Sitagliptin and metformin Grindeks

Package leaflet: Information for the patient

Sitagliptin/Metformin Grindeks 50 mg/850 mg film-coated tablets, mg/1000 mg film-coated tablets

sitagliptin/metformin hydrochloride
Equivalent medicine
Please 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 questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only. Do not give it to other people, even if their
symptoms are the same as yours, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet,
contact your doctor, pharmacist or nurse. See section 4.
Contents of this leaflet

1. What Sitagliptin/Metformin Grindeks is and what it is used for
2. What you need to know before taking Sitagliptin/Metformin Grindeks
3. How to take Sitagliptin/Metformin Grindeks
4. Possible side effects
5. How to store Sitagliptin/Metformin Grindeks
6. Contents of the pack and other information

1. What is Sitagliptin/Metformina Grindeks and what is it used for?

Sitagliptin/Metformina Grindeks contains two different medicines called sitagliptin and metformin.

• Sitagliptin belongs to a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors).
• Metformin belongs to a class of medicines called biguanides.

They work together to control blood sugar levels in adult patients with a form of diabetes called "type 2 diabetes mellitus". This medicine helps increase insulin levels produced after meals and reduces the amount of sugar produced by the body. Together with diet and exercise, this medicine helps lower blood sugar levels. This medicine can be used alone or in combination with certain other diabetes medicines (insulin, sulfonylureas or glitazones).

What is type 2 diabetes?

Type 2 diabetes is a condition in which the body does not produce enough insulin and the insulin produced by the body does not work as well as it should. Your body may also produce too much sugar. When this happens, sugar (glucose) builds up in the blood. This can lead to serious medical problems such as heart disease, kidney disease, blindness and amputation.

2. What you need to know before taking Sitagliptin/Metformina Grindeks

Do not take Sitagliptin/Metformina Grindeks
if you are allergic to sitagliptin, metformin, or any of the other ingredients of this
medicine (listed in section 6)
if you have severely reduced kidney function
if you have uncontrolled diabetes associated, for example, with severe hyperglycemia (high blood glucose levels), nausea, vomiting, diarrhea, rapid weight loss, lactic acidosis (see below “Risk of lactic acidosis”) or ketoacidosis. Ketoacidosis is a condition in which substances called “ketone bodies” accumulate in the blood and may lead to diabetic precoma. Symptoms include stomach pain, rapid and deep breathing, drowsiness, and breath with an unusual fruity odor.
if you have a severe infection or are dehydrated
if you are about to undergo an X-ray procedure involving a contrast agent. You will need to stop taking Sitagliptin/Metformina Grindeks at the time of the X-ray and for 2 or more days afterwards, as directed by your doctor, depending on how well your kidneys are functioning
if you have recently had a heart attack or have serious circulatory problems, such as “shock” or breathing difficulties
if you have liver problems
if you drink excessive amounts of alcohol (either regularly or occasionally)
if you are breastfeeding

Do not take Sitagliptin/Metformina Grindeks if you have any of the above conditions and speak with your doctor about alternative methods of managing diabetes. If you are unsure, speak with your doctor, pharmacist, or nurse before taking Sitagliptin/Metformina Grindeks.

Warnings and precautions

Cases of inflammation of the pancreas (pancreatitis) have been reported in patients treated with Sitagliptin/Metformina 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 ask you to stop treatment with Sitagliptin/Metformina Grindeks.

Risk of lactic acidosis
Sitagliptin/Metformina Grindeks may cause a very rare but serious side effect called lactic acidosis, particularly if your kidneys are not functioning properly. The risk of developing lactic acidosis is higher in the presence of uncontrolled diabetes, severe infections, prolonged fasting or alcohol consumption, dehydration (see below for further information), liver problems, or any other medical condition characterized by reduced oxygen supply to part of the body (such as severe heart disease).
If you have any of the medical conditions described above, consult your doctor for further instructions.

Contact your doctor immediately for further instructions if:

• you know you have a hereditary genetic disease affecting mitochondria (the components that produce energy within cells), such as MELAS syndrome (Mitochondrial Encephalopathy, myopathy, Lactic Acidosis and Stroke-like episodes, mitochondrial encephalomyopathy with lactic acidosis and stroke-like episodes) or maternally inherited diabetes and deafness (MIDD, Maternal Inherited Diabetes and Deafness);
• you experience any of the following symptoms after starting metformin: seizures, cognitive decline, movement difficulties, symptoms indicating nerve damage (e.g., pain or numbness), headache, or hearing loss.

Stop taking Sitagliptin/Metformina Grindeks temporarily if
you have a medical condition that may be associated with dehydration (significant loss of body fluids), such as severe vomiting, diarrhea, fever, heat exposure, or if you are drinking less fluid than usual. Consult your doctor for further instructions.

If you experience any of the symptoms of lactic acidosis, stop taking
Sitagliptin/Metformina Grindeks and contact your doctor or the nearest hospital immediately, because lactic acidosis can lead to coma. Symptoms of lactic acidosis include:
vomiting
stomach pain (abdominal pain)
muscle cramps
a general feeling of discomfort associated with severe fatigue
difficulty breathing
decreased body temperature and slower heart rate

Lactic acidosis is a medical emergency and must be treated in hospital.

Talk to your doctor or pharmacist before taking Sitagliptin/Metformina Grindeks:
if you have or have had a pancreatic disease (such as pancreatitis)
if you have or have had gallstones, alcohol dependence, or very high levels of triglycerides (a type of fat) in your blood. These medical conditions may increase your risk of developing pancreatitis (see section 4)
if you have type 1 diabetes. This is sometimes called insulin-dependent diabetes
if you have or have had an allergic reaction to sitagliptin, metformin, or Sitagliptin/Metformina Grindeks (see section 4)
if you are taking a sulfonylurea or insulin, diabetes medicines, together with Sitagliptin/Metformina Grindeks, as this may cause excessively low blood sugar levels (hypoglycemia). Your doctor may reduce the dose of sulfonylurea or insulin.
If you are scheduled for major surgery, you must stop taking Sitagliptin/Metformina Grindeks during the procedure and for a certain period afterwards. Your doctor will decide when you should stop and when you should restart treatment with Sitagliptin/Metformina Grindeks.
If you are unsure whether any of the conditions listed above apply to you, consult your doctor or pharmacist before taking Sitagliptin/Metformina Grindeks.
During treatment with Sitagliptin/Metformina Grindeks, your doctor will check your kidney function at least once a year, or more frequently if you are elderly and/or if kidney function worsens.

Children and adolescents
Children and adolescents under 18 years of age must not use this medicine. It is not effective in children and adolescents aged between 10 and 17 years. It is not known whether this medicine is safe and effective when used in children under 10 years of age.

Other medicines and Sitagliptin/Metformina Grindeks
If you are to receive an injection of an iodinated contrast agent into the bloodstream, for example for an X-ray procedure, you must stop taking Sitagliptin/Metformina Grindeks before or during the injection. Your doctor will decide when you should stop and when you should restart treatment with Sitagliptin/Metformina Grindeks.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine. You may need to have your blood glucose and kidney function tested more frequently, or your doctor may decide to adjust the dose of Sitagliptin/Metformina Grindeks. It is particularly important to mention the following:

• medicines (taken orally, by inhalation, or by injection) used to treat inflammatory diseases, such as asthma and 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 for treating high blood pressure (ACE inhibitors and angiotensin II receptor antagonists)
• specific medicines for treating bronchial asthma (β-receptor 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 specific type of thyroid cancer (medullary thyroid cancer)
• digoxin (for treating heart rhythm irregularities and other heart-related problems). It may be necessary to monitor digoxin blood levels if taken together with Sitagliptin/Metformina Grindeks.

Sitagliptin/Metformina Grindeks and alcohol
Avoid excessive alcohol consumption while being treated with Sitagliptin/Metformina Grindeks, as this may increase the risk of lactic acidosis (see section “Warnings and precautions”).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, plan to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
You must not take this medicine during pregnancy. Do not take this medicine if you are breastfeeding. See section 2,
Do not take Sitagliptin/Metformina Grindeks.

Driving and using machines
This medicine does not affect or affects only insignificantly the ability to drive and use machines. However, dizziness and drowsiness have been reported with sitagliptin, which may affect your ability to drive and use machines.
Taking this medicine together with other medicines called sulfonylureas or with insulin may cause hypoglycemia, which may affect your ability to drive, use machines, or work without protective barriers.

Sitagliptin/Metformina Grindeks contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially “sodium-free”.

3. How to take Sitagliptin/Metformina Grindeks

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.

• Take one tablet:
• twice daily by mouth,
• with meals to reduce the likelihood of stomach upset.
• Your doctor may need to increase your dose to help control the sugar levels in your blood.
• If you have reduced kidney function, your doctor may prescribe you a lower dose.

You must continue the diet recommended by your doctor during treatment with this medicine and ensure that carbohydrate intake is evenly distributed throughout the day.
It is unlikely that this medicine alone will cause abnormally low blood sugar levels (hypoglycaemia). However, when this medicine is used together with a sulphonylurea or insulin, low blood sugar may occur and your doctor may reduce your dose of sulphonylurea or insulin.

If you take more Sitagliptin/Metformina Grindeks than you should
If you take more of this medicine than prescribed, contact your doctor immediately. Go to hospital if you experience symptoms of lactic acidosis such as feeling cold or unwell, severe nausea or vomiting, stomach pain, unexplained weight loss, muscle cramps or rapid breathing (see section "Warnings and precautions").

If you forget to take Sitagliptin/Metformina Grindeks
If you miss a dose, take it as soon as you remember. If you do not remember until it is time for your next dose, skip the missed dose and take your next dose at the usual time. Do not take a double dose to make up for the forgotten dose.

If you stop taking Sitagliptin/Metformina Grindeks
Continue taking this medicine for as long as your doctor prescribes it, so that you can keep controlling your blood sugar levels. Do not stop taking this medicine without first talking to your doctor. If you stop treatment with Sitagliptin/Metformina Grindeks, your blood sugar levels may rise again.

If you have any questions about how to use this medicine, speak to your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
STOP taking Sitagliptin/Metformina Grindeks and contact your doctor immediately if you notice any of the following serious side effects:

• Severe and persistent pain in the abdomen (stomach area), which may extend to the back, with or without nausea and vomiting, as these may be signs of inflammation of the pancreas (pancreatitis).

Sitagliptin/Metformina Grindeks may cause a very rare (may affect up to 1 in 10,000 people) but very serious side effect called lactic acidosis (see section “Warnings and precautions”). If this occurs, you must stop taking Sitagliptin/Metformina Grindeks and seek immediate medical attention at the nearest doctor or hospital, because lactic acidosis can lead to coma.
If you experience a severe allergic reaction (frequency not known), including rash, hives, skin blisters/skin peeling, or swelling of the face, lips, tongue, or throat, which may cause difficulty breathing or swallowing, stop taking this medicine and contact your doctor immediately. Your doctor may prescribe a medicine to treat your allergic reaction and a different medicine for your diabetes.

Some patients taking metformin have experienced the following side effects after starting treatment with sitagliptin:
Common (may affect up to 1 in 10 people): low blood sugar levels, nausea, flatulence, vomiting
Uncommon (may affect up to 1 in 100 people): stomach ache, diarrhoea, constipation, drowsiness

Some patients have experienced diarrhoea, nausea, flatulence, constipation, stomach ache, or vomiting when starting combination treatment with sitagliptin and metformina together (frequency is common).

Some patients have experienced the following side effects while taking this medicine with a sulfonylurea such as glimepiride:
Very common (may affect more than 1 in 10 people): low blood sugar levels
Common: constipation

Some patients have experienced the following side effects while taking this medicine in combination with pioglitazone:
Common: swelling of the hands or legs

Some patients have experienced the following side effects while taking this medicine in combination with insulin:
Very common: low blood sugar levels
Uncommon: dry mouth, headache

During clinical studies, some patients experienced the following side effects when taking sitagliptin alone (one of the medicines contained in Sitagliptin/Metformina Grindeks) or during post-marketing use of Sitagliptin/Metformina Grindeks or sitagliptin alone or in combination with other diabetes medicines:
Common: low blood sugar levels, headache, upper respiratory tract infection, stuffy or runny nose, sore throat, osteoarthritis, pain in arms or legs
Uncommon: dizziness, constipation, itching sensation
Rare: reduced platelet count
Frequency not known: kidney problems (sometimes requiring dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of skin blister)

Some patients taking metformina alone have experienced the following side effects:
Very common: nausea, vomiting, diarrhoea, stomach ache, and loss of appetite. These symptoms may occur when you first start taking metformina and usually go away.
Common: metallic taste, low or decreased levels of vitamin B12 in the blood (symptoms may include extreme tiredness (fatigue), sore and red tongue (glossitis), tingling sensations (paraesthesia), or yellowish or pale skin). Your doctor may order blood tests to determine the cause of these symptoms, as some of them may also be caused by diabetes or other unrelated health problems.
Very rare: hepatitis (a liver problem), hives, skin redness (rash), or itching sensation.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the Italian Medicines Agency (Agenzia Italiana del Farmaco) at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Sitagliptin/Metformin Grindeks

Keep this medicine out of the sight and reach of children.
This product does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the blister pack and the carton after
“EXP”.
The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Sitagliptin/Metformin Grindeks contains
The active substances are sitagliptin and metformin hydrochloride.
Sitagliptin/Metformin 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 Grindeks 50 mg/1.000 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 components are:
Tablet core: povidone, sodium lauryl sulfate, microcrystalline cellulose, sodium stearyl fumarate.
Tablet coating
50 mg/850 mg tablets:
graft copolymer of polyethylene glycol and polyvinyl alcohol (E1209)
talc (E553b)
titanium dioxide (E171)
glycerol monocaprylocaprate (E471)
polyvinyl alcohol (E1203)
yellow iron oxide (E172)
red iron oxide (E172)
50 mg/1000 mg tablets:
graft copolymer of polyethylene glycol and polyvinyl alcohol (E1209)
talc (E553b)
titanium dioxide (E171)
glycerol monocaprylocaprate (E471)
polyvinyl alcohol (E1203)
red iron oxide (E172)
yellow iron oxide (E172)
black iron oxide (E172)

Description of the appearance of Sitagliptin/Metformin Grindeks and package contents
Sitagliptin/Metformin Grindeks 50 mg/850 mg film-coated tablets: film-coated, oval, biconvex, orange tablets with “SM85” engraved on one side. The tablet size is approximately 20 mm x 6.7 mm.
Sitagliptin/Metformin Grindeks 50 mg/1.000 mg film-coated tablets: film-coated, oval, biconvex, brown tablets with “SM100” engraved on one side. The tablet size is approximately 21 mm x 7.2 mm.
Sitagliptin/Metformin Grindeks is available in blisters containing 28, 56, 98 film-coated tablets or multipacks containing 196 film-coated tablets (2 packs of 98).
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
AS GRINDEKS
Krustpils iela 53
Rīga, LV-1057
Latvia
Phone: +371 67083205
Fax: +371 67083505
E-mail: [email protected]

This medicinal product is authorized 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,
Croatia Sitagliptin/metforminklorid Grindeks 50 mg/850 mg, 50 mg/1000 mg filmom obložene tablete
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 hydrochloride 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/1000 mg comprimidos recubiertos con película EFG