Sitagliptin/metformin hydrochloride Mylan: detailed information

Patient Information Leaflet

Sitagliptin/Metformin Hydrochloride Mylan 50 mg/850 mg Film-coated Tablets

sitagliptin/metformin hydrochloride
Read this entire leaflet carefully before 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. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

What Sitagliptin/Metformin Hydrochloride Mylan is and what it is used for
What you need to know before taking Sitagliptin/Metformin Hydrochloride Mylan
How to take Sitagliptin/Metformin Hydrochloride Mylan
Possible side effects
How to store Sitagliptin/Metformin Hydrochloride Mylan
Contents of the pack and other information

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

Sitagliptin/Metformin Hydrochloride Mylan contains two different active substances called sitagliptin and metformin.

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

Together, they work to control blood sugar levels in adult patients with a form of diabetes called "type 2 diabetes mellitus". This medicine helps increase insulin levels produced after meals and reduces the amount of sugar produced by the body. Along with diet and exercise, this medicine helps lower blood sugar levels. This medicine may be used alone or in combination with certain other diabetes medicines (insulin, sulfonylureas or glitazones).

What is type 2 diabetes?
Type 2 diabetes is a condition in which the body does not produce enough insulin and the insulin produced by the body does not work properly. 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 amputation.

2. What you need to know before taking 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 severely reduced kidney function
if you have uncontrolled diabetes associated, for example, with severe hyperglycaemia (high blood glucose levels), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see below “Risk of lactic acidosis”) or ketoacidosis. Ketoacidosis is a condition in which substances called “ketone bodies” accumulate in the blood and may lead to diabetic pre-coma.

The symptoms include stomach pain, rapid and deep breathing,
drowsiness, and breath with an unusual fruity odour.

if you have a severe infection or are dehydrated
if you are about to undergo radiography involving the use of a contrast medium. You will need to stop taking Sitagliptin/Metformin Hydrochloride Mylan at the time of the radiography 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 breathing difficulties
if you have liver problems
if you drink excessive amounts of alcohol (either regularly or occasionally)
if you are breastfeeding

Do not take Sitagliptin/Metformin Hydrochloride Mylan if you have any of the above conditions
and speak with your doctor about other methods of managing diabetes. If you are unsure, speak with your
doctor, pharmacist, or nurse before taking this medicine.
Warnings and precautions
Cases of inflammation of the pancreas (pancreatitis) have been reported in patients treated with Sitagliptin/Metformin Hydrochloride Mylan (see section 4).
If you develop blisters on your skin, this may be a sign of a condition called bullous pemphigoid. Your doctor may ask you to stop treatment with Sitagliptin/Metformin Hydrochloride Mylan.
Risk of lactic acidosis
Sitagliptin/Metformin Hydrochloride Mylan may cause a very rare but very serious side effect called lactic acidosis, particularly if the kidneys are not functioning properly. The risk of developing lactic acidosis is higher in the presence of uncontrolled diabetes, severe infections, prolonged fasting or alcohol consumption, dehydration (see below for further information), liver problems, or any other medical condition characterized by reduced oxygen supply to part of the body (such as in cases of acute severe heart disease).
If you have any of the medical conditions described above, consult your doctor for further instructions.
Temporarily stop taking Sitagliptin/Metformin Hydrochloride Mylan if you have a medical condition that may be associated with dehydration (significant loss of body fluids), such as severe vomiting, diarrhoea, fever, heat exposure, or if you are drinking less fluid than normal. Consult your doctor for further instructions.
If you experience any of the symptoms of lactic acidosis, stop taking Sitagliptin/Metformin Hydrochloride Mylan and contact your doctor or the nearest hospital immediately, because lactic acidosis may lead to coma.
Symptoms of lactic acidosis include:

vomiting
stomach ache (abdominal pain)
muscle cramps
a general feeling of discomfort associated with severe fatigue
difficulty breathing
reduced body temperature and slower heart rate

Lactic acidosis is a medical emergency and must be treated in hospital.
Consult your doctor or pharmacist before taking Sitagliptin/Metformin Hydrochloride Mylan:

if you have or have had a pancreatic disease (such as pancreatitis)
if you have or have had gallstones, alcohol dependence, or very high levels of triglycerides (a type of fat) in the blood. These medical conditions may increase your risk of developing pancreatitis (see section 4)
if you have type 1 diabetes. This is sometimes called 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, diabetes medicines, together with sitagliptin/metformin hydrochloride, as excessively low blood sugar levels (hypoglycaemia) may occur. Your doctor may reduce the dose of sulfonylurea or insulin.

If you are undergoing major surgery, you must stop taking Sitagliptin/Metformin Hydrochloride Mylan during and after the procedure for a certain period of time. Your doctor will decide when to stop and when to restart treatment with Sitagliptin/Metformin Hydrochloride Mylan.
If you are unsure whether any of the above conditions apply 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 frequently if you are elderly and/or if kidney function worsens.
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 not known whether this medicine is safe and effective when used in children under 10 years of age.
Other medicines and Sitagliptin/Metformin Hydrochloride Mylan
If you are to receive an injection of an iodinated contrast medium into the bloodstream, for example for radiography, you must stop taking Sitagliptin/Metformin Hydrochloride Mylan before or during the injection. Your doctor will decide when to stop and when to restart treatment with Sitagliptin/Metformin Hydrochloride Mylan.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. You may need to check your blood glucose and kidney function more frequently, or your doctor may decide to adjust the dose of Sitagliptin/Metformin Hydrochloride Mylan. It is particularly important to mention the following:

medicines (taken orally, inhaled, or injected) 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 the treatment of 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
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 the treatment of irregular heartbeat and other heart-related problems). It may be necessary to monitor digoxin blood levels if taken together with Sitagliptin/Metformin Hydrochloride Mylan.

Sitagliptin/Metformin Hydrochloride Mylan and alcohol
Avoid excessive alcohol consumption during treatment with 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, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine. You must not take this medicine during pregnancy. Do not take this medicine if you are breastfeeding. See section 2, Do not take Sitagliptin/Metformin Hydrochloride Mylan.
Driving and using machines
This medicine has no or negligible effect on the ability to drive and use machines. However, dizziness and drowsiness have been reported with sitagliptin, which may affect your ability to drive and use machines.
Taking this medicine together with other medicines called sulfonylureas or with insulin may cause hypoglycaemia, which may affect your ability to drive, use machines, or work without protective barriers.
Sitagliptin/Metformin Hydrochloride Mylan contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Sitagliptin/Metformin hydrochloride Mylan

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Take one tablet:
twice daily by mouth,
with meals to reduce the likelihood of stomach upset.
Your doctor may need to increase your dose to help control the sugar level in your blood.
If you have reduced kidney function, your doctor may prescribe you a lower dose.

You must continue the diet recommended by your doctor during treatment with this medicine and ensure that carbohydrate intake is evenly distributed throughout the day.
It is unlikely that this medicine alone will cause abnormally low blood sugar levels (hypoglycaemia). However, when this medicine is used together with a sulphonylurea or insulin, low blood sugar may occur, and your doctor may reduce your dose of sulphonylurea or insulin.

If you take more Sitagliptin/Metformin hydrochloride Mylan than you should
If you take more of this medicine than prescribed, contact your doctor immediately. Go to hospital if you experience 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 Sitagliptin/Metformin hydrochloride Mylan
If you miss 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 take your next dose at the usual time. Do not take a double dose of this medicine.

If you stop taking Sitagliptin/Metformin hydrochloride Mylan
Continue taking this medicine for as long as your doctor prescribes it, so that you can keep your blood sugar level under control. Do not stop taking this medicine without first talking to your doctor. If you stop taking Sitagliptin/Metformin hydrochloride Mylan, your blood sugar level may rise again.

If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
STOP taking Sitagliptin/Metformin Hydrochloride Mylan and contact your doctor immediately if you
experience any of the following serious side effects:

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

Sitagliptin/Metformin Hydrochloride Mylan may cause a very rare (may affect up to 1 in 10,000 people) but very serious side effect called lactic acidosis (see section “Warnings and precautions”). If this occurs, you must stop taking Sitagliptin/Metformin Hydrochloride Mylan and must seek immediate medical advice from your doctor or the nearest hospital, because lactic acidosis can lead to coma.

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

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

Common (may affect up to 1 in 10 people): low blood sugar levels, nausea, flatulence, vomiting
Uncommon (may affect up to 1 in 100 people): stomach ache, diarrhoea, constipation, drowsiness

Some patients have experienced diarrhoea, nausea, flatulence, constipation, stomach ache, or vomiting when starting treatment with the combination of sitagliptin and metformin together (frequency is 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 in combination with pioglitazone:

Common: swelling of the hands or legs

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

Very common: low blood sugar levels
Uncommon: dry mouth, headache

During clinical studies, some patients experienced the following side effects when taking sitagliptin alone (one of the medicines contained in Sitagliptin/Metformin Hydrochloride Mylan) or during post-marketing use of Sitagliptin/Metformin Hydrochloride Mylan or sitagliptin alone or in combination with other diabetes medicines:

Common: low blood sugar levels, headache, upper respiratory tract infection, stuffy or runny nose and sore throat, osteoarthritis, pain in arms or legs
Uncommon: dizziness, constipation, itching sensation
Rare: reduced platelet count
Frequency not known: kidney problems (sometimes requiring dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of skin blister)

Some patients taking metformin alone have experienced the following side effects:

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

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

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly through the national reporting system referred to in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sitagliptin/Metformin Hydrochloride Mylan

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after “EXP”.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Sitagliptin/Metformin hydrochloride Mylan contains

The active substances are sitagliptin and metformin.
Each 50 mg/850 mg film-coated tablet (tablet) contains sitagliptin hydrochloride monohydrate equivalent to 50 mg of sitagliptin and 850 mg of metformin hydrochloride.
The other components are microcrystalline cellulose, anhydrous colloidal silica, croscarmellose sodium, sodium lauryl sulfate, povidone, sodium stearyl fumarate, polyvinyl alcohol, macrogol, talc,

titanium dioxide (E171), red iron oxide (E172) and yellow iron oxide (E172). See
section 2 “Sitagliptin/Metformin hydrochloride Mylan contains sodium”.
Description of the appearance of Sitagliptin/Metformin hydrochloride Mylan and pack contents
The 50 mg/850 mg tablet is a pink, capsule-shaped, biconvex tablet with bevelled edges, marked with “M” on one side and “SM5” on the other.
Sitagliptin/Metformin hydrochloride 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
divisible 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.

Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan Pharmaceuticals Limited
Damastown Industrial Park,
Mulhuddart, Dublin 15,
DUBLIN
Ireland
Manufacturer(s)
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:
België/Belgique/Belgien Lietuva*
Viatris Viatris UAB
Tél/Tel: + 32 (0)2 658 61 00 Tel: +370 5 205 1288
България Luxembourg/Luxemburg
Майлан ЕООД Viatris
Тел.: +359 2 44 55 400 Tél/Tel: + 32 (0)2 658 61 00
(Belgique/Belgien)
Česká republika Magyarország
Viatris CZ s.r.o. Viatris Healthcare Kft.
Tel: + 420 222 004 400 Tel.: + 36 1 465 2100
Danmark* Malta
Viatris ApS V.J. Salomone Pharma Ltd
Tlf: +45 28 11 69 32 Tel: + 356 21 22 01 74
Deutschland Nederland
Viatris Healthcare GmbH Mylan BV
Tel: +49 800 0700 800 Tel: +31 (0)20 426 3300
Eesti* Norge*
Viatris OÜ Viatris AS
Tel: + 372 6363 052 Tlf: + 47 66 75 33 00
Ελλάδα Österreich
Viatris Hellas Ltd Viatris Austria GmbH
Τηλ: +30 2100 100 002 Tel: +43 1 86390
España Polska
Viatris Pharmaceuticals, S.L. Viatris Healthcare Sp. z o.o.
Tel: + 34 900 102 712 Tel.: + 48 22 546 64 00
France* Portugal
Viatris Santé Mylan, Lda.
Tél: +33 4 37 25 75 00 Tel: + 351 21 412 72 00
Hrvatska România
Viatris Hrvatska d.o.o. BGP Products SRL
Tel: +385 1 23 50 599 Tel: +40 372 579 000
Ireland Slovenija
Viatris Limited Viatris d.o.o.
Tel: +353 1 8711600 Tel: + 386 1 23 63 180
Ísland* Slovenská republika
Icepharma hf. Viatris Slovakia s.r.o.
Sími: +354 540 8000 Tel: +421 2 32 199 100
Italia Suomi/Finland*
Viatris Italia S.r.l. Viatris Oy
Tel: + 39 (0)2 612 46921 Puh/Tel: +358 20 720 9555
Κύπρος Sverige*
GPA Pharmaceuticals Ltd Viatris AB
Τηλ: +357 22863100 Tel: +46 (0)8 630 19 00
Latvija* United Kingdom (Northern Ireland)
Viatris SIA Mylan IRE Healthcare Limited
Tel: +371 676 055 80 Tel: +353 18711600
More detailed information on this medicine is available on the website of the European Medicines Agency, http://www.ema.europa.eu .

Patient information leaflet

Sitagliptin/Metformin Hydrochloride Mylan 50 mg/1,000 mg Film-coated Tablets

sitagliptin/metformin hydrochloride
Please read this leaflet carefully before 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. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

What Sitagliptin/Metformin Hydrochloride Mylan is and what it is used for
What you need to know before taking Sitagliptin/Metformin Hydrochloride Mylan
How to take Sitagliptin/Metformin Hydrochloride Mylan
Possible side effects
How to store Sitagliptin/Metformin Hydrochloride Mylan
Package contents and other information

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

Sitagliptin/Metformin Hydrochloride Mylan contains two different active substances called sitagliptin and metformine.

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 increase insulin levels produced after meals and reduces the amount of sugar produced by the body.
Together with diet and physical exercise, this medicine helps lower blood sugar levels. This medicine may be used alone or in combination with certain other diabetes medicines (insulin, sulfonylureas or glitazones).
What is type 2 diabetes?
Type 2 diabetes is a condition in which the body does not produce enough insulin and the insulin produced by the body does not work properly 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 amputation.

2. What you should know before taking 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 severely reduced kidney function
if you have uncontrolled diabetes associated, for example, with severe hyperglycaemia (high blood glucose levels), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see below “Risk of lactic acidosis”) or ketoacidosis. Ketoacidosis is a condition in which substances called “ketone bodies” accumulate in the blood and may lead to diabetic pre-coma.

Symptoms include stomach pain, rapid and deep breathing,
drowsiness and breath with an unusual fruity odour.
if you have a severe infection or are dehydrated
if you are about to have a radiographic examination involving the use of a contrast agent. You will need to stop taking Sitagliptin/Metformin Hydrochloride Mylan at the time of the radiographic examination 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 breathing difficulties
if you have liver problems
if you drink excessive amounts of alcohol (either regularly or occasionally)
if you are breastfeeding

Do not take Sitagliptin/Metformin Hydrochloride Mylan if you have any of the conditions listed above
and speak with your doctor about other methods of managing diabetes. If you are unsure, speak with your
doctor, pharmacist, or nurse before taking this medicine.
Warnings and precautions
Cases of inflammation of the pancreas (pancreatitis) have been reported in patients treated with Sitagliptin/Metformin Hydrochloride Mylan (see section 4).
If you develop blisters on your skin, this may be a sign of a condition called bullous pemphigoid. Your doctor may ask you to stop treatment with Sitagliptin/Metformin Hydrochloride Mylan.
Risk of lactic acidosis
Sitagliptin/Metformin Hydrochloride Mylan may cause a very rare but serious side effect called lactic acidosis, particularly if the kidneys are not functioning properly. The risk of developing lactic acidosis is higher in the presence of uncontrolled diabetes, severe infections, prolonged fasting, alcohol consumption, dehydration (see below for further information), liver problems, or any other medical condition characterised by reduced oxygen supply to part of the body (such as in cases of severe acute heart disease).
If you have any of the medical conditions described above, consult your doctor for further instructions.
Stop taking Sitagliptin/Metformin Hydrochloride Mylan temporarily if you develop a medical condition that may be associated with dehydration (significant loss of body fluids), such as severe vomiting, diarrhoea, fever, heat exposure, or if you are drinking less fluid than usual. Consult your doctor for further instructions.
If you experience any of the symptoms of lactic acidosis, stop taking Sitagliptin/Metformin Hydrochloride Mylan and contact your doctor or the nearest hospital immediately, because lactic acidosis can lead to coma.
Symptoms of lactic acidosis include:

vomiting
stomach ache (abdominal pain)
muscle cramps
a general feeling of discomfort associated with severe fatigue
difficulty breathing
lowered body temperature and slower heart rate

Lactic acidosis is a medical emergency and must be treated in hospital.
Consult your doctor or pharmacist before taking Sitagliptin/Metformin Hydrochloride Mylan:

if you have or have had a disease of the pancreas (such as pancreatitis)
if you have or have had gallstones, alcohol dependence, or very high levels of triglycerides (a type of fat) in the blood. These medical conditions may increase your risk of developing pancreatitis (see section 4)
if you have type 1 diabetes. This is sometimes called 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 sulphonylurea or insulin, medicines for diabetes, together with sitagliptin/metformin hydrochloride, as excessively low blood sugar levels (hypoglycaemia) may occur. Your doctor may reduce the dose of the sulphonylurea or insulin.

If you are undergoing major surgery, you must stop taking Sitagliptin/Metformin Hydrochloride Mylan during and for a certain period after the procedure. Your doctor will decide when you should stop and when you should restart treatment with Sitagliptin/Metformin Hydrochloride Mylan.
If you are unsure whether any of the conditions listed above apply 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 frequently if you are elderly and/or if kidney function worsens.
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 not known whether this medicine is safe and effective when used in children under 10 years of age.
Other medicines and Sitagliptin/Metformin Hydrochloride Mylan
If you are due to receive an injection of an iodinated contrast agent into the bloodstream, for example for a radiographic examination, you must stop taking Sitagliptin/Metformin Hydrochloride Mylan before or during the injection. Your doctor will decide when you should stop and when you should restart treatment with Sitagliptin/Metformin Hydrochloride Mylan.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. You may need to monitor your blood glucose and kidney function more frequently, or your doctor may decide to adjust the dose of Sitagliptin/Metformin Hydrochloride Mylan. It is particularly important to mention the following:

medicines (taken orally, by inhalation, or by injection) used to treat inflammatory diseases, 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 the treatment of 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
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 the treatment of irregular heartbeat and other heart-related problems). It may be necessary to monitor digoxin blood levels if taken together with Sitagliptin/Metformin Hydrochloride Mylan.

Sitagliptin/Metformin Hydrochloride Mylan and alcohol
Avoid excessive alcohol consumption during treatment with 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, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine. You must not take this medicine during pregnancy. Do not take this medicine if you are breastfeeding. See section 2, Do not take Sitagliptin/Metformin Hydrochloride Mylan.
Driving and using machines
This medicine has no effect or has a negligible effect on the ability to drive and use machines. However, dizziness and drowsiness have been reported with sitagliptin, which may affect your ability to drive and use machines.
Taking this medicine together with other medicines called sulphonylureas or with insulin may cause hypoglycaemia, which may affect your ability to drive, use machines, or work without protective barriers.
Sitagliptin/Metformin Hydrochloride Mylan contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Sitagliptin/Metformin hydrochloride Mylan

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.

Take one tablet:
twice daily by mouth,
with meals to reduce the likelihood of stomach problems.
Your doctor may need to increase your dose to control the sugar levels in your blood.
If you have reduced kidney function, your doctor may prescribe you a lower dose.

You must continue the diet recommended by your doctor during treatment with this medicine and ensure that carbohydrate intake is evenly distributed throughout the day.
It is unlikely that this medicine alone will cause abnormally low blood sugar levels (hypoglycaemia). However, when this medicine is used together with a sulphonylurea or insulin, low blood sugar may occur and your doctor may reduce your dose of sulphonylurea or insulin.

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 it is time for your next dose, skip the missed dose and take your next dose at the regular time. Do not take a double dose of this medicine.

If you stop taking Sitagliptin/Metformin hydrochloride Mylan
Continue taking this medicine for as long as your doctor prescribes it, so that you can keep controlling your blood sugar levels. Do not stop taking this medicine without first talking to your doctor. If you stop taking Sitagliptin/Metformin hydrochloride Mylan, your blood sugar levels may rise again.

If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
STOP taking Sitagliptin/Metformin Hydrochloride Mylan and contact your doctor immediately if you notice any of the following serious side effects:

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

If you experience a severe allergic reaction (frequency not known), including rash, hives, skin blisters/skin peeling, and swelling of the face, lips, tongue, or throat, which may cause difficulty breathing or swallowing, stop treatment with this medicine and contact your doctor immediately. Your doctor may prescribe a medicine to treat your allergic reaction and a different medicine for your diabetes.

Some patients taking 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, flatulence, vomiting
Uncommon (may affect up to 1 in 100 people): stomach ache, diarrhoea, constipation, drowsiness

Some patients have experienced the following side effects while 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 while taking this medicine in combination with pioglitazone:
Common: swelling of the hands or legs

Some patients have experienced the following side effects while taking this medicine in combination with insulin:
Very common: low blood sugar levels
Uncommon: dry mouth, headache

During clinical studies, some patients experienced the following side effects while taking sitagliptin alone (one of the medicines contained in Sitagliptin/Metformin Hydrochloride Mylan) or during post-marketing use of Sitagliptin/Metformin Hydrochloride Mylan or sitagliptin alone or in combination with other diabetes medicines:
Common: low blood sugar levels, headache, upper respiratory tract infection, stuffy or runny nose and sore throat, osteoarthritis, pain in arms or legs
Uncommon: dizziness, constipation, itching sensation
Rare: reduced platelet count
Frequency not known: kidney problems (sometimes requiring dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of skin blistering)

Some patients taking metformin alone have experienced the following side effects:
Very common: nausea, vomiting, diarrhoea, stomach ache, and loss of appetite. These symptoms may occur when you first start taking metformin and usually disappear:
Common: metallic taste, low or decreased blood levels of vitamin B12 (symptoms may include extreme tiredness (fatigue), sore and red tongue (glossitis), tingling (paraesthesia), or yellowish or pale skin). Your doctor may order some tests to determine the cause of the symptoms, as some of these may also be caused by diabetes or other unrelated health problems.
Very rare: hepatitis (a liver problem), urticaria, skin redness (rash), or itching sensation.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system referred to in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sitagliptin/Metformin hydrochloride Mylan

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after "EXP".
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Sitagliptin/Metformin Hydrochloride Mylan contains

The active substances are sitagliptin and metformin.
Each 50 mg/1.000 mg film-coated tablet contains sitagliptine hydrochloride monohydrate equivalent to 50 mg of sitagliptin and 1.000 mg of metformin hydrochloride.
The other components are microcrystalline cellulose, anhydrous colloidal silica, croscarmellose sodium, sodium lauryl sulfate, 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 Hydrochloride Mylan contains sodium”.

Description of the appearance of Sitagliptin/Metformin Hydrochloride Mylan and contents of the pack
The 50 mg/1.000 mg tablet is a capsule-shaped, peach to brown coloured, biconvex tablet with bevelled edges, marked with “M” on one side and “SM7” on the other.
Sitagliptin/Metformin Hydrochloride 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
divisible 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.

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Lietuva*
Viatris Viatris UAB
Tél/Tel: + 32 (0)2 658 61 00 Tel: +370 5 205 1288
България Luxembourg/Luxemburg
Mylan EOOD Viatris
Tel.: +359 2 44 55 400 Tél/Tel: + 32 (0)2 658 61 00
(Belgique/Belgien)
Česká republika Magyarország
Viatris CZ s.r.o. Viatris Healthcare Kft.
Tel: + 420 222 004 400 Tel.: + 36 1 465 2100
Danmark* Malta
Viatris ApS V.J. Salomone Pharma Ltd
Tlf: +45 28 11 69 32 Tel: + 356 21 22 01 74
Deutschland Nederland
Viatris Healthcare GmbH Mylan BV
Tel: +49 800 0700 800 Tel: +31 (0)20 426 3300
Eesti* Norge*
Viatris OÜ Viatris AS
Tel: + 372 6363 052 Tlf: + 47 66 75 33 00
Ελλάδα Österreich
Viatris Hellas Ltd Viatris Austria GmbH
Tel: +30 2100 100 002 Tel: +43 1 86390
España Polska
Viatris Pharmaceuticals, S.L. Viatris Healthcare Sp. z o.o.
Tel: + 34 900 102 712 Tel.: + 48 22 546 64 00
France* Portugal
Viatris Santé Mylan, Lda.
Tél: +33 4 37 25 75 00 Tel: + 351 21 412 72 00
Hrvatska România
Viatris Hrvatska d.o.o. BGP Products SRL
Tel: +385 1 23 50 599 Tel: +40 372 579 000
Ireland Slovenija
Viatris Limited Viatris d.o.o.
Tel: +353 1 8711600 Tel: + 386 1 23 63 180
Ísland* Slovenská republika
Icepharma hf. Viatris Slovakia s.r.o.
Sími: +354 540 8000 Tel: +421 2 32 199 100
Italia Suomi/Finland*
Viatris Italia S.r.l. Viatris Oy
Tel: + 39 (0)2 612 46921 Puh/Tel: +358 20 720 9555
Κύπρος Sverige*
GPA Pharmaceuticals Ltd Viatris AB
Tel: +357 22863100 Tel: +46 (0)8 630 19 00
Latvija* United Kingdom (Northern Ireland)
Viatris SIA Mylan IRE Healthcare Limited
Tel: +371 676 055 80 Tel: +353 18711600

More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.