Important Relaxis Safety Information: Learn about the potential risks with Relaxis by reading the information provided on this page, and talk to your doctor about whether Relaxis is right for you. Only your doctor can determine if Relaxis is appropriate for your condition of Restless Legs Syndrome (RLS).
Relaxis may not work for everyone.
Relaxis may cause RLS symptoms to worsen: Relaxis uses vibration as a counter-stimulus to RLS sensations. (Read more about counterstimulation here.) The vibratory counterstimulation provided by Relaxis should be soothing and pleasant. If vibration feels unpleasant to you, then it may cause further discomfort and you should stop using Relaxis.
During two clinical studies performed on Relaxis, the most common adverse effect reported by study participants was temporary worsening of RLS symptoms. In all cases, worsening of symptoms resolved without medical intervention within three weeks (or less) when participants stopped using Relaxis. There were no long-term effects observed and when these patients stopped using Relaxis, their RLS symptoms returned to the same level of severity they had reported before they began using Relaxis. If your RLS symptoms worsen, discontinue use of Relaxis and contact your physician.
Relaxis may cause leg cramping, tingling soreness, pain and motion sickness: During these two clinical studies, study participants also reported leg cramping, tingling, soreness, pain and motion sickness, though much less frequently. In all cases, these effects resolved on their own without any medical intervention or other treatment when affected study participants stopped using Relaxis. If you experience these problems or any other problems when using Relaxis, discontinue use and contact your physician.
If you have any questions about the potential risks with using the Relaxis device, contact your physician.
INDICATIONS FOR USE:
The purpose of the Relaxis device is to improve the quality of sleep in patients with primary Restless Legs Syndrome (RLS) through the use of vibratory counterstimulation.
This device should not be used by patients who have been diagnosed with deep venous thrombosis (DVT) in either leg during the last 6 months because of the known potential to dislodge or break up the clot.
For prescription use only.
WARNINGS & CAUTIONS:
- Relaxis is only intended for use by patients with primary Restless Legs Syndrome (RLS). It is not intended for use by people who have:
- Leg skin disorders such as eczema, psoriasis, cellulitis, non-healing wounds; or
- Secondary RLS.
- Contact your doctor if you have secondary RLS caused by iron deficiency anemia, back pain, kidney failure, diabetes, peripheral neuropathy (numbness or tingling in hands or feet), or pregnancy.
- Relaxis has not been tested on people who take drugs that may cause RLS or RLS symptoms. Safety and effectiveness have not been established in these people.
- You should be physically able to remove Relaxis if necessary.
- Only apply Relaxis to normal, intact, clean, healthy skin.
- The Relaxis pad and controller will become warmer during use. Stop use of Relaxis if the heat causes discomfort or pain.
- Relaxis consists of cotton (outer pad cover), polyvinyl chloride (inner pad cover), polyurethane foam (internal pad), acrylonitrile butadiene styrene and polyester plastic (controller). People with known allergic reactions to these materials should not use Relaxis. If a skin reaction occurs after you use Relaxis, contact your doctor.
- Stop using Relaxis and contact your doctor if your RLS symptoms worsen.
- Do not initiate more than two back-to-back 35-minute therapy cycles.
- Only apply Relaxis as needed. Too much stimulation may lead to discomfort.
- Do not use Relaxis in moist, wet, or dusty areas. This may increase the risk of electrical shock and failure.
- Do not use your Relaxis in oxygen rich areas.
If you have any questions about Relaxis safety or the potential risks with using Relaxis, contact your physician.