4flex puregel

Package leaflet: Information for the patient

4Flex PureGel, 100 mg/g, gel
Naproxen
Please read all of this leaflet carefully before using the medicine, because it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
the physician.

• Keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement or if you feel worse after 7 days, consult your doctor.

Table of contents of the leaflet

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 adverse reactions
5. How to store 4Flex PureGel
6. Contents of the pack and other information

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

4Flex PureGel is a medicine in the form of a gel. It contains the active substance naproxen at a concentration of 100 mg/g,
which belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs).
The gel is applied topically to the skin for analgesic and anti-inflammatory effects. Its action results in reduction of pain and swelling.
Indications:

• Musculoskeletal pain;
• Osteoarthritis.

2. Important information before using the medicine 4Flex PureGel

When not to use 4Flex PureGel:

• if the patient is allergic to naproxen or any of the other ingredients of this medicine (listed in section 6);
• if the patient is allergic to other non-steroidal anti-inflammatory drugs (NSAIDs) or acetylsalicylic acid;
• if the patient has inflammatory skin conditions, skin damage, or open wounds;
• if the patient is in the third trimester of pregnancy;
• in patients with a history of allergic reactions such as bronchospasm, urticaria, or acute rhinitis after taking acetylsalicylic acid or other substances inhibiting prostaglandin synthesis.

Warnings and precautions
Before starting treatment with 4Flex PureGel, consult your doctor or pharmacist.
Exercise caution:

• if allergic reactions (rash, itching, redness) occurred previously during use of other non-steroidal anti-inflammatory drugs;
• in case of hypersensitivity reactions with facial swelling, redness, or bronchospasm.

Prolonged use of naproxen in gel form over large areas of skin is not recommended, as systemic adverse effects may occur.
If any of the above reactions occur, discontinue use of the medicine immediately.
Do not use the medicine:

• if the patient has inflammatory skin conditions, skin damage, or open wounds;
• on mucous membranes or in the eyes – if the gel comes into contact with eyes or mucous membranes, remove immediately by thoroughly rinsing with water;
• under dressings (bandages or adhesive plasters);
• orally.

Additionally, during treatment and for 2 weeks after treatment ends, avoid direct sunlight and sunbeds.
Due to the possibility of naproxen being absorbed into the bloodstream, caution is advised when treating patients with hepatic or renal impairment, gastrointestinal ulcers, or bleeding disorders.
Children and adolescents
Do not use in children and adolescents.
4Flex PureGel and other medicines
Inform your doctor about all medicines currently used or recently used, as well as any medicines the patient plans to take.
4Flex PureGel may be used simultaneously with other pharmaceutical forms of naproxen (e.g. tablets, suppositories).
Before starting treatment with this medicine, talk to your doctor or pharmacist if the patient is taking any of the following medicines:

• Aspirin/acetylsalicylic acid used for prevention of blood clots. Naproxen may reduce platelet aggregation and prolong bleeding time.

Pregnancy, breastfeeding, and effects on fertility
Pregnancy
Oral forms (e.g. tablets) of 4Flex PureGel may cause adverse effects in the unborn child. It is not known whether this risk applies when using 4Flex PureGel on the skin.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Do not use 4Flex PureGel during the last 3 months of pregnancy. 4Flex PureGel should not be used during the first 6 months of pregnancy unless absolutely necessary and recommended by a doctor. If treatment is required during this period, the lowest possible dose should be used for the shortest possible duration.
This medicine should not be used during pregnancy except when specifically recommended and supervised by a doctor. Use of naproxen during the first and second trimesters of pregnancy requires careful consideration by the doctor of potential benefits to the mother and fetus. Use of the medicine during the third trimester of pregnancy is contraindicated. Data on administration of naproxen in pregnant women are limited or unavailable. Reproductive toxicity studies in animals have not indicated direct or indirect harmful effects.
Breastfeeding
Use of this medicine during breastfeeding is not recommended. A decision whether to discontinue breastfeeding or to discontinue therapy with naproxen in gel form should be made by weighing the risk to the breastfed infant against the benefit to the mother.
Fertility
No negative effect on fertility has been observed in relation to the active substance.
Driving and operating machinery
There are no data on the effect of topically applied naproxen on the ability to drive or operate machinery.
4Flex PureGel contains alcohol (ethanol)
This medicine contains 300 mg of alcohol (ethanol) per gram, equivalent to approximately 2 cm³ of gel squeezed from the tube. It may cause stinging on damaged skin.
The medicine contains alcohol; do not use near fire.

3. How to use 4Flex PureGel

This medicine should always be used exactly as described in this patient information leaflet or as advised by your doctor. If in doubt, consult your doctor or pharmacist.
Unless otherwise directed by your doctor, apply to the skin a strip of gel in an amount depending on the size of the painful area (usually a strip of gel approximately 4 cm long) and gently massage until fully absorbed. Apply 4 to 5 times daily at several-hour intervals. Do not use 4Flex PureGel for longer than a few weeks (usually up to 4 weeks). Do not exceed 1000 mg of naproxen per day.
After applying the medicine, wash your hands unless the hands are the treated area.
Do not cover the application site with dressings such as bandages or plasters.
If symptoms (e.g. pain and swelling) do not improve or worsen after one week of treatment, consult your doctor.
If skin redness or irritation occurs, discontinue use of the medicine; if symptoms persist, consult your doctor.
Use of a higher than recommended dose of 4Flex PureGel
Due to the low absorption of naproxen through the skin into the bloodstream, there is no significant risk of overdose or systemic poisoning with this topical medicine.
However, improper use or accidental ingestion may lead to systemic adverse effects. In such cases, the doctor will administer treatment appropriate for poisoning with non-steroidal anti-inflammatory drugs.
In case of accidental ingestion, contact your doctor immediately.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicinal product may cause adverse reactions, although not everybody experiences them.
4Flex PureGel is generally well tolerated.
Adverse reactions may occur with the following frequencies:
very common: more than 1 in 10 people
common: 1 to 10 in 100 people
uncommon: 1 to 10 in 1,000 people
rare: 1 to 10 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*, somnolence*.

Gastrointestinal disorders
Frequency not known: diarrhoea*, nausea*.

Skin and subcutaneous tissue
Rare: skin irritation (erythema, rash).
Frequency not known: generalized allergic skin reactions, photosensitivity, pruritus, vesicular rash, which resolve upon discontinuation of the medicine.

*With prolonged use over large areas of skin, systemic adverse effects may occur, such as nausea, diarrhoea, somnolence, headache, and hypersensitivity reactions (allergy). In such cases, consult a physician. If dyspnoea or skin changes occur, discontinue use immediately, consult a doctor or go to the nearest hospital.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. 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,
tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl .
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store 4Flex PureGel

Keep this medicine 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 medicine after the expiry date stated on the tube and carton.
The expiry date refers to the last day of the stated month.
Do not use this medicine if a change in appearance or odour is noticeable.
This medicine can be used for 6 months after first opening the tube.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What 4Flex PureGel contains

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

What 4Flex PureGel looks like and contents of the pack
4Flex PureGel is a transparent, colourless to slightly straw-coloured gel with an alcoholic odour.
The container is an aluminium tube internally coated with epoxy-phenolic lacquer, with a membrane and a cap made of HDPE, packed in a cardboard box.
Pack sizes:
1 tube containing 50 g
1 tube containing 100 g.
Not all pack sizes may be marketed.
Marketing Authorisation 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