Elmetacin

Package leaflet: Information for the user

Warning! Keep this 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 this 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 doctor or pharmacist.

• Keep this leaflet for future reference.
• 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 or pharmacist. See section 4.
• If there is no improvement after 3 days of treatment, or if your condition worsens, consult your doctor.

Leaflet contents:

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 pack and other information

1. What Elmetacin is and what it is used for

Elmetacin contains indometacin, a substance with anti-inflammatory and analgesic properties, belonging to the group of non-steroidal anti-inflammatory and analgesic drugs.
Indications
For symptomatic, topical treatment of pain caused by:

• inflammatory conditions resulting from acute injuries or trauma (sprains, dislocations, contusions),
• inflammation of soft tissues, e.g. tendinitis, tenosynovitis, bursitis, frozen shoulder,
• exacerbations of osteoarthritis.

If there is no improvement after 3 days of treatment, or if your condition worsens, consult your doctor.

2. Information before using 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 has asthma, skin irritation, or has experienced allergic symptoms after using other pain-relieving 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 intestines, unless otherwise directed by a physician;
• do not use Elmetacin during the last 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, discuss with 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 symptoms resembling hay fever);
• if the patient has hypersensitivity to pain-relieving or anti-rheumatic medicines. Use of Elmetacin increases the risk of asthma attacks (analgesic intolerance, analgesic-induced asthma), local swelling of the skin or mucous membranes (Quincke's oedema), or urticaria;
• if the patient has hypersensitivity (allergy) to other medicines, for example 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, Elmetacin may be used only if clearly necessary and under medical supervision.

Elmetacin and other medicines

Inform your doctor or pharmacist about all medicines the patient is currently using, has recently used, or plans to use.

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 her 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 and final trimester of pregnancy, Elmetacin must not be used.

Indometacin, the active ingredient in Elmetacin, passes into breast milk in small amounts.

While breastfeeding, avoid applying the medicine to large areas of skin or prolonged use, if possible. To prevent direct contact of the child with Elmetacin, the aerosol should not be applied to the breasts during breastfeeding.

Driving and operating machinery

There are no data available on the effect of the medicine on the ability to drive and operate machinery.

3. How to use Elmetacin

This medicine should always be used exactly as described in the patient leaflet or as directed by a
physician 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 ml to 1.5 ml of
Elmetacin aerosol, for example by pressing the pump 4 to 12 times (4 mg to 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 area; 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. 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.
Your doctor will decide how long the treatment should last. Usually, treatment lasting about 1 to
2 weeks is sufficient. The benefits of longer treatment have not been established.
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 skin 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. Depending
on the type of symptoms, the doctor will decide what treatment should be administered.
Missed dose of Elmetacin
Do not use a double dose to make up for a missed dose.
If you have any further doubts regarding 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 experiences them.
The following classification is used to assess the frequency of adverse reactions:
Very common: more frequently than in 1 out of 10 patients
Common: more frequently than in 1 out of 100 patients
Uncommon: more frequently than in 1 out of 1,000 patients
Rare: more frequently than in 1 out of 10,000 patients
Very rare: less frequently than in 1 out of 10,000 patients

• Common: local skin reactions such as redness, itching, burning sensation, 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 use of the medicine 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 adverse reactions occur, treatment with Elmetacin should be discontinued and you should contact your doctor.
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 effects occur, including any adverse effects not listed in this leaflet, inform your 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, tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Elmetacin

Keep the medicine out of the 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.
Expiry after first opening – 12 months.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack 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 ingredients 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. Outer packaging – 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, D-61118 Bad Vilbel, Germany
Mobilat Produktions GmbH, Luitpoldstrasse 1, 85276 Pfaffenhofen, Germany

Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw, Poland

Repackaged in:
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw, Poland
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland

Marketing Authorisation Number in the Czech Republic, country of export: 29/197/87-C
Parallel Import Authorisation Number: 68/19

Additional information for the patient

The aerosol bottle operates completely mechanically (it is not harmful to the environment).
Before the first spray, or if a long period of time has passed since the last use, press the pump several times until the aerosol bottle is ready for use.