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New Exelon 6 Mg 28 Capsules ingredient Rivastigmine View larger

Exelon 6 Mg 28 Capsules ingredient Rivastigmine

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Exelon 6 Mg 28 Capsules ingredient Rivastigmine

Please read this INSTRUCTIONS carefully before using this medicine, as it contains important information for you.

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4.6. Pregnancy and lactation

General advice

Pregnancy category: B.

Women with childbearing potential / contraception (contraception)

HealthHealth professionals who prescribe EXELON should describe the potential risks of these agents to women who have the potential to have children.

Pregnancy period In

animal studies, rivastigmine has no teratogenic effect. However, the safety of EXELON has not been confirmed in human pregnancy and EXELON should only be used to pregnant women if the benefit to be obtained from treatment is greater than the potential risk to the fetus.

Lactation

Women, who do not know whether or not Rivastigmine has passed into human milk, should not use rivastigmine.

Reproductive ability / Fertility

4.7. Effects ondrive and use machines

ability toAlzheimer's disease may cause a gradual deterioration in vehicle driving performance and impair the ability to operate the machine. Rivastigmine can induce dizziness and drowsiness at baseline and initiation of treatment. Therefore, in patients with dementia and treated with rivastigmine, the ability to continue driving and manage complex machines should be routinely evaluated by the attending physician.

8.4. Undesirable effects

Most reported adverse drug effects develop in the gastrointestinal tract and nausea (38%) and vomiting (23%) may occur during dose titration. During clinical studies, it was noted that female patients were more susceptible to gastrointestinal adverse drug reactions and weight loss than male patients.

Adverse events listed below; Compiled from cases of Alzheimer's dementia treated with EXELON.

Adverse drug reactions are listed below according to their frequency, with the most common adverse reaction being the first. In each frequency group, adverse reactions are listed according to the decreasing severity.

Very common (> 1/10); common (> 1/100 to <1/10); non-widespread (> 1 / 1,000 to <1/100); infrequently> 1 / 10,000 to <1/1000); Very sparse (<1 / 10,000), including isolated reports.

Infection and infestations

Very infrequently: Urinary infection.

Psychiatric disorders

Common: Agitation, confusion. Uncommon: Insomnia, depression. Very sparse: Hallucinations.

Nervous system disorders Very common: Dizziness Common: Headache, somnolans, tremor. Uncommon: Syncope.

Rare: Seizures.

Cardiac disorders

Rare: Angina pectoris, myocardial infarction.

Very rare: cardiac arrhythmia (eg bradycardia, atrio-ventricular block, atrial fibrillation and tachycardia).

Vascular disorders

Very sparse: Hypertension.

Gastrointestinal disorders

Very common: nausea, vomiting, diarrhea, loss of appetite. Common: Abdominal pain and dyspepsia. Rare: Stomach and duodenal ulcers.

Very rare: gastrointestinal bleeding, pancreatitis, severe vomiting accompanied by esophageal cracking.

Hepato-biliary disorders

Very rare: abnormal liver function tests.

Skin and subcutaneous tissue disorders

Common: Increased sweating. Rare: Skin rash, pruritus

General disorders and disorders related to the application area

Common: Fatigue and asthenia, malaise, weight loss.

Uncommon: Accidental fall.

The following adverse effects were observed with EXELON PATCH:

Uncommon: Cerebrovascular accident, delirium

Rare: Erythema, urticaria, bulla, allergic dermatitis.

Information from clinical trials with patients: The

with dementia associated with Parkinson's diseasefollowing additional adverse drug reactions have been identified in patients with Parkinson's disease-associated dementia and treated with Exelon capsules.

Common: Worsening of Parkinson's disease

4.9. Overdose and treatment

Symptoms:

Almost all cases of overdose caused by an accident were not accompanied by any clinical symptoms or symptoms, and almost all of these patients continued treatment with rivastigmine. Nausea, vomiting and diarrhea, hypertension or hallucinations; Symptoms of symptomatic overdose. Due to the known vagotonic effect of cholinesterase inhibitors on the heart; it may also develop bradycardia and / or syncope. A case of 46 mg rivastigmine was reported; The patient recovered completely within 24 hours with conservative treatment.

Treatment:

The half-life of Rivastigmine in plasma is approximately 1 hour and the duration of inhibition of acetylcholinesterase is approximately 9 hours; In the event of an asymptomatic overdose, it is recommended that the patient not be given another dose of rivastigmine within the next 24 hours. In case of overdose accompanied by severe nausea and vomiting, the use of antiemetics should be considered. Symptomatic treatment should be performed in other adverse events.

Atropine may be used during intense overdose. The recommended intravenous atropine sulfate initial dose is 0.03 mg / kg; subsequent doses are adjusted according to the clinical response. The use of scopolamine as an antidote is not recommended.

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