Rivastigmine Tartrate Capsules: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Rivastigmine tartrate capsules are one of a group of drugs known as “cholinesterase inhibitors” which is used for the treatment of the symptoms of patients with mild to moderate Alzheimer's disease or with dementia occurring at least 2 years following the diagnosis of Parkinson’s disease. Although there are differences between the two types of dementias in terms of changes to the brain and to mental function, it is known that with both conditions there are decreased levels of acetylcholine, a substance which is found in the brain and which is thought to be necessary for good cognitive function (memory and other mental function).

What it does:

Rivastigmine tartrate capsules works by increasing the amount of acetylcholine in the brain. In clinical studies with rivastigmine hydrogen tartrate, most patients with Alzheimer's disease had improved memory and other mental functions, or showed no further decline, as compared to placebo (sugar tablet) for up to 6 months. However, rivastigmine tartrate capsules may take as long as 12 weeks to begin working, and patient response to this medicine will vary. This medication should only be taken after proper diagnosis of your condition has been made by your doctor.

When it should not be used:

You should not take rivastigmine tartrate capsules

• If you know that you are allergic (hypersentitive) to

  rivastigmine or to any of the other substances listed in this leaflet (see `What the important nonmedicinal ingredients are'),

• If you have ever had an allergic reaction to a similar type of

  medicine,

• If you have severe liver problems.

If this applies to you, tell your doctor without taking rivastigmine tartrate capsules

Rivastigmine tartrate capsules should only be used if prescribed to you by your doctor.

What the medicinal ingredient is:

Rivastigmine tartrate capsules contains the active substance rivastigmine hydrogen tartrate.

What the important nonmedicinal ingredients are: Inactive ingredients are: colloidal silicon dioxide, hypromellose, magnesium stearate and microcrystalline cellulose; hard gelatin capsules contain: gelatin, titanium dioxide. In addition 1.5 mg hard gelatin capsules contain also D&C Yellow No. 10 and FD&C Yellow No. 6; 3 mg hard gelatin capsules contain also D&C Red No. 28, FD&C Red No. 40 and FD&C Yellow No. 10; 4.5 mg and 6 mg hard gelatin capsules contain also: red iron oxide and yellow iron oxide.

What dosage forms it comes in:

Capsules: Each hard gelatin capsule contains 1.5, 3.0, 4.5 or 6.0 mg of rivastigmine as rivastigmine hydrogen tartrate.

WARNINGS AND PRECAUTIONS

BEFORE you use rivastigmine tartrate capsules talk to your doctor or pharmacist if:

• if you have, or have ever had other medical problems, such as conditions affecting your heart or lungs;
• if you have, or have ever had seizures (fits or convulsions);
• if you have a history of stomach ulcers or have an increased risk of developing ulcers (for example you are taking non-steroidal anti-inflammatory drugs (NSAIDS) or high doses of acetylsalicylic acid [ASA];
• if you have, or have ever had difficulties in passing urine;
• if you have, or have ever had liver or kidney problems;

• if you are pregnant, planning on becoming pregnant, or breast feeding.

Your doctor will determine whether you can take rivastigmine tartrate capsules and how closely you will need to be monitored.

Can I drive vehicles and operate machinery?

Your doctor will tell you whether your illness allows you to drive vehicles and operate machinery safely.

INTERACTIONS WITH THIS MEDICATION

Make sure your doctor knows if you are taking, or begin to take, any other medicines, including drugs, or herbal (natural) products that you can buy without a prescription.

Rivastigmine tartrate capsules should not be given at the same time as other medicines with similar effects (cholinomimetic agents) or

with anticholinergic medicines (e.g. medicines used to relieve stomach cramps or spasms, to treat Parkinson’s disease or to prevent travel sickness).

Your doctor will tell you if you can also take rivastigmine tartrate capsules with your current medications. If you have to undergo surgery while taking rivastigmine tartrate capsules, you should inform the doctor before you are given any anaesthetics (drugs that produce a loss of sensation).

PROPER USE OF THIS MEDICATION

This medicine has been prescribed only for you. It must not be given to anybody else or used for any other illnesses.

Rivastigmine tartrate capsules should be taken with food.

Capsules: Swallow the capsules whole with a drink, without opening or crushing them.

Usual dose:

You must take rivastigmine tartrate capsules twice a day, once with your breakfast and once with your evening meal.

Your doctor will tell you what dosage of rivastigmine tartrate capsules to take, starting with a low dose and gradually increasing, depending on how you respond to the treatment. The highest dose that should be taken is 6 mg twice a day (12 mg/day).

To benefit from your medicine you must take it every day.

Overdose:

If more medication has been taken than what has been prescribed, contact either your doctor, hospital emergency department or the nearest poison control center immediately. Some people who have accidentally taken too much rivastigmine hydrogen tartrate have experienced nausea, vomiting, diarrhea, high blood pressure and hallucinations. Slow heart beat and fainting may also occur.

Missed Dose:

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

In clinical studies most side effects of rivastigmine hydrogen tartrate were of mild to moderate intensity.

The most common side effects noted were:

• nausea, vomiting, diarrhea, stomach discomfort after meal, stomach pains and loss of appetite;
• dizziness, headache, sleepiness, drowsiness, trembling;
• agitation, confusion;
• weakness, fatigue, a general feeling of being unwell;
• sweating;
• weight loss.

These side effects will most probably disappear gradually as your body becomes used to the medicine or with a reduction in dose. If they persist, however, you should tell your doctor.

Less frequently patients have experienced difficulty in sleeping, change in liver function tests, accidental falls, and very rarely, patients have experienced worsening of Parkinson’s disease symptoms (such as stiffness, difficulty in carrying out movements).

If you feel unwell in this or any other way or have any symptoms that you do not understand, or find distressing, you should contact your doctor immediately. If you experience severe adverse events and cannot contact your doctor, stop taking the drug until you can discuss your symptoms with your doctor.

If you find you have forgotten to take your dose of rivastigmine tartrate capsules, do not worry, wait and take the next dose at the usual time. Do NOT take two doses at once.

If you stop taking rivastigmine tartrate capsules for more than several days, do NOT begin to take rivastigmine tartrate capsules again without contacting your doctor.

REPORTING SUSPECTED SIDE EFFECTS You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3

ways:

Report online at www.healthcanada.gc.ca/medeffect Call toll-free at 1-866-234-2345

Complete a Canada Vigilance Reporting Form and:

• Fax toll-free to 1-866-678-6789, or

• Mail to: Canada Vigilance Program

  Health Canada

  Postal Locator 0701C

  Ottawa, ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at

www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

This is not a complete list of side effects. For any unexpected effects while taking rivastigmine tartrate capsules, contact your doctor or pharmacist.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be obtained by contacting the sponsor, Dr. Reddy’s Laboratories Limited., India.

by telephone: 1-888-550-6060

by post: Dr. Reddy’s Laboratories Limited.

Bachepalli – 502 325 INDIA

Please consult your doctor or pharmacist with any questions or concerns you may have regarding your individual condition.

India.. Last revised: November 3, 2011

HOW TO STORE IT

• Do not use rivastigmine tartrate capsules after the expiry date.

• Store rivastigmine tartrate capsules at room temperature (15 -

  30°C).

• Keep rivastigmine tartrate capsules in a safe place and out

  of the reach of children.