Traumon

Package Leaflet: Information for the Patient

TRAUMON, 100 mg/g, Gel

Etofenamate

Read the package leaflet carefully before using the medicine, as it contains

important information for the patient.
This medicine should always be used exactly as described in the package leaflet for the patient, or according to
the doctor's or pharmacist's instructions.

• This leaflet should be kept, so that it can be read again if necessary.
• 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 the 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 Traumon and what is it used for
• 2. Important information before using Traumon
• 3. How to use Traumon
• 4. Possible side effects
• 5. How to store Traumon
• 6. Contents of the pack and other information

1. What is Traumon and what is it used for

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

Indications:

• Blunt injuries, such as: bruises, sprains, muscle strains, tendon and joint strains
• Degenerative joint disease of the spine, knees, shoulders
• Extra-articular rheumatism:
• low back pain
• pathological changes in the soft tissues around the joints, such as bursitis, tendinitis, tendon sheath inflammation, joint capsule inflammation (so-called frozen joint)
• prepatellar bursitis.

2. Important information before using Traumon

When not to use Traumon

• if the patient is hypersensitive (allergic) to etofenamate, flufenamic acid, other nonsteroidal 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

• Traumon 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, 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 or chronic respiratory infections, especially in combination with symptoms similar to hay fever, may use Traumon only under certain precautions and under strict medical supervision.
• Systemic absorption may increase if the medicine is used for a longer period and/or on large areas of the body. Such use should therefore be avoided.
• Children should not come into contact with skin covered with this medicine.

Traumon Gel and other medicines

The doctor or pharmacist should be informed about all medicines currently or recently used by the patient, as well as about medicines that the patient plans to use.
No interactions have been found if Traumon is used as recommended.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant or plans to have a child, she should consult her doctor before using this medicine.
Traumon 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.
Traumon should not be used in women during the third trimester of pregnancy.
Since etofenamate passes into breast milk to a small extent, breastfeeding mothers should avoid prolonged use of Traumon and should 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.

Traumon Gel contains propylene glycol

This medicine contains 51-99 mg of propylene glycol (E 1520) in a 5 to 10 cm long gel strip, which corresponds to 30 mg of propylene glycol in 1 g of gel.
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 Traumon

This medicine should always be used exactly as described in the package leaflet for the patient, or according to
the doctor's or pharmacist's instructions. In case of doubts, the doctor or pharmacist should be consulted.
Unless the doctor recommends otherwise, a 5 to 10 cm long strip of Traumon gel 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 to 4 times a day.
Treatment of rheumatic conditions usually lasts 3 to 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.

Using a higher dose of Traumon than recommended

No cases of overdose have been reported if Traumon was used as recommended.
In case of applying the contents of the entire tube of Traumon and covering the entire body with it in a short time, headaches and dizziness as well as abdominal discomfort may occur. In such a case, the medicine should be washed off the skin with water.
If the patient or child accidentally ingests the medicine, they should see a doctor.

Missing a dose of Traumon

A double dose should not be used to make up for a missed dose.
In case of any further doubts about using this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, Traumon can cause side effects, although not everybody gets them.
Disorders of the skin and subcutaneous tissue
Uncommon side effects (may occur with a frequency of less than 1 in 100 but more than 1 in 1,000 people):

• redness, burning sensation of the skin.

Rare side effects (may occur with a frequency of less than 1 in 10,000 people):

• skin inflammation, such as severe itching, rash, swelling, blistering rash.

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

• phototoxic reaction.

The above side effects usually disappear after the medicine is discontinued.
Immune system disorders:
Frequency not known (frequency cannot be estimated from the available data):

• 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 rarely exfoliative and blistering skin changes (including toxic epidermal necrolysis and erythema multiforme).

If such symptoms occur, which is possible even after the first administration of the medicine, the patient should immediately seek medical attention.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Adverse Reactions to Medicinal Products of 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
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 Traumon

Keep out of the reach and sight of children.
Store in a temperature below 25°C.
Do not use Traumon 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 pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Traumon contains

• The active substance of Traumon is etofenamate (Etofenamatum).
• The other ingredients are: carbomer, macrogol oleate (Emulgin M8 Deo), sodium hydroxide, isopropyl alcohol, macrogol 400, propylene glycol, purified water. The medicine contains 30 mg of propylene glycol (E 1520) in 1 g of gel. See also "Traumon Gel contains propylene glycol" in section 2.

What Traumon looks like and contents of the pack

The pack contains an aluminum tube with a PE membrane and a screw cap in a cardboard box.
Pack sizes: 20 g, 50 g, 100 g or 150 g.

Marketing authorization holder:

Cooper Consumer Health B.V.
Verrijn Stuartweg 60
1112AX Diemen
Netherlands

Manufacturer:

Madaus GmbH
51101 Köln
Germany

For more information, please contact:

Viatris Healthcare Sp. z o.o.
tel.: 22 546 64 00
[logo of the marketing authorization holder]

Date of last revision of the leaflet: