Package leaflet: Information for the user

Silseq, 3 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 the patient.

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

Table of contents

What Silseq is and what it is used for
Important information 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 belongs to a group of medicines called "topical anti-acne agents". It is used in the treatment of acne vulgaris with comedones (open and closed) and numerous papules and pustules (inflammatory pimples).
It contains two active substances, adapalene and benzoyl peroxide, which act together but in different ways:
Adapalene belongs to a group of medicines called retinoids and specifically affects skin processes causing acne.
Benzoyl peroxide, the second active substance, has antimicrobial activity and causes softening and exfoliation of the outer layer of the skin.
This medicine should only be used in adults and adolescents aged 12 years and older.

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 cut, abraded, sunburned, or affected by rash.
Take care to avoid getting the gel into the eyes, mouth, nose, or other sensitive areas of the body. If this occurs, immediately rinse the affected area thoroughly 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, hands should be washed carefully.
If persistent skin irritation occurs after starting treatment with this gel, inform 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 at the same time.
Avoid using Silseq together with cosmetics that irritate, dry out, or exfoliate the skin.
Other medicines may affect the action of this medicine. Therefore, inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines you 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 topic.
If you become pregnant during treatment with this medicine, treatment must be discontinued immediately and you should inform your doctor as soon as possible for further monitoring.

Breastfeeding
If you are breastfeeding, consult your doctor before using this medicine. Your doctor will decide whether you should discontinue breastfeeding or stop using this medicine.
If your doctor considers it acceptable to continue treatment, avoid applying the gel on the chest area to prevent the infant's exposure to the medicine.

Driving and operating machinery
Silseq has no effect or negligible effect on the ability to drive or operate machinery.

Silseq contains propylene glycol, which may cause skin irritation.
The medicine contains 40 mg of propylene glycol (E1520) per one 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 per 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 your
doctor or pharmacist.
This medicine is intended for use only in adults and adolescents aged 12 years and older. This
medicine is for topical use only.
The choice of strength will be determined by the physician based on the severity and appearance of acne lesions. The physician will also decide whether the patient requires additional treatment.

The skin should be clean and dry before applying the gel.
A thin layer of gel should be applied evenly to the entire affected facial and/or trunk area once daily, before bedtime. Avoid contact of the gel with the eyes, mouth, nostrils, and mucous membranes.
When applying the gel to the face: wash and dry the face, then apply an amount of gel equal to the size of a pea to each facial area (e.g., forehead, chin, each cheek).
Hands should be thoroughly washed immediately after applying the gel.

The duration of treatment will be determined by the physician. If no improvement is observed after 4–8 weeks of treatment, discuss with your doctor the benefits of continuing therapy.
If persistent skin irritation occurs during the first weeks of treatment, contact your doctor. The doctor may recommend using a moisturizing cream, applying the gel less frequently, temporarily interrupting treatment, or completely discontinuing the gel.
Do not use cosmetics (such as other facial creams or makeup products) before the daily application of the gel. These products may be used after the gel has been applied and dried.
Use in children
This medicine should not be used in children under 12 years of age.
Use of more than the recommended dose of Silseq
Applying more gel than recommended to the skin will not result in faster acne improvement, but may cause skin irritation and redness.
Contact your doctor or go to hospital in the following situations:

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

The doctor will decide what actions should be taken.
Missed dose of Silseq
Do not apply a double dose to make up for a missed dose.
Skin lesions (comedones, papules, pustules) will only begin to improve after several applications. Continue using the medicine for as long as directed by your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Approximately 1 in 10 people using this medicine may experience adverse skin reactions.
The medicine should be discontinued and medical advice sought immediately if the patient experiences throat tightness, swelling around the eyes, swelling of the face, lips or tongue, weakness or difficulty breathing.
The medicine should be discontinued if the patient develops hives or 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):

Skin burning sensation
Skin irritation
Rash
Skin redness
Skin peeling

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

Eyelid redness
Tingling or numbness at the application site
Itching, allergic skin reaction
Eruption
Dry skin

In addition to the adverse reactions listed above, the following adverse reactions have also been reported after using a gel containing adapalene and benzoyl peroxide at a lower strength (1 mg/g + 25 mg/g):

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

Sunburn

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

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

Typical adverse reactions associated with the use of Silseq include mild to moderate local reactions such as skin irritation with redness, dryness, peeling, stinging, and/or burning.
Burning sensations at the application site are usually superficial, but more severe cases with blister formation have also been reported.
If persistent skin irritation occurs during the first weeks of treatment, the patient should contact their doctor.
Skin-related adverse reactions such as skin irritation occur more frequently with the higher strength gel compared to the lower strength gel (adapalene 1 mg/g and benzoyl peroxide 25 mg/g). The patient may be advised to use a moisturizing cream, reduce the frequency of gel application, temporarily interrupt treatment, or discontinue the gel completely. These reactions usually occur at the beginning of treatment and gradually diminish over time.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, the patient should inform their doctor or pharmacist. Adverse reactions can be reported directly to:
Department of Monitoring of Adverse Drug Reactions
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

Adverse reactions can also be reported to the marketing authorization holder. Reporting adverse reactions helps 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 stated 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 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 acryloyldimethyl taurate (1:1), isohexadecane, polysorbate 80, sorbitan oleate); poloxamer 124; disodium edetate; sodium docecylbenzenesulfonate, purified water.

What Silseq looks like and contents of the pack
A homogeneous, opaque gel of white to very pale yellow colour.
The gel is packed in a white plastic tube made of HDPE/LLDPE, with a white neck made of HDPE and an aluminium peel-off seal, and a white polypropylene (PP) cap.
Pack sizes: one tube of 15 g, 30 g, 45 g or 60 g.
Not all pack sizes may be marketed.
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 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
For further 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