Sitagliptin Zentiva Italia

Patient Information Leaflet: Information for the patient

Sitagliptin Zentiva Italia 25 mg film-coated tablets, 50 mg film-coated tablets, 100 mg film-coated tablets

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 or pharmacist.
• 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 or pharmacist. See section 4.

Contents of this leaflet

1. What Sitagliptin Zentiva Italia is and what it is used for
2. What you need to know before taking Sitagliptin Zentiva Italia
3. How to take Sitagliptin Zentiva Italia
4. Possible side effects
5. How to store Sitagliptin Zentiva Italia
6. Contents of the pack and other information

1. What Sitagliptin Zentiva is and what it is used for

Sitagliptin Zentiva Italia contains the active substance sitagliptin, which belongs to a class of medicines
called DPP-4 inhibitors (dipeptidyl peptidase-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 may be used alone or in combination
with other blood sugar-lowering medicines (insulin, metformin, sulphonylureas, or glitazones)
that you may already be taking for 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 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 amputation.

2. What you need to know before taking Sitagliptin Zentiva Italia

Do not take Sitagliptin Zentiva 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 (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 Zentiva Italia.
Inform 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 the likelihood 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 because it does not act when blood sugar levels are low. However, when this medicine is used in combination with a sulphonylurea medicine or with 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 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 Zentiva 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 irregular heartbeat and other heart problems). It may be necessary to monitor digoxin levels in the blood if taken together with Sitagliptin Zentiva Italia.
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 if you are planning to breastfeed.
Driving and using machines
This medicine does not affect or has negligible effect on the ability to drive or use machines. However, dizziness and drowsiness have been reported, which may affect the ability to drive or use machines.
Taking this medicine in combination with other medicines called sulphonylureas or with insulin may cause hypoglycaemia, which may affect the ability to drive or use machines or to work without protective barriers.
Sitagliptin Zentiva Italia contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Sitagliptin Zentiva Italia

Take this medicine exactly as your doctor has told you. If you are not sure, 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).
This medicine can be taken 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 Zentiva Italia, it is important to continue the diet and exercise plan recommended by your doctor.
If you take more Sitagliptin Zentiva Italia than you should
If you take more of this medicine than prescribed, contact your doctor immediately.
If you forget to take Sitagliptin Zentiva Italia
If you forget to take a dose, take it as soon as you remember. If you do not remember until it is time for the next dose, skip the missed dose and go back to your regular schedule. Do not take a double dose to make up for the forgotten tablet.
If you stop taking Sitagliptin Zentiva Italia
Continue taking this medicine for as long as your doctor prescribes it, to maintain control of your blood sugar levels. Do not stop taking this medicine without first talking to your doctor.
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 everybody gets them.
STOP taking Sitagliptin Zentiva 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) which may extend to the back, with or without nausea and vomiting, as these could be signs of inflammation of the pancreas (pancreatitis) (frequency not known: frequency cannot be estimated from the available data).
• Severe allergic reaction, including skin rashes, hives, blistering of the skin/desquamation of the skin, and swelling of the face, lips, tongue, and throat which may cause difficulty breathing or swallowing. Your doctor may prescribe a medicine to treat the allergic reaction and a different medicine for diabetes (frequency not known: frequency cannot be estimated from the available data).

Some patients experienced the following side effects when taking sitagliptin with metformin:
Common (may affect up to 1 in 10 people):

• low blood sugar level
• nausea
• flatulence
• vomiting
• various types of stomach discomfort when starting the combination of sitagliptin and metformin

Uncommon (may affect up to 1 in 100 people):

• stomach pain
• diarrhoea
• constipation
• drowsiness

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 (may affect up to 1 in 10 people):

• constipation

Some patients experienced the following side effects when taking sitagliptin and pioglitazone:
Common (may affect up to 1 in 10 people):

• flatulence
• swelling of the hands or legs

Some patients experienced the following side effects when taking sitagliptin in combination with pioglitazone and metformin:
Common (may affect up to 1 in 10 people):

• 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 (may affect up to 1 in 10 people):

• influenza

Uncommon (may affect up to 1 in 100 people):

• 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 (may affect up to 1 in 10 people):

• low blood sugar level
• headache
• upper respiratory tract infection
• stuffy or runny nose
• sore throat
• osteoarthritis
• pain in arms or legs

Uncommon (may affect up to 1 in 100 people):

• dizziness
• constipation
• itching

Rare (may affect up to 1 in 1,000 people):

• reduced number of platelets

Frequency not known (frequency cannot be estimated from the available data):

• kidney problems (which sometimes require 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 or pharmacist. You may 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.

5. How to store Sitagliptin Zentiva 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 the month.
PVC/PVDC/Aluminium blister:
Store below 30°C. Keep in the original packaging to protect the medicine from moisture.
PVC/PE/PVDC/Aluminium blister:
This medicine does not require any special storage conditions. Keep in the original packaging to protect the medicine from moisture.
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 Zentiva Italia contains

• The active substance is sitagliptin. Sitagliptin Zentiva Italia 25 mg film-coated tablets: each film-coated tablet contains sitagliptin phosphate monohydrate, equivalent to 25 mg of sitagliptin. Sitagliptin Zentiva Italia 50 mg film-coated tablets: each film-coated tablet contains sitagliptin phosphate monohydrate, equivalent to 50 mg of sitagliptin. Sitagliptin Zentiva Italia 100 mg film-coated tablets: each film-coated tablet contains sitagliptin phosphate monohydrate, equivalent to 100 mg of sitagliptin.
• The other components are:
  Tablet core: microcrystalline cellulose (E460), calcium hydrogen phosphate, croscarmellose sodium, anhydrous colloidal silica, sodium stearyl fumarate (E485), magnesium stearate (E470b).
  Tablet coating: poly(vinyl alcohol) (E1203), titanium dioxide (E171), macrogol, talc (E553b), yellow iron oxide (E172), red iron oxide (E172).

Description of the appearance of Sitagliptin Zentiva Italia and package contents
Sitagliptin Zentiva Italia 25 mg are round, biconvex, pink film-coated tablets with a diameter of approximately 5.6 mm.
Sitagliptin Zentiva Italia 50 mg are round, biconvex, beige film-coated tablets with "Z" engraved on one side and a diameter of approximately 7.1 mm.
Sitagliptin Zentiva Italia 100 mg are round, biconvex, film-coated tablets ranging in colour from orange to brown, with a diameter of approximately 9.1 mm.
PVC/PVDC/Aluminium blisters
PVC/PE/PVDC/Aluminium blisters
Pack sizes: 14, 28, 30, 56, 60, 90, 98 and 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zentiva Italia S.r.l.
Via P. Paleocapa, 7
20121 Milano
Italy

Manufacturer
Zentiva k.s
U kabelovny 130
Prague 10, 102 37
Czech Republic

This medicinal product is authorised in the European Economic Area countries under the following names:
Czech Republic, Germany, Sweden: Sitagliptin Zentiva k.s.
Austria, Estonia, Latvia, Lithuania: Sitagliptin Zentiva
France: Sitagliptine Zentiva k.s.
Italy: Sitagliptin Zentiva Italia
Portugal: Sitagliptina Zentiva k.s.
Finland, Denmark, Iceland, Norway: Sitagliptin Zentiva ApS

This Patient Information Leaflet was last revised on