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
Sitagliptinum
Please read carefully all the information in this leaflet before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the 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 increase the amount of insulin released after meals and reduces the amount of sugar
produced by the body.
Your doctor has prescribed this medicine to lower high blood sugar levels caused by type 2 diabetes. This medicine may be used alone or in combination with other blood sugar-lowering medicines (such as insulin, metformin, sulfonylureas, or glitazones), along with diet and an exercise program.
What is type 2 diabetes?
Type 2 diabetes is a condition in which the body does not produce enough insulin, the insulin produced does not work properly, or the body produces too much sugar. When this happens, sugar (glucose) accumulates in the blood. This may lead to serious health problems, such as heart disease, kidney disease, vision loss, and limb amputations.

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
Cases of pancreatitis (see section 4) have been reported in patients taking Sitagliptin +pharma.
If you develop blisters on your skin, this may be a sign of a disease called bullous pemphigoid. Your doctor may advise you to stop taking Sitagliptin +pharma.
Tell your doctor if you 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. In such cases, the risk of pancreatitis may be increased (see section 4)
• type 1 diabetes
• diabetic ketoacidosis (a diabetes complication characterized by high blood sugar levels, rapid weight loss, nausea or vomiting)
• any kidney problems currently or in the past
• an allergic reaction to Sitagliptin +pharma (see section 4)

Since this medicine does not act when blood sugar levels are low, it is unlikely to cause excessively low blood sugar levels. However, if this medicine is taken together with a sulfonylurea or insulin, low blood sugar (hypoglycaemia) may occur. Your doctor may reduce the dose of the sulfonylurea 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 whether this medicine is safe and effective in children under 10 years of age.
Sitagliptin +pharma and other medicines
Tell 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 heart rhythm disorders and other heart conditions). When taking Sitagliptin +pharma with digoxin, blood levels of digoxin should be monitored.
Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before taking this medicine. This medicine should not be used during pregnancy.
It is not known whether this medicine passes into human milk. Do not use this medicine while breastfeeding or if you are planning to breastfeed.
Driving and using machines
This medicine has no effect or a negligible effect on the ability to drive and use machines. However, bear in mind that dizziness and drowsiness have been reported.
Taking this medicine together with medicines called sulfonylureas or with insulin may lead to hypoglycaemia, which may affect the ability to drive and use machines or work without secure foot support.
Sitagliptin +pharma contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".
3. How to take Sitagliptin +pharma
Always take this medicine exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
The usual recommended dose is

• one 100 mg film-coated tablet
• taken once daily
• taken orally

If you have kidney problems, your doctor may recommend a lower dose of sitagliptin (e.g. 25 mg or 50 mg).
This medicine can be taken with or without food and drinks.
Your doctor may recommend taking only this medicine or this medicine together with certain other medicines that lower blood sugar levels.
Diet and physical exercise help your body use blood sugar more effectively. While taking Sitagliptin +pharma, it is important to follow the diet and exercise program recommended by your doctor.
Taking more Sitagliptin +pharma than prescribed
If you take more than the prescribed dose of this medicine, contact your doctor immediately.
Missing 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.
Stopping Sitagliptin +pharma
To maintain control of your blood sugar levels, continue taking this medicine for as long as your doctor recommends. Do not stop taking this medicine without first consulting your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everybody will experience them.
DISCONTINUE Sitagliptin +pharma and contact your doctor immediately if any of the following serious adverse reactions occur:

• severe and persistent abdominal pain (in the stomach area), possibly radiating to the back, with or without nausea and vomiting – these may be symptoms of pancreatitis

In case of a severe allergic reaction (frequency unknown), including rash, hives, blisters on the skin or peeling of the skin, and swelling of the face, lips, tongue or throat, which may cause difficulty breathing or swallowing, treatment with the medicine must be stopped and you should contact your doctor immediately. Your doctor may prescribe a medicine to treat the allergic reaction and another medicine to treat diabetes.

The following adverse reactions have been reported in some patients when sitagliptin was added to metformin:

Common (may affect up to 1 in 10 people): low blood sugar, nausea, flatulence, vomiting
Uncommon (may affect up to 1 in 100 people): stomach pain, diarrhoea, constipation, drowsiness

Gastrointestinal disorders of various kinds have occurred in some patients after starting treatment with sitagliptin in combination with metformin (common).

The following adverse reactions have been reported in some patients receiving sitagliptin in combination with a sulfonylurea and metformin:

Very common (may affect more than 1 in 10 people): low blood sugar
Common: constipation

The following adverse reactions have been reported in some patients receiving sitagliptin with pioglitazone:

Common: flatulence, swelling of hands or feet

The following adverse reactions have been reported in some patients receiving sitagliptin in combination with pioglitazone and metformin:

Common: swelling of hands or feet

The following adverse reactions have been reported in some patients receiving sitagliptin in combination with insulin (with or without metformin):

Common: influenza
Uncommon: dry mouth

The following adverse reactions have been reported in some patients receiving sitagliptin alone in clinical trials or after marketing authorization, either alone or in combination with other antidiabetic medicines:

Common: low blood sugar, headache, upper respiratory tract infections, blocked or runny nose and sore throat, bone and joint inflammation, pain in arm or leg
Uncommon: dizziness, constipation, itching
Rare (may affect up to 1 in 1,000 people): decreased platelet count
Frequency not known (frequency cannot be estimated from the available data): kidney disorders (sometimes requiring dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of blistering skin condition).

Reporting of adverse reactions

If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Adverse reactions can also be reported to the marketing authorization holder.

Reporting adverse reactions helps provide more information on the safety of the medicine.

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 stated on the cardboard packaging
and blister after "EXP". The expiry date refers to the last day of the stated month.
Store the medicine at a temperature below 30°C.
Medicines must not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
This will help protect the environment.

6. Contents of the pack and other information

What the medicine contains

• The active substance is sitagliptin.

Sitagliptin +pharma, 25 mg, film-coated tablets
Each film-coated tablet contains sitagliptin hydrochloride monohydrate equivalent to 25 mg of sitagliptin.
Sitagliptin +pharma, 50 mg, film-coated tablets
Each film-coated tablet contains sitagliptin hydrochloride monohydrate equivalent to 50 mg of sitagliptin.
Sitagliptin +pharma, 100 mg, film-coated tablets
Each film-coated tablet contains sitagliptin hydrochloride monohydrate equivalent to 100 mg of sitagliptin.

• Other ingredients are: tablet core: microcrystalline cellulose (PH 101), calcium hydrogen phosphate, sodium carboxymethyl starch (type A), magnesium stearate

film 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 the imprint "25" on one side, measuring 6.2 mm ± 0.2 mm
Sitagliptin +pharma, 50 mg, film-coated tablets
Round, light beige film-coated tablet with the imprint "50" on one side, measuring 8.0 mm ± 0.2 mm
Sitagliptin +pharma, 100 mg, film-coated tablets
Round, beige film-coated tablet with the imprint "100" on one side, measuring 9.9 mm ± 0.2 mm
Blister packs made of PVC/PE/PVDC/Aluminum or OPA/Aluminum/PVC/Aluminum in cardboard cartons.
Sitagliptin +pharma, 25 mg/50 mg/100 mg, film-coated tablets
Pack sizes of 30, 60, and 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 for sale in the European Economic Area under the following names:
Poland, Czech Republic: Sitagliptin +pharma

For further information about this medicine, please contact the Marketing Authorisation Holder's representative:
+pharma Polska sp. z o.o.
ul. Podgórska 34
31-536 Kraków, Poland
tel.: +48 12 262 32 36
e-mail: [email protected]