Lorinden A

Package Leaflet: Information for the Patient

LORINDEN A, (0.2 mg + 30 mg)/g, Ointment

Flumetasoni pivalas + Acidum salicylicum

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 pack and other information

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

Lorinden A in the form of an ointment is a medicine for use on the skin, containing the active substances flumetasoni pivalas and salicylic acid.
Flumetasoni pivalas is a medicine from the group of corticosteroids with moderately strong anti-inflammatory action,
used locally on the skin, it shows anti-inflammatory, anti-itching and vasoconstrictive effects.
Salicylic acid has a weak peeling effect and facilitates the penetration of flumetasoni pivalas through excessively keratinized epidermis.

Indications for Use

Local treatment of dry inflammatory skin conditions, especially 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,
• nummular eczema,
• allergic contact dermatitis,
• polymorphic erythema,
• erythema multiforme,
• chronic psoriasis,
• flat lichen.

It is necessary to carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• The leaflet should be kept in order to be able to re-read it if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for this 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.

2. Important information before using Lorinden A

When not to use Lorinden A

• if the patient is allergic (hypersensitive) to flumetasoni pivalas, 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 tumors,
• in common acne,
• in rosacea,
• in perioral dermatitis,
• in anal itching,
• in diaper rash,
• 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 - flumetasoni pivalas and salicylic acid - are absorbed through the skin. Therefore, during use, there is a risk of systemic side effects of corticosteroids (including adrenal cortex 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 eyelids, due to the risk of glaucoma or cataracts, and in patients with glaucoma or cataracts, as it may worsen the symptoms of the disease.
• Eye contact and contact with mucous membranes should be avoided.
• On facial skin and in the axillary and groin areas, the medicine should be used only when 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.
• The medicine should be used with caution in atrophic conditions of the subcutaneous tissue, especially in the elderly.
• The medicine should be used 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

The doctor or pharmacist should be informed about all medicines that the patient is currently taking or has recently taken, as well as about medicines that the patient plans to take.
No interactions are known to be associated with the local use of corticosteroids.
During treatment, especially on a large skin surface, the patient should not be vaccinated against smallpox.
No other vaccinations should be performed.
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 skin surfaces, due to the absorption of salicylic acid into the body, the effect of methotrexate, oral antidiabetic drugs of the sulfonylurea type may be enhanced.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant or plans to have a child, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
Lorinden A may be used during pregnancy only on the doctor's prescription, for a short period and on a small skin surface, when the doctor considers that the benefits of using the medicine for the mother outweigh the risk to the fetus.
The medicine should not be used 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 the doctor. In case of doubts, the doctor should be consulted. The medicine should not be used for longer than prescribed by the doctor.
The medicine is intended for use on the skin.
Usually, a small amount of the medicine is applied to the affected areas of the skin, no more than once or twice a day.
In cases of excessive lichenification or excessive keratinization of the affected skin, the use of a tightly sealing dressing is allowed, which should be changed every 24 hours.
The medicine should not be used for more than 2 weeks.
On facial skin, the medicine should not be used 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

The medicine should not be used in children under 2 years of age.
In children over 2 years of age, unless the doctor has prescribed otherwise, the medicine is usually used only once a day, on a small skin surface. The medicine should not be used on facial skin.

Using a larger dose of Lorinden A than recommended

Long-term or improper local use of the medicine or use on large skin surfaces may lead to growth and development disorders in children.
Overdose symptoms of flumetasoni pivalas may occur, including edema, hypertension, increased glucose levels in the blood, 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

A double dose should not be used to make up for a missed dose.

Stopping the use of Lorinden A

In case of further doubts about the use of this medicine, the doctor or pharmacist should be consulted.

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 estimated from the available data):
Symptoms similar to acne, perioral dermatitis, skin atrophy and subcutaneous tissue atrophy, dry 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 a papular rash may occur, or existing skin lesions may worsen.
Due to the content of salicylic acid, during long-term use of the medicine, skin irritation may occur.
Blurred vision.
When using the medicine on the eyelids, glaucoma or cataracts may occasionally occur.
Systemic side effects of unknown frequency (frequency cannot be estimated from the available data):
Due to the absorption of the medicine into the blood, systemic side effects of flumetasoni pivalas and salicylic acid may also occur.
They occur mainly in the case of long-term use of the medicine, use on a large skin surface, under a sealing dressing (occlusive) or in the case of use in children.
Systemic side effects of flumetasoni pivalas characteristic of corticosteroids include adrenal cortex suppression, Cushing's syndrome, growth and development disorders in children, excessive blood sugar levels, glucosuria, edema, hypertension, decreased immunity.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Drug Safety Monitoring 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
Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information on the safety of the medicine can be collected.

5. How to store Lorinden A

Store at a temperature below 25°C.
The medicine should be stored out of sight and reach of children.
Before first opening the tube, use the puncture device located in the cap.
The medicine should not be used after the expiry date stated on the carton and tube.
The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Lorinden A contains

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

What Lorinden A looks like and contents of the pack

Lorinden A is a white ointment with a light yellow tint.
The medicine is available in an aluminum tube containing 15 g of ointment, placed in a cardboard box.

Marketing authorization holder

Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland

Manufacturer

Przedsiębiorstwo Farmaceutyczne Jelfa S.A.
ul. Wincentego Pola 21
58-500 Jelenia Góra

Date of last revision of the leaflet: