Patient Information Leaflet

Etoxam, 100 mg/g, gel
Etofenamate
Please read this 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 patient leaflet or as directed by a 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 your condition does not improve or worsens, you should contact your doctor.

Table of Contents

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

1. What Etoxam is and what it is used for

Etofenamate – the active substance in Etoxam – has anti-inflammatory and analgesic properties.
Etofenamate belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs). When applied topically, it is absorbed through the skin and accumulates in inflamed tissues.
Topical application reduces the risk of adverse effects typical of orally administered NSAIDs.
Etoxam does not leave an oily residue on the skin.
Indications:

Minor injuries such as bruises, sprains, strains of muscles, tendons and joints;
Degenerative joint disease of the spine, knees, and shoulders;
Extra-articular rheumatism:
Lumbosacral pain,
Pathological changes in periarticular soft tissues, i.e. bursitis, tendinitis, tenosynovitis, joint capsules (so-called frozen shoulder),
Epicondylitis.

2. Important information before using Etoxam

When not to use Etoxam

if the patient is allergic (hypersensitive) to etofenamate, flufenamic acid, other non-steroidal anti-inflammatory drugs, or any of the other ingredients of this medicine (listed in section 6),
during the third trimester of pregnancy,
in children and adolescents.

Warnings and precautions
Before starting treatment with Etoxam, consult your doctor or pharmacist.

Do not use Etoxam if there are skin lesions or inflammatory skin eruptions, and avoid contact with mucous membranes or eyes. Therefore, hands should be washed after application or contact with these body parts should be avoided.
During treatment and for two weeks after treatment, treated areas should not be exposed to sunlight or (and) solarium.
Patients suffering from asthma, chronic obstructive pulmonary disease, hay fever, chronic nasal mucosa swelling (so-called nasal polyps), or chronic respiratory tract infections, especially in combination with hay fever-like symptoms, may use Etoxam only if taking precautions and under strict medical supervision.
Systemic absorption may increase if Etoxam is used long-term and (or) over large areas of the body. Such use should be avoided.
Children should not come into contact with skin areas treated with this medicine.

Children and adolescents
Etoxam should not be used in children and adolescents due to insufficient clinical data in this patient group.

Etoxam and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use.
No interactions have been reported when Etoxam is used as recommended.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor before using this medicine.
Etoxam may be used during the first and second trimesters of pregnancy only after a physician has evaluated the benefit-risk ratio. The recommended daily dose should not be exceeded.
Etoxam must not be used in women during the third trimester of pregnancy.
Since etofenamate passes into breast milk in small amounts, breastfeeding women should avoid prolonged use of Etoxam and must not exceed the recommended daily dose.
Do not apply the medicine to the breast area.

Driving and operating machinery
No studies have been conducted on the effects of the medicine on the ability to drive motor vehicles or operate mechanical equipment.

Etoxam contains propylene glycol
Propylene glycol may cause skin irritation.
Due to the presence of propylene glycol, the medicine should not be applied to open wounds or large areas of injured or damaged skin (e.g., burned skin) without consulting a doctor or pharmacist.

3. How to use Etoxam

This medicine should always be used exactly as described in this patient leaflet or as directed by a
physician or pharmacist. If in doubt, consult a physician or pharmacist.
Unless otherwise advised by a physician, apply a strip of Etoxam 5 to 10 cm long to the skin
over the painful area, covering a slightly larger surface than the affected area, and rub in until the
medicine is completely absorbed. Repeat 3 to 4 times daily.
Treatment of rheumatic conditions usually lasts 3 to 4 weeks, while treatment of blunt injuries (e.g.
sports injuries) lasts up to 2 weeks.
If you feel the effect of the medicine is too strong or too weak, consult a physician.
Use in children and adolescents
Use in children and adolescents is not recommended.
Use of a higher than recommended dose of Etoxam
There are no known cases of overdose with Etoxam when used as directed.
If the entire contents of a tube of Etoxam are applied and the whole body is covered in a short
period of time, headache, dizziness and epigastric discomfort may occur. In such cases, wash
the medicine off the skin with water.
If the patient or a child accidentally ingests the medicine, seek medical advice immediately.
Missed dose of Etoxam
Do not use a double dose to make up for a missed dose.
If you have any further doubts concerning the use of this medicine, consult a physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.

Uncommon adverse reactions (may occur in less than 1 in 100,
but more than 1 in 1,000 people):

redness, burning sensation of the skin.

Very rare adverse reactions (may occur in less than 1 in 10,
000 people):

skin inflammation, e.g. severe itching, rash, swelling, blistering rash.

Frequency not known (frequency cannot be estimated from the available data):

photosensitivity reaction.
hypersensitivity (non-specific allergic reaction and anaphylaxis, increased respiratory tract reactivity leading to asthma, worsening of asthma, bronchospasm or dyspnoea, various skin disorders including rash, itching, urticaria, angioedema, less frequently exfoliative and bullous skin lesions (including epidermal necrolysis and erythema multiforme)).

The adverse reactions listed above usually resolve after discontinuation of the medicine.
If any of these symptoms occur, which is possible even after the first dose, the patient should
seek medical help immediately.

Reporting of adverse reactions

If any adverse symptoms occur, including any adverse reactions not listed
in this leaflet, inform a doctor or pharmacist. Adverse reactions can
be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products,
Medical Devices and Biocidal Products, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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 this medicine.

5. How to store the medicine Etoxam

Keep the medicine out of sight and reach of children.
Store below 25°C.
Shelf life after first opening of the tube: 2 years, but not beyond the expiry date stated on the
packaging.
Do not use the medicine Etoxam after the expiry date indicated on the cardboard box.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Etoxam contains

The active substance is etofenamate (Etofenamatum). 1 g of Etoxam gel contains 100 mg of etofenamate (Etofenamatum).
Other ingredients: carbomer 980, oleyl cetyl ether macrogol (Eumulgin M8), isopropyl alcohol, macrogol 400, propylene glycol, sodium hydroxide (for pH adjustment), purified water. The medicine contains 30 mg of propylene glycol in 1 g of gel. See also section 2, "Etoxam contains propylene glycol".

What Etoxam looks like and contents of the pack
Etoxam is a clear, colourless to yellowish, homogeneous gel.
The packaging consists of an aluminium tube with an inner sealing membrane coated with epoxy-phenolic varnish, fitted with a HDPE cap with a piercing device, and placed in a cardboard box.
Pack size: 50 g.
Marketing Authorisation Holder:
Solinea Sp. z o.o.
Elizówka, ul. Szafranowa 6
21-003 Ciecierzyn
Manufacturer:
Mako Pharma Sp. z o.o.
ul. Kolejowa 231A
05-092 Dziekanów Polski
Medicofarma S.A.
ul. Tarnobrzeska 13
26-613 Radom
For further information, contact the Marketing Authorisation Holder:
Solinea Sp. z o.o.
tel.: +48 81 463 48 82
[logo Solinea]