Sitena Plus

Leaflet accompanying the packaging: patient information

Sytena Plus, 50 mg + 850 mg, film-coated tablets

Sytena Plus, 50 mg + 1000 mg, film-coated tablets

Sitagliptin + Metformin hydrochloride

It is essential to carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

Keep this leaflet, so you can read it again if necessary.
In case of any doubts, consult a doctor, pharmacist, or nurse.
This medicine has been prescribed to a specific person. Do not pass it on to others.
The medicine may harm another person, even if their symptoms are the same.
If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse.
See section 4.

Table of contents of the leaflet:

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

1. What is Sytena Plus and what is it used for

Sytena Plus contains two different active substances called sitagliptin and metformin.
Sitagliptin belongs to a group of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors)
Metformin belongs to a group of medicines called biguanides.
The combined action of these medicines leads to the normalization of blood sugar levels in adult patients with diabetes known as "type 2 diabetes". This medicine helps achieve higher insulin levels after meals and reduces the amount of sugar produced by the body.
The medicine is used in combination with diet and physical exercise to help lower blood sugar levels.
This medicine may be used as the only anti-diabetic medicine or in combination with certain other anti-diabetic medicines (insulin, sulfonylurea derivatives, or glitazones).
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, vision loss, and limb amputation.

2. Important information before taking Sytena Plus

When not to take Sytena Plus

if the patient is allergic to sitagliptin or metformin or any of the other ingredients of this medicine (listed in section 6),
if the patient has significantly reduced kidney function,
if the patient has uncontrolled diabetes, such as severe hyperglycemia (high blood sugar levels), nausea, vomiting, diarrhea, sudden weight loss, lactic acidosis (see "Risk of lactic acidosis" below), or diabetic ketoacidosis. Diabetic ketoacidosis is a condition in which substances called ketone bodies accumulate in the blood and can lead to a diabetic coma. Symptoms include: abdominal pain, rapid and deep breathing, drowsiness, or an unusual fruity odor from the mouth.
if the patient has severe infection or dehydration,
if the patient is scheduled to undergo a radiological examination with intravenous administration of a contrast agent. The patient should stop taking Sytena Plus during the radiological examination and for 2 or more days, according to the doctor's recommendations, depending on the patient's kidney function.
if the patient has recently had a heart attack or has severe circulatory disorders, such as shock or breathing difficulties,
if the patient has liver disease,
if the patient consumes excessive amounts of alcohol (either daily or from time to time),
if the patient is breastfeeding.
Do not take Sytena Plus if any of the above contraindications apply, and consult a doctor to determine other methods of controlling diabetes. In case of doubts, before taking Sytena Plus, discuss it with a doctor, pharmacist, or nurse.

Warnings and precautions

Patients taking Sytena Plus have reported cases of pancreatitis (see section 4).
If the patient develops blisters on the skin, it may be a sign of a disease called pemphigoid blisters. The doctor may recommend that the patient stop taking Sytena Plus.

Risk of lactic acidosis

Sytena Plus may cause a very rare but very serious side effect called lactic acidosis, especially if the patient has kidney problems. The risk of lactic acidosis also increases in cases of uncontrolled diabetes, severe infections, prolonged fasting, or alcohol consumption, dehydration (see below), liver problems, and any conditions in which a part of the body is not sufficiently supplied with oxygen (e.g., acute severe heart disease).
If any of the above situations apply to the patient, they should consult a doctor for more detailed instructions.

Temporary discontinuation of Sytena Plus is recommended if the patient has a condition that may lead to dehydration

(significant loss of water from the body), such as severe vomiting, diarrhea, fever, exposure to high temperatures, or if the patient drinks less fluid than usual. The patient should consult a doctor for more detailed instructions.

Discontinue Sytena Plus and immediately contact a doctor or the nearest hospital if the patient experiences any symptoms of lactic acidosis

, as this condition can lead to a coma.
Symptoms of lactic acidosis include:

• vomiting,
• abdominal pain,
• muscle cramps,
• general feeling of being unwell, accompanied by severe fatigue,
• breathing difficulties,
• decreased body temperature, and slowed heart rate.

Lactic acidosis is a life-threatening condition that requires hospital treatment.
The patient should immediately contact a doctor for further instructions if:

• the patient has a genetically inherited disease affecting the mitochondria (energy-producing structures in cells), such as MELAS syndrome (mitochondrial encephalopathy, myopathy, lactic acidosis, and stroke-like episodes) or inherited diabetes and deafness from the mother (MIDD, maternal inherited diabetes and deafness).

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If the patient experiences any of the following symptoms after starting metformin: seizures, impaired cognitive function, difficulty moving, signs of nerve damage (e.g., pain or numbness), migraine, or hearing loss.

• If the patient has or has had pancreatic disease (e.g., pancreatitis).
• If the patient has or has had gallstones, alcohol dependence, or very high triglyceride levels in the blood. In such cases, the risk of pancreatitis (see section 4) may increase.
• If the patient has type 1 diabetes. It is sometimes called insulin-dependent diabetes.
• If the patient has or has had allergic reactions to sitagliptin, metformin, or Sytena Plus (see section 4).
• If the patient is taking a sulfonylurea derivative or insulin, anti-diabetic medicines, at the same time as Sytena Plus, as this may lead to excessively low blood sugar levels (hypoglycemia). The doctor may reduce the dose of the sulfonylurea derivative or insulin.

If the patient is scheduled to undergo major surgery, they should not take Sytena Plus during the surgery and for some time after it. The doctor will decide when the patient should stop and resume treatment with Sytena Plus.
In case of doubts, whether any of the above situations apply to the patient, before taking Sytena Plus, they should discuss it with a doctor or pharmacist.
During treatment with Sytena Plus, the doctor will monitor the patient's kidney function at least once a year or more frequently if the patient is elderly and/or has deteriorating kidney function.

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 Plus and other medicines

If the patient is to receive an intravenous contrast agent containing iodine, for example, for an X-ray examination or computed tomography, they should stop taking Sytena Plus before or at the latest at the time of administration. The doctor will decide when the patient should stop and resume treatment with Sytena Plus.
The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. The patient may require more frequent blood glucose monitoring and kidney function tests or dose adjustments of Sytena Plus by the doctor. It is particularly important to inform about the following medicines:
medicines (taken orally, by inhalation, or by injection) used to treat inflammatory diseases, such as asthma or arthritis (corticosteroids),
medicines that increase urine production (diuretics),
medicines used to treat pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib),
certain medicines used to treat high blood pressure (ACE inhibitors and angiotensin II receptor antagonists),
specific medicines used to treat asthma (β-sympathomimetics),
contrast agents containing iodine or medicines containing alcohol,
certain medicines used to treat stomach disorders, such as cimetidine, ranolazine, a medicine used to treat angina pectoris,
dolutegravir, a medicine used to treat HIV infection,
vandetanib, a medicine used to treat a certain type of thyroid cancer (medullary thyroid cancer),
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digoxin (used to treat heart rhythm disorders and other heart diseases). When taking Sytena Plus with digoxin, the patient should have their digoxin levels monitored.

Sytena Plus and alcohol

The patient should avoid consuming excessive amounts of alcohol while taking Sytena Plus, as this may increase the risk of lactic acidosis (see "Warnings and precautions").

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medicine. This medicine should not be used during pregnancy or breastfeeding. See section 2, When not to take Sytena Plus.

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 during treatment with sitagliptin, which may affect the ability to drive and use machines.
Taking this medicine at the same time as sulfonylurea derivatives or insulin may lead to hypoglycemia, which can affect the ability to drive and use machines or work without safe foot support.

Sytena Plus contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, which means it is essentially "sodium-free".

3. How to take Sytena Plus

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult a doctor or pharmacist.
The patient should take one tablet:
twice a day, orally;
with meals to reduce the likelihood of stomach upset.
To control blood sugar levels, the doctor may increase the dose of the medicine.
If the patient has kidney problems, the doctor may prescribe a lower dose.
During treatment with this medicine, the patient should continue to follow the diet and exercise recommended by the doctor.
It is unlikely that taking this medicine alone will lead to abnormally low blood sugar levels (hypoglycemia). Low blood sugar levels may occur when taking this medicine with a sulfonylurea derivative or insulin – in such cases, the doctor may reduce the dose of the sulfonylurea derivative or insulin.
The score line on the tablet is not intended for breaking the tablet.

Taking a higher dose of Sytena Plus than recommended

In case of taking a higher dose of this medicine than recommended, the patient should immediately contact a doctor. The patient should go to the hospital if symptoms of lactic acidosis occur, such as feeling cold or uncomfortable, severe nausea or vomiting, stomach pain, unexplained weight loss, muscle cramps, or rapid breathing (see "Warnings and precautions").

Missing a dose of Sytena Plus

In case of missing a dose, the patient should take it as soon as possible. If it is almost time for the next dose, the patient should skip the missed dose and continue taking the medicine as usual. The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Sytena Plus

To maintain control of blood sugar levels, the patient should take the medicine for as long as the doctor recommends. The patient should not stop taking this medicine without consulting a doctor first.
Stopping treatment with Sytena Plus may cause blood sugar levels to rise again.
In case of any further doubts about taking this medicine, the patient should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The patient should STOPtaking Sytena Plus and immediately contact a doctor in case of 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, as these may be symptoms of pancreatitis.
Sytena Plus may very rarely cause (may occur less frequently than 1 in 10,000 patients) a very serious side effect called lactic acidosis (see "Warnings and precautions"). If this occurs, the patient should STOPtaking Sytena Plus and immediately contact a doctor or the nearest hospital, as lactic acidosis can lead to a coma.
In case of a severe allergic reaction (frequency not known), including rash, hives, blisters on the skin, and (or) peeling of the skin, as well as swelling of the face, lips, tongue, and throat, which can cause breathing or swallowing difficulties, the patient should stop taking the medicine and immediately contact a doctor. The doctor may prescribe a medicine to treat the allergic reaction and another medicine to treat diabetes.
In some patients taking metformin after starting sitagliptin, the following side effects have occurred:
Frequently(may occur less frequently than 1 in 10 patients): low blood sugar levels, nausea, bloating, vomiting
Less frequently(may occur less frequently than 1 in 100 patients): stomach pain, diarrhea, constipation, drowsiness
In some patients, diarrhea, nausea, bloating, constipation, stomach pain, or vomiting have occurred after starting treatment with sitagliptin in combination with metformin (frequently).
In some patients taking this medicine at the same time as a sulfonylurea derivative, such as glimepiride, the following side effects have occurred:
Very frequently(may occur more frequently than 1 in 10 patients): low blood sugar levels
Frequently(may occur less frequently than 1 in 10 patients): constipation
In some patients taking this medicine in combination with pioglitazone, the following side effects have occurred:
Frequently(may occur less frequently than 1 in 10 patients): swelling of the hands or feet
In some patients taking this medicine in combination with insulin, the following side effects have occurred:
Very frequently: low blood sugar levels
Less frequently: dry mouth, headache
In clinical trials, some patients taking only sitagliptin (one of the active substances of Sytena Plus) or after marketing authorization, during treatment with Sytena Plus or sitagliptin alone or with other anti-diabetic medicines, have experienced the following side effects:
Frequently: low blood sugar levels, headache, upper respiratory tract infection, stuffy nose or sore throat, and joint or muscle pain
Less frequently: dizziness, constipation, itching
Rarely:decreased platelet count
Frequency not known:kidney disease (sometimes requiring dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, pemphigoid blisters (a type of blisters on the skin).
In some patients taking only metformin, the following side effects have occurred:
Very frequently: nausea, vomiting, diarrhea, stomach pain, and loss of appetite. These symptoms may occur after starting metformin and usually disappear.
Frequently: metallic taste
Very rarely: decreased vitamin B12 levels, liver inflammation (liver disease), hives, skin redness (rash), or itching.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw
phone: +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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Sytena Plus

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton, after "EXP". The expiry date refers to the last day of the month.
Do not store above 30°C.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Sytena Plus contains

The active substances of Sytena Plus are sitagliptin and metformin hydrochloride.

Sytena Plus, 50 mg + 850 mg, film-coated tablets

Each film-coated tablet contains sitagliptin phosphate monohydrate equivalent to 50 mg of sitagliptin and 850 mg of metformin hydrochloride.

Sytena Plus, 50 mg + 1000 mg, film-coated tablets

Each film-coated tablet contains sitagliptin phosphate monohydrate equivalent to 50 mg of sitagliptin and 1000 mg of metformin hydrochloride.
Other ingredients are:
Tablet core:povidone K29/32, microcrystalline cellulose PH 102, crospovidone type A, and sodium stearyl fumarate.
Coating: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, iron oxide red (E172), and iron oxide black (E172).
In addition, Sytena Plus, 50 mg + 850 mg, film-coated tablets contain: iron oxide yellow (E172).

What Sytena Plus looks like and contents of the pack

Sytena Plus, 50 mg + 850 mg, film-coated tablets

Pink, elongated, oval film-coated tablets with a score line on one side and the letters "SA" on the other side. Tablet diameter: 19.5 ± 0.5 mm.

Sytena Plus, 50 mg + 1000 mg, film-coated tablets

Red to brown, elongated, oval film-coated tablets with a score line between the letters "S" and "B" on one side and a score line on the other side. Tablet diameter: 21.3 ± 0.5 mm.
The medicine is available in PVC/PVDC/Aluminum blisters in a carton box. The pack contains 56 film-coated tablets.
Marketing authorization holder and manufacturer
Marketing authorization holder
Farmak International Sp. z o.o.
ul. Koszykowa 65
00-667 Warsaw
phone: +48 22 822 93 06
email: [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 Plus 50 mg/850 mg & 50 mg/1000 mg film-coated tablets
Poland
Sytena Plus

Date of last revision of the leaflet:

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