that monitors pregnancy outcomes in women exposed to LYRICA during pregnancy [see USE IN SPECIFIC POPULATIONS (8.1)].
17.13 Lactation
Advise nursing mothers that breastfeeding is not recommended during treatment with LYRICA [see USE IN SPECIFIC POPULATIONS (8.2)].
17.14 Male Fertility
Inform men being treated with LYRICA who plan to father a child of the potential risk of male-mediated teratogenicity. In preclinical studies in rats, pregabalin was associated with an increased risk of male-mediated teratogenicity. The clinical significance of this finding is uncertain [see NONCLINICAL TOXICOLOGY (13.1) and USE IN SPECIFIC POPULATIONS (8.3)].
17.15 Dermatopathy
Instruct diabetic patients to pay particular attention to skin integrity while being treated with LYRICA. Some animals treated with pregabalin developed skin ulcerations, although no increased incidence of skin lesions associated with LYRICA was observed in clinical trials [see NONCLINICAL TOXICOLOGY (13.2)].
SPL UNCLASSIFIED SECTION
This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com.
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LAB-0294-25.1
MEDICATION GUIDE
This Medication Guide has been approved by the U.S. Food and Drug Administration. December 2016
MEDICATION GUIDE
LYRICA (LEER-i-kah)
(pregabalin)
Capsules, CV LYRICA (LEER-i-kah)
(pregabalin)
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:
Serious, even life-threatening, allergic reactions
Suicidal thoughts or actions
Swelling of your hands, legs and feet
Dizziness and sleepiness
These serious side effects are described below:
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
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 sy