Consumer Information for: SANDOZ MEMANTINE FCT

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

Sandoz Memantine FCT 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. Sandoz Memantine FCT belongs to a group of medicines called NMDA-receptor antagonists. The action of Sandoz Memantine FCT 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 Sandoz Memantine FCT 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 Sandoz Memantine FCT if you are breast-feeding.
  • Do not take Sandoz Memantine FCT if you are allergic to it, or to any of the other ingredients listed in this leaflet (see ‘What the non-medicinal ingredients are’).
  • Stop taking Sandoz Memantine FCT 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 anhydrous silica, glycerol triacetate, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol and titanium dioxide.

What dosage form it comes in

White 10 mg tablets in in bottles of 100 tablets.

Warnings and precautions

BEFORE you use Sandoz Memantine FCT 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 non-prescription) 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 Sandoz Memantine FCT 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 Sandoz Memantine FCT 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 Sandoz Memantine FCT 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:
10 mg Tablets
AM PM
Week 1 ½ tablet None
Week 2 ½ tablet ½ tablet
Week 3 1 tablet ½ tablet
Week 4 and beyond 1 tablet 1 tablet
  • Never change the dose of Sandoz Memantine FCT unless your doctor tells you to.
  • Swallow the tablets whole with some water. Do not chew tablets. Sandoz Memantine FCT can be taken with or without food.
  • Continue to take Sandoz Memantine FCT 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 Sandoz Memantine FCT 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 Sandoz Memantine FCT 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 all medicines, Sandoz Memantine FCT 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
  • skin allergies

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 Sandoz Memantine FCT.

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

Serious side effects, how often they happen and what to do about them
Symptom / effect Talk with your doctor, nurse, or pharmacist only if severe Talk with your doctor, nurse, or pharmacist in all cases Stop taking drug and seek immediate emergency treatment
Uncommon
Example: 1 ✔    
Abnormal gait [Abnormal way of walking]   ✔  
Heart failure [persistent chest pain, rapid heart rate, severe shortness of breath, swelling of legs or ankles, increased tiredness, lack of appetite, confusion]     ✔
Venous blood clotting [pain, swelling, changes in skin color, increased warmth in one leg]     ✔
Very rare
Seizures [loss of consciousness with uncontrollable shaking     ✔
Hepatitis/hepatic failure [yellow skin and eyes, nausea, loss of appetite, dark-coloured urine]     ✔
Serious skin reactions [rash, red skin, blistering of the lips, eyes or mouth, skin peeling]     ✔
Inflammation of the pancreas [severe upper stomach pain, often with nausea and vomiting]     ✔
Psychotic reaction     ✔
Serious skin reactions [rash, red skin, blistering of the lips, eyes or mouth, skin peeling]
For example:
Stevens-Johnson Syndrome: Severe rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals
Acute Generalized Exanthematous Pustulosis: Red rash covered with small pus-filled bumps that can spread over the body, sometimes with a fever
Erythema Multiforme: Rash that may blister, with spots that look like small targets		     ✔

This is not a complete list of side effects. For any unexpected effects while taking Sandoz Memantine FCT, 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
  • As with all medicines, keep Sandoz Memantine FCT out of the reach of children.
  • Store your tablets at room temperature (15°C-30°C) and in a dry place.
  • 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 side effects

NOTE: THIS IS NOT AN EMERGENCY NUMBER 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:

  • 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 ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM 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 the sponsor, Sandoz Canada Inc., at:

1-800-361-3062

or by written request at:
145 Jules-Léger
Boucherville QC
J4B 7K8

Or by e-mail at:
medinfo@sandoz.com

This leaflet was prepared by Sandoz Canada Inc.

Last revised: September 16, 2015

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