Etodal

Leaflet attached to the packaging: patient information

Etodal, 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 a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after 7 days there is no improvement or you feel worse, contact a doctor.

Table of contents of the leaflet

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

1. What is Etodal and what is it used for

Etodal is a medicine that contains the active substance etofenamate. Etofenamate belongs to the group of nonsteroidal anti-inflammatory drugs (NSAIDs). When applied locally, it is absorbed through the skin and accumulates in inflamed tissues.

Indications for use

• 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, tendonitis, tendon sheath inflammation, joint capsule inflammation (so-called frozen shoulder),
• epicondylitis.

Etodal is indicated for use in adults.

2. Important information before using Etodal

When not to use Etodal

• if the patient is 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 Etodal, discuss it with your doctor or pharmacist. Do not use Etodal in case of skin damage or inflammatory skin lesions, as well as on mucous membranes or eyes, therefore, after applying the medicine, wash your hands or avoid contact with these parts of the body. During treatment and for two weeks after treatment, avoid exposure of treated areas to sunlight and/or solarium. Patients with asthma, chronic obstructive pulmonary disease, hay fever or chronic nasal congestion (so-called nasal polyps), or chronic respiratory infections, especially in combination with symptoms similar to hay fever, may use Etodal only under certain precautions and under strict medical supervision. Do not use Etodal for a long time and on large areas of the body, as this may increase systemic absorption. Children should not come into contact with skin covered with this medicine.

Children and adolescents

Etodal is not recommended for use in children and adolescents due to insufficient clinical data in these patient groups.

Etodal and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take. No interactions have been found when Etodal is used as directed.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. Etodal may be used in the first and second trimester of pregnancy, only after a doctor has assessed the benefit-risk ratio. Do not exceed the recommended daily dose. Etodal must not be used during the third trimester of pregnancy. Etofenamate passes into breast milk in small amounts. Breastfeeding mothers should avoid prolonged use of Etodal and should 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 Etodal on the ability to drive and use machines. Etodal contains propylene glycol (E 1520)The medicine contains 30 mg of propylene glycol in each gram of gel. Propylene glycol may cause skin irritation. Due to the presence of propylene glycol, the medicine should not be applied to open wounds or large areas of damaged or broken skin (e.g. burned skin) without consulting a doctor or pharmacist.

3. How to use Etodal

This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist. In case of doubt, consult a doctor or pharmacist. Recommended dose Apply the gel to the painful area and gently rub it in until the medicine is completely absorbed. Depending on the size of the painful area, apply a strip of medicine 5 to 10 cm long. Use Etodal up to 3 to 4 times a day. Treatment of rheumatic conditions usually lasts from 3 to 4 weeks, and blunt injuries (e.g. sports injuries) - up to 2 weeks. If symptoms worsen or do not improve after 7 days, contact a doctor. Do not use the medicine for more than 2 weeks without consulting a doctor.

Use in children and adolescents

Etodal is not recommended for use in children and adolescents.

Overdose of Etodal

Overdose of the medicine after local application is unlikely. If the contents of the entire tube of Etodal are applied and the whole body is covered 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, seek medical attention immediately.

Missed dose of Etodal

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

4. Possible side effects

Like all medicines, Etodal can cause side effects, although not everybody gets them. The following side effects have been reported: Skin and subcutaneous tissue disorders Uncommon (affects less than 1 in 100 people but more than 1 in 1,000 people using the medicine):

• redness, skin burning.

Rare (affects less than 1 in 10,000 people using the medicine):

• skin inflammation (severe itching, rash, swelling, blistering rash).

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

• phototoxic reaction. The above side effects usually resolve quickly after the medicine is discontinued.

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

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

If you experience such symptoms, which is possible even after the first application, seek medical attention immediately.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your 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, 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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Etodal

Keep the medicine out of the sight and reach of children. Store in a temperature below 25°C. Shelf life after first opening the tube: 2 years. Do not use this medicine after the expiry date stated on the packaging after "EXP". 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 that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Etodal contains

• The active substance of the medicine is etofenamate. 1 g of gel contains 100 mg of etofenamate.
• The other ingredients are: propylene glycol (E 1520), macrogol 400, macrogol oleate, sodium hydroxide, carbomer 980, isopropyl alcohol, purified water.

What Etodal looks like and contents of the packaging

Etodal is a clear, colorless to slightly yellowish gel with a characteristic smell of isopropyl alcohol. Packaging: aluminum tube with a membrane, coated with an epoxy-phenolic lacquer from the inside, with a polyethylene screw cap equipped with a piercer, containing 50 g or 100 g of gel, in a cardboard box. Not all pack sizes may be marketed.

Marketing authorization holder

ZIAJA Ltd Pharmaceutical Manufacturing Plant sp. z o.o., ul. Jesienna 9, 80-298 Gdańsk, Poland, Tel.: +48 58 521 34 00

Manufacturer

ZIAJA Ltd Pharmaceutical Manufacturing Plant sp. z o.o., ul. Przemysłowa 12, 83-050 Kolbudy, Poland, Date of last revision of the leaflet:09/2024