3. VIMOVO, like other NSAID-containing products, can cause serious skin side effects such as exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, which may result in hospitalizations and even death. Although serious skin reactions may occur without warning, patients should be alert for the signs and symptoms of skin rash and blisters, fever, or other signs of hypersensitivity such as itching, and should ask for medical advice when observing any indicative signs or symptoms. Patients should be advised to stop the drug immediately if they develop any type of rash and contact their physicians as soon as possible [see Warnings and Precautions (5.9)].

4. Patients should promptly report signs or symptoms of unexplained weight gain or edema to their physicians.

5. Patients should be informed of the warning signs and symptoms of hepatotoxicity (eg, nausea, fatigue, lethargy, pruritus, jaundice, right upper quadrant tenderness, and “flu-like” symptoms). If these occur, patients should be instructed to stop therapy and seek immediate medical therapy [see Contraindications (4) and Warnings and Precautions (5.11)].

6. Patients should be informed of the signs of an anaphylactoid reaction (eg, difficulty breathing, swelling of the face or throat). If these occur, patients should be instructed to seek immediate emergency help [see Warnings and Precautions (5.8)].

7. In late pregnancy, as with other NSAIDs, VIMOVO should be avoided because it may cause premature closure of the ductus arteriosus [see Contraindications (4), Warnings and Precautions (5.10) and Use in Specific Populations (8.1)].

8. Caution should be exercised by patients whose activities require alertness if they experience drowsiness, dizziness, vertigo or depression during therapy with VIMOVO.

9. Patients should be instructed to tell their physicians if they have a history of asthma or aspirin-sensitive asthma because the use of NSAIDs in patients with aspirin-sensitive asthma has been associated with severe bronchospasm, which can be fatal. Patients with this form of aspirin sensitivity should be instructed not to take VIMOVO. Patients with preexisting asthma should be instructed to seek immediate medical attention if their asthma worsens after taking VIMOVO [see Warnings and Precautions (5.8, 5.13)].

10. Antacids may be used while taking VIMOVO.

11. VIMOVO tablets should be swallowed whole with liquid. Tablets should not be split, chewed, crushed or dissolved. VIMOVO tablets should be taken at least 30 minutes before meals [see Dosage and Administration (2)].

12. Advise patients to immediately report and seek care for any cardiovascular or neurological symptoms including palpitations, dizziness, seizures, and tetany as these may be signs of hypomagnesemia [see Warnings and Precautions (5.19)].

VIMOVO is a trademark of the AstraZeneca group of companies. Other trademarks are the property of their respective companies.

Distributed by: AstraZeneca LP, Wilmington, DE 19850

©AstraZeneca 2011

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