Jansitin duo

Package leaflet: Information for the patient

Jansitin Duo, 50 mg + 850 mg, film-coated tablets
Sitagliptin + Metformin hydrochloride
Please read carefully this leaflet before taking this medicine, because it contains
important information for you.

• Keep this leaflet as 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 a specific individual. Do not pass it on to others. It may harm someone else even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

1. What Jansitin Duo is and what it is used for
2. Important information before taking Jansitin Duo
3. How to take Jansitin Duo
4. Possible side effects
5. How to store Jansitin Duo
6. Contents of the pack and other information

1. What Jansitin Duo is and what it is used for

Jansitin Duo 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 two medicines helps regulate blood glucose levels in adult patients with diabetes known as "type 2 diabetes." This medicine helps increase insulin levels released after meals and reduces the amount of glucose produced by the body.
Used together with diet and physical exercise, it helps lower blood glucose levels.
This medicine may be used as the only antidiabetic treatment or in combination with certain other antidiabetic medicines (insulin, sulfonylurea derivatives, 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 glucose. As a result, sugar (glucose) accumulates in the blood. This may lead to serious health problems such as heart disease, kidney disease, vision loss, and limb amputations.

2. Important information before using Jansitin Duo

When not to take Jansitin Duo

• if the patient is allergic to sitagliptin or metformin, or to any of the other ingredients of this medicine (listed in section 6);
• if the patient has significantly reduced kidney function;
• if the patient has 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 the patient has severe infection or dehydration;
• if the patient is scheduled to undergo a radiological procedure with intravascular administration of contrast agents. The use of Jansitin Duo must be temporarily discontinued during the radiological procedure and for 2 or more days afterwards, as advised by the physician, depending on the patient's kidney function;
• if the patient has recently had a heart attack or has experienced severe circulatory disorders such as shock or breathing difficulties;
• if the patient has liver disease;
• if the patient consumes excessive amounts of alcohol (either daily or occasionally);
• if the patient is breastfeeding.

Do not take Jansitin Duo 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 Jansitin Duo.

Warnings and precautions

Cases of pancreatitis have been reported in patients taking Jansitin Duo (see section 4).
If the patient develops blisters on the skin, this may be a sign of a disease known as bullous pemphigoid. The doctor may advise the patient to discontinue taking Jansitin Duo.

Risk of lactic acidosis

Jansitin Duo may cause a very rare but serious adverse effect called lactic acidosis, particularly if the patient has impaired kidney function. The risk of lactic acidosis increases in cases of uncontrolled diabetes, severe infection, prolonged fasting, alcohol consumption, dehydration (see further information below), liver dysfunction, and any medical conditions in which a part of the body is inadequately supplied with oxygen (e.g. acute severe heart disease).

If any of the above conditions apply to the patient, consult a doctor for further instructions.

Temporarily discontinue use of Jansitin Duo if the patient develops a medical condition associated with dehydration (significant loss of body water), such as severe vomiting, diarrhoea, fever, exposure to high temperatures, or if the patient drinks less fluid than usual. Consult a doctor for further instructions.

Discontinue use of Jansitin Duo and contact a doctor or the nearest hospital immediately if the patient experiences any symptoms of lactic acidosis, as this condition may lead to coma.

Symptoms of lactic acidosis include:

• vomiting
• abdominal pain
• muscle cramps
• general malaise accompanied by profound fatigue
• difficulty breathing
• decreased body temperature and slowed heart rate

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

Seek immediate medical advice if:

• the patient has a genetically inherited mitochondrial disorder (cellular energy-producing structures), such as MELAS syndrome (mitochondrial encephalopathy, myopathy, lactic acidosis, and stroke-like episodes) or maternally inherited diabetes and deafness (MIDD).

• after starting metformin, the patient has experienced any of the following: seizures, worsening cognitive function, difficulty moving, symptoms indicating nerve damage (e.g. pain or tingling), migraine, or deafness.

Before starting treatment with Jansitin Duo, discuss the following with your doctor or pharmacist:

• if the patient has or has had pancreatic disease (e.g. pancreatitis);
• if the patient has or has 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 the patient has type 1 diabetes, sometimes referred to as insulin-dependent diabetes;
• if the patient has a current or past history of allergic reactions to sitagliptin, metformin, or Jansitin Duo (see section 4);
• if the patient is taking a sulfonylurea derivative or insulin together with Jansitin Duo, as this may lead to excessively low blood sugar levels (hypoglycaemia). The doctor may reduce the dose of the sulfonylurea derivative or insulin.

If the patient is to undergo major surgery, Jansitin Duo must not be used during the procedure and for a certain period afterwards. The doctor will decide when the patient should stop and restart treatment with Jansitin Duo.

If the patient is unsure whether any of the above apply, they should discuss this with their doctor or pharmacist before taking Jansitin Duo.

While being treated with Jansitin Duo, the doctor will monitor kidney function at least once a year, or more frequently if the patient is elderly and/or has worsening kidney function.

Children and adolescents

Jansitin Duo 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 unknown whether this medicine is safe and effective for use in children under 10 years of age.

Jansitin Duo and other medicines

If the patient is to receive an iodine-containing contrast agent intravenously, for example during an X-ray or CT scan, they must stop taking Jansitin Duo before or at the latest at the time of injection. The doctor will decide when the patient should stop and restart treatment with Jansitin Duo.

Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines they plan to take. The patient may require more frequent monitoring of blood glucose levels and kidney function assessments, or dose adjustments of Jansitin Duo by the doctor. It is especially important to inform the doctor about the following medicines:

• medicines (taken orally, inhaled, 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 receptor antagonists);
• specific medicines used to treat bronchial asthma (β-sympathomimetics);
• iodine-containing contrast agents or medicines containing alcohol;
• some medicines used to treat gastrointestinal disorders, such as cimetidine;
• ranolazine, a medicine used to treat angina pectoris;
• 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 Jansitin Duo is taken concomitantly with digoxin.

Jansitin Duo and alcohol

Avoid consuming excessive amounts of alcohol while taking Jansitin Duo, as this may increase the risk of lactic acidosis (see section "Warnings and precautions").

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before using this medicine. This medicine must not be used during pregnancy. It must not be taken during breastfeeding. See section 2, When not to take Jansitin Duo.

Driving and operating machinery

This medicine has no effect or negligible effect on the ability to drive and operate machinery. However, dizziness and drowsiness have been reported during treatment with sitagliptin, which may affect the ability to drive and operate machinery.

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

Jansitin Duo 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 take Jansitin Duo

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 gastrointestinal disturbances.
• To control blood glucose 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 maintain regular carbohydrate intake throughout the day.
It is unlikely that this medicine, when used alone, will cause abnormally low blood sugar levels (hypoglycaemia). Low blood sugar may occur when this medicine is used together with a sulfonylurea derivative or insulin – in such cases, your doctor may reduce the dose of the sulfonylurea derivative or insulin.
The break-line on the tablet is not intended for splitting the tablet.

Taking more Jansitin Duo than prescribed
If you have taken more than the prescribed amount of this medicine, contact your doctor immediately. Go to hospital if symptoms of lactic acidosis occur, 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").

Missed dose of Jansitin Duo
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 Jansitin Duo
To maintain control of blood glucose levels, take this medicine for as long as prescribed by your doctor. Do not stop taking this medicine without consulting your doctor first.
Discontinuing treatment with Jansitin Duo may lead to increased blood glucose levels.
If you have any further doubts or questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine may cause adverse reactions, although not everyone experiences them.

You must STOP taking Jansitin Duo 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.

Jansitin Duo may very rarely cause (may occur in less than 1 in 10,000 patients) a very serious adverse reaction known as lactic acidosis (see section "Warnings and precautions"). If lactic acidosis develops in a patient, the treatment with Jansitin Duo must be discontinued and immediate contact with a doctor or the nearest hospital is required, as lactic acidosis may lead to shock.

In case of a severe allergic reaction (frequency unknown), including rash, hives, skin blisters or peeling skin, and swelling of the face, lips, tongue or throat causing difficulty in breathing or swallowing, you must stop taking the medicine and contact your doctor immediately. Your doctor may prescribe treatment for the allergic reaction and may switch you to another medicine for diabetes.

In some patients taking metformin, the following adverse reactions occurred after starting treatment with sitagliptin:

Frequent (may occur in less than 1 in 10 patients): low blood sugar levels, nausea, flatulence, vomiting
Not frequent (may occur in less than 1 in 100 patients): stomach pain, diarrhoea, constipation, drowsiness

In some patients, diarrhoea, nausea, flatulence, constipation, stomach pain or vomiting occurred after starting treatment with sitagliptin in combination with metformin (frequent).

In some patients taking this medicine together with a sulfonylurea derivative such as glimepiride, the following adverse reactions occurred:

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

In some patients taking this medicine in combination with pioglitazone, the following adverse reactions occurred:

Frequent: swelling of hands or legs (oedema)

In some patients taking this medicine in combination with insulin, the following adverse reactions occurred:

Very frequent: low blood sugar levels
Not frequent: dry mouth, headache

In clinical trials, in some patients taking sitagliptin alone (one of the active substances in Jansitin Duo) or after marketing of Jansitin Duo or sitagliptin alone or in combination with other antidiabetic medicines, the following adverse reactions occurred:

Frequent: low blood sugar levels, headache, upper respiratory tract infections, nasal congestion or runny nose, sore throat, arthritis, shoulder or leg pain
Not frequent: dizziness, constipation, itching
Rare (may occur in less than 1 in 1,000 patients): 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)

In some patients taking metformin alone, the following adverse reactions occurred:

Very frequent: nausea, vomiting, diarrhoea, stomach pain and loss of appetite. These symptoms may occur when starting metformin and usually resolve over time.
Frequent: metallic taste, reduced or low blood levels of vitamin B (symptoms may include extreme fatigue, pain and redness of the tongue (glossitis), tingling or numbness sensations (paraesthesia), or pallor or yellowing of the skin). Your doctor may order certain tests to identify the cause of symptoms, as some of them may also be caused by diabetes or unrelated health problems.
Very rare: hepatitis (liver disease), urticaria, skin redness (rash) or itching.

Reporting of adverse reactions
If you experience any adverse effects, including any 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
Phone: +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 Jansitin Duo

Keep this medicine out of 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.
Store below 30°C.
Medicines must not be disposed of via the sewage system or in household waste.
Ask your pharmacist how to dispose of medicines no longer in use. This will help protect
the environment.

6. Contents of the pack and other information

What Jansitin Duo contains

• The active substances are sitagliptin and metformin. Each coated tablet (tablet) contains sitagliptin hydrochloride monohydrate, equivalent to 50 mg of sitagliptin and 850 mg of metformin hydrochloride.
• Other components are:
  Tablet core: povidone (K29/32), microcrystalline cellulose, crospovidone (Kollidon), sodium stearyl fumarate;
  Coating: polyvinyl alcohol, macrogol 3350, talc, titanium dioxide (E 171), red iron oxide (E 172), black iron oxide (E 172), yellow iron oxide (E 172).

What Jansitin Duo looks like and contents of the pack
Pink, elongated, oval-shaped coated tablets with a division line on one side and the imprint "SA" on the other side. Tablet diameter: 19.5 mm ± 0.5 mm.

Blister packs made of PVC/PVDC/Aluminum foil in cardboard boxes. Pack sizes: 56 coated tablets.

Marketing Authorisation Holder
G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria

Manufacturer
SAG MANUFACTURING S.L.U
Carretera Nacional I, Km 36
San Agustin de Guadalix
28750 Madrid
Spain
GALENICUM HEALTH, S.L.
Avda. Cornellá 144, 7º-1ª, Edificio Lekla
Esplugues de Llobregat
08950 Barcelona
Spain

For more detailed information about this medicine, contact the representative of the Marketing Authorisation Holder:
G.L. PHARMA POLAND Sp. z o.o.
Al. Jana Pawła II 61/313
01-031 Warsaw, Poland
Tel: 022/ 636 52 23; 636 53 02
[email protected]