INFILEA 500 mcg/g Shampoo

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Infilea, 500 micrograms/g, medicinal shampoo
   1. Read the leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Infilea and what is it used for
4. Important information before using Infilea
   1. When not to use Infilea medicinal shampoo
   2. Warnings and precautions
   3. Before starting to use Infilea medicinal shampoo, discuss it with your doctor or pharmacist if:
   4. When to be particularly careful when using Infilea medicinal shampoo
   5. Children and adolescents
   6. Infilea medicinal shampoo and other medicines
   7. Pregnancy, breastfeeding, and fertility
   8. Driving and using machines
   9. Infilea medicinal shampoo contains alcohol (ethanol)
5. How to use Infilea
   1. Use in children and adolescents
   2. Using more than the recommended dose of Infilea
   3. Missing a dose of Infilea
   4. Stopping use of Infilea
6. Possible side effects
   1. Reporting side effects
7. How to store Infilea
8. Contents of the packaging and other information
   1. What Infilea contains
   2. What Infilea looks like and contents of the packaging
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder
   5. Manufacturer
   6. The medicinal product is authorized in the Member States of the European Economic Area under the following names:

Leaflet accompanying the packaging: patient information

Infilea, 500 micrograms/g, medicinal shampoo

Clobetasol propionate

Read the 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 or pharmacist.
• 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 experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Infilea and what is it used for

Infilea medicinal shampoo contains clobetasol propionate as the active substance; it belongs to the group of medicines called topical corticosteroids (or steroids). Topical corticosteroids are divided into groups depending on their strength; clobetasol propionate is a very potent corticosteroid. The term "topical" means that it can only be applied to the skin surface. Topical steroids reduce redness, itching, and inflammation associated with skin diseases.
Scalp psoriasis is caused by the rapid formation of scalp cells. Infilea is used to treat moderate scalp psoriasis in adults.

2. Important information before using Infilea

When not to use Infilea medicinal shampoo

• If you are allergic to clobetasol propionate or any of the other ingredients of this medicine (listed in section 6).
• If you have bacterial, viral, fungal, or parasitic skin infections, such as herpes, chickenpox, shingles, impetigo (a type of rash on the face), fungal skin infections, athlete's foot, thrush, tuberculosis of the skin, or skin changes caused by syphilis.
• If you have weeping wounds on the scalp.
• In children under 2 years of age. Do not use this medicine on the eyes or eyelids (risk of glaucoma, or high pressure in the eye, and risk of cataracts, or clouding of the eye lens).

Warnings and precautions

Before starting to use Infilea medicinal shampoo, discuss it with your doctor or pharmacist if:

• you are using other oral/topical medicines containing corticosteroids or medicines that affect the immune system (e.g., in autoimmune disease or after organ transplantation). Using Infilea medicinal shampoo with such medicines may lead to severe infections,
• you have had an allergic reaction to another corticosteroid in the past,
• you have diabetes, you have common acne, rosacea (redness and visible blood vessels on the face), or perioral dermatitis (a patchy red rash around the mouth).

When to be particularly careful when using Infilea medicinal shampoo

• This medicine should only be used on the scalp; it should not be used as a regular shampoo, nor should it be used on other areas of the body or used as a shower gel, body wash, or bath liquid.
• When applying the medicine to the scalp, do not cover the treated area of the skin, for example, do not wear a shower cap, as this may cause the active substance to penetrate the skin and affect other parts of the body.
• When using the medicine, avoid contact with the face, eyelids, armpits, damaged (cracked) skin, and genital area. If any amount of the product runs off the head, it should be rinsed off immediately. If the medicine gets into the eye (eyes), it should be carefully rinsed with water. If irritation persists, consult a doctor. Infilea medicinal shampoo should only be used for the period prescribed by the doctor. If there is no improvement in scalp psoriasis, consult a doctor. If you experience blurred vision or other vision disturbances, consult a doctor. If you experience new bone pain or worsening of existing bone symptoms during treatment with Infilea, especially if Infilea has been used for a long time or if treatment is repeated, consult a doctor or pharmacist. If signs of local intolerance occur, such as a burning sensation or redness of the skin at the application site, do not use this medicine until the symptoms have resolved. If the disease worsens during treatment (this is more likely if the medicine has been used for a longer period than recommended) or if eyelid swelling, facial swelling, or lip swelling occurs, stop using the medicine and consult a doctor as soon as possible, as an allergy to the medicine or skin infection is possible. Using larger amounts or keeping the product on the scalp for longer than 15 minutes may: cause skin thinning, making it more susceptible to damage; lead to the penetration of the active substance through the skin; this may affect other parts of the body, especially in children and during pregnancy
• To avoid interactions with hair dye products, for example, changes in hair color, the medicine should be rinsed off with a large amount of water. If unusual, unexplained discomfort occurs, consult a doctor as soon as possible.

Children and adolescents

If the medicine has been prescribed for children or adolescents under 18 years of age, they should have a medical check-up every week before continuing to use the medicine.

Infilea medicinal shampoo and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, including medicines available without a prescription.

Pregnancy, breastfeeding, and fertility

Do not use this medicine if you are pregnant or breastfeeding, as well as in women of childbearing age who are not using effective contraception, unless your doctor has explicitly recommended it.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.

Driving and using machines

The medicine has no or negligible influence on the ability to drive and use machines.

Infilea medicinal shampoo contains alcohol (ethanol)

This medicine contains 100 mg of alcohol (ethanol) per 1 gram, which is equivalent to 10% w/w.
It may cause a burning sensation on damaged skin.

3. How to use Infilea

This medicine should always be used exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The typical daily dose used during 1 application is approximately half a tablespoon, which is enough to cover the entire scalp.
Unless your doctor has told you otherwise, after washing your hands, apply the medicine directly to the dry scalp once a day, trying to cover the affected areas thoroughly and massage the shampoo into them. Avoid using large amounts of the medicinal shampoo; only use enough to cover the dry scalp. After application, wash your hands carefully. Then leave the product on for 15 minutes without covering your head, and then add water, rinse, and dry your hair as usual. If you need to wash your hair with more shampoo, you can use your normal shampoo. Do not apply additional amounts of Infilea medicinal shampoo to your hair.
Your doctor will decide how long you should use Infilea medicinal shampoo to treat scalp psoriasis. The treatment should not last longer than 4 weeks. However, if the psoriatic skin changes on your scalp improve significantly before the end of the treatment, consult your doctor. Also, if there is no improvement at the end of the treatment period, tell your doctor. The treatment requires careful monitoring; you should have regular check-ups with your doctor. Do not use the medicine for longer than your doctor has told you. However, your doctor may recommend reusing Infilea medicinal shampoo after a break in its use.

Use in children and adolescents

If the medicine has been prescribed for children or adolescents between 2 and 18 years of age, follow the doctor's instructions. Have a medical check-up every week before continuing to use the medicine.

Using more than the recommended dose of Infilea

If you have used the medicine for a much longer period than recommended, consult your doctor.
The medicine is only intended for use on the scalp. Do not swallow it.
If you accidentally swallow it, small amounts of the medicine are not harmful. If you are concerned, consult your doctor immediately.

Missing a dose of Infilea

If you miss a dose, do not use a double dose to make up for the missed dose. Return to your regular dosing schedule. If you miss several doses, tell your doctor.

Stopping use of Infilea

If you stop using the medicine, consult your doctor. After stopping treatment, the disease may worsen, especially if the medicine has been used for a long time or if treatment is stopped abruptly.
If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Infilea medicinal shampoo can cause side effects, although not everybody gets them.
This medicine may cause the following side effects:
Common(may affect up to 1 in 10 people):
Burning sensation of the skin
Folliculitis or furunculosis (inflammation of the hair follicles)
Uncommon(may affect up to 1 in 100 people):
During the use of potent topical corticosteroids, especially when used on large areas of the skin or for prolonged periods, hormonal disorders (such as adrenal suppression, Cushing's syndrome) have been observed
Stinging or burning eyes
Irritation of the eyes
Feeling of pressure in the eye
Glaucoma
Hypersensitivity
Headache
Skin pain
Discomfort of the skin
Itching
Acne
Swelling of the skin
Teleangiectasias (blood vessels under the skin surface may become more visible)
Worsening of psoriasis
Hair loss
Dryness of the skin
Hives
Atrophy of the skin (thinning of the skin),
Irritation of the skin
Tension of the skin
Allergic contact dermatitis
Redness
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 work as it should).
Frequency not known(cannot be estimated from the available data):
Growth retardation in children
Worsening of diabetes
Blurred vision
Cataracts
Pustular eruptions (large pimples) and changes related to hair growth and skin color or skin discoloration; visible skin striae and petechiae (small blood spots) may appear. Such changes may sometimes occur when using topical corticosteroids for a long time.
Generalized pustular psoriasis (occurrence of pustules and psoriatic plaques all over the body)
Perioral dermatitis (patchy red rash around the mouth), when using the medicine on the face.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance 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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Infilea

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after EXP.
The expiry date refers to the last day of that month.
Discard the bottle after 4 weeks of first opening.
Do not store above 30°C. Store in the original packaging to protect from light.
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 packaging 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 is equivalent to 1 milliliter of shampoo.
• The other ingredients are: ethanol, coco-alkyldimethylbetaine, sodium lauryl ether 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 packaging

A thick, translucent, colorless to pale yellow, liquid shampoo with an alcohol smell.
Infilea is packaged in white, cylindrical high-density polyethylene (HDPE) bottles.
The bottle is closed with a low-density polyethylene (LDPE) cap and a white high-density polyethylene (HDPE) screw cap.
Pack size: 125 mL.

Marketing authorization holder and manufacturer

Marketing authorization holder

Egis Pharmaceuticals PLC
1106 Budapest,
Kereszturi ut 30-38
Hungary
For more information, contact your local representative of the marketing authorization holder:
EGIS Polska Sp. z o.o.
ul. Komitetu Obrony Robotników 45D
02-146 Warsaw
Phone: +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 authorized in the Member States of 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
Date of revision of the leaflet month YYYY}.
Detailed information on this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
https://rejestrymedyczne.ezdrowie.gov.pl/