Sitagliptin + metformin hydrochloride grindeks

Package leaflet: Information for the patient

Sitagliptin + Metformin hydrochloride Grindeks, 50 mg + 850 mg, film-coated tablets
Sitagliptin + Metformin hydrochloride Grindeks, 50 mg + 1000 mg, film-coated tablets
Sitagliptinum + Metformini hydrochloridum
Please read all of 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 Grindeks is and what it is used for
2. What you need to know before you take Sitagliptin + Metformin hydrochloride Grindeks
3. How to take Sitagliptin + Metformin hydrochloride Grindeks
4. Possible side effects
5. How to store Sitagliptin + Metformin hydrochloride Grindeks
6. Contents of the pack and other information

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

Sitagliptin + Metformin hydrochloride Grindeks 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.
The combined action of these medicines helps to control blood sugar levels in adult patients with
diabetes known as "type 2 diabetes". This medicine helps increase the amount of insulin released after meals and reduces the amount of sugar produced by the body.
Used together with diet and exercise, this medicine helps lower blood sugar levels.
This medicine may be used alone or in combination 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 may lead to serious health problems such as heart disease, kidney disease, vision loss, and limb amputations.

2. What you need to know before taking Sitagliptin + Metformin hydrochloride Grindeks

Do not take Sitagliptin + Metformin hydrochloride Grindeks

• 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 in which substances called ketones accumulate in the blood and may lead to diabetic pre-coma. Symptoms include: abdominal pain, rapid and deep breathing, drowsiness, or unusual fruity odour on the breath.
• if you have a severe infection or dehydration,
• if you are scheduled to undergo a radiological procedure with intravascular administration of contrast agents. You must stop taking Sitagliptin + Metformin hydrochloride Grindeks during the radiological procedure 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 consume excessive amounts of alcohol (either daily or occasionally),
• if you are breastfeeding.

Do not take Sitagliptin + Metformin hydrochloride Grindeks if any of the above contraindications apply to you, and consult your doctor to determine alternative methods of diabetes control. If in doubt, discuss this with your doctor, pharmacist, or nurse before taking Sitagliptin + Metformin hydrochloride Grindeks.

Warnings and precautions

Pancreatitis has been reported in patients taking Sitagliptin + Metformin hydrochloride Grindeks (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 Grindeks.

Risk of lactic acidosis
Sitagliptin + Metformin hydrochloride Grindeks may cause a very rare but serious side effect called lactic acidosis, especially if you have impaired kidney function. The risk of lactic acidosis increases in cases of uncontrolled diabetes, severe infection, prolonged fasting or alcohol consumption, dehydration (see more details below), liver dysfunction, and any condition in which part of the body is inadequately supplied with oxygen (e.g. acute severe heart disease).
If any of the above situations apply to you, consult your doctor for further instructions.

Contact your doctor immediately for further instructions if:

• you have a genetically inherited mitochondrial disorder (energy-producing structures in cells), such as MELAS (mitochondrial encephalopathy, myopathy, lactic acidosis and stroke-like episodes) or maternally inherited diabetes and deafness (MIDD).
• you experience any of the following symptoms after starting metformin: seizures, worsening cognitive function, difficulty moving, symptoms indicating nerve damage (e.g. pain or numbness), migraine, or deafness.

Temporarily stop taking Sitagliptin + Metformin hydrochloride Grindeks if you have a condition
that may lead to 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. Consult your doctor for further instructions.

Stop taking Sitagliptin + Metformin hydrochloride Grindeks 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,
• abdominal pain,
• muscle cramps,
• general feeling of being unwell accompanied by severe fatigue,
• difficulty breathing,
• decreased body temperature and slowed heart rate.

Lactic acidosis is an acute, life-threatening condition requiring immediate hospital treatment.

Before starting Sitagliptin + Metformin hydrochloride Grindeks, discuss with your doctor or pharmacist:

• if you have or have had pancreas disease (e.g. pancreatitis).
• if 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).
• if you have been diagnosed with type 1 diabetes. This is sometimes called insulin-dependent diabetes.
• if you currently have or have previously had allergic reactions to sitagliptin, metformin, or Sitagliptin + Metformin hydrochloride Grindeks (see section 4).
• if you are taking a sulfonylurea or insulin, antidiabetic medicines together with Sitagliptin + Metformin hydrochloride Grindeks, as this may lead to excessively 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 Grindeks during the procedure and for some time afterwards. Your doctor will decide when you should stop and resume treatment with Sitagliptin + Metformin hydrochloride Grindeks.
If you are unsure whether any of the above applies to you, discuss this with your doctor or pharmacist before taking Sitagliptin + Metformin hydrochloride Grindeks.
While being treated with Sitagliptin + Metformin hydrochloride Grindeks, 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
This medicine must 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 Grindeks and other medicines
If you are to receive an intravenous iodine-containing contrast agent, for example for an X-ray or CT scan, you must stop taking Sitagliptin + Metformin hydrochloride Grindeks before or at the latest at the time of injection. Your doctor will decide when you should stop and resume treatment with Sitagliptin + Metformin hydrochloride Grindeks.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. You may require more frequent monitoring of blood glucose levels and kidney function, or your doctor may need to adjust the dose of Sitagliptin + Metformin hydrochloride Grindeks. It is especially important to inform your doctor about the following medicines:

• medicines (taken orally, by inhalation, or by injection) 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),
• iodine-containing 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 specific 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 together with Sitagliptin + Metformin hydrochloride Grindeks.

Taking Sitagliptin + Metformin hydrochloride Grindeks with alcohol
Avoid consuming excessive amounts of alcohol while taking Sitagliptin + Metformin hydrochloride Grindeks, 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. This medicine must not be used during breastfeeding. See section 2, Do not take Sitagliptin + Metformin hydrochloride Grindeks.

Driving and using machines
This medicine has no effect or a negligible effect on the ability to drive and use machines. However, when driving and operating machinery, consider that dizziness and somnolence have been reported with sitagliptin, which may affect the ability to drive and operate machinery.
Taking this medicine together with medicines called sulfonylureas or insulin may lead to hypoglycaemia, which may affect the ability to drive and operate machinery or work without safe foot support.

Sitagliptin + Metformin hydrochloride Grindeks contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is considered "sodium-free".

3. How to use Sitagliptin + Metformin hydrochloride Grindeks

This medicine should always be taken as directed by your doctor. 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 the patient has impaired kidney function, the doctor may prescribe a lower dose.

While taking this medicine, continue to follow the diet recommended by your doctor and pay attention to evenly distributing carbohydrate intake throughout the day.
It is unlikely that taking this medicine alone would lead to abnormally low blood sugar levels (hypoglycaemia). Low blood sugar may occur when this medicine is taken together with a sulphonylurea or insulin – in such a case, your doctor may reduce the dose of the sulphonylurea or insulin.
Taking more Sitagliptin + Metformin hydrochloride Grindeks than prescribed
If you take more than the prescribed dose of this medicine, contact your doctor immediately. Go to hospital if symptoms of lactic acidosis occur, such as feeling cold or discomfort, 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 Grindeks
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 Sitagliptin + Metformin hydrochloride Grindeks
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 Grindeks may cause an increase in blood sugar levels.
If you have any further questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will get them.
You should STOP taking Sitagliptin + Metformin hydrochloride Grindeks and contact your doctor immediately if any of the following serious adverse reactions occur:

• Severe and persistent pain in the stomach area which may spread to the back, with or without nausea and vomiting – these may be symptoms of pancreatitis.

Sitagliptin + Metformin hydrochloride Grindeks may very rarely (may occur in no more than 1 in 10,000 patients) cause a very serious adverse reaction called lactic acidosis (see section “Warnings and precautions”). If this occurs in a patient, STOP taking Sitagliptin + Metformin hydrochloride Grindeks and contact your doctor or nearest hospital immediately, as lactic acidosis can lead to coma.
If a severe allergic reaction occurs (frequency unknown), including rash, hives, skin blisters or peeling of the skin, and swelling of the face, lips, tongue or throat which may cause difficulty in breathing or swallowing, stop taking the medicine and contact your doctor immediately. Your doctor may prescribe medication to treat the allergic reaction and another medicine for the treatment of diabetes.
In some patients taking metformin, the following adverse reactions occurred after starting sitagliptin:
Common (may affect up to 1 in 10 people): low blood sugar levels, nausea, bloating, vomiting
Uncommon (may affect up to 1 in 100 people): abdominal pain, diarrhoea, constipation, drowsiness
Some patients experienced diarrhoea, nausea, bloating, constipation, abdominal pain or vomiting after starting treatment with sitagliptin in combination with metformin (common).
In some patients taking this medicine together with a sulfonylurea derivative such as glimepiride, the following adverse reactions occurred:
Very common (may affect more than 1 in 10 people): low blood sugar levels
Common: constipation
In some patients taking this medicine together with pioglitazone, the following adverse reactions occurred:
Common: swelling of hands or feet
In some patients taking this medicine together with insulin, the following adverse reactions occurred:
Very common: low blood sugar levels
Uncommon: dry mouth, headache
In clinical studies, in some patients taking sitagliptin alone (one of the active substances in Sitagliptin + Metformin hydrochloride Grindeks) or after marketing of Sitagliptin + Metformin hydrochloride Grindeks or sitagliptin alone in combination with other antidiabetic medicines, the following adverse reactions occurred:
Common: low blood sugar levels, headache, upper respiratory tract infection, stuffy 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 skin blistering)
In some patients taking metformin alone, the following adverse reactions occurred:
Very common: nausea, vomiting, diarrhoea, abdominal pain and loss of appetite. These symptoms may occur when starting metformin and usually resolve over time.
Common: metallic taste, reduced or low levels of vitamin B12 in the blood (symptoms may include extreme tiredness (fatigue), pain and redness of the tongue (glossitis), tingling or numbness (paraesthesiae), or paleness or yellowing of the skin). Your doctor may order certain tests to determine the cause of the symptoms, as some of them may also be caused by diabetes or other unrelated health problems.
Very rare: urticaria, skin redness (rash) or itching

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. 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 marketing authorization holder.
By reporting adverse reactions, you help provide more information on the safety of this medicine.

5. How to store Sitagliptin + Metformin hydrochloride Grindeks

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
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 stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Sitagliptin + Metformin hydrochloride Grindeks contains

• The active substances are sitagliptin and metformin hydrochloride.
  Sitagliptin + Metformin hydrochloride Grindeks, 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 Grindeks, 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.

• Other ingredients are:
  Tablet core: povidone K30, sodium lauryl sulfate, microcrystalline cellulose, sodium stearyl fumarate
  Coating:
  Tablet 50 mg + 850 mg: Grafted copolymer of polyethylene glycol and poly(vinyl alcohol) (E 1209), talc (E 553b), titanium dioxide (E 171), glycerol monocaprylocapronate type 1 (E 471), polyvinyl alcohol (E 1203), yellow iron oxide (E 172), red iron oxide (E 172)
  Tablet 50 mg + 1000 mg: Grafted copolymer of polyethylene glycol and poly(vinyl alcohol) (E 1209), talc (E 553b), titanium dioxide (E 171), glycerol monocaprylocapronate type 1 (E 471), polyvinyl alcohol (E 1203), red iron oxide (E 172), yellow iron oxide (E 172), black iron oxide (E 172)

What Sitagliptin + Metformin hydrochloride Grindeks looks like and contents of the pack
Sitagliptin + Metformin hydrochloride Grindeks, 50 mg + 850 mg, film-coated tablets:
orange, oval, biconvex film-coated tablet, embossed with "SM85" on one side. Tablet size is approximately 20 mm x 6.7 mm.

Sitagliptin + Metformin hydrochloride Grindeks, 50 mg + 1000 mg, film-coated tablets:
brown, oval, biconvex film-coated tablet, embossed with "SM100" on one side.
Tablet size is approximately 21 mm x 7.2 mm.

Sitagliptin + Metformin hydrochloride Grindeks is available in blisters containing 28, 56, 98 film-coated tablets or in multi-packs containing 196 (2 packs of 98) film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
AS GRINDEKS
Krustpils iela 53
Rīga, LV-1057
Latvia

This medicinal product is authorised in the European Economic Area countries under the following names:
Sweden Sitagliptin/Metformin Grindeks
Austria Sitagliptin/Metformin Grindeks 50 mg/850 mg, 50 mg/1000 mg Filmtabletten
Belgium Sitagliptin/Metformin Grindeks 50 mg/850 mg, 50 mg/1000 mg comprimés pelliculés
Bulgaria Ситаглиптин/Метформин Гриндекс 50 mg/850 mg, 50 mg/1000 mg филмирани таблетки
Sitagliptin/Metformin Grindeks 50 mg/850 mg, 50 mg/1000 mg film-coated tablets
Croatia Sitagliptin/metformin chloride Grindeks 50 mg/850 mg, 50 mg/1000 mg film-coated tablets
Czech Republic Sitagliptin/Metformin Grindeks
Denmark Sitagliptin/Metformin Grindeks 50 mg/850 mg, 50 mg/1000 mg filmovertrukne tabletter
Estonia Metformin hydrochloride/Sitagliptin Grindeks
Finland Sitagliptin/Metformin Grindeks 50 mg/850 mg, 50 mg/1000 mg kalvopäällysteiset tabletit
France SITAGLIPTINE/METFORMINE GRINDEKS 50 mg/850 mg, comprimé pelliculé
SITAGLIPTINE/METFORMINE GRINDEKS 50 mg/1000 mg, comprimé pelliculé
Germany Sitagliptin/Metformin Grindeks 50 mg/850 mg, 50 mg/1000 mg Filmtabletten
Greece Sitagliptin/Metformin Grindeks 50 mg/850 mg, 50 mg/1000 mg επικαλυμμένα με λεπτό υμένιο δισκία
Hungary Sitagliptin/Metformin Grindeks 50 mg/850 mg, 50 mg/1000 mg filmtabletta
Ireland Sitagliptin/Metformin hydrochloride Grindeks 50 mg/850 mg, 50 mg/1000 mg film-coated tablets
Italy Sitagliptin/Metformina Grindeks
Latvia Sitagliptin/Metformin Grindeks 50 mg/850 mg, 50 mg/1000 mg apvalkotās tabletes
Lithuania Sitagliptin/Metformin hydrochloride Grindeks 50 mg/850 mg, 50 mg/1000 mg plėvele dengtos tabletės
Luxembourg Sitagliptin/Metformin Grindeks 50 mg/850 mg, 50 mg/1000 mg filmbeschichtete Pëllen
Netherlands Sitagliptine/Metformine Grindeks 50 mg/850 mg, 50 mg/1000 mg filmomhulde tabletten
Norway Sitagliptin/Metformin Grindeks
Poland Sitagliptin + Metformin hydrochloride Grindeks
Portugal Metformina + Sitagliptina Grindeks 850 mg + 50 mg, 1000 mg + 50 mg comprimidos revestidos por película
Romania Sitagliptin/Metformin Grindeks 50 mg/850 mg, 50 mg/1000 mg comprimate filmate
Slovakia Sitagliptin/Metformin Grindeks 50 mg/850 mg, 50 mg/1000 mg filmom obalené tablety
Slovenia Sitagliptin/metforminijev klorid Grindeks 50 mg/850 mg, 50 mg/1000 mg filmsko obložene tablete
Spain Sitagliptina/Metformina Grindeks 50 mg/850 mg, 50 mg/1.000 mg comprimidos recubiertos con película EFG