Elmetacin

Package Leaflet: Information for the User

Elmetacin, 10 mg/g, 1% solution, spray for external use

Indometacinum

Read the package 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 package leaflet for the patient 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 the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or 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 pack and other information

1. What is ELMETACIN and what is it used for

ELMETACIN contains indometacin, which has anti-inflammatory and analgesic properties and belongs to the group of nonsteroidal 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, dislocations, bruises),
• inflammation of soft tissues, such as tendonitis and tendon sheath inflammation, joint capsule inflammation, frozen shoulder,
• exacerbations of degenerative joint disease.

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

2. Important information before using ELMETACIN

When not to use ELMETACIN

• if the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6),
• if the patient has asthma, skin irritation, or has experienced allergic reactions after using other painkillers or anti-rheumatic drugs (nonsteroidal anti-inflammatory drugs), such as acetylsalicylic acid (e.g., Aspirin),
• 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 prescribed it otherwise,
• ELMETACIN should not be used 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 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 and under the supervision of a doctor.

ELMETACIN and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
No interactions with other medicines have been found when used as directed.

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, last trimester of pregnancy, ELMETACIN should not be used.
Indometacin, 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 package leaflet for the patient 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 the ELMETACIN spray should be applied, e.g., the pump should be pressed 5 to 15 times (4 mg to 12 mg of indometacin). ELMETACIN should be sprayed onto the affected area to completely cover it. The total daily dose should not exceed 7.5 ml of the ELMETACIN solution (which corresponds to 60 mg of indometacin and 75 pump actuations).
The medicine is intended for external use only, on the skin. It should not be taken orally!
The spray should be applied directly to the affected areas without rubbing it into the skin. The measuring scale on the label allows the patient to read the amount of medicine used. Before the first use, and also after a longer period of non-use, the pump should be pressed several times. Only then 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 under an occlusive dressing.
The doctor will decide how long to use the medicine. 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 washed with water.
Excessive use of the 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 symptoms, the doctor will decide what treatment to use.

Missing a dose of ELMETACIN

The patient should not use a double dose to make up for a missed dose.
In case of 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 1000 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: allergic 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 tract irritation.

• Uncommon: if ELMETACIN is used on a large skin surface 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 indometacin-containing medicinal products.

If side effects occur, the patient should stop using ELMETACIN and consult their doctor. If these are symptoms or an allergic 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 inform their doctor or pharmacist or nurse. Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, al. Jerozolimskie 181C, 02-222 Warszawa
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store ELMETACIN

The medicine should be kept out of the sight and reach of children.
Store in a temperature 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 label after "Expiry date". The expiry date refers to the last day of the month.
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 pack and other information

What ELMETACIN contains

The active substance of ELMETACIN is indometacin. 1 g of the solution contains 10 mg of indometacin.
The other ingredients are: isopropyl alcohol, isopropyl myristate.

What ELMETACIN looks like and contents of the pack

HDPE plastic bottle, 0.2% titanium dioxide; pump made of PP and PE; protective cap on the valve made of PP. Outer packaging – cardboard box.
Pack sizes: 50, 100 ml.

Marketing authorization holder and manufacturer

Marketing authorization holder:

STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel, Germany

Manufacturer:

STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel, Germany

Additional information for the patient:

The aerosol 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 aerosol container will be ready for use.

Date of last revision of the leaflet: