SITAGLIPTIN/METFORMIN STADA 50 mg/1000 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Sitagliptina/Metformina Stada 50 mg/1,000 mg film-coated tablets EFG

sitagliptina/metformina, 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 Sitagliptina/Metformina Stada is and what it is used for
2. What you need to know before you take Sitagliptina/Metformina Stada
3. How to take Sitagliptina/Metformina Stada
4. Possible side effects
5. Storage of Sitagliptina/Metformina Stada
6. Contents of the pack and other information

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

Sitagliptina/Metformina Stada contains two different medicines called sitagliptina and metformina.

• Sitagliptina belongs to a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors)
• Metformina 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 to increase the amounts of insulin produced after a meal and reduces the amount of sugar produced by your body.

Together with diet and exercise, this medicine helps you to lower your blood sugar level. This medicine can be used alone or with certain other 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 that 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 diseases (cardiac), kidney diseases (renal), blindness, and amputations.

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

Do not take Sitagliptina/Metformina Stada:

• if you are allergic to sitagliptina, metformina, 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. The 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 medium that contains iodine, for example, in the context of an X-ray or scan. You will need to stop taking sitagliptina/metformina 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 sitagliptina/metformina if you are affected by any of the above conditions and consult your doctor about other ways to control your diabetes. If you are not sure, consult your doctor, pharmacist, or nurse before taking sitagliptina/metformina.

Warnings and precautions

There have been reports of pancreatitis (inflammation of the pancreas) in patients treated with sitagliptina/metformina (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 sitagliptina/metformina.

Risk of lactic acidosis

Sitagliptina/metformina 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, serious 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 diseases).

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

Stop taking sitagliptina/metformina for a short period of time 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 takingsitagliptina/metformina 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 coma.

The symptoms of lactic acidosis include:

• vomiting
• stomach pain (abdominal pain)
• muscle cramps
• general feeling of discomfort, with intense tiredness
• difficulty breathing
• reduction of body temperature and heart rate

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

Consult your doctor or pharmacist before starting to take Sitagliptina/Metformina Stada:

• if you have or have had a disease of the pancreas (such as pancreatitis).
• if you have or have had gallstones, alcohol addiction, or have 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 is also called insulin-dependent diabetes.
• if you have had an allergic reaction to sitagliptina, metformina, or sitagliptina/metformina (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 need to reduce the dose of the sulfonylurea or insulin you are taking.

If you need to undergo major surgery, you should stop taking sitagliptina/metformina during the procedure and for some time after. Your doctor will decide when you should stop taking sitagliptina/metformina 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 sitagliptina/metformina.

During treatment with sitagliptina/metformina, 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 between 10 and 17 years. It is not known if this medicine is safe and effective when used in children under 10 years.

Other medicines and Sitagliptina/Metformina Stada

If you need to be given an injection of a contrast medium that contains iodine into your bloodstream, for example, in the context of an X-ray or scan, you should stop taking sitagliptina/metformina before the injection or at the time of the injection. Your doctor will decide when you should stop taking sitagliptina/metformina 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 sitagliptina/metformina. It is especially important to mention the following:

• medicines used to treat diseases that cause inflammation, such as asthma and arthritis, taken orally, inhaled, or injected (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 (β-sympathomimetics).
• iodinated contrast agents or medicines that contain alcohol.
• certain medicines used to treat stomach problems (such as cimetidine).
• a medicine used to treat angina pectoris (ranolazine).
• a medicine used to treat HIV infection (dolutegravir).
• a medicine used to treat a specific type of thyroid cancer, such as medullary thyroid cancer (vandetanib).
• for treating irregular heartbeat and other heart problems (digoxin). Your doctor may need to check the level of digoxin in your blood if you are taking sitagliptina/metformina.

Taking Sitagliptina/Metformina Stada with alcohol

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

Pregnancy and breast-feeding

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. You should not take this medicine during pregnancy or while breast-feeding. See section 2, Do not take Sitagliptina/Metformina Stada.

Driving and using machines

The effect of this medicine on your ability to drive and use machines is negligible. However, there have been reports of dizziness and drowsiness during treatment with sitagliptina, which may affect your ability to drive and use machines.

Taking this medicine with the medicines called sulfonylureas or with insulin may cause low blood sugar levels (hypoglycemia), which may affect your ability to drive and use machines or work without a safe support.

Sitagliptina/Metformina Stada contains sodium

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

3. How to take Sitagliptina/Metformina Stada

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

Dose

The recommended dose is one tablet twice a day.

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

Method of administration

It should be taken orally with food to reduce the likelihood of stomach upset.

Kidney problems

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

Other medicines and recommendations

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 you to have low blood sugar levels (hypoglycemia). Low blood sugar levels can occur when this medicine is taken with a medicine that contains a sulfonylurea or with insulin, so your doctor may need to reduce the dose of your sulfonylurea or insulin.

If you take more Sitagliptina/Metformina Stada than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount taken.

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

If you forget to take Sitagliptina/Metformina Stada

If you forget to take 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 normal treatment schedule. Do not take a double dose of this medicine.

If you stop taking Sitagliptina/Metformina Stada

Keep taking this medicine for as long as your doctor tells you to, so that it can help to control your blood sugar levels. Do not stop taking this medicine without first talking to your doctor. If you stop taking sitagliptina/metformina, 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 sitagliptin/metformin andcontact a doctor or the nearest hospitalimmediately if you notice any of the following serious adverse effects:

Very rare(may affect up to 1 in 10,000 people):

• Lactic acidosis (see section "Warnings and precautions"). Lactic acidosis can lead to coma

STOP taking sitagliptin/metformin andcontact a doctorimmediately if you notice any of the following serious adverse effects:

Frequency not known(frequency cannot be estimated from available data):

• Severe and persistent abdominal pain (stomach area) that can reach the back with or without nausea and vomiting. These can be signs of pancreatitis (inflammation of the pancreas)
• Severe allergic reaction, including skin rash, hives, blisters on the skin/skin peeling, and swelling of the face, lips, tongue, and throat that can cause difficulty breathing or swallowing

Your doctor will prescribe a medicine to treat the allergic reaction and change the medicine for diabetes treatment

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 levels
• Nausea
• Gas
• Vomiting

Uncommon(may affect up to 1 in 100 people):

• Stomach pain
• Diarrhea
• Constipation
• Drowsiness

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

Frequent:

• Diarrhea
• Nausea
• Gas
• Constipation
• Stomach pain
• Vomiting

Some patients have experienced the following adverse effects while takingthis medicine along with a sulfonylurea such as glimepiride:

Very frequent(may affect more than 1 in 10 people):

• Low blood sugar levels

Frequent:

• Constipation

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

Frequent:

• Swelling of hands or feet

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

Very frequent:

• Low blood sugar levels

Uncommon:

• Dry mouth
• Headache

Some patients have experienced the following adverse effectsduring clinical trials while taking sitagliptin alone(one of the medicines that contains sitagliptin/metformin) orduring 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
• Arthrosis
• Pain in the arm or leg

Uncommon:

• Dizziness
• Constipation
• Itching

Rare:

• Decreased platelet count

Frequency not known:

• Kidney problems (which may require dialysis)
• Vomiting
• Joint pain
• Muscle pain
• Back pain
• Interstitial lung disease
• A type of skin blister (bullous pemphigoid)

Some patients have experienced the following adverse effects after takingmetformin alone:

Very frequent:

• Nausea
• Vomiting
• Diarrhea
• Stomach pain
• 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 may also be caused by diabetes or other unrelated health problems

Very rare:

• Hepatitis (a liver problem)
• Hives
• Redness of the skin (rash)
• Itching

Reporting Adverse Effects

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

5. Storage of Sitagliptin/Metformin Stada

Keep this medicine out of sight and reach of children.

Bottles

Do not use this medicine after the expiration date shown on the bottle and packaging after CAD.

Blister packs

Do not use this medicine after the expiration date shown on the blister pack and packaging after CAD.

The expiration date is the last day of the month indicated.

Do not store above 30 °C.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Sitagliptin/Metformin Stada

• The active ingredients are sitagliptin and metformin. Each film-coated tablet (tablet) 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, povidone (K29/32), sodium lauryl sulfate, magnesium stearate.

Film coating: macrogol/poly(vinyl alcohol) graft copolymer (E1209), talc (E553b), titanium dioxide (E171), red iron oxide (E172), GMDCC, GMCC mono-/diglycerides Type 1, glycerol (E471), partially hydrolyzed polyvinyl alcohol (E1203), ferroso-ferric/iron black oxide (E172).

Appearance of Sitagliptin/Metformin Stada and Package Contents

Film-coated tablet, oval-shaped, biconvex, brown in color, approximately 21.5 mm x 10 mm, and with "S477" engraved on one side.

Bottles

The film-coated tablets are packaged in a high-density polyethylene (HDPE) bottle with a screw cap made of polypropylene (PP) and a safety ring, and a desiccant gel silica contained in the PP cap.

Packages of 100, 196 tablets.

Blister packs

The film-coated tablets are packaged in opaque aluminum hard/PVC/PVDC blister packs.

Packages of 14, 28, 30, 56, 60, 196, 210 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

or

Laboratorios Liconsa S.A.

Avenida Miralcampo 7

19200 Azuqueca De Henares

Spain

or

STADA Arzneimittel GmbH

Muthgasse 36/2

1190 Vienna

Austria

or

Clonmel Healthcare Limited

3 Waterford Road

E91 D768 Clonmel

Ireland

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

Netherlands Sitagliptine/Metformine hydrochloride STADA 50 mg/1,000 mg film-coated tablets

Austria Sitagliptin/Metformin STADA 50 mg/1,000 mg film-coated tablets

Czech Republic Sitagliptin/Metformin STADA

Germany Sitagliptin/Metformin STADA 50 mg/1,000 mg film-coated tablets

Denmark Sitagliptin/Metformin STADA

Spain Sitagliptina/Metformina Stada 50 mg/1,000 mg film-coated tablets EFG

Finland Sitagliptin/Metformin STADA 50 mg/1,000 mg film-coated tablets

France SITAGLIPTINE/METFORMINE EG 50 mg/1,000 mg, film-coated tablet

Ireland Sitagliptin/Metformin Clonmel 50 mg/1,000 mg film-coated tablets

Iceland Sitagliptin/Metformin STADA 50 mg/1,000 mg film-coated tablets

Italy Sitagliptin and Metformin EG

Portugal Metformina + Sitagliptina Ciclum

Sweden Sitagliptin/Metformin STADA 50 mg/1,000 mg film-coated tablets

Slovenia Sitagliptin/metformin hydrochloride STADA 50 mg/1,000 mg film-coated tablets

Slovakia Sitagliptin-Metformin STADA 50mg/1,000 mg film-coated tablets

Date of the last revision of this prospectus:March 2024

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/)