Fact Sheet - CO Memantine

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Contact : Bureau of Pharmaceutical Sciences

Authorization with conditions of CO Memantine (memantine hydrochloride) for use as a monotherapy for the symptomatic treatment of patients with moderate to severe dementia of the Alzheimer's type
Fact Sheet

What is CO Memantine?

The active substance in CO Memantine tablets is memantine hydrochloride. The other non-medicinal ingredients in the tablets are: lactose monohydrate, microcrystalline cellulose and magnesium stearate. In addition, the tablet film coating contains: titanium dioxide, lactose monohydrate, polyethylene glycol, and hydroxypropyl methylcellulose. Each tablet contains either 5 mg or 10 mg of memantine.

What is CO Memantine used for?

CO Memantine has been prescribed to you, or to someone in your care, by a doctor to relieve your symptoms of Alzheimer's disease in the moderate to severe stage of the disease.

What is Alzheimer's disease?

Alzheimer's disease is a progressive, neurodegenerative disease. Several changes occur in the brain of people with Alzheimer's disease. The brain cells shrink or disappear, and are replaced by dense, irregularly-shaped spots, or plaques. Another indicator of the disease is thread-like tangles within existing brain cells. These tangles eventually damage healthy brain cells.

As Alzheimer's disease affects each area of the brain, certain functions or abilities are lost. This results in specific symptoms or changes in behaviour. It is important to remember that once an ability is lost it can rarely be relearned. Although the disease results in changes, it does not affect the person's ability to appreciate, respond to and experience feelings such as joy, anger, fear, love or sadness.

While it is not possible to restore function to brain cells damaged by Alzheimer's disease, there are treatments and strategies that can help both the person with the disease and the caregiver.

How does CO Memantine work?

The brain contains N-methyl-D-aspartate (NMDA) receptors that are involved in transmitting nerve signals and may be important for learning and memory. Abnormal transmission of nerve signals through NMDA-receptors in the brain may affect memory and other mental functions and contribute to symptoms of Alzheimer's disease. CO Memantine belongs to a group of medicines called NMDA-receptor antagonists. The action of CO Memantine on NMDA-receptors may help normalize the transmission of nerve signals, which may help slow the decline in some of the symptoms of Alzheimer's disease.

What other treatments have been used to treat symptoms of moderate to severe Alzheimer disease?

A class of medication called acethylcholinesterase inhibitors are prescribed to patients in the mild to moderate stage of the Alzheimer's disease. At present there is no other specific treatment for the symptoms of patients with moderate to severe Alzheimer's disease.

What do patients need to know about using CO Memantine?

You should tell your doctor about the following information before taking CO Memantine:

• All your medical conditions, including heart problems, uncontrolled hypertension (high blood pressure), history of seizures (convulsions) or kidney disease.
• Any medications (prescription or non-prescription) which you are taking or have taken within the last 14 days, especially NMDA-receptor antagonists (for example [e.g.] amantadine), or any of the following medications: cimetidine, ranitidine, procainamide, quinidine, quinine, hydrochlorothiazide (or any combination with hydrochlorothiazide), anticholinergics (substances generally used to treat movement disorders such as Parkinson's disease or intestinal cramps), dopaminergic agonists (substances such as L-dopa, bromocriptine), ketamine, dextromethorphan (e.g. cough syrup containing dextromethorphan [DM]) and anticoagulant (blood thinner) medications taken by mouth.
• If you ever had an allergic reaction to any medication.
• There are conditions which can change the speed at which the body would normally eliminate the drug product over time and you should tell your doctor, as CO Memantine dosage may have to be revised if:
  • You have recently changed or intend to change your diet substantially (e.g. from normal diet to strict vegetarian diet)
  • You are suffering from renal tubulary acidosis (RTA), an excess of acidforming substances in the blood due to renal dysfunction [kidney problems]
  • You have a urinary tract infection
• If you are pregnant or thinking of becoming pregnant, or if you are breast-feeding.

Who should not use CO Memantine?

There are no adequate and well-controlled studies of memantine to establish the safe use in pregnant women. Therefore, CO Memantine should not be used during pregnancy, unless in the opinion of the physician, the expected benefits to the patient markedly outweigh the possible hazards to the foetus. It is not known whether memantine is excreted in human breast milk. Therefore, CO Memantine should not be used in nursing mother.

Do not take CO Memantine if you are allergic to it or to any of the components of its formulation (for list of components see the section on "What is CO Memantine").

Stop taking CO Memantine and contact your doctor immediately if you experience an allergic reaction or any severe side effect.

The safety and effectiveness of CO Memantine in any illness in children and young adults have not been established.

What are the side effects and what to do about them?

Like all medicines, CO Memantinemay cause unwanted effects (side-effects). These may include anxiety, confusion, constipation, dizziness, fatigue, hallucinations, headache, hypertension (high blood pressure), sleep disturbance, somnolence (or sleepiness) and vomiting.

If you develop any other unusual side effects while taking CO Memantine, please consult your doctor.

Your doctor will tell you whether your illness allows you to drive or operate machinery. Also, as this product may cause somnolence, or dizziness, do not drive or operate machinery under these conditions.

If you have experienced epileptic seizures, there is a slight possibility that CO Memantine may increase the chances of one occurring.

How is CO Memantine taken?

It is important that you take CO Memantine exactly as your doctor has instructed.

Usually your doctor will prescribe 20 milligrams (mg) per day, which you will take as two separate doses of 10 mg. In order to reduce the risk of side effects this dose will be achieved gradually by the following daily treatment scheme, starting at a dose of 5 mg per day:

	AM	PM
Week	1 1 x 5 milligram tablet	None
Week 2	1 x 5 milligram tablet	1 x 5 milligram tablet
Week 3	1 x 10 milligram tablet	1 x 5 milligram tablet
Week 4 and beyond	1 x 10 milligram tablet	1 x 10 milligram tablet

Swallow the tablets whole with some water. Do not chew the tablets. CO Memantine can be taken with or without food. Never change the dose of CO Memantine unless your doctor tells you to.

Continue to take CO Memantine as long as directed by your doctor and you do not experience any unacceptable side effects. Your doctor should assess your treatment on a regular basis.

Missed dose

If you miss a dose, do not worry. Do not take the missed tablet(s) - just take the next dose when it is due.

What else should patients know about taking CO Memantine?

Not applicable.

Where can I learn more about CO Memantine?

Should you need further information regarding CO Memantine, please talk to your physician or pharmacist or contact the customer service line at Cobalt Pharmaceuticals Inc. at Telephone Number 1-866-254-6111.

Who manufactures CO Memantine

CO Memantine tablets are made by:
Cobalt Pharmaceuticals Inc.
6500 Kitimat Road
Mississauga, Ontario
Canada
L5N 2B8