Memantine (Meliapharm): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

MEMANTINE has been prescribed to you, by a doctor to relieve symptoms of Alzheimer’s disease.

What it does:

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. Memantine Hydrochloride belongs to a group of medicines called NMDA-receptor antagonists. The action of memantine Hydrochloride on NMDA-receptors may help normalize the transmission of nerve signals, which may help slow the decline in some of the symptoms of Alzheimer disease.

When it should not be used:

• You should not be taking MEMANTINE if you are

  pregnant, unless in the opinion of the doctor, the expected benefit to the patient markedly outweighs the possible hazards to the foetus.

• You should not be taking MEMANTINE if you are breast-

  feeding.

• Do not take MEMANTINE if you are allergic to it, or to any of

  the other ingredients listed in this leaflet (see ‘What the nonmedicinal ingredients are’).

• Stop taking MEMANTINE and contact your doctor

  immediately if you experience an allergic reaction or any severe side effect.

What the medicinal ingredient is:

Memantine hydrochloride

What the non medicinal ingredients are:

Colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide.

What dosage forms it comes in:

Tablets: 10 mg

WARNINGS AND PRECAUTIONS

BEFORE you use MEMANTINE talk to your doctor or pharmacist if:

• You have/had a medical condition, including heart problems, uncontrolled hypertension (high blood pressure), history of seizures or kidney disease
• You are taking any medications (prescription or nonprescription) or have taken any within the last 14 days.
• You ever had an allergic reaction to any medication
• You are pregnant or thinking of becoming pregnant, or if you are breast-feeding.

• There are conditions which can change the speed at which the body would normally eliminate the drug over time and you should tell your doctor, as MEMANTINE dosage may have to be adjusted 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 acid-forming substances in the blood due to renal dysfunction [kidney problems])

  • You have a urinary tract infection

INTERACTIONS WITH THIS MEDICATION

Drugs that may interact with MEMANTINE include:

• NMDA-receptor antagonists (e.g. amantadine)
• Cimetidine
• Ranitidine
• Procainamide
• Quinidine
• Quinine
• Hydrochlorothiazide (or any combination with hydrochlorothiazide)
• Anticholinergics (generally used to treat movement disorders or intestinal cramps)
• L-dopa and dopaminergic agonists (drugs such as bromocriptine, ropinirole, pramipexole)
• Ketamine
• Dextromethorphan (found in cough syrup labelled DM)
• Anticoagulant (blood thinner) medications taken by mouth

PROPER USE OF THIS MEDICATION

Usual dose:

• It is important that you take MEMANTINE exactly as your

  doctor has instructed.

• Usually your doctor will prescribe 20 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:

• Never change the dose of MEMANTINE unless your

  doctor tells you to.

• Swallow the tablets whole with some water. Do not chew

  tablets. MEMANTINE can be taken with or without food.

• Continue to take 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.

Overdose:

If you have accidentally taken too much MEMANTINE contact your regional Poison Control Centre, hospital emergency department or your doctor immediately, even if you do not feel sick. You may require medical attention. If you go to the doctor or the hospital, take the MEMANTINE container with you.

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.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like other medicines, MEMANTINE can cause side effects, although not everybody gets them. In general, these are mild to moderate. If any of the side effects become severe or if they are troublesome or persistent, talk to your doctor.

Common side effects (affects 1 to 10 users in 100) may include:

• headache
• sleepiness

• constipation

  • tiredness
  • confusion
  • hallucinations (strange visions or sounds)
  • vomiting
  • loss of appetite
  • dizziness
  • sleep disturbance
  • anxiety
  • high blood pressure
  • change in frequency of urination

Uncommon side effects (affects 1 to 10 users in 1000) may include:

• fungal infections
• changes in vision

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

Alzheimer's disease has been associated with depression, thoughts of suicide and suicide. These events have been reported in patients treated with MEMANTINE.

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

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

If you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

HOW TO STORE IT

• As with all medicines, keep MEMANTINE out of the

  reach of children.

• Store your tablets at room temperature between 15°C and

  30°C. Protect from moisture.

• If your doctor tells you to stop taking your medicine you

  should return any leftover tablets to the pharmacist, unless the doctor tells you to keep them at home.

REMEMBER: This medicine is for YOU or for someone in your care. Only a doctor can prescribe it, so never offer it to any other person, even if their symptoms seem to be the same as yours or as for the person in your care.

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 0701E

  Ottawa, Ontario

  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.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals, can be obtained by contacting MELIAPHARM INC. at 1-888-550-6060.

MELIAPHARM INC.

Montréal Québec

H4P 2T4

Last revised: December 14, 2011