Sitagliptin Tecnigen Italia

Package leaflet: Information for the patient

Sitagliptin Tecnigen Italia 25 mg film-coated tablets

Sitagliptin
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 their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.
Contents of this leaflet
What Sitagliptin Tecnigen Italia is and what it is used for
What you need to know before taking Sitagliptin Tecnigen Italia
How to take Sitagliptin Tecnigen Italia
Possible side effects
How to store Sitagliptin Tecnigen Italia
Contents of the pack and other information

What Sitagliptin Tecnigen Italia is and what it is used for
Sitagliptin Tecnigen Italia contains the active substance sitagliptin, which belongs to a class of medicines called dipeptidyl peptidase-4 (DPP-4) inhibitors that lower blood sugar levels in adult patients with type 2 diabetes mellitus.
This medicine helps increase insulin levels produced after a meal and reduces the amount of sugar produced by the body.
Your doctor has prescribed this medicine to help you lower your blood sugar level, which is too high due to type 2 diabetes. This medicine can be used alone or in combination with other blood sugar-lowering medicines (insulin, metformin, sulfonylureas, or glitazones) that you may already be taking to treat your diabetes, together with a diet and exercise programme.

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

What you need to know before taking Sitagliptin Tecnigen Italia

Do not take Sitagliptin Tecnigen Italia
if you are allergic to sitagliptin or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Cases of inflammation of the pancreas (pancreatitis) have been observed in patients treated with Sitagliptin Tecnigen Italia (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.
Tell your doctor if you have or have had:

• a pancreatic disease (such as pancreatitis)
• 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)
• type 1 diabetes
• diabetic ketoacidosis (a diabetes complication with high blood sugar levels, rapid weight loss, nausea, or vomiting)
• any kidney problems, past or present
• an allergic reaction to Sitagliptin (see section 4)

It is unlikely that this medicine will cause low blood sugar levels because it does not act when blood sugar is low. However, when this medicine is taken with a sulfonylurea or insulin, low blood sugar (hypoglycaemia) may occur. Your doctor may reduce the dose of sulfonylurea or insulin.

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 Tecnigen Italia
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking digoxin (a medicine used to treat heart rhythm disorders and other heart conditions). It may be necessary to monitor digoxin blood levels if taken together with Sitagliptin Tecnigen Italia.

Sitagliptin Tecnigen Italia with food and drink
You may take this medicine with or without food and drink.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
You must not use this medicine during pregnancy.
It is not known whether this medicine passes into breast milk. You must not take this medicine if you are breastfeeding or think you may need to breastfeed.

Driving and using machines
This medicine has no or negligible effect on the ability to drive and use machines. However, dizziness and somnolence have been reported, which may affect your ability to drive and use machines.
Taking this medicine 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 Tecnigen Italia contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially “sodium-free”.

How to take Sitagliptin Tecnigen Italia
Always take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
The usual recommended dose is:

• one 100 mg film-coated tablet
• once daily
• by mouth

If you have kidney problems, your doctor may prescribe lower doses (such as 25 mg or 50 mg).
You may take this medicine with or without food and drink.
Your doctor may prescribe this medicine alone or in combination with other blood sugar-lowering medicines.
Diet and physical exercise can help your body use blood sugar more effectively. While taking Sitagliptin Tecnigen Italia, it is important to continue the diet and exercise programme recommended by your doctor.

If you take more Sitagliptin Tecnigen Italia than you should
If you take more of this medicine than prescribed, contact your doctor immediately.

If you forget to take Sitagliptin Tecnigen 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 Tecnigen Italia
Continue taking this medicine for as long as your doctor prescribes it so that you can keep controlling your blood sugar level. Do not stop treatment with this medicine without first talking to your doctor.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
STOP taking Sitagliptin Tecnigen Italia 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).

If you have a severe allergic reaction (frequency not known), including rash, hives, blisters on the skin/skin peeling, and swelling of the face, lips, tongue, and 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 the following side effects when sitagliptin was added to metformin:

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

Some patients experienced different types of stomach discomfort when starting concomitant therapy with sitagliptin and metformin (frequency is common).

Some patients experienced the following side effects when taking sitagliptin in combination with a sulfonylurea and metformin:

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

Some patients experienced the following side effects when taking sitagliptin with pioglitazone:

• Common: flatulence, swelling of the hands or legs

Some patients experienced the following side effects when taking sitagliptin in combination with pioglitazone and metformin:

• Common: swelling of the hands or legs

Some patients experienced the following side effects when taking sitagliptin with insulin (with or without metformin):

• Common: influenza
• Uncommon: dry mouth

Some patients experienced the following side effects when taking sitagliptin alone in clinical studies, or during post-marketing use alone and/or with other diabetes medicines:

• Common: low blood sugar, headache, upper respiratory tract infection, stuffy or runny nose and sore throat, osteoarthritis, pain in arms or legs
• Uncommon: dizziness, constipation, pruritus
• 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)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact 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. Reporting side effects can help provide more information on the safety of this medicine.

How to store Sitagliptin Tecnigen 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 and the outer packaging after “EXP”. The expiry date refers to the last day of that month.
This medicine requires no 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.

Contents of the pack and other information
What Sitagliptin Tecnigen Italia contains
The active substance is sitagliptin. Each film-coated tablet of Sitagliptin Tecnigen Italia 25 mg contains sitagliptin hydrochloride monohydrate, equivalent to 25 mg of sitagliptin.
The other ingredients are:

• Tablet core: calcium hydrogen phosphate, microcrystalline cellulose 102 (E460), croscarmellose sodium (E468), anhydrous colloidal silica, sodium stearyl fumarate, magnesium stearate (E470b).
• Tablet coating: poly(vinyl alcohol) (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b), yellow iron oxide (E172), red iron oxide (E172), and black iron oxide (E172).

Description of the appearance of Sitagliptin Tecnigen Italia and contents of the pack
Pink, round, film-coated tablets.
Opaque blisters (PVC/PE/PVDC and aluminium). Packs containing 14, 28, or 56 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Tecnigen srl
Viale Tunisia 50, 20124 Milano (MI), Italy.

Manufacturer
SAG Manufacturing S.L.U.
Ctra. N-I, Km 36, San Agustin de Guadalix 28750 Madrid, Spain.
or
Galenicum Health, S.L.U.
Sant Gabriel, 50, Esplugues de Llobregat, 08950, Barcelona, Spain.

Patient information leaflet

Sitagliptin Tecnigen Italia 50 mg film-coated tablets

Sitagliptin
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 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, contact your
doctor, pharmacist, or nurse. See section 4.
Contents of this leaflet
What Sitagliptin Tecnigen Italia is and what it is used for
What you need to know before taking Sitagliptin Tecnigen Italia
How to take Sitagliptin Tecnigen Italia
Possible side effects
How to store Sitagliptin Tecnigen Italia
Contents of the pack and other information

---

What Sitagliptin Tecnigen Italia is and what it is used for

Sitagliptin Tecnigen Italia contains the active substance sitagliptin, which belongs to a class of
medicines called dipeptidyl peptidase-4 (DPP-4) inhibitors that lower blood sugar levels in adult patients with type 2 diabetes mellitus.
This medicine helps increase insulin levels produced after a meal and reduces the amount of sugar produced by the body.
Your doctor has prescribed this medicine to help you lower your blood sugar level, which is too high due to type 2 diabetes. This medicine can be used alone or in combination with other blood sugar-lowering medicines (insulin, metformin, sulfonylureas, or glitazones) that you may already be taking to treat your diabetes, along with a diet and exercise program.

What is type 2 diabetes?

Type 2 diabetes is a condition in which the body does not produce enough insulin, and the insulin produced does not work properly. The body may also produce too much sugar. When this occurs, sugar (glucose) accumulates in the blood. This can lead to serious medical problems such as heart disease, kidney disease, blindness, and amputations.

---

What you need to know before taking Sitagliptin Tecnigen Italia

Do not take Sitagliptin Tecnigen Italia

if you are allergic to sitagliptin or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Cases of inflammation of the pancreas (pancreatitis) have been observed in patients treated with Sitagliptin Tecnigen Italia (see section 4).
If you develop blisters on the skin, it may be a sign of a condition called bullous pemphigoid. Your doctor may ask you to stop treatment with Sitagliptin.
Inform your doctor if you have or have had:

• a disease of the pancreas (such as pancreatitis)
• 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)
• type 1 diabetes
• diabetic ketoacidosis (a diabetes complication with high blood sugar levels, rapid weight loss, nausea, or vomiting)
• any past or present kidney problems
• an allergic reaction to Sitagliptin (see section 4)

It is unlikely that this medicine will cause low blood sugar levels because it does not act when blood sugar is low. However, when this medicine is taken with a sulfonylurea or insulin, low blood sugar (hypoglycaemia) may occur. Your doctor may reduce the dose of sulfonylurea or insulin.

Children and adolescents

Children and adolescents under 18 years of age should not use this medicine. It is not effective in children and adolescents aged 10 to 17 years. It is not known whether this medicine is safe and effective when used in children under 10 years of age.

Other medicines and Sitagliptin Tecnigen Italia

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking digoxin (a medicine used to treat heart rhythm irregularities and other heart conditions). It may be necessary to monitor digoxin levels in the blood if taken together with Sitagliptin Tecnigen Italia.

Sitagliptin Tecnigen Italia with food and drink

You may take this medicine with or without food and drink.

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 use this medicine during pregnancy.
It is not known whether this medicine passes into breast milk. You must not take this medicine if you are breastfeeding or think you may need to breastfeed.

Driving and using machines

This medicine has no or negligible influence on the ability to drive and use machines. However, dizziness and drowsiness have been reported, which may affect your ability to drive and use machines.
Taking this medicine 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 Tecnigen Italia contains sodium

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

---

How to take Sitagliptin Tecnigen Italia

Take this medicine exactly as prescribed by your doctor. If you are unsure, consult your doctor or pharmacist.
The usual recommended dose is:

• one 100 mg film-coated tablet
• once daily
• by mouth

If you have kidney problems, your doctor may prescribe lower doses (such as 25 mg or 50 mg).
You may take this medicine with or without food and drink.
Your doctor may prescribe this medicine alone or in combination with other blood sugar-lowering medicines.
Diet and physical activity can help your body use blood sugar more effectively. While taking Sitagliptin Tecnigen Italia, it is important to continue the diet and exercise program recommended by your doctor.

If you take more Sitagliptin Tecnigen Italia than you should

If you take more of this medicine than prescribed, contact your doctor immediately.

If you forget to take Sitagliptin Tecnigen 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 regular time.
Do not take a double dose of this medicine.

If you stop taking Sitagliptin Tecnigen Italia

Continue taking this medicine for as long as your doctor prescribes it so that you can maintain control of your blood sugar level. Do not stop treatment with this medicine without first discussing it with your doctor.
If you have any doubts about how to use this medicine, contact your doctor or pharmacist.

---

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
STOP taking Sitagliptin Tecnigen Italia 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).

If you experience a severe allergic reaction (frequency not known), including rash, hives, blisters on the skin/skin peeling, and swelling of the face, lips, tongue, and 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 the following side effects when sitagliptin was added to metformin:

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

Some patients experienced various types of stomach discomfort when starting concomitant therapy with sitagliptin and metformin (frequency common).

Some patients experienced the following side effects when taking sitagliptin in combination with a sulfonylurea and metformin:

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

Some patients experienced the following side effects when taking sitagliptin and pioglitazone:

• Common: flatulence, swelling of the hands or legs

Some patients experienced the following side effects when taking sitagliptin in combination with pioglitazone and metformin:

• Common: swelling of the hands or legs

Some patients experienced the following side effects when taking sitagliptin in combination with insulin (with or without metformin):

• Common: influenza
• Uncommon: dry mouth

Some patients experienced the following side effects when taking sitagliptin alone in clinical studies, or during post-approval use alone and/or with other diabetes medicines:

• Common: low blood sugar, headache, upper respiratory tract infection, stuffy or runny nose and sore throat, osteoarthritis, pain in arms or legs
• Uncommon: dizziness, constipation, itching
• 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)

---

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, contact 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. Reporting side effects can help provide more information on the safety of this medicine.

---

How to store Sitagliptin Tecnigen 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 and on the carton after “EXP”. The expiry date refers to the last day of that month.
This medicine requires no 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.

---

Contents of the pack and other information

What Sitagliptin Tecnigen Italia contains

The active substance is sitagliptin. Each film-coated tablet of Sitagliptin Tecnigen Italia 50 mg (tablet) contains sitagliptin monohydrochloride monohydrate, equivalent to 50 mg sitagliptin.
The other ingredients are:

• Core: calcium hydrogen phosphate, microcrystalline cellulose 102 (E460), sodium croscarmellose (E468), anhydrous colloidal silica, sodium stearyl fumarate, magnesium stearate (E470b).
• Coating: poly(vinyl alcohol) (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b), yellow iron oxide (E172), and red iron oxide (E172).

Description of the appearance of Sitagliptin Tecnigen Italia and contents of the pack

Film-coated, round, light beige tablets with an engraved “S” on one side.
Opaque blisters (PVC/PE/PVDC and aluminium). Packs of 14, 28, 30, 56 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Tecnigen srl
Viale Tunisia 50, 20124 Milano (MI), Italy.

Manufacturers
SAG Manufacturing S.L.U.
Ctra. N-I, Km 36, San Agustin de Guadalix, 28750 Madrid, Spain.
or
Galenicum Health, S.L.U.
Sant Gabriel, 50, Esplugues de Llobregat, 08950, Barcelona, Spain.

Patient information leaflet

Sitagliptin Tecnigen Italia 100 mg film-coated tablets

Sitagliptin
Please read this entire leaflet carefully before taking 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 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, contact your
doctor, pharmacist, or nurse. See section 4.
Contents of this leaflet
What Sitagliptin Tecnigen Italia is and what it is used for
What you need to know before taking Sitagliptin Tecnigen Italia
How to take Sitagliptin Tecnigen Italia
Possible side effects
How to store Sitagliptin Tecnigen Italia
Contents of the pack and other information
What Sitagliptin Tecnigen Italia is and what it is used for
Sitagliptin Tecnigen Italia contains the active substance sitagliptin, which belongs to a class of
medicines called dipeptidyl peptidase-4 (DPP-4) inhibitors that lower blood sugar levels in adult
patients with type 2 diabetes mellitus.
This medicine helps increase insulin levels produced after a meal and reduces the amount of sugar
produced by the body.
Your doctor has prescribed this medicine to help you lower your blood sugar level, which is too high
due to type 2 diabetes. This medicine can be used alone or in combination with other blood sugar-lowering
medicines (insulin, metformin, sulfonylureas, or glitazones) that you may already be taking to treat your
diabetes, along with a diet and exercise program.
What is type 2 diabetes?
Type 2 diabetes is a condition in which the body does not produce enough insulin, and the insulin
produced does not work properly. The 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 amputations.
What you need to know before taking Sitagliptin Tecnigen Italia
Do not take Sitagliptin Tecnigen Italia
if you are allergic to sitagliptin or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Cases of inflammation of the pancreas (pancreatitis) have been observed in patients treated with
Sitagliptin Tecnigen Italia (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.
Inform your doctor if you have or have had:
pancreatic disease (such as pancreatitis)
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)
type 1 diabetes
diabetic ketoacidosis (a diabetes complication with high blood sugar levels, rapid weight loss,
nausea, or vomiting)
any past or present kidney problems
an allergic reaction to Sitagliptin (see section 4)
It is unlikely that this medicine will cause low blood sugar levels because it does not act when blood
sugar is low. However, when this medicine is taken with a sulfonylurea or insulin, low blood sugar
(hypoglycemia) may occur. Your doctor may reduce the dose of the sulfonylurea or insulin.
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 10 to 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 Tecnigen Italia
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking digoxin (a medicine used to treat heart rhythm
disorders and other heart conditions). It may be necessary to monitor digoxin levels in the blood when
taken with Sitagliptin Tecnigen Italia.
Sitagliptin Tecnigen Italia with food and drink
You may take this medicine with or without food and drink.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding,
consult your doctor or pharmacist before taking this medicine.
You must not use this medicine during pregnancy.
It is not known whether this medicine passes into breast milk. You must not take this medicine if you are
breastfeeding or think you may need to breastfeed.
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, which may affect your ability to drive and use machines.
Taking this medicine 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 Tecnigen Italia contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially “sodium-free”.
How to take Sitagliptin Tecnigen Italia
Take this medicine exactly as your doctor has instructed. If you have any doubts, consult your doctor or
pharmacist.
The usual recommended dose is:

• one 100 mg film-coated tablet
• once daily
• by mouth

If you have kidney problems, your doctor may prescribe lower doses (such as 25 mg or 50 mg).
You may take this medicine with or without food and drink.
Your doctor may prescribe this medicine alone or in combination with other blood sugar-lowering
medicines.
Diet and exercise can help your body use blood sugar more effectively. While taking Sitagliptin Tecnigen
Italia, it is important to continue the diet and exercise program recommended by your doctor.
If you take more Sitagliptin Tecnigen Italia than you should
If you take more of this medicine than prescribed, contact your doctor immediately.
If you forget to take Sitagliptin Tecnigen 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 regular time.
Do not take a double dose of this medicine.
If you stop taking Sitagliptin Tecnigen Italia
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 have any questions about how to use this medicine, contact your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
STOP taking Sitagliptin Tecnigen Italia 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).

If you experience a severe allergic reaction (frequency not known), including rash, hives, blisters on
the skin/skin peeling, and swelling of the face, lips, tongue, and 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 the following side effects when sitagliptin was added to metformin:
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 pain, diarrhea, constipation, drowsiness
Some patients experienced various types of stomach discomfort when starting concomitant therapy with
sitagliptin and metformin (frequency is common).
Some patients experienced the following side effects when taking sitagliptin in combination with a
sulfonylurea and metformin:
Very common (may affect more than 1 in 10 people): low blood sugar level
Common: constipation
Some patients experienced the following side effects when taking sitagliptin and pioglitazone:
Common: flatulence, swelling of hands or legs
Some patients experienced the following side effects when taking sitagliptin in combination with
pioglitazone and metformin:
Common: swelling of hands or legs
Some patients experienced the following side effects when taking sitagliptin in combination with
insulin (with or without metformin):
Common: influenza
Uncommon: dry mouth
Some patients experienced the following side effects when taking sitagliptin alone in clinical trials,
or after approval, alone and/or with other diabetes medicines:
Common: low blood sugar level, headache, upper respiratory tract infection, nasal congestion or runny
nose and sore throat, osteoarthritis, pain in arms or legs
Uncommon: dizziness, constipation, itching
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)
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact 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.
How to store Sitagliptin Tecnigen 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 and packaging 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 no longer required. This will help protect the environment.
Contents of the pack and other
information
What Sitagliptin Tecnigen Italia contains
The active substance is sitagliptin. Each 100 mg film-coated tablet of Sitagliptin Tecnigen Italia
(tablet) contains sitagliptin hydrochloride monohydrate, equivalent to 100 mg sitagliptin.
The other components are:
o Tablet core: calcium hydrogen phosphate, microcrystalline cellulose 102
(E460), sodium croscarmellose (E468), colloidal anhydrous silica, sodium stearyl
fumarate, magnesium stearate (E470b).
o Tablet coating: poly(vinyl alcohol) (E1203), titanium dioxide (E171), macrogol
3350 (E1521), talc (E553b), yellow iron oxide (E172), and red iron oxide (E172).
Description of the appearance of Sitagliptin Tecnigen Italia and contents of the pack
Beige, round, film-coated tablets.
Opaque blisters (PVC/PE/PVDC and aluminum). Packs containing 14, 28, 30, or 56 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Tecnigen srl
Viale Tunisia 50, 20124 Milano (MI), Italy.
Manufacturer
SAG Manufacturing S.L.U.
Ctra. N-I, Km 36, San Agustin de Guadalix, 28750 Madrid, Spain.
or
Galenicum Health, S.L.U.
Sant Gabriel, 50, Esplugues de Llobregat, 08950, Barcelona, Spain.