NELADAP 1 mg /G + 25 Mg/G Gel

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Neladap, 1 mg/g + 25 mg/g, Gel
   1. Read the package leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of Contents of the Package Leaflet
3. What is Neladap and what is it used for
4. Important information before using Neladap
   1. When not to use Neladap
   2. Warnings and precautions
   3. Neladap and other medicines
   4. Pregnancy and breastfeeding Pregnancy
   5. Driving and using machines
   6. Neladap contains propylene glycol, which may cause skin irritation
   7. Neladap contains polysorbates, which may cause allergic reactions
   8. Neladap contains benzoyl peroxide, a decomposition product of benzoyl peroxide, which may cause local irritation.
5. How to use Neladap
   1. Using more than the recommended dose of Neladap
   2. Missing a dose of Neladap
6. Possible side effects
   1. Reporting side effects
7. How to store Neladap
8. Contents of the pack and other information
   1. What Neladap contains
   2. What Neladap looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. This medicine is authorized in the Member States of the European Economic Area under the following names:
   6. For more information about this medicine, contact the local representative of the marketing authorization holder:
   7. Date of last revision of the package leaflet:

Package Leaflet: Information for the User

Neladap, 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 package 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, tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Neladap and what is it 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 is Neladap and what is it used for

Neladap is used for the treatment of 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 processes in the skin that cause acne.
Benzoyl peroxide, the second active substance, has antibacterial effects and also softens and sheds the outer layer of the skin.

2. Important information before using Neladap

When not to use Neladap

• if you are allergic to adapalene or benzoyl peroxide, or any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant.
• if you are planning to become pregnant.

Warnings and precautions

Before starting to use this medicine, you should discuss it with your doctor or pharmacist.
Do not use this gel on skin with cuts, scrapes, or eczema.
Be careful not to get this gel in your eyes, mouth, nose, or other sensitive areas of the body.
If this happens, rinse the area 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 discolor them.
After using the medicine, wash your hands thoroughly.

Neladap and other medicines

Do not use other acne medicines (containing benzoyl peroxide and/or retinoids) at the same time as this gel.
Do not use Neladap at the same time as cosmetics that irritate, dry, or shed 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 USENeladap during pregnancy or if you are planning to become pregnant.
More information can be obtained from your doctor.
If you become pregnant while using this medicine, stop treatment and inform your doctor as soon as possible for further monitoring.
Breastfeeding
This gel can be used during breastfeeding. To avoid exposing the baby to the medicine, do not apply it to the breast area.
Before using any medicine, consult your doctor or pharmacist.

Driving and using machines

Not applicable.

Neladap contains propylene glycol, which may cause skin irritation

This medicine contains 40 mg of propylene glycol (E1520) per gram of gel, which corresponds to 4% w/w.

Neladap contains polysorbates, which may cause allergic reactions

This medicine contains 3 mg of polysorbate 80 per gram of gel, which corresponds to 0.3% w/w.

Neladap contains benzoyl peroxide, a decomposition product of benzoyl peroxide, which may cause local irritation.

3. How to use Neladap

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 use on the skin only.
Apply a thin layer of gel evenly to the affected area of the skin once a day, before going to bed, avoiding the area around the eyes, mouth, and nostrils. Before applying the medicine, the skin should be clean and dry. After using the gel, wash your hands thoroughly.
Your doctor will decide how long you should use this medicine.
If you think that the effect of Neladap is too strong or too weak, tell your doctor or pharmacist.
If you experience continuous irritation while using this medicine, contact your doctor. Your doctor may recommend using moisturizing creams, applying the gel less frequently, or stopping treatment for a while, or stopping treatment altogether.

Using more than the recommended dose of Neladap

Using more gel on the skin than recommended will not make acne disappear faster, but may cause irritation and redness of the skin.
Contact your doctor or go to the hospital:

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

Your doctor will tell you what to do.

Missing a dose of Neladap

Do not use a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop using the medicine and seek immediate medical attention if you experience a feeling of constriction in the throat or swelling of 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.
Common(may affect up to 1 in 10 people):

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

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

• itching of the skin
• sunburn

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

• facial swelling
• contact allergic reactions
• eyelid swelling
• feeling of constriction in the throat
• skin pain (stabbing pain)
• blisters on the skin
• difficulty breathing
• skin discoloration (changes in skin color)
• burning sensation at the application site

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 severe during the first week of use and subside without additional treatment.
Burning sensations at the application site are usually superficial, but cases of more severe burning sensations with blisters have been reported.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported 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
By reporting side effects, you can help provide more information on the safety of this medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store Neladap

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 or tube after: EXP = Expiry date. The expiry date refers to the last day of that month.
Do not store above 30°C.
After first opening the tube, the medicine should be used within 3 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 Neladap 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, which corresponds 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 Neladap looks like and contents of the pack

Homogeneous, opaque gel, white to very pale yellow in color.
Available pack sizes:
1 tube of 30 g, 45 g, or 60 g.
The gel is packed in white HDPE/LLDPE plastic tubes with a white HDPE neck and a peel-off aluminum seal, with a white PP cap, in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization 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 medicine is authorized in the Member States of the European Economic Area under the following names:

For more information about this medicine, contact the local representative of the marketing authorization holder:

Glenmark Pharmaceuticals Sp. z o. o.
ul. Dziekońskiego 3
00-728 Warsaw
Email: [email protected]

Date of last revision of the package leaflet: