Elmetacin
Poland
Table of Contents
Patient Information Leaflet
Elmetacin, 10 mg/g, 1% solution, topical spray
Indometacinum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.
- Keep this leaflet, as you may need to read it again.
- If you need advice or further information, please consult your pharmacist.
- If you experience any side effects, including any 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:
- 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 (NSAIDs).
Indications
For symptomatic, local treatment of pain caused by:
- inflammatory conditions resulting from acute injuries or trauma (sprains, dislocations, contusions),
- inflammatory conditions 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 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 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, do not use ELMETACIN in patients with peptic ulcer disease of the stomach or intestines, unless otherwise directed by a physician,
- 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 a history of asthma, hay fever, nasal polyps, chronic obstructive pulmonary disease (COPD), or chronic respiratory tract infections (especially in combination with symptoms resembling hay fever), or if the patient has hypersensitivity to painkillers or anti-rheumatic drugs. The use of ELMETACIN increases the risk of asthma attacks (drug intolerance, drug-induced asthma), localised swelling of the skin or mucous membranes (Quincke's oedema), or urticaria, particularly if the patient has a history of hypersensitivity (allergy) to other medicines, such as those causing skin reactions, itching, or hives.
Protect the eyes from exposure to the medicine.
ELMETACIN may be used during the first and second trimesters of pregnancy and during breastfeeding only if clearly necessary and under medical supervision.
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 recommended topical use.
Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
ELMETACIN may be used during the first and second trimesters of pregnancy only after consultation with a doctor.
ELMETACIN must not be used during the third and final trimester of pregnancy.
Indometacin, the active ingredient in ELMETACIN, passes into breast milk in small amounts.
During breastfeeding, if possible, avoid applying the medicine to large areas of skin or prolonged use. 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 is no data available regarding 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 leaflet or as directed by a doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Recommended dose
ELMETACIN should be applied 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 5 to 15 times (delivering 4 mg to 12 mg of indometacin). ELMETACIN should be sprayed directly onto the affected area to completely cover it. The total daily dose should not exceed 7.5 ml of ELMETACIN solution (equivalent to 60 mg of indometacin and 75 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 until the skin is 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 demonstrated with longer treatment duration.
Use of a higher than recommended dose of ELMETACIN
If more ELMETACIN has been used than recommended, remove the medicine from the skin and wash the area with water.
Excessive application of the 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 doubts about the use of this medicine, consult your doctor or pharmacist.
4. Possible adverse reactions
Like all medicines, this product can cause adverse reactions, although not everyone experiences them.
The following frequency classification is used to assess adverse reactions:
Very common: affects more than 1 in 10 patients
Common: affects more than 1 in 100 patients
Uncommon: affects more than 1 in 1,000 patients
Rare: affects more than 1 in 10,000 patients
Very rare: affects fewer than 1 in 10,000 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 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 following systemic administration of medicinal products containing indometacin.
If any adverse reactions occur, discontinue use of ELMETACIN and consult a doctor. If symptoms are signs of hypersensitivity or an allergic reaction, stop treatment immediately and never use ELMETACIN again.
Reporting of adverse reactions
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
e-mail: [email protected]
Adverse reactions may also be reported to the marketing authorization holder.
Reporting adverse reactions helps to enhance the safety information available for this medicine.
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 label after "Expiry date". 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 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 the medicinal product ELMETACIN contains
The active substance is indometacin. 1 g of the solution contains 10 mg of indometacin.
Other components: isopropyl alcohol, isopropyl myristate.
What ELMETACIN looks like and contents of the pack
Plastic bottle made of HDPE, coloured with 0.2% titanium dioxide; pump dispenser made of PP and PE;
protective cap for the valve made of PP. Outer packaging – cardboard box.
Pack sizes: 50, 100 ml.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel, Germany
Manufacturer:
STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel, Germany
Additional information intended 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 until the aerosol container is ready for use.