This combination product contains the medications linagliptin and metformin. Both these medications are used to control blood glucose levels for adults with type 2 diabetes. Linagliptin belongs to the group of medications called DPP-4 inhibitors. It works by increasing the amount of incretin released by the intestine. Incretin is a hormone that raises insulin levels when blood sugar is high (especially after a meal) and decreases the amount of sugar made by the body. Metformin belongs to the group of medications called oral hypoglycemics, which are medications that lower blood sugar. Metformin works by reducing the amount of glucose made by the liver and by making it easier for glucose to enter into the tissues of the body. Metformin has been found to be especially useful in delaying problems associated with diabetes for overweight people with diabetes.

This combination medication may be used alone or in combination with sulfonylureas such as glyburide or insulin, when diet, exercise, weight reduction, and other medications have not been found to control blood glucose well enough on their own.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

The recommended starting dose of linagliptin - metformin should be based on the doses of the individual medications that you are already taking. Before starting this medication, you should already be taking metformin alone or metformin with linagliptin as separate tablets.

Linagliptin - metformin should be taken twice daily with meals to reduce the side effects of the medication.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

To be most effective this medication should be taken regularly in addition to proper diet and exercise. It is not intended to replace diet and exercise in treating your diabetes.

It is important that this medication be taken exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

2.5 mg / 500 mg
Each light yellow, oval, biconvex, film-coated tablet debossed with "D2/500" on one side and the Boehringer Ingelheim logo on the other side contains 2.5 mg of linagliptin and 500 mg of metformin hydrochloride. Nonmedicinal ingredients: arginine, colloidal silicon dioxide, copovidone, magnesium stearate, and maize starch. Film coating: hypromellose, iron oxide red, iron oxide yellow, propylene glycol, talc, and titanium dioxide.

2.5 mg / 850 mg
Each light orange, oval, biconvex, film-coated tablet debossed with "D2/850" on one side and the Boehringer Ingelheim logo on the other side contains 2.5 mg of linagliptin and 850 mg of metformin hydrochloride. Nonmedicinal ingredients: arginine, colloidal silicon dioxide, copovidone, magnesium stearate, and maize starch. Film coating: hypromellose, iron oxide red, iron oxide yellow, propylene glycol, talc, and titanium dioxide.

2.5 mg / 1000 mg
Each light pink, oval, biconvex, film-coated tablet debossed with "D2/1000" on one side and the Boehringer Ingelheim logo on the other side contains 2.5 mg of linagliptin and 1,000 mg of metformin hydrochloride. Nonmedicinal ingredients: arginine, colloidal silicon dioxide, copovidone, magnesium stearate, and maize starch. Film coating: hypromellose, iron oxide red, iron oxide yellow, propylene glycol, talc, and titanium dioxide.

Do not take linagliptin - metformin if you:

• are allergic to linagliptin, metformin, or any ingredients of the medication
• have type 1 diabetes
• are experiencing or recovering from severe infections, trauma, or surgery
• are going to have or have had surgery where you are not eating or drinking normally
• are pregnant or breast-feeding
• are suffering severe dehydration (have lost a lot of water from your body)
• are undergoing radiologic studies involving use of iodinated contrast materials
• drink large amounts of alcohol in the short-term or on a regular basis
• have a history of lactic acidosis or acute/chronic metabolic acidosis (too much acid in the blood), diabetic ketoacidosis with or without coma, or history of ketoacidosis with or without coma
• have diseases associated with lack of oxygen to the tissues such as cardio-respiratory insufficiency
• have reduced kidney function
• have severely reduced liver function
• have very poor blood glucose control (if so, you should not take this medication as the only antidiabetic agent)

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• bloating
• cough
• diarrhea
• constipation
• gas
• heartburn
• increased sensitivity to sunlight
• loss of appetite
• metallic taste in mouth
• mouth ulcers
• nausea
• runny nose
• sore throat
• stuffy nose

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• decreased coordination
• decreased thyroid function (e.g., constipation, dry skin, tiredness, weight gain, sensitive to the cold)
• hives or rash
• severe joint pain
• signs of anemia (low red blood cells; e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath)
• signs of infection (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
• signs of muscle damage (e.g., unexplained muscle pain, tenderness or weakness, or brown or discoloured urine)
• skin blisters or erosions
• symptoms of low blood sugar (e.g., shaking, sweating, fast heartbeat, vision changes, hunger, headache, mood swings, slurred speech)
• tingling or numbness in hands or feet
• vomiting

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of encephalopathy (e.g., muscle weakness in one part of the body, poor decision making, difficulty speaking or swallowing, problems concentrating, twitching or trembling, seizures)
• signs of lactic acidosis (e.g., nausea, vomiting, increased breathing rate, abdominal pain, unusual muscle pain, unusual tiredness, dizziness, slow or irregular heart rate)
• signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
• signs of pancreatitis (e.g., abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, swollen abdomen)
• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
• signs of a severe skin reaction such as blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Alcohol intake: Alcohol increases the risk of developing lactic acidosis for people taking metformin. If you are taking this medication, avoid excessive alcohol intake. If you drink alcohol often or heavily, discuss with your doctor how this medication may affect you, how your alcohol intake may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Anemia: Rarely, metformin causes low levels of red blood cells. If you experience symptoms of reduced red blood cell count (anemia) such as shortness of breath, feeling unusually tired or pale skin, contact your doctor as soon as possible.

Your doctor will do blood tests regularly to monitor the number of specific types of blood cells, including red blood cells, in your blood.

Blood sugar monitoring: Monitor your blood sugar regularly at intervals as discussed with your doctor or diabetes educator.

Congestive heart failure and heart disease: The safety and effectiveness of linagliptin has not been established for people with congestive heart failure (CHF) or heart disease. For this reason, this medication is not recommended for people with CHF or heart disease.

If you have CHF or heart disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether this medication is appropriate for you.

Dye or contrast agents: If you are going to have an X-ray procedure that uses dye or a contrast agent, you may need to stop taking this medication for a short time. Contact your doctor for instructions.

Hypoglycemia (low blood sugar): Hypoglycemia can occur when linagliptin - metformin is used in combination with a sulfonylurea (e.g., glyburide, gliclazide) or insulin. Your doctor may suggest a lower dose of your sulfonylurea or insulin when you start this medication.

Hypoglycemia may also occur when you don't eat enough, exercise strenuously without eating enough, or drink alcohol. If you experience low blood sugar (e.g., headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, fast heartbeat, sweating, and feeling jittery) contact your doctor.

During times of stress (e.g., fever, trauma, surgery, infection), your doctor may suggest that you temporarily stop this medication and use insulin to help control your blood sugar levels.

Kidney function: Kidney disease or reduced kidney function may cause this medication to build up in the body, causing side effects and increasing the risk of lactic acidosis. If you have reduced kidney function or kidney disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Liver function: If you have reduced liver function or liver disease, you may be at an increased risk of developing lactic acidosis. Discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. This medication is not recommended if you have severely reduced liver function.

Lactic acidosis: Lactic acidosis is a rare but serious problem that occurs due to metformin accumulation (i.e., the body doesn't get rid of it fast enough) during treatment. If you have severe kidney disease, you are at higher risk of developing lactic acidosis. Since alcohol may increase the risk of lactic acidosis, do not drink a lot of alcohol over the short- or long-term while taking this medication. When it does occur (very rarely), it is fatal in 50% of cases. If you experience symptoms of lactic acidosis (e.g., weakness, tiredness, drowsiness, unusual muscle pain, trouble breathing, stomach pain with nausea, vomiting or diarrhea, feeling cold, dizziness, lightheadedness, or slow or irregular heartbeat), stop taking this medication and get immediate medical attention.

Pancreatitis: This medication may cause or worsen pancreatitis (inflammation of the pancreas). If you have a history of pancreatitis, gallstones, alcoholism, or high triglycerides, you may be more at risk of experiencing this and should be closely monitored by your doctor while taking this medication.

If you experience symptoms of pancreatitis (e.g., upper left abdominal pain, back pain, nausea, fever, chills, rapid heartbeat, swollen abdomen or prolonged and severe abdominal pain with or without vomiting), contact your doctor immediately.

Reduced response: Over time, this medication may become less effective as your diabetes worsens. Monitor your blood glucose levels regularly and if you notice them getting higher, contact your doctor to discuss alternatives.

Surgery: This medication should be stopped temporarily for surgery (except for minor surgery where food and fluid intake is not restricted). You will be restarted on this medication once you are eating and drinking, and your kidney function has been tested and is normal. Talk to your doctor for specific instructions.

Thyroid function: For people who have an underactive thyroid, metformin can cause the amount of thyroid hormone in the body to decrease further. If you have an underactive thyroid gland, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Vitamin B12 levels: Metformin may decrease vitamin B12 levels. Your doctor will monitor your B12 levels with blood tests while you are taking this medication.

Pregnancy: Metformin should not be used during pregnancy. If you become pregnant while taking this medication, contact your doctor immediately. During pregnancy, blood glucose levels should be kept as close to normal as possible using insulin.

Breast-feeding: It is not known if linagliptin passes into breast milk. Metformin does pass into breast milk. If you are breast-feeding, this medication may affect your baby, and so it is recommended that you do not use linagliptin - metformin.

Children: The safety and effectiveness of using this medication have not been established for children less than 18 years old.

Seniors: Seniors are more likely to have reduced liver and kidney function, and may be at increased risk of experiencing side effects to this medication.

There may be an interaction between linagliptin-metformin and any of the following:

• acetazolamide
• acetylsalicylic acid (ASA)
• alcohol
• androgens (e.g., testosterone)
• angiotensin converting enzyme inhibitors (ACEIs; e.g., captopril, lisinopril, ramipril)
• apalutamide
• atypical antipsychotics (e.g., aripiprazole, cariprazine, chlorpromazine, clozapine, olanzapine, quetiapine, risperidone)
• basiliximab
• bismuth subsalicylate
• bosentan
• beta-adrenergic blockers (e.g., atenolol, bisoprolol, carvedilol, metoprolol, propranolol)
• buserelin
• cephalexin
• chloroquine
• cimetidine
• inhaled corticosteroids (e.g., budesonide, ciclesonide, fluticasone)
• oral corticosteroids (e.g., dexamethasone, hydrocortisone, prednisone)
• danazol
• diazoxide
• digoxin
• disopyramide
• diuretics (water pills; e.g., furosemide, hydrochlorothiazide, triamterene)
• elagolix
• enfortumab
• enzalutamide
• epinephrine
• estrogens (e.g., conjugated estrogen, estradiol, ethinyl estradiol)
• everolimus
• glucagon
• glycopyrrolate
• goserelin
• green tea
• hepatitis C antivirals (e.g., glecaprevir, ledipasvir, sofosbuvir, velpatasvir)
• HIV integrase inhibitors (e.g., bictegravir, dolutegravir)
• HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., efavirenz, etravirine)
• HIV protease inhibitors (e.g., atazanavir, lopinavir, ritonavir, tipranavir)
• hormonal birth control
• hydroxychloroquine
• iodinated contrast agents
• insulin
• leuprolide
• linezolid
• lumacaftor and ivacaftor
• methazolamide
• mifepristone
• mitotane
• modafinil
• monoamine oxidase inhibitors (MAOIs; e.g., moclobemide, phenelzine, rasagiline, selegiline, tranylcypromine)
• morphine
• niacin
• non-steroidal anti-inflammatory medications (NSAIDs; e.g., celecoxib, diclofenac, ibuprofen, ketorolac, naproxen)
• ondansetron
• patiromer
• pegvisomant
• pentamidine
• progestins (e.g., cyproterone, dienogest, drospirenone, levonorgestrel, medroxyprogesterone, norethindrone, progesterone)
• protein kinase inhibitors (e.g., dabrafenib, nilotinib, sunitinib)
• pyrimethamine
• quinine
• quinolone antibiotics (e.g., ciprofloxacin, norfloxacin, ofloxacin)
• ranolazine
• rifabutin
• rifampin
• St. John's wort
• seizure medications (e.g., carbamazepine, lamotrigine, phenytoin, topiramate)
• selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, fluoxetine, paroxetine, sertraline, vortioxetine)
• sirolimus
• somatostatin-like medications (e.g., lanreotide, octreotide, pasireotide)
• somatrogon
• somatropin
• sulfadiazine
• sulfamethoxazole
• sulfonylureas (e.g., gliclazide, glimepiride, glyburide, repaglinide)
• tacrolimus (systemic)
• temsirolimus
• terbutaline
• tramadol
• trimethoprim
• triptorelin
• venetoclax
• verapamil
• vorinostat
• warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.