Details for: MYLAN-GALANTAMINE ER
Company: MYLAN PHARMACEUTICALS ULC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02339439 | MYLAN-GALANTAMINE ER | GALANTAMINE (GALANTAMINE HYDROBROMIDE) | 8 MG | CAPSULE (EXTENDED RELEASE) | ORAL |
| 02339447 | MYLAN-GALANTAMINE ER | GALANTAMINE (GALANTAMINE HYDROBROMIDE) | 16 MG | CAPSULE (EXTENDED RELEASE) | ORAL |
| 02339455 | MYLAN-GALANTAMINE ER | GALANTAMINE (GALANTAMINE HYDROBROMIDE) | 24 MG | CAPSULE (EXTENDED RELEASE) | 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
MYLAN-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. MYLAN-GALANTAMINE ER increases the amount of this substance in the brain, improving memory.
When it should not be used
Do not use MYLAN-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 non-medicinal ingredients are
MYLAN-GALANTAMINE ER extended release capsules:
colloidal silicon dioxide, gelatin, hydrogenated vegetable oil, magnesium stearate, polyvinyl acetate, povidone, sodium lauryl sulphate and titanium dioxide. The 16 mg capsule also contains FD&C Red 40. The 24 mg capsule also contains FD&C Blue 1, FD&C Yellow 6 and red iron oxide.
Printing Ink: Ink: Black Iron Oxide, Butyl Alcohol, Dehydrated Alcohol, Isopropyl Alcohol, Potassium Hydroxide, Propylene Glycol and Shellac.
What dosage form it comes in
Extended release capsules: 8 mg, 16 mg, 24 mg
Warnings and precautions
BEFORE you use MYLAN-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.
MYLAN-GALANTAMINE ER can cause weight loss. Your doctor will check your weight regularly while you are taking
MYLAN-GALANTAMINE ER.
Driving and using machines: Your doctor will tell you whether your illness allows you to drive vehicles and use machines safely. MYLAN-GALANTAMINE ER may make you feel dizzy or sleepy, especially during the first few weeks of treatment. If MYLAN-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.
MYLAN-GALANTAMINE ER should not be used with medicines that work in a similar way.
The following may interact with MYLAN-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)
MYLAN-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 MYLAN-GALANTAMINE ER, well in advance.
Proper use of this medication
You will start treatment with MYLAN-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 MYLAN-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 MYLAN-GALANTAMINE ER once a day in the morning, with water or other liquids. Try to take MYLAN-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 MYLAN-GALANTAMINE ER, or may decide this medicine is not suitable for you.
While you are taking MYLAN-GALANTAMINE ER
Drink plenty of liquids, to keep yourself hydrated.
Capsules must be swallowed whole. DO NOT open, divide, crush or chew the capsules.
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
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
| Symptom / effect | Talk to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| Common | |||
| Behavioral Changes: agitation and aggression | ✔ | ||
| Fainting | ✔ | ||
| High Blood Pressure: headache, dizziness, vision problems, shortness of breath | ✔ | ||
| Uncommon | |||
| Problems with Heart Rhythm: irregular beating of the heart | ✔ | ||
| 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 | ✔ | ||
| Rare | |||
| Allergic Reaction: rash, hives, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing | ✔ | ||
| Thoughts of suicide or self-harm | ✔ | ||
| Very Rare | |||
| Stomach ulcer and gastrointestinal hemorrhage: blood in the stools, black, tarry stools, or vomiting blood | ✔ | ||
| Unknown | |||
| 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 | ✔ | ||
| Acute Generalized Exanthematous 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 | ✔ | ||
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 MYLAN-GALANTAMINE ER, contact your doctor or pharmacist.
How to store
Store MYLAN-GALANTAMINE ER in a cool dry place (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 MYLAN-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 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 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
This document can be found at: www.mylan.ca.
The full Product Monograph prepared for health professionals can
be obtained by contacting the sponsor, Mylan Pharmaceuticals
ULC at: 1-800-575-1379
This leaflet was prepared by Mylan Pharmaceuticals ULC
Etobicoke, Ontario M8Z 2S6
Revised on: April 13, 2017
Mylan Pharmaceuticals ULC
Etobicoke, ON M8Z 2S6
1-800-575-1379
www.mylan.ca