Sitagliptin + Metformin hidrohloride +pharma

Leaflet attached to the packaging: patient information

Sitagliptin + Metformin hydrochloride+pharma, 50 mg + 850 mg, coated tablets
Sitagliptin + Metformin hydrochloride+pharma, 50 mg + 1000 mg, coated tablets
Sitagliptinum + Metformini hydrochloridum

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

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

Table of contents of the leaflet

1.
What is Sitagliptin + Metformin hydrochloride +pharmaand what is it used for

• 2. Important information before taking Sitagliptin + Metformin hydrochloride +pharma
• 3. How to take Sitagliptin + Metformin hydrochloride +pharma
• 4. Possible side effects
• 5. How to store Sitagliptin + Metformin hydrochloride +pharma
• 6. Contents of the packaging and other information

1.

What is Sitagliptin + Metformin hydrochloride+pharmaand what is it used for
Sitagliptin + Metformin hydrochloride +pharmacontains 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 to achieve a higher concentration
of insulin released after a meal and reduces the amount of sugar produced by the body.
The medicine used in combination with diet and physical exercise helps to reduce 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?
In type 2 diabetes, the body does not produce enough insulin, and the produced insulin does not work
properly. The body may also produce too much sugar. If this happens, sugar (glucose) accumulates 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 Sitagliptin + Metformin hydrochloride+pharma
When not to take Sitagliptin + Metformin hydrochloride+pharma

• 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), nausea, vomiting, diarrhea, sudden weight loss,

lactic acidosis (see "Risk of lactic acidosis" below) or ketoacidosis.
Ketoacidosis is a condition in which substances called ketone bodies accumulate in the blood and can lead to a diabetic pre-coma state.
Symptoms include: abdominal pain, rapid and deep breathing, drowsiness or unusual fruity breath odor.

• if the patient has a 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 Sitagliptin + Metformin hydrochloride +pharmaduring the radiological examination and for at least 2 days or more, as recommended by the doctor, depending on the patient's kidney function.
• if the patient has recently had a heart attack or has experienced severe circulatory disorders, such as shock or breathing difficulties
• if the patient has liver disease
• if the patient consumes excessive amounts of alcohol (daily or from time to time)
• if the patient is breastfeeding

Do not take Sitagliptin + Metformin hydrochloride +pharmaif any of the above contraindications apply. Consult a doctor to determine other methods of diabetes control. In case of doubts, before taking Sitagliptin + Metformin hydrochloride +pharma, consult a doctor, pharmacist, or nurse.

Warnings and precautions

In patients taking sitagliptin in combination with metformin, cases of pancreatitis (see section 4) have been reported.
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 Sitagliptin + Metformin hydrochloride +pharma.

Risk of lactic acidosis

Sitagliptin + Metformin hydrochloride +pharmamay cause a very rare but very serious side effect called lactic acidosis, especially if the patient has kidney problems. The risk of lactic acidosis increases in cases of uncontrolled diabetes, severe infection, prolonged fasting, or alcohol consumption, dehydration (see more information 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 their doctor for more detailed instructions.
The patient should immediately contact their 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 maternally inherited diabetes and deafness (MIDD).
• the patient has experienced any of the following symptoms after starting metformin: seizures, worsening cognitive abilities, difficulty moving, signs of nerve damage (e.g., pain or numbness), migraine, and hearing loss.

The patient should temporarily stop taking Sitagliptin + Metformin hydrochloride+pharma
if they experience a condition that may lead to dehydration(significant water loss 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 their doctor for more detailed instructions.
The patient should stop taking Sitagliptin + Metformin hydrochloride+pharma
and immediately contact their doctor or the nearest hospital if they experience
any symptoms of lactic acidosis, as this condition can lead to coma.
Symptoms of lactic acidosis include:
‐ vomiting
‐ abdominal pain
‐ muscle cramps
‐ general feeling of being unwell with severe fatigue
‐ breathing difficulties
‐ decreased body temperature and slowed heart rate
Lactic acidosis is a life-threatening condition that requires immediate hospital treatment.
Before starting Sitagliptin + Metformin hydrochloride +pharma, the patient should discuss the following with their doctor or pharmacist:
‐
if the patient has or has had pancreatitis (e.g., pancreatitis)
‐
if the patient has or has had gallstones, alcohol dependence, or very high triglyceride levels (a type of fat) 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 currently or in the past experienced allergic reactions to sitagliptin, metformin, or Sitagliptin + Metformin hydrochloride +pharma(see section 4)
‐
if the patient is taking a sulfonylurea derivative or insulin, anti-diabetic medicines, at the same time as Sitagliptin + Metformin hydrochloride +pharma, as this may lead to excessive blood sugar reduction (hypoglycemia). The doctor may reduce the dose of the sulfonylurea derivative or insulin.
If the patient is to undergo major surgery, they should not take Sitagliptin + Metformin hydrochloride +pharmaduring the surgery and for some time after it. The doctor will decide when the patient should stop and resume treatment with Sitagliptin + Metformin hydrochloride +pharma.
If the patient is unsure whether any of the above statements apply to them, they should discuss this with their doctor or pharmacist before starting Sitagliptin + Metformin hydrochloride +pharma.
During treatment with Sitagliptin + Metformin hydrochloride +pharma, the doctor will monitor the patient's kidney function at least once a year or more often if the patient is elderly and (or) has worsening 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.
Sitagliptin + Metformin hydrochloride+pharmaand other medicines
If it is necessary to inject a contrast agent into the bloodstream, for example, for an X-ray examination or computed tomography, the patient should stop taking Sitagliptin + Metformin hydrochloride +pharmabefore or at the latest at the time of injection. The doctor will decide when the patient should stop and resume treatment with Sitagliptin + Metformin hydrochloride +pharma.
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 need more frequent blood sugar checks and kidney function tests or dose adjustments of Sitagliptin + Metformin hydrochloride +pharmaby the doctor. It is especially 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)
• digoxin (used to treat heart rhythm disorders and other heart diseases). When taking Sitagliptin + Metformin hydrochloride +pharmawith digoxin, the patient should have their digoxin levels checked.

Sitagliptin + Metformin hydrochloride+pharmawith alcohol
The patient should avoid consuming excessive amounts of alcohol while taking Sitagliptin + Metformin hydrochloride +pharma, 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 their doctor or pharmacist before taking this medicine. This medicine should not be used during pregnancy or breastfeeding. See section 2 "When not to take Sitagliptin + Metformin hydrochloride+pharma".

Driving and using machines

This medicine has no or negligible influence on the ability to drive and use machines. However, when driving or using machines, the patient should take into account that dizziness and drowsiness have been reported when taking sitagliptin, which may affect the ability to drive and use machines.
Taking this medicine with sulfonylurea derivatives or insulin may lead to hypoglycemia, which may affect the ability to drive and use machines or work without safe foot support.
Sitagliptin + Metformin hydrochloride+pharmacontains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, which means that it is essentially "sodium-free".

3.

How to take Sitagliptin + Metformin hydrochloride+pharma
This medicine should always be taken exactly as prescribed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.

• The patient should take one tablet
• twice a day, orally
• with meals to reduce the likelihood of stomach upset
• The doctor may increase the dose of the medicine to control blood sugar levels.
• If the patient has kidney problems, the doctor may prescribe a lower dose.

While taking this medicine, the patient should continue to follow the diet recommended by their doctor and pay attention to evenly distributing carbohydrate intake throughout the day.
It is unlikely that taking this medicine alone will lead to abnormally low blood sugar levels (hypoglycemia). Hypoglycemia 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 only to facilitate breaking the tablet to make it easier to swallow, in case of difficulty swallowing it whole.
Taking a higher dose of Sitagliptin + Metformin hydrochloride+pharmathan recommended
If the patient takes a higher dose of this medicine than recommended, they should immediately contact their doctor. They should go to the hospital if they experience symptoms of lactic acidosis, such as feeling cold or uncomfortable, severe nausea or vomiting, abdominal pain, unexplained weight loss, muscle cramps, or rapid breathing (see "Warnings and precautions").
Missing a dose of Sitagliptin + Metformin hydrochloride+pharma
If the patient misses a dose, they should take it as soon as possible. If it is almost time for the next dose, they should skip the missed dose and continue taking the medicine as usual. The patient should not take a double dose of this medicine.
Stopping Sitagliptin + Metformin hydrochloride+pharma
To maintain control of blood sugar levels, the patient should take this medicine for as long as prescribed by their doctor. The patient should not stop taking this medicine without consulting their doctor first.
Stopping Sitagliptin + Metformin hydrochloride +pharmamay lead to increased blood sugar levels.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The patient should STOP taking Sitagliptin + Metformin hydrochloride+pharma
and immediately contact their doctorif they experience 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 - these may be symptoms of pancreatitis

Sitagliptin + Metformin hydrochloride +pharmamay very rarely (affecting up to 1 in 10,000 patients) cause a very serious side effect called lactic acidosis (see "Warnings and precautions"). If this occurs, the patient should stop taking Sitagliptin + Metformin hydrochloride+pharma
and immediately contact their doctor or the nearest hospital, as lactic acidosis can lead to coma.
In case of a severe allergic reaction (frequency not known), including rash, hives, blisters on the skin, or peeling skin, and swelling of the face, lips, tongue, and throat, which may cause breathing or swallowing difficulties, the patient should stop taking the medicine and immediately contact their 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 affect up to 1 in 10 patients): low blood sugar, nausea, bloating, vomiting
• Less frequently (may affect up to 1 in 100 patients): stomach pain, diarrhea, constipation, drowsiness

Some patients have experienced diarrhea, nausea, bloating, constipation, stomach pain, or vomiting after starting treatment with sitagliptin in combination with metformin (frequently).
In some patients taking this medicine with a sulfonylurea derivative, such as glimepiride, the following side effects have occurred:

• Very frequently (may affect more than 1 in 10 patients): low blood sugar
• Frequently: constipation

In some patients taking this medicine with pioglitazone, the following side effects have occurred:

• Frequently: swelling of the hands or feet

In some patients taking this medicine with insulin, the following side effects have occurred:

• Very frequently: low blood sugar
• Less frequently: dry mouth, headache

In clinical trials, some patients taking sitagliptin (one of the active substances of Sitagliptin + Metformin hydrochloride +pharma) alone or after marketing authorization of Sitagliptin + Metformin hydrochloride +pharmaor sitagliptin alone, or in combination with other anti-diabetic medicines, have experienced the following side effects:

• Frequently: low blood sugar, headache, upper respiratory tract infection, feeling of a blocked nose or cold, and throat pain, joint or arm or leg 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 metformin alone, the following side effects have occurred:

• Very frequently: nausea, vomiting, diarrhea, stomach pain, and loss of appetite. These symptoms usually 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 side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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.
Reporting side effects will help to gather more information on the safety of this medicine.

5.

How to store Sitagliptin + Metformin hydrochloride+pharma
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 stated.
Do not store above 25°C.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What does Sitagliptin + Metformin hydrochloride+pharmacontain

• The active substances of the medicine are sitagliptin and metformin.

Sitagliptin + Metformin hydrochloride +pharma, 50 mg + 850 mg, coated tablets
Each coated tablet contains sitagliptin hydrochloride monohydrate, equivalent to 50 mg of sitagliptin, and 850 mg of metformin hydrochloride.
Sitagliptin + Metformin hydrochloride +pharma, 50 mg + 1000 mg, coated tablets
Each coated tablet contains sitagliptin hydrochloride monohydrate, equivalent to 50 mg of sitagliptin, and 1000 mg of metformin hydrochloride.

• Other ingredients are: Tablet core: povidone (K27-32), sodium lauryl sulfate, microcrystalline cellulose (type 102), magnesium stearate

Tablet coating
50 mg + 850 mg, coated tablets
polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, iron oxide red (E 172), iron oxide black (E 172)
50 mg + 1000 mg, coated tablets
polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, iron oxide red (E 172), iron oxide yellow (E 172)
What Sitagliptin + Metformin hydrochloride+pharmalooks like and contents of the pack
Sitagliptin + Metformin hydrochloride +pharma, 50 mg + 850 mg, coated tablets
Pink, biconvex, capsule-shaped coated tablets, approximately 20.2 mm in length, 9.9 mm in width, and 7.0 mm in thickness, with "585" embossed on one side and a score line on the other side.
Sitagliptin + Metformin hydrochloride +pharma, 50 mg + 1000 mg, coated tablets
Red, biconvex, capsule-shaped coated tablets, approximately 21.4 mm in length, 10.4 mm in width, and 7.1 mm in thickness, with "5100" embossed on one side and a score line on the other side.
Non-transparent PVC/PE/PVDC/Aluminum or OPA/Aluminum/PVC/Aluminum blisters, perforated or non-perforated, in a cardboard box.
Packaging contains 30, 60, 90, 120 coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

+pharma arzneimittel gmbh
Hafnerstrasse 211
8054 Graz
Austria

Manufacturer

Rontis Hellas Medical and Pharmaceutical Products S.A.
P.O. Box 3012 Larissa Industrial Area
41500 Larissa
Greece
PharOS MT Ltd.
HF62X, Hal Far Industrial Estate
Birzebbugia BBG3000
Malta
Genericon Pharma Gesellschaft m.b.H.
Hafnerstrasse 211
8054 Graz
Austria
This medicine is authorized in the Member States of the European Economic Area under the following names:

Iceland
Sitagliptin/metformine hydrochloride Genericon 50 mg/850 mg film-coated tablets
Sitagliptin/metformine hydrochloride Genericon 50 mg/1000 mg film-coated tablets
Croatia
Sitagliptin/metformin hydrochloride Genericon 50 mg/850 mg film-coated tablets
Sitagliptin/metformin hydrochloride Genericon 50 mg/1000 mg film-coated tablets
Poland
Sitagliptin + Metformin hydrochloride +pharma
Czech Republic
Sitagliptin/Metformin +pharma
To obtain more detailed information on this medicine, the patient should contact the representative of the marketing authorization holder:

+pharma Polska sp. z o.o.
ul. Podgórska 34
31-536 Kraków, Poland
tel.: +48 12 262 32 36
e-mail: [email protected]
Date of last revision of the leaflet:March 2025