Neladap

Package leaflet: Information for the user

Neladap, 3 mg/g + 25 mg/g, gel
Adapalene + Benzoyl peroxide
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm another person, 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

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

1. What Neladap is and what it is used for

Neladap gel 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), numerous papules and pustules (inflammatory lesions).
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 skin processes that cause acne.
• Benzoyl peroxide, the second active substance, has antibacterial action and softens and desquamates the outer layer of the epidermis.

Neladap should only be used in adults and adolescents aged 12 years and older.

2. Important information before using Neladap

When not to use Neladap

• 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 is planning pregnancy.

Warnings and precautions
Before starting to use this medicine, discuss it with your doctor or pharmacist.
Do not apply this gel to skin that has cuts, abrasions, or rashes.
Take care to avoid getting this gel into the eyes, mouth, nose, or onto other sensitive areas of the body.
If this occurs, wash the affected areas thoroughly with plenty of warm water.
Avoid excessive exposure to sunlight and UV lamps.
Avoid contact of this gel with hair or dyed fabrics, as it may cause bleaching.
After applying the medicine, wash your hands thoroughly.
If persistent skin irritation occurs after starting treatment with the gel, contact your doctor (see section 3. How to use Neladap).

Neladap and other medicines
Do not use other anti-acne medications (containing benzoyl peroxide and/or retinoids) simultaneously with this gel.
Do not use Neladap gel together with cosmetics that are irritating, drying, or exfoliating to the skin.
Other medicines may affect treatment with this gel or be affected by it. Therefore, inform your doctor or pharmacist about all medicines you are currently using or have recently used, as well as any medicines you plan to use.

Pregnancy and breastfeeding
Pregnancy
DO NOT USE Neladap during pregnancy or if the patient is planning to become pregnant.
Further information should be obtained from your doctor.
If a woman becomes pregnant while using this medicine, treatment must be stopped immediately and the doctor informed as soon as possible for further monitoring.

Breastfeeding
If the patient is breastfeeding, she should consult her doctor before using this medicine. The doctor will advise whether breastfeeding should be discontinued or use of this gel avoided.
If the doctor recommends continuing treatment, do not apply the gel to the chest area to prevent the infant from being exposed to the medicine.

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

Neladap contains propylene glycol, which may cause skin irritation
This medicine contains 40 mg of propylene glycol (E1520) in each gram of gel, equivalent to 4% w/w.

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

Neladap contains benzoic acid, a breakdown product of benzoyl peroxide, which may cause local irritation.

3. How to use Neladap

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 only in adults and adolescents aged 12 years and older. This medicine is for topical use only.
The physician will decide which gel strength the patient requires, depending on the severity and appearance of acne lesions. The physician will also determine whether additional treatment is necessary.

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

The physician will inform the patient how long the medicine should be used. If no improvement is seen after 4–8 weeks, discuss with the physician the benefits of continuing treatment.
If persistent skin irritation occurs during the first few weeks of using this gel, contact the physician. The physician may recommend using a moisturizing cream, reducing the frequency of gel application, temporarily interrupting treatment, or permanently discontinuing use of the gel.
Cosmetics (such as other facial creams or makeup products) should not be used before daily application of the gel. These products may be used after the gel has been absorbed.

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

Use of more than the recommended dose of Neladap
Applying more gel to the skin than recommended does not lead to faster acne clearance and may cause skin irritation and redness.
Contact a doctor or go to hospital:

• if more Neladap medicine has been applied than recommended,
• if a child has accidentally used the medicine,
• if the medicine has been accidentally swallowed.

The physician will advise what actions should be taken.

Missed dose of Neladap
Do not use a double dose to make up for a missed dose.
Skin lesions (comedones, papules, and pustules) will improve only after several applications of this medicine.
Continue using this medicine for as long as directed by the physician.
If further doubts arise regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
Skin-related adverse reactions may occur in approximately 1 in 10 people using this medicine.
The medicine should be discontinued and immediate medical help should be sought if the patient experiences
a sensation of throat tightness or swelling around the eyes, 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 (may occur in up to 1 in 10 people):

• burning sensation of the skin
• skin irritation
• rash
• redness of the skin
• skin peeling

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

• eyelid redness
• tingling or pricking sensation at the application site
• itching of the skin, skin allergic reaction
• eruption
• dry skin

In addition to the adverse reactions listed above, the following adverse reactions have been reported after use of a lower-strength adapalene and benzoyl peroxide gel (1 mg/g + 25 mg/g):
Uncommon (may occur in up to 1 in 100 people):

• sunburn

Frequency unknown (frequency cannot be determined from available data):

• eyelid swelling
• sensation of throat tightness
• allergic contact dermatitis
• facial swelling
• skin pain (pricking pain)
• blisters
• breathing difficulties
• skin discoloration (changes in skin color)
• burning at the application site

Typical adverse reactions observed with the use of Neladap are mild to moderate local reactions at the application site, such as skin irritation with redness, dryness, peeling, pricking and/or burning sensation of the skin.
Burning at the application site is usually superficial, but cases with more severe intensity and blistering have been reported.
If persistent skin irritation occurs during the first weeks of treatment, consult a doctor. Cutaneous adverse reactions such as skin irritation occur more frequently with the higher-strength gel than with the lower-strength gel (adapalene and benzoyl peroxide 1 mg/g + 25 mg/g). The doctor may recommend using a moisturizing cream, reducing the frequency of gel application, temporarily discontinuing or completely stopping gel use.
These adverse reactions usually occur at the beginning of treatment and tend to gradually subside over time.
Reporting of adverse reactions
If any adverse effects occur, including any adverse effects 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, 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
Reporting adverse reactions helps to collect more information on the safety of the medicine.
Adverse reactions can also be reported to the marketing authorization holder.

5. How to store Neladap

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or tube: EXP = Expiry date. 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 should be used within 6 months.
Medicines must not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Neladap contains

• The active substances are: adapalene and benzoyl peroxide. Each 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.
• Other components: 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 docecynate; purified water.

What Neladap looks like and contents of the pack
A homogeneous, opaque gel, white to very pale yellow in colour.
The gel is filled into white plastic tubes made of HDPE/LLDPE with a white HDPE neck and an aluminium "peel-off" seal, and closed with a white polypropylene (PP) cap, packed in a cardboard box.
Pack sizes:
1 tube of 15 g, 30 g, 45 g or 60 g.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Glenmark Pharmaceuticals s.r.o.
Hvězdova 1716/2b
140 78 Prague 4
Czech Republic
Manufacturer
Adalvo Limited
Malta Life Sciences Park, Building 1, Level 4
Sir Temi Zammit Buildings
SGN 3000 San Gwann
Malta
Beltapharm S.p.A.
Via Stelvio 66
20095 Cusano Milanino
Italy
This medicinal product is authorised in the European Economic Area under the following names:

For more detailed information about this medicinal product, please contact the local representative of the marketing authorization holder:
Glenmark Pharmaceuticals Sp. z o.o.
Dziekonskiego 3 Street
00-728 Warsaw
Email: [email protected]