Dermisil

Leaflet attached to the packaging: patient information

Dermisil, (20 mg + 1 mg)/g, cream

Fusidic acid + Betamethasone

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.
• In case of any doubts, 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 any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Dermisil and what is it used for

Dermisil contains two different medicines: fusidic acid, which is an antibiotic, and betamethasone, which is a corticosteroid. Both medicines work at the same time, but in different ways.
Dermisil works as follows:

• the antibiotic inhibits the growth of microorganisms (bacteria) that cause the infection
• the corticosteroid reduces any type of swelling, redness, or itching of the skin.

Dermisil is used to treat:

• skin lesions with inflammation (rash or inflammation), as well as skin infections with microorganisms (bacteria).

If no improvement occurs after 7 days, the use of the cream should be stopped and a doctor should be consulted.

2. Important information before using Dermisil

When not to use Dermisil:

• if the patient is allergic to fusidic acid, betamethasone, or any of the other ingredients of this medicine (listed in section 6)
• to treat skin infections in infants under 1 year of age
• to treat skin lesions caused by syphilis or tuberculosis
• to treat common acne
• to treat rosacea - characterized by redness and inflammation of the skin on the nose and cheeks. You should ask your doctor if you are unsure of the symptoms of the disease.
• for perioral dermatitis - these are red rashes and eruptions around the mouth or chin
• to treat skin diseases caused by bacteria, such as boils or impetigo
• to treat skin diseases caused by viruses, such as herpes or chickenpox
• to treat skin diseases caused by fungi, such as interdigital fungal infection.

Warnings and precautions

Before starting to use Dermisil, the patient should discuss it with their doctor or pharmacist.

• Particular care should be taken when using this medicine near the eyes of the patient or child. If the cream gets into the eye, it may increase the pressure in the eyeball, which can lead to vision loss (glaucoma).
• If the patient experiences blurred vision or other vision disturbances, they should contact their doctor.
• If the cream is used for a long time or in large quantities, it may increase the frequency of side effects. The skin may also become more sensitive to the medicine.
• This medicine should not be used for a long time on the skin of the face.
• This medicine should not be used on open wounds or sensitive areas, such as the nostrils, ears, lips, or genital areas, unless advised by a doctor.
• This medicine should not be used on thin skin, skin ulcers, cracked blood vessels, or on acne, unless advised by a doctor.

Dermisil 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. This also applies to medicines available without a prescription.

Pregnancy and breastfeeding

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

• If the patient is pregnant or suspects they are pregnant, they should not use this medicine for a long time or in large quantities.
• Dermisil should not be used on the breast if the patient is breastfeeding.

The patient should tell their doctor if they become pregnant while using this medicine.

Driving and using machines

Dermisil usually has a minor effect on the ability to drive and use machines. The patient should contact their doctor if they experience any side effects that may affect their ability to drive and use machines.

Dermisil contains cetostearyl alcohol

The medicine may cause a local skin reaction (e.g., contact dermatitis).

Dermisil contains chlorocresol

The medicine may cause allergic reactions.
In case of doubts about any of the ingredients of this medicine, the patient should consult their doctor.

3. How to use Dermisil

This medicine should always be used as directed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
Method of administration
The medicine should be used only on the skin of an adult or child.
Do not swallow.
The medicine should not be used inside the body.
Method of use
Remove the cap.
Before using the cream for the first time, check if the tube's seal is not damaged.
Then, pierce the tube with the sharp point on the cap.
Before using Dermisil, the patient should always wash their hands.
Apply a thin layer of cream to the affected areas of the skin.
Be careful if the medicine is used on the skin of the face, to avoid the eye area.
The patient should always wash their hands after using Dermisil, unless the cream is used to treat the hands.
If the medicine gets into the eye, it should be rinsed immediately with cold water. If possible, rinse the eye with eye wash. The eye may sting. If there are problems with vision or if the eye hurts, the patient should contact their doctor immediately.
Dosage
The doctor will decide what amount of Dermisil the patient should use.
The treatment usually lasts up to 2 weeks. The patient should consult their doctor before using the medicine for more than 2 weeks.
Improvement can be seen after a few days of using the medicine.
If no improvement occurs after 7 days, the patient should stop using Dermisil and consult their doctor.
This medicine should usually be used twice a day, in the morning and evening. A reminder to use the medicine can be performing another regular activity, such as brushing teeth.
If the doctor has recommended covering the affected skin with a dressing or bandage, the patient should not use Dermisil too frequently.
A diaper can also act as a dressing. In this case, the patient should follow the doctor's instructions.
Adults and children:
The doctor should inform the patient about the appropriate amount of cream to use for themselves or their child. If the doctor has not recommended the appropriate amount of medicine, the patient should follow the instructions below.
To measure the appropriate amount of Dermisil to use, the patient can use their index finger.
To do this, squeeze the cream out of the tube, measuring the amount from the tip of the finger to the first joint. This is called a fingertip unit. Since different parts of the body may require treatment, the table below shows the appropriate amounts of cream to use for each part of the body. If there is a need to use more or less medicine, the patient should do so without fear. If the cream is used on a child's skin, the patient should also use an adult's finger to measure the fingertip unit.

Children from 1 to 10 years old

Missing a dose of Dermisil

In case of missing a dose at the usual time, the patient should use it as soon as possible. Then, they should use the medicine at the usual time. The patient should not use a double dose to make up for the missed dose.
In case of further doubts about using this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

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

In case of the following side effects, the patient should seek medical help immediately. This may be an allergic reaction to the medicine:

• difficulty breathing
• swelling of the face, eyelids, lips, tongue, or throat
• severe rash on the skin.

Other side effects:

• Any of the following side effects are more likely if the medicine is used for a long time, in large quantities, or on skin folds (under the arms or breasts).
• The following side effects are more common in infants and children. They also occur more frequently when using a dressing, bandage, or diaper on the affected skin.

Uncommon (affects less than 1 in 100 people):

• skin irritation
• burning sensation on the skin
• itching
• worsening rash
• stinging sensation on the skin
• redness of the skin.

Rare (affects less than 1 in 1000 people):

• hives
• dry skin.

Frequency not known (cannot be estimated from the available data):

• itchy skin or dermatitis at the application site
• rash
• visibility of small blood vessels near the application site
• blurred vision.

There were also side effects from betamethasone, one of the ingredients of Dermisil. The patient should inform their doctor if they experience any of the following side effects:

• thinning of the skin
• stretch marks
• inflammation or swelling of the hair root (folliculitis)
• changes in hair growth
• red rashes around the mouth and chin
• skin discoloration (depigmentation)
• vision loss due to damage to the optic nerve in the eye, as a result of increased pressure in the eyeball (glaucoma)
• the adrenal glands may stop working properly. Symptoms of this may include nausea, abdominal pain, headache, poor weight gain, lack of energy, fatigue, depression, and anxiety.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration 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 the medicine.

5. How to store Dermisil

The medicine should be stored 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 month stated.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot means the batch number.
Shelf life after first opening the tube: 6 months.
The patient should note the date of first opening the tube in the space provided on the carton.
Do not store above 30°C.
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 does Dermisil contain

• The active substances of the medicine are fusidic acid and betamethasone. Dermisil contains 20 mg/g of fusidic acid and 1 mg/g of betamethasone. 1 g of cream contains 20 mg of fusidic acid and 1 mg of betamethasone, in the form of 1.214 mg of betamethasone valerate.
• The other ingredients are: cetostearyl alcohol, macrogol cetostearyl ether 22, chlorocresol, sodium dihydrogen phosphate dihydrate, liquid paraffin, white petrolatum, all-rac-α-tocopherol, sodium hydroxide, purified water.

What does Dermisil look like and what does the packaging contain

White or almost white, smooth, uniform cream in an aluminum tube, placed in a cardboard box.
Each packaging contains 5 g, 15 g, 30 g, or 60 g of cream.
Not all pack sizes may be marketed.

Marketing authorization holder

PHARMACEUTICAL WORKS POLPHARMA S.A.
Pelplińska 19, 83-200 Starogard Gdański
phone: + 48 22 364 61 01

Manufacturer

KYMOS, S.L.
Ronda de Can Fatjo, 7B (Parque Tecnologico del Vallès), Cerdanyola del Vallès
08290 Barcelona
Spain

Date of last revision of the leaflet: