INFILEA 0.5 mg/g Cream

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Infilea, 0.5 mg/g, cream
   1. Please read carefully the contents of the leaflet 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:
   2. Warnings and precautions
   3. Children and adolescents
   4. Infilea and other medicines
   5. Pregnancy and breastfeeding
   6. Driving and using machines
   7. Infilea contains chlorocresol, cetyl alcohol, and propylene glycol
5. How to use Infilea
   1. How much medicine to use?
   2. How to use Infilea?
   3. Apply a thin layer of cream and gently rub it into the skin in the smallest amount necessary to cover the entire affected area.
   4. Guidelines for applying the cream
   5. If the patient has psoriasis
   6. If the patient has pemphigoid blisters
   7. Using more than the recommended dose of Infilea
   8. Missing a dose of Infilea
   9. Stopping the use of Infilea
6. Possible side effects
   1. The patient should stop using Infilea and consult a doctor immediately if they experience any of the following very rare side effects
   2. Other side effects that may occur during the use of Infilea are:
   3. 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 what the pack contains
   3. Marketing authorization holder
   4. Manufacturer
   5. This medicine is authorized in the Member States of the European Economic Area under the following names:
   6. Date of last revision of the leaflet:

Leaflet accompanying the packaging: patient information

Infilea, 0.5 mg/g, cream

Clobetasol propionate

Please read carefully the contents of the leaflet before using the medicine, as it contains important information for the patient.

• Please keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their 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

The active substance of Infilea is clobetasol propionate, which belongs to a group of medicines called steroids. The medicine helps to reduce redness, swelling, and skin irritation.

Infilea is used to relieve symptoms of certain skin diseases in adults and the elderly.

Such skin diseases include:

• psoriasis (thickened areas of inflamed skin, often covered with silvery scales),
• pemphigoid blisters, a rare skin disease characterized by large, fluid-filled blisters that occur in areas of frequent bending, such as on the abdomen, upper thighs, or armpits.

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

2. Important information before using Infilea

When not to use Infilea:

• in the treatment of the following skin problems, as it may worsen them:
• rosacea (severe redness of the skin on the nose, cheeks, chin, forehead, or entire face, with or without visible small blood vessels, bumps, or pus-filled bumps);
• acne;
• skin infections caused by viruses (e.g., herpes simplex, chickenpox), bacteria (e.g., impetigo), or fungi (e.g., candidiasis, ringworm), unless the infection is being treated with an anti-infective medicine at the same time;
• itching skin without inflammation;
• itching in the anal or genital area;
• red spots around the mouth (perioral dermatitis);
• in the treatment of skin lesions in children under 1 year of age, including diaper rash, as the use of Infilea is contraindicated in such cases.

If any of the above situations apply to the patient, they should not use Infilea. In case of doubts, before using Infilea, they should consult a doctor or pharmacist.

Warnings and precautions

• Before using Infilea, the patient should consult a doctor if they have had an allergic reaction to another steroid in the past.
• Infilea should be used for as long as the doctor has prescribed. If the condition does not improve within 2 to 4 weeks of treatment, the patient should consult a doctor.
• Tightly adhering dressings should only be used if prescribed by a doctor, as they may facilitate the penetration of the active substance through the skin. The patient may unintentionally apply too much cream.
• If the patient uses the cream under a tightly adhering dressing, including under a diaper, they should carefully clean the skin before applying a new dressing to prevent infections.
• Before applying the cream to a large skin surface, damaged skin, or skin with broken continuity, or to skin folds, the patient should consult a doctor.
• If the patient has psoriasis, the doctor may recommend more frequent check-ups.
• If an infection develops during the use of this medicine, the patient should consult a doctor or pharmacist.
• If the patient has eczema around leg ulcers, the use of topical corticosteroids may increase the risk of local allergic reactions or infections around the ulcers.
• Care should be taken when applying the cream to areas of the body 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 tightly adhering dressings should not be used.
• When applying the cream to areas of skin close to the eyes or eyelids, care should be taken to avoid contact with the eyes, as repeated penetration of the medicine into the eye may cause cataracts (clouding of the lens in the eye) or glaucoma (damage to the nerve in the eye, usually caused by high pressure in the eye). If the medicine gets into the eye, it should be rinsed with a large amount of water.
• If the patient experiences blurred vision or other vision disturbances, they should consult a doctor.
• If the patient experiences new bone pain or worsening of existing bone symptoms during treatment with Infilea, especially if Infilea has been used for a long time or treatment has been repeated, they should consult a doctor or pharmacist.
• If the patient is using other oral or topical medicines containing corticosteroids or medicines that affect the immune system (e.g., for the treatment of autoimmune disease or after organ transplantation), they should consult a doctor or pharmacist before using Infilea. The concurrent use of Infilea with such medicines may cause serious infections.

This medicine contains beeswax (a type of paraffin). During the use of Infilea, the patient should not smoke or approach an open flame due to the risk of severe burns. Materials (clothing, bedding, dressings, etc.) that have come into contact with this medicine are more easily ignited and pose a significant fire hazard. Washing clothing and bedding may reduce the accumulation of the medicine, but it will not remove it completely.

In case of doubts about whether any of the above situations apply to the patient, before using the medicine, they should consult a doctor or pharmacist.

Children and adolescents

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

Infilea and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those available without a prescription.

Some medicines may change the effect of Infilea or increase the likelihood of side effects. Examples of such medicines are:

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

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before using this medicine.

If the patient is using Infilea while breastfeeding, they should not apply the medicine to the breast area to avoid accidental ingestion by the child.

Driving and using machines

Infilea should not affect the patient's ability to drive or use machines.

Infilea contains chlorocresol, cetyl 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 cetyl 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

The medicine should always be used as directed by the doctor. In case of doubts, the patient should consult a doctor or pharmacist.

Infilea is intended for use on the skin only.

How much medicine to use?

Infilea cream is recommended to be used once or twice a day. The frequency of application can be reduced as the skin condition improves. The doctor may also prescribe a weaker steroid for use instead of this medicine.

If the patient feels that the effect of Infilea is too strong or too weak, they should inform their doctor or pharmacist.

Unless directed by the doctor, the patient should not use larger amounts of cream or apply the cream to larger skin surfaces for a long time (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 in the smallest amount necessary to cover the entire affected area.

Guidelines for applying the cream

• 1. Wash your hands.
• 2. Apply a thin layer of cream to the affected skin area and gently rub the cream into the skin until it is no longer visible. The amount of Infilea cream to be applied can be measured using the fingertip unit.
• 3. If the patient does not intend to apply the cream to their hands, after applying the cream to the affected skin area on themselves or another person, they should wash their hands again.

For an adult

It is worth noting that:

• 2 fingertip units are sufficient for both hands or 1 foot,
• 3 fingertip units are sufficient for 1 arm,
• 6 fingertip units are sufficient for 1 leg,
• 14 fingertip units are sufficient to cover the front and back of the body.

The patient should not worry if it turns out that a little more or less cream is needed for treatment. The amounts given are only a guide.

If the patient has psoriasis

In the presence of thick psoriatic lesions on the elbows or knees, the doctor may recommend using the cream under a tightly adhering dressing. Such a dressing will only be recommended at night to enhance the effect of the cream at the beginning of treatment. After a short time, the cream should be used as usual.

If the patient has pemphigoid blisters

If the patient has pemphigoid blisters, it may be necessary to use larger amounts of cream, if prescribed by the doctor. In this disease, the treatment time may be longer than 4 weeks.

Using more than the recommended dose of Infilea

It is essential to follow the doctor's instructions and the information in this leaflet carefully.

Using too much cream or accidentally swallowing Infilea may cause problems. The patient should rinse their mouth with a large amount of water and immediately consult a doctor or pharmacist for advice.

In the case of chronic overdose or improper use of the medicine, the following symptoms may occur: weight gain, moon face, rounding of the face, excessive hair growth on the body, changes in skin pigmentation, skin thinning, etc., and treatment should be discontinued. However, this should be done under the supervision of a doctor due to the risk of acute adrenal insufficiency.

Missing a dose of Infilea

If the patient misses a dose of Infilea, they should use the normal amount as soon as they remember, and then continue treatment as directed.

Stopping the use of Infilea

If the patient is using Infilea regularly, before stopping treatment, they must consult a doctor.

Do not stop treatment abruptly.After long-term treatment, the medicine should be discontinued gradually.

In case of any further doubts about the use of this medicine, the patient should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Infilea can cause side effects, although not everybody gets them.

Side effects occur on the skin but can also affect other organs of the body if sufficient amounts of the medicine are absorbed through the skin into the bloodstream.

The patient should stop using Infilea and consult a doctor immediately if they experience any of the following very rare side effects

(occurring in less 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.
• raised bumps under the skin filled with pus in a person with psoriasis. This condition may occur during or after treatment and is called pustular psoriasis.

Other side effects that may occur during the use of Infilea are:

Frequently(may occur in up to 1 in 10 people):

• itching,
• a burning or painful sensation at the application site.

Less frequently(may occur in up to 1 in 100 people):

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

Very rarely(may occur in less than 1 in 10,000 people):

Long-term use of Infilea or use under a tightly adhering dressing may cause the following symptoms:

• weight gain,
• moon face, rounding of the face,
• obesity,
• skin thinning,
• wrinkles on the skin,
• dry skin,
• changes in skin pigmentation,
• excessive hair growth on the body,
• hair loss or lack of hair growth, or damaged hair,
• slowed growth in children.

Other very rare skin reactions that may occur are:

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

Very rare side effects that may be revealed by blood tests or medical examinations:

• decreased cortisol levels in the blood,
• increased blood sugar or urine levels,
• high blood pressure,
• clouding of the lens in the eye (cataract),
• nerve damage in the eye, usually caused by high pressure in the eye (glaucoma),
• vision disturbances caused by retinal detachment in the eye (central serous chorioretinopathy),
• bone weakness due to gradual loss of mineral components (osteoporosis); to confirm this condition, additional tests may be necessary after a medical examination.

Side effect with unknown frequency(frequency cannot be estimated from available data):

• blurred vision.

Reporting side effects:

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. 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

Tel.: +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 can be collected on the safety of the medicine.

5. How to store Infilea

The medicine should be stored out of sight and reach of children.

Do not store above 30°C.

Shelf life after first opening the tube: 2 months.

Do not use this medicine after the expiry date stated on the carton and tube after: EXP. The expiry date refers to the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging 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).
• The other ingredients are: cetyl alcohol, chlorocresol, sodium citrate, propylene glycol (E 1520), self-emulsifying glycerol monostearate (Arlacel 165), white wax (Substitute 6621), glycerol monostearate 40-55, citric acid monohydrate, and purified water.

What Infilea looks like and what the pack contains

White to off-white cream.

30 g of cream in an aluminum tube with a polyethylene cap.

Marketing authorization 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 medicine is authorized 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

To obtain more detailed information about this medicine, the patient should contact the local representative of the marketing authorization holder:

EGIS Polska Sp. z o.o.

ul. Komitetu Obrony Robotników 45D

02-146 Warsaw

Tel.: +48 22 417 92 00

Date of last revision of the leaflet: