Details for: APO-MEMANTINE
Company: APOTEX INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02366487 | APO-MEMANTINE | MEMANTINE HYDROCHLORIDE | 10 MG | TABLET | ORAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
APO-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. APO-MEMANTINE belongs to a group of medicines called NMDA-receptor antagonists. The action of APO-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 disease.
When it should not be used
You should not be taking APO-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 APO-MEMANTINE if you are breast-feeding.
- Do not take APO-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 APO-MEMANTINE if you experience an allergic reaction or any severe side effect.
What the medicinal ingredient is
Memantine hydrochloride
What the non-medicinal ingredients are
Lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, hydroxypropylcellulose, hydroxypropylmethylcellulose, polyethylene glycol and titanium dioxide.
What dosage form it comes in
White 10 mg tablets in blister packs and bottles.
Warnings and precautions
BEFORE you use APO-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 APO-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 acidforming 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 APO-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 labeled DM)
- Anticoagulant (blood thinner) medications taken by mouth
Proper use of this medication
Usual Dose
- It is important that you take APO-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 APO-MEMANTINE unless your doctor tells you to.
- Swallow the tablets whole with some water. Do not chew tablets. APO-MEMANTINE can be taken with or without food.
- Continue to take APO-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.
| 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 |
Overdose
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, APO-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
- 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
APO-MEMANTINE.
If you have previously experienced epileptic seizures,
there is a possibility that APO-MEMANTINE may
increase the chances of one occurring.
| 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 | |||
| Fungal infection | ✔ | ||
| 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/hepa tic failure [yellow skin and eyes, nausea, loss of appetite, dark coloured urine] | ✔ | ||
| Inflammation of the pancreas [severe upper stomach pain, often with nausea and vomiting | ✔ | ||
| psychotic reactions | ✔ | ||
| Serious skin reactions [rash, red skin, blistering of the lips, eyes or mouth, skin peeling] | ✔ | ||
| For example: StevensJohnson Syndrome: Severe rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals Acute Generalized Exanthemato us Pustulosis: Red rash covered with small pusfilled 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 APO-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
- As with all medicines, keep APO-MEMANTINE out of the reach of children.
- Store your tablets at room temperature between 15°C-30°C.
- 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
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three 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 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
If you want more information about APO-MEMANTINE:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this patient medication information by visiting the Health Canada website (https://www.canada.ca/en/healthcanada/services/drugs-health-products/drugproducts/drug-product-database.html); the manufacturer’s website http://www.apotex.ca/products, or by calling 1-800-667-4708.
This leaflet was prepared by Apotex Inc., Toronto,
Ontario, M9L 1T9.
Last revised: October 23, 2018