Infilea

Package leaflet: Information for the patient

Infilea, 0.5 mg/g, cream
Clobetasol propionate
Read the following information carefully 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, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Infilea is and what it is 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 pack and other information

1. What Infilea is and what it is used for

The active substance in Infilea is clobetasol propionate, which belongs to a group of medicines called steroids. Infilea helps reduce redness, swelling, and irritation of the skin.
Infilea is used to relieve symptoms of certain skin conditions in adults and elderly people.
Such skin conditions include:

• psoriasis (thickened, inflamed, red areas of skin, often covered with silvery scales),
• bullous pemphigoid, a rare skin disease characterized by large, fluid-filled blisters occurring in skin folds, for example on the lower abdomen, upper thighs, or in the armpits.

The cream is particularly suitable for treating moist and weeping skin surfaces.

2. Important information before using Infilea

When not to use Infilea:

• if the patient is allergic to clobetasol propionate or any of the other ingredients of this medicine (listed in section 6);
• in the treatment of the following skin conditions, as it may worsen them:
  • rosacea (intense redness of the skin around the nose, cheeks, chin, forehead, or entire face, with or without visible small blood vessels, nodules (lumps), or pus-filled nodules (pimples));
  • acne;
  • skin infections caused by viruses (e.g. cold sores, chickenpox), bacteria (e.g. impetigo), or fungi (e.g. candidiasis, ringworm), unless the infection is simultaneously treated with an antimicrobial agent;
• itchy skin without inflammation;
• itching around the anus and genital area;
• perioral dermatitis (red, scaly rash around the mouth);
  • in the treatment of skin lesions in children under 1 year of age, including diaper dermatitis (diaper rash), as the use of Infilea is contraindicated in such cases.

If any of the above situations apply to the patient, Infilea must not be used. If in doubt, consult a doctor or pharmacist before using Infilea.

Warnings and precautions

• Consult a doctor before using Infilea if the patient has previously had an allergic reaction to another steroid.
• Infilea should be used exactly as prescribed by the doctor. If there is no improvement within 2 to 4 weeks of treatment, consult a doctor.
• Occlusive dressings (tightly adhering dressings) should only be used if specifically recommended by a doctor, as they may enhance the penetration of the active substance through the skin. This may unintentionally lead to excessive application of the cream.
• If the cream is used under an occlusive dressing, including under a diaper, the skin should be thoroughly cleaned before applying a new dressing to help prevent infections.
• Consult a doctor before applying the cream over large areas of skin, on damaged or broken skin, or in skin folds.
• If the patient has psoriasis, the doctor may recommend more frequent check-ups.
• If an infection develops during treatment with this medicine, consult a doctor or pharmacist.
• If the patient has dermatitis around leg ulcers, the use of topical corticosteroids may increase the risk of local allergic reactions or infections around the ulcers.
• Exercise caution when applying the cream to areas where the skin is thin, such as the face, as the medicine may cause skin thinning. When used on the face, treatment should be limited to 5 days, and occlusive dressings must not be used.
• Exercise caution when applying the cream near the eyes or on the eyelids to avoid contact with the eyes, as repeated exposure to the medicine in the eye may lead to cataracts (clouding of the eye lens) or glaucoma (damage to the optic nerve, usually caused by high intraocular pressure). If the medicine gets into the eye, rinse thoroughly with plenty of water.
• If blurred vision or other visual disturbances occur, consult a doctor.
• If new bone pain develops or existing bone symptoms worsen 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 the patient is using other oral or topical medicines containing corticosteroids or immunosuppressive medicines (e.g. for autoimmune diseases or after organ transplantation), consult a doctor or pharmacist before using Infilea. Concurrent use of Infilea with such medicines may lead to severe infections.

This medicine contains beeswax (a type of paraffin). While using Infilea, avoid smoking and exposure to open flames due to the risk of severe burns. Materials (clothing, bedding, dressings, etc.) that have come into contact with this medicine are more flammable and pose a significant fire hazard. Washing clothing and bedding may reduce drug accumulation but does not completely remove it.

If in doubt whether any of the above situations apply to the patient, consult a doctor or pharmacist before using Infilea.

Children and adolescents

• This medicine must not be used in children and adolescents under 18 years of age.

Infilea and other medicines

Inform the doctor or pharmacist about all medicines currently used or recently used, as well as any medicines planned for use, including those available without a prescription.

Some medicines may alter the effect of Infilea or increase the likelihood of adverse effects. Examples include:

• ritonavir (used in the treatment of HIV infection),
• itraconazole (used to treat and prevent fungal infections).

Pregnancy and breastfeeding

If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.

If the patient uses Infilea while breastfeeding, the cream should not be applied to the breast area to avoid accidental ingestion by the infant.

Driving and operating machinery

Infilea is unlikely to affect the ability to drive or operate machinery.

Infilea contains chlorocresol, cetostearyl alcohol, and propylene glycol

The medicine contains 0.75 mg of chlorocresol per gram of cream, which may cause allergic reactions.

The medicine contains 70 mg of cetostearyl alcohol per gram of cream, which may cause local skin reactions (e.g. contact dermatitis).

The medicine contains 475 mg of propylene glycol per gram of cream. Propylene glycol may cause skin irritation.

3. How to use Infilea

Always use this medicine exactly as your doctor has told you. If in doubt, consult your doctor or pharmacist.
Infilea is for external use on the skin only.
How much medicine should be used?
It is recommended to apply Infilea cream once or twice daily. The frequency of application may be reduced once the skin condition improves. Your doctor may also prescribe a weaker steroid to use instead of this medicine.
If you feel that the effect of Infilea is too strong or too weak, tell your doctor or pharmacist.
Unless otherwise directed by your doctor, do not use larger amounts of the cream or apply it to large areas of skin for prolonged periods (e.g. daily for several weeks or months).
Treatment should not last longer than 4 weeks.
How to use Infilea
Apply a thin layer of cream and gently rub it into the skin using the smallest amount sufficient to cover the entire affected area.
Tips on how to apply the cream

1. Wash your hands.
2. Apply a thin layer of cream to the affected area of skin and gently rub it in until it is no longer visible. The amount of Infilea cream to be applied can be measured using fingertip units (FTU).
3. If you are not treating your hands, wash your hands again after applying the cream to the affected area on yourself or another person.

For an adult
Please keep in mind that:

• 2 fingertip units (FTU) are sufficient for both palms or one foot,
• 3 fingertip units (FTU) are sufficient for one arm,
• 6 fingertip units (FTU) are sufficient for one leg,
• 14 fingertip units (FTU) are sufficient to cover the front and back of the body.

Do not be concerned if slightly more or less cream is needed for treatment. The amounts given here are only approximate.
If the patient has psoriasis
If thick psoriatic lesions are present on the elbows or knees, your doctor may recommend applying the cream under an occlusive dressing. Such a dressing will be recommended only at night, to enhance the effect of the cream at the beginning of treatment. After a short period, the cream should be used as usual.
If the patient has bullous pemphigoid
If the patient has bullous pemphigoid, larger amounts of cream may be required, as directed by the doctor. In this condition, treatment duration may exceed 4 weeks.
Use of more than the recommended dose of Infilea
It is important to strictly follow your doctor's instructions and the information contained in this leaflet.
Using too much cream or accidentally swallowing Infilea may cause adverse effects. Rinse the mouth thoroughly with plenty of water and contact your doctor or pharmacist immediately for advice.
In case of chronic overdose or improper use of the medicine, the following symptoms may occur: weight gain, moon face, facial rounding, excessive hair growth, skin pigmentation changes, skin thinning, etc., and treatment should be discontinued. However, this should be done under medical supervision due to the risk of acute adrenal insufficiency.
Missing a dose of Infilea
If you forget to apply Infilea, apply the usual amount as soon as you remember, then continue treatment as directed. Do not apply a double dose to make up for a missed dose.
Stopping treatment with Infilea
If you have been using Infilea regularly, you must talk to your doctor before stopping treatment. Do not stop treatment suddenly. After prolonged use, the medicine should be withdrawn gradually.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will get them.
Adverse reactions may occur on the skin, but may also affect other organs of the body if sufficient amounts of the medicine are absorbed through the skin into the bloodstream.
You should stop using Infilea cream immediately and consult a doctor if any of the following very rare adverse reactions occur
(occurring in fewer than 1 in 10,000 people):

• worsening of skin problems, generalized rash, or skin swelling during treatment. The patient may be allergic to the cream, may have an infection, or may require different treatment.
• pus-filled subcutaneous nodules in a person with psoriasis. This condition may appear during or after treatment and is known as pustular psoriasis.

Other adverse reactions that may occur during treatment with Infilea are:
Common (may affect up to 1 in 10 people):

• itching,
• burning sensation or pain at the site of cream application.

Uncommon (may affect up to 1 in 100 people):

• skin thinning, which may lead to the development of stretch marks,
• blood vessels beneath the skin surface may become more visible.

Very rare (may affect up to 1 in 10,000 people):
Prolonged use of Infilea or use under an occlusive dressing may lead to the following symptoms:

• weight gain,
• moon face, facial rounding,
• obesity,
• skin thinning,
• skin wrinkles,
• dry skin,
• skin discoloration,
• excessive hair growth,
• hair loss or lack of hair growth, or hair appearing damaged,
• slowed weight gain, slowed growth in children.

Other very rare skin reactions that may occur include:

• allergic reaction at the site of application,
• worsening of the disease,
• irritation at the application site,
• redness,
• rash or urticaria,
• acne.

Very rare adverse reactions that may be revealed during blood tests or medical examination:

• decreased blood cortisol hormone levels,

• increased blood or urine glucose levels,

• high blood pressure,

• lens clouding in the eye (cataract),

• optic nerve damage, usually caused by increased intraocular pressure (glaucoma),

• vision disturbances caused by retinal detachment (central serous chorioretinopathy),

• bone weakening due to gradual loss of mineral components (osteoporosis); additional tests may be required following a medical examination to confirm this condition.
  Adverse reaction with unknown frequency (frequency cannot be estimated from available data):

• blurred vision.

Reporting of adverse reactions:
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of 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 the medicine Infilea

Keep the medicine out of sight and reach of children.
Do not store above 30°C.
Keep the tube tightly closed after use.
Period of use after first opening the tube: 2 months.
Do not use this medicine after the expiry date stated on the cardboard packaging and on the tube
after: EXP. The expiry date refers to the last day of the stated 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 help protect the environment.

6. Contents of the package and other information

What Infilea contains

• The active substance is clobetasol propionate. 1 g of cream contains 0.5 mg of clobetasol propionate (equivalent to 0.44 mg of clobetasol).
• Other ingredients are: cetostearyl alcohol, chlorocresol, sodium citrate, propylene glycol (E 1520), self-emulsifying glyceryl monostearate (Arlacel 165), white wax (Substitute 6621), glyceryl monostearate 40-55, citric acid monohydrate and purified water.

What Infilea looks like and contents of the pack
A white to off-white cream.
30 g of cream in an aluminium tube closed with a polyethylene cap.
Marketing Authorisation Holder
Egis Pharmaceuticals PLC
Keresztúri út 30-38
1106 Budapest
Hungary
Manufacturer
Industrial Farmacéutica Cantabria, S.A.
Barrio Solía, nº 30
La Concha
Villaescusa Santander
39690 Cantabria
Spain
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Bulgaria ИНФИЛЕА 0,5 mg/g крем Infilea 0,5 mg/g cream
Czech Republic Infilea
Hungary Infilea 0.5 mg/g krém
Poland Infilea
Romania Infilea 0,5 mg/g cremă
Slovakia Infilea 0.5 mg/g krém
For more detailed information about this medicinal product, 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