Elmetacin

PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language!
Elmetacin
10 mg/g, cutaneous aerosol, solution
Indometacinum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in the patient leaflet or as
recommended 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 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 there is no improvement after 3 days, or if you feel worse, consult your doctor.

Table of contents of the leaflet:

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

1. What ELMETACIN is and what it is used for

ELMETACIN contains indometacin, which has anti-inflammatory and analgesic properties and belongs to the group of non-steroidal anti-inflammatory and analgesic drugs.

Indications for use
For symptomatic, topical treatment of pain caused by:

• inflammatory conditions resulting from acute injuries or trauma (sprains, dislocations, contusions),
• inflammatory conditions of soft tissues, e.g. tendonitis, tenosynovitis, bursitis, frozen shoulder,
• exacerbations of degenerative joint disease.

If there is no improvement after 3 days, or if you feel worse, consult your doctor.

2. Important information before using the medicine ELMETACIN

When not to use ELMETACIN

• if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6),
• if the patient suffers from asthma, skin irritation, or has experienced allergic symptoms after using other painkillers or anti-rheumatic medicines (non-steroidal anti-inflammatory drugs), such as acetylsalicylic acid (e.g. Aspirin),
• do not use ELMETACIN on open wounds, inflamed or infected skin, rashes (eczema), mucous membranes, or in the eyes. As a precaution, ELMETACIN should not be used in patients with peptic ulcer disease of the stomach or intestine, unless otherwise advised by a doctor,
• do not use ELMETACIN during the last, third trimester of pregnancy.

Children and adolescents: ELMETACIN should not be used in children and adolescents, as there is insufficient data on its use in this age group. Care should be taken to ensure that children do not come into contact with any area of the body to which the aerosol containing this medicine has been applied.

Warnings and precautions

• Before starting to use ELMETACIN, consult your doctor or pharmacist if the patient has been diagnosed with asthma, hay fever, nasal polyps, chronic obstructive pulmonary disease (COPD), or chronic respiratory tract infections (especially in combination with hay fever-like symptoms),
• in patients with hypersensitivity to painkillers or anti-rheumatic drugs. The use of ELMETACIN increases the risk of asthma attacks (drug intolerance, drug-induced asthma), local swelling of the skin or mucous membranes (Quincke's oedema), or urticaria, if the patient has previously experienced hypersensitivity (allergy) to other medicines, e.g. those causing skin reactions, itching, or hives.

Protect the eyes from exposure to the medicine.
During the first and second trimesters of pregnancy and during breastfeeding, the medicinal product ELMETACIN may be used only if there are significant medical reasons requiring such therapy, as prescribed by a doctor.

ELMETACIN and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned to be used.
No interactions with other medicines have been reported following topical use as recommended.

Pregnancy, breastfeeding and fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
During the first and second trimesters of pregnancy, ELMETACIN should be used only after consultation with a doctor.
During the third, final trimester of pregnancy, ELMETACIN must not be used.
Indometacin, the active ingredient in ELMETACIN, passes into breast milk in small amounts.
While breastfeeding, if possible, avoid applying the medicine to large areas of skin or using it for prolonged periods. To avoid direct contact of the child with ELMETACIN, the aerosol should not be applied to the breasts during breastfeeding.

Driving and operating machinery
There is no data available on the effect of this medicine on the ability to drive or operate machinery.

3. How to use ELMETACIN

This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.

Recommended dose
Apply ELMETACIN 3 to 5 times daily. Depending on the size of the painful area, apply 0.5–1.5 ml of ELMETACIN aerosol, for example by pressing the pump 4 to 12 times (4–12 mg of indometacin). ELMETACIN should be sprayed onto the affected area so that it is completely covered. The total daily dose should not exceed 7.5 ml of ELMETACIN solution (corresponding to 60 mg of indometacin and 60 actuations of the applicator).

This medicine is intended for topical use on the skin only. Do not take orally!
The aerosol should be sprayed directly onto the affected areas; there is no need to rub the medicine into the skin. Before first use, and after a prolonged period of non-use, press the applicator several times to prime the device. Only after this preparation is the container ready for use.
Wait a few minutes for the skin to dry before applying a dressing. Use under occlusive dressings is not recommended.

The duration of treatment will be determined by the doctor. Usually, treatment lasting about 1 to 2 weeks is sufficient. No additional benefit has been established for longer treatment periods.

Use of a higher than recommended dose of ELMETACIN
If more ELMETACIN has been applied than recommended, remove the medicine from the skin and wash the area with water.
Excessive amounts of applied aerosol may affect blood clotting.
In case of significant overdose or accidental oral ingestion of ELMETACIN, contact a doctor immediately. Depending on the nature of symptoms, the doctor will decide what treatment is required.

Missed dose of ELMETACIN
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 classification is used to assess the frequency of adverse reactions:
Very common: more frequently than in 1 out of 10 patients treated
Common: more frequently than in 1 out of 100 patients treated
Uncommon: more frequently than in 1 out of 1,000 patients treated
Rare: more frequently than in 1 out of 10,000 patients treated
Very rare: less frequently than in 1 out of 10,000 patients treated

• Common: local skin reactions such as redness, itching, burning, rash, or blisters.
• Rare: hypersensitivity reactions or local allergic reactions (contact dermatitis), gastrointestinal disturbances, pain, and dizziness.
• Very rare: bronchospasm in predisposed patients. Worsening of psoriatic lesions after topical application of ELMETACIN. Inhalation of the medicinal product may cause irritation of the respiratory tract.
• Uncommon: if ELMETACIN is applied over a large skin surface area and for prolonged periods, systemic or organ-specific adverse reactions may occur, similar to those observed after systemic administration of medicinal products containing indometacin.

If any adverse reactions occur, treatment with ELMETACIN should be discontinued and a doctor should be consulted. If symptoms or a hypersensitivity reaction occur, treatment must be stopped and ELMETACIN must never be used again.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse effects not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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
Reporting adverse reactions enables further information on the safety of the medicine to be collected.

5. How to store ELMETACIN

Keep this medicine out of sight and reach of children.
Store below 25°C.
The solution contains isopropyl alcohol, which is a flammable substance!
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Shelf life after first opening the bottle: 12 months.
Medicines must 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 packaging and other information

What ELMETACIN contains
The active substance is indometacin. 1 g of solution contains 10 mg of indometacin. 1 ml (0.8 g)
of solution contains 8 mg of indometacin.
The other components are: isopropyl alcohol, isopropyl myristate.

What ELMETACIN looks like and contents of the pack
White HDPE bottle with a colourless protective cap made of PP and a pump made of PP, PE and
stainless steel, in a cardboard box.
Pack size: 100 ml.
For more detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.

Marketing Authorisation Holder in the Czech Republic, country of export:
Stada Arzneimittel AG
Stadastrasse 2-18
D-61118 Bad Vilbel
Germany

Manufacturer:
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Mobilat Produktions GmbH
Luitpoldstrasse 1
82576 Pfaffenhofen
Germany

Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Marketing Authorisation number in the Czech Republic, country of export: 29/197/87-C
Parallel Import Authorisation number: 433/19

Additional information for the patient:

The aerosol container operates entirely mechanically (it is not harmful to the environment).
Before the first use, or if a long period of time has passed since the last use, press the applicator several times to prime the aerosol container before use.