Patient Medication Information: uses, side effects, how to take - Sandoz Galantamine ER
ABOUT THIS MEDICATION
What the medication is used for:
Sandoz 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. Alzheimer’s disease causes increasing memory loss, confusion and behavioural changes, which make it increasingly difficult to carry out normal daily activities.
This medication should only be taken after proper diagnosis of your condition has been made by your doctor.
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. Sandoz Galantamine ER increases the amount of this substance in the brain, improving memory.
When it should not be used:
Do not use Sandoz Galantamine ER if you/the person you are caring for:
- are/is allergic to galantamine hydrobromide or to any non-medicinal ingredient in the formulation
- have/has ever had an allergic reaction to a similar type of medicine
are/is a child under 18 years of age
What the medicinal ingredient is:
galantamine hydrobromide
What the nonmedicinal ingredients are:
Sandoz Galantamine ER extended release capsules: black ink (D&C yellow #10, FD&C blue #1, FD&C blue #2, FD&C red #40, iron oxide black, propylene glycol, shellac), ethylcellulose, gelatin, hydromellose, medium chain trigycerides, oleic acid, sugar spheres (sucrose and starch), talc, titanium dioxide. The 8 mg capsule also contains FD&C yellow #6.
What dosage forms it comes in:
Extended release capsules: 8 mg, 16 mg, 24 mg
WARNINGS AND PRECAUTIONS
BEFORE you use Sandoz Galantamine ER, talk to your doctor or pharmacist if you/the person you are caring for have, or had, any of the following:
- heart condition
- an ulcer or history of ulcers in the stomach or gut
- a blockage of the stomach or in the gut
- seizures [or fits] (such as epilepsy)
- a respiratory disease that affects breathing (such as asthma or obstructive pulmonary disease)
- problems 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 planning to become pregnant
- breast-feeding or planning to breast-feed
- 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
Talk to your doctor right away if you have any skin rashes or inflammation, blisters or swelling of the skin.
Also tell your doctor if you recently had an operation on the stomach, gut or bladder.
Sandoz Galantamine ER can cause weight loss. Your doctor will check your weight regularly while you are taking Sandoz Galantamine ER.
Driving and using machines: Your doctor will tell you whether your illness allows you to drive vehicles and use machines safely. Sandoz Galantamine ER may make you feel dizzy or sleepy, especially during the first few weeks of treatment. If Sandoz Galantamine ER affects you, do not drive or use any tools or machinery.
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.
Sandoz Galantamine ER should not be used with medicines that work in a similar way.
The following may interact with Sandoz Galantamine ER:
- anticholinergics (such as drugs for diarrhea, Parkinson’s disease, or airway spasms)
- medicines taken for heart conditions or high blood pressure (such as digoxin or beta-blockers)
- Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) or high doses of acetylsalicylic acid [ASA (Aspirin®)], which can increase the risk of ulcers
- antidepressants (such as amitriptyline, fluoxetine, fluvoxamine or paroxetine)
- ketoconazole (an antifungal)
- erythromycin (an antibiotic)
- quinidine (for irregular heart beat)
Sandoz Galantamine ER may affect some anesthetics. If you are going to have an operation under a general anesthetic, tell the doctor that you are taking Sandoz Galantamine ER, well in advance.
PROPER USE OF THIS MEDICATION
You will start treatment with Sandoz Galantamine ER at a low dose and then slowly increase this to find the most suitable dose for you. Your doctor will explain what dose to start with and when the dose should be increased. If you are not sure what to do, or find the effect of Sandoz Galantamine ER is too strong or too weak, talk to your doctor or pharmacist.
Usual dose:
- The usual starting dose is 8 mg, taken once a day.
- Your doctor may gradually increase your dose, every 4 weeks or more, until you reach a dose that is suitable for you.
- The maximum dose is 24 mg, taken once a day.
Take your dose of Sandoz Galantamine ER once a day in the morning, with water or other liquids. Try to take Sandoz Galantamine ER with food.
DO NOT take more than one capsule in a day unless instructed to by your doctor
If you have liver or kidney problems, your doctor may give you a reduced dose of Sandoz Galantamine ER, or may decide this medicine is not suitable for you.
While you are taking Sandoz Galantamine ER
Drink plenty of liquids, to keep yourself hydrated.
Your doctor will need to see you regularly, to check that this medicine is working and to discuss how you are feeling.
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:
If you think you/the person you are caring for have/has taken too much Sandoz Galantamine ER, contact your doctor, nurse, pharmacist, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
The signs of overdose may include:
- severe nausea and vomiting, abdominal cramps, sweating
- weak muscles, difficulty breathing
- seizures (fits)
- low blood pressure, abnormal heart rhythm that may cause loss of consciousness
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
- weight loss
- flushing
- dehydration (sometimes severe)
- weakness
- fever
- malaise
- leg cramps
- muscle spasms
- tingling in the hands or feet
- ringing in the ears
- headache
- dizziness
- blurred vision
- tiredness, sleepiness or sleeplessness
- depression
- runny nose
- sweating
- urinary tract infection, incontinence
- falling, sometimes resulting in injury
- trembling
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
|---|---|---|---|---|
| Symptom / effect | Talk with your doctor, nurse or pharmacist | Stop taking drug and seek immediate medical help | ||
| Only if severe | In all cases | |||
| C o m m o n | Behavioral Changes: agitation and aggression | ✓ | ||
| Fainting | ✓ | |||
| High Blood Pressure: headache, dizziness, vision problems, shortness of breath | ✓ | |||
| U n c o m m o n | Problems with Heart Rhythm: irregular beating of the heart | ✓ | ||
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM |
|---|
| Symptom / effect | Talk with your doctor, nurse or pharmacist | Stop taking drug and seek immediate medical help |
|---|
| Only if severe | In all cases | ||
|---|---|---|---|
| Heart Attack: pain or tightness in the chest | ✓ | ||
| Seizures: fits or convulsions | ✓ | ||
| Stroke: sudden weakness or numbness of the face, arms or legs, especially on one side, slurred speech or vision problems | ✓ | ||
| Low Blood Pressure: dizziness, fainting, lightheadedness may occur when you go from lying or sitting to standing up | ✓ | ||
| Severe confusion | ✓ | ||
| R a r e | |||
| Allergic Reaction: rash, hives, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing | ✓ | ||
| Thoughts of suicide or self-harm | ✓ | ||
| V e r y R a r e | |||
| Stomach ulcer and gastrointestinal hemorrhage: blood in the stools, black, tarry stools, or vomiting blood | ✓ | ||
| U n k n o w n | |||
| Liver Disorder: yellowing of the skin or eyes, dark urine, abdominal pain, nausea, vomiting, loss of appetite | ✓ | ||
| Decreased Levels of Potassium in the Blood: irregular heartbeats, muscle weakness and generally feeling unwell | ✓ | ||
| Hallucinations: seeing, feeling or hearing things that are not there | ✓ | ||
| 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, nurse or pharmacist | Stop taking drug and seek immediate medical help |
|---|
| Only if severe | In all cases | ||
|---|---|---|---|
| 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 | ✓ | ||
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 Sandoz Galantamine ER, contact your doctor or pharmacist.
HOW TO STORE IT
Store Sandoz Galantamine ER in a cool dry place between 15 to 30°C.
Keep out of the reach and sight of children.
Medicines can be kept for a limited period only. Therefore, do not use Sandoz 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: --------------------------------------------------------------------------
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 found 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