Zen Retard Tablets (Generic Carbamazepine Extended Release Tablets)

1. Zen Retard Tablets (Generic Carbamazepine Extended Release Tablets) © The Swiss Pharmacy

2. Zen Retard Tablets (Generic Carbamazepine Extended Release Tablets) Zen Retard Tablets (Generic Carbamazepine Extended Release Tablets) is used as an anticonvulsant medicine to treat Partial seizures with complex symptomatology (psychomotor, temporal lobe), Generalized tonic-clonic seizures (grand mal) and Mixed seizure patterns which include the above, or other partial or generalized seizures. Carbamazepine is also used in the treatment of the pain associated with true trigeminal neuralgia. © The Swiss Pharmacy

3. Zen Retard Tablets (Generic Carbamazepine Extended Release Tablets) Zen Retard Tablets (Generic Carbamazepine Extended Release Tablets) are manufactured by Intas Pharmaceuticals Limited, India in the strengths of 200 mg and 400 mg. © The Swiss Pharmacy

4. Zen Retard Tablets (Generic Carbamazepine Extended Release Tablets) Chemical Structure © The Swiss Pharmacy

5. Zen Retard Tablets (Generic Carbamazepine Extended Release Tablets) The active ingredient contained in Zen Retard tablets is Carbamazepine. 200mg: Each uncoated extended release Zen Retard tablet contains 200 mg of Carbamazepine. 400mg: Each uncoated extended release Zen Retard tablet contains 400 mg of Carbamazepine. © The Swiss Pharmacy

6. Zen Retard Tablets (Generic Carbamazepine Extended Release Tablets) Uses of Zen Retard 200 mg and 400 mg Tablets: Zen Retard Tablets (Generic Carbamazepine Extended Release Tablets) is used to treat certain types of seizures (eg, partial seizures, tonic-clonic seizures) and bipolar disorder. It is also used to relieve pain caused by trigeminal neuralgia (tic douloureux). Zen is indicated for use as an anticonvulsant medication that is used to treat: 1) Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvement than those with other types. 2) Generalized tonic-clonic seizures (grand mal). 3) Mixed seizure patterns which include the above, or other partial or generalized seizures. Absence seizures (petitmal) do not appear to be controlled by Carbamazepine. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9613_Carbamazepine-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9613_Carbamazepine-Tablets.html © The Swiss Pharmacy

7. Zen Retard Tablets (Generic Carbamazepine Extended Release Tablets) Uses of Zen Retard 200 mg and 400 mg Tablets: Zen Retard tablets are also used in the treatment of the pain associated with true trigeminal neuralgia. Beneficial results have also been reported in glossopharyngeal neuralgia. This medicine is also used for the prophylaxis of manic-depressive psychosis in patients unresponsive to lithium therapy. This medicine is not a simple analgesic and should not be used for the relief of trivial aches or pains. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9613_Carbamazepine-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9613_Carbamazepine-Tablets.html © The Swiss Pharmacy

8. Zen Retard Tablets (Generic Carbamazepine Extended Release Tablets) Recommended Adult Dosage For most patients (Adults and children over 12 years of age), the starting dose of Zen Retard Tablets Zen Retard Tablets (Generic Carbamazepine Extended Release Tablets) for the treatment of Epilepsy is 200 mg twice a day. Dosage is to be increased at weekly intervals by adding up to 200 mg/day using a three times a day or four times a day regimen until the optimal response is obtained. Dosage generally should not exceed 1000 mg daily in children 12 to 15 years of age, and 1200 mg daily in patients above 15 years of age. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9613_Carbamazepine-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9613_Carbamazepine-Tablets.html © The Swiss Pharmacy

9. Zen Retard Tablets (Generic Carbamazepine Extended Release Tablets) Recommended Adult Dosage The maintenance dose for the treatment of Epilepsy : Adjust dosage to the minimum effective level, usually 800mg to 1200 mg daily. Treatment of Epilepsy In Children 6 to 12 years of age: The initial dosage is 100 mg twice a day. Increase at weekly intervals by adding up to 100 mg/day using a three times a day or four times a day regimen until the optimal response is obtained. Dosage generally should not exceed 1000 mg daily. Maintenance: Adjust dosage to the minimum effective level, usually 400mg to 800 mg daily. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9613_Carbamazepine-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9613_Carbamazepine-Tablets.html © The Swiss Pharmacy

10. Zen Retard Tablets (Generic Carbamazepine Extended Release Tablets) Recommended Adult Dosage Trigeminal Neuralgia In Adults: Initial Dosage: On the first day, 100 mg twice a day for a total daily dose of 200 mg. This daily dose may be increased by up to 200 mg/day using increments of 100 mg every 12 hours only as needed to achieve freedom from pain. Do not exceed 1200 mg daily. Maintenance: Control of pain can be maintained in most patients with 400mg to 800 mg daily. However, some patients may be maintained on as little as 200 mg daily, while others may require as much as 1200 mg daily. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9613_Carbamazepine-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9613_Carbamazepine-Tablets.html © The Swiss Pharmacy

11. Zen Retard Tablets (Generic Carbamazepine Extended Release Tablets) Contraindications ➔Zen Retard tablets are contraindicated in patients with a known hypersensitivity to Carbamazepine or known sensitivity to any of the tricyclic compounds, such as Amitriptyline, Desipramine, Imipramine, Protriptyline, Nortriptyline, etc. or any component of the tablet. ➔Use of Zen Retard tablets (Generic Carbamazepine Extended Release tablets) with monoamine oxidase inhibitors is not recommended. Before administration of Carbamazepine, MAO inhibitors should be discontinued for a minimum of 14 days, or longer if the clinical situation permits. ➔Co-administration of Carbamazepine and Nefazodone may result in insufficient plasma concentrations of nefazodone and its active metabolite to achieve a therapeutic effect. Co-administration of Carbamazepine with Nefazodone is contraindicated. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9613_Carbamazepine-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9613_Carbamazepine-Tablets.html © The Swiss Pharmacy

12. Zen Retard Tablets (Generic Carbamazepine Extended Release Tablets) Storage Instructions Zen Retard Tablets (Generic Carbamazepine Extended Release Tablets) have to be stored at controlled room temperature i.e. from 20°C to 25°C (68°F to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F). Keep this as well as all other medicines away from children and pets. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9613_Carbamazepine-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9613_Carbamazepine-Tablets.html © The Swiss Pharmacy

13. Zen Retard Tablets (Generic Carbamazepine Extended Release Tablets) Black Box Warnings Serious Dermatologic Reactions: Serious Dermatologic Reactions: Serious and sometimes fatal dermatologic reactions, including toxic epidermal necrolysis (TEN) and Stevens-Johnson Syndrome (SJS),have occurred with Carbamazepine Extended Release tablets (Zen Retard tablets). Patients of Asian ancestry have a 10-fold greater risk of TEN/SJS, compared to other populations. In genetically at-risk patients, test for the HLA-B*1502 allele prior to initiating Zen Retard tablets. Discontinue Zen Retard tablets if these reactions occur. Aplastic Anemia and Agranulocytosis: Aplastic Anemia and Agranulocytosis: Aplastic anemia and agranulocytosis occurred with Carbamazepine Extended Release tablets (Zen Retard tablets). Obtain complete pretreatment hematological testing. Consider discontinuing Zen Retard tablets if significant bone marrow depression develops. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9613_Carbamazepine-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9613_Carbamazepine-Tablets.html © The Swiss Pharmacy

14. Zen Retard Tablets (Generic Carbamazepine Extended Release Tablets) Warnings Serious and sometimes fatal dermatologic reactions, including toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome (SJS), have been reported with carbamazepine treatment. The risk of these events is estimated to be about 1 to 6 per 10,000 new users in countries with mainly Caucasian populations. However, the risk in some Asian countries is estimated to be about 10 times higher. Carbamazepine Extended Release tablets (Zen Retard tablets) should be discontinued at the first sign of a rash, unless the rash is clearly not drug-related. Retrospective case-control studies have found that in patients of Chinese ancestry there is a strong association between the risk of developing SJS/TEN with Carbamazepine treatment and the presence of an inherited variant of the HLA-B gene, HLA-B*1502. The occurrence of higher rates of these reactions in countries with higher frequencies of this allele suggests that the risk may be increased in allele-positive individuals of any ethnicity. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9613_Carbamazepine-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9613_Carbamazepine-Tablets.html © The Swiss Pharmacy

15. Zen Retard Tablets (Generic Carbamazepine Extended Release Tablets) Warnings Patients with a history of adverse hematologic reaction to any drug may be particularly at risk of bone marrow depression. Carbamazepine Extended Release tablets (Zen Retard tablets) has shown mild anticholinergic activity; therefore, patients with increased intraocular pressure should be closely observed during therapy. Because of the relationship of the drug to other tricyclic compounds, the possibility of activation of a latent psychosis and, in elderly patients, of confusion or agitation should be borne in mind. The use of Carbamazepine Extended Release tablets (Zen Retard tablets) should be avoided in patients with a history of hepatic porphyria (e.g., acute intermittent porphyria, variegate porphyria, porphyria cutanea tarda). Acute attacks have been reported in such patients receiving Carbamazepine therapy. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9613_Carbamazepine-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9613_Carbamazepine-Tablets.html © The Swiss Pharmacy

16. Zen Retard Tablets (Generic Carbamazepine Extended Release Tablets) Warnings Carbamazepine tablets administration has also been demonstrated to increase porphyrin precursors in rodents, a presumed mechanism for the induction of acute attacks of porphyria. As with all antiepileptic drugs, Carbamazepine (Zen tablets) should be withdrawn gradually to minimize the potential of increased seizure frequency. Before starting therapy, a detailed history and physical examination should be made. Carbamazepine should be used with caution in patients with a mixed seizure disorder that includes atypical absence seizures, since in these patients Carbamazepine has been associated with increased frequency of generalized convulsion. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9613_Carbamazepine-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9613_Carbamazepine-Tablets.html © The Swiss Pharmacy

17. Zen Retard Tablets (Generic Carbamazepine Extended Release Tablets) Possible Side Effects Most commonly reported side effects with Carbamazepine Extended Release tablets (Zen Retard tablets) are CNS disturbances (e.g., drowsiness, headache, unsteadiness on the feet, diplopia, dizziness), gastrointestinal disturbances (nausea, vomiting), and allergic skin reactions. The more serious side effects observed are the hematologic, hepatic, cardiovascular and dermatologic reactions, which require discontinuation of therapy. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9613_Carbamazepine-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9613_Carbamazepine-Tablets.html © The Swiss Pharmacy

18. Zen Retard Tablets (Generic Carbamazepine Extended Release Tablets) Zen Retard Tablets Overdosage The presenting signs and symptoms of Carbamazepine Extended Release tablets (Zen Retard tablets) overdosage involve the central nervous, cardiovascular, respiratory systems and the side effects observed at the prescribed dose. Central nervous system: CNS depression; disorientation, depressed level of consciousness, somnolence, agitation, hallucination, coma; blurred vision, slurred speech, dysarthria, nystagmus, ataxia, dyskinesia, initially hyper-reflexia, later hyporeflexia; convulsions, psychomotor disturbances, myoclonus, hypothermia, mydriasis. Respiratory system: Respiratory depression, pulmonary oedema. Cardiovascular system: Tachycardia, hypotension and at times hypertension, conduction disturbance with widening of QRS complex; syncope in association with cardiac arrest. Gastro-intestinal system: Vomiting, delayed gastric emptying, reduced bowel motility. © The Swiss Pharmacy

19. Zen Retard Tablets (Generic Carbamazepine Extended Release Tablets) Zen Retard Tablets Overdosage Musculoskeletal system: There have been some cases which reported rhabdomyolysis in association with carbamazepine toxicity. Renal function: Retention of urine, oliguria or anuria; fluid retention, water intoxication due to ADH-like effect of carbamazepine. Laboratory findings: Hyponatraemia, possibly metabolic acidosis, possibly hyperglycaemia, increased muscle creatine phosphokinase. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9613_Carbamazepine-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9613_Carbamazepine-Tablets.html © The Swiss Pharmacy

20. Zen Retard Tablets (Generic Carbamazepine Extended Release Tablets) Treatment of Overdosage There is no specific antidote for Carbamazepine Extended Release tablets (Zen Retard tablets) . Management should initially be guided by the patient's clinical condition. Admission to hospital is necessary. Measurement of the plasma level to confirm Carbamazepine poisoning and to ascertain the size of the overdose. Evacuation of the stomach, gastric lavage, and administration of activated charcoal. Delay in evacuating the stomach may result in delayed absorption, leading to relapse during recovery from intoxication. Supportive medical care in an intensive care unit with cardiac monitoring and careful correction of electrolyte imbalance. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9613_Carbamazepine-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9613_Carbamazepine-Tablets.html © The Swiss Pharmacy

21. Zen Retard Tablets (Generic Carbamazepine Extended Release Tablets) Zen Retard Tablets During Pregnancy Carbamazepine (Zen Retard tablets) has been classified by the US FDA as Pregnancy Category D. Carbamazepine can cause fetal harm when administered to a pregnant woman. Epidemiological data suggest that there may be an association between the use of Carbamazepine (Zen Retard tablets) during pregnancy and congenital malformations, including spina bifida. There have also been reports that associate Carbamazepine with developmental disorders and congenital anomalies (e.g., craniofacial defects, cardiovascular malformations, hypospadias and anomalies involving various body systems). URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9613_Carbamazepine-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9613_Carbamazepine-Tablets.html © The Swiss Pharmacy

22. Zen Retard Tablets (Generic Carbamazepine Extended Release Tablets) Zen Retard Tablets During Pregnancy Developmental delays based on neurobehavioral assessments have been reported. In treating or counseling women of childbearing potential, the prescribing physician will wish to weigh the benefits of therapy against the risks. If this drug is used during pregnancy, or if the patient becomes pregnant while taking Zen Retard tablets, the patient should be apprised of the potential hazard to the fetus. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9613_Carbamazepine-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9613_Carbamazepine-Tablets.html © The Swiss Pharmacy

23. Zen Retard Tablets (Generic Carbamazepine Extended Release Tablets) Zen Retard Tablets Zen Retard Tablets (Generic Carbamazepine Extended Release Tablets) are manufactured by Intas Pharmaceuticals Limited, India. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9613_Carbamazepine-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9613_Carbamazepine-Tablets.html © The Swiss Pharmacy