Product Card

\\\DC - 69664/2 - #1258984 v 1

• If the patient is on any medication that may delay gastric emptying (e.g., calcium

channel blocking agents), it is recommended that the taking of this medication be

delayed till after the capsule endoscopy is complete. This, however, should be

discussed with the patient’s treating physician.

Adverse Events

• In patients with strictures of the gastrointestinal tract, the M2A™ Capsule can

potentially cause intestinal obstruction resulting in the need for hospitalization and

surgery. The use of the M2A™ Capsule in patients with strictures of the

gastrointestinal tract is contraindicated.

• Based on the experience gained so far, there is no adverse event related to the proper

use of the M2A™ Capsule.

Storage

• The M2A™ Capsules should be stored in a dry place away from magnetic sources.

• To prevent capsule activation, keep the M2A™ Capsules in the blister box until use.

• Even if stored in their original containers and according to recommendations, the

M2A™ Capsules can be kept for a limited period only. Please note the expiration date

of the capsules.

Labeling

• Read instructions before use

•

Single Use

Given Imaging Limited

New Industrial Park, P.O.Box 258 Yoqneam,

20692 ISRAEL