Product Information for the User

Jamesi50mg/850mg Film-Coated Tablets

Jamesi 50mg/1.000mg Film-Coated Tablets

sitagliptina/metformina hidrocloruro

Please read this entire product information carefully before starting to take this medicine, as it contains important information for you.

• Keep this product information, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this product information. See section 4.

1. What is Jamesi and what it is used for

2. What you need to know before starting to take Jamesi

3. How to take Jamesi

4. Possible side effects

5. Storage of Jamesi

6. Contents of the pack and additional information

Jamesicontains two distinct medications, called sitagliptin and metformin.

• Sitagliptin belongs to a class of medications known as DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors).
• Metformin belongs to a class of medications known as biguanides.

They act together to control blood sugar levels in adult patients with a form of diabetes called “type 2 diabetes mellitus”. This medication helps to increase the levels of insulin produced after a meal and reduces the amount of sugar produced by the body.

Along with diet and exercise, this medication helps to lower blood sugar levels. This medication can be used alone or with certain diabetes medications (insulin, sulfonylureas, or thiazolidinediones).

What is type 2 diabetes?

Type 2 diabetes is a disease in which the body does not produce enough insulin and the insulin produced by the body does not work as well as it should. The body may also produce too much sugar. When this occurs, sugar (glucose) accumulates in the blood. This can lead to serious medical problems, such as heart diseases (cardiovascular), kidney diseases (renal), blindness, and amputations.

Do not take Jamesi

• if you are allergic to sitagliptin, metformin, or any of the other ingredients in this medicine (listed in section 6)
• if you have severe kidney function reduction
• if you have uncontrolled diabetes, for example, severe hyperglycemia (high blood sugar), nausea, vomiting, diarrhea, rapid 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, which can lead to diabetic precoma. Symptoms include stomach pain, rapid and deep breathing, drowsiness, or if your breath develops an unusual fruity odor

• if you have a severe infection or are dehydrated
• if you are going to have a radiography for which they will inject a contrast agent. You will need to stop taking Jamesi at the time of the radiography and for 2 or more days afterwards, as instructed by your doctor, depending on the functioning of your kidneys
• if you have recently had a heart attack or have severe circulatory problems, such as “shock” or difficulty breathing
• if you have liver problems (hepatic)
• if you drink excessive amounts of alcohol (either daily or occasionally)
• if you are breastfeeding

Do not take this medicine if any of the above circumstances apply to you and consult your doctor about other ways to control your diabetes. If you are unsure, consult your doctor, pharmacist, or nurse before starting to take Jamesi.

Warnings and precautions

Cases of pancreatitis have been reported in patients treated with sitagliptin/metformin (see section 4).

If you notice blisters on your skin, it may be a sign of a condition called bullous pemphigoid. Your doctor may ask you to stop taking this medicine.

Risk of lactic acidosis

This medicine may cause a very rare but serious side effect called lactic acidosis, especially if your kidneys are not functioning properly. The risk of developing lactic acidosis is also increased with uncontrolled diabetes, severe infections, prolonged fasting, or alcohol consumption, dehydration (see more information below), liver problems, and any medical condition in which a part of the body has a reduced oxygen supply (such as acute and severe heart disease).

If any of the above applies to you, consult your doctor for further instructions.

Stop taking Jamesi for a short period of time if you have a condition that may be associated with dehydration(significant loss of body fluids), such as intense vomiting, diarrhea, fever, exposure to heat, or if you drink less fluid than normal. Consult your doctor for further instructions.

Stop taking Jamesi and contact a doctor or the nearest hospital immediately if you experience any of the symptoms that produce lactic acidosis, as this condition can lead to coma.

The symptoms of lactic acidosis include:

• vomiting,
• stomach pain (abdominal pain),
• muscle cramps,
• general feeling of discomfort, with intense fatigue,
• difficulty breathing,
• reduced body temperature and heart rate.

Lactic acidosis is a medical emergency and should be treated in a hospital. Consult your doctor or pharmacist before starting to take this medicine:

• if you have or have had pancreatitis,
• if you have or have had gallstones, alcohol addiction, or have very high levels of triglycerides (a type of fat) in your blood. These medical conditions may increase your risk of developing pancreatitis (see section 4),
• if you have type 1 diabetes. This disease is also known as insulin-dependent diabetes,
• if you have or have had an allergic reaction to sitagliptin, metformin, or Jamesi (see section 4),
• if you are taking a sulfonylurea or insulin, other diabetes medications, as you may experience low blood sugar (hypoglycemia). Your doctor may need to adjust the dose of the sulfonylurea or insulin you are taking.

If you need to undergo major surgery, stop taking this medicine while the procedure is being performed and for a period of time afterwards. Your doctor will decide when to interrupt treatment with this medicine and when to restart it.

If you are unsure whether you are affected by any of the above circumstances, consult your doctor or pharmacist before starting to take this medicine.

During treatment with Jamesi, your doctor will check your kidney function at least once a year or more frequently if you are an older person and/or if your kidney function is deteriorating.

Children and adolescents

Children and adolescents under 18 years old should not use this medicine. It is not effective in children and adolescents aged 10 to 17 years. The safety and efficacy of this medicine in children under 10 years old are unknown.

Other medicines and Jamesi

If you need to be administered an injection of a contrast agent containing iodine, such as in the context of a radiography or examination, you should stop taking this medicine before the injection or at the time of the injection. Your doctor will decide when to interrupt treatment with this medicine and when to restart it.

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine. You may need more frequent blood glucose and kidney function tests, or your doctor may need to adjust the dose of Jamesi. It is especially important to mention the following:

• medicines (taken orally, inhaled, or injected) used to treat inflammatory diseases, such as asthma and 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),
• some medicines used to treat high blood pressure (ACE inhibitors and angiotensin II receptor antagonists),
• specific medicines for the treatment of asthma bronchial (β-adrenergic agonists),
• contrast agents containing iodine or medicines containing alcohol,
• some medicines used to treat stomach problems 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 (to treat irregular heartbeat and other heart problems). You may need to have your digoxin blood level checked if you are taking Jamesi.

Jamesi and alcohol

Avoid excessive alcohol consumption while taking Jamesi, as this may increase the risk of lactic acidosis (see section “Warnings and precautions”).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medicine. Do not take this medicine during pregnancy. Do not take this medicine if you are breastfeeding. See section 2 “Do not take Jamesi”.

Driving and operating machinery

The influence of this medicine on your ability to drive and operate machinery is negligible or insignificant. However, cases of dizziness and somnolence have been reported during treatment with sitagliptin, which may affect your ability to drive and operate machinery.

Taking this medicine with sulfonylureas or insulin may cause hypoglycemia, which may affect your ability to drive and operate machinery or work without a secure support.

Jamesi contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet; it is essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

• Take a tablet:
• • twice a day by mouth,
  • with food to reduce the likelihood of feeling stomach discomfort.

• Your doctor may need to increase the dose to control blood sugar levels.

• If you have reduced renal function, your doctor may prescribe a lower dose.

You must continue with the diet recommended by your doctor during treatment with this medication and be careful to distribute carbohydrate intake evenly throughout the day.

It is unlikely that treatment with this medication alone will cause an abnormal drop in blood sugar (hypoglycemia). A drop in blood sugar may occur when this medication is taken with a medication containing sulfonylurea or with insulin, so it is likely that your doctor will consider reducing the dose of your sulfonylurea or insulin.

If you take more Jamesithan you should

If you take more than the prescribed dose of this medication, contact your doctor immediately. Go to the hospital if you experience symptoms of lactic acidosis such as feeling cold or unwell, intense nausea or vomiting, stomach pain, unexplained weight loss, muscle cramps, or agitated breathing (see section “Warnings and precautions”).

If you forget to take Jamesi

If you forget to take a dose, take it as soon as you remember. If you do not remember until the time of your next dose, skip the missed dose and continue with your regular treatment. Do not take a double dose of this medication.

If you interrupt treatment withJamesi

Continue taking this medication for as long as your doctor tells you to, to help control your blood sugar level. Do not stop taking this medication without first consulting your doctor. If you interrupt treatment withJamesi, your blood sugar may rise again.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

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

STOP takingJamesiand seek medical attention immediately if you notice any of the following severe side effects:

• Intense and persistent abdominal pain (stomach area) that can reach the back with or without nausea and vomiting, as these may be signs of pancreatitis (inflammation of the pancreas).

This medicinemay cause a rare but serious side effect (affects up to 1 in 10,000 people), called lactic acidosis (see section “Warnings and precautions”). If this occurs, you muststop takingJamesiand contact a doctor or the nearest hospital immediately, as lactic acidosis can lead to coma.

If you have a severe allergic reaction (frequency unknown), including skin rash, urticaria, blisters on the skin/skin peeling and swelling of the face, lips, tongue, and throat that may cause difficulty breathing or swallowing, stop taking this medicine and consult your doctor immediately. Your doctor will prescribe a medication to treat the allergic reaction and change the medication for diabetes treatment.

Some patients taking metformin have experienced the following side effects after starting treatment with sitagliptin:

Frequent (may affect up to 1 in 10 people): low blood sugar, nausea, gas, vomiting

Infrequent (may affect up to 1 in 100 people): stomach pain, diarrhea, constipation, drowsiness

Some patients have experienced diarrhea, nausea, gas, constipation, stomach pain, or vomiting when starting treatment with the combination of sitagliptin and metformin (frequency classified as frequent).

Some patients have experienced the following side effects when taking this medicine with a sulfonylurea such as glimepiride:

Very frequent (may affect more than 1 in 10 people): low blood sugar

Frequent: constipation

Some patients have experienced the following side effects when taking this medicine with pioglitazone:

Frequent: swelling of hands or feet

Some patients presented the following side effects while taking this medicine in combination with insulin:

Very frequent: low blood sugar

Infrequent: dry mouth, headache

Some patients have experienced the following side effects during clinical studies while taking sitagliptin alone (one of the medicines contained inJamesi) or during use after approval ofJamesior sitagliptin alone or with other diabetes medications:

Frequent: low blood sugar, headache, upper respiratory tract infection, congestion or nasal mucosity, and throat pain, arthritis, arm or leg pain

Infrequent: dizziness, constipation, itching

Rare: reduced platelet count

Unknown frequency: kidney problems (sometimes requiring dialysis), vomiting, joint pain, back pain, interstitial lung disease, bullous pemphigoid (a type of skin blister)

Some patients have experienced the following side effects after taking metformin alone:

Very frequent: nausea, vomiting, diarrhea, stomach pain, and loss of appetite. These symptoms may appear when you start taking metformin and usually disappear.

Frequent: metallic taste, low or decreased vitamin B12 levels in the blood (symptoms may include extreme fatigue, red and painful tongue (glossitis), tingling (paresthesia), or pale or yellowish skin). Your doctor may schedule some tests to find the cause of your symptoms because some of them can also be caused by diabetes or other unrelated health problems.

Rare: hepatitis (liver problem), urticaria, skin redness (rash) or itching.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the blister pack and on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the Sigre Point of the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofJamesi

• The active principles are sitagliptin and metformin.
• Each film-coated tablet of Jamesi 50 mg/850 mg contains sitagliptin hydrochloride monohydrate equivalent to 50 mg of sitagliptin and 850 mg of metformin hydrochloride.
• The active principles are sitagliptin and metformin. Each film-coated tablet of Jamesi 50 mg/1,000 mg contains sitagliptin hydrochloride monohydrate equivalent to 50 mg of sitagliptin and 1,000 mg of metformin hydrochloride.
• The other components are:

Core tablet: microcrystalline cellulose (Avicel PH 102), povidone, sodium lauryl sulfate, and magnesium stearate;

Jamesi film coating 50 mg/850 mg (Opadry QX pink (321A640002)):polyvinyl alcohol (PVA) partial esterification copolymer (E1209); talc (E553b); titanium dioxide (E171); mono- and diglycerides of fatty acids (E471); polyvinyl alcohol (E1203); red iron oxide (E172);

Jamesi film coating 50 mg/1,000 mg (Opadry QX brown (321A265038)):polyvinyl alcohol (PVA) partial esterification copolymer (E1209); talc (E553b); titanium dioxide (E171), red iron oxide (E172); mono- and diglycerides of fatty acids (E471), polyvinyl alcohol (E1203); black iron oxide (E172).

Appearance of the product and contents of the package

The film-coated tablets of Jamesi 50 mg/850 mg are oval, biconvex, approximately 20.5 mm x 9.5 mm in size, pink in color, and have the inscription “S476” on one side and no inscription on the other.

The film-coated tablets of Jamesi 50 mg/1,000 mg are oval, biconvex, approximately 21.5 mm x 10.0 mm in size, brown in color, and have the inscription “S477” on one side and no inscription on the other.

The product may be packaged in a cardboard box.

PVC/PVdC and aluminum blisters

Packages of 14, 28, 56, 60, and 196 film-coated tablets.

HDPE bottle with a PP cap containing silica gel desiccant.

Package size: 196 film-coated tablets.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Zentiva, k.s.

U kabelovny 130,

DolníMecholupy,

102 37 Praga 10

Republic of Czech

Responsible manufacturer

Laboratorios Liconsa S.A.

Avenida Miralcampo 7, Poligono Industrial Miralcampo,

19200 Azuqueca De Henares, Guadalajara,

Spain

For more information about this medication, please contact the local representative of the marketing authorization holder:

Zentiva Spain S.L.U.

Avenida de Europa, 19, Edificio 3, Planta 1.

28224 Pozuelo de Alarcón, Madrid

Spain

This medicinal product is authorized in the Member States of the European Economic Area with the following names::

Austria, Croatia, Spain, Estonia, Greece, Hungary, Latvia, Lithuania, Poland, Czech Republic, Slovak Republic, Romania: Jamesi

Bulgaria: ???????/Jamesi

Last review date of this leaflet:June 2024

For detailed and updated information about this medicinal product, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/