Patient Information Leaflet

NAPROXEN EMO, 100 mg/g, gel
( Naproxen )
Please read carefully all the information in this leaflet before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

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 side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 7 days of treatment, or if you feel worse, consult your doctor.

Table of contents

What NAPROXEN EMO is and what it is used for
Important information before using NAPROXEN EMO
How to use NAPROXEN EMO
Possible side effects
How to store NAPROXEN EMO
Contents of the pack and other information

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

NAPROXEN EMO is a gel containing the active substance naproxen at a concentration of 100 mg/g, which belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs).
It is an analgesic and anti-inflammatory gel for topical application to the skin.
It helps reduce pain and swelling, and restores mobility. The product produces a pleasant cooling sensation on the skin.
Indications:

Musculoskeletal pain;
Osteoarthritis.

2. Important information before using NAPROXEN EMO

When not to use NAPROXEN EMO:

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, including acetylsalicylic acid;
in children under 3 years of age;
in patients with a history of allergic reactions such as bronchospasm, urticaria, or acute inflammation of the nasal mucosa after taking acetylsalicylic acid or other substances inhibiting prostaglandin synthesis;
if the patient is in the third trimester of pregnancy.

Warnings and precautions
Before starting treatment with NAPROXEN EMO, consult your doctor or pharmacist:

if the patient has previously experienced allergic reactions (rash, itching, redness)
during treatment with medicines from the group of non-steroidal anti-inflammatory drugs;
if the patient has experienced hypersensitivity reactions with facial swelling, redness, or bronchospasm.
Prolonged use of naproxen in gel form over large skin areas is not recommended, as systemic adverse reactions may occur (see section 4).

If any of the above reactions occur, discontinue use of the medicine.
Do not use the medicine:

in the eyes or on mucous membranes; if the gel gets into the eyes or onto mucous membranes, rinse thoroughly with water;
on damaged skin, open wounds, or inflamed skin;
under dressings (bandages or adhesive plasters);
orally.

Additionally, during treatment and for 2 weeks after treatment ends, avoid direct sunlight (including solarium use).
Due to the possibility of naproxen being absorbed into the bloodstream, caution should be exercised
when treating patients with hepatic or renal insufficiency, gastrointestinal ulcers, or hemorrhagic diathesis.
Children and adolescents
Do not use NAPROXEN EMO in children under 3 years of age.
NAPROXEN EMO and other medicines
Inform your doctor about all medicines currently or recently used, as well as those planned for use.
NAPROXEN EMO may be used simultaneously with other pharmaceutical forms of naproxen (tablets, suppositories, etc.).
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 to prevent blood clots.
Naproxen may reduce platelet aggregation and prolong bleeding time.
Pregnancy, breastfeeding, and effect on fertility
Pregnancy
Oral forms (e.g., tablets) of NAPROXEN EMO may cause adverse effects in the unborn child. It is unknown whether the same risk applies when using NAPROXEN EMO on the skin.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Do not use NAPROXEN EMO during the last 3 months of pregnancy. NAPROXEN EMO 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, it should be administered for the shortest possible duration.
Breastfeeding
Do not use this medicine during breastfeeding. The decision whether to discontinue breastfeeding or to stop treatment with naproxen gel should be made after considering the risk to the breastfed infant or the benefit to the mother.
Fertility
No negative effects on fertility or fetal impairment related to the active substance have been observed.
Driving and operating machinery
There is no data on adverse effects following topical application of naproxen to the skin that may affect the ability to drive or operate machinery.
NAPROXEN EMO contains ethyl parahydroxybenzoate.
The medicine contains 1.50 mg of ethyl parahydroxybenzoate per gram. It may cause allergic reactions (including delayed-type reactions).
NAPROXEN EMO contains alcohol (ethanol).
This medicine contains 0.90 mg of alcohol (ethanol) per gram. It may cause stinging on damaged skin.

3. How to use NAPROXEN EMO

This medicine should always be used exactly as described in this patient information leaflet or as directed by a physician. If in doubt, consult a doctor or pharmacist.
Unless otherwise advised by a physician, the following dosage instructions should be followed: apply the medicine to the skin in an amount depending on the size of the painful area (usually a strip of gel approximately 4 cm long), spread it over the painful area and gently massage until completely absorbed.
The medicine should be applied 4 to 5 times daily, with several hours between applications.
After applying the medicine, hands should be washed, unless they are the area being treated.
Do not use NAPROXEN EMO for longer than a few weeks (usually up to 4 weeks).
If pain and swelling do not improve or worsen after 1 week of treatment, consult a doctor.
If redness or skin irritation occurs, discontinue use of the medicine until symptoms resolve; if symptoms persist, consult a doctor.
Do not use this medicine in children under 3 years of age.
Use of a higher than recommended dose of NAPROXEN EMO
Due to the minimal absorption of naproxen through the skin into the bloodstream, there is no risk of overdose or poisoning with this topically applied medicine.
However, improper use or accidental ingestion may lead to systemic adverse effects. In such cases, the physician will initiate therapeutic management appropriate for poisoning with non-steroidal anti-inflammatory drugs.
In case of accidental ingestion, contact a doctor immediately.
If you have any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
NAPROXEN EMO is usually well tolerated.
Adverse reactions may occur with the following frequency:
rare: in 1 to 10 out of 10,000 people,
frequency not known: frequency cannot be estimated from the available data.
Rare: skin irritation (redness, rash).
Frequency not known: hypersensitivity*, headache*, drowsiness*, diarrhoea*, nausea*, generalized allergic skin reaction, photosensitivity, itching, vesicular rash.
*When NAPROXEN EMO is used on large areas of skin and for prolonged periods, systemic adverse effects such as drowsiness, diarrhoea, nausea, headache, and hypersensitivity reactions (allergy) cannot be excluded. In such cases, a doctor should be informed. If shortness of breath or skin changes occur, the use of the medicine must be stopped immediately, and a doctor should be consulted or the nearest hospital visited without delay.
If any adverse reactions occur, including those not listed in this leaflet, inform a doctor or pharmacist.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. 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 may 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 NAPROXEN EMO

Keep the medicine out of sight and reach of children.
Do not store the medicine in a 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 stated month.
Do not use this medicine if you notice any change in its external appearance or odour.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What NAPROXEN EMO contains

The active substance is naproxen.
The other ingredients are: chloral hydrate, levomenthol, 96% ethanol, ethyl parahydroxybenzoate, sodium hydroxide, carbomer, purified water.

What NAPROXEN EMO looks like and contents of the pack
NAPROXEN EMO is a topical medicinal product in the form of a white gel with a menthol odour.
Packaging:
Aluminium tube containing 30 g, 55 g, 100 g or 150 g of gel in a unit pack.

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

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

This medicinal product is authorised in the European Economic Area member states 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