Sitagliptin + metformin hydrochloride +pharma

Package leaflet: Information for the user

Sitagliptin + Metformin hydrochloride +pharma , 50 mg + 850 mg, film-coated tablets
Sitagliptin + Metformin hydrochloride +pharma , 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 experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Sitagliptin + Metformin hydrochloride +pharma is and what it is 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 pack and other information

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

Sitagliptin + Metformin hydrochloride +pharma 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 helps to control blood sugar levels in adults 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. When used together with diet and
exercise, this medicine helps lower blood sugar levels. It 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 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 and kidney disease,
vision loss, and limb amputations.

2. Important information before taking Sitagliptin + Metformin hydrochloride +pharma

When not to take Sitagliptin + Metformin hydrochloride +pharma

• 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 a diabetic pre-coma state. Symptoms include: abdominal pain, rapid and deep breathing,
drowsiness, or an unusual fruity odour of the breath.

• if you have a severe infection or dehydration
• if you are scheduled to undergo a radiological examination with intravascular iodinated contrast medium. You must stop taking Sitagliptin + Metformin hydrochloride +pharma before or at the time of the examination and for 2 or more days afterwards, as directed by your doctor, depending on your kidney function.
• if you 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 (daily or occasionally)
• if you are breastfeeding

Do not take Sitagliptin + Metformin hydrochloride +pharma if any of the above contraindications apply to you. 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 +pharma.

Warnings and precautions
Pancreatitis (inflammation of the pancreas) has been reported in patients taking sitagliptin in combination with metformin (see section 4).
If you develop blisters on your skin, this may be a sign of a disease called bullous pemphigoid. Your doctor may advise you to stop taking Sitagliptin + Metformin hydrochloride +pharma.
Risk of lactic acidosis
Sitagliptin + Metformin hydrochloride +pharma 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 with uncontrolled diabetes, severe infection, prolonged fasting or alcohol consumption, dehydration (see more detailed information below), liver dysfunction, and any conditions 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.
Seek immediate medical advice 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 +pharma
if you develop an illness 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 +pharma
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 malaise with profound fatigue
‐ difficulty breathing
‐ decreased body temperature and slowed heart rate
Lactic acidosis is a sudden, life-threatening condition requiring immediate hospital treatment.
Before starting Sitagliptin + Metformin hydrochloride +pharma, discuss with your doctor or pharmacist:
‐ if you have or have had pancreatic disease (e.g. pancreatitis)
‐ if you have or have had gallstones, alcohol dependence, or very high blood triglyceride levels (a type of fat). In such cases, the risk of pancreatitis may increase (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 +pharma (see section 4)
‐ if you are taking a sulfonylurea or insulin together with Sitagliptin + Metformin hydrochloride +pharma, as this may lead to excessively low blood sugar (hypoglycaemia). Your doctor may reduce the dose of the sulfonylurea or insulin.
If you are undergoing major surgery, you must not take Sitagliptin + Metformin hydrochloride +pharma during the procedure and for some time afterwards. Your doctor will decide when you should stop and restart treatment with Sitagliptin + Metformin hydrochloride +pharma.
If you are unsure whether any of the above apply to you, discuss this with your doctor or pharmacist before starting Sitagliptin + Metformin hydrochloride +pharma.
While taking Sitagliptin + Metformin hydrochloride +pharma, 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 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 +pharma and other medicines
If you need to receive an intravenous iodinated contrast medium, for example during an X-ray or CT scan, you must stop taking Sitagliptin + Metformin hydrochloride +pharma before or at the time of injection. Your doctor will decide when you should stop and restart treatment with Sitagliptin + Metformin hydrochloride +pharma.
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take. 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 +pharma. It is especially important to inform them 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)
• iodinated contrast media 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 digoxin levels should be monitored when taking Sitagliptin + Metformin hydrochloride +pharma with digoxin.

Sitagliptin + Metformin hydrochloride +pharma and alcohol
Avoid consuming excessive amounts of alcohol while taking Sitagliptin + Metformin hydrochloride +pharma, 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, you should consult your doctor or pharmacist before using this medicine. Do not use this medicine during pregnancy or while breastfeeding. See section 2 "When not to take Sitagliptin + Metformin hydrochloride +pharma ".
Driving and operating machinery
This medicine has no effect or a negligible effect on the ability to drive and operate machinery. However, when driving or operating machinery, consider that dizziness and drowsiness have been reported with sitagliptin use, which may affect your ability to drive and operate machinery. Taking this medicine together with medicines called sulfonylureas or insulin may lead to hypoglycaemia, which may affect your ability to drive and operate machinery or work without secure foot support.
Sitagliptin + Metformin hydrochloride +pharma contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, meaning the medicine is considered "sodium-free".
3. How to take Sitagliptin + Metformin hydrochloride +pharma
Always take this medicine exactly as your doctor has told you. If in doubt, consult your doctor or pharmacist.

• Take one tablet
  • twice daily, orally
  • with meals to reduce the likelihood of stomach disturbances
• To control your blood sugar levels, your doctor may increase your dose.
• If you have impaired kidney function, your doctor may prescribe a lower dose.

While taking this medicine, continue with 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 will lead to abnormally low blood sugar levels (hypoglycaemia). Low blood sugar may occur if this medicine is taken together with a sulfonylurea or insulin – in such cases, your doctor may reduce the dose of the sulfonylurea or insulin.
The tablet's break line is intended only to facilitate breaking the tablet for easier swallowing in case of difficulty swallowing it whole.
Taking more Sitagliptin + Metformin hydrochloride +pharma 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").
If you forget to take Sitagliptin + Metformin hydrochloride +pharma
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 of this medicine.
Stopping Sitagliptin + Metformin hydrochloride +pharma
To maintain control of your 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 Sitagliptin + Metformin hydrochloride +pharma may cause your blood sugar levels to rise.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

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

• severe and persistent abdominal pain (in the stomach area), possibly radiating to the back, with or without nausea and vomiting – these may be symptoms of pancreatitis

Sitagliptin + Metformin hydrochloride +pharma may very rarely (in up to 1 in 10,000 patients) cause a very serious adverse reaction known as lactic acidosis (see section "Warnings and precautions"). If lactic acidosis occurs, STOP taking Sitagliptin + Metformin hydrochloride +pharma
and contact your doctor or nearest hospital immediately, as lactic acidosis can lead to coma.
If a severe allergic reaction occurs (frequency not known), including rash, hives, skin blisters or peeling, or swelling of the face, lips, tongue or throat, which may cause difficulty breathing or swallowing, treatment with this medicine should be stopped and medical advice should be sought 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 effects occurred after starting sitagliptin:

Common (may occur in up to 1 in 10 patients): low blood sugar levels, nausea, bloating, vomiting
Uncommon (may occur in up to 1 in 100 patients): stomach pain, diarrhoea, constipation, drowsiness

In some patients, diarrhoea, nausea, bloating, constipation, stomach pain or vomiting occurred 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 effects occurred:

Very common (may occur in more than 1 in 10 patients): low blood sugar levels
Common: constipation

In some patients taking this medicine together with pioglitazone, the following adverse effects occurred:

Common: swelling of hands or feet

In some patients taking this medicine together with insulin, the following adverse effects occurred:

Very common: low blood sugar levels
Uncommon: dry mouth, headache

In clinical trials, and after marketing of sitagliptin alone (one of the active substances in Sitagliptin + Metformin hydrochloride +pharma), or Sitagliptin + Metformin hydrochloride +pharma, or sitagliptin alone, or in combination with other antidiabetic medicines, the following adverse effects were observed in some patients:

Common: low blood sugar levels, headache, upper respiratory tract infection, stuffy or runny nose and sore throat, bone and joint pain, 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 effects occurred:

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, redness of the skin (rash) or itching

Reporting of adverse effects

If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps provide more information on the safety of this medicine.

5. How to store Sitagliptin + Metformin hydrochloride +pharma

Keep this medicine out of the 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 stated month.
Do not store above 25°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Sitagliptin + Metformin hydrochloride +pharma contains

• The active substances are sitagliptin and metformin.

Sitagliptin + Metformin hydrochloride +pharma, 50 mg + 850 mg, film-coated tablets
Each film-coated tablet (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, film-coated tablets
Each film-coated tablet (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, film-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, 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 +pharma looks like and contents of the pack
Sitagliptin + Metformin hydrochloride +pharma, 50 mg + 850 mg, film-coated tablets
Pink, biconvex, capsule-shaped film-coated tablets, approximately 20.2 mm in length, 9.9 mm in width and 7.0 mm in thickness, with the imprint "585" on one side and a score line on the other side.

Sitagliptin + Metformin hydrochloride +pharma, 50 mg + 1000 mg, film-coated tablets
Red, biconvex, capsule-shaped film-coated tablets, approximately 21.4 mm in length, 10.4 mm in width and 7.1 mm in thickness, with the imprint "5100" on one side and a score line on the other side.

Opaque PVC/PE/PVDC/Aluminium or OPA/Aluminium/PVC/Aluminium blisters, perforated or non-perforated, in a cardboard carton.
Packs contain 30, 60, 90 or 120 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation 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 medicinal product is authorised 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/metforminklorid Genericon 50 mg/850 mg film-coated tablets
Sitagliptin/metforminklorid Genericon 50 mg/1000 mg film-coated tablets
Poland: Sitagliptin + Metformin hydrochloride +pharma
Czech Republic: Sitagliptin/Metformin +pharma

For more detailed information about this medicinal product, please contact the representative of the Marketing Authorisation Holder:
+pharma Polska sp. z o.o.
ul. Podgórska 34
31-536 Kraków, Poland
Tel.: +48 12 262 32 36
E-mail: [email protected]