Juzimette

Package leaflet: Information for the patient
JUZIMETTE, 50 mg + 1000 mg, coated tablets
sitagliptin + metformin hydrochloride
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 Juzimette is and what it is used for
2. Important information before taking Juzimette
3. How to take Juzimette
4. Possible side effects
5. How to store Juzimette
6. Contents of the pack and other information

1. What Juzimette is and what it is used for

Juzimette 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.
Juzimette, used together with diet and exercise, helps lower blood glucose levels.
It may be used as the only antidiabetic medicine 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) builds up in the blood. This can lead to serious health problems, such as heart disease, kidney disease, vision loss, and limb amputations.

2. Important information before taking Juzimette

When not to take Juzimette:

• 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 a severe infection or dehydration;
• if the patient is scheduled to undergo a radiological procedure involving intravascular administration of contrast agents. The use of Juzimette should be temporarily discontinued during the radiological procedure and for 2 or more days afterwards, according to the physician's recommendation, 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.

Do not take Juzimette 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 Juzimette.

Warnings and precautions

Cases of pancreatitis have been reported in patients taking Juzimette (see section 4).
If the patient develops skin blisters, this may be a symptom of a disease known as bullous pemphigoid. The doctor may advise discontinuation of Juzimette.

Risk of lactic acidosis

Juzimette 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 or alcohol consumption, dehydration (see more detailed 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 Juzimette 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 Juzimette and contact a 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 combined with 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 develops any of the following symptoms: seizures, worsening cognitive function, difficulty moving, symptoms indicating nerve damage (e.g. pain or tingling), migraine, or hearing loss.

Before starting Juzimette, 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 history of allergic reactions to sitagliptin, metformin, or Juzimette (see section 4);
• if the patient is taking a sulfonylurea derivative or insulin, along with Juzimette, 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 scheduled for major surgery, Juzimette should not be used during the procedure and for some time afterwards. The doctor will decide when the patient should stop and restart treatment with Juzimette.

If the patient is unsure whether any of the above apply, discuss this with a doctor or pharmacist before taking Juzimette.

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

Children and adolescents

This medicine should not be used in children and adolescents under 18 years of age. The 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.

Juzimette and other medicines

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

Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take. The patient may require more frequent monitoring of blood glucose levels and kidney function, or dose adjustments of Juzimette. It is especially 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);
• 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 bronchial asthma (β-sympathomimetics);
• iodine-containing 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 (used to treat heart rhythm disorders and other heart conditions). Blood digoxin levels should be monitored when taking Juzimette with digoxin.

Juzimette and alcohol

Avoid consuming excessive amounts of alcohol while taking Juzimette, 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 is planning to have a child, she should consult her doctor or pharmacist before taking this medicine. This medicine should not be used during pregnancy. This medicine should not be taken while breastfeeding. See section 2, When not to take Juzimette.

Driving and operating machinery

This medicine has no 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 cause hypoglycaemia, which in turn may affect the ability to drive and operate machinery or to work without secure foot support.

Juzimette contains sodium

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

3. How to take Juzimette

This medicine should always be taken 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 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 the diet recommended by your doctor and pay attention to evenly distributing carbohydrate intake throughout the day.
It is unlikely that this medicine used alone will lead to abnormally low blood glucose levels (hypoglycaemia). Low blood glucose 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.
Taking more Juzimette 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 unwell, severe nausea or vomiting, stomach pain, unexplained weight loss, muscle cramps, or rapid breathing (see section "Warnings and precautions").
Missing a dose of Juzimette
If you miss a dose, take it as soon as possible. If it is almost time for the next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose of this medicine.
Stopping Juzimette
To maintain control of blood glucose levels, this medicine should be taken for as long as prescribed by your doctor. Do not stop taking this medicine without first consulting your doctor.
Discontinuing treatment with Juzimette may lead to increased blood glucose levels.
If you have any further doubts regarding 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 Juzimette and immediately contact your doctor 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.

Juzimette may very rarely (occurring in less than 1 in 10,000 patients) cause a very serious adverse reaction known as lactic acidosis (see section "Warnings and precautions"). If lactic acid游戏副本

5. How to store Juzimette

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the cardboard package 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 no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Juzimette contains
The active substances in Juzimette are sitagliptin and metformin. Each film-coated tablet contains
sitagliptin hydrochloride monohydrate, equivalent to 50 mg of sitagliptin and 1000 mg of metformin
hydrochloride (equivalent to 780 mg of metformin).
Other components:
Tablet core:
Microcrystalline cellulose, type 101
Povidone K29/32
Sodium stearyl fumarate
Sodium lauryl sulfate
Coating:
Polyvinyl alcohol, partially hydrolysed
Macrogol 4000
Talc
Titanium dioxide (E 171)
Iron oxide red (E 172)
Iron oxide black (E 172)

What Juzimette looks like and contents of the pack
Brown (white or almost white film-coated tablet with brown colouring), oblong (approximately 21.5 mm in length, 10.0 mm in width), biconvex. The tablet is marked with "AE4" on one side and has no marking on the other side.
The film-coated tablets are packed in white, opaque blisters made of PVC/PE/PVDC/Aluminium.
The blisters are placed in a cardboard box containing the patient leaflet.
The cardboard boxes contain 28, 30, 56, 60, 98 or 120 film-coated tablets; multipack containing 196 tablets (2 packs of 98 tablets).
Not all pack sizes may be marketed.

Marketing Authorisation Holder
GEDEON RICHTER POLSKA Sp. z o.o.
ul. Ks. J. Poniatowskiego 5,
05-825 Grodzisk Mazowiecki
Poland

Manufacturer
Gedeon Richter România S.A.
Str. Cuza-Vodă nr. 99-105
540306 Târgu-Mureș
Romania
Gedeon Richter Plc.
Gyömrői út 19-21
1103 Budapest
Hungary

This medicinal product is authorised in the European Economic Area countries under the following names:
Bulgaria Juzimette 50 mg/1000 mg, film-coated tablets
Czech Republic Juzimette
Estonia Juzimette
Hungary Juzimette 50 mg/1000 mg, filmtabletta
Latvia Juzimette 50 mg/1000 mg, apvalkotas tabletes
Poland Juzimette
Romania Juzimette 50 mg/1000 mg, comprimate filmate
Slovakia Juzimette 50 mg/1000 mg, filmom obalené tablety