Sitagliptin and metformin Mylan Italia: detailed information

Package leaflet: Information for the patient

Sitagliptin and Metformin Mylan Italia 50 mg/850 mg film-coated tablets, mg/1000 mg film-coated tablets

sitagliptin/metformin hydrochloride
Generic medicine
Please read all of 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 or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Sitagliptin and Metformin Mylan Italia contains two different medicines 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.

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. Along with diet and exercise, this medicine helps lower blood sugar levels. This medicine may be used alone or together 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 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 amputation.

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

Do not take Sitagliptin and Metformin Mylan Italia:

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, or breath with an unusual fruity odour
if you have a severe infection or are dehydrated
if you are about to undergo an X-ray procedure involving injection of a contrast agent. You will need to stop taking Sitagliptin and Metformin Mylan Italia at the time of the X-ray 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 and Metformin Mylan Italia if you have any of the above conditions and
speak with your doctor about other methods of managing diabetes. If you are unsure, consult your
doctor or pharmacist before taking Sitagliptin and Metformin Mylan Italia.
Warnings and precautions
Cases of inflammation of the pancreas (pancreatitis) have been reported in patients treated with sitagliptin/metformina (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 and Metformin Mylan Italia.
Risk of lactic acidosis
Sitagliptin and Metformin Mylan Italia 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 also 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 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 listed above, consult your doctor for further instructions.
Temporarily stop taking Sitagliptin and Metformin Mylan Italia if you have a medical condition
that may be associated with dehydration (significant loss of body fluids), such as severe vomiting, diarrhoea, fever, exposure to heat, 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 and
Metformin Mylan Italia and contact your doctor or the nearest hospital immediately, as this
condition may lead to coma.
Symptoms of lactic acidosis include:

vomiting,
stomach ache (abdominal pain),
muscle cramps,
a general feeling of being unwell associated with severe fatigue,
difficulty breathing,
low body temperature and heart rate.

Lactic acidosis is a medical emergency and must be treated in hospital.
Contact your doctor immediately for further instructions if:

you know you have a hereditary genetic disease affecting mitochondria (the components that produce energy within 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 metformin: seizures, decreased cognitive ability, difficulty with body movements, symptoms indicating nerve damage (e.g. pain or numbness), headache, or hearing loss.

Consult your doctor or pharmacist before taking Sitagliptin and Metformin Mylan Italia:

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 and Metformin Mylan Italia (see section 4),
if you are taking a sulphonylurea or insulin, medicines for diabetes, together with Sitagliptin and Metformin Mylan Italia, as this may cause low blood sugar levels (hypoglycaemia). Your doctor may reduce the dose of the sulphonylurea or insulin.

If you are undergoing major surgery, you must stop taking Sitagliptin and Metformin Mylan Italia during the procedure and for a certain period afterwards. Your doctor will decide when you should stop and when you should restart treatment with Sitagliptin and Metformin Mylan Italia.
If you are unsure whether any of the conditions listed above apply to you, consult your doctor or pharmacist before taking Sitagliptin and Metformin Mylan Italia.
During treatment with Sitagliptin and Metformin Mylan Italia, your doctor will monitor 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 and Metformin Mylan Italia
If you are due to receive an injection of iodinated contrast medium into the bloodstream, for example for an X-ray, you must stop taking Sitagliptin and Metformin Mylan Italia before or at the time of the injection. Your doctor will decide when you should stop and when you should restart treatment with Sitagliptin and Metformin Mylan Italia.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. You may need to have more frequent blood sugar and kidney function tests, or your doctor may decide to adjust the dose of Sitagliptin and Metformin Mylan Italia. It is particularly important to mention the following:

medicines (taken orally, inhaled, or injected) 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 for 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,
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 treating irregular heartbeat and other heart problems). It may be necessary to monitor digoxin blood levels if taken together with Sitagliptin and Metformin Mylan Italia.

Sitagliptin and Metformin Mylan Italia and alcohol
Avoid excessive alcohol consumption during treatment with Sitagliptin and Metformin Mylan Italia, 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 and Metformin Mylan Italia”.
Driving and using machines
This medicine has no effect or has a negligible effect on the ability to drive vehicles 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 and Metformin Mylan Italia 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 and Metformin Mylan Italia

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 help control your blood sugar levels.
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 need to reduce the dose of the sulphonylurea or insulin.

If you take more Sitagliptin and Metformin Mylan Italia 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 and Metformin Mylan Italia
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 and Metformin Mylan Italia
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 treatment with Sitagliptin and Metformin Mylan Italia, 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 gets them.
STOP taking Sitagliptin and Metformin Mylan Italia and contact a doctor immediately if you experience any of the following serious side effects:

Severe and 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 and Metformin Mylan Italia 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 and Metformin Mylan Italia and seek immediate medical attention at the nearest doctor or hospital, as lactic acidosis can lead to coma.

If you experience a severe allergic reaction (frequency not known), including rash, hives, blistering of the skin/desquamation of the skin, 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 therapy with sitagliptin:
Common (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 ache, diarrhoea, constipation, drowsiness.

Some patients have experienced diarrhoea, nausea, flatulence, constipation, stomach ache, or vomiting when starting combination therapy with sitagliptin and metformin together (frequency is common).

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 level
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 level.
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 and Metformin Mylan Italia) or during post-marketing use of Sitagliptin and Metformin Mylan Italia or sitagliptin alone or in combination with other diabetes medicines:
Common: low blood sugar level, headache, upper respiratory tract infection, stuffy or runny nose, 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 resolve over time.
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 request blood tests to determine the cause of these symptoms, as some of them may also be caused by diabetes or other unrelated health conditions.
Very rare: hepatitis (a liver problem), hives, 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 at the website https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sitagliptin and Metformin Mylan Italia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and carton after "EXP". The expiry date refers to the last day of that month.
Do not store above 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Sitagliptin and Metformin Mylan Italia contains

The active substances are sitagliptin and metformin. Each film-coated tablet contains sitagliptin monohydrochloride monohydrate equivalent to 50 mg of sitagliptin and 850 mg of metformin hydrochloride.
The active substances are sitagliptin and metformin. Each film-coated tablet contains sitagliptin monohydrochloride monohydrate equivalent to 50 mg of sitagliptin and 1000 mg of metformin hydrochloride.

The other components are:
Tablet core – microcrystalline cellulose (Avicel PH 102), povidone, sodium lauryl sulfate, magnesium stearate;
Tablet coating for Sitagliptin and Metformin Mylan Italia 50 mg/850 mg (Opadry QX Pink) – polyvinyl alcohol-polyethylene glycol graft copolymer (PEG) (E1209), talc (E553b), titanium dioxide (E171), mono- and diglycerides of fatty acids (E471), polyvinyl alcohol (E1203), red iron oxide (E172);
Tablet coating for Sitagliptin and Metformin Mylan Italia 50 mg/1000 mg (Opadry QX Brown) – polyvinyl alcohol-polyethylene glycol graft copolymer (PEG) (E1209), talc (E553b), titanium dioxide (E171), red iron oxide (E172), mono- and diglycerides of fatty acids (E471), polyvinyl alcohol (E1203), black iron oxide (E172).

Description of the appearance of Sitagliptin and Metformin Mylan Italia and package contents
Sitagliptin and Metformin Mylan Italia 50 mg/850 mg film-coated tablets are oval, biconvex, approximately 20.5 mm x 9.5 mm, pink, marked with "S476" on one side and smooth on the other.
Sitagliptin and Metformin Mylan Italia 50 mg/1000 mg film-coated tablets are oval, biconvex, approximately 21.5 mm x 10.0 mm, brown, marked with "S477" on one side and smooth on the other.

PVC/PVdC-Aluminium blisters
Pack sizes: 14, 28, 56, 60 and 196 film-coated tablets.
HDPE bottle with PP cap containing silica gel as desiccant.
Pack size: 196 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder
Mylan S.p.A.
Via Vittor Pisani 20
20124 Milano
Italy

Manufacturer
LABORATORIOS LICONSA S.A.
Avenida Miralcampo, 7
Poligono Industrial Miralcampo
19200 Azuqueca de Henares (Guadalajara)
Spain

This medicinal product is authorized in the European Economic Area Member States under the following names:
Czech Republic: SITAGLIPTIN/METFORMIN VIATRIS
Finland: Sitagliptin/Metformin Viatris 50 mg/850 mg, 50 mg/1000 mg film-coated tablets
France: Sitagliptine/Metformine VIATRIS SANTE 50 mg/1000 mg, comprimé pelliculé
Germany: Sitagliptin Metformin Viatris 50 mg/850 mg Filmtabletten
Sitagliptin Metformin Viatris 50 mg/1000 mg Filmtabletten
Iceland: Sitagliptin Metformin Zentiva
Italy: Sitagliptin e Metformina Mylan Italia
Portugal: Metformina + Sitagliptina Viatris
Sweden: Sitagliptin/Metformin hydrochloride Viatris