Sitagliptin Pharmacare
ItalyTable of Contents
Package leaflet: Information for the patient
Sitagliptin Pharmacare 25 mg film-coated tablets
Sitagliptin
Generic medicine
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor, pharmacist or nurse.
- This medicine has been prescribed for you only. Do not pass it on to other people, even if their symptoms are the same as yours, as it may be harmful.
- If you experience any side effect, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.
Contents of this leaflet:
- What Sitagliptin Pharmacare is and what it is used for
- What you need to know before taking Sitagliptin Pharmacare
- How to take Sitagliptin Pharmacare
- Possible side effects
- How to store Sitagliptin Pharmacare
- Contents of the pack and other information
1. What is Sitagliptin Pharmacare and what is it used for?
Sitagliptin Pharmacare 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 the levels of insulin released 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 that
is produced does not work as effectively as it should. 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.
2. What you need to know before taking Sitagliptin Pharmacare
Do not take Sitagliptin Pharmacare
- 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 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.
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 kidney problems, past or present
- an allergic reaction to sitagliptin (see section 4).
It is unlikely that this medicine will cause low blood sugar because it does not act when blood sugar is low. However, when this medicine is taken with a sulfonylurea or with 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 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 Pharmacare
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 irregular heartbeat and other heart-related problems). It may be necessary to monitor digoxin levels in the blood if taken together with Sitagliptin Pharmacare.
Sitagliptin Pharmacare 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 a pregnancy, or 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 does not affect or affects negligibly 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 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 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 Pharmacare
Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The 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 beverages.
Your doctor may prescribe this medicine alone or together with other antidiabetic medicines.
Diet and physical exercise can help your body use blood sugar more effectively.
While taking Sitagliptin Pharmacare, it is important to continue the diet and exercise plan recommended by your doctor.
If you take more Sitagliptin Pharmacare than you should
If you take more of this medicine than prescribed, contact your doctor immediately.
If you forget to take Sitagliptin 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 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 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 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) which may spread 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, blistering or peeling 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 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, diarrhoea, constipation, drowsiness.
Some patients experienced various types of stomach discomfort when starting sitagliptin and metformin together as part of combination therapy (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 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-marketing use alone and/or 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
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, 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 Pharmacare
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister pack 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 Pharmacare contains
- The active substance is sitagliptin. Each film-coated tablet (tablet) contains sitagliptin monohydrochloride monohydrate, equivalent to 25 mg of sitagliptin.
- The other components are:
Tablet core: calcium hydrogen phosphate, microcrystalline cellulose 102 (E460), croscarmellose sodium (E468), anhydrous colloidal silica, sodium stearate fumarate, magnesium stearate (E470b)
Coating material: 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 Pharmacare and contents of the pack
Pink, round, film-coated tablets.
Opaque blisters (PVC/PE/PVDC and aluminium). Packs containing 28, 56 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Pharmacare Srl
Via Marghera, 29
20149 Milan
Italy
Manufacturer
SAG Manufacturing S.L.U.
Ctra. N-I, Km 36,
San Agustin de Guadalix,
28750 Madrid,
Spain
Galenicum Health, S.L.U.
Sant Gabriel, 50,
Esplugues de Llobregat,
08950 Barcelona,
Spain
This medicinal product is authorised in the European Economic Area countries under the following names:
MT, IT: Sitagliptin Pharmacare
August 2024
Patient information leaflet
Sitagliptin Pharmacare 50 mg film-coated tablets
Sitagliptin
Generic 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 other people, even if they have the same symptoms as yours, because 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 Pharmacare is and what it is used for
- What you need to know before taking Sitagliptin Pharmacare
- How to take Sitagliptin Pharmacare
- Possible side effects
- How to store Sitagliptin Pharmacare
- Contents of the pack and other information
1. What is Sitagliptin Pharmacare and what is it used for?
Sitagliptin Pharmacare 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 the levels of insulin 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 may be used alone or together 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 by the body does not work as well as it should. The 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 amputations.
2. What you need to know before taking Sitagliptin Pharmacare
Do not take Sitagliptin Pharmacare
- 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 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.
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 kidney problems, past or present
- an allergic reaction to sitagliptin (see section 4).
It is unlikely that this medicine will cause low blood sugar because it does not act when blood sugar is low. However, when this medicine is taken together with a sulphonylurea or insulin, low blood sugar (hypoglycaemia) may occur. Your doctor may reduce the dose of the sulphonylurea 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 between 10 and 17 years of age. It is not known whether this medicine is safe and effective when used in children under 10 years of age.
Other medicines and Sitagliptin Pharmacare
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 irregular heartbeats and other heart-related problems). It may be necessary to monitor digoxin levels in the blood when taken together with Sitagliptin Pharmacare.
Sitagliptin Pharmacare with food and drinks
You may take this medicine with or without food and drinks.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are 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 does not affect or has 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 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 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 Pharmacare
Take this medicine exactly as your doctor has instructed you. If you have any doubts, consult your doctor or pharmacist.
The 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 drinks.
Your doctor may prescribe this medicine alone or together with other medicines that lower blood sugar levels.
Diet and physical exercise can help your body use blood sugar more effectively. While taking Sitagliptin Pharmacare, it is important to continue the diet and exercise plan recommended by your doctor.
If you take more Sitagliptin Pharmacare than you should
If you take more of this medicine than prescribed, contact your doctor immediately.
If you forget to take Sitagliptin Pharmacare
If you forget 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 Pharmacare
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 questions about how to use this medicine, consult 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 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), possibly radiating 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, blistering or peeling of the skin, 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 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, diarrhoea, constipation, drowsiness.
Some patients experienced various types of stomach discomfort when starting sitagliptin and metformin together as combination therapy (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 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-marketing use alone and/or 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.
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 blistering skin rash).
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 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.
This medicine does not require any special storage conditions.
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 Pharmacare contains
- The active substance is sitagliptin. Each film-coated tablet (tablet) contains sitagliptin monohydrochloride monohydrate, equivalent to 50 mg of sitagliptin.
- The other components are:
Tablet core: calcium hydrogen phosphate, microcrystalline cellulose 102 (E460), sodium croscarmellose (E468), colloidal anhydrous silica, sodium stearate fumarate, magnesium stearate (E470b).
Coating material: 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 Pharmacare and contents of the pack
Light beige, round, film-coated tablets, marked with "S" on one side.
Opaque blisters (PVC/PE/PVDC and aluminium). Packs containing 28 or 56 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Pharmacare Srl
Via Marghera, 29
20149 Milan
Italy
Manufacturers
SAG Manufacturing S.L.U.
Ctra. N-I, Km 36,
San Agustin de Guadalix,
28750 Madrid,
Spain
Galenicum Health, S.L.U.
Sant Gabriel, 50,
Esplugues de Llobregat,
08950 Barcelona,
Spain
This medicinal product is authorized in the European Economic Area Member States under the following names:
MT, IT: Sitagliptin Pharmacare
August 2024
Patient information leaflet
Sitagliptin Pharmacare 100 mg film-coated tablets
Sitagliptin
Generic medicine
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 adverse reactions, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.
Contents of this leaflet:
- What Sitagliptin Pharmacare is and what it is used for
- What you need to know before taking Sitagliptin Pharmacare
- How to take Sitagliptin Pharmacare
- Possible side effects
- How to store Sitagliptin Pharmacare
- Contents of the pack and other information
1. What is Sitagliptin Pharmacare and what is it used for?
Sitagliptin Pharmacare 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 levels, which are too high
due to type 2 diabetes. This medicine can be used alone or in combination with other blood sugar-lowering
medicines (such as 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 the
body produces does not work as effectively as it should. 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.
2. What you need to know before taking Sitagliptin Pharmacare
Do not take Sitagliptin Pharmacare
- 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 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.
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 kidney problems, past or present
- an allergic reaction to sitagliptin (see section 4).
It is unlikely that this medicine will cause low blood sugar 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 between 10 and 17 years of age. It is not known whether this medicine is safe and effective when used in children under 10 years of age.
Other medicines and Sitagliptin Pharmacare
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 irregular heartbeat and other heart-related problems). It may be necessary to monitor digoxin levels in the blood if taken together with Sitagliptin Pharmacare.
Sitagliptin Pharmacare 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 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 does not affect or has a 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 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 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 Pharmacare
Take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.
The recommended dose is:
one 100 mg film-coated tablet
once daily
by mouth
If you have kidney problems, your doctor may prescribe a lower dose (such as 25 mg or 50 mg).
You may take this medicine with or without food and drinks.
Your doctor may prescribe this medicine alone or together with other medicines that lower blood sugar levels.
Diet and exercise can help your body use blood sugar more effectively. While taking Sitagliptin Pharmacare, it is important to continue the diet and exercise plan recommended by your doctor.
If you take more Sitagliptin Pharmacare than you should
If you take more of this medicine than prescribed, contact your doctor immediately.
If you forget to take Sitagliptin Pharmacare
If you forget to take a dose, take it as soon as you remember. If you do not remember until it is time for your next dose, skip the missed dose and take your next dose at the regular time. Do not take a double dose of this medicine.
If you stop taking Sitagliptin Pharmacare
Keep taking this medicine for as long as your doctor prescribes it, so that you can continue to control your blood sugar levels. Do not stop taking this medicine without talking to your doctor first.
If you have any doubts 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 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).
If you have a severe allergic reaction (frequency not known), including rash, hives, blistering or peeling 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 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, diarrhoea, constipation, drowsiness.
Some patients experienced various types of stomach discomfort when starting sitagliptin and metformin together as combination therapy (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 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-marketing use alone and/or with other antidiabetic 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.
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 blistering skin rash).
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 Pharmacare
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and 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 Pharmacare contains
- The active substance is sitagliptin. Each film-coated tablet (tablet) contains sitagliptin monohydrochloride monohydrate, equivalent to 100 mg sitagliptin.
- The other components are:
Tablet core: calcium hydrogen phosphate, microcrystalline cellulose 102 (E460), croscarmellose sodium (E468), anhydrous colloidal silica, sodium stearate fumarate, magnesium stearate (E470b)
Coating material: 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 Pharmacare and package contents
Beige, round, film-coated tablets.
Opaque blisters (PVC/PE/PVDC and aluminium). Pack sizes of 28 and 56 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Pharmacare Srl
Via Marghera, 29
20149 Milan
Italy
Manufacturer
SAG Manufacturing S.L.U.
Ctra. N-I, Km 36,
San Agustin de Guadalix,
28750 Madrid,
Spain
Galenicum Health, S.L.U.
Sant Gabriel, 50,
Esplugues de Llobregat,
08950 Barcelona,
Spain
This medicinal product is authorised in the European Economic Area countries under the following names:
MT, IT: Sitagliptin Pharmacare
August 2024