Package leaflet: Information for the patient

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

Keep this leaflet for future reference.
If you have any questions, consult your doctor or pharmacist.
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 identical.
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 A is and what it is used for
What you need to know before using Lorinden A
How to use Lorinden A
Possible side effects
How to store Lorinden A
Contents of the pack and other information

1. WHAT LORINDEN A IS AND WHAT IT IS USED FOR

Lorinden A is a topical medicine containing the active substances flumetasone pivalate and
salicylic acid.
Flumetasone pivalate is a corticosteroid with moderately potent anti-inflammatory action. When applied locally to the skin, it exerts anti-inflammatory, antipruritic (anti-itch), and vasoconstrictive effects.
Salicylic acid has mild keratolytic (peeling) action and facilitates penetration of flumetasone pivalate through the thickened stratum corneum.

Indications
Local treatment of dry inflammatory skin conditions, particularly those of allergic origin, uncomplicated by secondary bacterial infection, responsive to corticosteroid therapy, and associated with excessive keratosis and persistent itching.
The medicine is especially indicated in:

Seborrheic dermatitis,
Atopic dermatitis,
Lichen planus,
Allergic contact dermatitis,
Erythema multiforme,
Systemic lupus erythematosus,
Chronic psoriasis,
Lichen simplex.

2. IMPORTANT INFORMATION BEFORE USING LORINDEN A

When not to use Lorinden A

if the patient is allergic (hypersensitive) to flumethasone pivalate, other corticosteroids, salicylic acid, or any of the other ingredients of this medicine (listed in section 6),
in viral infections (e.g. chickenpox, cold sores), fungal or bacterial skin infections,
in skin cancers,
in acne vulgaris,
in rosacea,
in perioral dermatitis,
in perianal itching,
in diaper dermatitis,
in phlebitis or venous 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 using Lorinden A, discuss it with your doctor or pharmacist.

If irritation, allergy symptoms, 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, or for prolonged periods or in large amounts, because the active substances in this medicine—flumethasone pivalate and salicylic acid—are absorbed through the skin. Therefore, there is a risk of systemic adverse effects from corticosteroids (including suppression of adrenal cortex function, reduced blood cortisol levels, Cushing's syndrome) and from salicylic acid.
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 a doctor.
Do not apply the medicine to the eyelids or to skin around the eyes due to the risk of glaucoma or cataracts, and especially avoid use in patients with glaucoma or cataracts, as symptoms may worsen.
Avoid contact of the medicine with eyes and mucous membranes.
Use on the facial skin and in the axillary or groin areas only when absolutely necessary, due to increased absorption of corticosteroids through thin skin, which increases the risk of telangiectasia, perioral dermatitis, and skin atrophy, even after short-term use.
Application under occlusive dressings should be limited to exceptional circumstances, as such dressings enhance systemic absorption of corticosteroids, 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 corticosteroid use 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
Lorinden A 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, adverse effects typical of corticosteroids may occur more easily than in adults, including disturbances in growth and development.

Lorinden A and other medicines
Inform your doctor or pharmacist about all medicines you are currently using, have recently used, or plan to use.
No interactions are known with topical corticosteroids.
During treatment with this medicine, especially when applied over large skin areas, do not get vaccinated against chickenpox. Do not receive any other vaccinations.
Lorinden A may interfere with the action of immunosuppressive medicines.
With prolonged use over large skin areas, systemic absorption of salicylic acid may enhance the effects of methotrexate and oral sulfonylurea antidiabetic drugs.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
Lorinden A may be used during pregnancy only on a doctor's prescription, for short durations and over 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
During breastfeeding, the doctor will decide whether to discontinue breastfeeding or the use of the medicine, taking into account the risk of adverse effects in the infant and the benefits of treatment for the mother.

Driving and using machines
Lorinden A has no effect or has a negligible effect on the ability to drive and operate machinery.

Lorinden A contains propylene glycol
The medicine contains 50 mg of propylene glycol in 1 g of ointment.
Propylene glycol may cause skin irritation.

Lorinden A contains lanolin
The medicine may cause local skin reactions (e.g. contact dermatitis).

3. HOW TO USE THE MEDICINAL PRODUCT LORINDEN A

This medicine should always be used exactly as prescribed by your doctor. In case of doubt, consult your doctor. Do not use the medicine for longer than recommended by your doctor.
This medicine is intended for topical application on the skin.
Usually, a small amount of the medicine should be applied to the affected areas of the skin, no more frequently than once or twice daily.
In cases of marked lichenification or marked hyperkeratosis of the diseased skin, occlusive dressings may be used, which should be changed every 24 hours.
Do not use the medicine for longer than 2 weeks.
On 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 only once daily and only to a small skin area. Do not apply to the face.

Use of a higher than recommended dose of Lorinden A
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 flumetasone pivalate overdose may occur, such as edema, hypertension, increased blood glucose levels, glycosuria, reduced immunity, and in severe cases, Cushing's syndrome.
Salicylate intoxication symptoms may rarely occur.
In case of overdose, the doctor will initiate appropriate treatment.

Missed dose of Lorinden A
Do not apply a double dose to make up for a missed dose.

Discontinuation of Lorinden A
If you have any further questions regarding the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Local adverse reactions with 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 discoloration, skin atrophy and striae, dilation of small blood vessels, perioral dermatitis, folliculitis, striae, secondary infections, skin irritation. Occasionally urticaria or maculopapular rash may occur, or exacerbation of existing skin lesions.
Due to the presence of salicylic acid, prolonged use of the medicine may lead to skin inflammation.
Blurred vision.
When the medicine is applied to the skin of the eyelids, glaucoma or cataract may occasionally occur.

Systemic adverse reactions with unknown frequency (frequency cannot be determined from available data):
Systemic adverse reactions of pivaloyloxyflumetasone and salicylic acid may also occur due to absorption of the medicine into the bloodstream.
These occur primarily during prolonged use, application over large areas of skin, use under occlusive dressings, or use in children.
Systemic adverse effects of pivaloyloxyflumetasone typical of corticosteroids include, among others: suppression of the hypothalamic–pituitary–adrenal axis, Cushing's syndrome, growth and developmental retardation in children, increased blood glucose levels, glycosuria, edema, hypertension, and reduced immunity.

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 of the 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 reactions helps to provide more information on the safety of the medicine.

5. HOW TO STORE LORINDEN A

Do not store at temperatures above 25°C.
Shelf life after first opening of the tube – 2 months.
Keep the medicine out of sight and reach of children.
To pierce the seal at first opening of the tube, use the piercing device located in the cap.
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 must 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.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Lorinden A contains

The active substances in Lorinden A are flumetasone pivalate and salicylic acid. One gram of the ointment contains 0.2 mg of flumetasone pivalate and 30 mg of salicylic acid.
Other components: propylene glycol, white soft paraffin, lanolin.

What Lorinden A looks like and contents of the pack
Lorinden A is a white or pale yellow, oily ointment.
The medicinal product is packed in a lacquered aluminum tube with a protective membrane, fitted with a cap made of HDPE, containing 15 g of ointment, placed in a cardboard carton.
For further information, please contact the responsible party or the parallel importer:
Marketing Authorisation Holder in Lithuania, country of export:
Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland
Manufacturer:
Przedsiębiorstwo Farmaceutyczne Jelfa 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 Authorisation number in Lithuania, country of export: LT/1/96/3170/001
Parallel Import Licence number: 93/16