Neladap

Package leaflet: Information for the user

Neladap, 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 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. This medicine may harm other people, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor or pharmacist immediately. See section 4.

Contents of the leaflet

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 package and other information

1. What Neladap is and what it is used for

Neladap is used in the treatment of acne vulgaris.
This gel 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 that cause acne.
Benzoyl peroxide, the second active substance, has antibacterial action and softens and exfoliates the outer layer of the epidermis.

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 plans pregnancy.

Warnings and precautions
Before starting treatment with this medicine, discuss it with your doctor or pharmacist.
Do not apply this gel to skin with cuts, abrasions, or eczema.
Take care to avoid contact of this gel with eyes, mouth, nose, or other sensitive areas of the body.
If such contact 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, hands should be washed thoroughly.
Neladap and other medicines
Do not use other anti-acne medicines (containing benzoyl peroxide and/or retinoids) at the same time as this gel.
Do not use Neladap simultaneously with cosmetics that irritate, dry out, or exfoliate the skin.
Inform your doctor or pharmacist about all medicines you are currently using, have recently used, or plan to use.
Pregnancy and breastfeeding
Pregnancy
DO NOT USE Neladap during pregnancy or if the patient plans to become pregnant.
Further information is available from your treating physician.
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
This gel may be used during breastfeeding. To avoid exposing the infant to the medicine, do not apply it to the chest area.
Before using any medicine, consult your doctor or pharmacist.
Driving and operating machinery
Not applicable.
Neladap contains propylene glycol, which may cause skin irritation
This medicine contains 40 mg of propylene glycol (E1520) per gram of gel, equivalent to 4% w/w.
Neladap contains polysorbates, which may cause allergic reactions
This medicine contains 3 mg of polysorbate 80 per 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 exactly as directed by the doctor. If in doubt, consult a doctor or pharmacist.
This medicine is intended for use only in adults, adolescents, and children aged 9 years and older. This medicine is for topical use only.
Apply a thin, even layer of the gel to the acne-affected skin area once daily, before bedtime, avoiding the eye area, lips, and nostrils. The skin should be clean and dry before application. After applying the gel, hands should be thoroughly washed.
The doctor will decide how long this medicine should be used.
If the patient feels that the effect of Neladap is too strong or too weak, consult a doctor or pharmacist.
If the patient experiences persistent irritation during treatment with this medicine, contact a doctor. The doctor may recommend using moisturizing creams, less frequent application of the gel, a temporary interruption of treatment, or complete discontinuation of treatment.
Use of more than the recommended dose of Neladap
Applying more gel to the skin than recommended does not lead to faster improvement of acne and may cause skin irritation and redness.
Contact a doctor or go to hospital:

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

The doctor will advise on the necessary actions.
Missed dose of Neladap
Do not use 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 everybody gets them.
Treatment must be discontinued and immediate medical help must be sought if the patient experiences
a sensation of tightness in the throat or swelling of the eyes, face, lips or tongue, weakness or difficulty
in breathing. Treatment must 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):

• dry skin
• localised rash (contact dermatitis due to irritation)
• burning sensation of the skin
• skin irritation
• redness of the skin
• peeling of the stratum corneum

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

• itching of the skin
• sunburn

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

• facial swelling
• allergic contact reactions
• eyelid swelling
• sensation of tightness in the throat
• skin pain (stabbing pain)
• blisters on the skin
• breathing difficulties
• skin discolouration (changes in skin colour)
• application site burn

If skin irritation occurs after using this medicine, it is usually mild or moderate, with local symptoms such as redness, dryness, peeling, burning, and skin pain (stabbing pain), which are most intense during the first week of treatment and resolve without additional therapy.
Application site burns are usually superficial, but cases of more severe intensity with blister formation have been reported.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a 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 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Through reporting adverse reactions, additional information on the safety of the medicine can be collected.
Adverse reactions may also be reported to the marketing authorisation holder.

5. How to store the medicine Neladap

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box or
tube after: 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 no longer in 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 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 are: propylene glycol E1520; glycerol; sepineo P600 (copolymer of acrylamide and sodium acryloyldimethyltaurate (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.
Pack sizes available:
1 tube containing 30 g, 45 g or 60 g.
The gel is packed in white plastic tubes made of HDPE/LLDPE with a white HDPE neck and an aluminium peel-off seal, with a white polypropylene (PP) cap, placed in a cardboard carton.
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 Street 3
00-728 Warsaw
Email: [email protected]