Sitagliptin/metformin Stada 50 mg/1.000 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Sitagliptina/Metformina Stada 50 mg/1.000 mg film-coated tablets EFG

sitagliptin/metformin, hydrochloride

Read the entire 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 questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

1. What Sitagliptina/Metformina Stada is and what it is used for
2. What you need to know before taking Sitagliptina/Metformina Stada
3. How to take Sitagliptina/Metformina Stada
4. Possible side effects
5. How to store 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 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 levels. 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 disease, kidney disease, blindness, and amputations.

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

DO NOT take Sitagliptina/Metformina Stada:

• 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 glucose), nausea, vomiting, diarrhea, rapid weight loss, lactic acidosis (see “Risk of lactic acidosis” below), or ketoacidosis. Ketoacidosis is a disorder 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 unusual 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 sitagliptin/metformin 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 serious 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 sitagliptin/metformin if any of the above 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 sitagliptin/metformin.

Warnings and precautions

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

If you develop blisters on your 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, serious 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 severe acute heart conditions).

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

Stop taking sitagliptin/metformin temporarily if you develop an illness that may 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 sitagliptin/metformin and contact a doctor or 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 discomfort with profound fatigue
• difficulty breathing
• decreased 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 Sitagliptina/Metformina Stada:

• 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 had or currently have an allergic reaction to sitagliptin, metformin, or sitagliptin/metformin (see section 4).
• if you are taking a sulfonylurea or insulin, other diabetes medications, along with sitagliptin/metformin, because 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 the procedure and for some time afterwards. Your doctor will decide when to interrupt and when to restart treatment with sitagliptin/metformin.

If you are unsure whether any of the above apply to you, consult your doctor or pharmacist before starting sitagliptin/metformin.

During treatment with sitagliptin/metformin, your doctor will check 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 must 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 in children under 10 years of age.

Other medicines and Sitagliptina/Metformina Stada

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 sitagliptin/metformin before or at the time of the injection. Your doctor will decide when to interrupt and when to restart treatment with sitagliptin/metformin.

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine. You may need 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 used to treat inflammatory conditions such as asthma and arthritis, taken orally, by inhalation, or by injection (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 bronchial asthma (β-sympathomimetics).
• iodinated contrast agents or medicines containing alcohol.
• certain medicines used to treat stomach problems (such as cimetidine).
• a medicine used to treat angina (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). Digoxin blood levels may need to be monitored if you are taking sitagliptin/metformin.

Taking Sitagliptina/Metformina Stada 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 and breastfeeding

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 or while breastfeeding. See section 2, DO NOT take Sitagliptina/Metformina Stada.

Driving and using machines

The effect of this medicine on the ability to drive and use machines is negligible or minor. However, 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 medicines called sulfonylureas or with insulin may cause hypoglycemia, which may affect your ability to drive and use machines or work without secure support.

Sitagliptina/Metformina Stada contains sodium

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

3. How to take Sitagliptina/Metformina Stada

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

Dosage

The recommended dose is one tablet twice daily.

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

Method of administration

This medicine should be taken orally with food to reduce the likelihood of stomach discomfort.

Kidney problems

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

Other medicines and recommendations

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.

Treatment with this medicine alone is unlikely to 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, so your doctor may consider it necessary to reduce the dose of your sulphonylurea or insulin.

If you take more Sitagliptina/Metformina Stada than you should

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

If you take more than the prescribed dose of this medicine, contact your doctor immediately. Go to 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 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 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 Sitagliptina/Metformina Stada

Keep taking this medicine for as long as your doctor prescribes it, to help control your blood sugar levels. Do not stop taking this medicine without first consulting your doctor. If you stop 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 experiences them.

STOP taking sitagliptin/metformin and contact a doctor or go to the nearest hospital immediately if you experience 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 may lead to coma

STOP taking sitagliptin/metformin and contact your doctor immediately if you experience any of the following serious adverse effects:

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

• severe and persistent pain in the abdomen (stomach area) that may extend to the back with or without nausea and vomiting. These may be signs of inflammation of the pancreas (pancreatitis)
• severe allergic reaction, including skin rash, hives, blistering or peeling of the skin, and swelling of the face, lips, tongue, and throat, which may cause difficulty breathing or swallowing

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:

Common (may affect up to 1 in 10 people):

• low blood sugar levels
• nausea
• gas (flatulence)
• vomiting

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

• stomach pain
• diarrhea
• constipation
• drowsiness

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

Common:

• diarrhea
• nausea
• gas (flatulence)
• constipation
• stomach pain
• vomiting

Some patients experienced the following adverse effects while taking this medicine together 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 sitagliptin/metformin) 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 and sore throat
• osteoarthritis
• pain in the 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
• a type of blistering skin condition (bullous pemphigoid)

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

Very common:

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

These symptoms may occur when you start taking metformin and usually go away over time.

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 (paresthesia), 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
• redness of the skin (rash)
• itching

Reporting of adverse effects

If you experience any 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: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Sitagliptin/Metformin Stada

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

Vials

Do not use this medicine after the expiry date stated on the vial and on the outer packaging following EXP.

Blister packs

Do not use this medicine after the expiry date stated on the blister and on the outer packaging following EXP.

The expiry date refers to the last day of the month indicated.

Do not store above 30 °C.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. Ask your pharmacist how to properly dispose of medicines and containers you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Sitagliptin/Metformin Stada

• The active substances are sitagliptin and metformin. Each film-coated tablet (tablet) contains sitagliptine 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: polyethylene glycol-grafted poly(vinyl alcohol) copolymer (E1209), talc (E553b), titanium dioxide (E171), iron oxide red (E172), GMDCC, GMCC mono/glycerides Type 1, glycerol (E471), partially hydrolyzed polyvinyl alcohol (E1203), ferroso-ferric oxide/iron oxide black (E172).

Appearance of Sitagliptin/Metformin Stada and contents of the pack

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

Bottles

The film-coated tablets are packed in high-density polyethylene (HDPE) bottles with polypropylene (PP) screw caps, security ring, and silica gel desiccant contained in the PP cap.

Pack sizes of 100, 196 tablets.

Blister packs

The film-coated tablets are packed in opaque hard aluminum/PVC/PVDC blisters.

Pack sizes of 14, 28, 30, 56, 60, 196, 210 tablets.

Only certain pack sizes may be commercially available.

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 medicinal product 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 Filmtabletten
Czech Republic: Sitagliptin/Metformin STADA
Germany: Sitagliptin/Metformin STADA 50 mg/1,000 mg Filmtabletten
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 kalvopäällysteiset tabletit
France: SITAGLIPTINE/METFORMINE EG 50 mg/1,000 mg, comprimé pelliculé
Ireland: Sitagliptin/Metformin Clonmel 50 mg/1,000 mg film-coated tablets
Iceland: Sitagliptin/Metformin STADA 50 mg/1,000 mg filmuhúðaðar töflur
Italy: Sitagliptin e Metformina EG
Portugal: Metformina + Sitagliptina Ciclum
Sweden: Sitagliptin/Metformin STADA 50 mg/1,000 mg filmdragerade tabletter
Slovenia: Sitagliptin/metforminijev klorid STADA 50 mg/1,000 mg filmsko obložene tablete
Slovakia: Sitagliptin-Metformin STADA 50 mg/1,000 mg filmom obalené tablety

Date of the most recent review of this leaflet: March 2024

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