JIVOLAR 50 MG/1.000 MG FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Jivolar 50 mg/850 mg film-coated tablets

Jivolar 50 mg/1,000 mg film-coated tablets

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 experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Jivolar and what is it used for

Jivolar 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 blood sugar levels 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 diabetes medicines (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 disease, kidney disease, blindness, and amputations.

2. What you need to know before you take Jivolar

Do not take Jivolar

• 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 if your breath develops an unusual fruity odor.
• if you have a severe infection or are dehydrated.
• if you are going to have an X-ray where you will be injected with a contrast agent. You will need to stop taking this medicine at the time of the X-ray and for 2 or more days after, as directed 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.
• if you drink excessive amounts of alcohol (either every day or only occasionally).
• if you are breast-feeding.

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

Warnings and precautions

There have been reports of pancreatitis (inflammation of the pancreas) in patients treated with this medicine (see section 4).

If you notice blisters on your 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

Sitagliptin/metformin can 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 your body has a reduced supply of oxygen (such as acute and severe heart disease).

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

Consult your doctor immediately for further instructions if:

• You know you have a genetic disease that affects the mitochondria (the energy-producing components within cells), such as MELAS syndrome (mitochondrial encephalomyopathy, lactic acidosis, and stroke-like episodes) or maternally inherited diabetes and deafness (MIDD).
• You experience any of these symptoms after starting treatment with metformin: seizures, cognitive impairment, difficulty moving, symptoms indicating nerve damage (e.g., pain or numbness), migraine, and hearing loss.

Stop taking this medicine 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, exposure to heat, or if you drink less fluid than usual. Consult your doctor for further instructions.

Stop taking this medicine and contact a doctor or the nearest hospital immediately if you experience any 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
• difficulty breathing
• decreased 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 pancreatitis (inflammation of the pancreas).
• if you have or have had gallstones, alcohol addiction, or very high blood triglyceride levels (a type of fat). 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 had an allergic reaction to sitagliptin, metformin, or sitagliptin/metformin (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 reducing 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 some time after. Your doctor will decide when you should stop taking sitagliptin/metformin and when you can restart it.

If you are not sure if any of the above applies to you, consult your doctor or pharmacist before taking this medicine.

During treatment with this medicine, 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 should not use this medicine. It is not effective in children and adolescents aged 10 to 17 years. It is not known if this medicine is safe and effective when used in children under 10 years.

Other medicines and Jivolar

If you need to be given an injection of a contrast agent containing iodine into your bloodstream, for example, in the context of an X-ray or scan, you should stop taking this medicine before 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 this medicine. 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 for treating high blood pressure (ACE inhibitors and angiotensin II receptor antagonists)

specific medicines for the treatment of bronchial asthma (beta-sympathomimetics)

• iodinated contrast agents or medicines containing 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 the level of digoxin in your blood if you are taking this medicine.

Taking Jivolar with alcohol

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

Pregnancy, breast-feeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not take this medicine during pregnancy. Do not take this medicine if you are breast-feeding. See section 2, “Do not take Jivolar”.

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.

Jivolar contains sodium

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

3. How to take Jivolar

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

• Take one tablet:

• twice a day by mouth
• with food to reduce the chance 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 sulfonylurea or insulin, so your doctor may consider reducing the dose of your sulfonylurea or insulin.

If you take more Jivolar than you should

If you take more than 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, severe nausea or vomiting, stomach pain, unexplained weight loss, muscle cramps, or rapid breathing (see section “Warnings and precautions”).

If you have taken too many tablets of this medicine, or if someone else has taken your tablets, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount used. You may need medical attention. If you have to visit a doctor or go to the hospital, take the package and this leaflet with you.

If you forget to take Jivolar

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

If you stop taking Jivolar

Keep taking this medicine for as long as your doctor recommends, to help keep your blood sugar levels under control. Do not stop taking this medicine without first talking to your doctor. If you stop taking Jivolar, 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 Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

STOP taking Jivolar and consult your doctor immediately if you notice any of the following serious adverse effects:

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

Sitagliptin/metformin may cause a very rare (may affect up to 1 in 10,000 people) but very serious adverse effect called lactic acidosis (see section "Warnings and Precautions"). If this happens to you, you must stop taking this medicine and contact a doctor or the nearest hospital immediately, as lactic acidosis can lead to coma.

If you have a severe allergic reaction (frequency not known), including skin rash, hives, blisters on the skin/desquamation of the skin, and swelling of the face, lips, tongue, and throat that can 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 the medicine for the treatment of diabetes.

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

Frequent(may affect up to 1 in 10 people): low blood sugar, 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 frequent).

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

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

Frequent: constipation,

Some patients have experienced the following adverse effects while taking this medicine in combination with pioglitazone:

Frequent: swelling of hands or feet.

Some patients have experienced the following adverse effects while taking this medicine in combination with insulin:

Very common: low blood sugar levels.

Uncommon: dry mouth, headache.

Some patients have experienced the following adverse effects during clinical trials while taking sitagliptin alone (one of the medicines that contains Jivolar) or during use after approval of sitagliptin/metformin or sitagliptin alone or with other diabetes medicines:

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

Uncommon: dizziness, constipation, itching.

Rare: reduction in 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 adverse 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.

Frequent: metallic taste, decreased or low vitamin B12 levels in blood (symptoms may include extreme fatigue, pain, and redness of the tongue, numbness or pale or yellowish skin). Your doctor may request tests to determine the cause of your symptoms because some of them can also be caused by diabetes or other unrelated health problems.

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

Reporting of Adverse Effects

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

5. Conservation of Jivolar

Keep this medicine out of sight and reach of children.

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

Store below 30 °C.

Keep the blisters in the outer packaging to protect them from light.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Jivolar

• The active ingredients are sitagliptin and metformin.

Jimantex 50 mg/850 mg film-coated tablets: Each film-coated tablet contains sitagliptin phosphate monohydrate equivalent to 50 mg of sitagliptin and 850 mg of metformin hydrochloride.

Jimantex 50 mg/1,000 mg film-coated tablets: Each film-coated tablet contains sitagliptin phosphate monohydrate equivalent to 50 mg of sitagliptin and 1,000 mg of metformin hydrochloride.

• The other components are: Tablet core: microcrystalline cellulose E460, povidone E1201, sodium lauryl sulfate E487, sodium stearyl fumarate; Film coating: Part of poly(vinyl alcohol) hydrolyzed E1203, Titanium dioxide E171, Macrogol E1521, Talc E553b, Red iron oxide E172, Black iron oxide E172.

Appearance of the Product and Package Contents

Jivolar 50 mg/850 mg film-coated tablets

Film-coated tablets, pink, oval, biconvex, smooth on one side and engraved with "MC" on the other side, with core dimensions of 9.8 mm x 20.1 mm.

Jivolar 50 mg/1,000 mg film-coated tablets

Film-coated tablets, biconvex, oval, brick-red, smooth on one side and engraved with the Medochemie logo on the other side, with core dimensions of 10.2 mm x 21.2 mm.

Opaque PVC/PE/PVDC-aluminum blisters.

Packaging of 14, 28, 30, 56, 60, 112, 168, 180, 196 film-coated tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

Medochemie Ltd.

1-10 Constantinoupoleos Street

3011 Limassol

Cyprus

Manufacturer

Medochemie Ltd,

Factory AZ, 2 Michael Erakleous Street,

Industrial Area Agios Athanassios,

4101 Limassol,

Cyprus

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Local Representative:

Medochemie Iberia S.A., Branch in Spain

Avenida de las Águilas, nº 2 B; 5th floor, office 6,

28044 Madrid

SPAIN

Date of the Last Revision of this Prospectus: 09/2025

Other Sources of Information

January 2023.

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