Clonil SR Tablets (Generic Clomipramine Hydrochloride SR Tablets)

1. Clonil SR Tablets (Generic Clomipramine Hydrochloride SR Tablets) © The Swiss Pharmacy

2. Clonil SR Tablets (Generic Clomipramine Hydrochloride SR Tablets) Clonil SR Tablets (Generic Clomipramine Hydrochloride SR Tablets) is used for the treatment of depression. Clonil SR also appears to have a mild sedative effect which may be helpful in alleviating the anxiety component often accompanying depression. Clonil SR is used for the treatment of obsessions and compulsions in patients with obsessive compulsive disorder (OCD). The obsessions and compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning. © The Swiss Pharmacy

3. Clonil SR Tablets (Generic Clomipramine Hydrochloride SR Tablets) Clonil SR Tablets are manufactured by Intas Pharmaceuticals Limited, India in the strength of 75 mg. © The Swiss Pharmacy

4. Clonil SR Tablets (Generic Clomipramine Hydrochloride SR Tablets) Chemical Structure - Clomipramine Hydrochloride © The Swiss Pharmacy

5. Clonil SR Tablets (Generic Clomipramine Hydrochloride SR Tablets) The active ingredient contained in Clonil SR tablets is Clomipramine Hydrochloride. Each film-coated prolonged release Clonil SR tablet contains 75 mg of Clomipramine Hydrochloride. © The Swiss Pharmacy

6. Clonil SR Tablets (Generic Clomipramine Hydrochloride SR Tablets) Uses of Clonil SR 75 mg tablets: Clonil SR (Generic Clomipramine Hydrochloride SR Tablets) is used to treat obsessive compulsive disorder (OCD). It helps decrease thoughts that are unwanted or that don't go away (obsessions), and it helps reduce the urge to perform repeated tasks (compulsions such as hand- washing, counting, checking) that interfere with daily living. It is used in the management of endogenous depression including manic depression, periodic and involutional depression, reactive and neurotic depression, obsessional and phobic states and as an adjunctive treatment of cataplexy associated with narcolepsy. This medication belongs to a class of medications called tricyclic antidepressants. It works by restoring the balance of certain natural substances (serotonin, among others) in the brain. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9897_Clomipramine-HCL-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9897_Clomipramine-HCL-Tablets.html © The Swiss Pharmacy

7. Clonil SR Tablets (Generic Clomipramine Hydrochloride SR Tablets) Uses of Clonil SR 75 mg tablets: In children and adolescents, there is not sufficient evidence of safety and efficacy of Clomipramine in the treatment of depressive states, phobias and cataplexy associated with narcolepsy. The use of Clomipramine in children and adolescents (0 to 17 years of age) in these indications is therefore not recommended. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9897_Clomipramine-HCL-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9897_Clomipramine-HCL-Tablets.html © The Swiss Pharmacy

8. Clonil SR Tablets (Generic Clomipramine Hydrochloride SR Tablets) Recommended Adult Dosage The dose of Clonil Tablets Clonil Tablets (Generic Clomipramine Tablets) is given below: Initial Treatment/Dose Adjustment (Adults): Initial Treatment/Dose Adjustment (Adults): Treatment with Clonil should be started at a dosage of 25 mg daily and gradually increased, as tolerated, to approximately 100 mg during the first 2 weeks. During initial titration, clomipramine should be given in divided doses with meals to reduce gastrointestinal side effects. Thereafter, the dosage may be increased gradually over the next several weeks, up to a maximum of 250 mg daily. After titration, the total daily dose may be given once daily at bedtime to minimize daytime sedation. Immediate release formulations and sustained-release tablets can be used interchangeably in equivalent doses. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9897_Clomipramine-HCL-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9897_Clomipramine-HCL-Tablets.html © The Swiss Pharmacy

9. Clonil SR Tablets (Generic Clomipramine Hydrochloride SR Tablets) Recommended Dosage Initial Treatment/Dose Adjustment (Children and Adolescents): Initial Treatment/Dose Adjustment (Children and Adolescents): As with adults, the starting dose is 25 mg daily and should be gradually increased (also given in divided doses with meals to reduce gastrointestinal side effects) during the first 2 weeks, as tolerated, up to a daily maximum of 3 mg/kg or 100 mg, whichever is smaller. Thereafter, the dosage may be increased gradually over the next several weeks up to a daily maximum of 3 mg/kg or 200 mg, whichever is smaller. As with adults, after titration, the total daily dose may be given once daily at bedtime to minimize daytime sedation. Safety and effectiveness in the pediatric population other than pediatric patients with OCD have not been established. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9897_Clomipramine-HCL-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9897_Clomipramine-HCL-Tablets.html © The Swiss Pharmacy

10. Clonil SR Tablets (Generic Clomipramine Hydrochloride SR Tablets) Recommended Dosage Maintenance/Continuation Treatment (Adults, Children, and Maintenance/Continuation Treatment (Adults, Children, and Adolescents): Adolescents): While there are no systematic studies that answer the question of how long to continue Clonil (Generic Clomipramine Hydrochloride Tablets), OCD is a chronic condition and it is reasonable to consider continuation for a responding patient. Although the efficacy of Clomipramine after 10 weeks has not been documented in controlled trials, patients have been continued in therapy under double- blind conditions for up to 1 year without loss of benefit. However, dosage adjustments should be made to maintain the patient on the lowest effective dosage, and patients should be periodically reassessed to determine the need for treatment. During maintenance, the total daily dose may be given once daily at bedtime. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9897_Clomipramine-HCL-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9897_Clomipramine-HCL-Tablets.html © The Swiss Pharmacy

11. Clonil SR Tablets (Generic Clomipramine Hydrochloride SR Tablets) Recommended Adult Dosage Obsessional/phobic states: Obsessional/phobic states: The maintenance dosage of Clonil is generally higher than that used in depression. It is recommended that the dose be built up to 100 mg to 150 mg Clonil (Generic Clomipramine Hydrochloride Tablets) daily, according to the severity of the condition. This should be attained gradually over a period of 2 weeks starting with 1 x 25 mg Clonil tablets daily. In elderly patients and those sensitive to tricyclic antidepressants a starting dose of 1 x 10 mg Clonil daily is recommended. Again where a higher dosage is required the Sustained-release 75 mg Again where a higher dosage is required the Sustained-release 75 mg formulation may be preferable. formulation may be preferable. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9897_Clomipramine-HCL-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9897_Clomipramine-HCL-Tablets.html © The Swiss Pharmacy

12. Clonil SR Tablets (Generic Clomipramine Hydrochloride SR Tablets) Contraindications ➔Clonil SR (Clomipramine Hydrochloride Tablets)is contraindicated in patients with a known hypersensitivity to Clomipramine Hydrochloride, other tricyclic antidepressants or any component of the tablet. ➔The use of MAOIs intended to treat psychiatric disorders with Clomipramine or within 14 days of stopping treatment with Clomipramine Hydrochloride Tablets is contraindicated because of an increased risk of serotonin syndrome. The use of Clonil SR within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9897_Clomipramine-HCL-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9897_Clomipramine-HCL-Tablets.html © The Swiss Pharmacy

13. Clonil SR Tablets (Generic Clomipramine Hydrochloride SR Tablets) Contraindications ➔Starting Clonil SR (Clomipramine Hydrochloride Tablets in a patient who is being treated with Linezolid or intravenous Methylene Blue is also contraindicated because of an increased risk of serotonin syndrome. ➔Clomipramine Hydrochloride tablets are contraindicated during the acute recovery period after a myocardial infarction. ➔Congenital long QT syndrome. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9897_Clomipramine-HCL-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9897_Clomipramine-HCL-Tablets.html © The Swiss Pharmacy

14. Clonil SR Tablets (Generic Clomipramine Hydrochloride SR Tablets) Storage Instructions Clonil SR (Generic Clomipramine Hydrochloride SR 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=p9897_Clomipramine-HCL-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9897_Clomipramine-HCL-Tablets.html © The Swiss Pharmacy

15. Clonil SR Tablets (Generic Clomipramine Hydrochloride SR Tablets) Warnings Clinical Worsening and Suicide Risk: Patients with Major Depressive Disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Screening Patients for Bipolar Disorder: A major depressive episode may be the initial presentation of bipolar disorder. It is generally believed (though not established in controlled trials) that treating such an episode with an antidepressant alone may increase the likelihood of precipitation of a mixed/manic episode in patients at risk for bipolar disorder. Whether any of the symptoms described above represent such a conversion is unknown. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9897_Clomipramine-HCL-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9897_Clomipramine-HCL-Tablets.html © The Swiss Pharmacy

16. Clonil SR Tablets (Generic Clomipramine Hydrochloride SR Tablets) Warnings Serotonin Syndrome: The development of a potentially life-threatening serotonin syndrome has been reported with SNRIs and SSRIs, including clomipramine hydrochloride, alone but particularly with concomitant use of other serotonergic drugs (including Triptans, Tricyclic Antidepressants, Fentanyl, Lithium, Tramadol, Tryptophan, Buspirone, and St. John's Wort) and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as Linezolid and intravenous Methylene Blue). The concomitant use of Clomipramine with MAOIs intended to treat psychiatric disorders is contraindicated. Clomipramine should also not be started in a patient who is being treated with MAOIs such As Linezolid or Intravenous Methylene Blue. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9897_Clomipramine-HCL-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9897_Clomipramine-HCL-Tablets.html © The Swiss Pharmacy

17. Clonil SR Tablets (Generic Clomipramine Hydrochloride SR Tablets) Warnings Angle-Closure Glaucoma: The pupillary dilation that occurs following use of many antidepressant drugs including Clomipramine Hydrochloride may trigger an angle closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy. Seizures: During premarket evaluation, seizure was identified as the most significant risk of Clomipramine Hydrochloride use. DRESS: Rare cases of Drug Rash With Eosinophilia And Systemic Symptoms (DRESS) have been reported with the use of Clomipramine Hydrochloride Tablets (Clonil SR). In the event of severe acute reactions such as DRESS, discontinue Clomipramine therapy immediately and institute appropriate treatment. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9897_Clomipramine-HCL-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9897_Clomipramine-HCL-Tablets.html © The Swiss Pharmacy

18. Clonil SR Tablets (Generic Clomipramine Hydrochloride SR Tablets) Possible Side Effects Most common side effects associated with the use of Clomipramine Hydrochloride tablets (Clonil SR and Clonil tablets) and not seen at an equivalent incidence among placebo-treated patients were gastrointestinal complaints, including dry mouth, constipation, nausea, dyspepsia, and anorexia; nervous system complaints, including somnolence, tremor, dizziness, nervousness, and myoclonus; genitourinary complaints, including changed libido, ejaculatory failure, impotence, and micturition disorder; and other miscellaneous complaints, including fatigue, sweating, increased appetite, weight gain, and visual changes. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9897_Clomipramine-HCL-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9897_Clomipramine-HCL-Tablets.html © The Swiss Pharmacy

19. Clonil SR Tablets (Generic Clomipramine Hydrochloride SR Tablets) Possible Side Effects The following side effects occurred in less than 1% or greater among patients with OCD who received Clomipramine Hydrochloride tablets (Clonil SR and Clonil tablets) in adult or pediatric placebo- controlled clinical trials: Nervous System: Somnolence, Tremor, Dizziness, Headache, Insomnia, Libido change, Nervousness, Myoclonus, Increased appetite, Paresthesia, Memory impairment, Anxiety, Twitching, Impaired concentration, Depression, Hypertonia, Sleep disorder, Psychosomatic disorder, Yawning, Confusion, Speech disorder, Abnormal dreaming, Agitation, Migraine, Depersonalization, Irritability, Emotional lability, Panic reaction, Aggressive reaction, Paresis. Skin and Appendages: Increased sweating, Rash, Pruritus, Dermatitis, Acne, Dry skin, Urticaria, Abnormal skin odor. Digestive System: Dry mouth, Constipation, Nausea, Dyspepsia, Diarrhea, Anorexia, Abdominal pain, Vomiting, Flatulence, Tooth disorder, Gastrointestinal disorder, Dysphagia, Esophagitis, Eructation, Ulcerative stomatitis. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9897_Clomipramine-HCL-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9897_Clomipramine-HCL-Tablets.html © The Swiss Pharmacy

20. Clonil SR Tablets (Generic Clomipramine Hydrochloride SR Tablets) Possible Side Effects The following side effects occurred in less than 1% or greater among patients with OCD who received Clomipramine Hydrochloride Tablets (Clonil SR and Clonil tablets) in adult or pediatric placebo- controlled clinical trials: Body as a Whole: Fatigue, Weight increase, Flushing, Hot flushes, Chest pain, Fever, Allergy, Pain, Local edema, Chills, Weight decrease, Otitis media, Asthenia, Halitosis, Cardiovascular System, Postural hypotension, Palpitation, Tachycardia, Syncope. Respiratory System: Pharyngitis, Rhinitis, Sinusitis, Coughing, Bronchospasm, Epistaxis, Dyspnea, Laryngitis. Urogenital System: Male and Female Patients Combined: Micturition disorder, Urinary tract infection, Micturition frequency, Urinary retention, Dysuria, Cystitis. Female Patients Only: Dysmenorrhea, Lactation (nonpuerperal), Menstrual disorder, Vaginitis, Leukorrhea, Breast enlargement, Breast pain, Amenorrhea. Male Patients Only: Ejaculation failure, Impotence. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9897_Clomipramine-HCL-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9897_Clomipramine-HCL-Tablets.html © The Swiss Pharmacy

21. Clonil SR Tablets (Generic Clomipramine Hydrochloride SR Tablets) Possible Side Effects The following side effects occurred in less than 1% or greater among patients with OCD who received Clomipramine Hydrochloride Tablets (Clonil SR and Clonil tablets) in adult or pediatric placebo- controlled clinical trials: Special Senses: Abnormal vision, Taste perversion, Tinnitus, Abnormal lacrimation, Mydriasis, Conjunctivitis, Anisocoria, Blepharospasm, Ocular allergy, Vestibular disorder. Musculoskeletal: Myalgia, Back pain, Arthralgia, Muscle weakness, Hemic and Lymphatic, Purpura, Anemia. Metabolic and Nutritional: Thirst. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9897_Clomipramine-HCL-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9897_Clomipramine-HCL-Tablets.html © The Swiss Pharmacy

22. Clonil SR Tablets (Generic Clomipramine Hydrochloride SR Tablets) Clonil SR Tablets Overdosage Deaths may occur from overdosage with this class of medications. Multiple drug ingestion (including alcohol) is common in deliberate tricyclic overdose. Signs and symptoms of toxicity develop rapidly after tricyclic overdose. Therefore, hospital monitoring is required as soon as possible. Signs and symptoms of Clomipramine Hydrochloride Tablets (Clonil) overdose vary in severity depending upon factors such as the amount of drug absorbed, the age of the patient, and the time elapsed since drug ingestion. Critical manifestations of overdose include cardiac dysrhythmias, severe hypotension, convulsions, and CNS depression including coma. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9897_Clomipramine-HCL-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9897_Clomipramine-HCL-Tablets.html © The Swiss Pharmacy

23. Clonil SR Tablets (Generic Clomipramine Hydrochloride SR Tablets) Clonil SR Tablets Overdosage Changes in the electrocardiogram, particularly in QRS axis or width, are clinically significant indicators of tricyclic toxicity. Other CNS manifestations may include drowsiness, stupor, ataxia, restlessness, agitation, delirium, severe perspiration, hyperactive reflexes, muscle rigidity, and athetoid and choreiform movements. Cardiac abnormalities may include tachycardia, signs of congestive heart failure, and in very rare cases, cardiac arrest. Respiratory depression, cyanosis, shock, vomiting, hyperpyrexia, mydriasis, and oliguria or anuria may also be present. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9897_Clomipramine-HCL-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9897_Clomipramine-HCL-Tablets.html © The Swiss Pharmacy

24. Clonil SR Tablets (Generic Clomipramine Hydrochloride SR Tablets) Treatment of Clonil SR Tablets Overdosage Obtain an ECG and immediately initiate cardiac monitoring. Protect the patient’s airway, establish an intravenous line, and initiate gastric decontamination. A minimum of 6 hours of observation with cardiac monitoring and observation for signs of CNS or respiratory depression, hypotension, cardiac dysrhythmias and/or conduction blocks, and seizures is necessary. If signs of toxicity occur at any time during this period, extended monitoring is required. There are case reports of patients succumbing to fatal dysrhythmias late after overdose; these patients had clinical evidence of significant poisoning prior to death and most received inadequate gastrointestinal decontamination. Monitoring of plasma drug levels should not guide management of the patient. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9897_Clomipramine-HCL-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9897_Clomipramine-HCL-Tablets.html © The Swiss Pharmacy

25. Clonil SR Tablets (Generic Clomipramine Hydrochloride SR Tablets) Clonil SR Tablets During Pregnancy Clomipramine Hydrochloride (Clonil SR Tablets) has been classified by the US FDA as Pregnancy Category C. No teratogenic effects were observed in studies performed in rats and mice at doses up to 100 mg/kg, which is 24 times the maximum recommended human daily dose (MRHD) on a mg/kg basis and 4 times (rats) and 2 times (mice) the MRHD on a mg/m2 basis. Slight nonspecific embryo/fetotoxic effects were seen in the offspring of treated rats given 50 and 100 mg/kg and of treated mice given 100 mg/kg. There are no adequate or well-controlled studies in pregnant women. Withdrawal symptoms, including jitteriness, tremor, and seizures, have been reported in neonates whose mothers had taken Clomipramine Tablets (Clonil) until delivery. Clonil Tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. © The Swiss Pharmacy

26. Clonil SR Tablets (Generic Clomipramine Hydrochloride SR Tablets) Clonil SR Tablets Clonil SR Tablets (Generic Clomipramine Hydrochloride SR Tablets) are manufactured by Intas Pharmaceuticals Limited, India. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9897_Clomipramine-HCL-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9897_Clomipramine-HCL-Tablets.html © The Swiss Pharmacy