Reusin 8 mg/ml solution for cutaneous spray
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: Information for the user
Reusin 8 mg/ml cutaneous spray solution
indometacin
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
Leaflet contents
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What Reusin is and what it is used for
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What you need to know before using Reusin
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How to use Reusin
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Possible adverse effects
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Storage of Reusin
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Contents of the pack and other information
1. What Reusin is and what it is used for
Reusin belongs to the group of medicines known as topical non-steroidal anti-inflammatory drugs.
Indometacin, the active substance in this medicine, works by reducing pain and inflammation.
Reusin is indicated in adults for the treatment of mild and occasional pain and inflammation in conditions such as osteoarthritis and acute musculoskeletal disorders and post-traumatic conditions including tendinitis, tenosynovitis, sprains, and low back pain.
2. What you need to know before using Reusin
Do not use Reusin
- if you are allergic to indometacin or to any of the other ingredients of this medicine (listed in section 6).
- if you have experienced an allergic reaction (hypersensitivity) after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs).
- if you have any other skin condition in the area to be treated.
- if the inflammation is caused by an infection.
- if you are pregnant or breastfeeding.
- .
Warnings and precautions
Consult your doctor or pharmacist before starting to use Reusin.
- if you are using the medicine over large areas of skin for long periods of time, as this may allow the active ingredient to pass into the bloodstream in significant amounts and cause more adverse effects.
- do not use an occlusive dressing.
- Reusin must not be ingested.
- Do not apply Reusin to the eyes, mucous membranes, or open wounds.
- Inhalation of the solution may cause irritation of the respiratory tract.
- Due to its alcohol content, the solution is highly flammable.
Children
This medicine must not be used in children and adolescents under 18 years of age due to lack of data on safety and efficacy.
Other medicines and Reusin
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Certain medicines may interact with Reusin. In such cases, it may be necessary to adjust the dose or discontinue treatment with some of the other medicines.
In particular, consult your doctor or pharmacist if you are taking medicines:
- that increase urine excretion (diuretics), as well as other medicines for high blood pressure, since Reusin may reduce their effectiveness;
- for the treatment of high blood pressure and certain heart conditions (angiotensin-converting enzyme inhibitors or angiotensin II antagonists), as their use together with Reusin may affect kidney function.
It is not recommended to apply cosmetics or other skin products to the affected area without first consulting your doctor.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Pregnancy
Indometacin is not recommended during pregnancy, as there is insufficient information on the use of topical indometacin in pregnant women. Therefore, its use during pregnancy is not recommended.
Lactation
Use of this medicine during breastfeeding is not recommended. It is unknown whether topically applied indometacin passes into breast milk, but it is known that indometacin passes into breast milk when administered orally (capsules, tablets, etc.).
Driving and using machines
No effects on the ability to drive or operate machinery have been reported following cutaneous administration of indometacin.
3. How to use Reusin
Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Reusin is intended for cutaneous use only (to be applied on the skin).
Recommended dose:
Adults
The usual dose is to apply 5 to 10 sprays, 3 to 4 times daily, unless your doctor has given you other instructions. This recommendation may be adjusted depending on the size of the area to be treated.
For the treatment of large areas, it is recommended not to exceed 25 ml per day, equivalent to 200 mg of indometacine (approximately 150 sprays).
Recommendations for correct application:
- When first using the container, press several times consecutively to remove air from the inner tube and ensure proper liquid delivery.
- Hold the spray nozzle at a distance of 10 to 15 cm from the affected area and press the valve fully the required number of times to complete the prescribed dose.
- After application to the affected area, gently massage to promote penetration of the medicine.
- It is advisable to wash your hands after using the medicine.
Use in children
The use of Reusin is not recommended in children and adolescents under 18 years of age due to the lack of data on its safety and efficacy.
If you use more Reusin than you should
Because this medicine is applied cutaneously, intoxication is unlikely. However, in case of accidental ingestion of large quantities, symptoms of overdose may include nausea, disorientation, deafness, tinnitus, unusual excitement, convulsions, unusual drowsiness, accelerated breathing, fever, and ultimately unconsciousness and death.
In case of overdose or accidental ingestion, contact the Toxicology Information Service at phone number 91 562 04 20, indicating the medicine and the amount ingested. It is recommended to bring the container and the package leaflet to the healthcare professional.
If you forget to use Reusin
Do not apply a double dose to make up for missed doses.
Continue treatment as normal without taking any specific action.
If you stop using Reusin
Stopping treatment with this medicine does not require any specific action.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.
The adverse effects of topical indometacin are generally local, mild, and transient.
The possible adverse effects that may occur with the use of this medicine are listed below in decreasing order of frequency:
Rare adverse effects (may affect up to 1 in 1,000 patients):
- Itching, redness, and local rashes.
- Local dryness and skin burning sensation.
- Sun-induced skin inflammation (dermatitis).
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Reusin
Keep this medicine out of sight and reach of children.
This medicine does not require any special storage conditions.
Do not bring the container near fire. Reusin contains alcohol and is therefore a flammable product.
Do not use Reusin after the expiry date stated on the container, after EXP. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the container and additional information
Composition of Reusin
- The active substance is indometacin. Each ml of cutaneous spray solution contains 8 mg of indometacin. Each spray actuation delivers 1.3 mg of indometacin.
- The other components (excipients) are: isopropyl alcohol and isopropyl myristate.
Appearance of the product and contents of the container
Reusin 8 mg/ml Cutaneous spray solution is a transparent, yellowish-green solution with a characteristic odour.
It is presented in a container holding 100 ml.
Marketing Authorization Holder
Laboratorio STADA, S.L.
Frederic Mompou, 5
08960 Sant Just Desvern
(Barcelona)
Manufacturer
STADA Arzneimittel AG
Stadastrasse 2-18
61118 - Bad Vilbel
Germany
Date of the most recent review of this leaflet: March 2021
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/