Sitagliptin/metformin Alter 50 mg/1000 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Sitagliptin/Metformin Alter 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, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Package leaflet contents

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

1. What Sitagliptina/Metformina Alter is and what it is used for

Sitagliptina/Metformina Alter 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 your body produces.

Along with diet and exercise, this medicine helps lower your blood sugar level. This medicine may 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 (cardiac) diseases, kidney (renal) diseases, blindness, and amputations.

2. What you need to know before starting to take Sitagliptina/Metformina Alter

Do not take Sitagliptina/Metformina Alter

• if you are allergic to sitagliptin, to metformin, or to 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 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” accumulate in the blood, which may lead to diabetic pre-coma. Symptoms include stomach pain, rapid deep breathing, drowsiness, or a fruity odor on your breath
• if you have a serious infection or are dehydrated
• if you are undergoing a radiographic 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 treatment with sitagliptin/metformin.

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

If you develop 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, particularly 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 consumption, dehydration (see further information below), liver problems, and any medical condition in which part of the body has 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 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 normal. 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 can 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 risk of developing pancreatitis (see section 4)
• if you have type 1 diabetes. This disease 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 are scheduled to undergo major surgery, you must stop taking sitagliptin/metformin 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 conditions 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 immediately for guidance if:

• You are known to have a genetic mitochondrial disease (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, movement difficulties, 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 Sitagliptin/Metformin Alter

If you need to receive an injection into your bloodstream of a contrast medium containing iodine, 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 you should stop treatment with sitagliptin/metformin and when you should restart it.

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 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 (used to treat irregular heartbeat and other heart problems). Blood levels of digoxin may need to be monitored if you are taking sitagliptin/metformin.

Sitagliptin/Metformin Alter and alcohol consumption

Avoid excessive alcohol intake 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, breastfeeding, think you may be pregnant, or planning to become pregnant, consult your doctor or pharmacist before using this medication. You should not take this medication during pregnancy or while breastfeeding. See section 2, Do not take Sitagliptin/Metformin Alter.

Driving and Operating Machines

The influence of this medicine on the ability to drive and operate machines 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 machines.

Taking this medicine together with medicines called sulfonylureas or with insulin may cause hypoglycemia, which can impair your ability to drive and operate machines or work without a secure support point.

Sitagliptin/Metformin Alter contains sodium

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

3. How to take Sitagliptin/Metformin Alter

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, 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 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, so your doctor may consider it necessary to reduce the dose of your sulfonylurea or insulin.

If you take more Sitagliptin/Metformin Alter 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 Sitagliptin/Metformin Alter

If you forget to take a dose, take it as soon as you remember. If you remember only at the time of your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose of this medicine.

If treatment with Sitagliptin/Metformin Alter is interrupted

Keep taking this medicine for as long as your doctor prescribes it, so that it can help you control your blood sugar level. Do not stop taking this medicine without first consulting your doctor. If you interrupt treatment with sitagliptin/metformin, your blood sugar level 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 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).

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 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, skin blistering/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 treatment for the allergic reaction and switch your diabetes medication.

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, gas, vomiting

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

Some patients have experienced diarrhoea, 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 together with a sulfonylurea such as glimepiride:

Very common (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 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 this medicine) or during post-marketing use 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, sore throat, osteoarthritis, arm or leg pain

Uncommon: dizziness, constipation, itching

Rare: reduction in platelet count

Frequency not known: kidney problems (which sometimes 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, diarrhoea, stomach pain, and loss of appetite. These symptoms may occur when you first start taking metformin and usually disappear 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 type of adverse effect, talk to 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 Sitagliptin/Metformin Alter

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date that appears on the blister pack and the 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 you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the container and other information

Composition of Sitagliptin/Metformin Alter

• The active substances are sitagliptin and metformin. Each tablet contains sitagliptine 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 (see section 2), 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 in color, oval-shaped, biconvex, with a score line on one side, approximately 21 x 10 mm.

The score line should not be used to split the tablet.

PVC/PVDC-aluminum blisters.

Packages containing 28, 50, 56, and 60 film-coated tablets.

Only certain package sizes may be marketed.

Marketing Authorization Holder and Manufacturing Responsibility

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

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

Spain Sitagliptin/Metformin Alter 50 mg/1000 mg film-coated tablets EFG

France SITAGLIPTIN/METFORMIN ALTER 50 mg/1000 mg, comprimé pelliculé

Date of 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 for Medicines and Health Products (AEMPS) https://www.aemps.gob.es/.