4FLEX PUREGEL 100 mg/g Gel

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. 4Flex PureGel, 100 mg/g, Gel
   1. Read the package leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Package Leaflet Contents
3. What 4Flex PureGel is and what it is used for
   1. Indications for use:
4. Important information before using 4Flex PureGel
   1. When not to use 4Flex PureGel:
   2. Warnings and precautions
   3. Caution:
   4. Do not use the medicinal product:
   5. Children and adolescents
   6. 4Flex PureGel and other medicinal products
   7. Pregnancy, breastfeeding, and fertility
   8. Driving and using machines
   9. 4Flex PureGel contains alcohol (ethanol)
5. How to use 4Flex PureGel
   1. Using a higher dose of 4Flex PureGel than recommended
6. Possible side effects
   1. Reporting side effects
7. How to store 4Flex PureGel
8. Package contents and other information
   1. What 4Flex PureGel contains
   2. What 4Flex PureGel looks like and what the package contains
   3. Marketing authorization holder:
   4. Manufacturer:
   5. Date of last revision of the package leaflet:

Package Leaflet: Information for the Patient

4Flex PureGel, 100 mg/g, Gel

Naproxen

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in this package leaflet for the patient or as directed by the doctor.

• Keep this package leaflet, you may need to read it again.
• If you need advice or further information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in this package leaflet, they should tell their doctor or pharmacist. See section 4.
• If after 7 days there is no improvement or the patient feels worse, they should contact their doctor.

Package Leaflet Contents

• 1. What 4Flex PureGel is and what it is used for
• 2. Important information before using 4Flex PureGel
• 3. How to use 4Flex PureGel
• 4. Possible side effects
• 5. How to store 4Flex PureGel
• 6. Package contents and other information

1. What 4Flex PureGel is and what it is used for

4Flex PureGel is a medicinal product in the form of a gel. It contains the active substance naproxen in the amount of 100 mg/g, belonging to nonsteroidal anti-inflammatory drugs (NSAIDs). The gel is applied topically to the skin, for analgesic and anti-inflammatory purposes. The effect of the action is to reduce pain and swelling.

Indications for use:

• Musculoskeletal pain;
• Osteoarthritis.

2. Important information before using 4Flex PureGel

When not to use 4Flex PureGel:

• in patients with a history of allergic reactions, such as bronchospasm, urticaria, or acute rhinitis after using acetylsalicylic acid or other substances that inhibit prostaglandin synthesis.

Warnings and precautions

Before starting to use 4Flex PureGel, the patient should discuss it with their doctor or pharmacist.

Caution:

• in case of hypersensitivity reactions with facial swelling, redness, or bronchospasm.

It is not recommended to use naproxen in the form of a gel for a long period and on large areas of skin, as systemic side effects may occur. If any of the above reactions occur, the use of the medicinal product should be discontinued.

Do not use the medicinal product:

• on mucous membranes and in the eyes - if the gel gets into the eyes or on the mucous membranes, it should be removed, rinsing abundantly with water;
• under dressings (bandages or wound dressings);
• orally.

Additionally, during treatment and for 2 weeks after the end of treatment, the patient should avoid direct sunlight and sunbathing in a solarium. Due to the possibility of naproxen absorption into the bloodstream, caution should be exercised when treating patients with liver, kidney, gastrointestinal ulcers, and bleeding disorders.

Children and adolescents

Do not use in children and adolescents.

4Flex PureGel and other medicinal products

The patient should tell their doctor about all medicinal products they are currently using or have recently used, as well as any medicinal products they plan to use. 4Flex PureGel can be used at the same time as other pharmaceutical forms of naproxen (tablets, suppositories, etc.). Before starting to use this medicinal product, the patient should talk to their doctor or pharmacist if they are using any of the following medicinal products:

• Aspirin/acetylsalicylic acid used to prevent blood clots. Naproxen may decrease platelet aggregation and prolong bleeding time.

Pregnancy, breastfeeding, and fertility

Pregnancy
Oral forms (e.g., tablets) of 4Flex PureGel may cause side effects in the unborn child. It is not known whether this risk occurs when using 4Flex PureGel on the skin. If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicinal product. Do not use 4Flex PureGel during the last 3 months of pregnancy. Do not use 4Flex PureGel during the first 6 months of pregnancy, unless absolutely necessary and recommended by a doctor. If treatment is necessary during this period, the patient should take the smallest possible dose for the shortest possible time. The medicinal product should not be used during pregnancy, except in cases recommended and supervised by a doctor. The use of naproxen in the first and second trimester of pregnancy requires careful consideration by the doctor of the potential benefits to the mother and the fetus. The use of the medicinal product in the third trimester of pregnancy is contraindicated. Data on the administration of naproxen in pregnant women are limited or not available. Reproductive toxicity studies in animals do not indicate direct or indirect harmful effects. Breastfeeding
It is not recommended to use the medicinal product during breastfeeding. The decision to stop breastfeeding or treat with naproxen in the form of a gel should be made after considering the risk to the breastfed child or the benefits to the mother. Fertility
No negative effect on fertility has been observed in relation to the active substance.

Driving and using machines

There are no data on the effect of naproxen used topically on the ability to drive and use machines.

4Flex PureGel contains alcohol (ethanol)

This medicinal product contains 300 mg of alcohol (ethanol) per gram, which is equivalent to about 2 cm of gel squeezed from the tube. It may cause a burning sensation on damaged skin. The medicinal product contains alcohol, do not use near fire.

3. How to use 4Flex PureGel

This medicinal product should always be used exactly as described in this package leaflet for the patient or as directed by the doctor. If in doubt, the patient should consult their doctor or pharmacist. Unless the doctor recommends otherwise, the medicinal product should be used as follows: apply a strip of gel to the skin, depending on the size of the painful area (usually a strip of gel about 4 cm long) and gently massage until absorbed. Use 4 to 5 times a day at intervals of several hours. Do not use 4Flex PureGel for more than a few weeks (usually up to 4 weeks). Do not use more than 1000 mg of naproxen per day. After using the medicinal product, the patient should wash their hands, unless the treatment concerns them. The application site should not be covered with dressings, such as bandages or wound dressings. If the symptoms (e.g., pain and swelling) do not improve or worsen after 1 week of using the medicinal product, the patient should contact their doctor. If redness and skin irritation occur, the patient should discontinue use, and if the symptoms do not improve, they should consult their doctor.

Using a higher dose of 4Flex PureGel than recommended

Due to the low absorption of naproxen through the skin into the bloodstream, there is no risk of overdose or poisoning with the medicinal product intended for topical use. However, as a result of improper use or accidental ingestion, systemic side effects may occur. In such a case, the doctor will use the treatment suitable for nonsteroidal anti-inflammatory drug poisoning. If the medicinal product is accidentally ingested, the patient should contact their doctor. If the patient has any further doubts about using this medicinal product, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicinal products, 4Flex PureGel can cause side effects, although not everybody gets them. 4Flex PureGel is usually well tolerated. Side effects may occur with the following frequency: very common: more than 1 in 10 people; common: 1 in 10 to 1 in 100 people; uncommon: 1 in 100 to 1 in 1000 people; rare: 1 in 1000 to 1 in 10,000 people; very rare: less than 1 in 10,000 people; frequency not known: frequency cannot be estimated from the available data. Immune system disorders
Frequency not known: hypersensitivity*. Nervous system disorders
Frequency not known: headache*, drowsiness*. Gastrointestinal disorders
Frequency not known: diarrhea*, nausea*. Skin and subcutaneous tissue disorders
Rare: skin irritation (redness, rash). Frequency not known: generalized allergic skin reaction, hypersensitivity to light, itching, blistering rash, which disappears after discontinuation of the medicinal product. *In the case of long-term use on large areas of skin, systemic side effects may occur, e.g., nausea, diarrhea, drowsiness, headaches, hypersensitivity reactions (allergies). In such cases, the patient should inform their doctor. If shortness of breath or skin changes occur, the patient should immediately stop using the medicinal product, consult their doctor, or go to the nearest hospital.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in this package leaflet, they should tell their doctor, pharmacist, or nurse. 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, it is possible to gather more information on the safety of the medicinal product.

5. How to store 4Flex PureGel

The medicinal product should be stored out of sight and reach of children. Do not store above 25°C. Do not store in the refrigerator or freeze. Do not use this medicinal product after the expiry date stated on the tube and carton. The expiry date refers to the last day of the specified month. Do not use this medicinal product if a change in appearance or smell is visible. The medicinal product can be used for 6 months after the first opening of the tube. Medicinal products should not be disposed of via wastewater or household waste containers. The patient should ask their pharmacist how to dispose of medicinal products that are no longer needed. This will help protect the environment.

6. Package contents and other information

What 4Flex PureGel contains

• The active substance of the medicinal product is naproxen. 100 mg of naproxen is present in 1 g of gel.
• The other excipients are: trometamol, ethanol 96%, carbomer, purified water.

What 4Flex PureGel looks like and what the package contains

4Flex PureGel is a colorless to light yellowish transparent gel with an alcohol smell. The package consists of an aluminum tube internally coated with an epoxy-phenolic lacquer with a membrane and a HDPE screw cap in a cardboard box. Package sizes: 1 tube of 50 g; 1 tube of 100 g. Not all package sizes may be marketed.

Marketing authorization holder:

Bausch Health Ireland Limited, 3013 Lake Drive, Citywest Business Campus, Dublin 24, D24PPT3, Ireland, Tel: +48 17 865 51 00

Manufacturer:

EMO-FARM Sp. z o.o., ul. Łódzka 52, 95-054 Ksawerów

Date of last revision of the package leaflet: