PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep this leaflet, information on the immediate packaging in a foreign language!
Lorinden C
(0.2 mg + 30 mg)/g, ointment
Flumetasone pivalate + Clioquinol
Please read this 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, ask 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 others, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Leaflet 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 activity. When applied topically to the skin, it exerts anti-inflammatory, antipruritic (anti-itch), and vasoconstrictive effects.
Clioquinol has antibacterial activity against certain Gram-positive and Gram-negative bacteria, as well as weak antifungal activity.
Indications
Local treatment of dry inflammatory skin conditions, particularly those of allergic origin, responsive to corticosteroid therapy, complicated by bacterial infection and associated with excessive keratosis and persistent itching.
Lorinden C is especially 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

When not to use Lorinden C

if the patient is allergic to flumetasone pivalate, other corticosteroids, clioquinol, or any of the other ingredients of the medicine (listed in section 6),
in viral (e.g. chickenpox, herpes simplex), fungal, or bacterial (e.g. tuberculosis) skin infections,
in skin cancers,
in acne vulgaris,
in rosacea,
in perioral dermatitis,
in anal pruritus,
in diaper dermatitis,
in phlebitis or venous ulceration,
on extensive skin lesions, particularly those associated with skin loss, such as burns,
in children under 2 years of age,
during the first trimester of pregnancy.

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 use the medicine continuously for longer than 2 weeks. Prolonged use over large skin areas may increase the frequency of adverse effects, including suppression of adrenal cortex function, reduced blood cortisol levels, and Cushing's syndrome. Your doctor may recommend periodic health monitoring. Avoid using this medicine on wounds, damaged skin, or in large amounts.
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. Your 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.
Avoid contact with eyes and mucous membranes. Avoid application to the eyelids or skin around the eyes in patients with narrow- or wide-angle glaucoma or cataracts, due to the risk of worsening disease symptoms.
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, perioral dermatitis, and skin atrophy, even with short-term use.
Use under occlusive dressings should be limited to exceptional circumstances, as such dressings enhance systemic absorption of corticosteroids. 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 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 a higher body surface area to body weight ratio compared to adults, suppression of the hypothalamic-pituitary-adrenal axis, Cushing's syndrome, and other corticosteroid-related adverse effects, including disturbances in growth and development, may occur more easily than in adults.
There is a risk of neurotoxic effects of clioquinol, particularly when the medicine is used long-term or under occlusive dressings.

Lorinden C and other medicines
Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.
No interactions are known with topical corticosteroids.
Lorinden C may interfere with the action of medicines affecting the immune system.

Pregnancy, breastfeeding, and 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 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 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.

Fertility
The effect of flumetasone pivalate on fertility has not been studied; however, effects on fertility have been reported for other corticosteroids.

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

3. How to use Lorinden C

This medicine should always be used as directed by the physician. If in doubt, consult a doctor or pharmacist.
Do not use the medicine for a longer period than recommended by the doctor.
This medicine is intended for topical use on the skin.
Usually, a small amount of the medicine is applied in a thin layer to the affected skin areas, no more than once or twice daily.
In cases of severe lichenification or excessive keratosis of the diseased skin, an occlusive dressing may be used, 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 physician, the medicine is usually applied once daily to a small skin area only.
Do not use on the facial skin.

Use of a higher than recommended dose of Lorinden C
Prolonged or improper topical use of the medicine, or application over large skin areas, may lead to suppression of growth and development in children.
Symptoms of flumetasone pivalate overdose may occur, such as edema, hypertension, increased blood glucose concentration, glucosuria, 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 use a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
Local adverse reactions occurring not frequently (may occur in less than 1 in 100 patients):
Blurred vision.
Local adverse reactions with unknown frequency (frequency cannot be estimated from available data):
May occur: acne, steroid-induced purpura, epidermal and subcutaneous tissue atrophy, dry skin, excessive hair growth or alopecia, skin depigmentation or discoloration, skin atrophy and striae, dilation of small blood vessels, perioral dermatitis, folliculitis, secondary infections, skin irritation, inhibition of epidermal growth. Occasionally, urticaria or maculopapular rash may occur, or exacerbation of existing skin lesions.
When the medicine is applied to the eyelid skin, glaucoma or cataract may occasionally occur.
Systemic adverse reactions with unknown frequency (frequency cannot be estimated from available data):
Systemic adverse reactions may also occur due to absorption of the medicine into the bloodstream. These occur primarily during 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 hypothalamic–pituitary–adrenal (HPA) axis suppression, Cushing's syndrome, growth and development retardation in children, soft tissue atrophy, hyperglycemia, glycosuria, edema, arterial hypertension, decreased immunity, and neurotoxicity.
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions 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
Phone: 22 49-21-301
Fax: 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Lorinden C

Do not store above 25°C.
Keep the medicine in a place inaccessible and out of sight 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 month indicated.
Usable period after first opening of the tube – 30 days.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What Lorinden C contains

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

What Lorinden C looks like and contents of the pack
Lorinden C is a yellowish or greyish ointment.
The available pack is an aluminium tube internally coated with epoxy resin, fitted with a cap made of HDPE, containing 15 g of ointment, placed in a cardboard box.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Lithuania, country of export:
PharmaSwiss Česká republika s.r.o.
Jankovcova 1569/2c
170 00 Prague 7
Czech Republic
Manufacturer:
Pharmaceutical Works JELFA SA
ul. Wincentego Pola 21
58-500 Jelenia Góra
Poland
Parallel importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorisation number in Lithuania, country of export: LT/1/95/2259/001
Parallel import authorisation number: 339/20