Package Leaflet: Information for the User

Sitagliptina/Metformina Stada 50 mg/1.000 mg Film-Coated Tablets EFG

sitagliptina/metformina, hydrochloride

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

-Keep this leaflet, as you may need to read it again.

-If you have any questions, ask your doctor, pharmacist or nurse.

-This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

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

2.What you need to know before you start taking 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 additional information

Sitagliptina/Metformina Stada 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 to increase the levels of insulin produced after a meal and reduces the amount of sugar produced by the body.

Along with diet and exercise, this medicine helps to lower your blood sugar level. This medicine can be used alone or with certain diabetes medicines (insulin, sulfonylureas or thiazolidinediones).

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 occurs, sugar (glucose) accumulates in the blood. This can lead to serious medical problems, such as heart diseases (cardiovascular), kidney diseases (renal), blindness, and amputations.

Do not take Sitagliptina/MetforminaStada:

-if you are allergic to sitagliptin, metformin, or any of the other components of this medication (listed in section 6)

-if you have severe kidney function reduction

-if you have uncontrolled diabetes, 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 disorder in which ketone bodies accumulate in the blood, which can lead to diabetic precoma. Symptoms include stomach pain, rapid and deep breathing, drowsiness, or an unusual fruity odor in your breath

-if you have a severe infection or are dehydrated

-if you are going to have a radiography that requires the injection of a contrast agent. You will need to stop taking sitagliptin/metformin at the time of the radiography and for 2 or more days after, as instructed 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 difficulty breathing

-if you have liver problems

-if you drink excessive amounts of alcohol (either daily or occasionally)

-if you are breastfeeding

Do not take sitagliptin/metformina if any of the above circumstances apply to you and consult your doctor about other ways to control your diabetes. If you are unsure, consult your doctor, pharmacist, or nurse before starting to take sitagliptin/metformina.

Warnings and precautions

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

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

Risk of lactic acidosis

Sitagliptin/metformin may cause a rare but serious side effect called lactic acidosis, especially if your kidneys do not function properly. The risk of developing lactic acidosis is also increased with uncontrolled diabetes, severe infections, prolonged fasting, or alcohol consumption, dehydration (see below for more information), liver problems, and any medical condition in which a part of the body has a reduced oxygen supply (such as acute and severe heart disease).

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

Stop taking sitagliptin/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 intense vomiting, diarrhea, fever, exposure to heat, or if you drink less fluid than normal. Consult your doctor for further instructions.

Stop taking sitagliptin/metformina and contact a doctor or the nearest hospital immediately if you experience any of the symptoms that produce 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 fatigue

-difficulty breathing

-reduced body temperature and heart rate

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

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

-if you have or have had pancreatitis.

-if you have or have had gallstones, alcohol addiction, or have very high levels of triglycerides (a type of fat) in your blood. 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 or have had an allergic reaction to sitagliptin, metformin, or sitagliptin/metformin (see section 4).

-if you are taking a sulfonylurea or insulin, other diabetes medications, because you may experience low blood sugar (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 sitagliptin/metformina while the procedure is being performed and for a period of time after. Your doctor will decide when to stop and when to restart treatment with sitagliptin/metformina.

If you are unsure whether you are affected by any of the above circumstances, consult your doctor or pharmacist before starting to take sitagliptin/metformina.

During treatment with sitagliptin/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 old should not use this medication. It is not effective in children and adolescents aged 10 to 17 years. The safety and efficacy of this medication in children under 10 years old are unknown.

Other medications and Sitagliptina/Metformina Stada

If you need to receive an injection of a contrast agent containing iodine, such as in the context of a radiography or examination, you should stop taking sitagliptin/metformina before the injection or at the time of the injection. Your doctor will decide when to stop and when to restart treatment with sitagliptin/metformina.

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

• medications used to treat inflammatory diseases, such as asthma and arthritis, taken orally, inhaled, or injected (corticosteroids).
• medications that increase urine production (diuretics).
• medications used to treat pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib).
• specific medications used to treat high blood pressure (ACE inhibitors and angiotensin II receptor antagonists).
• medications specifically used to treat asthma (β-adrenergic agonists).
• iodinated contrast agents or medications containing alcohol.
• specific medications used to treat stomach problems (such as cimetidine).
• a medication used to treat angina pectoris (ranolazine).
• a medication used to treat HIV infection (dolutegravir).
• a medication used to treat a specific type of thyroid cancer, such as medullary thyroid cancer (vandetanib).
• to treat irregular heartbeat and other heart problems (digoxin). You may need to have your digoxin level checked in your blood if you are taking sitagliptin/metformina.

Taking Sitagliptina/Metformina Stada with alcohol

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication. Do not take this medication during pregnancy or while breastfeeding. See section 2, Do not take Sitagliptina/Metformina Stada

Driving and operating machinery

The influence of this medication on your ability to drive and operate machinery is negligible or insignificant. 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 medication with sulfonylureas or insulin may cause hypoglycemia, which may affect your ability to drive and operate machinery or work without a secure support.

Sitagliptina/Metformina Stada contains sodium

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

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Dosage

The recommended dose is one tablet twice a day.

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

Administration form

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

Kidney problems

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

Other medications and recommendations

You should continue with the diet recommended by your doctor during treatment with this medication and be careful to distribute carbohydrate intake evenly throughout the day.

It is unlikely that treatment with this medication alone will cause an abnormal drop in blood sugar (hypoglycemia). A drop in blood sugar may occur when this medication is taken with a medication containing sulfonylurea or with insulin, so it is likely that your doctor will consider reducing 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you take more than the prescribed dose of this medication, contact your doctor immediately. Go to the hospital if you have symptoms of lactic acidosis such as feeling cold or unwell, intense nausea or vomiting, stomach pain, unexplained weight loss, muscle cramps, or agitated breathing (see "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 regular treatment. Do not take a double dose of this medication.

If you interrupt treatment with Sitagliptina/Metformina Stada

Continue taking this medication as long as your doctor tells you to, to help you control your blood sugar level. Do not stop taking this medication without first consulting your doctor. If you interrupt treatment with sitagliptin/metformin, your blood sugar may rise again.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

STOP taking sitagliptin/metformin andcontact a doctor or the nearest hospital immediately if you notice any of the following serious side effects:

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

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

STOP taking sitagliptin/metformin andcontact a doctor immediately if you notice any of the following serious side effects:

Unknown frequency(frequency cannot be estimated from available data):

• intense and persistent abdominal pain (stomach area) that can reach the back with or without nausea and vomiting. These may be signs of pancreatitis inflammation
• severe allergic reaction, including skin rash, urticaria, 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 medication to treat the allergic reaction and change the medication for diabetes treatment

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

Common(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 taking metformin have experienced the following side effects after starting treatment with thecombination of sitagliptin and metformin:

Common:

• diarrhea
• nausea
• gas
• constipation
• stomach pain
• vomiting

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

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

• low blood sugar levels

Common:

• constipation

Some patients presented the following side effects while takingthis medication in combination with pioglitazone:

Common:

• swelling of hands or feet

Some patients presented the following side effects while takingthis medication in combination with insulin:

Very common:

• low blood sugar levels

Uncommon:

• dry mouth
• headache

Some patients have experienced the following side effectsduring clinical studies while taking sitagliptin alone(one of the medications contained in sitagliptin/metformina) orduring use after approval of sitagliptin/metformina or sitagliptin alone or with other diabetes medications:

Common:

• low blood sugar levels
• headache
• upper respiratory tract infection
• congestion or nasal mucus and sore throat
• arthrosis
• pain in the arm or leg

Uncommon:

• dizziness
• constipation
• itching

Rare:

• reduction in platelet count

Unknown frequency:

• kidney problems (which may require dialysis)
• vomiting
• joint pain
• muscle pain
• back pain
• interstitial lung disease
• a type of blister on the skin (bullous pemphigoid)

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

Very common:

• nausea
• vomiting
• diarrhea
• stomach pain
• loss of appetite

These symptoms may appear when you start taking metformin and usually disappear.

Common:

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

Very rare:

• hepatitis (liver problem)
• urticaria
• skin redness (rash)
• itching

Reporting of side effects

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

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

Amber Glass Bottles

Do not use this medication after the expiration date that appears on the bottle and on the packaging after CAD.

Blister Packs

Do not use this medication after the expiration date that appears on the blister pack and on the packaging after CAD.

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

Do not store at a temperature above 30 °C.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Sitagliptina/Metformina Stada

-The active principles are sitagliptin and metformin. Each film-coated tablet contains sitagliptin hydrochloride monohydrate equivalent to 50 mg of sitagliptin and 1,000 mg of metformin hydrochloride.

-The other components are:

Tablet core:microcrystalline cellulose, povidone (K29/32), sodium lauryl sulfate, magnesium stearate.

Film coating:copolymer of grafting of macrogol and poly(vinyl alcohol) (E1209), talc (E553b), titanium dioxide (E171), iron oxide red (E172), GMDCC, GMCC mono/glycerides Type 1, glycerol (E471), partially hydrolyzed polyvinyl alcohol (E1203), iron(II,III)/iron(III) oxide black (E172).

Appearance of Sitagliptina/Metformina Stada and packaging content

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

Bottles

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

Packaging of 100, 196 film-coated tablets.

Blister packs

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

Packaging of 14, 28, 30, 56, 60, 196, 210 film-coated tablets.

Only some packaging sizes may be commercially available.

Marketing authorization holder

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing

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 Economic Space with the following names:

NetherlandsSitagliptine/Metformine hydrochloride STADA 50 mg/1.000 mg filmomhulde tabletten

AustriaSitagliptin/Metformin STADA 50 mg/1.000 mg Filmtabletten

Czech RepublicSitagliptin/Metformin STADA

GermanySitagliptin/Metformin STADA 50 mg/1.000 mg Filmtabletten

DenmarkSitagliptin/Metformin STADA

SpainSitagliptina/Metformina Stada 50 mg/1.000 mg comprimidos recubiertos con película EFG

FinlandSitagliptin/Metformin STADA 50 mg/1.000 mg kalvopäällysteiset tabletit

FranceSITAGLIPTINE/METFORMINE EG 50 mg/1.000 mg, comprimé pelliculé

IrelandSitagliptin/Metformin Clonmel 50 mg/1.000 mg film-coated tablets

IcelandSitagliptin/Metformin STADA 50 mg/1.000 mg filmuhúðaðar töflur

ItalySitagliptin e Metformina EG

PortugalMetformina + Sitagliptina Ciclum

SwedenSitagliptin/Metformin STADA 50 mg/1.000 mg filmdragerade tabletter

SloveniaSitagliptin/metforminijev klorid STADA 50 mg/1.000 mg filmsko obložene tablete

SlovakiaSitagliptin-Metformin STADA 50mg/1.000 mg filmom obalené tablety

Last review date of this leaflet:March 2024

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