Package leaflet: Information for the patient

Warning! Keep the 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 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 questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This 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 or pharmacist. See section 4.

Table of contents of the leaflet

What Lorinden A is and what it is used for.
Important information 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 ointment 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-itching), and vasoconstrictive effects.
Salicylic acid has mild keratolytic action and facilitates penetration of flumetasone pivalate through the hyperkeratotic epidermis.
Indications for use
Topical treatment of dry inflammatory skin conditions, particularly of allergic origin, not complicated by secondary bacterial infection, responsive to corticosteroid therapy, and associated with excessive keratosis and persistent pruritus.
The medicine is especially indicated in:

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

2. Important information before using Lorinden A

When not to use Lorinden A

if the patient is allergic (hypersensitive) to flumetasone pivalate, other corticosteroids, salicylic acid, 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 anal pruritus,
in diaper dermatitis,
in inflammatory or ulcerative phlebopathy,
in extensive skin lesions, particularly those associated with skin loss, such as burns,
in children under 2 years of age.

Warnings and precautions
Before starting treatment with Lorinden A, discuss it with your doctor or pharmacist.

If symptoms of irritation, allergy, or excessive skin drying occur 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, as the active substances of this medicine – flumetasone 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 in the treated area, 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 has resolved.
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 face, underarms, and groin areas only when absolutely necessary, due to increased absorption of corticosteroids through thin and sensitive skin, which increases the 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 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 corticosteroids may be dangerous in psoriasis for various reasons, including disease rebound due to tolerance development, risk of generalized pustular psoriasis, and systemic toxic effects due to 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 characteristic of corticosteroids – including disturbances in growth and development – may occur more easily than in adults.

Lorinden A and other medicines
Inform your doctor or pharmacist about any 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 to large skin areas, vaccination against smallpox should not be performed. Other vaccinations should also be avoided.
Lorinden A may interfere with the action of medicines affecting the immune system.
With prolonged use on 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 or 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 periods and on small skin areas, when the doctor considers that the benefits to the mother outweigh the risks to the fetus.
The medicine must not be used during the first trimester of pregnancy.

Breastfeeding
During breastfeeding, the doctor will decide whether breastfeeding or treatment with the medicine should be discontinued, taking into account the risk of adverse effects in infants and the benefits of treatment for the mother.

Driving and operating machinery
Lorinden A has no effect or 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 Lorinden A

This medicine should always be used as directed by the physician. In case of doubts, consult
your doctor. Do not use the medicine for longer than recommended by the doctor.
This medicine is intended for topical use on the skin.
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 extensive lichenification or extensive hyperkeratosis 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 area of skin. 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 areas of skin,
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, glycosuria, reduced immunity, and in
severe cases, Cushing's syndrome.
Rarely, salicylate intoxication symptoms may occur.
In case of overdose, the physician will administer appropriate treatment.
Missed dose of Lorinden A
Do not use a double dose to make up for a missed dose.
Discontinuation of Lorinden A
If you have any further questions about the use of this medicine, consult your
physician or pharmacist.

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):
Acneiform eruptions, steroid 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, 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 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 absorption of the medicine into the bloodstream, systemic adverse effects of flumetasone pivalate and salicylic acid may also occur.
These occur primarily during prolonged use, application over large skin areas, under occlusive dressings, or when used in children.
Systemic adverse effects of flumetasone pivalate typical of corticosteroids include, among others: suppression of the hypothalamic-pituitary-adrenal axis, Cushing's syndrome, growth and development retardation in children, elevated blood glucose levels, glycosuria, edema, hypertension, and decreased immunity.

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

5. How to store Lorinden A

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

6. Contents of the Package and Other Information

What Lorinden A Contains

The active substances in the medicine are flumetasone pivalate and salicylic acid. One gram of ointment contains 0.2 mg of flumetasone pivalate and 30 mg of salicylic acid.
Other ingredients: propylene glycol, white petrolatum, lanolin.

What Lorinden A Looks Like and Contents of the Pack
Lorinden A is a white ointment with a pale yellow tint.
The medicine is packed in an aluminum tube containing 15 g of ointment, placed in a cardboard box.
For further detailed information, please contact the marketing authorization holder or the parallel importer.
Marketing Authorization Holder in Lithuania, the country of export:
Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland
Manufacturer:
Przedsiębiorstwo Farmaceutyczne Jelfa
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 Authorization Number in Lithuania, the country of export: LT/1/96/3170/001
Parallel Import Authorization Number: 267/19