Sitagliptin + metformin hydrochloride reddy

Package leaflet: Information for the patient

Sytagliptyna + Metforminy chlorowodorek Reddy, 50 mg + 850 mg, film-coated tablets
Sytagliptyna + Metforminy chlorowodorek Reddy, 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, pharmacist or nurse. See section 4.

Contents of the leaflet

1. What Sytagliptyna + Metforminy chlorowodorek Reddy is and what it is used for

2. What you need to know before taking Sytagliptyna + Metforminy chlorowodorek Reddy

3. How to take Sytagliptyna + Metforminy chlorowodorek Reddy

4. Possible side effects

5. How to store Sytagliptyna + Metforminy chlorowodorek Reddy

6. Contents of the pack and other information

7. What Sytagliptyna + Metforminy chlorowodorek Reddy is and what it is used for

Sytagliptyna + Metforminy chlorowodorek Reddy contains two different active substances:
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 regulate 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, it 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 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, vision loss and limb amputations.

2. What you need to know before taking Sytagliptyna + Metforminy chlorowodorek Reddy

When not to take Sytagliptyna + Metforminy chlorowodorek Reddy

• 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 ketone bodies accumulate in the blood and which may lead to diabetic pre-coma. 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 Sytagliptyna + Metforminy chlorowodorek Reddy during the radiological examination and for 2 or more days afterwards, as advised by your doctor, depending on your kidney function.
• if you have recently had a heart attack or have severe circulatory disorders 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 Sytagliptyna + Metforminy chlorowodorek Reddy if any of the above contraindications apply. Consult your doctor to determine alternative methods of diabetes control. If in doubt, discuss this with your doctor, pharmacist or nurse before taking Sytagliptyna + Metforminy chlorowodorek Reddy.

Warnings and precautions

Cases of pancreatitis have been reported in patients taking Sytagliptyna + Metforminy chlorowodorek Reddy (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 Sytagliptyna + Metforminy chlorowodorek Reddy.

Risk of lactic acidosis

Sytagliptyna + Metforminy chlorowodorek Reddy 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 detailed information below), impaired liver function, 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.

You should temporarily stop taking Sytagliptyna + Metforminy chlorowodorek Reddy if you develop an illness that may involve 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.

You should stop taking Sytagliptyna + Metforminy chlorowodorek Reddy 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 combined with severe fatigue,
• difficulty breathing,
• decreased body temperature and slowed heart rate.

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

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.

Before starting Sytagliptyna + Metforminy chlorowodorek Reddy, discuss the following 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 Sytagliptyna + Metforminy chlorowodorek Reddy (see section 4).
• if you are taking a sulfonylurea derivative or insulin, antidiabetic medicines together with Sytagliptyna + Metforminy chlorowodorek Reddy, as this may lead to excessively low blood sugar levels (hypoglycaemia). Your doctor may reduce the dose of the sulfonylurea derivative or insulin.

If you are undergoing major surgery, you must not take Sytagliptyna + Metforminy chlorowodorek Reddy during the procedure and for some time afterwards. Your doctor will decide when you should stop and restart treatment with Sytagliptyna + Metforminy chlorowodorek Reddy.

If in doubt, discuss this with your doctor or pharmacist before taking Sytagliptyna + Metforminy chlorowodorek Reddy.

During treatment with Sytagliptyna + Metforminy chlorowodorek Reddy, your doctor will monitor your kidney function at least once a year, or more frequently if you are elderly and/or have deteriorating 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.

Sytagliptyna + Metforminy chlorowodorek Reddy and other medicines

If you are to receive an intravenous iodinated contrast medium, for example for an X-ray or CT scan, you must stop taking Sytagliptyna + Metforminy chlorowodorek Reddy before or at the latest at the time of injection. Your doctor will decide when you should stop and restart treatment with Sytagliptyna + Metforminy chlorowodorek Reddy.

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 Sytagliptyna + Metforminy chlorowodorek Reddy. 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 gastrointestinal 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 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 Sytagliptyna + Metforminy chlorowodorek Reddy with digoxin.

Taking Sytagliptyna + Metforminy chlorowodorek Reddy with alcohol

Avoid consuming excessive amounts of alcohol while taking Sytagliptyna + Metforminy chlorowodorek Reddy, 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 child, consult 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, When not to take Sytagliptyna + Metforminy chlorowodorek Reddy.

Driving and operating machinery

This medicine has no effect or negligible effect on the ability to drive and operate machinery. However, when driving and operating machinery, take into account that dizziness and drowsiness have been reported with sitagliptin, which may affect the ability to drive and operate machinery.

Taking this medicine together with medicines called sulfonylurea derivatives or insulin may lead to hypoglycaemia, which may affect the ability to drive and operate machinery or work without secure foot support.

Sytagliptyna + Metforminy chlorowodorek Reddy contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".

3. How to take Sytagliptyna + Metforminy chlorowodorek Reddy

This medicine should always be taken exactly as prescribed 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 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 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 when this medicine is used in combination with a sulphonylurea or insulin – in such cases, your doctor may reduce the dose of the sulphonylurea or insulin.
If you take more Sytagliptyna + Metforminy chlorowodorek Reddy 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 Sytagliptyna + Metforminy chlorowodorek Reddy
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 Sytagliptyna + Metforminy chlorowodorek Reddy
To maintain control of blood sugar levels, continue taking this medicine for as long as your doctor recommends. Do not stop taking this medicine without first consulting your doctor.
Discontinuing treatment with Sytagliptyna + Metforminy chlorowodorek Reddy may cause 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 reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
You should STOP taking Sytagliptyna + Metforminy chlorowodorek Reddy and
contact your doctor immediately if any of the following serious adverse reactions 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.

Sytagliptyna + Metforminy chlorowodorek Reddy may very rarely (may occur 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 Sytagliptyna + Metforminy chlorowodorek Reddy and contact your doctor or nearest hospital immediately, as lactic acidosis may lead to coma.
In case of a severe allergic reaction (frequency not known), including rash, hives, skin blisters or peeling, or swelling of the face, lips, tongue and throat, which may cause difficulty in breathing or swallowing, you should stop taking the medicine and contact your doctor immediately. Your doctor may prescribe medication to treat the allergic reaction and may switch you to another medicine (change your 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): 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 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 trials, in some patients taking sitagliptin alone (one of the active substances in Sytagliptyna + Metforminy chlorowodorek Reddy) or after marketing of Sytagliptyna + Metforminy chlorowodorek Reddy or sitagliptin alone or in combination with other antidiabetic medicines, the following adverse reactions were observed:
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 blister)

In some patients taking metformin alone, the following adverse reactions 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, reduced or low blood levels of vitamin B12 (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 your symptoms, as some of them may also be caused by diabetes or other unrelated health problems.
Very rare: hepatitis (liver disease), urticaria, skin redness (rash) or itching

Reporting of adverse reactions
If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at 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. Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store the medicine Sytagliptyna + Metforminy chlorowodorek Reddy

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack after "EXP" and on the carton after "Expiry date (EXP)". The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the packaging and other information

What Sytagliptyna + Metforminy chlorowodorek Reddy contains

• The active substances are sitagliptin and metformin.
• Sytagliptyna + Metforminy chlorowodorek Reddy, 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.
• Sytagliptyna + Metforminy chlorowodorek Reddy, 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, sodium lauryl sulfate, microcrystalline cellulose, magnesium stearate.
  Coating: polyvinyl alcohol, macrogol 3350, talc, titanium dioxide (E 171).
  Additionally, for the 50 mg + 1000 mg strength only: iron oxide red (E 172), iron oxide yellow (E 172).

What Sytagliptyna + Metforminy chlorowodorek Reddy looks like and contents of the pack
Sytagliptyna + Metforminy chlorowodorek Reddy, 50 mg + 850 mg, film-coated tablets are white, biconvex, oval-shaped tablets with a "ǀ" embossed on one side and no marking on the other side.
Approximate tablet dimensions: 20 mm x 10 mm x 6 mm.
Sytagliptyna + Metforminy chlorowodorek Reddy, 50 mg + 1000 mg, film-coated tablets are brown, biconvex, oval-shaped tablets with a "7" embossed on one side and no marking on the other side.
Approximate tablet dimensions: 21 mm x 10 mm x 7 mm.
Packaging: Blister pack made of OPA/Aluminium/PVC/Aluminium in a cardboard box.
Pack sizes: 56 and 196 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Reddy Holding GmbH
Kobelweg 95
86156 Augsburg
Germany
Tel.: +49 821 74881 0

Manufacturer
Betapharm Arzneimittel GmbH
Kobelweg 95
86156 Augsburg
Germany
Rual Laboratories SRL
313, Splaiul Unirii, Building H, 1st floor, sector 3
030138 Bucharest
Romania
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park
Paola PLA 3000
Malta

Importer:
Betapharm Arzneimittel GmbH
Kobelweg 95
86156 Augsburg
Germany
Dr Reddy’s Laboratories Romania SRL
71-73 Nicolae Caramfil, 1st floor, sector 1,
014142 Bucharest
Romania
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park
Paola PLA 3000
Malta

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Austria: Sitagliptin/Metforminhydrochlorid Reddy 50 mg/850 mg Filmtabletten
Sitagliptin/Metforminhydrochlorid Reddy 50 mg/1000 mg Filmtabletten
Czech Republic: Sitagliptin/Metformin Reddy
Denmark: Sitagliptin/Metformin Reddy
Finland: Sitagliptin/Metformin Reddy 50 mg/850 mg kalvopäällysteiset tabletit
Sitagliptin/Metformin Reddy 50 mg/1000 mg kalvopäällysteiset tabletit
France: SITAGLIPTINE/METFORMINE REDDY PHARMA 50 mg/850 mg, comprimé pelliculé
SITAGLIPTINE/METFORMINE REDDY PHARMA 50 mg/1000 mg, comprimé pelliculé
Spain: Sitagliptina/metformina Dr. Reddys 50 mg/850 mg comprimidos recubiertos con película EFG
Sitagliptina/metformina Dr. Reddys 50 mg/1000 mg comprimidos recubiertos con película EFG
Netherlands: Sitagliptine/Metformine hydrochloride Reddy 50 mg/850 mg filmomhulde tabletten
Sitagliptine/Metformine hydrochloride Reddy 50 mg/1000 mg filmomhulde tabletten
Germany: Sitagliptin/Metformin beta 50 mg/850 mg Filmtabletten
Sitagliptin/Metformin beta 50 mg/1000 mg Filmtabletten
Norway: Sitagliptin/Metformin Reddy
Poland: Sytagliptyna + Metforminy chlorowodorek Reddy
Romania: Sitagliptină/Metformin Dr. Reddy’s 50 mg/850 mg comprimate filmate
Sitagliptină/Metformin Dr. Reddy’s 50 mg/1000 mg comprimate filmate
Slovakia: Sitagliptin/Metformin Reddy 50 mg/850 mg filmom obalené tablety
Sitagliptin/Metformin Reddy 50 mg/1000 mg filmom obalené tablety
Sweden: Sitagliptin/Metformin Reddy 50 mg/850 mg filmdragerade tabletter
Sitagliptin/Metformin Reddy 50 mg/1000 mg filmdragerade tabletter
Italy: Sitagliptin e Metformina Dr. Reddy’s