Jansitin duo

Package leaflet: Information for the patient

Jansitin Duo, 50 mg + 1000 mg, coated tablets
Sitagliptin + Metformin hydrochloride
Please read carefully the entire leaflet before using the medicine, as it contains important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same as yours.
• If you experience any adverse effects, 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. When used together with diet and exercise, it helps lower blood glucose levels.
This medicine may be used alone as a single 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 that is produced does not work properly. The body may also produce too much glucose. When this happens, 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 may lead to diabetic pre-coma. Symptoms include: abdominal pain, rapid and deep breathing, drowsiness, or an unusual fruity odour on the breath;
• if the patient has a severe infection or dehydration;
• if the patient is scheduled to undergo a radiological procedure involving intravenous administration of contrast agents. The use of Jansitin Duo must be temporarily discontinued during the radiological examination and for 2 or more days afterwards, as advised by the physician, depending on the patient's kidney function;
• if the patient has recently suffered 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.

Jansitin Duo must not be taken if any of the above contraindications apply. The patient should consult their doctor to determine alternative methods of diabetes control. If in doubt, discuss this with the 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 skin blisters, this may be a sign of a disease known as bullous pemphigoid. The doctor may advise discontinuation of Jansitin Duo.

Risk of lactic acidosis

Jansitin Duo may cause a very rare but serious adverse effect called lactic acidosis, especially 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 details below), liver dysfunction, or any medical condition in which 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, medical advice should be sought for further instructions.

Jansitin Duo should be temporarily discontinued if the patient develops any illness associated with dehydration (significant loss of body water), such as severe vomiting, diarrhoea, fever, exposure to high temperatures, or reduced fluid intake compared to usual. Seek medical advice promptly.

Jansitin Duo must be discontinued and the patient should contact their doctor or the nearest hospital immediately if any symptoms of lactic acidosis occur, 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 experiences any of the following: seizures, worsening cognitive function, difficulty moving, symptoms indicating nerve damage (e.g. pain or tingling), migraine, or deafness.

Before starting Jansitin Duo, discuss the following with the 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 currently has or has previously experienced allergic reactions to sitagliptin, metformin, or the medicine Jansitin Duo (see section 4);
• if the patient is taking a sulfonylurea derivative or insulin alongside 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 undergoing major surgery, Jansitin Duo must not be used during the procedure and for some time afterwards. The doctor will decide when to discontinue and resume 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 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 administration. The doctor will decide when to discontinue and resume treatment with Jansitin Duo.

Inform the doctor or pharmacist about all medicines currently used, recently used, or planned for use. The patient may require more frequent monitoring of blood glucose levels and kidney function, or dose adjustments of Jansitin Duo. It is particularly important to inform about the following medicines:

• medicines (taken orally, by inhalation, or by injection) used to treat inflammatory conditions such as asthma or arthritis (corticosteroids);
• diuretics (medicines that increase urine production);
• 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 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 levels of digoxin should be monitored when taken with Jansitin Duo.

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, 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 or negligible influence on the ability to drive and operate machinery. However, dizziness and drowsiness have been reported during treatment with sitagliptin, which may affect these abilities.

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

Jansitin Duo contains sodium

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

3. How to take Jansitin Duo

This medicine should always be taken as directed by the 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 the diet recommended by your doctor and pay attention to
an even intake of carbohydrates throughout the day.
It is unlikely that this medicine, when used alone, will cause abnormally low blood sugar (hypoglycaemia). Low blood sugar may occur when this medicine is used together with a sulfonylurea derivative or insulin – in such a case, your doctor may reduce the dose of the sulfonylurea derivative or insulin.
The breakline on the tablet is not intended for splitting the tablet.
Taking more than the recommended dose of Jansitin Duo
If more than the recommended dose of this medicine is taken, 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 Jansitin Duo
If a dose is missed, take it as soon as possible. If it is almost time for the next dose, skip the missed dose and continue with the regular dosing schedule. Do not take a double dose of this medicine.
Stopping Jansitin Duo
To maintain control of blood sugar levels, the medicine should be taken for as long as directed by the doctor. Do not stop taking this medicine without first consulting your doctor.
Discontinuing Jansitin Duo may lead to increased blood sugar levels.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

You must STOP taking Jansitin Duo and contact your doctor immediately if you experience any of the following serious side effects:

• 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 (may occur in less than 1 in 10,000 people) cause a very serious side effect called lactic acidosis (see section “Warnings and precautions”). If lactic acidosis occurs, you must STOP taking Jansitin Duo and contact your doctor or the nearest hospital immediately, as lactic acidosis can lead to coma.

If you experience a severe allergic reaction (frequency unknown), including rash, hives, skin blisters or peeling skin, and swelling of the face, lips, tongue or throat which may cause 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 switch you to another medicine for diabetes.

In some patients taking metformin, the following side effects occurred after starting sitagliptin:

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

Some patients experienced diarrhoea, nausea, bloating, constipation, stomach 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 side effects occurred:

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

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

Common: swelling of hands or legs

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

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

In clinical trials, some patients experienced the following side effects during treatment with sitagliptin alone (one of the active substances in Jansitin Duo), or after market authorization during treatment with Jansitin Duo or sitagliptin alone or in combination with other antidiabetic medicines:

Common: low blood sugar levels, headache, upper respiratory tract infection, stuffy or runny nose or sore throat, joint pain, pain in arms or legs
Uncommon: dizziness, constipation, itching
Rare (may occur in less than 1 in 1,000 people): 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 side 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, reduced or low levels of vitamin B$_{12}$ in the blood (symptoms may include extreme tiredness (fatigue), pain and redness of the tongue (glossitis), tingling or numbness (paraesthesia), or paleness or yellowing of the skin). Your doctor may order certain tests to determine the cause of symptoms, as some of them may also be caused by diabetes or other unrelated health problems.
Very rare: liver inflammation (liver disease), hives, skin redness (rash) or itching.

Reporting of side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. Side effects can also be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:

Al. Jerozolimskie 181C,
02-222 Warszawa
Tel: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the responsible entity.

By reporting side effects, more information on the safety of this medicine can be collected.

5. How to store Jansitin Duo

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.
Store below 30°C.
Medicines must 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 Jansitin Duo contains

• The active substances are sitagliptin and metformin. Each coated tablet (tablet) contains sitagliptin hydrochloride monohydrate, equivalent to 50 mg sitagliptin and 1000 mg metformin hydrochloride.
• Other ingredients are:
  Tablet core: povidone (K29/32), microcrystalline cellulose, crospovidone (Kollidon), sodium stearyl fumarate;
  Coating: polyvinyl alcohol, macrogol 3350, talc, titanium dioxide (E 171), iron oxide red (E 172), iron oxide black (E 172).

What Jansitin Duo looks like and contents of the pack
Reddish-brown, elongated, oval coated tablets with a breakline between the markings “S” and “B” on one side and a breakline on the other side.
Tablet diameter: 21.3 mm ± 0.5 mm
Blister packs made of PVC/PVDC/Aluminum in cardboard boxes. Pack sizes: 56 coated tablets.

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

Manufacturers
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 further information about this medicinal product, 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]