Sitena

Package Leaflet: Information for the Patient

Sytena, 25 mg, coated tablets

Sytena, 50 mg, coated tablets

Sytena, 100 mg, coated tablets

Sitagliptin

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• 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 those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is Sytena and what is it used for
• 2. Important information before taking Sytena
• 3. How to take Sytena
• 4. Possible side effects
• 5. How to store Sytena
• 6. Contents of the pack and other information

1. What is Sytena and what is it used for

Sytena 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. This 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 as it should. 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 limb amputation.

2. Important information before taking Sytena

When not to take Sytena

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

Warnings and precautions

In patients taking Sytena, cases of pancreatitis (see section 4) have been reported.
If you develop blisters on your skin, it may be a sign of a disease called bullous pemphigoid. Your doctor may advise you to stop taking sitagliptin.
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 these situations, 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 that has occurred in the past or is present;
• an allergic reaction to sitagliptin (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 a sulfonylurea derivative or insulin, low blood sugar levels (hypoglycemia) may occur. Your doctor may reduce the dose of the sulfonylurea derivative 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 from 10 to 17 years of age. It is not known whether this medicine is safe and effective when used in children under 10 years of age.

Sytena and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to 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 Sytena with digoxin, your doctor may need to check your digoxin levels.

Sytena with food and drink

This medicine can be taken with or without food and drink.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan 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 whether this medicine passes into breast milk. Do not take 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, 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.

Sytena 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 Sytena

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The usual recommended dose is:

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

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

Taking a higher dose of Sytena than recommended

If you take more of this medicine than you should, contact your doctor immediately.

Missing a dose of Sytena

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 treatment with Sytena

To maintain control of your blood sugar levels, you should continue taking this medicine for 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 medicine, 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 Sytena 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 - these may be symptoms of pancreatitis.

If you experience a severe allergic reaction (frequency not known), including rash, hives, 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, 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 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 took sitagliptin in combination with metformin, various gastrointestinal symptoms (common) were reported after starting treatment with sitagliptin.
In some patients who took sitagliptin in combination with a sulfonylurea derivative 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 in combination with pioglitazone and metformin, the following side effects were reported:
Common: swelling of the hands or feet.
In some patients who took sitagliptin in combination 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 trials or after marketing, when used alone or with other anti-diabetic medicines, 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, pain in the arms or legs.
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 blistering skin condition).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sytena

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.
There are no special storage instructions for this medicine.
Medicines should 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 Sytena contains

• The active substance is sitagliptin.

Sytena, 25 mg, coated tablets

• Each coated tablet contains sitagliptin phosphate monohydrate equivalent to 25 mg of sitagliptin. Sytena, 50 mg, coated tablets
• Each coated tablet contains sitagliptin phosphate monohydrate equivalent to 50 mg of sitagliptin. Sytena, 100 mg, coated tablets
• Each coated tablet contains sitagliptin phosphate monohydrate equivalent to 100 mg of sitagliptin.
• The other ingredients are: Tablet core: calcium hydrogen phosphate, microcrystalline cellulose, type 102, sodium carmellose, colloidal anhydrous silica, sodium stearyl fumarate, magnesium stearate. Coating: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172), red iron oxide (E172). Additionally, Sytena, 25 mg, coated tablets:black iron oxide (E 172).

What Sytena looks like and contents of the pack

Sytena, 25 mg, coated tablets
Round, pink coated tablets.
Sytena, 50 mg, coated tablets
Round, light beige coated tablets with the letter "S" embossed on one side.
Sytena, 100 mg, coated tablets
Round, beige coated tablets.
The medicine is available in transparent PVC/PE/PVDC/Aluminum blisters in cardboard boxes containing 10, 28, 30, 60, 98 coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Farmak International Sp. z o.o.
ul. Koszykowa 65
00-667 Warsaw
tel. +48 22 822 93 06
e-mail: [email protected]

Manufacturer

SAG Manufacturing S.L.U.
Ctra. N-I, Km 36,
San Agustin de Guadalix,
28750 Madrid,
Spain
Galenicum Health, S.L.
Avda. Cornellá 144, 7º-1ª, Edificio Lekla,
Esplugues de Llobregat,
08950 Barcelona,
Spain

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

Malta
Sytena 25mg/50mg/100mg film-coated tablets
Poland
Sytena

Date of last revision of the leaflet: