Sitagliptin and metformin Pharmacare: detailed information

Patient Information Leaflet

Sitagliptin and Metformin Pharmacare

50 mg/850 mg film-coated tablets
sitagliptin/metformin hydrochloride
Equivalent medicine
Please read all of this leaflet carefully before you take this medicine, as 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 their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What is Sitagliptin and Metformin Pharmacare and what it is used for

Sitagliptin and Metformin Pharmacare contains two different medicines called sitagliptin and metformin.

sitagliptin belongs to a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors)
metformin belongs to a class of medicines called biguanides.

They work together to control blood sugar levels in adult patients with a form of diabetes called "type 2 diabetes mellitus". This medicine helps increase insulin levels produced after meals and reduces the amount of sugar produced by the body.
Together with diet and exercise, this medicine helps lower blood sugar levels. This medicine can 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) accumulates 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 Pharmacare

Do not take Sitagliptin and Metformin Pharmacare

if you are allergic to sitagliptin or metformin or to 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 hyperglycemia (high blood glucose levels), nausea, vomiting, diarrhea, 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, deep and rapid breathing, drowsiness, and breath with an unusual fruity odor.
if you have a severe infection or are dehydrated
if you are about to undergo an X-ray procedure involving the use of a contrast agent. You will need to stop taking Sitagliptin and Metformin Pharmacare 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 recently had a heart attack or have serious circulatory problems, such as “shock” or difficulty breathing
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 Pharmacare if you have any of the above conditions and discuss with your doctor alternative methods for managing diabetes. If you are unsure, speak with your doctor, pharmacist, or nurse before taking Sitagliptin and Metformin Pharmacare.

Warnings and precautions
Cases of inflammation of the pancreas (pancreatitis) have been reported in patients treated with Sitagliptin and Metformin Pharmacare (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 treatment with Sitagliptin and Metformin Pharmacare.
Risk of lactic acidosis
Sitagliptin and Metformin Pharmacare 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 severe heart disease).
If you have any of the medical conditions listed above, consult your doctor for further instructions.
Temporarily stop taking Sitagliptin and Metformin Pharmacare
if you have a medical condition that may be associated with dehydration (significant loss of body fluids), such as severe vomiting, diarrhea, fever, heat exposure, or if you are drinking less fluids than normal. Consult your doctor for further instructions.
If you experience any of the symptoms of lactic acidosis, stop taking Sitagliptin and
Metformin Pharmacare 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 being unwell associated with severe tiredness
difficulty breathing
decreased body temperature and slower heartbeat
Lactic acidosis is a medical emergency and must be treated in hospital.
Talk to your doctor or pharmacist before taking Sitagliptin and Metformin Pharmacare:
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 and Metformin Pharmacare (see section 4)
if you are taking a sulfonylurea or insulin, diabetes medicines, together with Sitagliptin and Metformin Pharmacare, as this may cause an excessive drop in blood sugar levels (hypoglycemia). Your doctor may reduce the dose of sulfonylurea or insulin.
If you are scheduled for major surgery, you must stop taking Sitagliptin and Metformin Pharmacare during and for a certain period after the procedure. Your doctor will decide when to stop and when to restart treatment with Sitagliptin and Metformin Pharmacare.
If you are unsure whether any of the above conditions apply to you, consult your doctor or pharmacist before taking Sitagliptin and Metformin Pharmacare.
During treatment with Sitagliptin and Metformin Pharmacare, 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 and Metformin Pharmacare
If you are to receive an injection of iodinated contrast medium into the bloodstream, for example for an X-ray procedure, you must stop taking Sitagliptin and Metformin Pharmacare before or during the injection. Your doctor will decide when to stop and when to restart treatment with Sitagliptin and Metformin Pharmacare.
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 and Metformin Pharmacare. 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 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 (used to treat irregular heartbeat and other heart problems). It may be necessary to monitor digoxin blood levels when taken with Sitagliptin and Metformin Pharmacare.

Sitagliptin and Metformin Pharmacare and alcohol
Avoid excessive alcohol consumption while taking Sitagliptin and Metformin Pharmacare, as this may increase the risk of lactic acidosis (see section “Warnings and precautions”).
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine. You must not take this medicine during pregnancy or while breastfeeding. See section 2, Do not take
Sitagliptin and Metformin Pharmacare.
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 sulfonylureas or with insulin may cause hypoglycemia, which may affect your ability to drive, use machines, or work without protective barriers.
Sitagliptin and Metformin Pharmacare 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 Pharmacare

Take this medicine exactly as your doctor has told you. If you are not sure, consult 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 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 reduce your dose of sulphonylurea or insulin.
The break line is not intended for splitting the tablet.

If you take more Sitagliptin and Metformin Pharmacare 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 Pharmacare
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 Pharmacare
Continue taking this medicine for as long as your doctor prescribes it, so that you can keep your blood sugar levels under control. Do not stop treatment with this medicine without first talking to your doctor. If you stop treatment with Sitagliptin and Metformin Pharmacare, 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 and Metformin Pharmacare and contact your doctor immediately if you notice any of the following serious side effects:

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

Sitagliptin and Metformin Pharmacare 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 Pharmacare and seek immediate medical attention at the nearest doctor or hospital, because lactic acidosis can lead to coma.
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 sitagliptin therapy:
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 metformina 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 while taking sitagliptin alone (one of the medicines contained in Sitagliptin and Metformin Pharmacare) or during post-marketing use of Sitagliptin and Metformin Pharmacare or sitagliptin alone or in combination with other diabetes medicines:
Common: low blood sugar level, headache, upper respiratory tract infection, stuffy or runny nose and sore throat, osteoarthritis, pain in arms or legs
Uncommon: dizziness, constipation, itching sensation
Rare (may affect up to 1 in 1,000 people): 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 resolve over time.
Common: metallic taste
Very rare: decreased vitamin B12 levels, hepatitis (a liver problem), urticaria, skin redness (rash), or itching sensation.

Reporting of side effects
If you experience any side effects, 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 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 Pharmacare

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.
Store below 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 Pharmacare contains

The active substances are sitagliptin and metformin. Each film-coated tablet (tablet) contains sitagliptin hydrochloride monohydrate equivalent to 50 mg of sitagliptin and 850 mg of metformin hydrochloride.
The other components are: in the tablet core: povidone K 29/32, microcrystalline cellulose, crospovidone Kollidon  and sodium stearyl fumarate. Additionally, the film coating contains: polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol/PEG (E1521), talc (E553b), yellow iron oxide (E172), red iron oxide (E172) and black iron oxide (E172).

Description of the appearance of Sitagliptin and Metformin Pharmacare and contents of the pack
Film-coated capsule-shaped tablets, pink, with a score line on one side and "SA" on the other side.
Tablet diameter: 19.5 ± 0.5 mm
Blister packs made of PVC-PVDC/Aluminum. Packs containing 56 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Pharmacare S.r.l.
Via Marghera 29
20149 Milan - Italy

Manufacturer
SAG MANUFACTURING, S.L.U.
Ctra. N-I, km 36,
San Agustín de Guadalix,
28750 Madrid,
Spain

GALENICUM HEALTH, S.L.
Sant Gabriel, 50,
Esplugues De Llobregat,
08950 Barcelona,
Spain

Patient information leaflet

Sitagliptin and Metformin Pharmacare

50 mg/1000 mg film-coated tablets
sitagliptin/metformin hydrochloride
Equivalent medicine
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 others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

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

Sitagliptin and Metformin Pharmacare 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 made by the body.
Together 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 the body produces 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 and Metformin Pharmacare

Do not take Sitagliptin and Metformin Pharmacare

if you are allergic to sitagliptin or metformin or to 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 hyperglycemia (high blood glucose levels), nausea, vomiting, diarrhea, 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 odor.
if you have a severe infection or are dehydrated
if you are about to undergo an X-ray procedure involving the use of a contrast agent. You will need to stop taking Sitagliptin and Metformin Pharmacare 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 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 Pharmacare if you have any of the conditions listed above and
speak with your doctor about other methods of managing diabetes. If you are unsure, talk to your
doctor, pharmacist, or nurse before taking Sitagliptin and Metformin Pharmacare.
Warnings and precautions
Cases of inflammation of the pancreas (pancreatitis) have been reported in patients treated with Sitagliptin and Metformin Pharmacare (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 Pharmacare.
Risk of lactic acidosis
Sitagliptin and Metformin Pharmacare 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 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 severe heart disease).
If you have any of the medical conditions described above, consult your doctor for further instructions.
Temporarily stop taking Sitagliptin and Metformin Pharmacare if you develop a medical 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 normal. Consult your doctor for further instructions.
If you experience any of the symptoms of lactic acidosis, stop taking Sitagliptin and Metformin Pharmacare and contact your doctor or go to the nearest hospital immediately, because lactic acidosis can lead to coma.
Symptoms of lactic acidosis include:
vomiting
stomach pain (abdominal pain)
muscle cramps
a general feeling of being unwell 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.
Talk to your doctor or pharmacist before taking Sitagliptin and Metformin Pharmacare if:
you have or have had a disease of the pancreas (such as pancreatitis)
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)
you have type 1 diabetes. This is sometimes called insulin-dependent diabetes
you have or have had an allergic reaction to sitagliptin, metformin, or Sitagliptin and Metformin Pharmacare (see section 4)
you are taking a sulfonylurea or insulin, medicines for diabetes, together with Sitagliptin and Metformin Pharmacare, as this may cause an excessive drop in blood sugar levels (hypoglycemia). Your doctor may reduce the dose of the sulfonylurea or insulin.
If you are undergoing major surgery, you must stop taking Sitagliptin and Metformin Pharmacare 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 Pharmacare.
If you are unsure whether any of the conditions listed above apply to you, consult your doctor or pharmacist before taking Sitagliptin and Metformin Pharmacare.
During treatment with Sitagliptin and Metformin Pharmacare, 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 Pharmacare
If you are scheduled to receive an injection of an iodinated contrast agent into the bloodstream, for example during an X-ray procedure, you must stop taking Sitagliptin and Metformin Pharmacare before or during the injection. Your doctor will decide when to stop and when to restart treatment with Sitagliptin and Metformin Pharmacare.
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 glucose and kidney function tests, or your doctor may decide to adjust the dose of Sitagliptin and Metformin Pharmacare. 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 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
some 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 (used to treat irregular heartbeat and other heart-related problems). It may be necessary to monitor digoxin blood levels if taken together with Sitagliptin and Metformin Pharmacare.

Sitagliptin and Metformin Pharmacare and alcohol
Avoid excessive alcohol consumption while taking Sitagliptin and Metformin Pharmacare, 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, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine. You must not take this medicine during pregnancy or while breastfeeding. See section 2, Do not take Sitagliptin and Metformin Pharmacare.
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 sulfonylureas or with insulin may cause hypoglycemia, which may affect your ability to drive, use machines, or work without protective barriers.
Sitagliptin and Metformin Pharmacare 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 Pharmacare

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 upset.
Your doctor may need to increase your dose to 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 reduce your dose of sulphonylurea or insulin.
The score line is not intended for dividing the tablet.

If you take more Sitagliptin and Metformin Pharmacare 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 Pharmacare
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 and Metformin Pharmacare
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 and Metformin Pharmacare, 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 everyone gets them.
STOP taking Sitagliptin and Metformin Pharmacare and contact your doctor immediately if you experience any of the following serious side effects:

Severe and persistent pain in the abdomen (stomach area) that may extend to the back, with or without nausea and vomiting, as these may be signs of inflammation of the pancreas (pancreatitis). Sitagliptin and Metformin Pharmacare 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 Pharmacare and seek immediate medical attention at the nearest doctor or hospital, because lactic acidosis can lead to coma.

If you experience a severe allergic reaction (frequency not known), including rash, hives, skin blisters/skin peeling, or 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 experienced diarrhoea, nausea, flatulence, constipation, stomach ache, or vomiting when starting combination treatment with sitagliptin and metformina (frequency is common).

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

Some patients 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 while taking sitagliptin alone (one of the medicines contained in Sitagliptin and Metformin Pharmacare) or after marketing of Sitagliptin and Metformin Pharmacare, 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 (may affect up to 1 in 1,000 people): 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 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
Very rare: decreased levels of vitamin B12, 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 at 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 Pharmacare

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.
Store below 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 Pharmacare contains

The active substances are sitagliptin and metformin. Each film-coated tablet (tablet) contains sitagliptin hydrochloride monohydrate equivalent to 50 mg of sitagliptin and 1000 mg of metformin hydrochloride.
The other components are: in the tablet core: povidone K 29/32, microcrystalline cellulose, crospovidone Kollidon and sodium stearil fumarate. Additionally, the film coating contains: polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol/PEG (E1521), talc (E553b), red iron oxide (E172) and black iron oxide (E172).

Description of the appearance of Sitagliptin and Metformin Pharmacare and package contents
Film-coated capsule-shaped tablets, red to brown in colour, with a score line between "S" and "B" on one side and a score line on the other side.
Tablet diameter: 21.3 ± 0.5 mm
Blister packs made of PVC-PVDC/Aluminium. Packs containing 56 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Pharmacare S.r.l.
Via Marghera 29
20149 Milan - Italy

Manufacturer
SAG MANUFACTURING, S.L.U.
Ctra. N-I, km 36,
San Agustín de Guadalix,
28750 Madrid,
Spain

GALENICUM HEALTH, S.L.
Sant Gabriel, 50,
Esplugues De Llobregat,
08950 Barcelona,
Spain