Andogablin can cause a severe allergic reaction. Stop taking Andogablin and get emergency medical help if you have: hives or blisters on your skin; difficult breathing; swelling of your face, lips, tongue, or throat.
Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, depression, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.
Call your doctor at once if you have:
weak or shallow breathing;
blue-colored skin, lips, fingers, and toes;
confusion, extreme drowsiness or weakness;
vision problems;
skin sores (if you have diabetes);
easy bruising, unusual bleeding;
swelling in your hands or feet, rapid weight gain (especially if you have diabetes or heart problems); or
unexplained muscle pain, tenderness, or weakness (especially if you also have fever or don't feel well).
Andogablin can cause life-threatening breathing problems. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up. Breathing problems may be more likely in older adults or in people with COPD.
If you have diabetes, tell your doctor right away if you have any new sores or other skin problems.
Common Andogablin side effects may include:
dizziness, drowsiness;
swelling in your hands and feet;
trouble concentrating;
increased appetite;
weight gain;
dry mouth; or
blurred vision.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Andogablin side effects (more detail)
Side effects of Andogablin in details
A side effect of any drug can be defined as the unwanted or undesired effect produced by the drug. The side effect can be major or in few medications minor that can be ignored. Side effects not only vary from drug to drug, but it also depends on the dose of the drug, the individual sensitivity of the person, brand or company which manufactures it. If side effects overweigh the actual effect of the medicine, it may be difficult to convince the patient to take the drug. Few patients get specific side effects to specific drugs; in that case, a doctor replaces the drug with another. If you feel any side effect and it troubles you, do not forget to share with your healthcare practitioner.
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Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In all controlled and uncontrolled trials across various patient populations during the premarketing development of Andogablin, more than 10,000 patients have received Andogablin. Approximately 5000 patients were treated for 6 months or more, over 3100 patients were treated for 1 year or longer, and over 1400 patients were treated for at least 2 years.
Adverse Reactions Most Commonly Leading To Discontinuation In All Premarketing Controlled Clinical Studies
In premarketing controlled trials of all populations combined, 14% of patients treated with Andogablin and 7% of patients treated with placebo discontinued prematurely due to adverse reactions. In the Andogablin treatment group, the adverse reactions most frequently leading to discontinuation were dizziness (4%) and somnolence (4%). In the placebo group, 1% of patients withdrew due to dizziness and less than 1% withdrew due to somnolence. Other adverse reactions that led to discontinuation from controlled trials more frequently in the Andogablin group compared to the placebo group were ataxia, confusion, asthenia, thinking abnormal, blurred vision, incoordination, and peripheral edema (1% each).
Most Common Adverse Reactions In All Premarketing Controlled Clinical Studies
In premarketing controlled trials of all patient populations combined, dizziness, somnolence, dry mouth, edema, blurred vision, weight gain, and “thinking abnormal” (primarily difficulty with concentration/attention) were more commonly reported by subjects treated with Andogablin than by subjects treated with placebo (greater than or equal to 5% and twice the rate of that seen in placebo).
Controlled Studies With Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
Adverse Reactions Leading to Discontinuation
In clinical trials in patients with neuropathic pain associated with diabetic peripheral neuropathy, 9% of patients treated with Andogablin and 4% of patients treated with placebo discontinued prematurely due to adverse reactions. In the Andogablin treatment group, the most common reasons for discontinuation due to adverse reactions were dizziness (3%) and somnolence (2%). In comparison, less than 1% of placebo patients withdrew due to dizziness and somnolence. Other reasons for discontinuation from the trials, occurring with greater frequency in the Andogablin group than in the placebo group, were asthenia, confusion, and peripheral edema. Each of these events led to withdrawal in approximately 1% of patients.
Most Common Adverse Reactions
Table 3 lists all adverse reactions, regardless of causality, occurring in greater than or equal to 1% of patients with neuropathic pain associated with diabetic neuropathy in the combined Andogablin group for which the incidence was greater in this combined Andogablin group than in the placebo group. A majority of Andogablin-treated patients in clinical studies had adverse reactions with a maximum intensity of “mild” or “moderate”.
Table 3: Treatment-emergent adverse reaction incidence in controlled trials in neuropathic pain associated with diabetic peripheral neuropathy (events in at least 1% of all Andogablin-treated patients and at least numerically more in all Andogablin than in the placebo group)
Body system Preferred term
75 mg/day
[N=77] %
150 mg/day
[N=212] %
300 mg/day
[N=321] %
600 mg/day
[N=369] %
All PGB*
[N=979] %
Placebo
[N=459] %
Body as a whole
Asthenia
4
2
4
7
5
2
Accidental injury
5
2
2
6
4
3
Back pain
0
2
1
2
2
0
Chest pain
4
1
1
2
2
1
Face edema
0
1
1
2
1
0
Digestive system
Dry mouth
3
2
5
7
5
1
Constipation
0
2
4
6
4
2
Flatulence
3
0
2
3
2
1
Metabolic and nutritional disorders
Peripheral edema
4
6
9
12
9
2
Weight gain
0
4
4
6
4
0
Edema
0
2
4
2
2
0
Hypoglycemia
1
3
2
1
2
1
Nervous system
Dizziness
8
9
23
29
21
5
Somnolence
4
6
13
16
12
3
Neuropathy
9
2
2
5
4
3
Ataxia
6
1
2
4
3
1
Vertigo
1
2
2
4
3
1
Confusion
0
1
2
3
2
1
Euphoria
0
0
3
2
2
0
Incoordination
1
0
2
2
2
0
Thinking abnormal†
1
0
1
3
2
0
Tremor
1
1
1
2
1
0
Abnormal gait
1
0
1
3
1
0
Amnesia
3
1
0
2
1
0
Nervousness
0
1
1
1
1
0
Respiratory system
Dyspnea
3
0
2
2
2
1
Special senses
Blurry vision‡
3
1
3
6
4
2
Abnormal vision
1
0
1
1
1
* PGB: Andogablin
† Thinking abnormal primarily consists of events related to difficulty with concentration/attention but also includes events related to cognition and language problems and slowed thinking.
‡ Investigator term; summary level term is amblyopia
Controlled Studies In Postherpetic Neuralgia
Adverse Reactions Leading to Discontinuation
In clinical trials in patients with postherpetic neuralgia, 14% of patients treated with Andogablin and 7% of patients treated with placebo discontinued prematurely due to adverse reactions. In the Andogablin treatment group, the most common reasons for discontinuation due to adverse reactions were dizziness (4%) and somnolence (3%). In comparison, less than 1% of placebo patients withdrew due to dizziness and somnolence. Other reasons for discontinuation from the trials, occurring in greater frequency in the Andogablin group than in the placebo group, were confusion (2%), as well as peripheral edema, asthenia, ataxia, and abnormal gait (1% each).
Most Common Adverse Reactions
Table 4 lists all adverse reactions, regardless of causality, occurring in greater than or equal to 1% of patients with neuropathic pain associated with postherpetic neuralgia in the combined Andogablin group for which the incidence was greater in this combined Andogablin group than in the placebo group. In addition, an event is included, even if the incidence in the all Andogablin group is not greater than in the placebo group, if the incidence of the event in the 600 mg/day group is more than twice that in the placebo group. A majority of Andogablin-treated patients in clinical studies had adverse reactions with a maximum intensity of &dquo;mild” or “moderate”. Overall, 12.4% of all Andogablin-treated patients and 9.0% of all placebo-treated patients had at least one severe event while 8% of Andogablin-treated patients and 4.3% of placebo-treated patients had at least one severe treatment-related adverse event.
Table 4: Treatment-emergent adverse reaction incidence in controlled trials in neuropathic pain associated with postherpetic neuralgia (events in at least 1% of all Andogablin-treated patients and at least numerically more in all Andogablin than in the placebo group)
Body system Preferred term
75 mg/d
[N=84] %
150 mg/d
[N=302] %
300 mg/d
[N=312] %
600 mg/d
[N=154] %
All PGB*
[N=852] %
Placebo
[N=398] %
Body as a whole
Infection
14
8
6
3
7
4
Headache
5
9
5
8
7
5
Pain
5
4
5
5
5
4
Accidental injury
4
3
3
5
3
2
Flu syndrome
1
2
2
1
2
1
Face edema
0
2
1
3
2
1
Digestive system
Dry mouth
7
7
6
15
8
3
Constipation
4
5
5
5
5
2
Flatulence
2
1
2
3
2
1
Vomiting
1
1
3
3
2
1
Metabolic and nutritional disorders
Peripheral edema
0
8
16
16
12
4
Weight gain
1
2
5
7
4
0
Edema
0
1
2
6
2
1
Musculoskeletal system
Myasthenia
1
1
1
1
1
0
Nervous system
Dizziness
11
18
31
37
26
9
Somnolence
8
12
18
25
16
5
Ataxia
1
2
5
9
5
1
Abnormal gait
0
2
4
8
4
1
Confusion
1
2
3
7
3
0
Thinking abnormal†
0
2
1
6
2
2
Incoordination
2
2
1
3
2
0
Amnesia
0
1
1
4
2
0
Speech disorder
0
0
1
3
1
0
Respiratory system
Bronchitis
0
1
1
3
1
1
Special senses
Blurry vision‡
1
5
5
9
5
3
Diplopia
0
2
2
4
2
0
Abnormal vision
0
1
2
5
2
0
Eye Disorder
0
1
1
2
1
0
Urogenital System
Urinary Incontinence
0
1
1
2
1
0
* PGB: Andogablin
† Thinking abnormal primarily consists of events related to difficulty with concentration/attention but also includes events related to cognition and language problems and slowed thinking.
‡ Investigator term; summary level term is amblyopia
Controlled Add-On Studies In Adjunctive Therapy For Adult Patients With Partial Onset Seizures
Adverse Reactions Leading to Discontinuation
Approximately 15% of patients receiving Andogablin and 6% of patients receiving placebo in add-on epilepsy trials discontinued prematurely due to adverse reactions. In the Andogablin treatment group, the adverse reactions most frequently leading to discontinuation were dizziness (6%), ataxia (4%), and somnolence (3%). In comparison, less than 1% of patients in the placebo group withdrew due to each of these events. Other adverse reactions that led to discontinuation of at least 1% of patients in the Andogablin group and at least twice as frequently compared to the placebo group were asthenia, diplopia, blurred vision, thinking abnormal, nausea, tremor, vertigo, headache, and confusion (which each led to withdrawal in 2% or less of patients).
Most Common Adverse Reactions
Table 5 lists all dose-related adverse reactions occurring in at least 2% of all Andogablin-treated patients. Dose-relatedness was defined as the incidence of the adverse event in the 600 mg/day group was at least 2% greater than the rate in both the placebo and 150 mg/day groups. In these studies, 758 patients received Andogablin and 294 patients received placebo for up to 12 weeks. Because patients were also treated with 1 to 3 other AEDs, it is not possible to determine whether the following adverse reactions can be ascribed to Andogablin alone, or the combination of Andogablin and other AEDs. A majority of Andogablin-treated patients in clinical studies had adverse reactions with a maximum intensity of “mild” or “moderate”.
Table 5: Dose-related treatment-emergent adverse reaction incidence in controlled trials in adjunctive therapy for adult patients with partial onset seizures (events in at least 2% of all Andogablin-treated patients and the adverse reaction in the 600 mg/day group was greater than or equal to 2% the rate in both the placebo and 150 mg/day groups)
Body System Preferred Term
150 mg/d
[N = 185] %
300 mg/d
[N = 90] %
600 mg/d
[N = 395] %
All PGB*
[N = 670]† %
Placebo
[N = 294] %
Body as a Whole
Accidental Injury
7
11
10
9
5
Pain
3
2
5
4
3
Digestive System
Increased Appetite
2
3
6
5
1
Dry Mouth
1
2
6
4
1
Constipation
1
1
7
4
2
Metabolic and Nutritional Disorders
Weight Gain
5
7
16
12
1
Peripheral Edema
3
3
6
5
2
Nervous System
Dizziness
18
31
38
32
11
Somnolence
11
18
28
22
11
Ataxia
6
10
20
15
4
Tremor
3
7
11
8
4
Thinking Abnormal‡
4
8
9
8
2
Amnesia
3
2
6
5
2
Speech Disorder
1
2
7
5
1
Incoordination
1
3
6
4
1
Abnormal Gait
1
3
5
4
0
Twitching
0
4
5
4
1
Confusion
1
2
5
4
2
Myoclonus
1
0
4
2
0
Special Senses
Blurred Vision§
5
8
12
10
4
Diplopia
5
7
12
9
4
Abnormal Vision
3
1
5
4
1
* PGB: Andogablin
† Excludes patients who received the 50 mg dose in Study E1.
‡ Thinking abnormal primarily consists of events related to difficulty with concentration/attention but also includes events related to cognition and language problems and slowed thinking.
§ Investigator term; summary level term is amblyopia.
Controlled Studies With Fibromyalgia
Adverse Reactions Leading to Discontinuation
In clinical trials of patients with fibromyalgia, 19% of patients treated with Andogablin (150– 600 mg/day) and 10% of patients treated with placebo discontinued prematurely due to adverse reactions. In the Andogablin treatment group, the most common reasons for discontinuation due to adverse reactions were dizziness (6%) and somnolence (3%). In comparison, less than 1% of placebo-treated patients withdrew due to dizziness and somnolence. Other reasons for discontinuation from the trials, occurring with greater frequency in the Andogablin treatment group than in the placebo treatment group, were fatigue, headache, balance disorder, and weight increased. Each of these adverse reactions led to withdrawal in approximately 1% of patients.
Most Common Adverse Reactions
Table 6 lists all adverse reactions, regardless of causality, occurring in greater than or equal to 2% of patients with fibromyalgia in the 'all Andogablin' treatment group for which the incidence was greater than in the placebo treatment group. A majority of Andogablin-treated patients in clinical studies experienced adverse reactions with a maximum intensity of “mild” or “moderate”.
Table 6: Treatment-emergent adverse reaction incidence in controlled trials in fibromyalgia (events) in at least 2% of all Andogablin-treated patients and occurring more frequently in the all Andogablin-group than in the placebo treatment group)
System Organ Class Preferred term
150 mg/d
[N=132] %
300 mg/d
[N=502] %
450 mg/d
[N=505] %
600 mg/d
[N=378] %
All PGB*
[N=1517] %
Placebo
[N=505] %
Ear and Labyrinth Disorders
Vertigo
2
2
2
1
2
0
Eye Disorders
Vision blurred
8
7
7
12
8
1
Gastrointestinal Disorders
Dry mouth
7
6
9
9
8
2
Constipation
4
4
7
10
7
2
Vomiting
2
3
3
2
3
2
Flatulence
1
1
2
2
2
1
Abdominal distension
2
2
2
2
2
1
General Disorders and Administrative Site Conditions
Fatigue
5
7
6
8
7
4
Edema peripheral
5
5
6
9
6
2
Chest pain
2
1
1
2
2
1
Feeling abnormal
1
3
2
2
2
0
Edema
1
2
1
2
2
1
Feeling drunk
1
2
1
2
2
0
Infections and Infestations
Sinusitis
4
5
7
5
5
4
Investigations
Weight increased
8
10
10
14
11
2
Metabolism and Nutrition Disorders
Increased appetite
4
3
5
7
5
1
Fluid retention
2
3
3
2
2
1
Musculoskeletal and Connective Tissue Disorders
Arthralgia
4
3
3
6
4
2
Muscle spasms
2
4
4
4
4
2
Back pain
2
3
4
3
3
3
Nervous System Disorders
Dizziness
23
31
43
45
38
9
Somnolence
13
18
22
22
20
4
Headache
11
12
14
10
12
12
Disturbance in attention
4
4
6
6
5
1
Balance disorder
2
3
6
9
5
0
Memory impairment
1
3
4
4
3
0
Coordination abnormal
2
1
2
2
2
1
Hypoesthesia
2
2
3
2
2
1
Lethargy
2
2
1
2
2
0
Tremor
0
1
3
2
2
0
Psychiatric Disorders
Euphoric Mood
2
5
6
7
6
1
Confusional state
0
2
3
4
3
0
Anxiety
2
2
2
2
2
1
Disorientation
1
0
2
1
2
0
Depression
2
2
2
2
2
2
Respiratory, Thoracic and Mediastinal Disorders
Pharyngolaryngeal pain
2
1
3
3
2
2
* PGB: Andogablin
Controlled Studies In Neuropathic Pain Associated With Spinal Cord Injury
Adverse Reactions Leading to Discontinuation
In clinical trials of patients with neuropathic pain associated with spinal cord injury, 13% of patients treated with Andogablin and 10% of patients treated with placebo discontinued prematurely due to adverse reactions. In the Andogablin treatment group, the most common reasons for discontinuation due to adverse reactions were somnolence (3%) and edema (2%). In comparison, none of the placebo-treated patients withdrew due to somnolence and edema. Other reasons for discontinuation from the trials, occurring with greater frequency in the Andogablin treatment group than in the placebo treatment group, were fatigue and balance disorder. Each of these adverse reactions led to withdrawal in less than 2% of patients.
Most Common Adverse Reactions
Table 7 lists all adverse reactions, regardless of causality, occurring ingreater than or equal to 2% of patients with neuropathic pain associated with spinal cord injury in the controlled trials. A majority of Andogablin-treated patients in clinical studies experienced adverse reactions with a maximum intensity of “mild” or “moderate”.
Table 7: Treatment-emergent adverse reaction incidence in controlled trials in neuropathic pain associated with spinal cord injury (events in at least 2% of all Andogablin-treated patients and occurring more frequently in the all Andogablin-group than in the placebo treatment group)
System Organ Class
Preferred term
PGB*
(N=182)%
Placebo
(N=174)%
Ear and labryrinth disorders
Vertigo
2.7
1.1
Eye disorders
Vision blurred
6.6
1.1
Gastrointestinal disorders
Dry mouth
11.0
2.9
Constipation
8.2
5.7
Nausea
4.9
4.0
Vomiting
2.7
1.1
General disorders and administration site conditions
Fatigue
11.0
4.0
Edema peripheral
10.4
5.2
Edema
8.2
1.1
Pain
3.3
1.1
Infections and infestations
Nasopharyngitis
8.2
4.6
Investigations
Weight increased
3.3
1.1
Blood creatine phosphokinase increased
2.7
0
Musculoskeletal and connective tissue disorders
Muscular weakness
4.9
1.7
Pain in extremity
3.3
2.3
Neck pain
2.7
1.1
Back pain
2.2
1.7
Joint swelling
2.2
0
Nervous system disorders
Somnolence
35.7
11.5
Dizziness
20.9
6.9
Disturbance in attention
3.8
0
Memory impairment
3.3
1.1
Paresthesia
2.2
0.6
Psychiatric disorders
Insomnia
3.8
2.9
Euphoric mood
2.2
0.6
Renal and urinary disorders
Urinary incontinence
2.7
1.1
Skin and subcutaneous tissue disorders
Decubitus ulcer
2.7
1.1
Vascular disorders
Hypertension
2.2
1.1
Hypotension
2.2
0
* PGB: Andogablin
Other Adverse Reactions Observed During The Clinical Studies Of Andogablin
Following is a list of treatment-emergent adverse reactions reported by patients treated with Andogablin during all clinical trials. The listing does not include those events already listed in the previous tables or elsewhere in labeling, those events for which a drug cause was remote, those events which were so general as to be uninformative, and those events reported only once which did not have a substantial probability of being acutely life-threatening.
Events are categorized by body system and listed in order of decreasing frequency according to the following definitions: frequent adverse reactions are those occurring on one or more occasions in at least 1/100 patients; infrequent adverse reactions are those occurring in 1/100 to 1/1000 patients; rare reactions are those occurring in fewer than 1/1000 patients. Events of major clinical importance are described in the WARNINGS AND PRECAUTIONS).
The overall adverse event profile of Andogablin was similar between women and men. There are insufficient data to support a statement regarding the distribution of adverse experience reports by race.
Post-marketing Experience
The following adverse reactions have been identified during postapproval use of Andogablin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Nervous System Disorders – Headache
Gastrointestinal Disorders – Nausea, Diarrhea
Reproductive System and Breast Disorders – Gynecomastia, Breast Enlargement
In addition, there are post-marketing reports of events related to reduced lower gastrointestinal tract function (e.g., intestinal obstruction, paralytic ileus, constipation) when Andogablin was co- administered with medications that have the potential to produce constipation, such as opioid analgesics. There are also post-marketing reports of respiratory failure and coma in patients taking Andogablin and other CNS depressant medications.
What is the most important information I should know about Andogablin?
Andogablin solution may cause drowsiness, dizziness, blurred vision, or light-headedness. These effects may be worse if you take it with alcohol or certain medicines. Use Andogablin solution with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Do not drink alcohol while you are taking Andogablin solution.
Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are taking Andogablin solution; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
Andogablin solution may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
Do not suddenly stop taking Andogablin solution or change your dose without checking with your doctor. If you stop taking Andogablin solution suddenly, you may have headaches, nausea, diarrhea, trouble sleeping, anxiety, or increased sweating. If you have epilepsy and you stop taking Andogablin solution suddenly, you may have seizures more often. If you need to stop taking Andogablin solution, your dose should be gradually reduced over a period of at least 1 week.
If you stop taking Andogablin solution for any reason, contact your doctor right away. Do not start taking it again unless your doctor tells you to. Discuss any questions or concerns with your doctor.
If you develop new or worsening seizures, contact your doctor right away.
Patients who take Andogablin solution may be at increased risk of suicidal thoughts or actions. The risk may be greater in patients who have had suicidal thoughts or actions in the past. Watch patients who take Andogablin solution closely. Contact the doctor at once if new, worsened, or sudden symptoms (eg, depressed mood; anxious, restless, or irritable behavior; panic attacks; any unusual change in mood or behavior) occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.
Tell your doctor or dentist that you take Andogablin solution before you receive any medical or dental care, emergency care, or surgery.
Diabetes patients - Monitor your skin closely for any new or unusual sores while you take Andogablin solution.
In animal studies, birth defects were seen in the babies of male animals who were treated with Andogablin solution. It is not known if this may also occur in humans. If you are planning to father a child, discuss the possible risks with your doctor.
Use Andogablin solution with caution in the ELDERLY; they may be more sensitive to its effects.
Andogablin solution should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Andogablin solution while you are pregnant. It is not known if Andogablin solution is found in breast milk. Do not breast-feed while taking Andogablin solution.
Andogablin contraindications
Contraindication can be described as a special circumstance or a disease or a condition wherein you are not supposed to use the drug or undergo particular treatment as it can harm the patient; at times, it can be dangerous and life threatening as well. When a procedure should not be combined with other procedure or when a medicine cannot be taken with another medicine, it is called Relative contraindication. Contraindications should be taken seriously as they are based on the relative clinical experience of health care providers or from proven research findings.
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You may have thoughts about suicide while taking this medication. Your doctor will need to check you at regular visits. Do not miss any scheduled appointments.
Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, insomnia, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.
If you are taking Andogablin to prevent seizures, keep taking the medication even if you feel fine.
Do not stop using Andogablin without first talking to your doctor, even if you feel fine. You may have increased seizures or withdrawal symptoms such as headache, sleep problems, nausea, and diarrhea. Ask your doctor how to avoid withdrawal symptoms when you stop using Andogablin.
Do not change your dose of Andogablin without your doctor's advice. Tell your doctor if the medication does not seem to work as well in treating your condition.
Wear a medical alert tag or carry an ID card stating that you take Andogablin. Any medical care provider who treats you should know that you take seizure medication.
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References
DailyMed. "PREGABALIN: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
European Chemicals Agency - ECHA. "(3S)-3-(aminomethyl)-5-methylhexanoic: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).
The results of a survey conducted on ndrugs.com for Andogablin are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Andogablin. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.
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