Sitagliptin Sandoz

Package Leaflet: Information for the Patient

Sitagliptin Sandoz, 25 mg, film-coated tablets

Sitagliptin Sandoz, 50 mg, film-coated tablets

Sitagliptin Sandoz, 100 mg, film-coated tablets

Sitagliptin

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

Keep this package leaflet, you may need to read it again.
In case of any doubts, consult a doctor, pharmacist, or nurse.
This medicine has been prescribed to you specifically. Do not pass it on to others.
The medicine may harm another person, even if their symptoms are the same.
If the patient experiences any side effects, including those not listed in this package leaflet, they should inform their doctor, pharmacist, or nurse.
See section 4.

Package Leaflet Contents:

• 1. What Sitagliptin Sandoz is and what it is used for
• 2. Important information before taking Sitagliptin Sandoz
• 3. How to take Sitagliptin Sandoz
• 4. Possible side effects
• 5. How to store Sitagliptin Sandoz
• 6. Package contents and other information

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

Sitagliptin Sandoz contains the active substance sitagliptin, which belongs to a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors), which reduce blood sugar levels in adults with type 2 diabetes.
This medicine helps to increase the amount of insulin released after a meal and decrease the amount of sugar produced by the body.
Your doctor has prescribed this medicine to reduce high blood sugar levels caused by type 2 diabetes. The medicine can be used alone or in combination with other medicines (insulin, metformin, sulfonylurea derivatives, or glitazones) that lower blood sugar levels, which may already be taken for diabetes, along with diet and exercise.
What is type 2 diabetes?
Type 2 diabetes is a disease 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. If this happens, sugar (glucose) builds up in the blood. This can lead to serious diseases, such as heart disease, kidney disease, vision loss, and limb amputation.

2. Important information before taking Sitagliptin Sandoz

When not to take Sitagliptin Sandoz

• if the patient is allergic to sitagliptin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

In patients taking Sitagliptin Sandoz, cases of pancreatitis (see section 4) have been reported.
If the patient develops blisters on the skin, it may be a sign of a disease called bullous pemphigoid. The doctor may advise the patient to stop taking Sitagliptin Sandoz.
The patient should inform their doctor if they have or have had:

• pancreatic disease (e.g., pancreatitis);
• gallstones, alcohol dependence, or very high triglyceride levels in the blood. In such cases, the risk of pancreatitis (see section 4) may increase;
• type 1 diabetes;
• diabetic ketoacidosis (a complication of diabetes characterized by high blood sugar levels, rapid weight loss, nausea, or vomiting);
• any kidney disease, past or present;
• allergic reaction to Sitagliptin Sandoz (see section 4).

Since this medicine does not work when blood sugar levels are low, it is unlikely to cause low blood sugar levels. However, if this medicine is taken with sulfonylurea derivatives or insulin, it may cause low blood sugar levels (hypoglycemia). The doctor may reduce the dose of sulfonylurea derivatives or insulin.

Children and adolescents

This medicine should not be used in children and adolescents under 18 years of age. This medicine is not effective in children and adolescents aged 10 to 17 years. It is not known if this medicine is safe and effective in children under 10 years of age.

Sitagliptin Sandoz and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take.
In particular, the patient should inform their doctor if they are taking digoxin (a medicine used to treat heart rhythm disorders and other heart conditions). When taking Sitagliptin Sandoz with digoxin, the patient's digoxin blood levels should be monitored.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
This medicine should not be used during pregnancy.
It is not known if this medicine passes into breast milk. This medicine should not be used during breastfeeding or if the patient plans 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 the ability to drive and use machines.
Taking this medicine with sulfonylurea derivatives or insulin may cause low blood sugar levels (hypoglycemia), which may affect the ability to drive and use machines or work without safe foot support.

Sitagliptin Sandoz contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially 'sodium-free'.

3. How to take Sitagliptin Sandoz

This medicine should always be taken exactly as prescribed by the doctor. In case of doubt, the patient should consult their doctor or pharmacist.
The recommended dose is:

• one 100 mg film-coated tablet;
• once a day;
• taken orally.

If the patient has kidney problems, the doctor may prescribe a lower dose of Sitagliptin Sandoz (e.g., 25 mg or 50 mg).
This medicine can be taken with or without food and drink.
The doctor may recommend taking only this medicine or this medicine and certain other medicines that lower blood sugar levels. Diet and exercise help the body use sugar from the blood. While taking Sitagliptin Sandoz, it is important to follow the diet and exercise recommended by the doctor.

Taking a higher dose of Sitagliptin Sandoz than prescribed

If the patient takes more of this medicine than they should, they should contact their doctor immediately.

Missing a dose of Sitagliptin Sandoz

If the patient misses a dose, they should take it as soon as possible. If it is almost time for the next dose, the patient should skip the missed dose and continue with their regular dosing schedule. The patient should not take a double dose of this medicine.

Stopping treatment with Sitagliptin Sandoz

To maintain control of blood sugar levels, the patient should take this medicine for as long as their doctor recommends. The patient should not stop taking this medicine without consulting their doctor first.
If the patient has any further questions on the use of this medicine, they should ask their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The patient should STOP taking Sitagliptin Sandoz and contact their doctor immediately if they experience any of the following serious side effects:
Severe and persistent stomach pain (in the abdomen), which may radiate to the back, with or without nausea and vomiting – these may be symptoms of pancreatitis.
In case of a severe allergic reaction (frequency not known), including rash, urticaria, blisters on the skin, or peeling of the skin, as well as swelling of the face, lips, tongue, and throat, which may cause difficulty breathing or swallowing, the patient should stop taking the medicine and contact their doctor immediately. The doctor may prescribe a medicine to treat the allergic reaction and another medicine to treat diabetes.
In some patients who added sitagliptin to metformin, the following side effects were reported:
Common (may affect up to 1 in 10 people): low blood sugar levels, nausea, bloating, vomiting
Uncommon (may affect up to 1 in 100 people): stomach pain, diarrhea, constipation, drowsiness
In some patients who started taking sitagliptin with metformin, various stomach problems were reported (common).
In some patients who took sitagliptin with sulfonylurea derivatives and metformin, the following side effects were reported:
Very common (may affect more than 1 in 10 people): low blood sugar levels
Common: constipation
In some patients who took sitagliptin and pioglitazone, the following side effects were reported:
Common: bloating, swelling of the hands or feet
In some patients who took sitagliptin with pioglitazone and metformin, the following side effects were reported:
Common: swelling of the hands or feet
In some patients who took sitagliptin with insulin (with or without metformin), the following side effects were reported:
Common: flu
Uncommon: dry mouth
In some patients who took sitagliptin alone in clinical studies or took sitagliptin alone and/or with other anti-diabetic medicines after the medicine was approved, the following side effects were reported:
Common: low blood sugar levels, headache, upper respiratory tract infections, stuffy nose or sinusitis, and sore throat, joint pain, arm or leg pain
Uncommon: dizziness, constipation, itching
Rare: reduced platelet count
Frequency not known: kidney disease (sometimes requiring dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of blisters on the skin).

Reporting side effects

If the patient experiences any side effects, including those not listed in this package leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: + 48 22 49 21 301/fax: + 48 22 49 21 309/website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Sitagliptin Sandoz

The medicine should be stored 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 the month.
There are no special storage instructions for this medicine. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Package contents and other information

What Sitagliptin Sandoz contains

The active substance is sitagliptin.
Sitagliptin Sandoz, 25 mg, film-coated tablets
Each film-coated tablet contains sitagliptin phosphate monohydrate equivalent to 25 mg of sitagliptin.
Sitagliptin Sandoz, 50 mg, film-coated tablets
Each film-coated tablet contains sitagliptin phosphate monohydrate equivalent to 50 mg of sitagliptin.
Sitagliptin Sandoz, 100 mg, film-coated tablets
Each film-coated tablet contains sitagliptin phosphate monohydrate equivalent to 100 mg of sitagliptin.
The other ingredients are:
Tablet core: microcrystalline cellulose, calcium hydrogen phosphate, sodium carboxymethyl cellulose (type A), magnesium stearate.
Tablet coating:
Sitagliptin Sandoz, 25 mg, film-coated tablets; Sitagliptin Sandoz, 100 mg, film-coated tablets
polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, yellow iron oxide (E 172), red iron oxide (E 172)
Sitagliptin Sandoz, 50 mg, film-coated tablets
polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, yellow iron oxide (E 172), red iron oxide (E 172), black iron oxide (E 172).

What Sitagliptin Sandoz looks like and contents of the pack

Sitagliptin Sandoz, 25 mg, film-coated tablets
Pink, round film-coated tablet with "25" engraved on one side, 6.2 mm ± 0.2 mm in size.
Sitagliptin Sandoz, 50 mg, film-coated tablets
Light beige, round film-coated tablet with "50" engraved on one side, 8.0 mm ± 0.2 mm in size.
Sitagliptin Sandoz, 100 mg, film-coated tablets
Beige, round film-coated tablet with "100" engraved on one side, 9.9 mm ± 0.2 mm in size.
Opaque blister pack (PVC/PE/PVDC/Aluminum or OPA/Aluminum/PVC/Aluminum), perforated or non-perforated.
Packs contain 28 film-coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl
Austria
Manufacturer
PharOS MT Ltd
HF62X, Hal Far Industrial Estate
BBG3000 Birzebbugia
Malta
Rontis Hellas Medical and Pharmaceutical Products S.A
P.O Box 3012 Larissa Industrial Area
41500 Larissa
Greece
Lek Pharmaceuticals d.d.
Verovškova Ulica 57
1526 Ljubljana,
Slovenia

This medicine is authorized in the Member States of the European Economic Area under the following names:

Netherlands
Sitagliptin Sandoz 25 mg, filmomhulde tabletten
Sitagliptin Sandoz 50 mg, filmomhulde tabletten
Sitagliptin Sandoz 100 mg, filmomhulde tabletten
Poland
Sitagliptin Sandoz
Romania
Sitagliptină Sandoz 100 mg comprimate filmate

For further information on this medicine, the patient should contact their local representative of the marketing authorization holder:

Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00
Date of last revision of the package leaflet:04/2024