NELADAP 3 mg /G + 25 Mg/G Gel

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Neladap, 3 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 breast-feeding 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 which may cause local irritation
5. How to use Neladap
   1. Use in children
   2. Using more than the recommended dose of Neladap
   3. 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 further information about this medicine, please 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, 3 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 only. 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 gel belongs to a group of medicines called "topical anti-acne agents". It is used to treat mild to moderate acne vulgaris, with open and closed comedones, multiple 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 the processes in the skin that cause acne.
• Benzoyl peroxide, the second active substance, has antibacterial properties and also softens and sheds the outer layer of the skin.

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

Warnings and precautions

Before starting to use this medicine, discuss it with your doctor or pharmacist.
Do not use this gel on skin with cuts, abrasions 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.
If you experience persistent skin irritation 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 medicines (containing benzoyl peroxide and/or retinoids) at the same time as the gel.
Do not use this medicine at the same time as cosmetics that irritate, dry or peel the skin.
Other medicines may affect the treatment or the gel, so tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.

Pregnancy and breast-feeding Pregnancy

DO NOT USENeladap during pregnancy or if you are planning to become pregnant.
For more information, consult your doctor.
If you become pregnant while using this medicine, stop treatment and inform your doctor as soon as possible for further monitoring.
Breast-feeding
If you are breast-feeding, consult your doctor before using this medicine. Your doctor will advise you whether to stop breast-feeding or avoid using the gel.
If your doctor recommends continuing treatment, do not apply the gel to the breast area to prevent exposure of the child to the medicine.

Driving and using machines

Neladap has no or negligible influence on the ability to drive and use machines.

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 which may cause local irritation

3. How to use Neladap

This medicine should always be used as directed by your doctor. If you are unsure, 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 use on the skin only.
Your doctor will decide which strength of the gel you need, depending on the severity of the condition and the appearance of the acne lesions. Your doctor will also decide whether to use additional treatment.

• The skin should be clean and dry before applying the gel.
• Apply a thin layer of the gel evenly to the entire affected area of the face and/or trunk once a day, before bedtime. Avoid contact with the eyes, mouth, nostrils and mucous membranes.
• When using on the face: wash and dry the face and apply an amount the size of a grain of rice to each area of the face (e.g. forehead, chin, each cheek)
• After applying the gel, wash your hands thoroughly.

Your doctor will tell you how long to use this medicine. If there is no improvement after 4-8 weeks, discuss the benefits of continuing treatment with your doctor.
If you experience persistent skin irritation during the first weeks of using the gel, contact your doctor. Your doctor may recommend using a moisturizing cream, applying the gel less frequently, temporarily stopping treatment or completely stopping treatment with the gel.
Do not use cosmetics (such as other face creams or makeup products) before applying the gel daily. These products can be applied after the gel has been absorbed.

Use in children

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

Using more than the recommended dose of Neladap

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

Your doctor will tell you what actions to take.

Missing a dose of Neladap

Do not use a double dose to make up for a forgotten dose.
Lesions (comedones, papules and pustules) will decrease only after several applications of the medicine.
Continue to use this medicine for as long as your doctor recommends.
If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
About 1 in 10 people using this medicine may experience unwanted skin reactions.
Stop using the medicine and seek immediate medical attention if you experience a feeling of tightness 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):

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

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

• eyelid redness
• tingling or stinging sensation at the application site
• itching of the skin, skin allergic reaction
• rash
• dryness of the skin

Besides the side effects listed above, the following side effects have also been reported with the use of a lower-strength gel containing adapalene and benzoyl peroxide (1 mg/g + 25 mg/g):
Uncommon(may affect up to 1 in 100 people):

• sunburn

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

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

Typical side effects that occur with the use of Neladap are mild to moderate reactions at the application site, such as skin irritation with redness, dryness, peeling, stinging or burning sensation of the skin.
Burning sensations at the application site are usually superficial, but cases of more severe burning sensations with blisters have been reported.
If persistent skin irritation occurs during the first weeks of using the medicine, contact your doctor. Skin side effects, such as skin irritation, occur more frequently with the use of a higher-strength gel than with a lower-strength gel (adapalene and benzoyl peroxide 1 mg/g + 25 mg/g). Your doctor may recommend using a moisturizing cream, applying the gel less frequently, temporarily stopping treatment or completely stopping treatment with the gel.
These side effects usually occur at the beginning of treatment and tend to disappear over time.

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 Drug Safety Monitoring of the 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
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 and 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 3 mg (0.3% w/w) of adapalene and benzoyl peroxide with water, corresponding 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, non-transparent gel, white to very pale yellow in color.
The gel is packed in white HDPE/LLDPE plastic tubes with a white HDPE neck and a peel-off type aluminum seal, with a white PP cap, in a cardboard box.
Available pack sizes:
1 tube of 15 g, 30 g, 45 g or 60 g.
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 further information about this medicine, please 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: