Novo-Rivastigmine: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Rivastigmine hydrogen tartrate is 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 hydrogen tartrate works by increasing the amount of acetylcholine in the brain. In clinical studies with Rivastigmine, 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 hydrogen tartrate 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 NOVO-RIVASTIGMINE:

• if you know that you are allergic 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 Novo-Rivastigmine.

NOVO-RIVASTIGMINE should only be used if prescribed to you by your doctor.

What the medicinal ingredient is:

NOVO-RIVASTIGMINE contains the active substance rivastigmine hydrogen tartrate.

What the important nonmedicinal ingredients are:

NOVO-RIVASTIGMINE capsules contain the following inactive substances: hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose and silicon dioxide. The capsule shell is made of gelatin with red and/or yellow iron oxide and titanium dioxide. The printing ink is based on red iron oxide.

What dosage forms it comes in:

Capsules: Each hard gelatin capsule contains 1.5, 3, 4.5 or 6 mg of rivastigmine as rivastigmine hydrogen tartrate.

WARNINGS AND PRECAUTIONS

BEFORE you use NOVO-RIVASTIGMINE 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 NOVO-RIVASTIGMINE 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.

NOVO-RIVASTIGMINE 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 NOVO-RIVASTIGMINE with your current medications. If you have to undergo surgery while taking NOVO-RIVASTIGMINE, 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.

NOVO-RIVASTIGMINE should be taken with food.

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

Usual dose

You must take NOVO-RIVASTIGMINE twice a day, once with your breakfast and once with your evening meal.

Your doctor will tell you what dosage of NOVO-

RIVASTIGMINE 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. In case of accidental overdose, consult a physician immediately or contact your regional Poison Control Centre.

Missed Dose

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

If you stop taking NOVO-RIVASTIGMINE for more than several days, do NOT begin to take NOVO-RIVASTIGMINE again without contacting your doctor.

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, heartburn, stomach pains and loss

  of appetite;

• dizziness, headache, sleepiness, 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

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

HOW TO STORE IT

• Do not use NOVO-RIVASTIGMINE after the expiry date.

  Store NOVO-RIVASTIGMINE at room temperature (15 - 30°C) and protect from moisture.

• Keep NOVO-RIVASTIGMINE in a safe place and out of

  the reach of children.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found by contacting Novopharm Limited at:

1-800-268-4127 ext. 5005 (English Canada); 1-877-777-9117 (French Canada)

or druginfo@novopharm.com

Novopharm Limited

30 Novopharm Court

Toronto, Ontario

Canada, M1B 2K9

Date of Revision: April 1, 2009

REPORTING SUSPECTED SIDE EFFECTS

To monitor drug safety, Health Canada through the Canada Vigilance Program collects information on serious and unexpected side effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Canada Vigilance:

By toll-free telephone: 866-234-2345

By toll-free fax: 866-678-6789

Online: www.healthcanada.gc.ca/medeffect By email: CanadaVigilance@hc-sc.gc.ca

By regular mail:

Canada Vigilance National Office

Marketed Health Products Safety and

Effectiveness Information Bureau

Marketed Health Products Directorate

Health Products and Food Branch

Health Canada

Tunney’s Pasture, AL 0701C

Ottawa ON K1A 0K9

NOTE: Should you require information related to the management of the side effect, please contact your health care provider before notifying Canada Vigilance. The Canada Vigilance Program does not provide medical advice.