• Swelling of your hands, legs and feet. This swelling can be a serious problem for people with heart problems.
• Dizziness and sleepiness. Do not drive a car, work with machines, or do other dangerous activities until you know how Lyrica affects you. Ask your healthcare provider about when it will be okay to do these activities.

What is LYRICA?

LYRICA is a prescription medicine used in adults, 18 years of age and older to treat:

• pain from damaged nerves (neuropathic pain) that happens with diabetes
• pain from damaged nerves (neuropathic pain) that follows healing of shingles
• fibromyalgia (pain all over your body)
• pain from damaged nerves (neuropathic pain) that follows spinal cord injury

It is not known if LYRICA is safe and effective in people under 18 years of age for the treatment of fibromyalgia and neuropathic pain with diabetes, shingles, or spinal cord injury.

LYRICA is a prescription medicine used in people 4 years of age and older to treat:

• partial onset seizures when taken together with other seizure medicines.

For the treatment of partial onset seizures when taken together with other seizure medicines, it is not known if LYRICA is safe and effective in children under 4 years of age.

Who should not take LYRICA?

Do not take LYRICA if you are allergic to pregabalin or any of the ingredients in LYRICA.

See "What is the most important information I should know about LYRICA?" for the signs of an allergic reaction.

See the end of this leaflet for a complete list of ingredients in LYRICA.

What should I tell my healthcare provider before taking LYRICA?

Before taking LYRICA, tell your healthcare provider about all your medical conditions, including if you:

• have or have had depression, mood problems or suicidal thoughts or behavior.
• have kidney problems or get kidney dialysis.
• have heart problems including heart failure.
• have a bleeding problem or a low blood platelet count.
• have abused prescription medicines, street drugs, or alcohol in the past.
• have ever had swelling of your face, mouth, tongue, lips, gums, neck, or throat (angioedema).
• plan to father a child. Animal studies have shown that pregabalin, the active ingredient in LYRICA, made male animals less fertile and caused sperm to change. Also, in animal studies, birth defects were seen in the offspring (babies) of male animals treated with pregabalin. It is not known if these problems can happen in people who take LYRICA.
• are pregnant or plan to become pregnant. LYRICA may harm your unborn baby. You and your healthcare provider will decide if you should take LYRICA while you are pregnant.
  • If you become pregnant while taking LYRICA, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334. The purpose of this registry is to collect information about the safety of antiepileptic drugs during pregnancy. Information about the registry can also be found at the website, http://www.aedpregnancyregistry.org/.
• are breastfeeding or plan to breastfeed. LYRICA passes into your breast milk. It is not known if Lyrica can harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take LYRICA. Breastfeeding is not recommended while taking LYRICA.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins or herbal supplements. LYRICA and other medicines may affect each other causing side effects. Especially tell your healthcare provider if you take:

• angiotensin converting enzyme (ACE) inhibitors, which are used to treat many conditions, including high blood pressure. You may have a higher chance for swelling and hives if these medicines are taken with LYRICA.
• Avandia (rosiglitazone) or Actos (pioglitazone) for diabetes. You may have a higher chance of weight gain or swelling of your hands or feet if these medicines are taken with LYRICA.
• any narcotic pain medicine (such as oxycodone), tranquilizers or medicines for anxiety (such as lorazepam). You may have a higher chance for dizziness and sleepiness if these medicines are taken with LYRICA.
• any medicines that make you sleepy.

Know the medicines you take. Keep a list of them with you to show your healthcare provider and pharmacist each time you get a new medicine. Do not start a new medicine without talking with your healthcare provider.

How should I take LYRICA?

• Take LYRICA exactly as prescribed. Your healthcare provider will tell you how much LYRICA to take and when to take it.
• LYRICA may be taken with or without food.
• Your healthcare provider may change your dose. Do not change your dose without talking to your healthcare provider.
• Do not stop taking LYRICA without talking to your healthcare provider. If you stop taking LYRICA suddenly you may have headaches, nausea, diarrhea, trouble sleeping, increased sweating, or you may feel anxious. If you have epilepsy and you stop taking LYRICA suddenly, you may have seizures more often. Talk with your healthcare provider about how to stop LYRICA slowly.
• If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, just skip the missed dose. Take the next dose at your regular time. Do not take two doses at the same time.
• If you take too much LYRICA, call your healthcare provider or poison control center, or go to the nearest emergency room right away.

What should I avoid while taking LYRICA?

• Do not drive a car, work with machines, or do other dangerous activities until you know how LYRICA affects you.
• Do not drink alcohol while taking LYRICA. LYRICA and alcohol can affect each other and increase side effects such as sleepiness and dizziness.

The most common side effects of LYRICA in children are weight gain, increase in appetite, and sleepiness.

LYRICA caused skin sores in animal studies. Skin sores did not happen in studies in people. If you have diabetes, you should pay attention to your skin while taking LYRICA and tell your healthcare provider about any sores or skin problems.

Tell your healthcare provider about any side effect that bothers you or that does not go away.

These are not all the possible side effects of LYRICA. For more information, ask your healthcare provider or pharmacist.

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

How should I store LYRICA?

• Store LYRICA capsules and oral solution at room temperature between 68°F to 77°F (20°C to 25°C) in its original package.
• Safely throw away any LYRICA that is out of date or no longer needed.

Keep LYRICA and all medicines out of the reach of children.

General information about the safe and effective use of LYRICA

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use LYRICA for a condition for which it was not prescribed. Do not give LYRICA to other people, even if they have the same symptoms you have. It may harm them. You can ask your healthcare provider or pharmacist for information about LYRICA that is written for health professionals.