Sitagliptin-Metformin (Sivem Pharmaceuticals, 50 mg / 850 mg): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

SITAGLIPTIN-METFORMIN is used in addition to diet and exercise to improve blood sugar levels in patients with type 2 diabetes mellitus

• Alone, in patients who are not controlled on metformin alone

  or currently on sitagliptin and metformin; OR

• In combination with a sulfonylurea, in patients who are not

  controlled on metformin and a sulfonylurea.

• SITAGLIPTIN-METFORMIN can be taken with premixed

  or long/intermediate acting insulin.

• In combination with pioglitazone, in patients who are not

  controlled on metformin and pioglitazone.

What it does:

SITAGLIPTIN-METFORMIN is a tablet that contains sitagliptin and metformin. These two medicines work together to help you achieve better blood sugar control.

Sitagliptin is a member of a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors). Sitagliptin helps to improve the levels of insulin when blood sugar level is high, especially after a meal. Sitagliptin also helps to decrease the amount of sugar made by the body. Sitagliptin is unlikely to cause low blood sugar (hypoglycemia).

Metformin is a member of the biguanide class of medicines, it helps to lower the amount of sugar made by the liver. Together, these medicines help you to achieve better blood sugar control.

What is type 2 diabetes?

Type 2 diabetes is a condition in which your body does not make enough insulin, and/or does not use the insulin that your body

produces as well as it should. When this happens, sugar (glucose) builds up in the blood. This can lead to serious problems.

When it should not be used:

Do not take SITAGLIPTIN-METFORMIN if you:

• Have unstable and/or insulin-dependent (type 1) diabetes mellitus.
• Have metabolic acidosis (including diabetic ketoacidosis, history or ketoacidosis or lactic acidosis – too much acid in the blood).
• Have severe kidney disease.
• Have liver problems.
• Drink alcohol very often or drink a lot of alcohol in the short term (“binge” drinking).
• Have severe heart problems or heart failure.

• Have a lack of oxygen in the blood. This is called hypoxemia.

  This can happen when you have conditions that affect your heart or breathing.

• Are stressed, have severe infections, are experiencing trauma, are about to have surgery, or are recovering from surgery.
• Have severe dehydration (have lost a lot of water from your body) or shock.
• Are allergic to sitagliptin, metformin, or any of the ingredients in SITAGLIPTIN-METFORMIN. See “What the non-medicinal ingredients are”.

• Are breastfeeding.

• Are pregnant or planning to become pregnant.
• Are going to get or receive an injection of dye or contrast agent for an x-ray procedure. Talk to your physician or pharmacist about when to stop SITAGLIPTIN-METFORMIN and when to start again.

What the medicinal ingredients are:

Sitagliptin phosphate monohydrate and metformin hydrochloride

What the non-medicinal ingredients are:

Each film-coated tablet of SITAGLIPTIN-METFORMIN contains the following inactive ingredients: Povidone, sodium lauryl sulfate, microcrystalline cellulose, croscarmellose sodium, sodium stearyl fumarate.. In addition, the film coating contains the following inactive ingredients: Hypromellose, Hydroxypropyl cellulose, triethyl citrate, titanium dioxide, talc, ferric oxide red. SITAGLIPTIN-METFORMIN 50 mg/850 mg and 50 mg/1000 mg contains the additional inactive ingredient ferric oxide yellow.

What dosage forms it comes in:

SITAGLIPTIN-METFORMIN tablets contain

sitagliptin/metformin hydrochloride 50 mg/500 mg, 50 mg/850 mg, or 50 mg/1000 mg.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions Lactic acidosis is a rare but serious buildup of acid in the blood. It can cause death. It must be treated in the hospital. SITAGLIPTIN-METFORMIN contains a drug called metformin hydrochloride. If you build up too much metformin in your blood you are at risk for lactic acidosis.

Alcohol increases the risk of lactic acidosis caused by metformin. Do not “binge” drink or drink alcohol often when you are taking SITAGLIPTIN-METFORMIN.

Lactic Acidosis

Stop taking SITAGLIPTIN-METFORMIN if you get the following symptoms of lactic acidosis:

• You feel very weak and tired.
• You have unusual (not normal) muscle pain.
• You have trouble breathing.

• You have stomach pain with nausea and vomiting, or

  diarrhea.

• You feel cold, especially in your arms and legs.
• You feel dizzy or lightheaded.
• You have a slow or irregular heartbeat.
• Your medical condition suddenly changes.

You have a higher chance of getting lactic acidosis if you:

• have severe kidney problems. Your kidneys can be affected

  by certain x-ray tests that use injected dye. SITAGLIPTIN-METFORMIN is usually stopped before and for two days after such a test. Your doctor should discuss this with you;

• have liver problems

• have congestive heart failure that requires treatment with

  medicines;

• drink a lot of alcohol (very often or short-term “binge”

  drinking);

• get dehydration (lose a large amount of body fluids). This

  can happen if you are sick with a fever, vomiting, or diarrhea. Dehydration can also happen when you sweat a lot with activity or exercise and don’t drink enough fluids;

• have certain x-ray tests with injectable dyes or contrast agents

  used;

• have surgery. Talk with your doctor before any surgery if you

  must restrict what you eat and drink. In these cases, SITAGLIPTIN-METFORMIN should be stopped for 2 days before the surgery. Wait until you are eating and drinking again before you restart SITAGLIPTIN-METFORMIN. You doctor should discuss this with you;

• have a heart attack, severe infection, or stroke;
• take other medications;

BEFORE or while taking SITAGLIPTIN-METFORMIN talk to your physician or pharmacist if:

• you are older than 65 years of age;

  • you have or have had pancreatitis (inflammation of the pancreas);

  • you have risk factors for pancreatitis such as:

    • gallstones (solid particles that form in the gall bladder),
    • a history of alcoholism,
    • high triglyceride levels;

  • you are receiving treatment with insulin or are taking a sulfonylurea. When SITAGLIPTIN-METFORMIN is used in combination with sulfonylurea or insulin, low blood sugar can occur. Your physician may consider lowering the dose of the sulfonylurea or insulin. Take precautions to avoid low blood sugar while driving or using machinery;

  • you have heart problems including congestive heart failure (a condition where your heart becomes weaker and less able to pump the blood that your body needs);
  • you have or have had severe kidney problems;
  • you have liver problems;
  • you had an organ transplant;
  • you have human immunodeficiency syndrome (HIV);
  • you have vitamin B₁₂ deficiency or anemia;
  • you have hypothyroidism (low levels of thyroid hormones).

SITAGLIPTIN-METFORMIN is not recommended for use in patients under 18 years of age.

SITAGLIPTIN-METFORMIN may cause abnormal kidney function.

Cases of inflammation of the pancreas (pancreatitis) have been reported in patients taking SITAGLIPTIN-METFORMIN. Pancreatitis can be severe and lead to death.

Cases of serious skin reactions can occur and have been reported in patients taking SITAGLIPTIN-METFORMIN. These skin reactions are called Stevens-Johnson syndrome and bullous pemphigoid. They can happen after the first dose or up to 3 months on the drug. You may need treatment in a hospital. You may need to see a dermatologist to diagnose and treat these skin reactions.

INTERACTIONS WITH THIS MEDICATION

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements, or alternative medicines.

If you start any new medicine, tell your healthcare professional.

The following may interact with SITAGLIPTIN-METFORMIN:

• Other diabetes drugs such as glyburide.
• Furosemide.
• Nifedipine (used to treat high blood pressure and chest pain).

• Drugs that decrease the rate of elimination of metformin from

  your body (e.g., ranolazine, vandetanib, dolutegravir and cimetidine).

• Certain “blood thinners” (phenprocoumon or other

  antivitamin K anticoagulants).

• Other drugs that tend to produce high blood sugar

  (hyperglycemia) and may lead to a loss of blood sugar control. Some example of drugs that can increase the blood sugar include:

• Thiazide and other diuretics (water pills)
• Corticosteroids (used to treat joint pain and swelling)
• Phenothiazines (used to treat schizophrenia)
• Thyroid products
• Estrogens or estrogens plus progestogen
• Oral contraceptives (birth control pills)
• Phenytoin (used to treat epilepsy)
• Nicotinic Acid
• Sympathomimetics (used for heart problems)
• Calcium channel blocking drugs (used for high blood pressure)
• Isoniazid (used to treat tuberculosis)
• Beta-2-agonists (used to treat breathing problems)
• Carbonic anhydrase inhibitors

• ACE inhibitors drugs may lower blood glucose and the

  combination with SITAGLIPTIN-METFORMIN should be carefully monitored.

PROPER USE OF THIS MEDICATION

Your doctor will individualize your starting dose of SITAGLIPTIN-METFORMIN based on your current treatment regimen. Take SITAGLIPTIN-METFORMIN exactly as your physician has prescribed. Your physician will tell you how many SITAGLIPTIN-METFORMIN tablets to take and how often you should take them.

Your physician may adjust your dose, if needed to further control your blood sugar level.

Usual adult dose:

SITAGLIPTIN-METFORMIN should be given 2 times a day by mouth with a meal to lower your chance of an upset stomach.

Continue to take SITAGLIPTIN-METFORMIN as long as your physician prescribes it so you can continue to help control your blood sugar.

You may need to stop SITAGLIPTIN-METFORMIN for a short time. Call your physician for instructions if you:

• have a condition that may be associated with dehydration (large

  loss of body fluids) such as being sick with severe vomiting, diarrhea or fever, or if you drink fluids a lot less than normal;

• plan to have surgery;

• are going to get or receive an injection of dye or contrast agent

  for an x-ray procedure.

Overdose:

If you think you have taken too much SITAGLIPTIN-METFORMIN, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose:

If you miss a dose, take it with food as soon as you remember. If you do not remember until it is time for your next dose, skip the missed dose and go back to your regular schedule. Do not take two doses of SITAGLIPTIN-METFORMIN at the same time.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

These are not all the possible side effects that you may have when taking SITAGLIPTIN-METFORMIN. If you experience any side effects not listed here, contact your healthcare professional.

Side effects of SITAGLIPTIN-METFORMIN include:

• Stuffy or runny nose
• Sore throat
• Gastrointestinal symptoms: diarrhea, constipation, nausea, vomiting, abdominal bloating, upset stomach, gas and loss of appetite
• Headache
• Joint pain
• Arm or leg pain
• Back pain
• Muscle aches
• Itching
• Blisters

When SITAGLIPTIN-METFORMIN is used with a sulfonylurea medicine or with insulin, low blood sugar (hypoglycemia) can occur. Lower doses of the sulfonylurea medicine or insulin may be required while you used SITAGLIPTIN-METFORMIN.

SITAGLIPTIN-METFORMIN can cause abnormal blood test results. Your doctor will do blood tests before you start SITAGLIPTIN-METFORMIN and while you take it. They may check your blood sugar, liver and thyroid function, amount of vitamin B₁₂ and how well your kidneys are working. Your doctor will decide when to perform blood tests and will interpret the results.

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

HOW TO STORE IT

The product should be stored at room temperature (15°C to 30°C).

Keep out of reach and sight of children.

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

  (https://www.canada.ca/en/health-

  canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) 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

If you want more information about SITAGLIPTIN-METFORMIN:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website www.sivem.ca, or by calling 1-855-788-3153.

Sivem Pharmaceuticals ULC

4705 Dobrin Street

Saint-Laurent, Quebec

Canada H4R 2P7

Last revised: JAN 5, 2023