Patient Medication Information: uses, side effects, how to take - Teva-Galantamine ER
ABOUT THIS MEDICATION
What the medication is used for:
TEVA-GALANTAMINE ER is used to treat the symptoms of mild to moderate Alzheimer’s disease (a type of dementia), a disease that alters brain function. The symptoms include progressive memory loss, increasing confusion and behavioural changes, as a result of which it becomes more and more difficult to carry out the activities of daily living.
What it does:
This medication is one of a group of drugs called “cholinesterase inhibitors” which are used to treat the symptoms of mild to moderate Alzheimer’s disease.
Dementia due to Alzheimer’s disease is believed to be related to lack of a substance in the brain called acetylcholine, a substance which is thought to be necessary for good brain function. TEVA-GALANTAMINE ER increases the amount of this substance in the brain, improving memory.
When it should not be used:
- If you/the person you are caring for has an allergic reaction to this medicine or to any of the inactive ingredients in this product
- If you/the person you are caring for has ever had an allergic reaction to a similar type of medicine
If you/the person you are caring for is a child under 18 years of age
- Unless you/the person you are caring for has been diagnosed with Alzheimer’s disease
What the medicinal ingredient is:
galantamine hydrobromide
What the nonmedicinal ingredients are:
TEVA-GALANTAMINE ER extended release capsules: Gelatin, ethylcellulose, hypromellose, polyethylene glycol, titanium dioxide, triethyl citrate, sugar spheres (sucrose and starch), printing ink Opacode Black 1028 (iron oxide black, propylene glycol and shellac glaze), printing ink TekPrintTMSW-9008 Black Ink 1014 (iron oxide black, propylene glycol and shellac glaze). The 16 mg capsule also contains erythrosine and quinoline yellow (E104). The 24 mg capsule also contains iron oxide red and iron oxide yellow.
What dosage forms it comes in:
Extended release capsules: 8 mg, 16 mg, 24 mg
WARNINGS AND PRECAUTIONS
BEFORE you use TEVA-GALANTAMINE ER, talk to your doctor or pharmacist if you have any of the following problems or conditions:
- heart disorders
- stomach ulcer or history of ulcer
- acute abdominal pain
- some disorders of the nervous system (like epilepsy)
- respiratory diseases that interfere with breathing (like asthma)
- a recent operation on the gut or bladder or difficulties in passing urine
- an increased risk of developing ulcers (for example, you are taking non-steroidal anti-inflammatory drugs (NSAIDs) or high doses of acetylsalicylic acid [ASA (Aspirin®)]
- liver or kidney problems
pregnant or possibly pregnant
- breast-feeding
- having an operation with general anesthesia (medication that puts you to sleep)
- taking any other medications, including prescription, over-the-counter, herbal medicines or natural health products
If any of these happen after you start taking your medication, make sure you tell your doctor.
TEVA-GALANTAMINE ER, as well as Alzheimer’s disease itself, can affect the ability to drive or operate machinery. Therefore, this matter should be discussed with your doctor.
INTERACTIONS WITH THIS MEDICATION
Always tell your doctor, nurse or pharmacist if you are taking any other medicines, either prescription, over-the counter, herbal medicines, or natural health products, because taking some medicines together can be harmful.
Tell your doctor if you are taking:
- drugs for diarrhea, Parkinson’s disease, or airway spasms
- drugs for certain heart problems, such as digoxin
- certain drugs taken for depression such as paroxetine
- ketoconazole, a drug used to treat fungal infections
PROPER USE OF THIS MEDICATION
Usual dose:
TEVA-GALANTAMINE ER is started at a low dose and then slowly increased to the most suitable dose, depending on how you respond to the treatment. TEVA-GALANTAMINE ER extended release capsules should be taken once a day in the morning, preferably with food. Be sure to drink plenty of liquids during your treatment to keep yourself hydrated.
REMEMBER: This medicine is for you. Only a doctor can prescribe it for you. Never give it to someone else. It may harm them even if their symptoms appear to be similar to yours.
Overdose:
| In the case of overdose, contact a health care practitioner, hospital emergency department of regional Poison Control Centre immediately, even if there are no symptoms. |
Missed dose:
If you forget to take a dose, do not worry, wait and take the next dose at the usual time. Do NOT take two doses at once.
If your treatment is interrupted for several days or longer, do NOT re-initiate treatment without contacting your doctor.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
If side effects occur, they are mainly experienced early in the treatment or when the dose is increased. Most tend to disappear gradually as the body adapts to the treatment; for example, nausea (feeling sick) and vomiting (being sick) generally pass after a few days. However, you should tell your doctor about any side effects, especially if they persist.
Other possible side effects include:
- abdominal pain, diarrhea, indigestion, decreased appetite
- difficulty swallowing
- bleeding in the digestive system
- weight loss
- low blood potassium
- low blood pressure
- dehydration (sometimes severe)
- behavioural disturbances like agitation, aggression and hallucinations
- weakness
- fever
- malaise
- leg cramps
- tingling in the hands or feet
- ringing in the ears
- headache
- dizziness
- tiredness, sleepiness or sleeplessness
- confusion
- runny nose
- sweating
- urinary tract infection, incontinence
falling, sometimes resulting in injury
- fainting and fluttering of the heart
- trembling
- heart rhythm disorder
- slow heartbeat
- heart attack
- stroke
- other side effects described below
SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
| Symptom / effect | Seek medical attention immediately | Stop taking drug and call your doctor or pharmacist | ||
| Only if severe | In all cases | |||
| Uncommon | Irregular beating of the heart | √ | ||
Pain or tightness in the chest | √ | |||
| Seizures | √ | |||
Sudden weakness or numbness of the face, arms or legs, especially on one side, slurred speech or vision problems | √ | |||
| Rare | Symptoms of allergic reaction such as skin rash, or swelling of the face, lips or tongue | √ | ||
Thoughts of suicide or self-harm | √ | |||
| Very Rare | Blood in the stools, black, tarry stools, or vomiting blood | √ | ||
If you are caring for a patient with Alzheimer's disease who has new symptoms you should discuss them with his or her doctor.
If you feel unwell in the ways described in this section or any other way, or have any symptoms that you do not understand or find distressing, you should contact your doctor immediately. If you experience side effects that are severe, stop taking the drug and contact your doctor immediately.
This is not a complete list of side effects. For any unexpected effects while taking TEVA-GALANTAMINE ER, contact your doctor or pharmacist.
HOW TO STORE IT
As with all medicines, TEVA-GALANTAMINE ER should be kept in a safe place where children cannot reach it. Also keep this medicine in a cool dry place (15 to 30°C).
Medicines can be kept for a limited period only. Therefore, do not use TEVA-GALANTAMINE ER after the date
(month and year) printed after “EXP”, even if it has been stored properly. Always return old medicines to your pharmacist.
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:
www.healthcanada.gc.ca/medeffect
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 the side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice. |
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MORE INFORMATION
Please consult your doctor or pharmacist with any questions or concerns you may have regarding your individual condition.
This document plus the full product monograph, prepared for health professionals can be found by contacting Teva Canada Limited.
at: 1-800-268-4127 ext. 5005 (English)
and at 1-877-777-9117 (French)
or druginfo@tevacanada.com
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada, M1B 2K9
www.tevacanada.com
Date: September 3, 2014