Naproxen Emo

Package Leaflet: Information for the Patient

NAPROXEN EMO, 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 a doctor or pharmacist.

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

Table of Contents of the Leaflet

• 1. What is NAPROXEN EMO and what is it used for
• 2. Important information before using NAPROXEN EMO
• 3. How to use NAPROXEN EMO
• 4. Possible side effects
• 5. How to store NAPROXEN EMO
• 6. Contents of the pack and other information

1. What is NAPROXEN EMO and what is it used for

NAPROXEN EMO is a gel. It contains the active substance naproxen in the amount of 100 mg/g, which belongs to nonsteroidal anti-inflammatory drugs (NSAIDs). The medicine is a pain-relieving and anti-inflammatory gel for topical use on the skin. As a result, there is a reduction in pain and swelling, as well as a return of mobility. The medicine causes a pleasant cooling sensation on the skin.

Indications for use:

• Musculoskeletal pain;
• Osteoarthritis.

2. Important information before using NAPROXEN EMO

When not to use NAPROXEN EMO:

Warnings and precautions

Before starting to use NAPROXEN EMO, the patient should discuss it with their doctor or pharmacist:

while being treated with nonsteroidal anti-inflammatory drugs;

If any of the above reactions occur, the patient should stop using the medicine.

Do not use the medicine:

• in the eyes and on mucous membranes; if the gel gets into the eyes or on mucous membranes, it should be removed by rinsing with plenty of water;
• on injured skin, open wounds, and skin inflammatory conditions;
• under bandages (dressings or band-aids);
• orally.

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

Children and adolescents

Do not use NAPROXEN EMO in children under 3 years of age.

NAPROXEN EMO and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. NAPROXEN EMO can be used at the same time as other pharmaceutical forms of naproxen (tablets, suppositories, etc.). Before starting to take this medicine, the patient should talk to their doctor or pharmacist if they are taking any of the following medicines: 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 NAPROXEN EMO may cause side effects in the unborn child. It is not known if the same risk occurs when using NAPROXEN EMO 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 medicine. Do not use NAPROXEN EMO during the last 3 months of pregnancy. Do not use NAPROXEN EMO during the first 6 months of pregnancy, unless absolutely necessary and recommended by a doctor. In case of necessity to treat during this period, the shortest possible time should be used. Breastfeeding Do not use the medicine while 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 or fetal harm has been found in relation to the active substance.

Driving and using machines

There are no data on side effects after topical use of naproxen on the skin that may affect the ability to drive and use machines.

NAPROXEN EMO contains ethyl 4-hydroxybenzoate

The medicine contains 1.50 mg of ethyl 4-hydroxybenzoate in each gram. It may cause allergic reactions (possible late reactions).

NAPROXEN EMO contains alcohol (ethanol)

This medicine contains 0.90 mg of alcohol (ethanol) in each gram. It may cause a burning sensation on damaged skin.

3. How to use NAPROXEN EMO

This medicine should always be used exactly as described in this package leaflet for the patient or as directed by a doctor. In case of doubt, the patient should consult their doctor or pharmacist. Unless the doctor recommends otherwise, the patient should follow the following dosage regimen: apply the medicine to the skin in an amount dependent on the size of the painful area (usually a strip of gel about 4 cm long), spread it over the painful area, and gently massage until completely absorbed. The medicine should be used 4 to 5 times a day, at intervals of several hours. After using the medicine, the patient should wash their hands, unless they are being treated. Do not use NAPROXEN EMO for more than a few weeks (usually up to 4 weeks). If the pain and swelling do not subside or worsen after 1 week of using the medicine, the patient should contact their doctor. If redness and skin irritation occur, the patient should stop using the medicine until the symptoms subside; if the symptoms do not subside, they should consult their doctor. Do not use the medicine in children under 3 years of age.

Using a higher dose of NAPROXEN EMO 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 medicine 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 appropriate therapeutic approach for nonsteroidal anti-inflammatory drug poisoning. In case of accidental ingestion of the medicine, the patient should contact their doctor. If the patient has any further doubts about using this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, NAPROXEN EMO can cause side effects, although not everybody gets them. NAPROXEN EMO is usually well tolerated. Side effects may occur with the following frequency: rare: in 1 to 10 people out of 10,000, frequency not known: frequency cannot be estimated from the available data Rare: skin irritation (redness, rash). Frequency not known: hypersensitivity*, headache*, drowsiness*, diarrhea*, nausea*, generalized allergic skin reaction, hypersensitivity to light, itching, vesicular rash, *In case NAPROXEN EMO is used on large areas of skin for a longer period, it cannot be excluded that systemic side effects may occur, such as drowsiness, diarrhea, nausea, headache, hypersensitivity reactions (allergy). In such cases, the patient should inform their doctor. If shortness of breath or skin changes occur, the patient should stop using the medicine immediately, inform their doctor, or go to the nearest hospital. If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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 medicine.

5. How to store NAPROXEN EMO

The medicine should be stored out of sight and reach of children. Do not store the medicine in the refrigerator or freeze it. 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 given month. Do not use this medicine if the patient notices a change in its appearance or smell. Medicines should not be disposed of via wastewater or household waste containers. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What NAPROXEN EMO contains

• The active substance of the medicine is naproxen.
• The other ingredients are: chloral hydrate, levomenthol, ethanol 96%, ethyl 4-hydroxybenzoate, sodium hydroxide, carbomer, purified water.

What NAPROXEN EMO looks like and what the pack contains.

NAPROXEN EMO is a medicine for external use in the form of a gel, white in color, with a menthol smell. Packaging: Aluminum tube containing 30 g, 55 g, 100 g, or 150 g of the medicine in a single pack.

Marketing authorization holder

Bausch Health Ireland Limited 3013 Lake Drive Citywest Business Campus Dublin 24, D24PPT3 Ireland

Manufacturer

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

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Czech Republic - EMOXEN Slovakia - EMOXEN GEL Estonia - EMOX Lithuania - EMOX 100 mg/g gelis Latvia - EMOX 100 mg/g gels Hungary - Apranax Dolo 100 mg/g gél Poland - NAPROXEN EMO Date of last revision of the leaflet: 10/2024