Alvogen Inc.

Pregabalin

Generic

Generic for Pregabalin extended release

ID: 47781037930

NaN

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📜 Prescription Required

FORM

Tablet

STRENGTH

82.5 mg

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TL;DR — Quick Summary

Key facts from the full medication guide below

1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2.1 Important Dosage and Administration Instructions 2.2 Neuropathic Pain Associated with Diabetic Peripheral Neuropathy 2.3 Postherpetic Neuralgia

🩺What it's for

Pregabalin extended-release tablets are indicated for the management of: Neuropathic pain associated with diabetic peripheral neuropathy Postherpetic neuralgia Efficacy of pregabalin extended-release tablets has not been established for the management of fibromyalgia or as adjunctive therapy for adult patients with partial onset seizures.

💊How to take it

Pregabalin extended-release tablets should be administered once daily after an evening meal. It should be swallowed whole and should not be split, crushed, or chewed. (2.1) Dosing recommendations for pregabalin extended-release tablets: Indication Dosing Regimen Initial Dose Maximum Dose DPN Pain (2.2) Single dose per day 165 mg/day 330 mg/day within 1 week. PHN (2.3) Single dose per day 165 mg/day 330 mg/day within 1 week. Maximum dose of 660 mg/day.

ℹ️Common side effects

The following adverse reactions are described elsewhere in the labeling: Angioedema [see Warnings and Precautions (5.1)] Hypersensitivity Reactions [see Warnings and Precautions (5.2)] Suicidal Behavior and Ideation [see Warnings and Precautions (5.3)] Respiratory Depression [see Warnings and Precautions (5.4)] Dizziness and Somnolence [see Warnings and Precautions (5.5)] Risks Associated with Abrupt or Rapid Discontinuation [see Warnings and Precautions (5.6)] Peripheral Edema [see Warnings…

⚠️Serious risks

Angioedema: Angioedema [e.g., swelling of the face, mouth (tongue, lips, and gums) and neck (throat and larynx)] can occur and may be associated with life-threatening respiratory compromise requiring emergency treatment. Discontinue pregabalin extended-release tablets immediately in patients with these symptoms. (5.1) Hypersensitivity reactions: Hypersensitivity reactions (e.g., hives, dyspnea, and wheezing) can occur. Discontinue pregabalin extended-release tablets immediately in these patients.

📋Interactions & cautions

Since pregabalin is predominantly excreted unchanged in the urine, undergoes negligible metabolism in humans (less than 2% of a dose recovered in urine as metabolites), and does not bind to plasma proteins, its pharmacokinetics are unlikely to be affected by other agents through metabolic interactions or protein binding displacement. In vitro studies showed that pregabalin is unlikely to be involved in significant pharmacokinetic drug interactions [see Clinical Pharmacology (12)].

📦Storage & missed dose

Pregabalin extended-release tablets are supplied in the following strengths and package configurations: Pregabalin Extended-Release Tablets Package Configuration Tablet Strength (mg) NDC Tablet Description Bottles of 30 tablets 82.5 mg NDC 47781-379-30 White, oval-shaped, film-coated tablets, ALV 379 imprinted in black ink on one side, blank on the other side.

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Antiepileptic drugs (AEDs), including pregabalin, the active ingredient in pregabalin extended-release tablets, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Monitor patients treated with any AED for any indication for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Pooled analyses of 199 placebo-controlled clinical trials (mono- and adjunctive therapy) of 11 different AEDs showed that patients randomized to one of the AEDs had approximately twice the risk (adjusted Relative Risk 1.8, 95% CI:1.2, 2.7) of suicidal thinking or behavior compared to patients randomized to placebo. In these trials, which had a median treatment duration of 12 weeks, the estimated incidence rate of suicidal behavior or ideation among 27,863 AED-treated patients was 0.43%, compared to 0.24% among 16,029 placebo-treated patients, representing an increase of approximately one case of suicidal thinking or behavior for every 530 patients treated. There were four suicides in drug-treated patients in the trials and none in placebo-treated patients, but the number is too small to allow any conclusion about drug effect on suicide. The increased risk of suicidal thoughts or behavior with AEDs was observed as early as one week after starting drug treatment with AEDs and persisted for the duration of treatment assessed. Because most trials included in the analysis did not extend beyond 24 weeks, the risk of suicidal thoughts or behavior beyond 24 weeks could not be assessed. The risk of suicidal thoughts or behavior was generally consistent among drugs in the data analyzed. The finding of increased risk with AEDs of varying mechanisms of action and across a range of indications suggests that the risk applies to all AEDs used for any indication. The risk did not vary substantially by age (5 to 100 years) in the clinical trials analyzed. Table 3 shows absolute and relative risk by indication for all evaluated AEDs. Table 3. Risk by Indication for Antiepileptic Drugs in the Pooled Analysis Indication Placebo Patients With Events per 1000 Patients Drug Patients With Events per 1000 Patients Relative Risk: Incidence of Events in Drug Patients/Incidence in Placebo Patients Risk Difference: Additional Drug Patients With Events per 1000 Patients Epilepsy 1.0 3.4 3.5 2.4 Psychiatric 5.7 8.5 1.5 2.9 Other 1.0 1.8 1.9 0.9 Total 2.4 4.3 1.8 1.9 The relative risk for suicidal thoughts or behavior was higher in clinical trials for epilepsy than in clinical trials for psychiatric or other conditions, but the absolute risk differences were similar for the epilepsy and psychiatric indications. Anyone considering prescribing pregabalin extended-release tablets must balance the risk of suicidal thoughts or behavior with the risk of untreated illness. Many other illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior. Should suicidal thoughts and behavior emerge during treatment, the prescriber needs to consider whether the emergence of these symptoms in any given patient may be related to the illness being treated. Inform patients, their caregivers, and families that pregabalin extended-release tablets can increase the risk of suicidal thoughts and behavior and advise them of the need to be alert for the emergence or worsening of the signs and 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.

Pregabalin extended-release tablets treatment may cause peripheral edema. In short-term trials of patients without clinically significant heart or peripheral vascular disease, there was no apparent association between peripheral edema and cardiovascular complications such as hypertension or congestive heart failure. Peripheral edema was not associated with laboratory changes suggestive of deterioration in renal or hepatic function. In controlled clinical trials for pain indications, the incidence of peripheral edema for patients receiving pregabalin extended-release tablets in the single-blind phase was 5.3% of patients. In controlled clinical trials for pain indications, 0.8% of pregabalin extended-release tablets patients withdrew due to peripheral edema during the single-blind phase. Higher frequencies of weight gain and peripheral edema were observed in patients taking both pregabalin and a thiazolidinedione antidiabetic agent compared to patients taking either drug alone. The majority of patients using thiazolidinedione antidiabetic agents in the overall safety database were participants in studies of pain associated with diabetic peripheral neuropathy. In this population, peripheral edema was reported in 3% (2/60) of patients who were using thiazolidinedione antidiabetic agents only, 8% (69/859) of patients who were treated with pregabalin only, and 19% (23/120) of patients who were on both pregabalin and thiazolidinedione antidiabetic agents. Similarly, weight gain was reported in 0% (0/60) of patients on thiazolidinediones only; 4% (35/859) of patients on pregabalin only; and 7.5% (9/120) of patients on both drugs. As the thiazolidinedione class of antidiabetic drugs can cause weight gain and/or fluid retention, possibly exacerbating or leading to heart failure, monitor patients for the development of edema when co-administering pregabalin extended-release tablets and these agents. Because there are limited data on congestive heart failure patients with New York Heart Association (NYHA) Class III or IV cardiac status, monitor these patients for possible exacerbation of congestive heart failure symptoms when using pregabalin extended-release tablets.

Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to pregabalin during pregnancy. To provide information regarding the effects of in utero exposure to pregabalin extended-release tablets, physicians are advised to recommend that pregnant patients taking pregabalin extended-release tablets enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. This can be done by calling the toll free number 1-888-233-2334, and must be done by patients themselves. Information on the registry can also be found at the website http://www.aedpregnancyregistry.org/. Risk Summary Observational studies on the use of pregabalin during pregnancy suggest a possible small increase in the rate of overall major birth defects, but there was no consistent or specific pattern of major birth defects identified (see Data). Available postmarketing data on miscarriage and other maternal, fetal, and long term developmental adverse effects were insufficient to identify risk associated with pregabalin. In animal reproduction studies, increased incidences of fetal structural abnormalities and other manifestations of developmental toxicity, including skeletal malformations, retarded ossification, and decreased fetal body weight were observed in the offspring of rats and rabbits given pregabalin orally during organogenesis, at doses that produced plasma pregabalin exposures (AUC) greater than or equal to 18 times human exposure at the maximum recommended dose (MRD) of 660 mg/day (see Data). In an animal development study, lethality, growth retardation, and nervous and reproductive system functional impairment were observed in the offspring of rats given pregabalin during gestation and lactation. The no-effect dose for developmental toxicity was approximately twice the human exposure at MRD. The background risk of major birth defects and miscarriage for the indicated populations are unknown. However, the background risk in the U.S. general population of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies. Data Human Data One database study, which included over 2,700 pregnancies exposed to pregabalin (monotherapy) during the first trimester compared to 3,063,251 pregnancies unexposed to antiepileptics demonstrated prevalence ratios for major malformations overall of 1.14 (CI 95% 0.96 to 1.35) for pregabalin, 1.29 (CI 95% 1.01 to 1.65) for lamotrigine, 1.39 (CI 95% 1.07 to 1.82) for duloxetine, and 1.24 (CI 95% 1.00 to 1.54) for exposure to either lamotrigine or duloxetine. Important study limitations include uncertainty of whether women who filled a prescription took the medication and inability to adequately control for the underlying disease and other potential confounders. A published study included results from two separate databases. One database, which included 353 pregnancies exposed to pregabalin (monotherapy) during the first trimester compared to 368,489 pregnancies unexposed to antiepileptics, showed no increase in risk of major birth defects; adjusted relative risk 0.87 (CI 95% 0.53 to 1.42). The second database, which included 118 pregnancies exposed to pregabalin (monotherapy) during the first trimester compared to 380,347 pregnancies unexposed to antiepileptics, suggested a small increase in risk of major birth defects; adjusted relative risk 1.26 (CI 95% 0.64 to 2.49). The risk estimates crossed the null, and the study had limitations similar to the prior study. Other published epidemiologic studies reported inconsistent findings. No specific pattern of birth defects was identified across studies. All of the studies had limitations due to their retrospective design. Animal Data When pregnant rats were given pregabalin (500, 1250, or 2500 mg/kg) orally throughout the period of organogenesis, incidences of specific skull alterations attributed to abnormally advanced ossification (premature fusion of the jugal and nasal sutures) were increased at greater than or equal to 1250 mg/kg, and incidences of skeletal variations and retarded ossification were increased at all doses. Fetal body weights were decreased at the highest dose. The low dose in this study was associated with a plasma exposure (AUC) approximately 18 times human exposure at the MRD of 660 mg/day. A no-effect dose for rat embryo-fetal developmental toxicity was not established. When pregnant rabbits were given pregabalin (250, 500, or 1250 mg/kg) orally throughout the period of organogenesis, decreased fetal body weight and increased incidences of skeletal malformations, visceral variations, and retarded ossification were observed at the highest dose. The no-effect dose for developmental toxicity in rabbits (500 mg/kg) was associated with a plasma exposure approximately 17 times human exposure at the MRD. In a study in which female rats were dosed with pregabalin (50, 100, 250, 1250, or 2500 mg/kg) throughout gestation and lactation, offspring growth was reduced at greater than or equal to 100 mg/kg and offspring survival was decreased at greater than or equal to 250 mg/kg. The effect on offspring survival was pronounced at doses greater than or equal to 1250 mg/kg, with 100% mortality in high-dose litters. When offspring were tested as adults, neurobehavioral abnormalities (decreased auditory startle responding) were observed at greater than or equal to 250 mg/kg and reproductive impairment (decreased fertility and litter size) was seen at 1250 mg/kg. The no-effect dose for pre- and postnatal developmental toxicity in rats (50 mg/kg) produced a plasma exposure approximately 2 times human exposure at the MRD. In the prenatal-postnatal study in rats, pregabalin prolonged gestation and induced dystocia at exposures greater than or equal to 50 times the mean human exposure (AUC (0 24) of 123 g hr/mL) at the MRD.

Support for efficacy of pregabalin extended-release tablets for the management of PHN and diabetic peripheral neuropathy (DPN) was based on the efficacy of pregabalin for these indications along with an adequate and well-controlled study in adults with PHN. This 19-week randomized withdrawal study compared daily doses of pregabalin extended-release tablets 82.5 mg, 165 mg, 247.5 mg, 330 mg, 495 mg, or 660 mg with placebo. Those enrolled were required to have pain present for more than 3 months after healing of the herpes zoster skin rash and a baseline pain score of greater than or equal to 4 on the numeric rating scale (NRS)-Pain (assessed over a 1 week recall period). The baseline mean pain scores were 6.83 for pregabalin extended-release tablets-treated patients vs. 6.85 for placebo-treated patients. A total of 82.4% of patients completed the single-blind phase of the study. Patients were considered responders if they had at least a 50% reduction in pain in the single-blind phase. Those who responded to treatment were then randomized in the double-blind phase to treatment with either the pregabalin extended-release tablets dose achieved in the single-blind phase or placebo. Patients were treated for up to 3 months following randomization. A total of 87.5% of pregabalin extended-release tablets-treated patients and 78% of placebo-treated patients completed the double-blind phase of the study. Pregabalin extended-release tablets treatment demonstrated statistically significant improvement in the endpoint change in mean pain score from baseline compared to placebo. For a range of levels of improvement in pain intensity from baseline to study endpoint, Figure 1 shows the fraction of patients achieving that degree of improvement. The figure is cumulative, so that patients whose change from baseline is, for example, 50%, are also included at every level of improvement below 50%. Patients who did not complete the study were assigned 0% improvement. In the pregabalin extended-release tablets group, 79.8% of subjects achieved at least a 30% improvement and 73.6% at least 50% improvement in pain intensity. In the placebo group, 64.9% of subjects achieved at least a 30% improvement and 54.6% at least a 50% improvement in pain intensity. Figure 1. Percent of Patients Achieving Various Levels of Improvement in Pain Intensity (N=413)

Advise the patient to read the FDA-approved patient labeling (Medication Guide). Angioedema Advise patients that pregabalin 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 extended-release tablets and immediately seek medical care if they experience these symptoms [see Warnings and Precautions (5.1)]. Hypersensitivity Advise patients that pregabalin extended-release tablets has been associated with hypersensitivity reactions such as skin redness, blisters, hives, rash, dyspnea, and wheezing. Instruct patients to discontinue pregabalin extended-release tablets and immediately seek medical care if they experience these symptoms [see Warnings and Precautions (5.2)]. Suicidal Thinking and Behavior Counsel patients, their caregivers, and families that AEDs, including pregabalin, the active ingredient in pregabalin extended-release tablets, 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. Instruct patients, caregivers, and families to report behaviors of concern immediately to a healthcare provider [see Warnings and Precautions (5.3)]. Respiratory Depression Inform patients about the risk of respiratory depression. Include information that the risk is greatest for those using concomitant central nervous system (CNS) depressants (such as opioid analgesics) or in those with underlying respiratory impairment. Teach patients how to recognize respiratory depression and advise them to seek medical attention immediately if it occurs [see Warnings and Precautions (5.4)]. Dizziness and Somnolence Inform patients that pregabalin extended-release tablets 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 extended-release tablets to gauge whether or not it affects their mental, visual, and/or motor performance adversely [see Warnings and Precautions (5.5)]. 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 respiratory depression, somnolence, and dizziness [see Warnings and Precautions (5.4, 5.5) and Drug Interactions (7)]. Advise patients to avoid consuming alcohol while taking pregabalin extended-release tablets, as pregabalin extended-release tablets may potentiate the impairment of motor skills and sedating effects of alcohol [see Drug Interactions (7)]. Abrupt or Rapid Discontinuation Advise patients to take pregabalin extended-release tablets as prescribed. Abrupt or rapid discontinuation may result in insomnia, nausea, headache, anxiety, or diarrhea. Advise patients with seizure disorders that abrupt or rapid discontinuation may increase seizure frequency [see Warnings and Precautions (5.6)]. Missed Dose Instruct patients that if they miss taking their dose of pregabalin extended-release tablets after an evening meal, then they should take their usual dose of pregabalin extended-release tablets prior to bedtime following a snack. If they miss taking the dose of pregabalin extended-release tablets prior to bedtime, then they should take their usual dose of pregabalin extended-release tablets following a morning meal. If they miss taking the dose of pregabalin extended-release tablets following the morning meal, then they should take their usual dose of pregabalin extended-release tablets at the usual time that evening following an evening meal. Weight Gain and Edema Inform patients that pregabalin extended-release tablets may cause edema and weight gain. Advise patients that concomitant treatment with pregabalin extended-release tablets and a thiazolidinedione antidiabetic agent may lead to an additive effect on edema and weight gain. Advise patients with preexisting cardiac conditions that this may increase the risk of heart failure [see Warnings and Precautions (5.7, 5.8)]. Ophthalmological Effects Counsel patients that pregabalin extended-release tablets may cause visual disturbances. Inform patients that if changes in vision occur, they should notify their physician [see Warnings and Precautions (5.10)]. 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 (5.11)]. Use in Pregnancy Advise pregnant patients to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry [see Use in Specific Populations (8.1)]. Lactation Advise nursing mothers that breastfeeding is not recommended during treatment with pregabalin extended-release tablets [see Use in Specific Populations (8.2)]. Male Fertility Inform men being treated with pregabalin extended-release tablets who plan to father a child of the potential risk of male-mediated teratogenicity [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 extended-release tablets [see Nonclinical Toxicology (13.2)].

MEDICATION GUIDE Pregabalin (pree gab a lin) Extended-Release Tablets, CV This Medication Guide has been approved by the U.S. Food and Drug Administration. Issued: 08/2024 PL379-01 Read this Medication Guide before you start taking pregabalin extended-release tablets 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 extended-release tablets, ask your healthcare provider or pharmacist. What is the most important information I should know about pregabalin extended-release tablets? Pregabalin extended-release tablets may cause serious side effects including: Serious, even life-threatening, allergic reactions Suicidal thoughts or actions Serious breathing problems 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 extended-release tablets 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 skin redness Pregabalin extended-release tablets 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 trouble sleeping (insomnia) new or worse irritability new or worse depression new or worse anxiety feeling agitated or restless panic attacks 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 pregabalin extended-release tablets without first talking to a healthcare provider. Stopping pregabalin extended-release tablets 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. Serious breathing problems can occur when pregabalin is taken with other medicines that can cause severe sleepiness or decreased awareness, or when it is taken by someone who already has breathing problems. Watch for increased sleepiness or decreased breathing when starting pregabalin or when the dose is increased. Get help right away if breathing problems occur. 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 extended-release tablets affects you. Ask your healthcare provider about when it will be okay to do these activities. What are pregabalin extended-release tablets? Pregabalin extended-release tablets are a prescription medicine used to treat: pain from damaged nerves (neuropathic pain) that happens with diabetes pain from damaged nerves (neuropathic pain) that follows healing of shingles It is not known if pregabalin extended-release tablets are safe and effective in children.It is not known if pregabalin extended-release tablets are effective when used for the treatment of fibromyalgia, or when taken with other seizure medicines for adults with partial onset seizures. Who Should Not Take Pregabalin Extended-Release Tablets?Do not take pregabalin extended-release tablets if you are allergic to pregabalin or any of the ingredients in pregabalin extended-release tablets. See "What is the most important information I should know about pregabalin extended-release tablets?" for the signs of an allergic reaction.See the end of this leaflet for a complete list of ingredients in pregabalin extended-release tablets. What should I tell my healthcare provider before taking pregabalin extended-release tablets? Before taking pregabalin extended-release tablets, 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 breathing problems 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 extended-release tablets, 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 extended-release tablets. are pregnant or plan to become pregnant. It is not known if pregabalin extended-release tablets will harm your unborn baby. You and your healthcare provider will have to decide if you should take pregabalin extended-release tablets while you are pregnant. If you become pregnant while taking pregabalin extended-release tablets, 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, including pregabalin, the active ingredient in pregabalin extended-release tablets. Information about the registry can 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 extended-release tablets can harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take pregabalin extended-release tablets. Breastfeeding is not recommended while taking pregabalin extended-release tablets. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins or herbal supplements. Pregabalin extended-release tablets 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 extended-release tablets. See "What is the most important information I should know about pregabalin extended-release tablets?" Avandia (rosiglitazone), Avandamet (contains rosiglitazone and metformin), 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 extended-release tablets. See "What are the possible side effects of pregabalin extended-release tablets." any opioid pain medicine (such as oxycodone), or medicines for anxiety (such as lorazepam) or insomnia (such as zolpidem). You may have a higher chance for dizziness, sleepiness or serious breathing problems if these medicines are taken with pregabalin extended-release tablets. 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 extended-release tablets? Take pregabalin extended-release tablets exactly as prescribed. Your healthcare provider will tell you how much pregabalin extended-release tablets to take and when to take it. Take pregabalin extended-release tablets at the same time each day. Pregabalin extended-release tablets must be taken after your evening meal. Swallow the tablet whole and do not split, crush or chew the tablet. Your healthcare provider may change your dose. Do not change your dose without talking to your healthcare provider. Do not stop taking pregabalin extended-release tablets without talking to your healthcare provider. If you stop taking pregabalin extended-release tablets suddenly you may have headaches, nausea, diarrhea, trouble sleeping, or you may feel anxious. If you have epilepsy, are taking pregabalin extended-release tablets for pain, and stop taking pregabalin extended-release tablets suddenly, you may have seizures more often. Talk with your healthcare provider about how to stop pregabalin extended-release tablets slowly. If you miss a dose after your evening meal, take it prior to bedtime following a snack. If you miss the dose prior to bedtime, then take it following your morning meal. If you do not take the dose the following morning, then take the next dose at your regular time after your evening meal. Do not take 2 doses at the same time. If you take too much pregabalin extended-release tablets, call your healthcare provider or poison control center, or go to the nearest emergency room right away. What should I avoid while taking pregabalin extended-release tablets? Do not drive a car, work with machines, or do other dangerous activities until you know how pregabalin extended-release tablets affects you. Do not drink alcohol while taking pregabalin extended-release tablets. Pregabalin extended-release tablets and alcohol can affect each other and increase side effects such as sleepiness and dizziness. What are the possible side effects of pregabalin extended-release tablets? Pregabalin extended-release tablets may cause serious side effects, including: 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 extended-release tablets are: dizziness blurry vision weight gain sleepiness fatigue (tiredness) swelling of hands and feet dry mouth nausea Pregabalin extended-release tablets 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 extended-release tablets 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 extended-release tablets. 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 extended-release tablets? Store pregabalin extended-release tablets at room temperature between 68 F to 77 F (20 C to 25 C) in its original package. Safely throw away any pregabalin extended-release tablets that is out of date or no longer needed. Keep pregabalin extended-release tablets and all medicines out of the reach of children. General information about the safe and effective use of pregabalin extended-release tablets. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use pregabalin extended-release tablets for a condition for which it was not prescribed. Do not give pregabalin extended-release tablets to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacists or healthcare provider for information about pregabalin extended-release tablets that is written for health professionals. You can also call Alvogen, Inc. at 1-866-770-3024. What are the ingredients in pregabalin extended-release tablets? Active ingredient: pregabalin Inactive ingredients : amino methacrylate copolymer, colloidal silicon dioxide, crospovidone, hydroxypropyl cellulose, hypromellose, and magnesium stearate. The monogramming ink is comprised of ammonium hydroxide, black iron oxide, isopropyl alcohol, N-butyl alcohol, propylene glycol and shellac glaze. The 82.5 mg tablets also contain macrogol, polyvinyl alcohol, talc, and titanium dioxide. The 165 mg tablets also contain iron oxide yellow, iron oxide red, macrogol, polyvinyl alcohol, talc, and titanium dioxide. The 330 mg tablets also contain ferrosoferric oxide, iron oxide red, macrogol, polyvinyl alcohol, talc, and titanium dioxide. Distributed by: Alvogen, Inc. Morristown, NJ 07960 USA