Side Effects

Placebo

N=128

PRINORELAX  15mg

N=127

PRINORELAX  30mg

N=126

Dry mouth

2%

6%

14%

Dizziness

2%

3%

6%

Fatigue

2%

3%

3%

Constipation

0%

1%

3%

Somnolence

0%

1%

2%

Nausea

1%

3%

3%

Dyspepsia

1%

0%

4%

*PRINORELAX  15mg QD, PRINORELAX  30mg QD  tablets

Precautions

- Serotonin Syndrome

The development of a potentially life-threatening serotonin syndrome has been reported with cyclobenzaprine when used in combination with other drugs, such as selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors, (SNRIs), tricyclic antidepressants (TCAs), tramadol, bupropion, meperidine, verapamil, or MAO inhibitors. The concomitant use of PRINORELAX with MAO inhibitors is contraindicated. Serotonin syndrome symptoms may include mental status changes (e.g., confusion, agitation, hallucinations), autonomic instability (e.g., diaphoresis, tachycardia, labile blood pressure, hyperthermia), neuromuscular abnormalities (e.g., tremor, ataxia, hyperreflexia, clonus, muscle rigidity), and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Treatment with PRINORELAX and any concomitant serotonergic agents should be discontinued immediately if the above reactions occur and supportive symptomatic treatment should be initiated. If concomitant treatment with PRINORELAX and other serotonergic drugs is clinically warranted, careful observation is advised, particularly during treatment initiation or dose increases.

All Rights Reserved Liptis Pharmaceuticals 2021