Donecept Tablets (Generic Donepezil Hydrochloride Tablets)

1. Donecept Tablets (Generic Donepezil Hydrochloride Tablets) © The Swiss Pharmacy

2. Donecept Tablets (Generic Donepezil Hydrochloride Tablets) Donecept Tablets (Generic Donepezil Hydrochloride Tablets) belong to a group of medicines called acetylcholinesterase inhibitors and are used to treat the symptoms of dementia in patients diagnosed as having mild to moderately severe Alzheimer’s disease. They are also are indicated for the treatment of vascular dementia. © The Swiss Pharmacy

3. Donecept Tablets (Generic Donepezil Hydrochloride Tablets) Donecept Tablets (Generic Donepezil Hydrochloride Tablets) are manufactured by Cipla Limited, India in the strengths of 5 mg and 10 mg. © The Swiss Pharmacy

4. Donecept Tablets (Generic Donepezil Hydrochloride Tablets) Chemical Structure © The Swiss Pharmacy

5. Donecept Tablets (Generic Donepezil Hydrochloride Tablets) The active ingredient contained in Donecept tablets is Donepezil Hydrochloride. Each film-coated Donecept tablet contains 5 mg or 10 mg of Donepezil Hydrochloride equivalent to 4.56 mg or 9.12 mg Donepezil free base, respectively. © The Swiss Pharmacy

6. Donecept Tablets (Generic Donepezil Hydrochloride Tablets) Uses of Donecept 5 mg and 10 mg Tablets: Donecept (Generic Donepezil Hydrochloride Tablets) is a prescription medicine to treat dementia (memory loss and mental changes) associated with mild, moderate and severe Alzheimer’s disease. Donepezil Hydrochloride tablets can help with mental function and with doing daily tasks. Donepezil Hydrochloride tablets do not work the same in all people. Some patients may seem much better, get better in small ways or stay the same, get worse over time but slower than expected, not change and then get worse as expected. Donepezil will not not cure Alzheimer's disease, but it may improve memory, awareness, and the ability to function. This medication is an enzyme blocker that works by restoring the balance of natural substances (neurotransmitters) in the brain. Donepezil Hydrochloride tablets do not cure Alzheimer’s disease. All patients with Alzheimer’s disease get worse over time, even if they take Donepezil Hydrochloride tablets. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9519_Donepezil-HCl-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9519_Donepezil-HCl-Tablets.html © The Swiss Pharmacy

7. Donecept Tablets (Generic Donepezil Hydrochloride Tablets) Recommended Adult Dosage The dose of Donecept Tablets Donecept Tablets (Generic Donepezil Hydrochloride Tablets) is given below: Mild to Moderate Alzheimer’s Disease: 5 mg or 10 mg administered once daily Treatment should be initiated with Donecept Tablets 5 mg/day (once- a-day dosing). Donecept Tablets should be taken orally just before bedtime. Donecept Tablets can be taken with or without food. The dose of 5 mg/day should be maintained for at least 1 month in order to allow the earliest clinical responses to treatment to be assessed and to allow steady-state concentrations of Donepezil Hydrochloride to be achieved. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9519_Donepezil-HCl-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9519_Donepezil-HCl-Tablets.html © The Swiss Pharmacy

8. Donecept Tablets (Generic Donepezil Hydrochloride Tablets) Recommended Adult Dosage A dose of 10 mg once daily can be administered once patients have been on a daily dose of 5 mg for 4 to 6 weeks. Donepezil Hydrochloride tablets have not been approved as a treatment for any medical condition in children. © The Swiss Pharmacy

9. Donecept Tablets (Generic Donepezil Hydrochloride Tablets) Contraindications ➔Donecept tablets are contraindicated in patients with a known hypersensitivity to Donepezil Hydrochloride, piperidine derivatives or any component of the tablet. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9519_Donepezil-HCl-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9519_Donepezil-HCl-Tablets.html © The Swiss Pharmacy

10. Donecept Tablets (Generic Donepezil Hydrochloride Tablets) Storage Instructions Donecept Tablets (Generic Donepezil Hydrochloride 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=p9519_Donepezil-HCl-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9519_Donepezil-HCl-Tablets.html © The Swiss Pharmacy

11. Donecept Tablets (Generic Donepezil Hydrochloride Tablets) Warnings Cholinesterase inhibitors are likely to exaggerate succinylcholine type muscle relaxation during anesthesia. Cholinesterase inhibitors may have vagotonic effects on the sinoatrial and atrioventricular nodes manifesting as bradycardia or heart block. Donecept can cause vomiting. Patients should be observed closely at initiation of treatment and after dose increases. Patients should be monitored closely for symptoms of active or occult gastrointestinal (GI) bleeding, especially those at increased risk for developing ulcers. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9519_Donepezil-HCl-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9519_Donepezil-HCl-Tablets.html © The Swiss Pharmacy

12. Donecept Tablets (Generic Donepezil Hydrochloride Tablets) Warnings The use of Donecept tablets in a dose of 23 mg once daily is associated with weight loss. Although not observed in clinical trials of Donepezil Hydrochloride tablets, Cholinomimetics may cause bladder outflow obstructions Cholinomimetics are believed to have some potential to cause generalized convulsions. Cholinesterase inhibitors should be prescribed with care to patients with a history of asthma or obstructive pulmonary disease. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9519_Donepezil-HCl-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9519_Donepezil-HCl-Tablets.html © The Swiss Pharmacy

13. Donecept Tablets (Generic Donepezil Hydrochloride Tablets) Possible Side Effects Most common side effects observed during clinical studies of Donepezil Hydrochloride tablets were nausea, diarrhea, insomnia, vomiting, muscle cramps, fatigue, and anorexia. Call the doctor immediately in case the patient has the following Donecept side effects: fainting, heartburn or stomach pain that is new or won’t go away, nausea or vomiting, blood in the vomit, dark vomit that looks like coffee grounds, bowel movements or stools that look like black tar, new or worse asthma or breathing problems, seizures or difficulty passing urine. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9519_Donepezil-HCl-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9519_Donepezil-HCl-Tablets.html © The Swiss Pharmacy

14. Donecept Tablets (Generic Donepezil Hydrochloride Tablets) Possible Side Effects The most side effects, defined as those occurring at a frequency of at least 5% in patients receiving 10 mg/day and twice the placebo rate, are largely predicted by the cholinomimetic effects of Donepezil. These include nausea, diarrhea, insomnia, vomiting, muscle cramp, fatigue and anorexia. These side effects were often transient, resolving during continued Donepezil treatment without the need for dose modification. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9519_Donepezil-HCl-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9519_Donepezil-HCl-Tablets.html © The Swiss Pharmacy

15. Donecept Tablets (Generic Donepezil Hydrochloride Tablets) Donecept Tablets Overdosage Overdosage with cholinesterase inhibitors can result in cholinergic crisis characterized by severe nausea, vomiting, salivation, sweating, bradycardia, hypotension, respiratory depression, collapse and convulsions. Increasing muscle weakness is a possibility and may result in death if respiratory muscles are involved. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9519_Donepezil-HCl-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9519_Donepezil-HCl-Tablets.html © The Swiss Pharmacy

16. Donecept Tablets (Generic Donepezil Hydrochloride Tablets) Treatment of Donecept Tablets Overdosage Tertiary anticholinergics such as Atropine may be used as an antidote for Donepezil Hydrochloride (Donecept Tablets) overdosage. Intravenous Atropine Sulfate titrated to effect is recommended: an initial dose of 1.0 to 2.0 mg IV with subsequent doses based upon clinical response. Atypical responses in blood pressure and heart rate have been reported with other cholinomimetics when co-administered with quaternary anticholinergics such as glycopyrrolate. It is not known whether Donepezil Hydrochloride (Donecept Tablets) and/or its metabolites can be removed by dialysis. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9519_Donepezil-HCl-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9519_Donepezil-HCl-Tablets.html © The Swiss Pharmacy

17. Donecept Tablets (Generic Donepezil Hydrochloride Tablets) Donecept Tablets During Pregnancy Donepezil Hydrochloride (Donecept Tablets) has been classified by the US FDA as Pregnancy Category C. There are no adequate or well-controlled studies in pregnant women. Donecept (Donepezil Hydrochloride Tablets) should be administered during pregnancy only if the potential benefit justifies the potential risk to the fetus. Oral administration of Donepezil to pregnant rats and rabbits during the period of organogenesis did not produce any teratogenic effects at doses up to 16 mg/kg/day (approximately 6 times the maximum recommended human dose [MRHD] of 23 mg/day on a mg/m2 basis) and 10 mg/kg/day (approximately 7 times the MRHD on a mg/m2 basis), respectively. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9519_Donepezil-HCl-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9519_Donepezil-HCl-Tablets.html © The Swiss Pharmacy

18. Donecept Tablets (Generic Donepezil Hydrochloride Tablets) Donecept Tablets Donecept Tablets (Generic Donepezil Hydrochloride Tablets) are manufactured by Cipla Limited, India. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9519_Donepezil-HCl-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9519_Donepezil-HCl-Tablets.html © The Swiss Pharmacy