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.

• You should keep this 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. 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 those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

1.
What Sitagliptin +pharma is and what it is 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 Sitagliptin +pharma is and what it is 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 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 medicines that lower blood sugar levels (insulin, metformin, sulfonylureas, or glitazones), which you may already be taking for your diabetes, together with diet and exercise.

What is type 2 diabetes?

Type 2 diabetes is a condition where 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 amputation of limbs.

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

There have been reports of pancreatitis (see section 4) in patients taking Sitagliptin +pharma.
If you experience blisters on your skin, this may be a sign of a condition called bullous pemphigoid. Your doctor may tell you to stop taking Sitagliptin +pharma.
Tell your doctor if you have or have had:

• pancreatitis (inflammation of the pancreas)
• 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 problems, past or present
• an allergic reaction to Sitagliptin +pharma (see section 4)

As this medicine does not work when your blood sugar levels are low, it is unlikely to cause low blood sugar levels (hypoglycemia). However, if you take this medicine in combination with a sulfonylurea or insulin, you may experience low blood sugar levels (hypoglycemia). Your doctor may reduce the dose of the sulfonylurea or insulin.

Children and adolescents

Do not take this medicine if you are under 18 years old. 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.

Sitagliptin +pharma with other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take, including those you have bought without a prescription.
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 the level of digoxin in your blood.

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 take this medicine during pregnancy.
It is not known if this medicine passes into breast milk. Do not take this medicine while breastfeeding or if you are planning 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 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

• one 100 mg film-coated tablet
• once a day
• by mouth

If you have kidney problems, your doctor may prescribe a lower dose of sitagliptin (e.g., 25 mg or 50 mg).
This medicine can be taken with or without food and drink.
Your doctor may also prescribe this medicine alone or in combination with other medicines that lower 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.

What to do if you take more Sitagliptin +pharma than you should

If you take more than the prescribed dose, contact your doctor immediately.

What to do if you miss a dose of Sitagliptin +pharma

If you miss a dose, take it as soon as possible. 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.

What to do if you stop taking Sitagliptin +pharma

To maintain control of your blood sugar levels, you should continue taking this medicine as long as your doctor recommends. 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 stomach pain (in the abdomen), 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 of the 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 to treat your diabetes.
In some patients, when sitagliptin was added to metformin, the following side effects were reported:
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, when sitagliptin was taken in combination with a sulfonylurea and metformin, the following side effects were reported:
Very common(may affect more than 1 in 10 people): low blood sugar
Common: constipation
In some patients, when sitagliptin and pioglitazone were taken, the following side effects were reported:
Common: bloating, swelling of the hands or feet
In some patients, when sitagliptin was taken in combination with pioglitazone and metformin, the following side effects were reported:
Common: swelling of the hands or feet
In some patients, when sitagliptin was taken in combination with insulin (with or without metformin), the following side effects were reported:
Common: flu
Uncommon: dry mouth
In some patients, when sitagliptin was taken alone in clinical studies or when sitagliptin was taken alone or with other anti-diabetic medicines after the medicine was approved, the following side effects were reported:
Common: low blood sugar, headache, upper respiratory tract infections, stuffy or runny nose and sore throat, and pain in the bones or joints, arm or leg pain
Uncommon: dizziness, constipation, itching
Rare(may affect up to 1 in 1,000 people): reduced number of platelets in the blood
Frequency not known(frequency cannot be estimated from the available data): kidney problems (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 those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly to the national reporting system via the Medicines and Healthcare products Regulatory Agency (MHRA) Yellow Card Scheme (www.mhra.gov.uk/yellowcard). By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sitagliptin +pharma

Keep this medicine out of the sight and reach of children.
Do not take this medicine after the expiry date stated on the carton and blister after ‘EXP’. The expiry date refers to the last day of that month.
Store in a temperature not exceeding 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 carboxymethyl cellulose (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 box.
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 Authorisation 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 authorised in the Member States of the European Economic Area under the following names:

Poland, Czech Republic
Sitagliptin +pharma
For further information on this medicine, contact the representative of the Marketing Authorisation Holder:
+pharma Polska sp. z o.o.
ul. Podgórska 34
31-536 Kraków, Poland
tel.: +48 12 262 32 36
e-mail: krakow@pluspharma.eu
Date of last revision of the leaflet:February 2025