LYRICA- pregabalin capsule 
LYRICA- pregabalin solution 
Parke-Davis Div of Pfizer Inc

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MEDICATION GUIDE

LYRICA (LEER-i-kah)
(pregabalin)
Capsules and Oral Solution, CV

Read this Medication Guide before you start taking LYRICA and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. If you have any questions about LYRICA, ask your healthcare provider or pharmacist.

What is the most important information I should know about LYRICA?

LYRICA may cause serious side effects including:

These serious side effects are described below:

1.
Serious, even life-threatening, allergic reactions.

Stop taking LYRICA and call your healthcare provider right away if you have any of these signs of a serious allergic reaction:

  • swelling of your face, mouth, lips, gums, tongue, throat or neck
  • trouble breathing
  • rash, hives (raised bumps) or blisters
2.
Like other antiepileptic drugs, LYRICA may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.

Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:

  • thoughts about suicide or dying
  • attempts to commit suicide
  • new or worse depression
  • new or worse anxiety
  • feeling agitated or restless
  • panic attacks
  • trouble sleeping (insomnia)
  • new or worse irritability
  • acting aggressive, being angry, or violent
  • acting on dangerous impulses
  • an extreme increase in activity and talking (mania)
  • other unusual changes in behavior or mood

If you have suicidal thoughts or actions, do not stop LYRICA without first talking to a healthcare provider.

  • Stopping LYRICA suddenly can cause serious problems.
  • Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.

How can I watch for early symptoms of suicidal thoughts and actions?

  • Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.
  • Keep all follow-up visits with your healthcare provider as scheduled.
  • Call your healthcare provider between visits as needed, especially if you are worried about symptoms.
3.
Swelling of your hands, legs and feet. This swelling can be a serious problem for people with heart problems.
4.
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 and older, to treat:

LYRICA has not been studied in children under 18 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:

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

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?

What should I avoid while taking LYRICA?

What are the possible side effects of LYRICA?

LYRICA may cause serious side effects, including:

The most common side effects of LYRICA are:

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?

General information about 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.

This Medication Guide summarizes the most important information about LYRICA. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about LYRICA that is written for health professionals.

You can also visit the LYRICA website at www.LYRICA.com or call 1-866-459-7422 (1-866-4LYRICA).

What are the ingredients In LYRICA?

Active ingredient: pregabalin

Inactive ingredients:

LYRICA capsules: lactose monohydrate, cornstarch, talc

Capsule shell: gelatin and titanium dioxide; Orange capsule shell: red iron oxide; White capsule shell: sodium lauryl sulfate, colloidal silicon dioxide. Colloidal silicon dioxide is a manufacturing aid that may or may not be present in the capsule shells.

Imprinting ink: shellac, black iron oxide, propylene glycol, potassium hydroxide.

LYRICA oral solution: methylparaben, propylparaben, monobasic sodium phosphate anhydrous, dibasic sodium phosphate anhydrous, sucralose, artificial strawberry #11545 and purified water.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Revised: 12/2013
Document Id: 93603f5d-bfe5-440c-92fe-e2ad380db921
Set id: 60185c88-ecfd-46f9-adb9-b97c6b00a553
Version: 19
Effective Time: 20131231
 
Parke-Davis Div of Pfizer Inc