Sytena

Package leaflet: Information for the patient

Sytena, 25 mg, film-coated tablets
Sytena, 50 mg, film-coated tablets
Sytena, 100 mg, film-coated tablets
Sitagliptin
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

1. What Sytena is and what it is 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 Sytena is and what it is 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 glucose levels in adults with type 2 diabetes.
This medicine helps increase insulin levels released after meals and reduces the amount of glucose produced by the body.
Your doctor has prescribed this medicine to lower high blood glucose levels caused by type 2 diabetes. This medicine may be used alone or in combination with other glucose-lowering medicines (such as insulin, metformin, sulfonylureas, or glitazones) that you may already be taking, 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 may also produce too much glucose. 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 using Sytena

When not to use Sytena

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

Warnings and precautions
Cases of pancreatitis have been reported in patients taking Sytena (see section 4).
If the patient develops blisters on the skin, this may be a sign of a disease called bullous pemphigoid.
The doctor may advise the patient to stop taking sitagliptin.
Inform the doctor if the patient has had or currently has:

• diseases of the pancreas (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 increase (see section 4);
• type 1 diabetes;
• diabetic ketoacidosis (a complication of diabetes characterized by high blood sugar levels, rapid weight loss, nausea or vomiting);
• any kidney disease in the past or currently;
• allergic reaction to sitagliptin (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 used together with a sulfonylurea or insulin, low blood sugar (hypoglycaemia) may occur. The 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.
Sytena and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
In particular, inform the doctor if the patient is taking digoxin (a medicine used to treat heart rhythm disorders and other heart conditions). Blood levels of digoxin should be monitored when Sytena is taken with digoxin.
Sytena with food and drink
This medicine can be taken regardless of meals and drinks.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine. This medicine should not be used during pregnancy.
It is not known whether this medicine passes into human milk. This medicine should not be used during breastfeeding or if breastfeeding is planned.
Driving and using machines
This medicine has no effect or a negligible effect on the ability to drive and use machines. However, dizziness and somnolence have been reported, which may affect the ability to drive and use machines.
Taking this medicine together with medicines called sulfonylureas or with insulin may lead to low blood sugar (hypoglycaemia), which may affect the ability to drive and use machines or work without secure foot support.
Sytena contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered to be "sodium-free".

3. How to take Sytena

This medicine should always be taken exactly as directed by your doctor. If in doubt, consult your
doctor or pharmacist.
The usual recommended dose is:

• one 100 mg coated tablet;
• once daily;
• taken orally.

If the patient has renal function impairment, the doctor may recommend a lower dose of the medicine
(e.g. 25 mg or 50 mg).
This medicine can be taken regardless of meals or drinks.
The 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 the body to use more effectively the sugar present in the blood.
While taking Sytena, it is important to follow the diet and perform the physical exercises
recommended by your doctor.
Taking more Sytena than prescribed
If you take more of this medicine than prescribed, 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 the next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose of this medicine.
Stopping Sytena treatment
To maintain control of blood sugar levels, take this medicine for as long as your doctor recommends. Do not stop taking this medicine without consulting your doctor first.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You should DISCONTINUE Sytena and contact your doctor immediately if any of the following severe 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, skin blisters or skin peeling, and swelling of the face, lips, tongue or throat, which may cause difficulty breathing or swallowing, you must stop taking the medicine and contact your doctor immediately. Your doctor may prescribe a medicine to treat the allergic reaction and another medicine to treat diabetes.

In some patients, the following adverse reactions occurred when sitagliptin was added to metformin:

Frequent (may occur in up to 1 in 10 people): low blood sugar levels, nausea, bloating, vomiting.

Uncommon (may occur in up to 1 in 100 people): stomach pain, diarrhoea, constipation, drowsiness.

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

In some patients, the following adverse reactions occurred during treatment with sitagliptin in combination with a sulfonylurea and metformin:

Very common (may occur in more than 1 in 10 people): low blood sugar levels.

Frequent: constipation.

In some patients, the following adverse reactions occurred during treatment with sitagliptin and pioglitazone:

Frequent: bloating, swelling of hands or feet.

In some patients, the following adverse reactions occurred during treatment with sitagliptin in combination with pioglitazone and metformin:

Frequent: swelling of hands or feet.

In some patients, the following adverse reactions occurred during treatment with sitagliptin in combination with insulin (with or without metformin):

Frequent: influenza-like illness.

Uncommon: dry mouth.

In some patients, the following adverse reactions occurred during clinical trials or after marketing when sitagliptin was used alone or in combination with other antidiabetic medicines:

Frequent: low blood sugar levels, headache, upper respiratory tract infections, stuffy or runny nose and sore throat, bone and joint inflammation, pain in arm or leg.

Uncommon: dizziness, constipation, itching.

Rare: decreased platelet count.

Frequency not known: kidney disorders (sometimes requiring dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of skin blistering).

Reporting of adverse reactions

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

Reporting adverse reactions helps to provide more information on the safety of the 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 stated on the cardboard box and
blister pack following EXP. The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
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 Sytena contains

• The active substance is sitagliptin.

Sytena 25 mg, film-coated tablets

• Each film-coated tablet (tablet) contains sitagliptin hydrochloride monohydrate equivalent to 25 mg of sitagliptin.

Sytena 50 mg, film-coated tablets

• Each film-coated tablet (tablet) contains sitagliptin hydrochloride monohydrate equivalent to 50 mg of sitagliptin.

Sytena 100 mg, film-coated tablets

• Each film-coated tablet (tablet) contains sitagliptin hydrochloride monohydrate equivalent to 100 mg of sitagliptin.

• Other ingredients are:
  Tablet core: calcium hydrogen phosphate, microcrystalline cellulose, type 102, sodium croscarmellose, anhydrous colloidal 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, film-coated tablets: black iron oxide (E172).

What Sytena looks like and contents of the pack
Sytena 25 mg, film-coated tablets
Round, pink film-coated tablets.
Sytena 50 mg, film-coated tablets
Round, light beige film-coated tablets with the letter "S" embossed on one side.
Sytena 100 mg, film-coated tablets
Round, beige film-coated tablets.
The medicine is available in transparent PVC/PE/PVDC/Aluminium blister packs in cardboard boxes containing 10, 28, 30, 60 or 98 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation 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 authorised for sale in the European Economic Area countries under the following names:
Malta Sytena 25mg/50mg/100mg film-coated tablets
Poland Sytena