Etodal

Poland
Brand name Etodal
Form gel
Active substance / Dosage
etofenamate · 100 mg/g
Prescription type Over-the-counter
ATC code
M02AA06
Registration number 100409074
Manufacturer Ziaja Ltd. - Pharmaceutical Production Plant Sp. z o.o.
Etodal gel

Table of Contents

Package leaflet: Information for the patient

Etodal, 100 mg/g, gel
Etofenamate
Please read all of 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 the
physician or pharmacist.

  • Keep this leaflet, as you may need to read it again.
  • If you need advice or further information, please consult your pharmacist.
  • If you experience any adverse reactions, including any 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 after 7 days, consult your doctor.

Table of contents

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

1. What Etodal is and what it is used for

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

Indications

  • Blunt injuries, such as bruises, sprains, strains of muscles, tendons and joints;
  • Degenerative joint disease of the spine, knees, shoulders;
  • Periarticular rheumatism:
    • lumbosacral pain,
    • pathological changes in soft tissues around joints, i.e. bursitis, tendinitis, tenosynovitis, synovitis (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 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
Before starting treatment with Etodal, consult your doctor or pharmacist.
Do not use Etodal if the skin is damaged or affected by inflammatory skin eruptions, and avoid contact with mucous membranes or eyes. Therefore, hands should be washed after application or contact with these areas should be avoided.
During treatment and for two weeks after stopping treatment, avoid exposing treated areas to sunlight and/or solarium.
Patients suffering from asthma, chronic obstructive pulmonary disease, hay fever, chronic mucosal nasal edema (so-called nasal polyps), or chronic respiratory tract infections, especially in combination with symptoms resembling hay fever, should use Etodal only with caution and under strict medical supervision.
Prolonged use of Etodal over large areas of the body should be avoided, as this may increase systemic absorption.
Children should not come into contact with skin treated with this medicine.

Children and adolescents
Use in children and adolescents is not recommended due to insufficient clinical data in these patient groups.

Etodal and other medicines
Inform your doctor or pharmacist about any medicines you are currently using, have recently used, or plan to use.
No interactions have been reported 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, consult your doctor or pharmacist before using this medicine.
Etodal may be used during the first and second trimesters of pregnancy only after careful assessment by a doctor of the benefit-risk ratio. The recommended daily dose must not be exceeded.
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 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 Etodal on the ability to drive or operate machinery.

Etodal contains propylene glycol (E 1520)
This 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, 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 Etodal

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.

Recommended dose
Apply the gel to the painful area and gently rub in until completely absorbed. Depending on the size of the affected area, apply a strip of medicine 5 to 10 cm long. Etodal should be used up to a maximum of 3 to 4 times daily.

Treatment of rheumatic conditions usually lasts from 3 to 4 weeks, while treatment of blunt injuries (e.g. sports injuries) lasts up to 2 weeks.
If symptoms worsen or do not improve within 7 days, consult a doctor.
Do not use the medicine for longer than 2 weeks without consulting a doctor.

Use in children and adolescents
Use in children and adolescents is not recommended.

Use of a higher than recommended dose of Etodal
Overdose following topical application is unlikely. However, if the entire contents of a tube of Etodal are used and the whole body is covered within a short time, headache, dizziness, and upper abdominal discomfort may occur. In such a case, wash the medicine off the skin with water.
If the medicine is accidentally ingested by a patient or child, seek immediate medical advice.

Missed dose of Etodal
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 doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions have been reported:

Skin and subcutaneous tissue disorders
Not common (occurs in less than 1 in 100 people but more than 1 in 1,000 people taking the medicine):

  • erythema, burning sensation of the skin.

Very rare (occurs in less than 1 in 10,000 people taking the medicine):

  • dermatitis (intense itching, rash, swelling, blistering rash).

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

  • photosensitivity reaction. The adverse reactions listed above usually resolve quickly after discontinuation of the medicine.

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

  • hypersensitivity (non-specific allergic reactions and anaphylactic reactions, increased respiratory reactivity leading to asthma, worsening of asthma, bronchospasm or dyspnea, or various skin disorders including different types of rashes, pruritus, urticaria, angioedema, and much more rarely exfoliative and bullous skin lesions (including epidermal necrolysis and erythema multiforme)).

If such symptoms occur, which is possible even after the first dose, the patient should immediately seek medical help.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 4921301
Fax: +48 22 4921309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the Marketing Authorization Holder.
Reporting adverse reactions enables further collection of information on the safety of using the medicine.

5. How to store Etodal

Keep this medicine out of sight and reach of children.
Store 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines no longer in use. This helps protect the environment.

6. Contents of the packaging and other information

What Etodal contains

  • The active substance is etofenamate. 1 g of gel contains 100 mg of etofenamate.
  • Other components are: propylene glycol (E 1520), macrogol 400, oleic cetyl alcohol polyether, sodium hydroxide, carbomer 980, isopropyl alcohol, purified water.

What Etodal looks like and contents of the pack
Etodal is a transparent, colourless to slightly yellow gel with a characteristic odour of isopropyl alcohol.
Pack: aluminium tube with an epoxy-phenolic varnish lining, fitted with a polyethylene cap equipped with a piercing device, containing 50 g or 100 g of gel, packed in a cardboard box.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
ZIAJA Ltd Zakład Produkcji Leków sp. z o.o.
ul. Jesienna 9
80-298 Gdańsk
Poland
Tel.: +48 58 521 34 00
Manufacturer
ZIAJA Ltd Zakład Produkcji Leków sp. z o.o.
ul. Przemysłowa 12
83-050 Kolbudy
Poland