Package leaflet: Information for the patient

Infilea, 500 micrograms/g, medicated shampoo
Clobetasol propionate
Please read carefully the entire leaflet before using the 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. The medicine may harm others, 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 Infilea is and what it is used for
Important information before using Infilea
How to use Infilea
Possible side effects
How to store Infilea
Contents of the pack and other information

1. What Infilea is and what it is used for

Infilea medicated shampoo contains clobetasol propionate as the active substance; it belongs to a group of medicines called topical corticosteroids (or steroids). Topical corticosteroids are classified into groups according to their potency; clobetasol propionate is a corticosteroid with very high potency. The term "topical" means that it should be applied only to the skin surface. Topical steroids reduce redness, itching, and inflammation associated with skin disorders.

Scalp psoriasis is caused by excessive and rapid production of skin cells on the scalp. Infilea is used to treat moderate scalp psoriasis in adults.

2. Important information before using Infilea

When not to use Infilea medicated shampoo

If the patient is allergic to clobetasol propionate or any of the other ingredients of this medicine (listed in section 6).
If the patient has bacterial, viral, fungal or parasitic skin infections such as herpes simplex, chickenpox, shingles, pityriasis (a type of facial rash), fungal skin infection, athlete's foot, tinea versicolor, cutaneous tuberculosis or skin lesions caused by syphilis.
If the patient has ulcerating (weeping) wounds on the scalp.
In children under 2 years of age. This medicine must not be used in the eyes or on the eyelids (risk of glaucoma, i.e. high pressure in the eye, and risk of cataract, i.e. clouding of the eye lens).

Warnings and precautions
Before starting treatment with Infilea medicated shampoo, discuss with your doctor
or pharmacist if:

the patient is taking other oral/topical medicines containing corticosteroids or medicines affecting the immune system (e.g. in autoimmune disease or after organ transplantation). Concomitant use of Infilea medicated shampoo with such medicines may lead to severe infections,
the patient previously had an allergic reaction to another corticosteroid,
the patient has diabetes, acne vulgaris, rosacea (facial redness and visible blood vessels) or perioral dermatitis (a red, scaly skin rash around the mouth).

When to exercise special caution when using Infilea medicated shampoo

This medicine should be used only on the hairy scalp; it should not be used as a regular shampoo, nor applied to other body areas, nor used as shower gel, body wash or bath additive.
When applying the medicine to the hairy scalp, the treated area must not be covered, for example by wearing a shower cap, as this could lead to penetration of the active substance through the skin and systemic effects on other organs.
Avoid contact with the face, eyelids, armpits, damaged (cracked) skin, and genital area. If any amount of product runs down from the head, it should be immediately rinsed off. If the medicine gets into the eye(s), rinse thoroughly with water. If irritation persists, consult a doctor. Infilea medicated shampoo should be used only for the duration prescribed by the doctor. If there is no improvement in scalp psoriasis, consult a doctor. In case of blurred vision or other visual disturbances, consult a doctor. If new bone pain or worsening of pre-existing bone symptoms occur during treatment with Infilea, especially if Infilea has been used for a prolonged period or treatment has been repeated frequently, consult a doctor or pharmacist. If local intolerance symptoms such as burning sensation or redness of the skin at the application site occur, do not use this medicine until symptoms resolve. If the condition worsens during treatment (more likely if the medicine has been used longer than recommended), or if swelling of the eyelids, face or lips occurs, discontinue use and consult a doctor as soon as possible, as this may indicate an allergic reaction or skin infection. Using larger amounts or leaving the product on the scalp longer than 15 minutes may: cause skin thinning, making it more susceptible to injury; lead to penetration of the active substance through the skin, potentially affecting other parts of the body, especially in children and during pregnancy.
To avoid interactions with hair dye products, such as hair discoloration, rinse the product thoroughly with large amounts of water. If unusual, unexplained discomfort occurs, inform your doctor immediately.

Children and adolescents
If the medicine has been prescribed for children or adolescents under 18 years of age, weekly medical check-ups are required before continuing treatment.
Infilea medicated shampoo and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including over-the-counter medicines.
Pregnancy, breastfeeding and fertility
This medicine should not be used if the patient is pregnant or breastfeeding, or in women of childbearing potential who are not using effective contraception, unless specifically advised by a doctor.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Driving and operating machinery
This medicine has no effect or negligible effect on the ability to drive and operate machinery.
Infilea medicated shampoo contains alcohol (ethanol)
This medicine contains 100 mg of alcohol (ethanol) per 1 gram, equivalent to 10% w/w.
It may cause stinging on damaged skin.

3. How to use Infilea

This medicine should always be used exactly as directed by your doctor. If in doubt, consult your
doctor or pharmacist.
The usual daily dose applied per single application corresponds approximately to half a tablespoon,
which is sufficient to cover the entire hairy scalp.
Unless otherwise advised by your doctor, after washing your hands, apply the medicine directly to
dry, hairy scalp once daily, carefully covering the affected areas and massaging it in like a shampoo.
Avoid using large amounts of the medicinal shampoo; apply only the amount sufficient to cover the
dry, hairy scalp. After application, wash your hands thoroughly. Leave the product on for 15 minutes
without covering the head, then add water, rinse off, and dry the hair in the usual way. If additional
shampoo is needed to wash the hair, you may use your regular shampoo. Do not apply additional
amounts of the medicinal shampoo Infilea to the hair.
Your doctor will determine how long you should use the medicinal shampoo Infilea for the treatment
of psoriasis of the hairy scalp. Treatment should not last longer than 4 weeks. However, if psoriatic
skin lesions on the scalp show significant improvement before the end of treatment, inform your
doctor. Likewise, if there is no improvement by the end of the treatment period, inform your doctor.
Treatment requires careful monitoring; you should attend regular follow-up appointments with your
doctor. Do not use the medicine longer than prescribed by your doctor.
However, in the future, your doctor may recommend resuming treatment with the medicinal shampoo
Infilea after a treatment-free interval.
Use in children and adolescents
If this medicine has been prescribed for children or adolescents aged 2 to 18 years, follow the
doctor's instructions carefully. Weekly medical check-ups are required before continuing treatment.
Use of a higher than recommended dose of Infilea
If the medicine is used for a much longer period than recommended, consult your doctor.
This medicine is intended for external use on the hairy scalp only. It must not be swallowed.
If accidentally swallowed, small quantities of the medicine are not harmful. In case of doubt, seek
medical advice immediately.
Missed dose of Infilea
If you miss a dose, do not apply a double dose at the next application to make up for the missed
dose. Resume your regular dosing schedule. If you have missed several doses, inform your doctor.
Stopping treatment with Infilea
If you stop using the medicine, consult your doctor. After discontinuation of treatment, the condition
may worsen, especially if the medicine had been used for a prolonged period or if treatment is
stopped abruptly.
If you have any further doubts concerning the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, the Infilea medicinal shampoo may cause adverse effects, although they do not occur in everyone.
This medicine may cause the following adverse effects:
Common (may affect up to 1 in 10 people):
Skin burning sensation
Inflammation of hair follicles
Uncommon (may affect up to 1 in 100 people):
Hormonal disturbances (such as adrenal suppression, Cushing's syndrome) have been observed during the use of potent topical corticosteroids, particularly when applied over large skin areas or for prolonged periods
Eye pricking or stinging
Eye irritation
Feeling of eye pressure
Glaucoma
Hypersensitivity
Headache
Skin pain
Skin discomfort
Itching
Acne
Skin swelling
Telangiectasias (blood vessels under the skin surface may become more visible)
Worsening of psoriasis
Hair loss
Dry skin
Urticaria
Skin atrophy (thinning of the skin)
Skin irritation
Skin tightness
Allergic contact dermatitis
Erythema
Rash
Rare (may affect up to 1 in 1,000 people):
Opportunistic infections (caused by bacteria, viruses, due to weakened immune system)
Immunosuppression (the immune system does not function properly)
Frequency unknown (cannot be estimated from available data):
Growth retardation in children
Worsening of diabetes
Blurred vision
Cataract
Pustular eruptions (large pimples) and changes in hair growth, skin color, or skin depigmentation; visible stretch marks and purpura (bruising) may also occur. Such changes may occasionally appear when repeated courses of topical corticosteroid therapy are used over a prolonged period.
Generalized pustular psoriasis (pustules and psoriatic plaques appearing over the entire body)
Perioral dermatitis (a macular red rash around the mouth), when the medicine is used on the face
Exacerbation of rosacea (facial redness associated with skin flushing and papulopustular lesions)
Reporting of adverse reactions
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Infilea medicine

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the stated month.
Dispose of the bottle 4 weeks after first opening.
Do not store above 30°C. Store in the original packaging to protect from light.
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 pack and other information

What Infilea contains

The active substance is clobetasol propionate.
1 gram of medicinal shampoo contains 500 micrograms of clobetasol propionate. 1 gram of shampoo corresponds to 1 millilitre of shampoo.
The other ingredients are: ethanol, cocoyl dimethyl betaine, ethoxylated sodium lauryl sulfate, polyquaternium-10, sodium citrate (for pH adjustment), citric acid monohydrate (for pH adjustment), and purified water.

What Infilea looks like and contents of the pack
A thick, semi-transparent, colourless to pale yellow, liquid shampoo with an alcoholic odour.
Infilea is packed in white, cylindrical bottles made of high-density polyethylene (HDPE).
The bottle is closed with a stopper made of low-density polyethylene (LDPE) and a white screw cap made of high-density polyethylene.
Pack size: 125 mL.

Marketing Authorisation Holder
Egis Pharmaceuticals PLC
1106 Budapest,
Kereszturi ut 30-38
Hungary
For further information, please contact the local representative of the Marketing Authorisation Holder:
EGIS Polska Sp. z o.o.
ul. Komitetu Obrony Robotników 45D
02-146 Warsaw
Tel.: +48 22 417 92 00

Manufacturer
INDUSTRIAL FARMACÉUTICA CANTABRIA, S.A.
Barrio Solía nº 30, La Concha, Villaescusa
39690 Santander, Cantabria
Spain

The medicinal product is authorised for sale in the European Economic Area under the following names:
Bulgaria Инфилеа 500 mcg/g шампоан
Infilea 500 mcg/g shampoo
Czech Republic Infilea
Denmark Infilea
Hungary Infilea 500 mcg/g sampon
Poland Infilea
Romania Infilea 500 mcg/g şampon
Slovakia Infilea 500 µg/g šampón

Detailed information on this medicinal product is available on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
https://rejestrymedyczne.ezdrowie.gov.pl/