Elmetacin

Leaflet attached to the packaging: information for the user

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Elmetacin

10 mg/g, spray for the skin, solution

Indometacinum

You should carefully read the contents of the leaflet 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 directed by a doctor or pharmacist.

• The leaflet should be kept so that it can be read again if necessary.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 3 days or if the patient feels worse, they should contact their doctor.

Table of contents of the leaflet:

• 1. What is Elmetacin and what is it 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 is Elmetacin and what is it used for

Elmetacin contains indomethacin, 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, local use in the treatment of pain caused by:

• inflammatory conditions resulting from acute injuries, trauma (sprains, strains, bruises),
• inflammation of soft tissues, such as tendonitis and bursitis, joint capsules, frozen shoulder,
• exacerbations of degenerative joint disease.

If there is no improvement after 3 days or if the patient feels worse, they should consult their doctor.

2. Important information before using Elmetacin

When not to use Elmetacin

• Elmetacin should not be used on open wounds, inflamed or infected skin, eczema, mucous membranes, or in the eyes. As a precaution, Elmetacin should not be used in patients with stomach or intestinal ulcers, unless a doctor has advised otherwise,

Children and adolescents: Elmetacin should not be used in children and adolescents, as there is insufficient data on the use of the medicine in this age group. It should be ensured that children do not touch any area of the body where the spray has been applied.

Warnings and precautions

• Before starting to use Elmetacin, the patient should discuss it with their doctor or pharmacist if they have asthma, hay fever, nasal polyps, chronic obstructive pulmonary disease (COPD), or chronic respiratory infections (especially in combination with symptoms similar to hay fever),
• in patients with hypersensitivity to painkillers or anti-rheumatic drugs. The use of Elmetacin increases the risk of an asthma attack (intolerance to painkillers, painkiller-induced asthma), local skin edema or mucous membrane edema (Quincke's edema) or urticaria, if the patient has hypersensitivity (allergy) to other medicines, e.g., those that cause skin reactions, itching, or urticaria.

The eyes should be protected from exposure to the medicine.

In the first and second trimester of pregnancy and during breastfeeding, the medicinal product Elmetacin may be used only if necessary, as directed by a doctor.

Elmetacin and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

After local use in accordance with the recommendations, no interactions with other medicines have been found.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.

In the first and second trimester of pregnancy, Elmetacin can be used only after consulting a doctor.

In the third, final trimester of pregnancy, Elmetacin should not be used.

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

During breastfeeding, if possible, the patient should avoid applying the medicine to large areas of skin or using it for a long time. To avoid direct contact between the child and the medicine, the spray should not be applied to the breast during breastfeeding.

Driving and using machines

There are no data on the effect of the medicine on the ability to drive and use machines.

3. How to use Elmetacin

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.

Recommended dose

Elmetacin should be applied 3 to 5 times a day. Depending on the size of the painful area, 0.5 ml to 1.5 ml of Elmetacin spray should be applied, e.g., the pump should be pressed 4 to 12 times (4 mg to 12 mg of indomethacin). Elmetacin should be sprayed onto the affected area so as to completely cover it. The total daily dose should not exceed 7.5 ml of Elmetacin solution (which corresponds to 60 mg of indomethacin and 60 pump actuations).

The medicine is intended for local use on the skin only. It should not be taken orally!

The spray should be applied directly to the affected areas without massaging it into the skin. The measuring scale on the label of the container allows the patient to read the amount of medicine used. Before the first use and after a longer period of non-use, the pump should be pressed several times. Only after such preparation is the container ready for use.

Before applying a dressing, the patient should wait a few minutes until the skin is dry. It is not recommended to use the medicine under an occlusive dressing.

The doctor will decide how long the medicine should be used. Usually, treatment for about 1 to 2 weeks is sufficient. No benefits have been established for longer treatment.

Using a higher dose of Elmetacin than recommended

If a higher dose of Elmetacin than recommended has been used, the medicine should be removed from the skin and the skin should be washed with water.

An excessive amount of spray may affect blood clotting.

In case of significant overdose or accidental oral ingestion of Elmetacin, the patient should contact their doctor. Depending on the type of symptoms, the doctor will decide what treatment to use.

Missing a dose of Elmetacin

A double dose should not be used to make up for a missed dose.

If there are any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Elmetacin can cause side effects, although not everybody gets them.

The following classification of frequency of occurrence has been used to evaluate side effects:

Very common: more than 1 in 10 treated patients

Common: more than 1 in 100 treated patients

Uncommon: more than 1 in 1,000 treated patients

Rare: more than 1 in 10,000 treated patients

Very rare: less than 1 in 10,000 treated patients

• Common: local skin reactions, such as redness, itching, burning, rash, or blisters.
• Rare: hypersensitivity reactions or local allergic reactions (contact dermatitis), gastrointestinal disorders, headaches, and dizziness.
• Very rare: bronchospasm in predisposed patients. Worsening of psoriatic lesions after local use of Elmetacin. Inhalation of the medicinal product may cause respiratory irritation.
• Uncommon: if Elmetacin is used on a large area of skin and for a long time, side effects specific to organs or the whole body may occur, similar to those that occur after systemic use of medicines containing indomethacin.

If side effects occur, the patient should stop using Elmetacin and consult their doctor. If these are symptoms or a hypersensitivity reaction, the patient should stop the treatment and never use Elmetacin again.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, al. Jerozolimskie 181C, 02-222 Warsaw

Phone: +48 22 49 21 301

Fax: +48 22 49 21 309

Website: https://smz.ezdrowie.gov.pl

By reporting side effects, it is possible to gather more information on the safety of the medicine.

5. How to store Elmetacin

The medicine should be stored out of sight and reach of children.

Store in a temperature below 25°C.

The solution contains isopropyl alcohol, which is a flammable substance!

This medicine should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.

Shelf life after first opening: 12 months.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 Elmetacin contains

The active substance of Elmetacin is indomethacin. 1 g of solution contains 10 mg of indomethacin. 1 ml (0.8 g) of solution contains 8 mg of indomethacin.

The other ingredients are: isopropyl alcohol, isopropyl myristate.

What Elmetacin looks like and what the packaging contains

HDPE bottle with a colorless protective cap on the valve with PP and pump with PP and PE, in a cardboard box.

The packaging contains 100 ml of spray for the skin, solution.

For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in the Czech Republic, the 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

82576 Pfaffenhofen

Germany

Parallel importer:

Delfarma Sp. z o.o.

ul. Św. Teresy od Dzieciątka Jezus 111

91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.

ul. Św. Teresy od Dzieciątka Jezus 111

91-222 Łódź

Authorization number in the Czech Republic, the country of export: 29/197/87-C

Parallel import authorization number: 256/18

Additional information for the patient:

The spray container works completely mechanically (it is not harmful to the environment).

Before the first spraying or if a long period of time has passed since the last use, the pump should be pressed several times, then the spray container will be ready for use.

Date of leaflet approval: 31.05.2023

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