Package leaflet: information for the patient

TRAUMUSCOL, 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
physician or pharmacist.

Keep this leaflet so that you can read it again if necessary.
If you need advice or further information, consult your pharmacist.
If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
If your symptoms do not improve or if you feel worse, consult your doctor.

Table of contents

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

1. What Traumuscol is and what it is used for

Etofenamate – the active ingredient in Traumuscol – 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.
Traumuscol does not leave an oily residue on the skin.

Indications:
Traumuscol is indicated in adults for the local treatment of the following conditions:

Blunt injuries, such as bruises, sprains, strains of muscles, tendons, and joints
Degenerative joint disease of the spine, knees, and shoulders
Periarticular 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 Traumuscol

When not to use Traumuscol

if the patient is allergic (hypersensitive) to etofenamate, flufenamic acid, other non-steroidal anti-inflammatory drugs, or to 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 Traumuscol, discuss it with your doctor or pharmacist.

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

Children and adolescents
Do not use Traumuscol in children and adolescents due to insufficient clinical data in this patient group.

Traumuscol and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
No interactions have been reported when Traumuscol is used as directed.

Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor before using this medicine.
Traumuscol should be used during the first and second trimesters of pregnancy only after the doctor has evaluated the benefit-risk ratio. The recommended daily dose should not be exceeded.
Do not use Traumuscol in women during the third trimester of pregnancy.
Etofenamate passes into breast milk to a small extent; therefore, breastfeeding women should avoid prolonged use of Traumuscol and should 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 mechanical vehicles or operate mechanical equipment in motion.

3. How to use Traumuscol

This medicine should always be used exactly as described in this patient information leaflet, or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Unless otherwise advised by a doctor, apply a strip of Traumuscol gel 2.5 to 5 cm in length to the skin over the painful area, covering a slightly larger surface than the painful region, and rub in until completely absorbed. Repeat 3 to 4 times daily.
A significant reduction in pain has been observed after 3 or 4 days of using Traumuscol.
In rheumatic conditions, during prolonged treatment, the number of applications should be reduced to two or three times daily.
It is not recommended to use Traumuscol for longer than 14 days in cases of soft tissue injuries and/or rheumatism, or for longer than 21 days in cases of joint pain, unless otherwise advised by a doctor.
If symptoms do not improve after 7 days of treatment, or if the patient feels worse, medical advice should be sought to determine further management.

Special patient groups
Liver impairment
No dose adjustment is required in patients with liver disorders.
Renal impairment
No dose adjustment is required in patients with kidney disorders.

Use of a higher than recommended dose of Traumuscol
There are no known cases of overdose with Traumuscol when used as recommended.
If the entire contents of a tube of Traumuscol are applied and the whole body is covered within a short time, headache, dizziness, and epigastric discomfort may occur. In such cases, the medicine should be washed off the skin with water.
If the medicine is accidentally ingested by a patient or child, medical advice should be sought immediately.

Missed dose of Traumuscol
Do not apply a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.

Uncommon adverse reactions (may occur in less than 1 in 100 but more than 1 in 1,000 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, blistering rash.

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

Photosensitivity reaction.
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, and 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 immediate medical assistance.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the 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 the medicine.

5. How to store Traumuscol

Keep out of the sight and reach of children.
There are no special storage temperature requirements for this medicine. Store in the original
pack to protect from light. Do not freeze.
Do not use Traumuscol after the expiry date stated on the carton.
The expiry date refers to the last day of the stated month.
Usable period after first opening of the tube: 6 months.
Medicines should 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 Traumuscol contains

The active substance is etofenamate (Etofenamatum). 1 g of gel contains 100 mg of etofenamate.
The other ingredients (excipients) are: isopropyl alcohol, glycerol, trolamine, carbomer 934, purified water.

What Traumuscol looks like and contents of the pack
Traumuscol is a transparent, white or almost white gel with a homogeneous appearance and a characteristic odour of isopropyl alcohol.
Aluminium tube with a sealing membrane internally coated with epoxy-phenolic golden lacquer, fitted with a HDPE cap with a piercing device, containing 50 g of gel, in a cardboard carton.

Marketing Authorisation Holder:
Synoptis Pharma Sp. z o.o.
Krakowiaków Street 65
02-255 Warsaw
Tel.: 22 32 16 240

Manufacturer:
Laboratórios Basi - Indústria Farmacêutica, S.A.
Parque Industrial Manuel Lourenço Ferreira, Lotes 8, 15 e 16
3450-232 Mortágua
Portugal