Package Insert: Information for the User

Sitagliptin/Metformin Mylan 50 mg/1 000 mg Film-Coated Tablets

sitagliptin/metformin hydrochloride

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only for you, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

Sitagliptina/Metformina Mylan contains two different medicines, called sitagliptin and metformin.

• Sitagliptin belongs to a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors)
• Metformin belongs to a class of medicines called biguanides.

They work together to control blood sugar levels in adult patients with a form of diabetes called “type 2 diabetes mellitus”. This medicine helps to increase the levels of insulin produced after a meal and reduces the amount of sugar produced by the body.

Along with diet and exercise, this medicine helps to lower your blood sugar level. This medicine can be used alone or with certain diabetes medicines (insulin, sulfonylureas or thiazolidinediones).

What is type 2 diabetes?

Type 2 diabetes is a disease in which your body does not produce enough insulin and the insulin that your body produces does not work as well as it should. Your body may also produce too much sugar. When this occurs, sugar (glucose) accumulates in the blood. This can lead to serious medical problems, such as heart diseases (cardiovascular), kidney diseases (renal), blindness, and amputations.

Do not take Sitagliptin/Metformin hydrochloride Mylan:

• if you are allergic to sitagliptin, metformin, or any of the other ingredients in this medication (listed in section 6)
• if you have severe kidney function reduction
• if you have uncontrolled diabetes with, for example, severe hyperglycemia (high blood sugar), nausea, vomiting, diarrhea, rapid weight loss, lactic acidosis (see "Risk of lactic acidosis" below) or ketoacidosis. Ketoacidosis is a condition in which ketone bodies accumulate in the blood, which can lead to diabetic precoma. Symptoms include stomach pain, rapid and deep breathing, drowsiness, or an unusual fruity odor on your breath
• if you have a severe infection or are dehydrated
• if you are scheduled to have a radiography that requires the injection of a contrast agent. You will need to stop taking Sitagliptin/Metformin Mylan at the time of the radiography and for 2 or more days afterwards, as instructed by your doctor, depending on your kidney function
• if you have recently had a heart attack or have severe circulatory problems, such as "shock" or difficulty breathing
• if you have liver problems (hepatic)
• if you drink excessive amounts of alcohol (whether daily or occasionally)
• if you are breastfeeding

Do not take Sitagliptin/Metformin Mylan if any of the above circumstances apply to you and consult your doctor about other ways to control your diabetes. If you are unsure, consult your doctor, pharmacist, or nurse before starting to take this medication.

Warnings and precautions

Cases of pancreatitis have been reported in patients treated with Sitagliptin/Metformin Mylan (see section 4).

If you notice blisters on your skin, it may be a sign of a condition called bullous pemphigoid. Your doctor may ask you to stop taking Sitagliptin/Metformin hydrochloride Mylan.

Risk of lactic acidosis

Sitagliptin/Metformin Mylan may cause a rare but serious side effect called lactic acidosis, especially if your kidneys are not functioning properly. The risk of developing lactic acidosis is also increased with uncontrolled diabetes, severe infections, prolonged fasting, alcohol consumption, dehydration (see below for more information), liver problems, and any medical condition in which a part of the body has reduced oxygen supply (such as acute and severe heart disease).

If any of the above applies to you, consult your doctor for further instructions.

Stop taking Sitagliptin/Metformin Mylan for a short period of time if you have a condition that may be associated with dehydration(significant loss of body fluids), such as intense vomiting, diarrhea, fever, exposure to heat, or if you drink less fluid than normal. Consult your doctor for further instructions.

Stop taking Sitagliptin/Metformin Mylan and contact a doctor or the nearest hospital immediately if you experience any of the symptoms that produce lactic acidosis,as this condition can lead to coma.

The symptoms of lactic acidosis include:

• vomiting
• stomach pain (abdominal pain)
• muscle cramps
• general feeling of discomfort, with intense fatigue
• difficulty breathing
• reduced body temperature and heart rate

Lactic acidosis is a medical emergency and should be treated in a hospital.

Consult your doctor or pharmacist before starting to take Sitagliptin/Metformin hydrochloride Mylan:

• if you have or have had a pancreatic disease (such as pancreatitis)
• if you have or have had gallstones, alcohol addiction, or have very high triglyceride levels (a type of fat) in your blood. These medical conditions may increase your risk of developing pancreatitis (see section 4)
• if you have type 1 diabetes. This disease is also known as insulin-dependent diabetes
• if you have or have had an allergic reaction to sitagliptin, metformin, or sitagliptin/metformin hydrochloride (see section 4)
• if you are taking a sulfonylurea or insulin, other diabetes medications, as you may experience low blood sugar (hypoglycemia). Your doctor may need to reduce the dose of the sulfonylurea or insulin you are taking

If you need to undergo major surgery, stop taking Sitagliptin/Metformin Mylan while the procedure is being performed and for a period of time afterwards. Your doctor will decide when to interrupt treatment with Sitagliptin/Metformin Mylan and when to restart it.

If you are unsure whether any of the above circumstances apply to you, consult your doctor or pharmacist before starting to take Sitagliptin/Metformin hydrochloride Mylan.

During treatment with Sitagliptin/Metformin hydrochloride Mylan, your doctor will check your kidney function at least once a year or more frequently if you are an older person and/or if your kidney function is worsening.

Children and adolescents

Children and adolescents under 18 years old should not use this medication.

This medication is not effective in children and adolescents aged 10-17 years. The safety and efficacy of this medication in children under 10 years old are unknown.

Other medications and Sitagliptin/Metformin hydrochloride Mylan

If you need to receive an injection of a contrast agent containing iodine, such as during a radiography or examination, stop taking Sitagliptin/Metformin Mylan before the injection or at the time of the injection. Your doctor will decide when to interrupt treatment with Sitagliptin/Metformin Mylan and when to restart it.

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. You may need more frequent blood glucose and kidney function tests, or your doctor may need to adjust the dose of Sitagliptin/Metformin hydrochloride Mylan. It is especially important to mention the following:

• medications (taken orally, inhaled, or injected) used to treat inflammatory diseases, such as asthma and arthritis (corticosteroids)
• medications that increase urine production (diuretics)
• medications used to treat pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib)
• specific medications used to treat high blood pressure (ACE inhibitors and angiotensin II receptor antagonists)
• specific medications used to treat asthma (beta-2 agonists)
• iodine-containing contrast agents or medications containing alcohol
• specific medications used to treat stomach problems, such as cimetidine
• ranolazine, a medication used to treat angina pectoris
• dolutegravir, a medication used to treat HIV infection
• vandetanib, a medication used to treat a specific type of thyroid cancer (medullary thyroid cancer)
• digoxin (to treat irregular heartbeat and other heart problems). You may need to have your digoxin blood level checked if you are taking Sitagliptin/Metformin hydrochloride Mylan.

Taking Sitagliptin/Metformin Mylan with alcohol

Avoid excessive alcohol consumption while taking Sitagliptin/Metformin hydrochloride Mylan, as this may increase the risk of lactic acidosis (see section "Warnings and precautions").

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication. Do not take this medication during pregnancy or while breastfeeding. See section 2, Do not take Sitagliptin/Metformin hydrochloride Mylan.

Driving and operating machinery

The influence of this medication on your ability to drive and operate machinery is negligible or insignificant. However, cases of dizziness and somnolence have been reported during treatment with sitagliptin, which may affect your ability to drive and operate machinery.

Takingthis medication with sulfonylureas or insulin may cause hypoglycemia, which may affect your ability to drive and operate machinery or work without a secure support.

Sitagliptin/Metformin Mylan contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

• If you have reduced renal function, your doctor may prescribe a lower dose.

You must continue with the diet recommended by your doctor during treatment with this medication and be careful to distribute carbohydrate intake evenly throughout the day.

It is unlikely that treatment with this medication alone will cause an abnormal drop in blood sugar (hypoglycemia). A drop in blood sugar may occur when this medication is taken with a medication containing sulfonylurea or with insulin, so your doctor may consider reducing the dose of your sulfonylurea or insulin.

If you take more Sitagliptin/Metformin Mylan than you should

If you take more than the prescribed dose of this medication, contact your doctor immediately. Go to the hospital if you experience symptoms of lactic acidosis such as feeling cold or unwell, intense nausea or vomiting, stomach pain, unexplained weight loss, muscle cramps, or agitated breathing (see "Warnings and precautions").

If you forget to take Sitagliptin/Metformin hydrochloride Mylan

If you forget to take a dose, take it as soon as you remember. If you do not remember until the time of your next dose, skip the missed dose and continue with your regular treatment. Do not take a double dose of this medication.

If you interrupt treatment with Sitagliptin/Metformin hydrochloride Mylan

Continue taking this medication as directed by your doctor to help control your blood sugar levels. Do not stop taking this medication without first consulting your doctor. If you stop taking Sitagliptin/Metformin hydrochloride Mylan, your blood sugar levels may increase again.

If you have any other questions about using this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

STOP taking Sitagliptina/Metformina Mylan and see your doctor immediately if you notice any of the following serious side effects:

• Intense and persistent abdominal pain (stomach area) that can reach the back with or without nausea and vomiting, as these can be signs of pancreatitis inflammation.

Sitagliptina/Metformina Mylan can cause a very rare but serious side effect (can affect up to 1 in 10,000 people), called lactic acidosis (see "Warnings and precautions" section). If this happens to you, you muststop taking Sitagliptina/Metformina Mylan and contact a doctor or the nearest hospital immediately, as lactic acidosis can lead to coma.

If you have a severe allergic reaction (unknown frequency), including skin rash, urticaria, blisters on the skin/skin peeling and swelling of the face, lips, tongue, and throat that can cause difficulty breathing or swallowing, stop taking this medicine and consult your doctor immediately. Your doctor will prescribe a medication to treat the allergic reaction and change the medication for diabetes treatment.

Some patients taking metformin have experienced the following side effects after starting treatment with sitagliptin:

Frequent (can affect up to 1 in 10 people): low blood sugar, nausea, gas, vomiting

Rarely (can affect up to 1 in 100 people): stomach pain, diarrhea, constipation, drowsiness

Some patients have experienced diarrhea, nausea, gas, constipation, stomach pain, or vomiting when starting treatment with the combination of sitagliptin and metformin (frequency classified as frequent).

Some patients have experienced the following side effects when taking this medicine with a sulfonylurea such as glimepiride:

Very frequent (can affect more than 1 in 10 people): low blood sugar Frequent: constipation

Some patients presented the following side effects while taking this medicine in combination with pioglitazone:

Frequent: swelling of hands or feet

Some patients presented the following side effects while taking this medicine in combination with insulin:

Very frequent: low blood sugar Rare: dry mouth, headache

Some patients have experienced the following side effects during clinical studies while taking sitagliptin alone (one of the medicines contained in Sitagliptin/Metformin hydrochloride Mylan) or during use after approval of Sitagliptina/Metformina Mylan or sitagliptin alone or with other diabetes medications:

Frequent: low blood sugar, headache, upper respiratory tract infection, congestion or nasal mucosities, and throat pain, osteoarthritis, arm or leg pain

Rare: dizziness, constipation, itching Rare: reduction in platelet count

Unknown frequency: kidney problems (which sometimes require dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of skin blister)

Some patients have experienced the following side effects after taking metformin alone: Very frequent: nausea, vomiting, diarrhea, stomach pain, and loss of appetite. These symptoms may appear when you start taking metformin and usually disappear

Frequent: metallic taste

Very rare: reduction of vitamin B12 levels, hepatitis (liver problem), urticaria, skin redness (rash) or itching

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through thenational notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the blister pack and on the outer packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through the drains or in the trash. Ask your pharmacist how to dispose of the packaging and the medication that you no longer need. This will help protect the environment.

Composition of Sitagliptin/Metformin hydrochloride Mylan

• The active ingredients are metformin and sitagliptin.
• Each film-coated tablet of 50 mg/1,000 mg (tablet) contains sitagliptin hydrochloride monohydrate equivalent to 50 mg of sitagliptin and 1,000 mg of metformin hydrochloride.

• The other components are microcrystalline cellulose, anhydrous colloidal silica, sodium croscarmellose, sodium lauryl sulfate, povidone, sodium stearyl fumarate, polyvinyl alcohol, macrogol, talc, titanium dioxide (E171), iron oxide red (E172), and iron oxide black (E172). See section 2, “Sitagliptina/Metformina Mylan contains sodium”.

Appearance of the product and contents of the pack

The 50 mg/1,000 mg tablet is a capsule-shaped, biconvex, orange-brown to brown tablet with beveled edges and the inscription “M” on one face of the tablet and “SM7” on the other face.

Sitagliptina/Metformina Mylan is available in:

• blister packs containing 14, 56, 98, or 196 film-coated tablets,
• multiple pack containing 196 (2 packs of 98) film-coated tablets,
• single-dose blister packs containing 14 x 1, 56 x 1, or 60 x 1 film-coated tablets,
• bottles containing 90 or 196 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Mylan Ireland Limited

Unit 35/36 Grange Parade,

Baldoyle Industrial Estate

Dublin 13,

Ireland.

Manufacturers

McDermott Laboratories Limited t/a Gerard Laboratories t/a Mylan Dublin, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland

Medis International as, Prumyslova 961/16, Bolatice, 747 23, Czech Republic

Mylan Hungary Kft, Mylan utca 1, 2900 Komárom, Hungary

Mylan Germany GmbH Zweigniederlassung Bad Homburg v. d. Hoehe, Benzstrasse 1

Bad Homburg v. d. Hoehe Hessen, 61352, Germany

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Last update of this leaflet:{MM/AAAA}.

For more detailed information about this medicine, please visit the website of the European Medicines Agency:http://www.ema.europa.eu.