Silseq

Package Leaflet: Information for the User

Silseq, 1 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. 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, please 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 is used to treat acne vulgaris.
This gel contains two active substances, adapalene and benzoyl peroxide, which work together but in a different way.
Adapalene belongs to a group of medicines called retinoids and acts specifically on the skin processes that cause acne.
Benzoyl peroxide, the second active substance, has antibacterial effects and causes softening and peeling of the outer layer of the skin.

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, sunburn, or eczema.
Be careful not to get the gel in your eyes, mouth, or nose, or other very sensitive areas of the body. If this happens, rinse the area with plenty of warm water immediately.
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.

Silseq and other medicines

Do not use other anti-acne products (containing benzoyl peroxide and/or retinoids) at the same time as this gel.
Avoid using Silseq at the same time as cosmetics that irritate, dry, or peel the skin.
Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, and about 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 with it must be stopped and you should inform your doctor as soon as possible for further monitoring.
Breastfeeding
This gel can be used during breastfeeding. Avoid applying the gel to the breast area to prevent exposure of the child to the medicine.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Not applicable.

Silseq contains propylene glycol, which may cause skin irritation.

This medicine contains 40 mg of propylene glycol (E1520) per gram of gel, corresponding to a weight/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, corresponding to 0.3% w/w.

Silseq contains benzoyl oxide, a breakdown product of benzoyl peroxide, 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, adolescents, and children from 9 years of age.
This medicine is for external use only.
Apply a thin layer of gel evenly to the affected area of the skin once a day, before going to bed, avoiding contact with the eyes, mouth, and nostrils. Before applying the medicine, the skin should be clean and dry. After applying the gel, wash your hands thoroughly.
Your doctor will tell you how long to use this medicine.
If you feel that the effect of Silseq is too strong or too weak, talk to your doctor or pharmacist.
If you experience persistent skin irritation, contact your doctor. Your doctor may recommend using a moisturizing preparation, applying the gel less frequently, stopping the use of the gel for a short time, or completely stopping the use of the gel.

Using more Silseq than you should

If you apply more gel to the skin than you should, 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.

Forgetting to use Silseq

Do not apply a double dose to make up for forgotten doses.

4. Possible side effects

Like all medicines, Silseq can cause side effects, although not everybody gets them.
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):

• Dry skin
• Local rash (irritant contact dermatitis)
• Burning sensation of the skin
• Skin irritation
• Redness of the skin
• Peeling of the skin

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

• Itching of the skin (pruritus)
• Sunburn

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

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

Skin irritation that may occur after using this medicine is usually mild or moderate, with local symptoms such as redness, dryness, peeling, or burning of the skin, as well as skin pain (stabbing pain), most pronounced in the first week of use and resolving without additional treatment.
Burns at the application site are usually superficial, but more severe cases with blistering have been reported.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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
You can also report side effects 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 1 mg (0.1% 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, non-transparent 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, with a white cap with PP.
Pack sizes: one tube of 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 1 mg/g + 25 mg/g gel
Bulgaria
Силсек 1 mg/g + 25 mg/g Гел
Czech Republic
Silseq
Hungary
Silseq 1 mg/g + 25 mg/g gél
Lithuania
Silseq 1 mg/25 mg/g gelis
Latvia
Silseq 1 mg/g/25 mg/g gels
Poland
Silseq
Romania
Silseq 1 mg/g + 25 mg/g gel
Slovakia
Silseq 1 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