PREGABALIN- pregabalin capsule
Aphena Pharma Solutions - Tennessee, LLC
Pregabalin Capsules, CV
[pree gab’ a lin]
Read this Medication Guide before you start taking pregabalin capsules 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 pregabalin capsules, ask your healthcare provider or pharmacist.
What is the most important information I should know about Pregabalin capsules?
Pregabalin capsules may cause serious side effects including:
These serious side effects are described below:
|• thoughts about suicide or dying||• trouble sleeping (insomnia)|
|• attempts to commit suicide||• new or worse irritability|
|• new or worse depression||• acting aggressive, being angry, or violent|
|• new or worse anxiety||• acting on dangerous impulses|
|• feeling agitated or restless||• an extreme increase in activity and talking (mania)|
|• panic attacks||• other unusual changes in behavior or mood|
If you have suicidal thoughts or actions, do not stop Pregabalin capsules without first talking to a healthcare provider.
How can I watch for early symptoms of suicidal thoughts and actions?
What are Pregabalin capsules?
Pregabalin capsules are a prescription medicine used in adults, 18 years of age and older, to treat:
|• pain from damaged nerves (neuropathic pain) that happens with diabetes||• fibromyalgia (pain all over your body)|
|• pain from damaged nerves (neuropathic pain) that follows healing of shingles||• pain from damaged nerves (neuropathic pain) that follows spinal cord injury|
It is not known if pregabalin capsules 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.
Pregabalin capsules is a prescription medicine used in people 17 years of age and older to treat:
For the treatment of partial-onset seizures when taken together with other seizure medicines, it is not known if pregabalin capsules is safe and effective in children under 1 month of age
Who should not take Pregabalin capsules?
Do not take Pregabalin capsules if you are allergic to pregabalin or any of the ingredients in Pregabalin capsules.
See “What is the most important information I should know about pregabalin capsules?” for the signs of an allergic reaction.
See the end of this Medication Guide for a complete list of ingredients in pregabalin capsules.
What should I tell my healthcare provider before taking Pregabalin capsules?
Before taking pregabalin capsules, 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 over-the-counter medicines, vitamins or herbal supplements. Pregabalin capsules 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 Pregabalin capsules?
What should I avoid while taking Pregabalin capsules?
Pregabalin capsules may cause serious side effects, including:
The most common side effects of pregabalin capsules in adults are:
|• dizziness||• trouble concentrating|
|• blurry vision||• swelling of hands and feet|
|• weight gain||• dry mouth|
Pregabalin capsules 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 pregabalin capsules 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 pregabalin capsules. 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 Pregabalin capsules?
Keep Pregabalin capsules and all medicines out of the reach of children.
General information about the safe and effective use of Pregabalin capsules
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use pregabalin capsules for a condition for which it was not prescribed. Do not give pregabalin capsules 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 pregabalin capsules that is written for health professionals.
For more information about pregabalin capsules, call Exelan Pharmaceuticals, Inc. at 1-866-604-3268
What are the ingredients in Pregabalin capsules?
Active ingredient: Pregabalin
Inactive ingredients: pregelatinized starch, corn starch, talc.
Capsule shells for 25 mg, 50 mg & 150 mg contains: gelatin and titanium dioxide
Capsule shells for 75 mg, 100 mg, 200 mg, 225 mg & 300 mg contains: gelatin, FD&C Blue No.1, FD&C Red No.40, FD&C Yellow No.6 and titanium dioxide.
Imprinting ink contains: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide and purified water.
Pediatric use information is approved for Pfizer’s LYRICA (pregabalin) Capsules and Oral Solution products. However, due to Pfizer’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
All brand names mentioned are registered trademarks of their respective owners and are not of Exelan Pharmaceuticals, Inc.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Exelan Pharmaceuticals, Inc.
Lawrenceville, GA 30046
InvaGen Pharmaceuticals Inc.,
(a subsidiary of Cipla Ltd.)
Hauppauge, NY 11788