Sitagliptin + Metformin hidrohloride Sandoz

Leaflet accompanying the packaging: patient information

Sitagliptin + Metformin hydrochloride Sandoz, 50 mg + 850 mg, film-coated tablets

Sitagliptin + Metformin hydrochloride Sandoz, 50 mg + 1000 mg, film-coated tablets

Sitagliptin + Metformin hydrochloride

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

You should keep this leaflet, so you can read it again if you need to.
In case of any doubts, you should consult a doctor, pharmacist, or nurse.
This medicine has been prescribed specifically for you. Do not pass it on to others.
The medicine may harm another person, even if their symptoms are the same as yours.
If the patient experiences any side effects, including any side effects 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 Sitagliptin + Metformin hydrochloride Sandoz and what is it used for
• 2. Important information before taking Sitagliptin + Metformin hydrochloride Sandoz
• 3. How to take Sitagliptin + Metformin hydrochloride Sandoz
• 4. Possible side effects
• 5. How to store Sitagliptin + Metformin hydrochloride Sandoz
• 6. Contents of the packaging and other information

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

Sitagliptin + Metformin hydrochloride Sandoz 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 to increase the amount of insulin released after a meal and reduce the amount of sugar produced by the body.
The medicine is used in combination with diet and exercise 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 as it should. 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 Sandoz

When not to take Sitagliptin + Metformin hydrochloride Sandoz

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 Sandoz during the radiological examination and for 2 or more days, 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 (either daily or from time to time),
if the patient is breastfeeding.
Do not take Sitagliptin + Metformin hydrochloride Sandoz if any of the above contraindications occur. Consult a doctor to determine other methods of diabetes control. In case of doubts, before taking Sitagliptin + Metformin hydrochloride Sandoz, consult a doctor, pharmacist, or nurse.

Warnings and precautions

In patients taking Sitagliptin + Metformin hydrochloride Sandoz, 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 Sandoz.

Risk of lactic acidosis

Sitagliptin + Metformin hydrochloride Sandoz 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 case of uncontrolled diabetes, severe infections, prolonged fasting or alcohol consumption, dehydration (see additional 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 a doctor for more detailed instructions.

Temporarily discontinue use of Sitagliptin + Metformin hydrochloride Sandoz,

if the patient has a condition that may lead to dehydration(significant water loss), 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 use of Sitagliptin + Metformin hydrochloride Sandoz and immediately contact a doctor or the nearest hospital if the patient experiences any of the following

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 along with severe fatigue,
• breathing difficulties,
• decreased body temperature and slowed heart rate.

Lactic acidosis is a life-threatening condition that must be treated in a hospital.
Before starting to take Sitagliptin + Metformin hydrochloride Sandoz, 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 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 has had allergic reactions to sitagliptin, metformin, or Sitagliptin + Metformin hydrochloride Sandoz (see section 4).
• if the patient is taking a sulfonylurea derivative or insulin, anti-diabetic medicines, at the same time as Sitagliptin + Metformin hydrochloride Sandoz, 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 to undergo major surgery, they should not take Sitagliptin + Metformin hydrochloride Sandoz during the surgery and for some time after it. The doctor will decide when the patient must stop and resume treatment with Sitagliptin + Metformin hydrochloride Sandoz.
In case of doubts, whether any of the above situations apply to the patient, before taking Sitagliptin + Metformin hydrochloride Sandoz, they should discuss it with their doctor or pharmacist.
During treatment with Sitagliptin + Metformin hydrochloride Sandoz, 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 when used in children under 10 years of age.

Sitagliptin + Metformin hydrochloride Sandoz and other medicines

If the patient is to be injected with a contrast agent containing iodine, for example, for an X-ray examination or computed tomography, they should stop taking Sitagliptin + Metformin hydrochloride Sandoz before or at the latest at the time of injection. The doctor will decide when the patient must stop and resume treatment with Sitagliptin + Metformin hydrochloride Sandoz.
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 assessments or dose adjustments of Sitagliptin + Metformin hydrochloride Sandoz by the doctor. It is especially important to inform about the following medicines:
medicines (taken orally, inhaled, or injected) 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,
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 conditions). During treatment with Sitagliptin + Metformin hydrochloride Sandoz and digoxin, the patient's digoxin blood levels should be monitored.

Sitagliptin + Metformin hydrochloride Sandoz and alcohol

The patient should avoid consuming excessive amounts of alcohol while taking Sitagliptin + Metformin hydrochloride Sandoz, 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 Sitagliptin + Metformin hydrochloride Sandoz.

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 may affect the ability to drive and use machines or work without safe foot support.

Sitagliptin + Metformin hydrochloride Sandoz contains sodium

This 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 Sitagliptin + Metformin hydrochloride Sandoz

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. 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 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 only to facilitate breaking the tablet, if the patient has difficulty swallowing it whole.

Taking a higher dose of Sitagliptin + Metformin hydrochloride Sandoz than prescribed

In case of taking a higher dose of this medicine than prescribed, the patient should immediately contact a doctor. The patient should go to the hospital if they experience symptoms of lactic acidosis, 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 Sitagliptin + Metformin hydrochloride Sandoz

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 Sitagliptin + Metformin hydrochloride Sandoz

To maintain control of blood sugar levels, the medicine should be taken for as long as prescribed by the doctor. The patient should not stop taking this medicine without consulting a doctor first.
Stopping treatment with Sitagliptin + Metformin hydrochloride Sandoz 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 Sitagliptin + Metformin hydrochloride Sandoz and immediately contact a doctor if 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, as these may be symptoms of pancreatitis.
Sitagliptin + Metformin hydrochloride Sandoz may very rarely cause (may occur less often than in 1 in 10,000 people) a very serious side effect called lactic acidosis (see "Warnings and precautions"). If this occurs in the patient, they should stop taking Sitagliptin + Metformin hydrochloride Sandoz and immediately contact a 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, and (or) peeling of the skin, as well as 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 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 to take sitagliptin, the following side effects have occurred:
Frequently(may occur less often than in 1 in 10 people): low blood sugar, nausea, bloating, vomiting
Less frequently(may occur less often than in 1 in 100 people): 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 often than in 1 in 10 people): low blood sugar
Frequently(may occur less often than in 1 in 10 people): constipation
In some patients taking this medicine in combination with pioglitazone, the following side effects have occurred:
Frequently(may occur less often than in 1 in 10 people): 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
Less frequently: dry mouth, headache
In clinical trials, some patients taking only sitagliptin (one of the active substances of Sitagliptin + Metformin hydrochloride Sandoz) or after marketing authorization of Sitagliptin + Metformin hydrochloride Sandoz or sitagliptin alone or with other anti-diabetic medicines, the following side effects have occurred:
Frequently: low blood sugar, 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 to take 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, 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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Sitagliptin + Metformin hydrochloride Sandoz

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.
Non-transparent blister pack (PVC/PE/PVDC/Aluminum):
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 Sitagliptin + Metformin hydrochloride Sandoz contains

The active substances of the medicine are sitagliptin and metformin.
Sitagliptin + Metformin hydrochloride Sandoz, 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.
Sitagliptin + Metformin hydrochloride Sandoz, 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:
Core of the tablet:povidone (K27-32), sodium lauryl sulfate, microcrystalline cellulose (type 102), magnesium stearate.
The coating of the film-coated tablets also contains:
Sitagliptin + Metformin hydrochloride Sandoz, 50 mg + 850 mg, film-coated tablets
Polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, iron oxide red (E 172), iron oxide black (E 172).
Sitagliptin + Metformin hydrochloride Sandoz, 50 mg + 1000 mg, film-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 Sandoz looks like and contents of the pack

Sitagliptin + Metformin hydrochloride Sandoz, 50 mg + 850 mg, film-coated tablets
Pink, biconvex, film-coated tablet in the shape of a capsule with the imprint "585" on one side and a score line on the other side.
Sitagliptin + Metformin hydrochloride Sandoz, 50 mg + 1000 mg, film-coated tablets
Red, biconvex, film-coated tablet in the shape of a capsule with the imprint "5100" on one side and a score line on the other side.
Non-transparent blister pack (PVC/PE/PVDC/Aluminum) perforated or non-perforated in a carton. The packs contain 28 film-coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl
Austria
Manufacturer
PharOS MT Ltd
HF62X, Hal Far Industrial Estate
BBG3000 Birzebbugia
Malta
Rontis Hellas Medical and Pharmaceutical Products S.A
P.O Box 3012 Larissa Industrial Area
41500 Larissa
Greece
Lek Pharmaceuticals d.d.
Verovškova Ulica 57
1526 Ljubljana,
Slovenia

To obtain more detailed information about this medicine, the patient should contact the local representative of the marketing authorization holder:

Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warszawa
tel. 22 209 70 00

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

Netherlands
Sitagliptine/Metformine HCl Sandoz 50mg/850 mg, filmomhulde tabletten
Sitagliptine/Metformine HCl Sandoz 50/1000 mg, filmomhulde tabletten
Poland
Sitagliptin + Metformin hydrochloride Sandoz
Romania
Sitagliptină/ Clorhidrat de metformină Sandoz 50 mg + 1000 mg comprimate filmate
Date of last revision of the leaflet:04/2024
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