PREGABALIN (Page 10 of 11)

16 HOW SUPPLIED/STORAGE AND HANDLING

50 mg capsules:

White opaque/white opaque size “3″ hard gelatin capsules imprinted with “LA” on cap and “42″, black band on body with black ink, filled with white to off-white granular powder; available in:

Overbagged with 10 capsules per bag

NDC 55154-8097-0

75 mg capsules:

Red opaque/white opaque size “4″ hard gelatin capsules imprinted with “LA” on cap and “43″ on body with black ink, filled with white to off-white granular powder; available in:

Overbagged with 10 capsules per bag

NDC 55154-8098-0

Storage and Handling

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.]
Dispense in tight container.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Angioedema

Advise patients that pregabalin capsules may cause angioedema, with swelling of the face, mouth (lip, gum, tongue) and neck (larynx and pharynx) that can lead to life-threatening respiratory compromise. Instruct patients to discontinue pregabalin capsules and immediately seek medical care if they experience these symptoms [see Warnings and Precautions (5.1)].

Hypersensitivity

Advise patients that pregabalin capsules has been associated with hypersensitivity reactions such as wheezing, dyspnea, rash, hives, and blisters. Instruct patients to discontinue pregabalin capsules and immediately seek medical care if they experience these symptoms [see Warnings and Precautions (5.2)].

Adverse Reactions with Abrupt or Rapid Discontinuation
Advise patients to take pregabalin capsules as prescribed. Abrupt or rapid discontinuation may result in increased seizure frequency in patients with seizure disorders, and insomnia, nausea, headache, anxiety, hyperhidrosis, or diarrhea [see Warnings and Precautions (5.3)].

Suicidal Thinking and Behavior

Patients, their caregivers, and families should be counseled that AEDs, including pregabalin capsules, may increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Report behaviors of concern immediately to healthcare providers [see Warnings and Precautions (5.4)].

Dizziness and Somnolence

Counsel patients that pregabalin capsules may cause dizziness, somnolence, blurred vision and other CNS signs and symptoms. Accordingly, advise patients not to drive, operate complex machinery, or engage in other hazardous activities until they have gained sufficient experience on pregabalin to gauge whether or not it affects their mental, visual, and/or motor performance adversely [see Warnings and Precautions (5.6)].

Weight Gain and Edema

Counsel patients that pregabalin capsules may cause edema and weight gain. Advise patients that concomitant treatment with pregabalin and a thiazolidinedione antidiabetic agent may lead to an additive effect on edema and weight gain. For patients with preexisting cardiac conditions, this may increase the risk of heart failure [see Warnings and Precautions (5.5 and 5.7)].

Ophthalmological Effects

Counsel patients that pregabalin capsules may cause visual disturbances. Inform patients that if changes in vision occur, they should notify their physician [see Warnings and Precautions (5.9)].

Creatine Kinase Elevations

Instruct patients to promptly report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever [see Warnings and Precautions (5.10)].

CNS Depressants

Inform patients who require concomitant treatment with central nervous system depressants such as opiates or benzodiazepines that they may experience additive CNS side effects, such as somnolence [see Warnings and Precautions (5.6) and Drug Interactions (7)].

Alcohol

Tell patients to avoid consuming alcohol while taking pregabalin capsules, as pregabalin may potentiate the impairment of motor skills and sedating effects of alcohol.

Missed Dose

Counsel patients if they miss a dose, they should take it as soon as they remember. If it is almost time for the next dose, they should skip the missed dose and take the next dose at their regularly scheduled time. Instruct patients not to take two doses at the same time.

Pregnancy

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to pregabalin during pregnancy [see Use in Specific Populations (8.1)].

Lactation

Advise nursing mothers that breastfeeding is not recommended during treatment with pregabalin [see Use in Specific Populations (8.2)].

Male Fertility

Inform men being treated with pregabalin 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)].

Dermatopathy

Instruct diabetic patients to pay particular attention to skin integrity while being treated with pregabalin and to inform their healthcare provider about any sores or skin problems. Some animals treated with pregabalin developed skin ulcerations, although no increased incidence of skin lesions associated with pregabalin was observed in clinical trials [see Nonclinical Toxicology (13.2)].

Distributed by:
Rising Pharmaceuticals, Inc.
Saddle Brook, NJ 07663


Manufactured by:
Laurus Labs Limited
Visakhapatnam-531011
India

M. L. No.: 16/VSP/AP/2015/F & B/CC

Distributed By:

Cardinal Health

Dublin, OH 43017

Revised: 07/2019


Medication Guide
Pregabalin (pre-GAB-a-lin)
Capsules, CV
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:

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 pregabalin capsules 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, pregabalin capsules 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: 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?
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
Stopping pregabalin capsules 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.
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.
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 pregabalin capsules affects you. Ask your healthcare provider about when it will be okay to do these activities.

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
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 pregabalin capsules are 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 are a prescription medicine used in people 17 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 pregabalin capsules are 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:

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 pregabalin capsules, 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 pregabalin capsules.
are pregnant or plan to become pregnant. Pregabalin may harm your unborn baby. You and your healthcare provider will decide if you should take pregabalin capsules while you are pregnant.
If you become pregnant while taking pregabalin capsules, 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. Pregabalin passes into your breast milk. It is not known if pregabalin capsules can harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take pregabalin capsules. Breastfeeding is not recommended while taking pregabalin capsules.

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:

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 pregabalin capsules.
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 pregabalin capsules.
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 pregabalin capsules.
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 pregabalin capsules?

Take pregabalin capsules exactly as prescribed. Your healthcare provider will tell you how much pregabalin capsules to take and when to take it.
Pregabalin capsules 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 pregabalin capsules without talking to your healthcare provider. If you stop taking pregabalin capsules suddenly you may have headaches, nausea, diarrhea, trouble sleeping, increased sweating, or you may feel anxious. If you have epilepsy and you stop taking pregabalin capsules suddenly, you may have seizures more often. Talk with your healthcare provider about how to stop pregabalin capsules 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 2 doses at the same time.
If you take too much pregabalin capsules, call your healthcare provider or poison control center, or go to the nearest emergency room right away.

What should I avoid while taking pregabalin capsules?

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

What are the possible side effects of pregabalin capsules?

Pregabalin capsules may cause serious side effects, including:

See “What is the most important information I should know about pregabalin capsules?”
Muscle problems, muscle pain, soreness, or weakness. If you have these symptoms, especially if you feel sick and have a fever, tell your healthcare provider right away.
Problems with your eyesight, including blurry vision. Call your healthcare provider if you have any changes in your eyesight.
Weight gain. If you have diabetes, weight gain may affect the management of your diabetes. Weight gain can also be a serious problem for people with heart problems.
Feeling “high”.

The most common side effects of pregabalin capsules in adults are:

dizziness
blurry vision
dry mouth
weight gain
sleepiness
trouble concentrating
swelling of hands and feet

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?

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

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 call Rising Pharmaceuticals, Inc. at 1-866-562-4597.
What are the ingredients in pregabalin capsules?

Active ingredient: pregabalin

Inactive ingredients:

Pregabalin capsules: pregelatinized starch, talc
Capsule shell: gelatin, sodium lauryl sulfate and titanium dioxide; Orange & Red capsule shell: red iron oxide; Imprinting ink: shellac, black iron oxide, propylene glycol, potassium hydroxide.

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.

*The brands listed are trademarks of their respective owners and are not trademarks of Rising Pharmaceuticals, Inc.
This Medication Guide has been approved by the U.S. Food and Drug Administration.

Distributed by:
Rising Pharmaceuticals, Inc.
Saddle Brook, NJ 07663

Manufactured by:
Laurus Labs Limited
Visakhapatnam-531011
India

M. L. No.: 16/VSP/AP/2015/F & B/CC 2000336

Distributed By:

Cardinal Health

Dublin, OH 43017

LC6459990620

LC6460050620

Revised: 06/2019

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