Package leaflet: Information for the user

Silseq, 1 mg/g + 25 mg/g, gel
Adapalene + Benzoyl peroxide
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.

Keep this leaflet, as you may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same as yours.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

What Silseq is and what it is used for
What you need to know before using Silseq
How to use Silseq
Possible side effects
How to store Silseq
Contents of the pack and other information

1. What Silseq is and what it is used for

Silseq is used in the treatment of acne vulgaris.
This gel 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 specifically affects the skin processes that cause acne.
Benzoyl peroxide, the second active substance, has antibacterial action and causes softening and desquamation of the outer layer of the skin.

2. Important information before using Silseq

When not to use Silseq

if the patient is allergic to adapalene or benzoyl peroxide, or to any of the other ingredients of this medicine (listed in section 6)
if the patient is pregnant
if the patient plans to become pregnant.

Warnings and precautions
Before starting to use this medicine, discuss it with your doctor or pharmacist.
Do not use this gel on areas of skin that are cuts, abrasions, sunburned, or affected by eczema.
Take care to avoid getting the gel into the eyes, mouth, nose, or other sensitive areas of the body. If this occurs, rinse the area immediately with plenty of warm water.
Avoid excessive exposure to sunlight and UV lamps.
Avoid contact of the gel with hair or coloured fabrics, as the gel may bleach them.
After applying this medicine, wash hands thoroughly.

Silseq and other medicines
During treatment with this gel, do not use other acne medications (containing benzoyl peroxide and/or retinoids) at the same time.
Avoid using Silseq together with cosmetics that irritate, dry out, or exfoliate the skin.
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.

Pregnancy and breastfeeding
Pregnancy
DO NOT USE Silseq if you are pregnant or planning to become pregnant.
Your doctor can provide further information on this.
If you become pregnant while using this medicine, treatment must be stopped immediately and you should inform your doctor as soon as possible for further monitoring.

Breastfeeding
This gel may be used during breastfeeding. Avoid applying the gel to the chest area to prevent the baby from coming into contact with the medicine.
Consult your doctor or pharmacist before using any medicine.

Driving and operating machinery
Not applicable.

Silseq contains propylene glycol, which may cause skin irritation.
This medicine contains 40 mg of propylene glycol (E1520) in each gram of gel, corresponding to a weight concentration of 4.00%.

Silseq contains polysorbates, which may cause allergic reactions.
This medicine contains 3 mg of polysorbate 80 in each gram of gel, corresponding to 0.3% w/w.

Silseq contains benzoic acid, a degradation product of benzoyl peroxide, which may cause local irritation.

3. How to use Silseq

This medicine should always be used as directed by the physician. If in doubt, consult a doctor or pharmacist.
This medicine is intended for use in adults, adolescents, and children aged 9 years and older.
This medicine is for external use only.
Apply a thin layer of the gel evenly to the skin area affected by acne once daily, before bedtime, avoiding contact with the eyes, mouth, and nostrils. The skin should be clean and dry before application. After applying the gel, hands should be washed thoroughly.
The physician will inform the patient how long the treatment should continue.
If the patient feels that the effect of Silseq is too strong or too weak, consult a doctor or pharmacist.
If persistent skin irritation occurs, the patient should contact a physician. The physician may recommend using a moisturizing product, applying the gel less frequently, temporarily discontinuing the gel, or completely stopping treatment.

Use of more Silseq than recommended
Applying more gel than recommended will not lead to faster improvement of acne, but may cause skin irritation and redness.
Contact a doctor or go to hospital in the following situations:

If the patient has used more Silseq than recommended.
If a child has accidentally used the medicine.
If the medicine has been accidentally swallowed.

The physician will decide what actions should be taken.

Missed dose of Silseq
Do not apply a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Discontinue use of the medicine and seek immediate medical advice if the patient experiences throat tightness, swelling around the eyes, swelling of the face, lips or tongue, weakness or difficulty breathing.
Discontinue use of the medicine if the patient develops hives or experiences itching of the face or body.
The frequency of these adverse reactions is unknown.

Common adverse reactions (may occur in up to 1 in 10 people):

Dry skin
Local skin rash (contact dermatitis due to irritation)
Skin burning sensation
Skin irritation
Skin redness
Skin peeling

Uncommon adverse reactions (may occur in up to 1 in 100 people):

Skin itching (pruritus)
Sunburn

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

Facial swelling
Allergic contact reactions
Eyelid swelling
Throat tightness sensation
Skin pain (pricking pain)
Blisters (vesicles)
Breathing difficulties
Skin discolouration (change in skin colour)
Burning sensation at the site of application

Skin irritation following application of this medicine is usually mild or moderate in severity, with local symptoms such as redness, dryness, peeling, burning sensation or skin pain (pricking pain), most pronounced during the first week of treatment and resolving without additional therapy.
Burning sensation at the site of application is usually superficial, but more severe cases with blister formation have also been reported.

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 at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warszawa
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 Silseq

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and tube. The expiry date refers to the last day of the specified month.
Do not store above 30°C.
After first opening the tube, the medicine can be used for 6 months.
Medicines must 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.
Other ingredients: propylene glycol E1520; glycerol; sepineo P600 (acrylamide/sodium acryloyldimethyl taurate copolymer (1:1), isohexadecane, polysorbate 80, sorbitan oleate); poloxamer 124; disodium edetate; sodium docecylsulfate; purified water.

What Silseq looks like and contents of the pack
A homogeneous, opaque gel, white to very pale yellow in colour.
The gel is packed in a white plastic tube made of HDPE/LLDPE, with a white HDPE neck and an aluminium peel-off seal, and a white PP cap.
Pack sizes: one tube of 30 g, 45 g, or 60 g.
Not all pack sizes may be available on the market.

Marketing Authorisation 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 medicinal product is authorised in the European Economic Area countries 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

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