About ZIPSOR®

ZIPSOR® (diclofenac potassium) Liquid Filled Capsules is a prescription treatment for mild to moderate acute pain in adults (18 years of age and older).

ZIPSOR was tested with adult men and women who experienced pain following orthopedic surgery to remove a bony deformity on the foot (bunion).
In these studies, ZIPSOR provided significant pain relief following surgery.

The most common side effects of ZIPSOR include abdominal pain, constipation, diarrhea, dyspepsia, nausea, and vomiting; also reported were dizziness, headache, somnolence, pruritus, and increased sweating.

Zipsor Bottle

Why ZIPSOR?

When treating mild to moderate acute pain in adults, doctors want to use a treatment that works well and works fast to help you reduce pain.

ZIPSOR is a non-steroidal anti-inflammatory drug (NSAID) designed to significantly relieve
mild to moderate acute pain in adults.

ZIPSOR is a pain reliever and was generally well tolerated in short-term clinical studies.
Please see the Important Safety Information or the Medication Guide for more information.
You can also talk to your healthcare provider.

Patients taking ZIPSOR generally experienced pain relief within 1 hour. ZIPSOR, with
advanced ProSorb® dispersion technology, is designed to be absorbed rapidly.

ZIPSOR should be used at the lowest dose for the shortest duration. Different NSAIDs should not be used at the same time because this increases the risk of serious adverse events.

ZIPSOR is a prescription product. Only your doctor can determine if it is the right pain medication for you.

If you have a prescription for ZIPSOR, you will need to take it to a pharmacy to get it filled. ZIPSOR capsules are liquid filled capsules for oral administration, golden in color, and stamped with “X592”.

If you have other questions about ZIPSOR, you can:

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088,
or call Depomed, Inc., at 1-866-458-6389.

Please see Important Safety Information and full Prescribing Information, including BOXED WARNING.

Indication

ZIPSOR® (diclofenac potassium) liquid filled capsules is a prescription Non-Steroidal Anti-Inflammatory Drug (NSAID). ZIPSOR is used for relief of mild to moderate pain in adults (18 years of age and older).

IMPORTANT SAFETY INFORMATION

Like all NSAID medicines, ZIPSOR may increase the chance of a heart attack or stroke that can lead to death. This chance increases:

  • with longer use of NSAID medicines
  • in people who have heart disease

NSAID medicines should never be used right before or after a heart surgery called a “coronary artery bypass graft (CABG).”
Tell your doctor if you have had or plan to have this surgery.

Do not take ZIPSOR if:

  • if you had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID medicine
  • for pain right before or after heart bypass surgery

Serious side effects for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) include, heart attack, stroke, high blood pressure, heart failure from fluid
retention, kidney problems (including kidney failure), bleeding and ulcers in the stomach and intestine, anemia, life-threatening skin reactions,
life-threatening allergic reactions, liver problems including liver failure, asthma attacks in people who have asthma.

Get emergency help right away if you have any of the following symptoms:

  • shortness of breath or trouble breathing
  • chest pain
  • weakness in one part or side of your body
  • slurred speech
  • swelling of the face or throat

NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding:

  • can happen without warning symptoms
  • may cause death

NSAID medicines should only be used:

  • exactly as prescribed
  • at the lowest dose possible for your treatment
  • or the shortest time needed

Tell your healthcare provider:

  • about all of your medical conditions.
  • about all of the medicines you take. NSAIDs and some other medicines can interact with each other and cause serious side effects. Keep a list of your medicines to show to your healthcare provider and pharmacist.
  • if you are pregnant, NSAID medicines should not be used past 30 weeks of pregnancy.
  • if you are breastfeeding, talk to your doctor.

The most common side effects (≥ 2%) of ZIPSOR in clinical trials included nausea, headache, abdominal pain, vomiting, dizziness, constipation, drowsiness, and diarrhea. These are not the only possible side effects of ZIPSOR. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. You may also report negative side effects to Depomed at 1-866-458-6389.

For additional information, talk to your healthcare provider and read the FDA-approved Medication Guide or the full Prescribing Information
for ZIPSOR.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088,
or call Depomed, Inc., at 1-866-458-6389.

ProSorb is a registered trademark of Depomed, Inc.