Sandoz.ca

IMPORTANT: PLEASE READ
PART III: CONSUMER INFORMATION
Sandoz® Metformin FC
This leaflet is part III of a three-part “Product Monograph” published when lactose monohydrate, methylhydroxypropylcel ulose, titanium oxide and Sandoz Metformin FC was approved for sale in Canada and is designed specifical y for consumers. This leaflet is a summary and will not tell you What dosage forms it comes in:
everything about Sandoz Metformin FC. Contact your doctor or pharmacist Sandoz Metformin FC (metformin hydrochloride) is formulated into 500 mg if you have any questions about the drug. film-coated tablets and 850 mg film-coated tablets for oral administration.
ABOUT THIS MEDICATION
WARNINGS AND PRECAUTIONS
What the medication is used for:
Sandoz Metformin FC (metformin hydrochloride) is used to treat type 2
Serious Warning and Precautions
diabetes which cannot be control ed by proper diet, exercise and weight Sandoz Metformin FC may rarely cause a serious, life-threatening con- dition cal ed lactic acidosis (see section Lactic Acidosis below).
What it does:
You should not drink a lot of alcohol if you take Sandoz Metformin FC Sandoz Metformin FC is used to treat type 2 diabetes. People with type 2 (see section Lactic Acidosis below).
diabetes are not able to make enough insulin or respond normal y to the insulin their bodies make. When this happens, sugar (glucose) builds up in Lactic Acidosis
the blood. This can lead to serious medical problems including kidney dam- Sandoz Metformin FC may rarely cause a serious, life-threatening condi- age, amputations, and blindness. Diabetes is also closely linked to heart disease. The main goal of treating diabetes is to lower your blood sugar to a normal level.
You should not take Sandoz Metformin FC due to greater risk for lactic acidosis if you: High blood sugar can be lowered by diet and exercise, by a number of medicines taken by mouth, and by insulin shots. While you take your dia- betes medicine, continue to exercise and fol ow the diet advised for your • are 80 years or older and you have NOT had your kidney function No matter what your recommended diabetes management plan is, studies • are seriously dehydrated (have lost a lot of water from your body); have shown that maintaining good blood sugar control can prevent or delay complications of diabetes, such as blindness.
• drink a lot of alcohol (regularly drink alcohol or sometimes drink a lot of Sandoz Metformin FC helps control your blood sugar. Although the mode of action is not fully understood, it is believed to help your body respond better to the insulin it makes natural y by: • have an x-ray procedure with injection of dyes (contrast agents); • decreasing the amount of sugar your liver makes; • prior to surgery or during recovery phase; • decreasing the amount of sugar your intestines absorb.
• develop a serious medical condition, such as heart attack, severe in- When it should not be used:
Due to greater risk for lactic acidosis, you should talk to your doctor if you • have unstable and/or insulin-dependent (Type I) diabetes mel itus; • have metabolic acidosis (including diabetic ketoacidosis, history of ke- • develop or experience a worsening of heart disease and particularly toacidosis or lactic acidosis – too much acid in the blood); Signs and symptoms of lactic acidosis include: discomfort, muscle pain, difficult or fast breathing, extreme tiredness, weakness, upset stomach, stomach pain, feeling cold, low blood pressure or slow heartbeat.
• are going to have x-ray procedure with injection of dyes; If any of the above side effects occur, consult your doctor immediately. • are stressed, have severe infections, are experiencing trauma, prior to Tell your doctor if you are pregnant or plan to become pregnant. Sandoz Metformin FC should not be used during pregnancy and insulin treatment is • suffer from severe dehydration (have lost a lot of water from your recommended during pregnancy. Talk with your doctor about your choices. You must not take Sandoz Metformin FC if you are nursing a child. • are hypersensitive or al ergic to metformin hydrochloride or any ingre- Tell your doctor of any other medical condition including: vitamin B-12 de- dient in the formulation or component of the container; ficiency, anemia, excessive alcohol use or al ergies. Do not start or stop any medicine without doctor or pharmacist approval.
• are pregnant or planning to become pregnant; INTERACTIONS WITH THIS MEDICATION
• have cardiovascular col apse (abrupt failure of blood circulation) or car- Some drugs may interact with Sandoz Metformin FC. Careful moni-
toring is advised. Tell your doctor if you are taking:
What the medicinal ingredient is:
The medicinal ingredient for Sandoz Metformin FC is metformin hydro-
• other diabetes drugs such as glyburide; What the nonmedicinal ingredients are:
Sandoz Metformin FC tablets contain the fol owing nonmedicinal ingredients: microcrystal ine cel ulose, sodium starch glycolate, polyvinylpyrrolidone, col oidal anhydrous silica, magnesium stearate. The film-coating contains: • cationic drugs (e.g., amiloride, digoxin, morphine, procainamide, quini- These side effects general y go away after you take the medicine for a while. dine, quinine, ranitidine, triamterene, trimethoprim, and vancomycin); Taking your medicine with meals can help reduce these side effects. Tell your • other drugs tend to produce hyperglycemia (high blood sugar) and may doctor if the side effects bother you a lot, last for more than a few weeks, lead to a loss of blood sugar control. Some example of drugs that can come back after they’ve gone away, or start later in therapy. You may need a lower dose or need to stop taking the medicine for a short period or for good.
- Thiazide and other diuretics (water pil s); Sandoz Metformin FC rarely causes hypoglycemia (low blood sugar) by it-self. However, hypoglycemia can happen if you do not eat enough, if you drink alcohol, or if you take other medicines to lower blood sugar.
Lactic Acidosis. In rare cases, Sandoz Metformin FC causes a serious
side effect called lactic acidosis. This is caused by a buildup of lac-
tic acid in your blood. This buildup can cause serious damage. Lactic
- Estrogens or estrogens plus progestogen; acidosis caused by Sandoz Metformin FC is rare and has occurred mostly in people whose kidneys were not working normal y. Although rare, if lactic acidosis does occur, it can be fatal in up to half the people who develop it. It is also important for your liver to be working normal y when you take Sandoz Metformin FC. Your liver helps remove lactic acid from your blood.
Make sure you tell your doctor before you use Sandoz Metformin FC if you You should also stop using Sandoz Metformin FC and call your doctor
right away if you have signs of lactic acidosis. Lactic acidosis is a
• ACE inhibitors drugs may lower blood glucose and the combination with medical emergency that must be treated in a hospital.
Sandoz Metformin FC should be carefully monitored.
If your medical condition suddenly changes, stop taking Sandoz Metformin Before using any drugs or herbal products, check with your doctor or your FC and call your doctor right away. This may be a sign of lactic acidosis or PROPER USE OF THIS MEDICATION
SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO
Usual dose:
ABOUT THEM
Your doctor will tell you how much medicine to take and when to take it. Fol ow the directions provided by your doctor for using this medicine. Tak- Stop taking
ing this medicine with food will decrease symptoms such as nausea and drug and cal
Symptom/effect
your doctor or
Overdose:
pharmacist
In general, an overdose may lead to increased symptoms as described un-der “SIDE EFFECTS AND WHAT TO DO ABOUT THEM” including stomach Feeling very weak, tired or
discomfort, nausea, vomiting, diarrhea, drowsiness, weakness, dizziness, uncomfortable
Unusual muscle pain
A serious, life-threatening condition cal ed lactic acidosis may also occur Trouble breathing
(see WARNINGS and PRECAUTIONS, Lactic Acidosis). Unusual or unexpected stomach
If you have taken too much Sandoz Metformin FC, see immediately your Uncommon
discomfort
doctor, contact the Poison Control Centre or go to the nearest hospital emergency department. Do this even if there are no signs of discomfort or Feeling cold
Feeling dizzy or lightheaded
In case of an overdose, contact a physician, hospital emergency depart- Suddenly developing a slow or
ment or regional Poison Control Centre immediately, even if there are no irregular heartbeat
Missed Dose:
Lactic acidosis and symptoms
If you forget to take Sandoz Metformin FC tablets, do not take a double which may be
dose to make up for forgotten individual doses. Take the next dose at the SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Common side effects of Sandoz Metformin FC include: This is not a complete list of side effects. For any unexpected effects
while taking Sandoz Metformin FC, contact your doctor or pharmacist.
HOW TO STORE IT
Store at room temperature (15°C to 30°C) in well closed containers. Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
Keep all medicines out of reach of children.
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
fol owing 3 ways:
• Report online at www.healthcanada.gc.ca/medeffect• Cal tol -free at 1-866-234-2345• Complete a Canada Vigilance Reporting Form and: - Fax tol -free to 1-866-678-6789, or- Mail to: Canada Vigilance Program Health CanadaPostal Locator 0701EOttawa, ON K1A 0K9 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 profes-
sionals, can be obtained by contacting the sponsor, Sandoz Canada Inc.,
at 1-800-361-3062
or by written request at:
145, Jules-Léger
Boucherville, (QC), Canada
J4B 7K8
or by e-mail at: medinfo@sandoz.com
This leaflet was prepared by Sandoz Canada Inc.
® Registered trademark used under license by Sandoz Canada Inc.
Sandoz Canada Inc.
Qc, Canada J4B 7K8
medinfo@sandoz.com
? 1-800-361-3062
Last revised: May 4, 2011
46104062 vi

Source: http://www.sandoz.ca/cs/groups/public/documents/document/n_prod_998762.pdf