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

Package leaflet: Information for the user

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 the entire leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this leaflet, 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 should not give it to others, even if they have the same symptoms as you, since it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Package leaflet contents

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

1. What Jivolar is and what it is used for

Jivolar contains two different medicines called sitagliptin and metformin.

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

Together, they work to control blood sugar levels in adult patients with a form of diabetes called "type 2 diabetes mellitus". This medicine helps increase insulin levels 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 in combination with certain other diabetes medicines (insulin, sulfonylureas, or glitazones).

What is type 2 diabetes?

Type 2 diabetes is a condition in which your body does not produce enough insulin, and the insulin your body does produce 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 starting to 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 severely reduced kidney function.
• if you have uncontrolled diabetes, for example, with 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 may lead to diabetic pre-coma. Symptoms include stomach pain, rapid and deep breathing, drowsiness, or fruity-smelling breath.
• if you have a serious infection or are dehydrated.
• if you are going to have an X-ray scan requiring injection of a contrast agent. You will need to stop taking this medicine at the time of the scan and for 2 or more days afterwards, as directed by your doctor, depending on how well your kidneys are functioning.
• if you have recently had a heart attack or have severe circulatory problems, such as “shock” or difficulty breathing.
• if you have liver problems.
• if you drink alcohol excessively (either daily or occasionally).
• if you are breastfeeding.

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

Warnings and precautions

Cases of inflammation of the pancreas (pancreatitis) have been reported in patients treated with this medicine (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

Sitagliptin/metformin may cause a very rare but serious adverse effect called lactic acidosis, especially if your kidneys are not functioning properly. The risk of developing lactic acidosis is also increased in cases of uncontrolled diabetes, severe infections, prolonged fasting or alcohol consumption, dehydration (see further 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.

Contact your doctor immediately for further advice if:

• You are known to have a genetic hereditary disease affecting mitochondria (the components responsible for producing energy within cells), such as MELAS syndrome (mitochondrial encephalopathy, myopathy, lactic acidosis, and stroke-like episodes) or maternally inherited diabetes and deafness (MIDD).
• You experience any of the following symptoms after starting treatment with metformin: seizures, cognitive decline, difficulty with body movements, symptoms indicating nerve damage (e.g., pain or numbness), migraine, and deafness.

Stop taking this medicine temporarily if you have a condition that could be associated with dehydration (significant loss of body fluids), such as severe vomiting, diarrhea, fever, heat exposure, or if you are drinking less fluid than usual. Consult your doctor for further instructions.

Stop taking this medicine and contact a doctor or go to the nearest hospital immediately if you experience any of the symptoms of lactic acidosis, as this condition may lead to coma.

Symptoms of lactic acidosis include:

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

Lactic acidosis is a medical emergency and must be treated in a hospital.

Consult your doctor or pharmacist before starting this medicine:

• if you have or have had a pancreatic disease (such as pancreatitis).
• if you have or have had gallstones, alcohol addiction, or very high blood levels of triglycerides (a type of fat). These medical conditions may increase your likelihood of developing pancreatitis (see section 4).
• if you have type 1 diabetes. This condition may also be called insulin-dependent diabetes.
• if you have had or have an allergic reaction to sitagliptin, metformin, or sitagliptin/metformin (see section 4).
• if you are taking a sulfonylurea or insulin, or other antidiabetic medications along with sitagliptin/metformin, 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 must stop taking this medicine during the procedure and for a period afterward. Your doctor will decide when to interrupt and when to restart treatment with sitagliptin/metformin.

If you are unsure whether any of the above situations apply to you, consult your doctor or pharmacist before starting this medicine.

During treatment with this medicine, your doctor will monitor your kidney function at least once a year, or more frequently if you are elderly and/or if your kidney function is deteriorating.

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 unknown whether this medicine is safe and effective when used in children under 10 years of age.

Other medicines and Jivolar

If you need to receive an intravenous injection of an iodine-containing contrast agent, for example during an X-ray or scan, you must stop taking this medicine before or at the time of the injection. Your doctor will decide when to interrupt and when to restart treatment with this medicine.

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. You may require 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:

• medications (taken orally, by inhalation, or by injection) used to treat inflammatory conditions such as asthma and arthritis (corticosteroids)
• medications that increase urine production (diuretics)
• medications used to treat pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib)
• certain medications used to treat hypertension (ACE inhibitors and angiotensin II receptor antagonists)
• specific medications for the treatment of bronchial asthma (β-sympathomimetics)
• iodinated contrast agents or medications containing alcohol
• certain medications used to treat stomach problems such as cimetidine
• ranolazine, a medication used to treat angina pectoris
• dolutegravir, a medication used to treat HIV infection
• vandetanib, a medication used to treat a specific type of thyroid cancer (medullary thyroid cancer)
• digoxin (to treat irregular heartbeat and other heart problems). Blood levels of digoxin may need to be monitored if you are taking this medicine.

Taking Jivolar with alcohol

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

You must not take this medicine during pregnancy. Do not take this medicine if you are breastfeeding. See section 2, “Do not take Jivolar”.

Driving and using machines

The effect of this medicine on the ability to drive and use machines is negligible or none. However, cases of dizziness and drowsiness have been reported during treatment with sitagliptin, which may affect your ability to drive and use machines.

Taking this medicine together with medications called sulfonylureas or with insulin may cause hypoglycemia, which may impair your ability to drive and use machines or work without secure support.

Jivolar contains sodium

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

3. How to take Jivolar

Follow exactly the instructions for use of this medicine provided by your doctor. If in doubt, consult your doctor or pharmacist again.

• Take one tablet:

• twice daily by mouth

• with food to reduce the likelihood of stomach discomfort

Your doctor may need to increase the dose to control blood sugar levels.
If you have reduced kidney function, your doctor may prescribe you a lower dose.

You must continue the diet recommended by your doctor during treatment with this medicine and take care to distribute carbohydrate intake evenly throughout the day.

It is unlikely that treatment with this medicine alone will cause abnormally low blood sugar (hypoglycaemia). However, low blood sugar may occur when this medicine is taken together with a medicine containing a sulphonylurea or with insulin; therefore, your doctor may consider it necessary to reduce the dose of your sulphonylurea 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 experience 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, contact your doctor, pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount taken. You may require medical attention. If you need to visit a doctor or go to the nearest hospital, take the container 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 it is time for your next dose, skip the missed dose and continue with your regular dosing 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 tells you, to help control your blood sugar levels. You must not stop taking this medicine without first consulting your doctor. If you stop treatment with Jivolar, your blood sugar levels may rise again.

If you have any further questions about 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 everyone will experience them.

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

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

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 occurs, you must stop taking this medicine and contact a doctor or go to the nearest hospital immediately, as lactic acidosis can lead to coma.

If you experience a severe allergic reaction (frequency not known), including skin rash, hives, blistering or peeling of the skin, and swelling of the face, lips, tongue, or throat that may cause difficulty breathing or swallowing, stop taking this medicine and contact your doctor immediately. Your doctor will prescribe treatment for the allergic reaction and switch you to another medicine for the treatment of diabetes.

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

Common (may affect up to 1 in 10 people): low blood sugar levels, nausea, flatulence, vomiting, stomach pain, diarrhoea, constipation, somnolence.

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

Some patients have experienced the following adverse effects while taking this medicine in combination with a sulfonylurea such as glimepiride:

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

Common: constipation.

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

Common: swelling of hands or legs.

Some patients 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 experienced the following adverse effects during clinical studies while taking sitagliptin alone (one of the medicines contained in Jivolar) or during post-approval use of sitagliptin/metformin or sitagliptin alone or in combination with other diabetes medicines:

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

Uncommon: dizziness, constipation, itching.

Rare: reduction in the number of platelets.

Frequency not known: kidney problems (sometimes requiring dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of blistering skin condition).

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

Very common: nausea, vomiting, diarrhoea, stomach pain, and loss of appetite. These symptoms may occur when you first start taking metformin and usually go away.

Common: metallic taste, decreased or low levels of vitamin B12 in the blood (symptoms may include extreme tiredness (fatigue), pain and redness of the tongue (glossitis), tingling (paraesthesia), or pale or yellowish skin). Your doctor may order tests to determine the cause of your symptoms, as some of them may also be caused by diabetes or other unrelated health problems.

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

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Jivolar

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Store below 30 ºC.

Keep blister packs in the outer packaging to protect them from light.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be handed over to the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Jivolar

• The active substances 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: poly(vinyl alcohol) partially hydrolyzed E1203, titanium dioxide E171, macrogol E1521, talc E553b, red iron oxide E172, black iron oxide E172.

Appearance of the Product and Contents of the Pack

Jivolar 50 mg/850 mg film-coated tablets

Film-coated tablets, pink in colour, oval-shaped, 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-shaped, brick-red in colour, 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.

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

Only some pack 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

Further information on this medicinal product is available upon request by contacting the local representative of the Marketing Authorization Holder:

Local representative:

Átika Pharma,

Calle Viera y Clavijo, 30, 2º,

35002 Las Palmas de Gran Canaria, Las Palmas,

Spain

Date of most recent review of this leaflet: October 2024

Other sources of information

January 2023.

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