Reminyl -(4mg): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

REMINYL/REMINYL 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. REMINYL/REMINYL 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:

REMINYL tablets: Lactose monohydrate, microcrystalline cellulose, colloidal anhydrous silica, crospovidone, magnesium stearate, hypromellose, propylene glycol, talc and titanium dioxide. The 4 mg tablet also contains yellow ferric oxide. The 8 mg tablet also contains red ferric oxide. The 12 mg tablet also contains red ferric oxide and FD & C yellow #6 (orange yellow S aluminum lake).

REMINYL ER extended release capsules: Gelatin, diethyl phthalate, ethylcellulose, hypromellose, polyethylene glycol, titanium dioxide and sugar spheres (sucrose and starch). The 16 mg capsule also contains red ferric oxide. The 24 mg capsule also contains red ferric oxide and yellow ferric oxide.

What dosage forms it comes in:

Tablets: 4 mg, 8 mg, 12 mg

Extended release capsules: 8 mg, 16 mg, 24 mg

WARNINGS AND PRECAUTIONS

BEFORE you use REMINYL/REMINYL 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.

REMINYL/REMINYL ER, as well as Alzheimer’s disease itself, can affect the ability to drive or operate machinery. Therefore, this matter should be discussed with the 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:

REMINYL/REMINYL ER is started at a low dose and then slowly increased to the most suitable dose, depending on how you respond to the treatment. REMINYL tablets should be taken twice a day, preferably with the morning and evening meals. REMINYL 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:

If you have taken more medication than you have been told, contact either your doctor, hospital emergency department, or nearest poison control centre immediately, even if you do not feel sick.

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
  • urinary tract infection
  • 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

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 REMINYL/REMINYL ER, contact your doctor or pharmacist.

HOW TO STORE IT

As with all medicines, REMINYL/REMINYL 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 REMINYL/REMINYL 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

To monitor drug safety, Health Canada through the Canada Vigilance Program collects information on serious and unexpected side effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Canada Vigilance:

By toll-free telephone: 866-234-2345

By toll-free fax: 866-678-6789

Online: www.healthcanada.gc.ca/medeffect By email: CanadaVigilance@hc-sc.gc.ca

By regular mail:

Canada Vigilance National Office

Marketed Health Products Safety and Effectiveness Information Bureau

Marketed Health Products Directorate

Health Products and Food Branch

Health Canada

Tunney’s Pasture, AL 0701C

Ottawa ON K1A 0K9

NOTE: Should you require information related to the management of the side effect, please contact your health care provider before notifying Canada Vigilance. 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 at:

http://www.janssen-ortho.com

or by contacting the sponsor, Janssen-Ortho Inc., at: 1-800-567-3331

Janssen-Ortho Inc.

Toronto, Ontario M3C 1L9

Last revised: July 24, 2008

*All trademark rights used under license