SANDOZ-CARBAMAZEPINE CR

2 Recommended Dose and Dosage Adjustment, Use in Epilepsy, Adults and Children Over 12 Years of Age and Children 6-12 Years of Age).

Trigeminal Neuralgia:

Pediatrics (< 18 years of age) The safety and efficacy of carbamazepine in pediatric patients (<18 years of age) have not been studied. Carbamazepine is not authorized for pediatric use in trigeminal neuralgia. SANDOZ-CARBAMAZEPINE CR (Carbamazepine Controlled-Release Tablets) Page 5 of 40 Treatment of Acute Mania and Prophylaxis in Bipolar (Manic-Depressive) Disorders: Pediatrics (< 18 years of age) The safety and efficacy of carbamazepine in pediatric patients (<18 years of age) have not been studied.

Carbamazepine is not authorized for pediatric use in acute mania and prophylaxis in bipolar (manic- depressive) disorders. 2 Geriatrics Geriatrics (> 65 years of age) For all indications, due to drug interactions and different antiepileptic drug pharmacokinetics, the dosage of Sandoz-Carbamazepine CR should be selected with caution in elderly patients.

1 Dosing Considerations, Geriatrics. 2 CONTRAINDICATIONS Sandoz-Carbamazepine CR is contraindicated in: • Patients who are hypersensitive to carbamazepine or to any of the components of the tablets. For a complete listing, see

). Relapse and aggravation of the symptomatology on the 2nd or 3rd day after overdose, due to delayed absorption, should be anticipated.

Central Nervous System:

CNS depression, disorientation, depressed level of consciousness, tremor, restlessness, somnolence, agitation, hallucination, coma, blurred vision, nystagmus, mydriasis, slurred speech, dysarthria, ataxia, dyskinesia, abnormal reflexes (slowed/hyperactive), convulsions, psychomotor disturbances, myoclonus, opisthotonia, hypothermia/ hyperthermia, flushed skin/cyanosis, EEG changes.

Respiratory System: respiratory depression, pulmonary edema. Cardiovascular System: tachycardia, hypotension/hypertension, conduction disturbance with widening of QRS complex, syncope in association with cardiac arrest. Gastrointestinal System: nausea, vomiting, delayed gastric emptying, reduced bowel motility.

Musculoskeletal System:

There have been some cases which reported rhabdomyolysis in association with carbamazepine toxicity. Renal Function: urinary retention, oliguria or anuria; fluid retention, and water intoxication. Laboratory Findings: hyponatremia, hypokalemia, leukocytosis, reduced white cell count, metabolic acidosis, hyperglycemia, glycosuria, acetonuria, increased muscle creatine phosphokinase.

Treatment of Overdosage There is no known specific antidote to carbamazepine. Evacuate the stomach, with an emetic or by gastric lavage and then administer activated charcoal. Delay in evacuating the stomach may result in delayed absorption, leading to relapse during recovery from intoxication.

Hemodialysis is the effective treatment modality in the management of the carbamazepine overdose. Vital signs, including electrocardiogram to detect any cardiac arrhythmias or conduction defects, should be watched and symptomatic treatment should be administered as required.

1 Pregnant Women 08/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES .............................................................................................

2 TABLE OF CONTENTS................................................................................................................ 2 PART I: HEALTH PROFESSIONAL INFORMATION .......................................................................

4 1 INDICATIONS ................................................................................................................ 1 Pediatrics .................................................................................................................

2 Geriatrics ................................................................................................................. 5 2 CONTRAINDICATIONS ...................................................................................................

5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX .............................................................. 5 4 DOSAGE AND ADMINISTRATION .................................................................................. 1 Dosing Considerations .............................................................................................

2 Recommended Dose and Dosage Adjustment ......................................................... 5 Missed Dose............................................................................................................. 8 5 OVERDOSAGE ...............................................................................................................

8 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................ 10 7 WARNINGS AND PRECAUTIONS.................................................................................. 1 Special Populations ................................................................................................

Sandoz-Carbamazepine CR is contraindicated in: • Patients who are hypersensitive to carbamazepine or to any of the components of the tablets. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. g. amitriptyline, trimipramine, imipramine, or their analogues or metabolites).

• Patients with hepatic disease, a history of bone-marrow depression, a history of hepatic porphyria (acute intermittent porphyria, variegate porphyria, porphyria cutanea tarda), or serious blood disorder. • Conjunction with, or immediately after, a monoamine oxidase (MAO) inhibitor.

See 9 DRUG INTERACTIONS. • Conjunction with itraconazole and voriconazole. See 9 DRUG INTERACTIONS. • Patients presenting atrioventricular heart block. See 7 WARNINGS AND PRECAUTIONS, Cardiovascular.