Sitagliptin +pharma

Package Leaflet: Information for the User

Sitagliptin +pharma, 25 mg, film-coated tablets

Sitagliptin +pharma, 50 mg, film-coated tablets

Sitagliptin +pharma, 100 mg, film-coated tablets

Sitagliptin

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

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this package leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

1.
What is Sitagliptin +pharma and what is it used for

• 2. Important information before taking Sitagliptin +pharma
• 3. How to take Sitagliptin +pharma
• 4. Possible side effects
• 5. How to store Sitagliptin +pharma
• 6. Contents of the pack and other information

1. What is Sitagliptin +pharma and what is it used for

Sitagliptin +pharma 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 made by the body.
Your doctor has prescribed this medicine to reduce high blood sugar levels caused by type 2 diabetes. This medicine can be used alone or in combination with other medicines that reduce blood sugar levels (insulin, metformin, sulfonylureas, or glitazones) which you are already taking for type 2 diabetes, together with diet and exercise.

What is type 2 diabetes?

Type 2 diabetes is a condition in which the body does not produce enough insulin, and the insulin that it does produce 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 health problems, such as heart disease, kidney disease, loss of vision, and foot amputation.

2. Important information before taking Sitagliptin +pharma

When not to take Sitagliptin +pharma

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

Warnings and precautions

Patients taking Sitagliptin +pharma have reported cases of pancreatitis (see section 4).
If you experience blisters on your skin, it may be a sign of a condition called bullous pemphigoid. Your doctor may advise you to stop taking Sitagliptin +pharma.
Tell 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. In these cases, the risk of pancreatitis (see section 4) may be increased
• 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 +pharma (see section 4)

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

Children and adolescents

Do not use this medicine in children and adolescents under 18 years of age. This medicine is not effective in children and adolescents from 10 to 17 years of age. It is not known if this medicine is safe and effective when used in children under 10 years of age.

Sitagliptin +pharma with other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take.
In particular, tell your doctor if you are taking digoxin (a medicine used to treat heart rhythm disorders and other heart conditions). When taking Sitagliptin +pharma with digoxin, your doctor may need to check your digoxin blood levels.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Do not use this medicine during pregnancy.
It is not known if this medicine passes into breast milk. Do not use this medicine while breastfeeding or if you plan to breastfeed.

Driving and using machines

This medicine has no or negligible influence on the ability to drive and use machines. However, when driving or operating machinery, consider that dizziness and drowsiness have been reported.

Sitagliptin +pharma 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 +pharma

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Recommended dose is

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

If you have kidney problems, your doctor may prescribe a lower dose of sitagliptin (such as 25 mg or 50 mg).
This medicine can be taken with or without food and drink.
Your doctor may advise you to take this medicine alone or with certain other medicines that reduce blood sugar levels.
Diet and exercise help your body use blood sugar better. While taking Sitagliptin +pharma, it is important to follow the diet and exercise plan recommended by your doctor.

If you take more Sitagliptin +pharma than you should

If you have taken more Sitagliptin +pharma than you should, contact your doctor immediately.

If you forget to take Sitagliptin +pharma

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose of this medicine.

Stopping Sitagliptin +pharma treatment

To maintain control of your blood sugar levels, you should continue to take this medicine for as long as your doctor tells you. Do not stop taking this medicine without first talking to your doctor.
If you have any further questions on the use of this product, 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 +pharma and contact your doctor immediately if you experience any of the following serious side effects:

• severe and persistent abdominal pain (in the stomach area), which may radiate to the back, with or without nausea and vomiting - this may be a sign of pancreatitis

In case of a severe allergic reaction (frequency not known), including rash, hives, blisters on the skin, or peeling skin, 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 the allergic reaction and another medicine for diabetes.
In some patients, after adding sitagliptin to metformin, the following side effects have occurred:
Common(may affect up to 1 in 10 people): low blood sugar, nausea, bloating, vomiting
Uncommon(may affect up to 1 in 100 people): stomach pain, diarrhea, constipation, drowsiness
In some patients, gastrointestinal symptoms have occurred after starting sitagliptin in combination with metformin (commonly).
In some patients, after adding sitagliptin to a sulfonylurea and metformin, the following side effects have occurred:
Very common(may affect more than 1 in 10 people): low blood sugar
Common: constipation
In some patients, after taking sitagliptin and pioglitazone, the following side effects have occurred:
Common: bloating, swelling of the hands or feet
In some patients, after taking sitagliptin, pioglitazone, and metformin, the following side effects have occurred:
Common: swelling of the hands or feet
In some patients, after taking sitagliptin and insulin (with or without metformin), the following side effects have occurred:
Common: flu
Uncommon: dry mouth
In some patients, after taking sitagliptin alone in clinical studies or after taking sitagliptin with other anti-diabetic medicines after the medicine was approved, the following side effects have occurred:
Common: low blood sugar, headache, upper respiratory tract infections, stuffy nose or sinusitis, and sore throat
Uncommon: 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 disease (sometimes requiring dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of blistering skin condition).

Reporting of side effects

If you experience any side effects, including any not listed in this package leaflet, please tell your doctor or pharmacist. You can also report side effects directly to the national reporting system via the Medicines Agency website: https://smz.ezdrowie.gov.pl
You can also report side effects to the marketing authorization holder.

5. How to store Sitagliptin +pharma

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 carton and blister after 'EXP'. The expiry date refers to the last day of that month.
Store in a temperature below 30°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Sitagliptin +pharma contains

• The active substance is sitagliptin.

Sitagliptin +pharma, 25 mg, film-coated tablets
Each film-coated tablet contains sitagliptin phosphate monohydrate, equivalent to 25 mg of sitagliptin.
Sitagliptin +pharma, 50 mg, film-coated tablets
Each film-coated tablet contains sitagliptin phosphate monohydrate, equivalent to 50 mg of sitagliptin.
Sitagliptin +pharma, 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 (PH 101), calcium hydrogen phosphate, sodium carboxymethylcellulose (type A), magnesium stearate

tablet coating
Sitagliptin +pharma, 25 mg/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 +pharma, 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 +pharma looks like and contents of the pack

Sitagliptin +pharma, 25 mg, film-coated tablets
Round, pink film-coated tablet with "25" engraved on one side, 6.2 mm ± 0.2 mm in diameter
Sitagliptin +pharma, 50 mg, film-coated tablets
Round, light beige film-coated tablet with "50" engraved on one side, 8.0 mm ± 0.2 mm in diameter
Sitagliptin +pharma, 100 mg, film-coated tablets
Round, beige film-coated tablet with "100" engraved on one side, 9.9 mm ± 0.2 mm in diameter
PVC/PE/PVDC/Aluminium or OPA/Aluminium/PVC/Aluminium blisters in a carton.
Sitagliptin +pharma, 25 mg/50 mg/100 mg, film-coated tablets
Pack sizes of 30, 60, 90 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

+pharma arzneimittel gmbh
Hafnerstrasse 211
8054 Graz
Austria

Manufacturer

PharOS MT Ltd
HF62X, Hal Far Industrial Estate
BBG3000 Birzebbugia
Malta
Rontis Hellas Medical and Pharmaceutical Products S.A.
Larissa Industrial Area
P.O Box 3012
41500 Larissa
Greece
Genericon Pharma Gesellschaft m.b.H
Hafnerstrasse 211
8054 Graz
Austria

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

Poland, Czech Republic
Sitagliptin +pharma
To obtain more detailed information on this medicine, contact the representative of the marketing authorization holder:
+pharma Polska sp. z o.o.
ul. Podgórska 34
31-536 Kraków, Poland
tel.: +48 12 262 32 36
e-mail: [email protected]
Date of last revision of the package leaflet:February 2025