Synjardy

Synjardy is a prescription medication used to treat type 2 diabetes.

It is a single product containing 2 medications: empagliflozin and metformin.

Empagliflozin belongs to a group of drugs called sodium-glucose co-transporter 2 (SGLT2) inhibitors. These drugs work by stopping the reabsorption of glucose by the kidney, increasing glucose excretion from the body, and lowering blood sugar levels. Metformin belongs to a group of drugs called biguanides. These drugs work by helping your body respond better to the insulin it makes naturally, decreasing the amount of sugar your liver makes, and decreasing the amount of sugar your intestines absorb.

This medication comes in tablet form and is taken twice daily with meals.

Common side effects include stuffy or runny nose, diarrhea, nausea/vomiting, flatulence, abdominal discomfort, indigestion, asthenia, and headache. Synjardy may also cause urinary tract infections and female genital yeast infections.

Synjardy can also cause low blood sugar, which can cause drowsiness and dizziness. Do not drive or operate heavy machinery until you know how Synjardy affects you.

Synjardy is a prescription medication used to treat type 2 diabetes.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Boehringer Ingelheim Pharmaceuticals, Inc.

Serious side effects have been reported with Synjardy. See the “Synjardy Precautions” section.

Common side effects of Synjardy include the following:

• runny or stuffy nose
• diarrhea
• nausea/vomiting
• flatulence
• abdominal discomfort
• indigestion
• asthenia
• headache

Synjardy may also cause urinary tract infections and female genital yeast infections.

This is not a complete list of Synjardy side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• beta-blockers such as metoprolol (Toprol XL, Lopressor), carvedilol (Coreg), bisoprolol (Zebeta), betaxolol (Kerlone), nebivolol (Bystolic), propranolol (Inderal)
• cough and cold products containing decongestants
• calcium channel blockers
• cimetidine (Tagamet)
• corticosteroids
• digoxin (Lanoxin)
• diuretics such as acetazolamide (Diamox), amiloride (Midamor), bumetanide (Bumex), chlorothiazide (Diuril), chlorthalidone (Thalitone), ethacrynic acid (Edecrin), furosemide (Lasix), hydrochlorothiazide (Microzide, HCTZ), metolazone (Zaroxolyn), or torsemide (Demadex)
• estrogens
• Insulin or insulin-releasing drugs that can lower blood sugar such as glipizide (Glucotrol), glimepiride (Amaryl), repaglinide (Prandin), and nateglinide (Starlix)
• isoniazid (INH, Nydrazid)
• morphine
• niacin (nicotinic acid, Niaspan)
• nifedipine
• oral contraceptives
• oral steroids
• phenothiazines such as promethazine (Phenergan)
• phenytoin (Dilantin)
• procainamide
• quinidine
• quinine
• ranitidine
• thyroid medicines such as levothyroxine (Levothroid, Levoxyl, Synthroid)
• triamterene
• trimethoprim
• vancomycin

This is not a complete list of Synjardy drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Synjardy including the following:

• Lactic acidosis. Rarely, metformin can cause a serious side effect called lactic acidosis. This is caused by a buildup of lactic acid in your blood. This build-up can cause serious damage. Make sure you tell your doctor before you use metformin if you have kidney or liver problems. Lactic acidosis is a medical emergency that must be treated in a hospital. You should also stop using metformin and call your doctor right away if you have signs of lactic acidosis including:
  • feeling very weak, tired, or uncomfortable
  • unusual muscle pain
  • trouble breathing
  • unusual or unexpected stomach discomfort
  • feeling cold
  • feeling dizzy or lightheaded
  • suddenly developing a slow or irregular heartbeat
• Decreased blood pressure (hypotension). Tell your healthcare provider right away if you have some or all of the following symptoms of low blood pressure.
  • dizziness or lightheadedness
  • fainting (syncope)
  • lack of concentration
  • blurred vision
  • nausea
  • cold, clammy, pale skin
  • rapid, shallow breathing
  • fatigue
  • depression
  • thirst
• Impaired renal function. Changes in kidney function can occur with Synjardy, especially in people older than 75 years of age and those with existing kidney problems.

Synjardy can cause low blood sugar, which can cause dizziness and drowsiness. Do not drive or operate heavy machinery until you know how Synjardy affects you.

Do not take Synjardy if you:

• are allergic to Synjardy or to any of its ingredients
• have serious kidney problems or are on dialysis
• have metabolic acidosis or diabetic ketoacidosis

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Synjardy, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Synjardy, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Synjardy or to any of its ingredients
• have kidney problems
• have liver problems
• have a history of urinary tract infection or problems with urination
• have heart problems, including congestive heart failure
• drink alcohol very often, or drink a lot of alcohol in short term “binge” drinking
• are going to get an injection of dye or contrast agents for an x-ray procedure.
• have a history of urinary tract infections or problems with urination
• have type 1 diabetes. Synjardy should not be used to treat people with type 1 diabetes.
• have any other medical conditions
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X - are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Synjardy falls into category C. There are no well-controlled studies that have been done in pregnant women. Synjardy should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Synjardy crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Synjardy.

Take Synjardy exactly as prescribed.

Synjardy comes in tablet form and is taken 2 times daily with meals.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take 2 doses of Synjardy at the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• other medical conditions you have
• other medications you are taking
• how you respond to this medication

The recommended starting dose of Synjardy is based on a patient’s current dose of either component (metformin or empagliflozin) alone. The dose can be gradually increased based on the patient’s response and side effects to the medication.

If you take too much Synjardy, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Synjardy is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store Synjardy at room temperature.
• Keep this and all medicines out of the reach of children.

WARNING: RISK OF LACTIC ACIDOSIS

Lactic acidosis is a rare, but serious, complication that can occur due to metformin accumulation. The risk increases with conditions such as renal impairment, sepsis, dehydration, excess alcohol intake, hepatic impairment, and acute congestive heart failure.

The onset is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, increasing somnolence, and nonspecific abdominal distress.

Laboratory abnormalities include low pH, increased anion gap, and elevated blood lactate.

If acidosis is suspected, Synjardy should be discontinued and the patient hospitalized immediately.