 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 exacerbation of existing skin lesions.
Blurred vision.
When the medicine is applied to the eyelid skin, glaucoma or cataract may occasionally occur.

Systemic adverse effects with unknown frequency (frequency cannot be determined from available data):
As a result of systemic absorption, systemic adverse effects may also occur. These occur primarily during prolonged use, application over large areas of skin, under occlusive dressings, or when used in children.
Systemic adverse effects of flumetasone pivalate are typical of corticosteroids and include suppression of the hypothalamic-pituitary-adrenal (HPA) axis, Cushing's syndrome, growth and development retardation in children, increased blood glucose levels, glycosuria, edema, 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 any 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 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.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Lorinden C

Store below 25°C.
Keep the medicine out of the sight and reach of children.
Do not use the 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 properly dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Lorinden C contains
The active substances in Lorinden C are flumetasone pivalate and clioquinol.
1 g of ointment contains 0.2 mg of flumetasone pivalate and 30 mg of clioquinol.
Other components: white wax, white soft paraffin.

What Lorinden C looks like and contents of the pack
Lorinden C is a yellowish or greyish ointment.
The available packaging is an aluminum tube with a membrane, internally lacquered, with a screw cap,
containing 15 g of ointment, placed in a cardboard box.
For further detailed information, please contact the responsible party or the parallel importer.

Marketing Authorisation Holder in Latvia, country of export:
PharmaSwiss Česká republika s.r.o.
Jankovcova 1569/2c
170 00 Prague 7, Czech Republic

Manufacturer:
Jelfa S.A. Pharmaceutical Company
ul. Wincentego Pola 21
58-500 Jelenia Góra, Poland

Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw, Poland

Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland

Marketing Authorisation Number in Latvia, country of export: 97-0051
Parallel Import Authorisation Number: 75/22