ElectroCore gammaCore Sapphire SLC, Instructions For Use Manual

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3. COMMON SIDE EFFECTS ASSOCIATED WITH GAMMACORE
The most common side effects (reported in more than 1% of patients who participated in
gammaCore studies) include:
• Application site discomfort
• Application site irritation/redness
• Local pain, face/head/neck area (including toothache)
• Muscle twitching and/or contractions, face/head/neck area (including facial droop and/or lip pull)
• Headache/migraine
• Dizziness
• Tingling, pricking, or a feeling of “pins and needles” on the skin where the device is applied
(paresthesia/dysesthesia)
These side effects typically resolve immediately after the stimulation is complete.
4. WILL I STILL NEED TO TAKE MEDICATIONS?
People respond differently to gammaCore. You and your HCP should discuss your ongoing treatment
routine, including the use of any additional therapies and/or medications. It is important to always
follow your HCP’s recommendations about your medications. gammaCore can be used with existing
medications for the preventive treatment of cluster headache or migraine headache and the acute
treatment of cluster headache or migraine headache.
5. CONTRAINDICATIONS
Contraindications include but are not limited to:
• Patients with an active implantable medical device, such as a pacemaker, hearing aid implant,
or any implanted electronic device
• Patients with metallic device such as a stent, bone plate or bone screw implanted at or near
their neck
• Patients who are using another device at the same time (e.g., TENS Unit, muscle stimulator)
or any portable electronic device (e.g., mobile phone)
Patients should not use gammaCore:
• While driving, operating machinery, or during any activity that may put patient at risk of injury
• Near microwave machines, magnetic resonance imaging, radio frequency surgical,
or computer-aided tomography machines
• In an explosive atmosphere or in the presence of flammable gas mixtures
• If patient has an open wound, rash, infection, swelling, cut, sore, drug patch, or surgical scar(s)
on the neck at the treatment location
• If patient has wet skin, is in the water, or just stepped out of the water (eg, shower, bath, pool)