Sitagliptin Adamed

Package Leaflet: Information for the Patient

Sitagliptin Adamed, Film-Coated Tablets, 25 mg

Sitagliptin Adamed, Film-Coated Tablets, 50 mg

Sitagliptin Adamed, Film-Coated Tablets, 100 mg

Sitagliptin

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

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

Table of Contents of the Package Leaflet

• 1. What is Sitagliptin Adamed and What is it Used For
• 2. Important Information Before Taking Sitagliptin Adamed
• 3. How to Take Sitagliptin Adamed
• 4. Possible Side Effects
• 5. How to Store Sitagliptin Adamed
• 6. Contents of the Package and Other Information

1. What is Sitagliptin Adamed and What is it Used For

Sitagliptin Adamed contains the active substance sitagliptin, which belongs to a group of medications called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors), which lower blood glucose levels in adults with type 2 diabetes.
This medication facilitates the increase in insulin levels produced after a meal and also lowers the level of sugar produced by the body.
The doctor has prescribed this medication to help lower blood glucose levels, a consequence of type 2 diabetes. This medication can be used alone or in combination with other specified medications (insulin, metformin, sulfonylurea derivatives, or glitazone), which lower blood glucose levels and may already be taken by the patient with meals and a physical exercise plan.
What is type 2 diabetes?
Type 2 diabetes is a condition in which the body does not produce enough insulin, and the produced insulin does not work as well as it should. The patient's body may also produce too much sugar. In such a situation, glucose (sugar) accumulates in the blood. This can lead to serious health problems, such as heart disease, kidney disease, vision loss, and limb amputation.

2. Important Information Before Taking Sitagliptin Adamed

When Not to Take Sitagliptin Adamed

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

Warnings and Precautions

In patients taking sitagliptin, cases of pancreatitis (inflammation of the pancreas) have been observed (see section 4).
The appearance of blisters on the skin may be a sign of a disease called bullous pemphigoid.
The doctor may recommend stopping the use of Sitagliptin Adamed.
The patient should inform their doctor if they have or have had:

• pancreatic disease (e.g., pancreatitis);
• gallstones, alcohol dependence, or very high levels of triglycerides (a type of fat) in the blood; these conditions may increase the risk of pancreatitis (see section 4).
• type 1 diabetes;
• diabetic ketoacidosis (a complication of diabetes associated with high blood glucose levels, rapid weight loss, nausea, or vomiting);
• current or past kidney problems;
• allergic reaction to Sitagliptin Adamed (see section 4). It is unlikely that this medication will cause low blood glucose levels, as it does not work when blood glucose levels are low. However, if this medication is used in combination with sulfonylurea derivatives or insulin, it may cause low blood glucose levels (hypoglycemia). The doctor may reduce the dose of sulfonylurea derivatives or insulin.

Children and Adolescents

Children and adolescents under 18 years of age should not take this medication.
This medication is not effective in children and adolescents between 10 and 17 years of age. It is not known whether this medication is safe and effective in children under 10 years of age.

Sitagliptin Adamed and Other Medications

The patient should tell their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take.
In particular, the patient should inform their doctor if they are taking digoxin (a medication used to treat irregular heart rhythm and other heart problems). It may be necessary to check the level of digoxin in the patient's blood if it is taken with Sitagliptin Adamed.

Pregnancy and Breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medication.
This medication should not be used during pregnancy.
It is not known whether this medication passes into breast milk. This medication should not be used if the patient is breastfeeding or plans to breastfeed.

Driving and Operating Machines

This medication has no or negligible influence on the ability to drive and operate machines. However, dizziness and drowsiness have been observed, which may affect the ability to drive and operate machines.
Taking this medication in combination with medications such as sulfonylurea derivatives and insulin may cause hypoglycemia, which may affect the ability to drive and operate machines or work without a safe foothold.

Sitagliptin Adamed Contains Sodium

This medication contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to Take Sitagliptin Adamed

This medication should always be taken as directed by the doctor. In case of doubts, 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 (e.g., 25 mg or 50 mg). This medication can be taken with or without food.

The doctor may prescribe this medication to be taken alone or in combination with other specified medications that lower blood glucose levels.
Diet and physical activity can help the body use sugar better. During treatment with Sitagliptin Adamed, it is essential to continue with the diet and physical activity plan recommended by the doctor.

Taking a Higher Dose of Sitagliptin Adamed Than Recommended

In case of taking a higher dose of the medication than prescribed, the patient should immediately contact their doctor.

Missing a Dose of Sitagliptin Adamed

If the patient misses a dose, they should take it as soon as they remember. However, if they do not remember until it is time for the next dose, they should not take the missed dose and should return to their regular dosing schedule. The patient should not take a double dose of this medication.

Stopping Treatment with Sitagliptin Adamed

This medication should be taken for the period prescribed by the doctor to continuously support blood glucose control. The patient should not stop taking this medication without consulting their doctor first.
In case of any further doubts about the use of this medication, the patient should consult their doctor or pharmacist.

4. Possible Side Effects

Like all medications, Sitagliptin Adamed can cause side effects, although not everybody gets them.
The patient should STOP taking Sitagliptin Adamed and immediately contact their doctor if they observe any of the following serious side effects:

• severe and persistent abdominal pain (in the stomach area), which may radiate to the back and may be accompanied by nausea and vomiting, as these may be symptoms of pancreatitis.

In case of a severe allergic reaction (the frequency of which is not known), including rash, urticaria, blisters on the skin/peeling of the skin, and swelling of the face, lips, tongue, and throat, which may cause difficulty breathing and swallowing, the patient should stop taking this medication and immediately contact their doctor. The doctor may prescribe a medication to treat the allergic reaction and another medication to treat diabetes.
In some patients, the following side effects have been observed after adding sitagliptin to metformin treatment:
Common (may affect up to 1 in 10 patients): low blood glucose levels, nausea, bloating, vomiting
Uncommon (may affect up to 1 in 100 patients): abdominal pain, diarrhea, constipation, drowsiness
In some patients, the following side effects have been observed when taking sitagliptin in combination with sulfonylurea derivatives and metformin:
Very common (may affect more than 1 in 10 patients): low blood glucose levels
Common: constipation
In some patients, the following side effects have been observed when taking sitagliptin and pioglitazone:
Common: bloating, swelling of the hands or feet
In some patients, the following side effects have been observed when taking sitagliptin in combination with pioglitazone and metformin:
Common: swelling of the hands or feet
In some patients, the following side effects have been observed when taking sitagliptin in combination with insulin (with or without metformin):
Common: flu
Uncommon: dry mouth
In some patients, the following side effects have been observed when taking sitagliptin alone and/or in combination with other antidiabetic medications during clinical trials or after the medication was marketed:
Common: low blood glucose levels, headache, upper respiratory tract infection, stuffy nose or sore throat and sore throat, degenerative joint disease, limb pain
Uncommon: dizziness, constipation, fatigue
Rare: decreased blood 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 disease).

Reporting Side Effects

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

5. How to Store Sitagliptin Adamed

The medication should be stored out of sight and reach of children.
Do not use this medication 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 precautions for storage.
Medications should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the Package and Other Information

What Sitagliptin Adamed Contains

• The active substance of the medication is sitagliptin. Each film-coated tablet contains sitagliptin hydrochloride monohydrate, equivalent to 25 mg, 50 mg, or 100 mg of sitagliptin.
• Other ingredients are: Tablet core: calcium hydrogen phosphate, microcrystalline cellulose, sodium carmellose, sodium stearyl fumarate, magnesium stearate. Tablet coating: polyvinyl alcohol, macrogol 4000, titanium dioxide (E 171), talc, iron oxide red (E 172), and iron oxide yellow (E 172).

What Sitagliptin Adamed Looks Like and Contents of the Package

25 mg tablet: orange, round, biconvex film-coated tablet with "25" embossed on one side.
50 mg tablet: orange, round, biconvex film-coated tablet with "50" embossed on one side.
100 mg tablet: orange, round, biconvex film-coated tablet with "100" embossed on one side.

Packaging

Blisters (PVC/PVDC/Aluminum)
Packages containing 28, 98 film-coated tablets in blisters, placed in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorization Holder

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów

Manufacturer

Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice

Date of Last Revision of the Package Leaflet: December 2020