Silseq

Package Leaflet: Information for the User

Silseq, 3 mg/g + 25 mg/g, Gel

Adapalene + Benzoyl Peroxide

Read the package 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 any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Silseq and what is it used for

Silseq belongs to a group of medicines called "topical anti-acne agents". It is used to treat mild to moderate acne vulgaris, with a combination of blackheads (open and closed) and numerous pimples (inflammatory papules and pustules).
It contains two active substances, adapalene and benzoyl peroxide, which work together but in different ways:
Adapalene belongs to a group of medicines called retinoids and acts specifically on the processes in the skin that cause acne.
Benzoyl peroxide, the second active substance, has antibacterial properties and causes softening and peeling of the outer layer of the skin.
This medicine should only be used in adults and adolescents from 12 years of age.

2. Important information before using Silseq

When not to use Silseq

Warnings and precautions

Before starting to use this medicine, discuss it with your doctor or pharmacist.
Do not use this gel on areas of the skin where there are cuts, scrapes, sunburns, or eczema.
Be careful not to get the gel in your eyes, mouth, or nose, or on other sensitive areas of the body. If this happens, rinse the area with plenty of warm water.
Avoid excessive exposure to sunlight and UV lamps.
Avoid contact between the gel and hair or colored fabrics, as the gel may discolor them.
After using this medicine, wash your hands carefully.
If you experience persistent skin irritation after starting to use the gel, tell your doctor (see section 3. How to use Silseq).

Silseq and other medicines

During treatment with this gel, do not use other anti-acne products (containing benzoyl peroxide and/or retinoids).
Avoid using Silseq at the same time as cosmetics that irritate, dry, or peel the skin.
Other medicines may affect the effects of this medicine, so tell your doctor or pharmacist about all the medicines you are taking or have recently taken, as well as any medicines you plan to take.

Pregnancy and breastfeeding Pregnancy

DO NOT USESilseq if you are pregnant or planning to become pregnant.
Your doctor can provide additional information on this.
If you become pregnant while using this medicine, treatment must be stopped and you should inform your doctor as soon as possible for further monitoring.
Breastfeeding
If you are breastfeeding, ask your doctor for advice before using this medicine. The doctor will decide whether you should stop breastfeeding or stop using this medicine.
If the doctor decides that you can continue treatment, avoid applying the gel to the breast area to prevent the baby from coming into contact with the medicine.

Driving and using machines

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

Silseq contains propylene glycol, which may cause skin irritation.

The medicine contains 40 mg of propylene glycol (E1520) per gram of gel, which corresponds to a weight concentration of 4.00%.

Silseq contains polysorbates, which may cause allergic reactions.

This medicine contains 3 mg of polysorbate 80 per gram of gel, which corresponds to 0.3% w/w.

Silseq contains benzoyl peroxide breakdown product, benzoic acid, which may cause local irritation.

3. How to use Silseq

Always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
This medicine is for use in adults and adolescents from 12 years of age. This medicine is for external use only.
The choice of medicine strength will be decided by your doctor based on the severity and appearance of acne lesions. Your doctor will also decide if you need additional treatment.

• Before applying the gel, the skin should be clean and dry.
• A thin layer of gel should be applied evenly to the entire area of the face and/or trunk affected by acne, once a day, before bedtime. Avoid contact between the gel and the eyes, mouth, nostrils, and mucous membranes.
• When applying the gel to the face: wash and dry your face, then apply a amount of gel equivalent to a grain of pea to each area of the face (e.g. forehead, chin, each cheek).
• Immediately after applying the gel, wash your hands thoroughly.

Your doctor will decide how long you should use Silseq. If there is no improvement after 4-8 weeks of treatment, discuss the benefits of continuing treatment with your doctor.
If you experience persistent skin irritation in the first few weeks of treatment, contact your doctor. Your doctor may recommend using a moisturizing cream, reducing the frequency of gel application, temporarily stopping the use of the gel, or completely stopping the use of the gel.
Do not use cosmetics (such as other face creams or makeup products) before the daily application of the gel. These products can be used after applying and drying the gel.

Use in children

This medicine should not be used in children under 12 years of age.

Using more Silseq than you should

If you apply more gel to the skin than recommended, you will not get rid of acne faster, but your skin may become irritated and red.
In the following situations, contact your doctor or go to the hospital:

• If you have used more Silseq than you should.
• If a child has accidentally used the medicine.
• If you have accidentally swallowed the medicine. Your doctor will decide what actions to take.

Missing a dose of Silseq

Do not apply a double dose to make up for a forgotten dose.
Acne lesions (blackheads, pimples) will decrease only after several applications of the medicine. Continue to use the medicine for as long as your doctor recommends.
If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Silseq can cause side effects, although not everybody gets them.
About 1 in 10 people using this medicine may experience unwanted skin reactions.
Stop using the medicine and tell your doctor immediately if you experience tightness in the throat, swelling around the eyes, face, lips, or tongue, weakness, or difficulty breathing.
Stop using the medicine if you experience hives or itching of the face or body.
The frequency of these side effects is not known.
Commonside effects (may affect up to 1 in 10 people):

• Burning sensation of the skin
• Skin irritation
• Redness
• Peeling of the skin
• Dryness of the skin

Uncommonside effects (may affect up to 1 in 100 people):

• Redness of the eyelids
• Feeling of tingling or numbness at the application site
• Itching of the skin, allergic skin reaction
• Rash
• Dryness of the skin

Besides the side effects listed above, the following side effects have also been reported with the use of a gel containing adapalene and benzoyl peroxide at a lower strength (1 mg/g + 25 mg/g):
Uncommonside effects (may affect up to 1 in 100 people):

• Sunburn

Frequency not known(cannot be estimated from the available data
Swelling of the eyelid

• Feeling of tightness in the throat
• Allergic contact reactions
• Swelling of the face
• Pain in the skin (prickling pain) Blisters (vesicles)
• Difficulty breathing Discoloration of the skin (change in skin color)
• Burn at the application site

Typical side effects associated with the use of Silseq include mild to moderate reactions at the application site, such as skin irritation with redness, dryness, peeling, stinging, and/or burning of the skin.
Burns at the application site are usually superficial, but more severe cases with blistering have been reported.
If you experience persistent skin irritation in the first few weeks of treatment, contact your doctor. Skin-related side effects, such as skin irritation, occur more frequently with the use of a higher-strength gel compared to a lower-strength gel (adapalene 1 mg/g and benzoyl peroxide 25 mg/g). You may be advised to use a moisturizing cream, reduce the frequency of gel application, temporarily stop using the gel, or completely stop using the gel. Such reactions usually occur at the beginning of treatment and decrease over time.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to
the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocides
Jerozolimskie Avenue 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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Silseq

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 carton and tube. The expiry date refers to the last day of that month.
Do not store above 30°C.
After first opening the tube, the medicine can be used for 6 months.
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 pack and other information

What Silseq contains

• The active substances are adapalene and benzoyl peroxide. 1 g of gel contains 3 mg (0.3% w/w) of adapalene and benzoyl peroxide with water equivalent to 25 mg (2.5% w/w) of anhydrous benzoyl peroxide.
• The other ingredients are: propylene glycol E1520; glycerol; sepineo P600 (copolymer of acrylamide and sodium acryloyldimethyltaurine (1:1), isohexadecane, polysorbate 80, sorbitan oleate); poloxamer 124; disodium edetate; sodium docusate; purified water.

What Silseq looks like and contents of the pack

A homogeneous, opaque gel, white to very pale yellow in color.
The gel is packed in a white plastic tube with HDPE/LLDPE, with a white neck with HDPE and a peel-off type seal with aluminum, and a white cap with PP.
Pack sizes: one tube of 15 g, 30 g, 45 g, or 60 g.
Not all pack sizes may be marketed.

Marketing authorization holder

Egis Pharmaceuticals PLC
Keresztúri út 30-38
1106 Budapest
Hungary

Manufacturer

BELTAPHARM S.p.A
Via Stelvio 66, 20095 Cusano Milanino
Milan
Italy
Adalvo Limited
Malta Life Sciences Park, Building 1, Level 4
Sir Temi Zammit Buildings, San Gwann, SGN 3000,
Malta

This medicine is authorized in the Member States of the European Economic Area under the following names:

Netherlands (RMS)
Silseq 3 mg/g + 25 mg/g gel
Bulgaria
Силсек 3 mg/g + 25 mg/g Гел
Czech Republic
Silseq
Hungary
Silseq 3 mg/g + 25 mg/g gél
Lithuania
Silseq 3 mg/25 mg/g gelis
Latvia
Silseq 3 mg/g/25 mg/g gels
Poland
Silseq
Romania
Silseq 3 mg/g + 25 mg/g gel
Slovakia
Silseq 3 mg/g + 25 mg/g Gél
To obtain more detailed information on this medicine, contact the 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

Date of last revision of the leaflet 05.2026