Abridged Information for Use: Nerivio

Indications: Nerivio is a wearable, battery-powered medical device for the acute and/or preventive treatment of migraine with or without aura in patients 12 years of age or older. Contraindications: The device should not be used by people with uncontrolled epilepsy. The device should not be used by people with an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device. Such use could cause electric shock, electrical interference or serious injuries or medical conditions. WARNINGS: Do not use the device on the heart, chest, neck, head or any other body location other than the upper arm, because this could cause severe muscle spasms resulting in closure of your airway, difficulty in breathing, or adverse effects on heart rhythm or blood pressure. Do not use the device over skin conditions, such as open wounds or rashes, or over swollen, red, infected or inflamed areas or skin eruptions or fragile skin on your upper arm at the treatment location. Do not share the device with other people. Do not disassemble, crush, incinerate or short-circuit the battery. Precautions: The device has not been evaluated for use in people with congestive heart failure (CHF), severe cardiac or cerebrovascular disease. Do not use the device over or in proximity to cancerous lesions. Do not use the device while driving, cycling, or operating any vehicle or machinery. Do not use the device on wet skin or when bathing, showering, during exercise, while sweating or in high humidity. Do not use the device in the presence of electro-magnetic monitoring equipment (e.g., cardiac monitors, ECG alarms, MRI). The device has not been evaluated for use in pregnant women and people less than 12 years of age. Do not use the device if the electrodes become significantly dirty or damaged. Keep the device out of the reach of infants, toddlers, children and pets. Adverse Events: User might experience a temporary sensation of warmth, local tingling, numbness in the arm, pain in the arm, redness of the skin or muscle spasm, which should disappear shortly after the end of the treatment.For the use of a Registered Medical Practitioner, Hospital or Laboratory only or as per the description under Form 46 of the Drugs & Cosmetics Act, 1940. Dr. Reddy's Laboratories Ltd., Global Generics-India, 7-1-27, Ameerpet, Hyderabad - 500 016, India. Dated 25 May 2023.