Package leaflet: Information for the patient

TRAUMON, 100 mg/ml, cutaneous spray, solution
Etofenamate
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by the doctor or pharmacist.

Keep this leaflet so that you can read it again if necessary.
If you need advice or further information, please contact your pharmacist.
If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement or if you feel worse, consult your doctor.

Table of contents

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

1. What Traumon is and what it is used for

Etofenamate – the active substance in Traumon – has anti-inflammatory and analgesic effects. 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 reactions typical of orally administered NSAIDs.
Traumon does not leave an oily residue on the skin.

Indications:

Blunt 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 soft periarticular tissues, i.e. bursitis, tendinitis, tenosynovitis, synovitis (so-called frozen shoulder)
- Epicondylitis

2. Important information before using Traumon

When not to use Traumon

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

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

Traumon, cutaneous aerosol, solution and other medicines
Inform your doctor or pharmacist about any medicines you are currently taking, have recently taken, or plan to take.
No interactions have been reported when Traumon is used as recommended.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to become pregnant, she should consult her doctor before using this medicine.
Traumon should be used during the first and second trimesters of pregnancy only after the physician has evaluated the benefit-risk ratio. The recommended daily dose must not be exceeded.
Traumon must not be used in women during the third trimester of pregnancy.
Since etofenamate passes into breast milk in small amounts, breastfeeding mothers should avoid prolonged use of Traumon 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 this medicine on the ability to drive motor vehicles or operate mechanical equipment.

Traumon, cutaneous aerosol, solution contains propylene glycol
This medicine contains 7.2 mg of propylene glycol (E 1520) per dose (spray), corresponding to 40 mg of propylene glycol per 1 ml of solution.
Propylene glycol may cause skin irritation.
Due to the presence of propylene glycol, this 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 Traumon

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, spray the affected skin area 3 to 5 times daily, covering a slightly larger area than the painful region. Usually, a single application of up to 7 doses of Traumon is sufficient, although the dose may be increased if necessary. After each 1 to 2 doses, gently rub the medicine into the skin and leave it to dry.
Treatment of rheumatic conditions typically 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 your physician.
Use of a higher than recommended dose of Traumon
There are no known cases of overdose with Traumon when used as directed.
However, if the entire contents of a bottle of Traumon are applied and cover the whole body within a short time, symptoms such as headache, dizziness, and epigastric discomfort may occur. In such a case, wash the medicine off the body surface with water.
If the medicine is accidentally ingested by a patient or child, seek medical advice immediately.
Missed dose of Traumon
Do not use a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Skin and subcutaneous tissue disorders
Uncommon adverse reactions (may occur in less than 1 in
100 but more than 1 in 1000 people):

erythema, burning sensation of the skin.

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

dermatitis, e.g. severe itching, rash, swelling, bullous rash.

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

photosensitivity reaction.

The adverse reactions listed above usually resolve after discontinuation of the medicine.
Immune system disorders:
Frequency not known (frequency cannot be estimated from the available data):

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

If any of these symptoms occur, which is possible even after the first dose of the medicine, the patient should
seek medical help immediately.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed
in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Traumon

Keep out of the reach and sight of children.
Store below 25ºC.
Do not use this medicine after the expiry date stated on the cardboard package.
The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Traumon contains

The active substance is etofenamate (Etofenamatum).
The other ingredients are: diisopropyl adipate, oleoyl macrogol glycerides (Emulgin M8 Deo), macrogol 400, isopropyl alcohol, propylene glycol, purified water. The product contains 40 mg of propylene glycol (E 1520) in 1 ml of solution. See also section 2, “Traumon, cutaneous spray solution contains propylene glycol”.

What Traumon looks like and contents of the pack
The pack contains a bottle made of amber glass with a dispenser, in a cardboard box.
Pack size: 50 ml.
Marketing Authorisation Holder:
Cooper Consumer Health B.V.
Verrijn Stuartweg 60
1112AX Diemen
The Netherlands
Manufacturer:
Madaus GmbH
51101 Köln
Germany
For further information, please contact:
Viatris Healthcare Sp. z o.o.
tel.: 22 546 64 00