Sitagliptin + metformin hydrochloride sandoz

Package leaflet: Information for the user

Sitagliptin + Metformin hydrochloride Sandoz, 50 mg + 850 mg, film-coated tablets
Sitagliptin + Metformin hydrochloride Sandoz, 50 mg + 1000 mg, film-coated tablets
Sitagliptinum + Metformini hydrochloridum
Read this leaflet carefully before taking this medicine because it contains important information for you.
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 get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
Contents of the leaflet:

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

2. What you need to know 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 pack and other information

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

Sitagliptin + Metformin hydrochloride Sandoz is a medicine that contains two different active substances called sitagliptin and metformin.
Sitagliptin belongs to a group of medicines known as DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors).
Metformin belongs to a group of medicines known as biguanides.
Together, these medicines help to control blood sugar levels in adults with diabetes known as "type 2 diabetes". This medicine helps increase the amount of insulin released after a meal and reduces the amount of sugar made by the body.
Used together with diet and exercise, this medicine helps lower blood sugar levels.
This medicine may be used alone or together with certain other antidiabetic medicines (insulin, sulfonylureas or glitazones).

What is type 2 diabetes?
In type 2 diabetes, the body does not produce enough insulin and the insulin that is produced does not work properly. The body may also produce too much sugar. When 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. What you need to know before taking Sitagliptin + Metformin hydrochloride Sandoz

Do not take Sitagliptin + Metformin hydrochloride Sandoz:

• if you are allergic to sitagliptin or metformin or any of the other ingredients of this medicine (listed in section 6);
• if you have significantly reduced kidney function;
• if you have uncontrolled diabetes, for example severe hyperglycaemia (high blood glucose levels), nausea, vomiting, diarrhoea, sudden weight loss, lactic acidosis (see “Risk of lactic acidosis” below) or ketoacidosis. Ketoacidosis is a condition where substances called ketone bodies build up in the blood and may lead to a diabetic pre-coma state. Symptoms include: stomach pain, rapid and deep breathing, drowsiness or unusual fruity smell on the breath;
• if you have a severe infection or dehydration;
• if you are scheduled to have a radiological examination with intravascular iodinated contrast medium. You must stop taking Sitagliptin + Metformin hydrochloride Sandoz for the examination and for 2 or more days afterwards, as directed by your doctor, depending on your kidney function;
• if you have recently had a heart attack or have severe circulatory problems such as shock or breathing difficulties;
• if you have liver disease;
• if you drink excessive amounts of alcohol (either daily or occasionally);
• if you are breastfeeding.

Do not take Sitagliptin + Metformin hydrochloride Sandoz if any of the above apply to you. Talk to your doctor about other ways to control your diabetes. If you are not sure, talk to your doctor, pharmacist or nurse before taking Sitagliptin + Metformin hydrochloride Sandoz.

Warnings and precautions

Cases of pancreatitis (inflammation of the pancreas) have been reported in patients taking Sitagliptin + Metformin hydrochloride Sandoz (see section 4).
If you develop blisters on your skin, this may be a sign of a condition called bullous pemphigoid. Your doctor may advise you to stop taking Sitagliptin + Metformin hydrochloride Sandoz.

Risk of lactic acidosis

Sitagliptin + Metformin hydrochloride Sandoz may cause a very rare but serious side effect called lactic acidosis, especially if you have kidney problems. The risk of lactic acidosis is also increased in uncontrolled diabetes, severe infections, prolonged fasting, alcohol consumption, dehydration (see additional information below), liver problems, or any condition in which part of the body is not getting enough oxygen (e.g. severe heart disease). If any of these situations apply to you, talk to your doctor for further advice.

Temporarily stop taking Sitagliptin + Metformin hydrochloride Sandoz if you develop an illness that may cause dehydration (significant loss of water from the body), such as severe vomiting, diarrhoea, fever, exposure to high temperatures, or if you are drinking less fluid than usual. Talk to your doctor for further advice.

Stop taking Sitagliptin + Metformin hydrochloride Sandoz and contact your doctor or nearest hospital immediately if you experience any symptoms of lactic acidosis, as this condition may lead to coma.
Symptoms of lactic acidosis include:

• vomiting,
• stomach pain,
• muscle cramps,
• general feeling of being unwell with marked tiredness,
• difficulty breathing,
• lowering of body temperature and slowing of the heartbeat.

Lactic acidosis is a sudden, life-threatening condition that must be treated in hospital.

Before starting Sitagliptin + Metformin hydrochloride Sandoz, talk to your doctor or pharmacist if:

• you have or have had a problem with your pancreas (e.g. pancreatitis);
• you have or have had gallstones, alcohol dependence or very high levels of triglycerides (a type of fat) in your blood. In such cases, the risk of pancreatitis may be increased (see section 4);
• you have type 1 diabetes. This is sometimes called insulin-dependent diabetes;
• you currently have or have had an allergic reaction to sitagliptin, metformin or Sitagliptin + Metformin hydrochloride Sandoz (see section 4);
• you are taking a sulfonylurea or insulin together with Sitagliptin + Metformin hydrochloride Sandoz, as this may lead to low blood sugar levels (hypoglycaemia). Your doctor may reduce the dose of the sulfonylurea or insulin.

If you are scheduled for major surgery, you must not take Sitagliptin + Metformin hydrochloride Sandoz during the procedure and for a period afterwards. Your doctor will decide when you should stop and restart treatment with Sitagliptin + Metformin hydrochloride Sandoz.
If you are not sure whether any of the above apply to you, talk to your doctor or pharmacist before taking Sitagliptin + Metformin hydrochloride Sandoz.

While taking Sitagliptin + Metformin hydrochloride Sandoz, your doctor will monitor your kidney function at least once a year, or more frequently if you are elderly and/or have worsening kidney function.

Children and adolescents
Do not use this medicine 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 Sandoz and other medicines
If you are to be given an iodinated contrast agent into a vein, for example for an X-ray or CT scan, you must stop taking Sitagliptin + Metformin hydrochloride Sandoz before or at the time of the injection. Your doctor will decide when you should stop and restart treatment with Sitagliptin + Metformin hydrochloride Sandoz.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. You may need more frequent blood glucose monitoring and kidney function assessments, or your doctor may need to adjust your dose of Sitagliptin + Metformin hydrochloride Sandoz. It is especially important to tell your doctor about the following medicines:

• medicines (taken by mouth, inhaled or injected) used to treat inflammatory conditions 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);
• iodinated contrast agents or medicines containing alcohol;
• some medicines used to treat stomach problems 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). Blood levels of digoxin should be monitored when taken with Sitagliptin + Metformin hydrochloride Sandoz.

Sitagliptin + Metformin hydrochloride Sandoz and alcohol
Avoid drinking excessive amounts of alcohol while taking Sitagliptin + Metformin hydrochloride Sandoz, as this may increase the risk of lactic acidosis (see section “Warnings and precautions”).

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, talk to your doctor or pharmacist before taking this medicine. Do not use this medicine during pregnancy or while breastfeeding. See section 2, Do not take Sitagliptin + Metformin hydrochloride Sandoz.

Driving and using machines
This medicine has no or negligible effect on the ability to drive and use machines. However, dizziness and drowsiness have been reported with sitagliptin, which may affect the ability to drive or use machines.
Taking this medicine together with medicines called sulfonylureas or with insulin may cause hypoglycaemia, which may affect the ability to drive and use machines or to work without secure foot support.

Sitagliptin + Metformin hydrochloride Sandoz contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. essentially “sodium-free”.

3. How to take Sitagliptin + Metformin hydrochloride Sandoz

This medicine should always be taken as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Take one tablet:
twice daily, orally;
with meals to reduce the likelihood of stomach upset.
To control blood sugar levels, your doctor may increase the dose of this medicine.
If you have impaired kidney function, your doctor may prescribe a lower dose.
While taking this medicine, continue to follow the diet recommended by your doctor and pay attention to
an even intake of carbohydrates throughout the day.
It is unlikely that taking this medicine alone will lead to abnormally low blood sugar levels (hypoglycaemia).
Low blood sugar may occur when this medicine is taken together with a sulphonylurea derivative or insulin – in such a case,
your doctor may reduce the dose of the sulphonylurea derivative or insulin.
The score line on the tablet is intended only to facilitate breaking the tablet if you have difficulty
swallowing it whole.
Taking more Sitagliptin + Metformin hydrochloride Sandoz than prescribed
If you take more of this medicine than prescribed, contact your doctor immediately.
Go to 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 section “Warnings and precautions”).
Missing a dose of Sitagliptin + Metformin hydrochloride Sandoz
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 to make up for a missed dose.
Stopping treatment with Sitagliptin + Metformin hydrochloride Sandoz
To maintain control of blood sugar levels, take this medicine for as long as your doctor recommends.
Do not stop taking this medicine without first consulting your doctor.
Stopping treatment with Sitagliptin + Metformin hydrochloride Sandoz may cause blood sugar levels to rise again.
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 STOP taking Sitagliptin + Metformin hydrochloride Sandoz and immediately contact your doctor if any of the following serious adverse reactions occur:
Severe and persistent pain in the stomach area, possibly radiating to the back, with or without nausea and vomiting, as these may be symptoms of pancreatitis.
Sitagliptin + Metformin hydrochloride Sandoz may very rarely (may occur in fewer than 1 in 10,000 people) cause a very serious adverse reaction known as lactic acidosis (see section “Warnings and precautions”). If this occurs in a patient, treatment with Sitagliptin + Metformin hydrochloride Sandoz must be discontinued and immediate contact made with a doctor or the nearest hospital, as lactic acidosis may lead to coma.
In case of a severe allergic reaction (frequency not known), including rash, urticaria, skin blisters and/or skin peeling, and swelling of the face, lips, tongue, or throat, which may cause difficulty in breathing or swallowing, treatment with the medicine should be stopped and immediate medical advice sought. The doctor may prescribe medication to treat the allergic reaction and another medicine for the treatment of diabetes.
The following adverse reactions have been reported in some patients taking metformin after starting sitagliptin:
Common (may affect fewer than 1 in 10 people): low blood sugar levels, nausea, bloating, vomiting
Uncommon (may affect fewer than 1 in 100 people): stomach pain, diarrhoea, constipation, drowsiness
Diarrhoea, nausea, bloating, constipation, stomach pain, or vomiting may occur in some patients after starting treatment with sitagliptin in combination with metformin (common).
The following adverse reactions have been reported in some patients taking this medicine in combination with a sulfonylurea derivative such as glimepiride:
Very common (may affect more than 1 in 10 people): low blood sugar levels
Common (may affect fewer than 1 in 10 people): constipation
The following adverse reactions have been reported in some patients taking this medicine in combination with pioglitazone:
Common (may affect fewer than 1 in 10 people): swelling of hands or feet
The following adverse reactions have been reported in some patients taking this medicine in combination with insulin:
Very common: low blood sugar levels
Uncommon: dry mouth, headache
In clinical trials and post-marketing experience, the following adverse reactions have been reported in some patients taking sitagliptin alone (one of the active substances in Sitagliptin + Metformin hydrochloride Sandoz) or Sitagliptin + Metformin hydrochloride Sandoz alone or in combination with other antidiabetic medicines:
Common: low blood sugar levels, headache, upper respiratory tract infection, nasal congestion or runny nose and sore throat, bone and joint inflammation, pain in arms or legs
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 blistering skin condition)
The following adverse reactions have been reported in some patients taking metformin alone:
Very common: nausea, vomiting, diarrhoea, stomach pain, and loss of appetite. These symptoms may occur when starting metformin and usually resolve over time.
Common: metallic taste
Very rare: decreased vitamin B12 levels, hepatitis (liver disease), urticaria, skin redness (rash), or itching

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 Adverse Drug Reactions 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
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Sitagliptin + Metformin hydrochloride Sandoz

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the cardboard
package, following "EXP". The expiry date refers to the last day of the specified month.
Opaque blister made of PVC/PE/PVDC/Aluminium:
Do not store above 30°C.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Such measures help
protect the environment.

6. Contents of the pack and other information

What Sitagliptin + Metformin hydrochloride Sandoz contains
The active substances are sitagliptin and metformin.
Sitagliptin + Metformin hydrochloride Sandoz, 50 mg + 850 mg, film-coated tablets
Each film-coated tablet contains sitagliptin hydrochloride 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 hydrochloride monohydrate equivalent to 50 mg
of sitagliptin and 1000 mg of metformin hydrochloride.

The other ingredients are:
Tablet core: povidone (K27-32), sodium lauryl sulfate, microcrystalline cellulose (type 102),
magnesium stearate.
The film coating of the tablets additionally 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, capsule-shaped film-coated tablet with "585" engraved on one side and a break line on the other.
Sitagliptin + Metformin hydrochloride Sandoz, 50 mg + 1000 mg, film-coated tablets
Red, biconvex, capsule-shaped film-coated tablet with "5100" engraved on one side and a break line on the other.
Opaque PVC/PE/PVDC/Aluminium blister, perforated or non-perforated, packed in a cardboard box. Packs contain 28 film-coated tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl
Austria

Manufacturers
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

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warszawa
tel. 22 209 70 00

This medicine is authorised for marketing in the European Economic Area countries 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