Elmetacin
Poland
Table of Contents
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 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 a physician or pharmacist.
- Keep this leaflet, so that you can read it again if necessary.
- If you need advice or further information, please contact 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 of treatment, or if you feel worse, consult your doctor.
Table of contents of the leaflet:
- What Elmetacin is and what it is used for
- Important information before using Elmetacin
- How to use Elmetacin
- Possible side effects
- How to store Elmetacin
- 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 degenerative joint disease.
If there is no improvement after 3 days of treatment, or if you feel worse, 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 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, do not use ELMETACIN in patients with gastric or intestinal ulcers, unless otherwise advised by a doctor,
- do not use ELMETACIN during the last, third trimester of pregnancy.
Children and adolescents: do not use ELMETACIN in children and adolescents, as there is insufficient data on the use of this medicine in this age group. Care should be taken to ensure that children do not touch 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 (analgesic intolerance, analgesic-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, for example 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 there are compelling medical reasons and under the advice of 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 become pregnant, 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 and final trimester of pregnancy, do not use ELMETACIN.
Indometacin, the active ingredient in ELMETACIN, passes into breast milk in small amounts.
During breastfeeding, application to large skin areas or prolonged use should be avoided if possible. To avoid direct contact of the infant 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 the patient information leaflet or as directed by your doctor or pharmacist. If in doubt, consult your 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 directly onto the affected area, completely covering it. The total daily dose should not exceed 7.5 ml of ELMETACIN solution (equivalent 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. The measuring scale on the container label allows you to monitor the amount of medicine used. 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.
Your doctor will decide how long you should use this medicine. Treatment usually lasts about 1 to 2 weeks. No additional benefit has been established for longer treatment durations.
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 your doctor immediately. Depending on the nature of symptoms, the doctor will decide what treatment is necessary.
Missed dose of ELMETACIN
Do not apply 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 effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The following frequency classification has been used to assess adverse effects:
Very common: affects more than 1 in 10 treated patients
Common: affects more than 1 in 100 treated patients
Uncommon: affects more than 1 in 1,000 treated patients
Rare: affects more than 1 in 10,000 treated patients
Very rare: affects fewer 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 disturbances, pain and dizziness.
- Very rare: bronchospasm in predisposed patients. Worsening of psoriatic lesions following topical application of ELMETACIN. Inhalation use 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, adverse effects specific to organs or the whole organism, similar to those observed after systemic administration of medicinal products containing indometacin, may occur.
If adverse effects 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 effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring 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 effects allows additional 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.
Expiry date after first use – 12 months.
Medicines must not be disposed of via the sewage system 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
HDPE bottle with a colorless protective cap on valve made of PP and pump made of PP and PE, in
a cardboard box.
The pack contains 100 ml of cutaneous aerosol solution.
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
82576 Pfaffenhofen
Germany
Parallel importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland
Marketing authorisation number in the Czech Republic, country of export: 29/197/87-C
Parallel import authorisation number: 256/18
Additional information for the patient:
The aerosol container operates entirely 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 applicator several times to prime the aerosol container before use.