EMOX 10% GEL 55G

ATC code: M02AA12 

Active substances: Naproxenum

Vendor, principal: Emo-Farm Sp.z.0.0.. 
No prescription needed/Patient care products, dressings, gloves, medical devices,...

EMOX 100MG/1G 55G

Package leaflet: Information for the user

Emox 100 mg/g gel

Naproxen

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Always use this medicine exactly as described in this leaflet or as your doctor has told you.
-   Keep this leaflet. You may need to read it again.
-   Ask your pharmacist if you need more information or advice.
-   If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
-   You must talk to a doctor if you do not feel better or if you feel worse after 7 days.

What is in this leaflet

1.   What Emox is and what it is used for
2.   What you need to know before you use Emox
3.   How to use Emox
4.   Possible side effects
5   How to store Emox
6.   Contents of the pack and other information

1. What Emox is and what it is used for

Emox contains the active substance naproxen, a non-steroidal anti-inflammatory drug.
Emox is a white therapeutic gel which is meant for topical use and smells like menthol. Naproxen, the active ingredient of the gel, has an analgesic and anti-inflammatory effect when applied on the skin. Emox is used for the topical relief of pain in case of painful and inflammatory conditions of soft tissues. The gel is absorbed well into the skin and reduces pain and swelling.

2. What you need to know before you use Emox Do not use Emox

-   if you are allergic to naproxen or any of the other ingredient(s) of this medicine (listed in section 6);
-   starting from the sixth month of pregnancy and during breast-feeding;
-   in case of skin inflammations and injuries and open wounds.

Warnings and precautions

-   if you have or have previously had allergic reactions (rash, redness, pruritus) during treatment with other non-steroidal anti-inflammatory drugs;
-   in case of extended use of the medicine on large areas of skin;
-   Emox is not recommended for children under 3 years of age.

Other medicines and Emox

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Emox can be used with other forms of medicine containing naproxen (tablets, suppositories, etc.).
Talk to your doctor if you are taking any of the medicines listed below:
• Aspirin / Acetylsalicylic acid to prevent blood clot formation.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Emox should not be used starting from the six months of pregnancy or during breast-feeding due to insufficient clinical data.

Driving and using machines

There is no information about the adverse effect of naproxen on the ability to drive or use machines.

Emox contains ethyl parahydroxybenzoate (E214).

3. How to use Emox

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose is a strip of gel approximately 4 cm in length. Apply the medicine on dry and clean skin, depending on the size of the damaged area, spread over the painful area, and massage gently until the medicine has been completely absorbed.
Emox can be used 4 to 5 times per day. Emox should not be used for longer than 4 weeks.
Wash your hand after using the medicine, unless the application of the medicine on the hands was the goal of the treatment.
NOTE
Do not use Emox:
-   on mucous membranes and in the eyes (if the gel gets in the eyes or on mucous membranes, rinse with copious amounts of water
to remove the gel);
-   under wound dressings (gauzes, bandages);
-   orally.
Contact with direct sunlight (including radiation from a solarium) should be avoided during the treatment and 2 weeks after the treatment.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
If you feel that the effect of Emox is too strong or too weak, talk to your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
In most cases, Emox is well-tolerated.
In rare cases (> 1/10,000 to < 1/1,000), local skin irritation (redness, rash, pruritus) can be observed. This will disappear after the treatment is discontinued.
Systemic side effects, such as sleepiness, diarrhoea, nausea, headache, and hypersensitivity reactions cannot be excluded in case of long-term use of Emox. Talk to your doctor if these symptoms occur.
In case of respiratory problems or skin changes, immediately stop the treatment and talk to your doctor or turn to the nearest hospital.
In some patients, other side effects can be observed during treatment with Emox.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via www.ravimiamet.ee. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Emox

Keep this medicine out of the sight and reach of children.
Do not use Emox after the expiry date which is stated on the package. The expiry date refers to the last day of that month.
Do not use the medicine if the appearance or smell of the medicine has changed.
Keep in original package, tightly sealed.
Do not store in refrigerator or freezer.
After initial opening, use the medicine within 6 months.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6.   Contents of the pack and other information

What Emox contains

The active substance is naproxen.
The excipients are chloral hydrate, levomenthol, ethanol, ethyl parahydroxybenzoate (E214), sodium hydroxide, carbomer, purified water.

What Emox looks like and contents of the pack

Emox is a homogenous white gel without any solid impurities and with the aroma characteristic of menthol.
55 grams of gel in a tube packaged in a carton.

Marketing Authorisation Holder

PharmaSwiss Ceska republika s.r.o.
Jankovcova 1569/2c 170 00 Praha 7 Czech Republic

Manufacturer

Emo-Farm Sp. z.o.o.
52 Lodzka St 95-054 Ksawerow Poland
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
PharmaSwiss Eesti OÜ Tammsaare tee 47 11316 Tallinn Phone +372 682 7400

This leaflet was last revised in June 2018.

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