Naproxen Emo 100g

Naproxen Emo is a topical treatment intended for muscle and joint pain, and osteoarthritis. Its active substance is Naproxenum.

Composition

1 g of gel contains 100 mg of naproxen (Naproxenum).

Excipient with known effect: 1.5 mg ethyl parahydroxybenzoate in 1 g of gel.

For a full list of excipients, see section 6.1.

Dosage

NAPROXEN EMO should be applied topically to the skin 4 to 5 times a day at intervals of several hours. The dose depends on the area affected, most often a strip of gel approximately 4 cm long should be used.

Children and youth

NAPROXEN EMO should not be used in children aged 0-3 years.

Method of administration

After rubbing, spread the gel on the pain site and massage until completely absorbed. Unless the treatment is concerned, wash your hands after using the medicinal product. The medicinal product should not be covered with dressings such as bandages or plasters.

Duration of treatment

The duration of treatment depends on the type of disease and the effectiveness of the treatment, usually not longer than a few weeks (most often up to 4 weeks). If pain and swelling do not improve or worsen after one week of using the medicinal product, consult a physician.

Contraindications

Hypersensitivity to:

• The active substance naproxen or to any of the excipients
• Salicylates and other non-steroidal anti-inflammatory drugs (including acetylsalicylic acid).

NAPROXEN EMO should not be used in children aged 0-3 years.

Contents

NAPROXEN EMO is a medicine for external use in the form of a gel, white in color with the smell of menthol. Packaging: Aluminum tube containing 100 g of the drug in a unit package.

Storage method

15°C-25°C

Manufacturer

BAUSCH HEALTH

Warnings

The medicinal product should be used with caution:

• If you have had allergic reactions in the past (rash, itching, redness) during treatment with medicines from the group of non-steroidal anti-inflammatory drugs;
• When it is used on large areas of the skin for a long time, as there is a possibility of systemic adverse reactions.

The medicinal product should be discontinued upon the occurrence of the above-mentioned symptoms.

Due to the possibility of absorption of naproxen into the bloodstream, caution should be exercised in treating patients with hepatic and renal insufficiency, gastrointestinal ulceration and haemorrhagic diathesis.

CAUTION:

The medicinal product should not be used on damaged skin, open wounds, inflammation of the skin, mucous membranes and eyes. If the gel gets into the eyes or on mucous membranes, remove the gel by rinsing thoroughly with water.

In addition, direct sunlight (including tanning beds) should be avoided during the treatment period and for 2 weeks after the end of treatment.

The product contains ethyl parahydroxybenzoate, which may cause allergic reactions (possible delayed reactions).

Pregnancy

Naproxen causes delayed labor in animals and affects the cardiovascular system of the human fetus (closure of the ductus arteriosus). For this reason, the product should not be used during pregnancy, except in cases recommended and supervised by a physician. The use of naproxen during pregnancy requires careful consideration of the potential benefits to the mother and the fetus, especially in the first and third trimesters of pregnancy.

Breast-feeding

Should not be used during breastfeeding. Naproxen passes into breast milk, therefore the physician should decide whether to discontinue breastfeeding or to discontinue the drug.

Driving vehicles

There are no data on adverse reactions after topical application of naproxen to the skin affecting the ability to drive and use machines.

Overdosage

No case of overdose has been reported.

Due to the low absorption of naproxen through the skin into the bloodstream, there is no risk of overdose or poisoning with the topical medicinal product. However, as a result of misuse or accidental ingestion, systemic side effects are possible. In such a case, appropriate therapeutic measures should be taken in the event of poisoning with NSAIDs.

Interactions with other drugs

With proper use of NAPROXEN EMO, due to the low absorption of the active substance into the bloodstream (approximately 1%), clinically significant drug interactions of naproxen are unlikely.

So far, no interactions of naproxen applied topically to the skin with other drugs have been observed. However, in the event of long-term application of the medicinal product to large areas of the skin, the possibility of such an interaction cannot be totally excluded.

Side effects

Adverse reactions (Table 1) are listed by frequency of occurrence, the most frequent first, using the following convention: very common (≥ 1/10); common (≥ 1/100, <1/10); uncommon (≥ 1/1000, <1/100); rare (≥ 1 / 10,000, <1 / 1,000); very rare (<1 / 10,000), not known (frequency cannot be estimated from the available data).

Table 1

Skin and subcutaneous tissue disorders
	Rarely:	local skin irritation (erythema, itching, burning sensation) which disappears after discontinuation of the medicinal product. Few cases of vesicular skin rash of varying severity have also been observed.

In the case of long-term use on large areas of the skin, side effects resulting from the general effects of naproxen may occur (e.g. nausea, diarrhea, drowsiness, headaches, hypersensitivity reactions).

Sensitization to light are possible.