ETOXAM 100 mg /G Gel

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Etoxam, 100 mg/g, gel
   1. Read the leaflet carefully before using the medicine, as it contains
   2. Table of contents of the leaflet
3. What is Etoxam and what is it used for
   1. Indications:
4. Important information before using Etoxam
   1. When not to use Etoxam
   2. Warnings and precautions
   3. Children and adolescents
   4. Etoxam and other medicines
   5. Pregnancy and breastfeeding
   6. Driving and using machines
   7. Etoxam contains propylene glycol
5. How to use Etoxam
   1. Use in children and adolescents
   2. Using more than the recommended dose of Etoxam
   3. Missing a dose of Etoxam
6. Possible side effects
   1. Reporting side effects
7. How to store Etoxam
8. Contents of the packaging and other information
   1. What Etoxam contains
   2. What Etoxam looks like and what the pack contains
   3. Marketing authorization holder:
   4. Manufacturer:
   5. To obtain more detailed information, please contact the marketing authorization holder:
   6. Date of last revision of the leaflet: 05/2024

Leaflet attached to the packaging: patient information

Etoxam, 100 mg/g, gel

Etofenamate

Read the 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 according to the doctor's or pharmacist's instructions.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, the pharmacist should be consulted.
• 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 or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

1. What is Etoxam and what is it used for

Etofenamate, the active substance of Etoxam, has anti-inflammatory and analgesic effects.
Etofenamate belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs). When applied locally, it is absorbed through the skin and accumulates in inflamed tissues.
Local application to the skin reduces the risk of side effects typical of NSAIDs taken orally.
Etoxam does not leave a greasy layer on the skin.

Indications:

• Blunt injuries, such as: bruises, sprains, muscle, tendon, and joint strains;
• Degenerative joint disease of the spine, knees, shoulders;
• Extra-articular rheumatism:
• lower back pain,
• pathological changes in the soft tissues around the joints, i.e., bursitis, tendinitis, tenosynovitis, joint capsules (so-called frozen joint),
• epicondylitis.

2. Important information before using Etoxam

When not to use Etoxam

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

Warnings and precautions

Before starting to use Etoxam, the patient should discuss it with their doctor or pharmacist.

• Etoxam should not be used in case of skin damage or inflammatory rashes on the skin, as well as on mucous membranes or eyes. Therefore, after applying the medicine, the hands should be washed or contact with these parts of the body should be avoided.
• During treatment and for two weeks after treatment, exposure of the treated areas to the sun and/or solarium should be avoided.
• Patients with asthma, chronic obstructive pulmonary disease, hay fever, or chronic nasal polyps, especially in combination with symptoms similar to hay fever, may use Etoxam only under medical supervision and with caution.
• Systemic absorption may increase if the medicine is used for a long time and/or on large areas of the body. Such use should be avoided.
• Children should not come into contact with skin treated with this medicine.

Children and adolescents

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

Etoxam and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
No interactions have been found when Etoxam is used as recommended.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before using this medicine.
Etoxam should be used in the first and second trimester of pregnancy only after the doctor has assessed the benefit-risk ratio. The recommended daily dose should not be exceeded.
Etoxam should not be used in women in the third trimester of pregnancy.
Since etofenamate is excreted in breast milk to a small extent, breastfeeding women should avoid prolonged use of Etoxam and not exceed the recommended daily dose.
The medicine should not be applied to the breast area.

Driving and using machines

No studies have been conducted on the effect of the medicine on the ability to drive vehicles and operate machinery.

Etoxam contains propylene glycol

Propylene glycol may cause skin irritation.
Due to the presence of propylene glycol, the medicine should not be used on open wounds or large areas of damaged or injured 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 according to the doctor's or pharmacist's instructions. If in doubt, the patient should consult their doctor or pharmacist.
Unless the doctor recommends otherwise, a 5-10 cm strip of Etoxam should be applied to the skin in the painful area, covering a surface slightly larger than the painful area, and rubbed in until the medicine is completely absorbed. This should be repeated 3-4 times a day.
Treatment of rheumatic conditions usually lasts 3-4 weeks, and blunt injuries (e.g., sports injuries) - up to 2 weeks.
If the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor.

Use in children and adolescents

Etoxam is not recommended for use in children and adolescents.

Using more than the recommended dose of Etoxam

No cases of overdose have been reported when Etoxam was used as recommended.
If the entire contents of the Etoxam tube are applied to the body in a short time, headaches, dizziness, and abdominal discomfort may occur. In such cases, the medicine should be washed off the skin with water.
If the patient or child accidentally ingests the medicine, they should consult a doctor.

Missing a dose of Etoxam

A double dose should not be used to make up for a missed dose.
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, Etoxam can cause side effects, although not everybody gets them.
Uncommon side effects (may occur with a frequency of less than 1 in 100, but more than 1 in 1,000 people):

• redness, skin burning.

Rare side effects (may occur with a frequency of 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):

• phototoxic reaction.
• hypersensitivity (non-specific allergic reaction and anaphylaxis, increased respiratory tract reactivity leading to asthma, asthma exacerbation, bronchospasm, or shortness of breath, various skin disorders, including rash, itching, urticaria, angioedema, and rare exfoliative and blistering skin changes (including toxic epidermal necrolysis and erythema multiforme)).

The above side effects usually disappear after the medicine is discontinued.
If such symptoms occur, which is possible even after the first application of the medicine, the patient should seek medical attention immediately.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Etoxam

The medicine should be stored out of sight and reach of children.
Store at a temperature below 25°C.
Shelf life after first opening the tube: 2 years, but no longer than the expiry date stated on the packaging.
Etoxam should not be used after the expiry date stated on the carton.
The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. 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 packaging and other information

What Etoxam contains

• The active substance of Etoxam is etofenamate (Etofenamatum). 1 g of Etoxam gel contains 100 mg of etofenamate (Etofenamatum).
• The other ingredients are: carbomer 980, macrogol ether oleilocetyl (Eumulgin M8), isopropyl alcohol, macrogol 400, propylene glycol, sodium hydroxide (to adjust pH), purified water. The medicine contains 30 mg of propylene glycol per 1 g of gel. See also section 2 "Etoxam contains propylene glycol".

What Etoxam looks like and what the pack contains

Etoxam is a clear, colorless to yellowish, homogeneous gel.
The packaging consists of an aluminum tube with an internal membrane, coated with an epoxy-phenolic lacquer, with a HDPE screw cap and a piercer, in a cardboard box.
Pack size: 50 g.

Marketing authorization 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

To obtain more detailed information, please contact the marketing authorization holder:

Solinea Sp. z o.o.
phone: +48 81 463 48 82
[logo Solinea]

Date of last revision of the leaflet: 05/2024