Disimet 50 mg/1000 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Package leaflet: information for the patient

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

sitagliptin/metformin hydrochloride

Read the entire leaflet carefully before you start taking 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, pharmacist, or nurse, even if the adverse effects are not listed in this leaflet. See section 4.

Package leaflet contents

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

1. What Disimet is and what it is used for

Disimet 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 the levels of insulin produced after a meal and reduces the amount of sugar your body produces.

Along with diet and exercise, this medicine helps lower your blood sugar levels. It can be used alone or in combination with certain 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 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 (cardiovascular) diseases, kidney (renal) diseases, blindness, and amputations.

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

Do not take Disimet

• if you are allergic to sitagliptin, metformin, or any of the other components of this medicine (listed in section 6)
• if you have severely reduced kidney function
• if you have uncontrolled diabetes with, for example, severe hyperglycemia (high blood glucose), 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 may lead to diabetic pre-coma. Symptoms include stomach pain, deep and rapid breathing, drowsiness, or a fruity odor on your breath
• if you have a serious infection or are dehydrated
• if you are undergoing an X-ray procedure requiring injection of a contrast agent. You will need to stop taking this medicine at the time of the procedure 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 serious circulatory problems, such as “shock” or difficulty breathing
• if you have liver problems (hepatic)
• 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

Consult your doctor, pharmacist, or nurse before starting to take Disimet.

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

If you notice blisters on the skin, this may be a sign of a condition called bullous pemphigoid. Your doctor may ask you to stop taking sitagliptin/metformin.

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 uncontrolled diabetes, severe infections, prolonged fasting or alcohol intake, dehydration (see further information below), liver problems, and any medical condition in which 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 this medicine temporarily if you develop a condition that could lead to 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 advice.

Stop taking this medicine and contact a doctor or go to the nearest hospital immediately if you experience any 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 being unwell, 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 risk of developing pancreatitis (see section 4)
• if you have type 1 diabetes. This condition may also be called insulin-dependent diabetes
• if you have or have had 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 your sulfonylurea or insulin
• if you need to undergo major surgery, you must stop taking sitagliptin/metformin during and for some time after the procedure. 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 sitagliptin/metformin, 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.

Contact your doctor promptly for guidance if:

• You are known to have a genetic mitochondrial disorder (components responsible for energy production 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, signs of nerve damage (e.g., pain or numbness), migraine, or hearing loss.

Children and adolescents

Children and adolescents under 18 years of age must not use this medicine. It is not known whether this medicine is safe and effective when used in children and adolescents under 18 years of age.

Other medicines and Disimet

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 treatment with sitagliptin/metformin and when to restart it.

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

• medicines (taken orally, by inhalation, or by injection) used to treat inflammatory conditions 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)
• specific medicines for the treatment of bronchial asthma (β-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 (to treat irregular heartbeat and other heart problems). Blood levels of digoxin may need to be monitored if you are taking sitagliptin/metformin.

Taking Disimet with alcohol

Avoid excessive alcohol consumption while taking this medication, 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 become pregnant, consult your doctor or pharmacist before using this medicine. You should not take this medicine during pregnancy or while breastfeeding. See section 2, Do not take Disimet.

Driving and operating machines

The influence of this medication on the ability to drive and operate machinery is none or negligible. 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 together with medicines called sulfonylureas or with insulin may cause hypoglycaemia, which could impair your ability to drive and operate machinery or to work without a secure support point.

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

3. How to take Disimet

Follow exactly the instructions for using this medicine as given by your doctor. If you are unsure, consult your doctor or pharmacist again.

• Take one tablet:

  • twice daily, orally
  • with food to reduce the likelihood of stomach discomfort

• Your doctor may need to increase the dose to control your 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 ensure that carbohydrate intake is evenly distributed throughout the day.

It is unlikely that treatment with this medicine alone will cause abnormally low blood sugar (hypoglycemia). However, low blood sugar may occur when this medicine is taken together with a medication containing a sulfonylurea or with insulin; therefore, your doctor may consider it necessary to reduce the dose of your sulfonylurea or insulin.

If you take more Disimet 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”).

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone 91 562 04 20.

If you forget to take Disimet

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 treatment schedule. Do not take a double dose of this medicine.

If you stop treatment with Disimet

Keep taking this medicine for as long as your doctor prescribes it, so that it can help you control your blood sugar levels. Do not stop taking this medicine without first consulting your doctor. If you interrupt treatment with sitagliptin/metformin, 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 this medicine and contact your doctor immediately if you notice any of the following serious adverse effects:

• Severe and persistent abdominal pain (in the 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).

This medicine 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 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, skin blisters/skin peeling, and swelling of the face, lips, tongue, and throat that may cause difficulty breathing or swallowing, stop taking this medicine and contact your doctor immediately. Your doctor will prescribe a medicine to treat the allergic reaction and will switch you to a different medicine for the treatment of diabetes.

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

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

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

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

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

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

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

Frequent: swelling of hands or legs

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

Very frequent: 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 this medicine) or during post-marketing use of sitagliptin/metformin or sitagliptin alone or in combination with other antidiabetic medicines:

Frequent: 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 platelet count

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 frequent: nausea, vomiting, diarrhoea, stomach pain, and loss of appetite. These symptoms may occur when you first start taking metformin and usually resolve over time
Frequent: metallic taste

Very rare: decreased levels of vitamin B12, hepatitis (a liver problem), hives, skin redness (rash), or itching

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, 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: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Disimet

Keep this medicine out of sight and reach of children.

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

Store below 25°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If in doubt, please consult your pharmacist on how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Disimet

• The active substances are sitagliptin and metformin. Each tablet contains sitagliptin hydrochloride monohydrate equivalent to 50 mg of sitagliptin and 1,000 mg of metformin hydrochloride.
• The other components are:

Tablet core: polyvinyl alcohol-polyethylene glycol copolymer, sodium lauryl sulfate, pregelatinized corn starch, silicified microcrystalline cellulose, and sodium stearyl fumarate.

Coating (OPADRY II 85F18422): partially hydrolyzed polyvinyl alcohol, macrogol 4000, titanium dioxide (E171), talc, yellow iron oxide (E172), and red iron oxide (E172).

Appearance of the Product and Contents of the Package

Film-coated tablet, red-colored, oval, biconvex, with a score line on one side.

The score line is not intended for dividing the tablet.

PVC/PVDC-aluminum blisters.

Packages containing 56 film-coated tablets.

Marketing Authorization Holder and Manufacturing Responsible

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Date of the most recent review of this leaflet: March 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) https://www.aemps.gob.es/.