Propoxyphene/aspirin/caffeine (By mouth)

Introduction

Aspirin (AS-pir-in), Caffeine (KAF-een), Propoxyphene Hydrochloride (proe-POX-i-feen hye-droe-KLOR-ide)

Treats various types of pain. Propoxyphene belongs to a class of drugs called narcotic analgesics. Products containing propoxyphene were withdrawn from the U.S. market starting November 19, 2010.

Brand Name(s)

When This Medicine Should Not Be Used

How to Use This Medicine

Tablet

• Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
• You may take with food to lessen stomach upset.
• Drink plenty of fluids to help avoid constipation.

If a dose is missed:

• If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Throw any unused medicine by mixing it with used coffee grounds or kitty litter and place it in a sealable bag, empty can, or container.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are also taking blood thinners (such as warfarin, Coumadin®), medicine for gout, or any medicines that could make you drowsy such as sedatives, sleeping pills, or muscle relaxants.
• Do not drink alcohol while you are using this medicine.

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, or a history of depression.
• Talk to your doctor first before you stop taking this medicine and changing to another pain medicine.
• This medicine can cause changes in heart rhythms, such as conditions called PR, QRS, and QT prolongation. It may change the way your heart beats and cause fainting, dizziness, lightheadedness, or serious side effects in some patients. Contact your doctor right away if you have any symptoms of heart rhythm problems, such as fast, pounding, or irregular heartbeats.
• This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.
• Do not stop using this medicine suddenly without asking your doctor. You may need to slowly decrease your dose before stopping it completely.
• This medicine may make you drowsy or dizzy. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert.
• This medicine may cause constipation. This is more common if you use it for a long time. Ask your doctor if you should also use a laxative to prevent and treat constipation.
• Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing.
• Fast or slow heartbeat.
• Severe confusion or tiredness.
• Trouble breathing.
• Yellowing of the skin or whitening of the eyes.

If you notice these less serious side effects, talk with your doctor:

• Constipation, nausea, or vomiting.
• Drowsiness, dizziness, or weakness.
• Dry mouth.
• Headache or blurred vision.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088