JAMESI 50 MG/850 MG FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Jamesi50mg/850mg film-coated tablets EFG

Jamesi 50mg/1.000mg film-coated tabletsEFG

sitagliptin/metformin hydrochloride

Read all of this leaflet carefully before you start 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Jamesi and what is it used for
2. What you need to know before you take Jamesi
3. How to take Jamesi
4. Possible side effects
5. Storage of Jamesi
6. Contents of the pack and other information

1. What is Jamesi and what is it used for

Jamesi contains two different medicines called sitagliptin and metformin.

• Sitagliptin belongs to a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors).
• Metformin belongs to a class of medicines called biguanides.

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

Along with diet and exercise, this medicine helps lower your blood sugar level. This medicine can be used alone or with certain medicines for diabetes (insulin, sulfonylureas, or glitazones).

What is type 2 diabetes?

Type 2 diabetes is a disease in which your body does not produce enough insulin and the insulin your body produces does not work as well as it should. Your body may also produce too much sugar. When this happens, sugar (glucose) builds up in the blood. This can lead to serious medical problems, such as heart (cardiac) diseases, kidney (renal) diseases, blindness, and amputations.

2. What you need to know before you take Jamesi

Do not take Jamesi

• if you are allergic to sitagliptin, metformin, or any of the other ingredients of this medicine (listed in section 6)
• if you have severe kidney problems
• if you have uncontrolled diabetes with, 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” build up in the blood, which can lead to a pre-diabetic coma. Symptoms include stomach pain, rapid and deep breathing, drowsiness, or unusual fruity odor on the breath

• if you have a severe infection or are dehydrated
• if you are going to have a radiograph for which you will be injected with a contrast medium. You will need to stop taking Jamesi at the time of the radiograph and for 2 or more days after, as indicated by your doctor, depending on your kidney function
• if you have recently had a heart attack or have severe circulatory problems, such as “shock” or breathing difficulties
• if you have liver problems (hepatic)
• if you drink excessive amounts of alcohol (either every day or only occasionally)
• if you are breastfeeding.

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

Warnings and precautions

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

If you notice blisters on the skin, it may be a sign of a disease 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 very serious side effect called lactic acidosis, especially if your kidneys are not working properly. The risk of developing lactic acidosis is also increased with uncontrolled diabetes, severe infections, prolonged fasting, or alcohol intake, 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 diseases).

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

Stop taking Jamesi for a short period if you have a condition that may be associated with dehydration(significant loss of body fluids), such as severe vomiting, diarrhea, fever, heat exposure, or if you drink less fluid than usual. 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 of lactic acidosis, as this condition can lead to a coma.

The symptoms of lactic acidosis include:

• vomiting,
• stomach pain (abdominal pain),
• muscle cramps,
• general feeling of discomfort, with intense fatigue,
• breathing difficulties,
• 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 taking this medicine:

• if you have or have had a pancreatic disease (such as pancreatitis),
• if you have or have had gallstones, alcohol addiction, or have very high blood triglyceride levels (a type of fat). These medical conditions may increase your likelihood of developing pancreatitis (see section 4),
• if you have type 1 diabetes. This disease is also called insulin-dependent diabetes,
• if you have had an allergic reaction to sitagliptin, metformin, or Jamesi (see section 4),
• if you are taking a sulfonylurea or insulin, other diabetes medicines, as you may experience low blood sugar levels (hypoglycemia). Your doctor may consider it necessary to reduce the dose of the sulfonylurea or insulin you are taking.

If you need to undergo major surgery, you should stop taking this medicine during the procedure and for a period after. Your doctor will decide when you should stop taking this medicine and when you can restart it.

If you are not sure if any of the above circumstances apply to you, consult your doctor or pharmacist before taking 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 elderly person and/or if your kidney function is worsening.

Children and adolescents

Children and adolescents under 18 years of age should not use this medicine. It is not effective in children and adolescents aged between 10 and 17 years. It is not known if this medicine is safe and effective when used in children under 10 years of age.

Other medicines and Jamesi

If you need to be given an injection of a contrast medium that contains iodine into your bloodstream, for example, in the context of a radiograph or examination, you should stop taking this medicine before the injection or at the time of the injection. Your doctor will decide when you should stop taking this medicine and when you can restart it.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. 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 diseases that cause inflammation, 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),
• certain medicines used to treat high blood pressure (ACE inhibitors and angiotensin II receptor antagonists),
• medicines used to treat bronchial asthma (beta-2 sympathomimetics),
• iodinated contrast agents or medicines that contain alcohol,
• certain 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 (for treating irregular heartbeat and other heart problems). Your doctor may need to check your digoxin blood levels if you are taking Jamesi.

Taking Jamesi with alcohol

Avoid excessive alcohol intake 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, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. You should not take this medicine during pregnancy. You should not take this medicine if you are breastfeeding. See section 2 “Do not take Jamesi”.

Driving and using machines

The effect of this medicine on your ability to drive or use machines is negligible or non-existent. However, cases of dizziness and drowsiness have been reported during treatment with sitagliptin, which may affect your ability to drive or use machines.

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

Jamesi contains sodium

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

3. How to take Jamesi

Follow exactly the administration instructions of this medicine given by your doctor. If you are not sure, consult your doctor or pharmacist again.

• Take one tablet:
• • twice a day orally,
  • with food to reduce the likelihood of stomach upset.

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

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

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

It is unlikely that treatment with this medicine alone will cause abnormally low blood sugar levels (hypoglycemia). Hypoglycemia may occur when this medicine is taken with a medicine that contains a sulfonylurea or with insulin, so your doctor may consider it necessary to reduce the dose of your sulfonylurea or insulin.

If you take more Jamesi than you should

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

If you forget to take Jamesi

If you miss 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 medicine.

If you stop taking Jamesi

Continue to take this medicine for as long as your doctor tells you to, to help control your blood sugar levels. Do not stop taking this medicine without first talking to your doctor. If you stop taking Jamesi, your blood sugar levels may increase again.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

STOP taking Jamesi and contact a doctor immediately if you notice any of the following serious side effects:

• Severe and persistent stomach pain (abdominal pain) that may radiate to the back with or without nausea and vomiting, as these may be signs of pancreatitis.

This medicine may cause a very rare but very serious side effect called lactic acidosis (see section “Warnings and precautions”). If this happens to you, you must stop taking Jamesi and contact a doctor or the nearest hospital immediately, as lactic acidosis can lead to a coma.

If you have a severe allergic reaction (frequency not known), including skin rash, hives, blisters on the skin/peeling of the skin, 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 medicine to treat the allergic reaction and change your diabetes medicine.

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

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

Uncommon (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 common).

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

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

Common: constipation

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

Common: swelling of hands or feet

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

Very common: low blood sugar levels

Uncommon: dry mouth, headache

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

Common: low blood sugar levels, headache, upper respiratory tract infection, nasal congestion or runny nose, and sore throat, arthrosis, pain in the arm or leg

Uncommon: dizziness, constipation, itching

Rare: reduced platelet count

Frequency not known: kidney problems (which may require dialysis), vomiting, joint pain, muscle 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 common: nausea, vomiting, diarrhea, stomach pain, and loss of appetite. These symptoms may appear when you start taking metformin and usually disappear.

Common: metallic taste, low or reduced vitamin B12 levels in the blood (symptoms may include extreme fatigue, red and sore tongue, numbness or tingling). Your doctor may schedule some tests to find the cause of your symptoms because some of them may also be caused by diabetes or other health problems not related to this medicine.

Very rare: hepatitis (a liver problem), hives, skin redness (rash), or itching.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Jamesi

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

Do not use this medicine after the expiry date which is stated on the blister and on the carton after CAD. The expiry date is the last day of the month indicated.

Do not store above 30 °C.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the Sigre Collection Point at your pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package Contents and Additional Information

Composition ofJamesi

• The active substances 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 substances 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 ingredients are:

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

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

Jamesi 50 mg/1,000 mg film coating (Opadry QX brown (321A265038)): macrogol (PEG) graft copolymer of polyvinyl alcohol (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 Productand Package Contents

The Jamesi 50 mg/850 mg film-coated tablets 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 Jamesi 50 mg/1,000 mg film-coated tablets 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

Packaging containing 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 certain package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Zentiva, k.s.

U kabelovny 130,

Dolní Mecholupy,

102 37 Prague 10

Czech Republic

Manufacturer

Laboratorios Liconsa S.A.

Avenida Miralcampo 7, Poligono Industrial Miralcampo,

19200 Azuqueca De Henares, Guadalajara,

Spain

For further information about this medicine, 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 medicine is authorized in the Member States of the European Economic Area under the following names:

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

Bulgaria: ???????/Jamesi

Date of the last revision of this leaflet:June 2024

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/