Traumuscol

Package Leaflet: Information for the Patient

TRAUMUSCOL, 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 as directed by
your doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, ask your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.
• If you do not feel better or feel worse, you should contact your doctor.

Table of Contents of the Leaflet

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

1. What is Traumuscol and what is it used for

Etofenamate - the active substance of Traumuscol, 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.
Traumuscol does not leave a greasy layer on the skin.

Indications:

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

• Blunt injuries, such as: bruises, sprains, muscle strains, 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, tendon sheath inflammation, joint capsule inflammation (so-called frozen shoulder)
• bursitis.

2. Important information before using Traumuscol

When not to use Traumuscol

• 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);
• in the third trimester of pregnancy;
• in children and adolescents.

Warnings and precautions

Before starting to use Traumuscol, you should discuss it with your doctor or pharmacist.

• Traumuscol should not be applied to damaged skin or to inflammatory skin lesions or to mucous membranes or eyes, therefore after applying the medicine, you should wash your hands or avoid contact with these parts of the body.
• During treatment and for two weeks after treatment, you should avoid exposure of the treated areas to sunlight and/or solarium.
• 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 Traumuscol only under certain precautions and under strict medical supervision.
• Systemic absorption may increase if the medicine is used for a long time and/or on large areas of the body. Therefore, such use should be avoided.
• Children should not come into contact with skin covered with this medicine.

Children and adolescents

Traumuscol should not be used in children and adolescents due to insufficient clinical data for this group of patients.

Traumuscol and other medicines

You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
No interactions have been found when Traumuscol is used as recommended.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.
Traumuscol should be used in the first and second trimester of pregnancy only after assessing the benefit-risk ratio by your doctor. Do not exceed the recommended daily dose.
Do not use Traumuscol in the third trimester of pregnancy.
Etofenamate is excreted in small amounts into breast milk, so breastfeeding mothers should avoid prolonged use of Traumuscol and not exceed the recommended daily dose.
Do not apply the medicine 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.

3. How to use Traumuscol

This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist.
Unless your doctor advises otherwise, apply a 2.5 to 5 cm long strip of Traumuscol gel to the skin in the painful area, covering a surface slightly larger than the painful area, and rub in until the medicine is completely absorbed. Repeat 3 to 4 times a day.
A significant reduction in pain is usually observed after 3 or 4 days of using Traumuscol.
In the case of rheumatic disorders, during longer treatment periods, the number of applications should be reduced to two or three times a day.
Traumuscol should not be used for more than 14 days in the case of soft tissue injuries and/or rheumatism or more than 21 days in the case of joint pain, unless your doctor advises otherwise.
If after 7 days of using the medicine the symptoms do not improve or you feel worse, you should consult your doctor to determine further action.
Special patient groups
Liver disorder
No dose adjustment is required in patients with liver disorders.
Kidney disorder
No dose adjustment is required in patients with kidney disorders.

Using more than the recommended dose of Traumuscol

No cases of overdose with Traumuscol have been reported when used as recommended.
In the event of applying the contents of the entire tube of Traumuscol and covering the entire body in a short time, headaches and dizziness as well as abdominal discomfort may occur. In this case, wash the medicine off the skin with water.
If you or your child accidentally swallow the medicine, you should see a doctor.

Missing a dose of Traumuscol

Do not use a double dose to make up for a missed dose.
If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Traumuscol can cause side effects, although not everybody gets them.
Uncommon side effects (may affect up to 1 in 100 people, but more than 1 in 1,000 people):

• redness, skin burning. Rare side effects (may affect up to 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 less frequently exfoliative and blistering skin changes (including toxic epidermal necrolysis and erythema multiforme)).

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

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Pharmacovigilance of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49 21 301, fax: 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Traumuscol

Keep out of the sight and reach of children.
No special storage precautions are required. Store in the original packaging 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 month.
Shelf life after first opening 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 are: isopropyl alcohol, glycerol, trometamol, carbomer 934, purified water.

What Traumuscol looks like and contents of the pack

Traumuscol is a clear, white or almost white gel with a uniform appearance and characteristic isopropyl alcohol smell.
An aluminum tube with a membrane seal, internally coated with a gold epoxy-phenolic varnish, with a HDPE cap with a piercer, containing 50 g of gel, in a cardboard box.

Marketing authorization holder:

Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 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

Date of last revision of the leaflet: