Patient Medication Information: uses, side effects, how to take - Apo-Memantine
ABOUT THIS MEDICATION
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 non-medicinal 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 nonmedicinal ingredients are: Lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, hydroxypropylcellulose,
hydroxypropylmethylcellulose, polyethylene glycol and titanium dioxide.
What dosage forms 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 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 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:
| 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 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.
Overdose:
If you think you have taken too much APO-MEMANTINE, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.
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.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY | ||||||
| HAPPEN AND WHAT TO DO ABOUT THEM | ||||||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and seek immediate emergency treatment | ||||
Only if severe | In all cases | |||||
| 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 | |||||
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY | ||||||
| HAPPEN AND WHAT TO DO ABOUT THEM | ||||||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and seek immediate emergency treatment | ||||
| Only if severe | In all cases | |||||
| 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] | ||||||
| Very rare (continued) | For example: Stevens- Johnson Syndrome: Severe rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals | |||||
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY | ||||||
| HAPPEN AND WHAT TO DO ABOUT THEM | ||||||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and seek immediate emergency treatment | ||||
Only if severe | In all cases | |||||
Acute Generalized Exanthemato us 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 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 IT
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 side effects associated with the use of health products to Health Canada by:
Visiting the Web page on Adverse
Reaction Reporting (http://www.hc-sc.gc.ca/dhpmps/medeff/report-declaration/index-eng.php) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. 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/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website
http://www.apotex.ca/products, or by calling 1-800-667-4708.