SITAGLIPTIN/METFORMIN MYLAN 50 mg/1000 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Sitagliptin/Metformin Mylan 50 mg/1,000 mg film-coated tablets

sitagliptin/metformin hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Sitagliptin/Metformin Mylan is and what it is used for
2. What you need to know before you take Sitagliptin/Metformin hydrochloride Mylan
3. How to take Sitagliptin/Metformin hydrochloride Mylan
4. Possible side effects
5. Storage of Sitagliptin/Metformin hydrochloride Mylan
6. Contents of the pack and other information

1. What Sitagliptin/Metformin Mylan is and what it is used for

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

Together with diet and exercise, this medicine helps to lower your blood sugar levels. This medicine can be used alone or with certain other medicines for diabetes (insulin, sulfonylureas, or glitazones).

What is type 2 diabetes?

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

2. What you need to know before you take Sitagliptin/Metformin hydrochloride Mylan

Do not take Sitagliptin/Metformin hydrochloride Mylan:

• if you are allergic to sitagliptin, metformin, or any of the other ingredients of this medicine (listed in section 6)
• if you have severe kidney problems
• if you have uncontrolled diabetes with, for example, severe hyperglycemia, nausea, vomiting, diarrhea, rapid weight loss, lactic acidosis (see “Risk of lactic acidosis” below), or ketoacidosis. Ketoacidosis is a condition in which substances called “ketone bodies” build up in the blood, which can lead to diabetic pre-coma. Symptoms include stomach pain, rapid and deep breathing, drowsiness, or unusual fruity odor to the breath
• if you have a severe infection or are dehydrated
• if you are going to have an X-ray where you will be injected with a contrast agent. You will need to stop taking Sitagliptin/Metformin Mylan at the time of the X-ray and for 2 or more days after, as directed 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 breathing difficulties
• if you have liver problems
• if you drink excessive amounts of alcohol (either every day or only from time to time)
• if you are breast-feeding.

Do not take Sitagliptin/Metformin Mylan if any of the above applies to you and consult your doctor about other ways to control your diabetes. If you are not sure, consult your doctor, pharmacist, or nurse before taking this medicine.

Warnings and precautions

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

If you notice blisters on your skin, it may be a sign of a disease 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 very rare but very serious side effect called lactic acidosis, especially if your kidneys are not working properly. The risk of developing lactic acidosis is also increased by uncontrolled diabetes, serious infections, prolonged fasting, or alcohol intake, dehydration (see more information below), liver problems, and any medical condition in which a part of your body has a reduced supply of oxygen (such as severe and acute heart disease).

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

Stop taking Sitagliptin/Metformin Mylan for a short time if you have a condition that may be associated with dehydration(significant loss of body fluids), such as severe 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 of 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 being unwell, with intense tiredness
• difficulty breathing
• reduction in body temperature and heart rate

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

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

• if you have or have had pancreatitis
• if you have or have had gallstones, alcohol dependence, or very high blood levels of triglycerides (a type of fat). These medical conditions may increase your risk of developing pancreatitis (see section 4)
• if you have type 1 diabetes. This disease is also called insulin-dependent diabetes
• if you 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 medicines, because you may experience low blood sugar levels (hypoglycemia). Your doctor may need to reduce the dose of the sulfonylurea or insulin you are taking

If you need to undergo major surgery, you should stop taking Sitagliptin/Metformin Mylan during the procedure and for some time after. Your doctor will decide when you should stop taking Sitagliptin/Metformin Mylan and when you can start taking it again.

If you are not sure if any of the above applies to you, consult your doctor or pharmacist before taking 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 often if you are an elderly person and/or if your kidney function is getting worse.

Children and adolescents

Children and adolescents under 18 years of age should not use this medicine.

It is not effective in children and adolescents aged 10 to 17 years. It is not known if this medicine is safe and effective when used in children under 10 years of age.

Other medicines and Sitagliptin/Metformin hydrochloride Mylan

If you need to be given an injection of a contrast agent that contains iodine into your bloodstream, for example, in the context of an X-ray or scan, you should stop taking Sitagliptin/Metformin Mylan before or at the time of the injection. Your doctor will decide when you should stop taking Sitagliptin/Metformin Mylan and when you can start taking it again.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. 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:

• medicines (taken orally, inhaled, or injected) used to treat diseases that cause inflammation, such as asthma and arthritis (corticosteroids)
• medicines that increase urine production (diuretics)
• medicines used to treat pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib)
• certain medicines used to treat high blood pressure (ACE inhibitors and angiotensin II receptor antagonists)
• medicines used to treat bronchial asthma (beta-2 adrenergic agents)
• iodinated contrast agents or medicines that contain alcohol
• certain medicines used to treat stomach problems such as cimetidine
• ranolazine, a medicine used to treat angina pectoris
• dolutegravir, a medicine used to treat HIV infection
• vandetanib, a medicine used to treat a specific type of thyroid cancer (medullary thyroid cancer)
• digoxin (for irregular heartbeat and other heart problems). Your doctor may need to check the level of digoxin in your blood if you are taking Sitagliptin/Metformin hydrochloride Mylan.

Taking Sitagliptin/Metformin Mylan with alcohol

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

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. You should not take this medicine during pregnancy or while breast-feeding. See section 2, Do not take Sitagliptin/Metformin hydrochloride Mylan.

Driving and using machines

The effect of this medicine on your ability to drive or use machines is negligible or minimal. However, cases of dizziness and drowsiness have been reported during treatment with sitagliptin, which may affect your ability to drive or use machines.

Taking this medicine with sulfonylureas or insulin may cause low blood sugar levels, which may affect your ability to drive or use machines or work without a safe support.

Sitagliptin/Metformin Mylan contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially “sodium-free”.

3. How to take Sitagliptin/Metformin hydrochloride Mylan

Follow exactly the instructions for administration of this medicine given by your doctor. If you are not sure, consult your doctor or pharmacist again.

• Take one tablet:
• twice a day by mouth
• with food to reduce the chance of stomach upset

• Your doctor may need to increase the dose to control your blood sugar levels.

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

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

It is unlikely that treatment with this medicine alone will cause abnormally low blood sugar levels (hypoglycemia). Low blood sugar levels can occur when this medicine is taken with a sulfonylurea or insulin, so your doctor may need to reduce 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 medicine, contact your doctor immediately. Go to the hospital if you have symptoms of lactic acidosis such as feeling cold or unwell, nausea or vomiting, stomach pain, unexplained weight loss, muscle cramps, or rapid breathing (see section “Warnings and precautions”).

If you forget to take Sitagliptin/Metformin hydrochloride Mylan

If you miss a dose, take it as soon as you remember. If you do not remember until the time for your next dose, skip the missed dose and continue with your normal treatment schedule. Do not take a double dose of this medicine.

If you stop taking Sitagliptin/Metformin hydrochloride Mylan

Keep taking this medicine for as long as your doctor tells you to, so that it can help control your blood sugar levels. Do not stop taking this medicine without talking to your doctor first. If you stop taking Sitagliptin/Metformin hydrochloride Mylan, your blood sugar levels may increase again.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

STOP taking Sitagliptin/Metformin Mylan and contact a doctor immediately if you notice any of the following serious side effects:

• Severe and persistent stomach pain (which may radiate to the back) with or without nausea and vomiting, as these may be signs of pancreatitis.

Sitagliptin/Metformin Mylan may cause a very rare but very serious side effect called lactic acidosis (see section “Warnings and precautions”). If this happens, you must stop taking Sitagliptin/Metformin Mylan and contact a doctor or the nearest hospital immediately, as lactic acidosis can lead to coma.

If you have a severe allergic reaction (frequency not known), including skin rash, hives, blisters on the skin/peeling of the skin, and swelling of the face, lips, tongue, and throat that may cause difficulty breathing or swallowing, stop taking this medicine and consult your doctor immediately. Your doctor will prescribe a medicine to treat the allergic reaction and change your diabetes medicine.

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

Common (may affect up to 1 in 10 people): low blood sugar levels, nausea, gas, vomiting

Uncommon (may 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 common).

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

Very common (may affect more than 1 in 10 people): low blood sugar levels

Common: constipation

Some patients have experienced the following side effects when taking this medicine with pioglitazone:

Common: swelling of hands or feet

Some patients have experienced the following side effects when taking this medicine with insulin:

Very common: low blood sugar levels

Uncommon: dry mouth, headache

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

Common: low blood sugar levels, headache, upper respiratory tract infection, nasal congestion or runny nose, and sore throat, osteoarthritis, pain in the arm or leg

Uncommon: dizziness, constipation, itching

Rare: reduced platelet count

Frequency not known: kidney problems (which may require dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of blistering skin condition)

Some patients have experienced the following side effects after taking metformin alone: Very common: nausea, vomiting, diarrhea, stomach pain, and loss of appetite. These symptoms usually occur when you start taking metformin and usually go away

Common: metallic taste

Very rare: reduced vitamin B12 levels, hepatitis (a liver problem), hives, skin rash, or itching

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Sitagliptin/Metformin hydrochloride Mylan

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

Do not use this medicine after the expiry date which is stated on the blister and on the carton after EXP. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help to protect the environment.

6. Contents of the pack and other information

Composition of Sitagliptin/Metformin hydrochloride Mylan

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

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

Appearance of the product and pack contents

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

Sitagliptin/Metformin Mylan is available in:

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

Not all pack sizes may be marketed.

Marketing authorisation 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 further information about this medicine, please contact the local representative of the marketing authorisation holder:

Date of last revision of this leaflet:{MM/AAAA}.

Detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu.