What is Synjardy?

• Synjardy contains a combination of empagliflozin and metformin. Empagliflozin and metformin are oral diabetes medicines that help control blood sugar levels. Empagliflozin works by helping the kidneys get rid of glucose from your bloodstream. Metformin lowers glucose production in the liver and also causes your intestines to absorb less glucose.
• Synjardy is used together with diet and exercise to treat type 2 diabetes.
• Synjardy is not for treating type 1 diabetes.

Before taking this medicine

You should not use Synjardy if you are allergic to empagliflozin (Jardiance, Glyxambi) or metformin (Glucophage, Actoplus Met, Avandamet, Fortamet, Glucovance, Janumet, Jentadueto, Kazano, Kombiglyze, Metaglip, PrandiMet, Riomet), or if you have:

• severe kidney disease (or if you are on dialysis); or
• if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).
• If you need to have any type of x-ray or CT scan using a dye that is injected into your veins, you will need to temporarily stop taking Synjardy.

Some people taking metformin develop a serious condition called lactic acidosis. This may be more likely if you have liver or kidney disease, congestive heart failure, a severe infection, if you are dehydrated, or if you drink large amounts of alcohol. Talk with your doctor about your risk.

To make sure Synjardy is safe for you, tell your doctor if you have:

• liver or kidney disease;
• low blood pressure;
• a history of bladder infections or urination problems;
• high cholesterol levels;
• a history of heart attack or stroke;
• if you are on a low-salt diet;
• if you take blood pressure medicine such as a diuretic (water pill); or
• if you are 80 or older and your kidneys have not been tested.

It is not known whether Synjardy will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether empagliflozin and metformin passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Synjardy is not approved for use by anyone younger than 18 years old.

How should I take Synjardy?

• Take Synjardy exactly as it was prescribed for you. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.
• Your doctor may perform kidney function tests before you start taking Synjardy.
• Take Synjardy with food to prevent upset stomach.
• Your blood sugar will need to be checked often, and you may need other blood tests at your doctor's office.
• Do not crush, chew, or break a Synjardy extended-release tablet. Swallow the tablet whole.
• Your doctor may have you take extra vitamin B12 while you are taking Synjardy. Take only the amount of vitamin B12 that your doctor has prescribed.
• Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking Synjardy, which can lead to severely low blood pressure or a serious electrolyte imbalance.
• Synjardy can cause positive results with certain lab tests for glucose (sugar) in the urine. Tell any doctor who treats you that you are using empagliflozin.
• Low blood sugar (hypoglycemia) can happen to everyone who has diabetes. Symptoms include headache, hunger, sweating, pale skin, irritability, dizziness, feeling shaky, or trouble concentrating. Always keep a source of sugar with you in case you have low blood sugar. Sugar sources include fruit juice, hard candy, crackers, raisins, and non-diet soda. Be sure your family and close friends know how to help you in an emergency.
• If you have severe hypoglycemia and cannot eat or drink, use a glucagon injection. Your doctor can prescribe a glucagon emergency injection kit and tell you how to use it.
• Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, and weight loss.
• Check your blood sugar carefully during times of stress, travel, illness, surgery or medical emergency, vigorous exercise, or if you drink alcohol or skip meals. These things can affect your glucose levels and your dose needs may also change. Do not change your medication dose or schedule without your doctor's advice.
• Synjardy is only part of a treatment program that may also include diet, exercise, weight control, blood sugar testing, and special medical care. Follow your doctor's instructions very closely.
• Store Synjardy t room temperature, away from moisture and heat.

Synjardy dosing information

Usual Adult Dose of Synjardy for Diabetes Type 2:

Initial dose: Individualize based on patient's current regimen; take orally twice a day:

• In patients on metformin, switch to empagliflozin-metformin containing empagliflozin 5 mg with a similar total daily dose of metformin
• In patients on empagliflozin, switch to empagliflozin-metformin containing metformin 500 mg with a similar total daily dose of empagliflozin
• In patients already treated with empagliflozin and metformin, switch to empagliflozin-metformin containing the same total daily doses of each component.
• Adjust dose based on efficacy and tolerability; a gradual dose escalation of metformin will help to reduce gastrointestinal side effects.

Maximum dose: Empagliflozin: 25 mg per day; Metformin: 2000 mg per day

Comments:

• When used in combination with insulin or an insulin secretagogue, a lower dose of insulin or insulin secretagogue may be considered to reduce the risk of hypoglycemia.
• Correct volume depletion prior to beginning this drug.

Use: An adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus who are not adequately controlled on a regimen containing empagliflozin or metformin, or in patients already being treated with both empagliflozin and metformin.

What happens if I miss a dose?

• Take the missed dose as soon as you remember (be sure to take the medicine with food). Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Synjardy side effects

Get emergency medical help if you have signs of an allergic reaction to Synjardy:

• hives
• difficult breathing
• swelling of your face, lips, tongue, or throat.

Early symptoms of lactic acidosis may get worse over time and this condition can be fatal. Get emergency medical help if you have even mild symptoms: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, slow or uneven heart rate, dizziness, or feeling very weak or tired.

Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;
• dehydration symptoms - feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin;
• signs of a kidney problem - little or no urinating; painful or difficult urination; swelling in your feet or ankles; feeling tired or short of breath;
• signs of a bladder infection - pain or burning when you urinate, urine that looks cloudy, pain in pelvis or back; or
• signs of a genital infection (penis or vagina) - pain, burning, itching, rash, redness, odor, or discharge.

Side effects may be more likely to occur in older adults.

Common Synjardy side effects may include:

• bladder infection or genital infection;
• headache;
• stomach pain, gas, indigestion, nausea, vomiting, diarrhea;
• weakness; or
• cold symptoms such as stuffy nose, sneezing, sore throat.

If you have any more questions please ask your Pharmacist.

Remember to keep all medicines out of reach of children
Please Note: We have made every effort to ensure that the content of this information sheet is correct at time of publish, but remember that information about drugs may change. This sheet does not list all the uses and side-effects associated with this drug. For full details please see the drug information leaflet which comes with your medicine. Your doctor will assess your medical circumstances and draw your attention to any information or side-effects which may be relevant in your particular case.

References:

http://www.rxlist.com/synjardy-drug.htm

https://www.medicines.org.uk/emc/medicine/30781

https://www.synjardy.com

http://www.ema.europa.eu/docs/en_GB/document_library/Referrals_document/SGLT2_inhibitors__20/European_Commission_final_decision/WC500206513.pdf

https://www.drugs.com/sfx/synjardy-side-effects.html

https://www.scottishmedicines.org.uk/SMC_Advice/Advice/1092_15_empagliflozin_metformin_Synjardy/empagliflozin_metformin_Synjardy