Sitagliptin/metformin Mylan 50 mg/1000 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

sitagliptin/metformin hydrochloride

Read the entire 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 questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you. It may harm them.
• If you experience any adverse effects, talk to your doctor, pharmacist or nurse, even if the adverse effects are not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Sitagliptina/Metformina Mylan is and what it is used for

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

• Sitagliptin belongs to a group of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors).
• Metformin belongs to a group 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 increase the levels of insulin produced after a meal and reduces the amount of sugar made by your body.

Together with diet and exercise, this medicine helps you lower your blood sugar level. This medicine can be used alone or in combination with certain diabetes medicines (insulin, sulfonylureas, or glitazones).

What is type 2 diabetes?

Type 2 diabetes is a condition in which your body does not produce enough insulin and the insulin your body does produce 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 (cardiovascular) disease, kidney (renal) disease, blindness, and amputations.

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

Do not take Sitagliptin/Metformin Mylan:

• if you are allergic to sitagliptin, metformin, or any of the other ingredients of this medicine (listed in section 6)
• if you have severely reduced kidney function
• if you have uncontrolled diabetes with, for example, severe hyperglycemia (high blood glucose), 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 may lead to diabetic pre-coma. Symptoms include stomach pain, rapid and deep breathing, drowsiness, or fruity-smelling breath
• if you have a serious infection or are dehydrated
• if you are scheduled for an X-ray requiring injection of a contrast agent. You will need to stop taking Sitagliptin/Metformin Mylan at the time of the scan and for 2 or more days afterwards, as directed by your doctor, depending on how well your kidneys are functioning
• if you have recently had a heart attack or have serious circulatory problems, such as shock or difficulty breathing
• if you have liver problems (hepatic impairment)
• if you drink alcohol excessively (either daily or intermittently)
• if you are breastfeeding.

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

Warnings and precautions

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

If you develop blisters on the skin, this may be a sign of a condition called bullous pemphigoid. Your doctor may ask you to stop taking Sitagliptin/Metformin Mylan.

Risk of lactic acidosis

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

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

Stop taking Sitagliptin/Metformin Mylan temporarily if you develop a condition that may lead to dehydration (significant loss of body fluids), such as severe vomiting, diarrhea, fever, heat exposure, or if you are drinking less fluid than usual. Consult your doctor for further instructions.

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

Symptoms of lactic acidosis include:

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

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

Contact your doctor promptly for advice if:

• You are known to have a genetic mitochondrial disease (components that produce energy inside cells), such as MELAS syndrome (mitochondrial encephalopathy, myopathy, lactic acidosis, and stroke-like episodes) or maternally inherited diabetes and deafness (MIDD).
• You experience any of the following symptoms after starting treatment with metformin: seizures, cognitive decline, difficulty with body movements, signs of nerve damage (e.g., pain or numbness), migraine, or hearing loss.

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

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

If you require major surgery, you must stop taking Sitagliptin/Metformin Mylan during the procedure and for a period afterwards. Your doctor will decide when to interrupt and when to restart treatment with Sitagliptin/Metformin Mylan.

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

During treatment with Sitagliptin/Metformin Mylan, your doctor will monitor your kidney function at least once a year, or more frequently if you are elderly and/or if your kidney function is deteriorating.

Children and adolescents

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

It is not effective in children and adolescents aged between 10 and 17 years. It is unknown whether this medicine is safe and effective in children under 10 years of age.

Other medicines and Sitagliptin/Metformin Mylan

If you need to receive an intravenous injection of an iodine-containing contrast agent, for example during an X-ray or scan, you must stop taking Sitagliptin/Metformin Mylan before or at the time of injection. Your doctor will decide when to interrupt and when to restart treatment with Sitagliptin/Metformin Mylan.

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

• medicines (taken orally, by inhalation, or by injection) used to treat inflammatory conditions 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)
• specific medicines for bronchial asthma (β-sympathomimetics)
• iodinated contrast agents or medicines containing 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 (to treat irregular heartbeat and other heart problems). Blood levels of digoxin may need to be monitored if you are taking Sitagliptin/Metformin Mylan.

Taking Sitagliptin/Metformin Mylan with alcohol

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. You must not take this medicine during pregnancy or while breastfeeding. See section 2, Do not take Sitagliptin/Metformin Mylan.

Driving and using machines

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

Taking this medicine together with medicines called sulfonylureas or with insulin may cause hypoglycemia, which may affect your ability to drive and use machines or work without secure support.

Sitagliptin/Metformin Mylan contains sodium

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

3. How to take Sitagliptina/Metformina Mylan

Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

• Take one tablet:

• twice daily, orally

• with food to reduce the likelihood of stomach discomfort

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

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

You must continue the diet recommended by your doctor during treatment with this medicine and take care to ensure that carbohydrate intake is evenly distributed throughout the day.

It is unlikely that treatment with this medicine alone will cause abnormally low blood sugar (hypoglycaemia). Low blood sugar may occur when this medicine is taken together with a medicine containing a sulphonylurea or with insulin, so your doctor may consider it necessary to reduce the dose of your sulphonylurea or insulin.

If you take more Sitagliptina/Metformina Mylan than you should

If you take more than the prescribed dose of this medicine, contact your doctor immediately. Go to hospital if you have symptoms of lactic acidosis such as feeling cold or unwell, severe nausea or vomiting, stomach pain, unexplained weight loss, muscle cramps or rapid breathing (see section “Warnings and precautions”).

If you forget to take Sitagliptina/Metformina Mylan

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

If you stop taking Sitagliptina/Metformina Mylan

Keep taking this medicine for as long as your doctor tells you, to help control your blood sugar levels. You should not stop taking this medicine without first consulting your doctor. If you stop taking Sitagliptina/Metformina Mylan, your blood sugar levels may rise again.

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

4. Possible adverse effects

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

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

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

Sitagliptin/Metformin Mylan may cause a very rare (may affect up to 1 in 10,000 people), but very serious adverse effect called lactic acidosis (see section “Warnings and precautions”). If this occurs, you must stop taking Sitagliptin/Metformin Mylan and contact a doctor or go to 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, skin blistering or peeling, or swelling of the face, lips, tongue, and throat that may cause difficulty breathing or swallowing, stop taking this medicine and contact your doctor immediately. Your doctor will prescribe a medicine to treat the allergic reaction and switch you to a different medicine for the treatment of diabetes.

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

• Frequent (may affect up to 1 in 10 people): low blood sugar level, nausea, flatulence, vomiting.

• Uncommon (may affect up to 1 in 100 people): stomach pain, diarrhoea, constipation, drowsiness.

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

Some patients experienced the following adverse effects when taking this medicine in combination with a sulfonylurea such as glimepiride:

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

• Frequent: constipation.

Some patients experienced the following adverse effects while taking this medicine in combination with pioglitazone:

• Frequent: swelling of hands or legs.

Some patients experienced the following adverse effects while taking this medicine in combination with insulin:

• Very common: low blood sugar levels.

• Uncommon: dry mouth, headache.

Some patients experienced the following adverse effects during clinical studies while taking sitagliptin alone (one of the medicines contained in Sitagliptin/Metformin Mylan) or during post-marketing use of Sitagliptin/Metformin Mylan or sitagliptin alone or with other diabetes medicines:

• Frequent: 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: reduction in the number of platelets.

• Frequency not known: kidney problems (sometimes requiring dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of blistering skin condition).

Some patients experienced the following adverse effects after taking metformin alone:

• Very common: nausea, vomiting, diarrhoea, stomach pain, and loss of appetite. These symptoms may occur when you first start taking metformin and usually go away over time.

• Frequent: metallic taste, decreased or low levels of vitamin B12 in the blood (symptoms may include extreme tiredness (fatigue), pain and redness of the tongue (glossitis), tingling (paraesthesia), or pale or yellowish skin). Your doctor may order tests to determine the cause of your symptoms, as some of these may also be caused by diabetes or other unrelated health problems.

• Very rare: hepatitis (a liver problem), hives, skin redness (rash), or itching.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system listed in Appendix V. By reporting adverse 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 outer packaging after EXP. The expiry date corresponds to the last day of the month indicated.

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 and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Sitagliptin/Metformin Mylan

• The active substances are metformin and sitagliptin.

• Each 50 mg/1,000 mg film-coated tablet contains sitagliptin hydrochloride monohydrate equivalent to 50 mg of sitagliptin and 1,000 mg of metformin hydrochloride.

• The other components are microcrystalline cellulose, colloidal anhydrous silica, sodium croscarmellose, sodium lauryl sulfate, povidone, sodium fumarate stearate, 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 contents of the pack

The 50 mg/1,000 mg tablet is an oblong-shaped, peach to brown, biconvex tablet with bevelled edges, marked with “M” on one side and “SM7” on the other.

Sitagliptin/Metformin Mylan is available in:

• blister packs containing 14, 56, 98 or 196 film-coated tablets,
• multiple pack containing 196 (2 x 98) film-coated tablets,
• unit 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 Pharmaceuticals Limited

Damastown Industrial Park,

Mulhuddart, Dublin 15,

DUBLIN

Ireland

Manufacturers

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 medicinal product, please contact the local representative of the Marketing Authorization Holder:

Date of the last review of this leaflet:

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