Sitagliptin/metformin Cinfamed 50 mg/1,000 mg film-coated tablets EFG

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the Patient

sitagliptin/metformin cinfamed 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, ask 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 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 sitagliptin/metformin cinfamed is and what it is used for
2. What you need to know before taking sitagliptin/metformin cinfamed
3. How to take sitagliptin/metformin cinfamed
4. Possible side effects
5. How to store sitagliptin/metformin cinfamed
6. Contents of the pack and other information

1. What sitagliptin/metformin cinfamed is and what it is used for

This medicine 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 type 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 can 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 (cardiovascular) disease, kidney (renal) disease, blindness, and amputations.

2. What you need to know before starting to take sitagliptin/metformin cinfamed

Do not takesitagliptin/metformin cinfamed

• 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, 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 your breath developing an unusual fruity odor
• 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 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

Cases of inflammation of the pancreas (pancreatitis) have been reported in patients treated with this medicine (see section 4).

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

Risk of lactic acidosis

This medicine 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 consumption, 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 serious heart diseases).

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

Contact your doctor promptly for guidance if:

• You are known to have a genetic inherited mitochondrial disease (components that produce energy inside 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, symptoms indicating nerve damage (e.g., pain or numbness), migraine, or hearing loss.

Stop taking sitagliptin/metformin cinfamed temporarily if you develop a condition 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 cinfamed and contact a doctor or go to the nearest hospital immediately if you experience any of the 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 marked 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 to take 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 this medicine (see section 4)
• if you are taking a sulfonylurea or insulin, or other diabetes medicines at the same time as this medicine, because you may experience low blood sugar levels (hypoglycemia). Your doctor may consider reducing the dose of the sulfonylurea or insulin you are taking

If you need to undergo major surgery, you must stop taking this medicine during the procedure and for some time afterwards. Your doctor will decide when to interrupt treatment with this medicine and when to restart it.

If you are unsure whether any of the above conditions apply to you, consult your doctor or pharmacist before starting to take this medicine.

During treatment with this medicine, 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 known whether this medicine is safe and effective when used in children and adolescents under 18 years of age.

Other medicines and sitagliptin/metformin cinfamed

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 and when to restart treatment with this medicine.

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to 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 this medicine. 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 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 this medicine.

Taking sitagliptin/metformin cinfamed with alcohol

Avoid excessive alcohol consumption while taking this medicine, 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 takesitagliptin/metformin cinfamed.

Driving and using machines

The influence of this medicine on the ability to drive and use machines is negligible or none. 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.

sitagliptin/metformin cinfamed contains sodium

sitagliptin/metformin cinfamed 50 mg/1,000 mg film-coated tablets EFGEsthis medicine contains less than 1 mmol of sodium (23 mg) per dose; hence, essentially “sodium-free”.

3. How to take sitagliptin/metformin cinfamed

Follow exactly the administration instructions for this medicine as given by your doctor. 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 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 take care to distribute carbohydrate intake evenly throughout the day.

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

If you take more sitagliptin/metformin cinfamed than you should

If you take more than the prescribed dose of this medicine, contact your doctor immediately. Go to hospital if you have 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 cinfamed

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 sitagliptin/metformin cinfamed

Continue taking this medicine for the entire duration indicated by your doctor, so that it helps you control your blood sugar levels. You should not stop taking this medicine without first consulting your doctor. If you stop treatment with this medicine, 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 pain in the abdomen (stomach area) that may extend 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 happens to you, 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, blistering or peeling of the skin, and swelling of the face, lips, tongue, or throat that may cause difficulty breathing or swallowing, stop taking this medicine and consult your doctor immediately. Your doctor will prescribe a medicine to treat the allergic reaction and will switch your diabetes treatment to another medicine.

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 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 this medicine 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 (sometimes requiring dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of blistering skin rash)

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

Very frequent: nausea, vomiting, diarrhoea, stomach pain, loss of appetite. These symptoms may occur when you first start taking metformin and usually resolve over time
Frequent: metallic taste
Very rare: reduced vitamin B12 levels, hepatitis (a liver problem), hives, redness of the skin (rash), or itching

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist, or nurse, 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 cinfamed

Keep this medicine out of the 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.

Do not store above 25°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. If in doubt, ask your pharmacist how to properly dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of sitagliptin/metformin cinfamed

sitagliptin/metformin cinfamed 50 mg/1,000 mg film-coated tablets EFG

• The active substances are sitagliptin and metformin hydrochloride. Each film-coated tablet (tablet) contains monohydrate sitagliptin hydrochloride equivalent to 50 mg of sitagliptin and 1,000 mg of metformin hydrochloride.
• Other components are: In the tablet core: microcrystalline cellulose, povidone, sodium lauryl sulfate, and sodium fumarate. The film coating additionally contains: polyvinyl alcohol, macrogol 3350, talc, titanium dioxide (E171), black iron oxide (E172), and red iron oxide (E172).

Nature of the product and contents of the container

sitagliptin/metformin cinfamed 50 mg/1,000 mg film-coated tablets EFG

Red, oval, biconvex film-coated tablets, engraved with “1000” on one side. The tablet length is 21.1 to 21.6 mm and the width is 10.3 to 10.8 mm.

Blister packs (aluminum/PVC/PVDC) in an outer carton. Pack sizes: 28, 56, and 196 film-coated tablets.

Some pack sizes may not be marketed.

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Manufacturer

FARMAPROJECTS S.A.U.

Parc Cientific de Barcelona

C/ Baldiri Reixac, 4/12 and 15

08028 Barcelona, Spain

or

Zaklady Farmaceutyczne POLPHARMA S.A.

ul. Pelplinska 19, 83-200 Starogard Gdanski

Poland

This medicinal product is authorized in the European Economic Area member states under the following names:

Poland:

Sitagliptyna/Chlorowodorek metforminy Polpharma

Sitagliptyna/Chlorowodorek metforminy Polpharma

Germany:

Sitagliptin/Metforminhydrochlorid Polpharma 50 mg/850 mg, filmtabletten
Sitagliptin/Metforminhydrochlorid Polpharma 50 mg/1000 mg, filmtabletten

France:

SITAGLIPTINE / METFORMINE POLPHARMA 50 mg/850 mg, comprimé pelliculé
SITAGLIPTINE / METFORMINE POLPHARMA 50 mg/1000 mg, comprimé pelliculé

Italy:

Sitagliptin e Metformina Polpharma

Portugal:

Sitagliptina/Cloridrato de metformina Polpharma 50 mg/850 mg comprimidos revestidos por película
Sitagliptina/Cloridrato de metformina Polpharma 50 mg/1000 mg comprimidos revestidos por película

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

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

You can access detailed and up-to-date information about this medicinal product by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/85858/P_85858.html

QR code to: https://cima.aemps.es/cima/dochtml/p/85858/P_85858.html