Lorinden A

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Lorinden A

(0.2 mg + 30 mg)/g, ointment
Flumetasoni pivalas + Acidum salicylicum

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Lorinden A and what is it used for.
• 2. Important information before using Lorinden A.
• 3. How to use Lorinden A.
• 4. Possible side effects.
• 5. How to store Lorinden A.
• 6. Contents of the packaging and other information.

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

Lorinden A is a medicine in the form of an ointment for application to the skin, containing the active substances flumetazoni pivalas and salicylic acid.
Flumetazoni pivalas is a medicine from the group of corticosteroids with moderate anti-inflammatory action, used locally on the skin, it has anti-inflammatory, antipruritic and vasoconstrictive effects.
Salicylic acid has a mild keratolytic effect and facilitates the penetration of flumetazoni pivalas through the hyperkeratotic epidermis.

Indications for use

Local treatment of dry inflammatory skin conditions, especially those of allergic origin, not complicated by secondary bacterial infection, responding to corticosteroid treatment, with excessive keratinization and persistent itching.
The medicine is used especially in:

• seborrheic dermatitis,
• atopic dermatitis,
• lichen planus,
• allergic contact dermatitis,
• polymorphic erythema,
• erythema multiforme,
• chronic psoriasis,
• lichen planus.

2. Important information before using Lorinden A

When not to use Lorinden A

• if the patient is hypersensitive (allergic) to flumetazoni pivalas, other corticosteroids, salicylic acid or any of the other ingredients of this medicine (listed in section 6),
• 6),
• in viral (e.g. chickenpox, herpes simplex), fungal or bacterial skin infections,
• in skin tumors,
• in common acne,
• in rosacea,
• in perioral dermatitis,
• in anal itching,
• in diaper dermatitis,
• in venous leg ulcers,
• on extensive skin lesions, especially those with skin loss, e.g. in burns,
• in children under 2 years of age.

Warnings and precautions

Before starting to use Lorinden A, you should discuss it with your doctor or pharmacist.

• If symptoms of irritation, hypersensitivity or excessive drying of the skin occur during use, you should stop using the medicine immediately and contact your doctor.
• The medicine should not be used on large areas of skin, on wounds, on damaged skin, for a long time or in large doses, because the active substances of this medicine - flumetazoni pivalas and salicylic acid - are absorbed through the skin. Therefore, during use, there is a risk of systemic side effects of corticosteroids (including adrenal suppression, decreased cortisol levels in the blood, Cushing's syndrome) and salicylic acid.
• In the event of a skin infection at the treatment site, the doctor will use appropriate antibacterial or antifungal treatment. If the symptoms of the infection persist, you should contact your doctor. The doctor will decide whether the treatment should be discontinued until the infection is cured.
• If the patient experiences blurred vision or other vision disturbances, they should contact their doctor.
• The medicine should not be used on the eyelids or on the skin around the eyes, due to the risk of glaucoma or cataracts, and in people with glaucoma or cataracts, as it may worsen the symptoms of the disease.
• Avoid contact of the medicine with the eyes and mucous membranes.
• On the skin of the face and in the armpits and groin, use only in cases where it is absolutely necessary, due to increased absorption of corticosteroids through delicate skin and the associated increased risk of widening of small blood vessels and perioral dermatitis, skin atrophy, even after short-term use.
• The use of the medicine under a tightly sealing dressing should be limited to exceptional situations, as the dressing increases the absorption of corticosteroids into the body, and skin atrophy, stretch marks and superinfections may occur.
• Use with caution in atrophic conditions of the subcutaneous tissue, especially in the elderly.
• Use with special caution in patients with psoriasis, as local use of corticosteroids in psoriasis can be dangerous for many reasons, including the risk of relapse of the disease caused by the development of tolerance, the risk of generalized pustular psoriasis and general toxic effects caused by skin discontinuity.

Children and adolescents

Lorinden A should be used with caution in children over 2 years of age.
In children, due to the greater ratio of body surface area to body mass than in adults, it is easier for side effects characteristic of corticosteroids to occur, including growth and development disorders.

Lorinden A and other medicines

You should tell your doctor or pharmacist about all medicines that the patient is currently taking or has recently taken, as well as any medicines that the patient plans to take.
No interactions are known to be associated with the local use of corticosteroids.
During use, especially on a large area of skin, you should not be vaccinated against smallpox. You should not undergo other vaccinations either.
Lorinden A may interfere with the action of medicines that affect the immune system.
In the case of long-term use of the medicine on large areas of skin, due to the absorption of salicylic acid into the body, the action of methotrexate, oral antidiabetic sulfonylurea derivatives may be enhanced.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects that she may be pregnant or plans to have a child, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
Lorinden A may be used during pregnancy only on the advice of a doctor, for a short period and on a small area of skin, when the doctor considers that the benefits of using the medicine for the mother outweigh the risk to the fetus.
Do not use the medicine during the first trimester of pregnancy.
Breastfeeding
During breastfeeding, the doctor will decide whether to stop breastfeeding or using the medicine, taking into account the risk of side effects in children and the benefits of treatment for the mother.

Driving and using machines

Lorinden A has no influence or negligible influence on the ability to drive and use machines.

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 your doctor. In case of doubts, you should consult your doctor. Do not use the medicine for longer than recommended by your doctor.
The medicine is intended for use on the skin.
Usually, a small amount of medicine is applied to the affected areas of skin, no more than once or twice a day.
In excessive lichenification or hyperkeratosis of the affected skin, the use of a tightly sealing dressing is allowed, which should be changed every 24 hours.
Do not use the medicine for more than 2 weeks.
On the skin of the face, do not use for more than 7 days. During one week, no more than 1 tube (15 g) of ointment can be used.

Use in children and adolescents

Do not use in children under 2 years of age.
In children over 2 years of age, unless the doctor recommends otherwise, the medicine is usually used only once a day, on a small area of skin. Do not use on the skin of the face.

Using more than the recommended dose of Lorinden A

Prolonged or improper local use of the medicine or use on large areas of skin may lead to growth and development disorders in children.
Overdose symptoms of flumetazoni pivalas may occur, including edema, hypertension, increased blood glucose levels, glucosuria, decreased immunity, and in severe cases, Cushing's syndrome.
Rarely, salicylate poisoning symptoms may occur.
In case of overdose, the doctor will use appropriate treatment.

Missing a dose of Lorinden A

You should not use a double dose to make up for a missed dose.

Stopping use of Lorinden A

In case of any further doubts about using this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Local side effects of unknown frequency (frequency cannot be determined from available data):
Acne-like symptoms, perioral dermatitis, skin atrophy and subcutaneous tissue, dryness of the skin, excessive hair growth or hair loss, skin discoloration or hyperpigmentation, skin atrophy and stretch marks, widening of small blood vessels, perioral dermatitis, folliculitis, stretch marks, secondary infections, skin irritation. Sometimes, urticaria or papular-pustular rash may occur, or worsening of existing skin lesions.
Due to the content of salicylic acid, during prolonged use of the medicine, skin irritation may occur.
Blurred vision.
When using the medicine on the skin of the eyelids, glaucoma or cataracts may occasionally occur.
Systemic side effects of unknown frequency (frequency cannot be determined from available data):
Due to the absorption of the medicine into the blood, systemic side effects of flumetazoni pivalas and salicylic acid may also occur.
They occur mainly in the case of prolonged use of the medicine, use on large areas of skin, under a sealing dressing (occlusive) or in the case of use in children.
Systemic side effects of flumetazoni pivalas characteristic of corticosteroids include adrenal suppression, Cushing's syndrome, growth and development disorders in children, increased blood glucose levels, glucosuria, edema, hypertension, decreased immunity.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Lorinden A

Do not store above 25°C.
The shelf life of the ointment after opening the tube is 2 months.
The medicine should be stored out of sight and reach of children.
Before opening the tube for the first time, use the puncture device 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 specified month.
Medicines should not be disposed of via wastewater or household waste containers. You should ask your pharmacist how to dispose of medicines that are no longer used. This will help protect the environment.

6. Contents of the packaging and other information

What Lorinden A contains

• The active substances of the medicine are flumetazoni pivalas and salicylic acid. 1 g of ointment contains 0.2 mg of flumetazoni pivalas and 30 mg of salicylic acid.
• The other ingredients are: propylene glycol, white petrolatum, lanolin.

What Lorinden A looks like and what the packaging contains

Lorinden A is a white ointment with a light yellow tint.
The packaging of the medicine is an aluminum tube containing 15 g of ointment, placed in a cardboard box.
To obtain more detailed information, you should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Lithuania, 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 by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorization number in Lithuania, country of export: LT/1/96/3170/001
Parallel import authorization number: 267/19

Date of leaflet approval: 10.07.2024

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