Lorinden C

Package Leaflet: Information for the Patient

LORINDEN C, (0.2 mg + 30 mg)/g ointment

Flumetasoni pivalas + Clioquinolum

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• -Keep this leaflet, you may need to read it again.
• -If you have any further questions, ask your doctor, pharmacist, or nurse.
• -This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• -If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Table of Contents of the Leaflet

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

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

Lorinden C is an ointment for use on the skin, containing the active substances flumetasoni pivalas and clioquinol.
Flumetasoni pivalas is a moderately potent corticosteroid with anti-inflammatory, antipruritic, and vasoconstrictive properties when applied topically to the skin.
Clioquinol has antibacterial effects against certain Gram-positive and Gram-negative bacteria and weak antifungal effects.

Indications for Use

Local treatment of dry inflammatory skin conditions, especially those of allergic origin, responding to corticosteroid treatment, complicated by bacterial infections and characterized by excessive scaling and persistent itching.
Lorinden C ointment is used particularly in:

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

2. Important Information Before Using Lorinden C

When Not to Use Lorinden C

• if you are allergic to flumetasoni pivalas, other corticosteroids, clioquinol, 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 (e.g., tuberculosis),
• in skin tumors,
• in acne vulgaris,
• 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,
• during the first trimester of pregnancy.

Warnings and Precautions

Before starting treatment with Lorinden C, discuss it with your doctor, pharmacist, or nurse.

• If you experience signs of irritation, hypersensitivity, or excessive skin dryness during treatment, stop using the medicine and consult your doctor.
• Do not use the medicine continuously for more than 2 weeks. Prolonged use on large areas of skin may increase the frequency of side effects, including suppression of adrenal function, decreased cortisol levels in the blood, and Cushing's syndrome. Your doctor may recommend periodic health checks. Avoid using this medicine on wounds, damaged skin, or in large doses.
• In case of skin infection at the treatment site, your doctor will prescribe appropriate antibacterial or antifungal treatment. If the symptoms of infection do not improve, consult your doctor. The doctor will decide whether treatment should be discontinued until the infection is cured.
• If you experience blurred vision or other visual disturbances, consult your doctor.
• Avoid contact of the medicine with the eyes and mucous membranes. Avoid applying the medicine to the eyelids or the skin around the eyes in patients with narrow-angle or wide-angle glaucoma and cataracts, as it may worsen the symptoms of the disease.
• On facial skin and skin of the armpits and groin, use only when absolutely necessary, due to increased absorption of corticosteroids through delicate skin and the associated increased risk of telangiectasia, perioral dermatitis, skin atrophy, even after short-term use.
• The use of the medicine under a tightly sealing bandage should be limited to exceptional situations, as the bandage enhances the absorption of corticosteroids into the body, and may cause skin atrophy, striae, and superinfections.
• Use with caution in atrophic conditions of the subcutaneous tissue, especially in the elderly.
• Use with particular caution in patients with psoriasis, as local corticosteroid treatment in psoriasis can be hazardous for several reasons, including the risk of relapse caused by the development of tolerance, the risk of generalized pustular psoriasis, and general toxic effects due to skin barrier disruption.

Children and Adolescents

Use with caution in children over 2 years of age.
In children, due to the larger ratio of body surface area to body mass compared to adults, it is easier for them to experience suppression of the hypothalamic-pituitary-adrenal axis and Cushing's syndrome, as well as the occurrence of side effects characteristic of corticosteroids, including growth and development disorders.
There is a risk of toxic effects of clioquinol on the nervous system, especially when the medicine is used for a long time or under an occlusive dressing.

Lorinden C and Other Medicines

Tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
No interactions are known to be associated with topical corticosteroid use.
Lorinden C may interfere with the effects of medicines that affect the immune system.

Pregnancy, Breast-Feeding, and Fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
Lorinden C 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 risks for the fetus.
Do not use the medicine during the first trimester of pregnancy.
Breast-Feeding
The doctor will consider, taking into account the possibility of side effects in children and the benefits of treatment for the mother, whether the medicine can be used during breast-feeding.
Fertility
The effect of flumetasoni pivalas on fertility has not been studied, but other corticosteroids have been reported to affect fertility.

Driving and Using Machines

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

3. How to Use Lorinden C

Always use this medicine exactly as your doctor has told you.
If you are not sure, ask your doctor or pharmacist.
Do not use the medicine for longer than your doctor has told you.
The medicine is for use on the skin.
Usually, a small amount of the medicine is applied as a thin layer to the affected areas of skin, no more than once or twice a day.
In cases of excessive lichenification or scaling of the affected skin, an occlusive dressing may be used, which should be changed every 24 hours.
Do not use the medicine for more than 2 weeks.
On facial skin, do not use for more than 7 days.
During one week, no more than 1 tube (15 g) of ointment should 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 has prescribed otherwise, the medicine is usually used only once a day, on a small area of skin.
Do not use on facial skin.

Using More Than the Recommended Dose of Lorinden C

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

Missing a Dose of Lorinden C

Do not use a double dose to make up for a forgotten dose.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Local side effects that occur not very often (may affect up to 1 in 100 people):
Blurred vision.
Local side effects of unknown frequency (frequency cannot be estimated from the available data):
May include: acne, perioral dermatitis, skin atrophy and subcutaneous tissue atrophy, dryness of the skin, excessive hair growth or hair loss, skin discoloration or hyperpigmentation, skin thinning and striae, telangiectasia, perioral dermatitis, folliculitis, secondary infections, skin irritation, suppression of skin growth. Sometimes, urticaria or papulovesicular rash may occur, or worsening of existing skin conditions.
In case of use on the skin of the eyelids, glaucoma or cataracts may occasionally occur.
Systemic side effects of unknown frequency (frequency cannot be estimated from the available data):
Due to absorption of the medicine into the bloodstream, systemic side effects may also occur.
These occur mainly in case of prolonged use of the medicine, use on large areas of skin, under an occlusive dressing, or in case of use in children.
Systemic side effects of flumetasoni pivalas are characteristic of corticosteroids, including suppression of the hypothalamic-pituitary-adrenal axis, Cushing's syndrome, growth and development suppression in children, soft tissue atrophy, hyperglycemia, glucosuria, edema, hypertension, decreased immunity, neurotoxicity.
If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist.

Reporting of Suspected Side Effects

If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Medicinal Product Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: 22 49-21-301
fax: 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, you can help provide more information on the safety of this medicine.

5. How to Store Lorinden C

Store below 25°C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton.
The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the Pack and Other Information

What Lorinden C Contains

• The active substances are flumetasoni pivalas and clioquinol. 1 g of ointment contains 0.2 mg of flumetasoni pivalas and 30 mg of clioquinol.
• The other ingredients are: white wax, white petrolatum.

What Lorinden C Looks Like and Contents of the Pack

Lorinden C is a yellow or grey ointment.
The medicine is available in an aluminum tube containing 15 g of ointment, placed in a carton.

Marketing Authorization Holder

Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland
Tel: +48 17 865 51 00

Manufacturer

Przedsiębiorstwo Farmaceutyczne Jelfa S.A.
ul. Wincentego Pola 21

• 58- 500 Jelenia Góra

Date of Last Revision of the Leaflet: