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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Sitagliptin/Metformin Normon 50 mg/1.000 mg film-coated tablets EFG

Sitagliptin/Metformine hydrochloride

Read all of 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 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 side effects, talk to your doctor, pharmacist or nurse, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What is Sitagliptine/Metformin Normon and what is it used for?

Sitagliptine/Metformin Normon contains two different medicines called sitagliptine and metformin.

• Sitagliptine 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 help 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.

Together 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 disease (cardiovascular), kidney disease (renal), blindness, and amputations.

2. What you need to know before taking Sitagliptin/Metformin Normon

Do not take Sitagliptin/Metformin Normon

• 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 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 fruity-smelling breath.
• If you have a serious infection or are dehydrated.
• If you are scheduled for an X-ray procedure requiring injection of a contrast agent. You will need to stop taking this medicine at the time of the X-ray and for 2 or more days afterwards, as directed by your doctor, depending on how well your kidneys are functioning.
• If you recently had a heart attack or have serious circulatory problems, such as shock or difficulty breathing.
• If you have liver problems (hepatic impairment).
• If you drink excessive amounts of alcohol (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, speak with your doctor, pharmacist, or nurse before starting this medicine.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting this medicine.

Cases of inflammation of the pancreas (pancreatitis) have been reported in patients treated with this medicine (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 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 working 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 receives 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 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, difficulty with body movements, signs of nerve damage (e.g., pain or numbness), migraine, or hearing loss.

Stop taking this medicine temporarily if you develop a condition that could lead to dehydration (significant loss of body fluids), such as severe vomiting, diarrhea, fever, heat exposure, or reduced fluid intake. Consult your doctor for further instructions.

Stop taking this medicine 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.

Talk to 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 condition may also be referred to as insulin-dependent diabetes.
• If you have had or currently have an allergic reaction to sitagliptin, metformin, or the combination of sitagliptin/metformin (see section 4).
• If you are taking a sulfonylurea or insulin, or other antidiabetic medicines, as 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 this medicine during the procedure and for some time afterwards. Your doctor will decide when to interrupt and when to restart treatment with this medicine.

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

While taking 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 should 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 Sitagliptin/Metformin Normon

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.

Tell 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 this medicine. It is especially important to mention the following:

• Medicines (taken orally, inhaled, or injected) 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 (used 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 Normon 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 take Sitagliptin/Metformin Normon.

Driving and using machines

This medicine has no or negligible influence on the ability to drive and use machines. 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 impair your ability to drive and use machines or work without secure support.

Sitagliptin/Metformin Normon contains sodium

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

3. How to take Sitagliptina/Metformina Normon

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, please 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 a lower dose.

You should 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 (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 Normon than you should

If you take more than the prescribed dose of this medicine, contact your doctor immediately.

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

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 Normon

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 to make up for a missed dose.

If you stop taking Sitagliptina/Metformina Normon

Continue 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 this medicine, your blood sugar levels may rise again.

If you have any further questions about using 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 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 or peeling, and swelling of the face, lips, tongue, or throat that may cause difficulty breathing or swallowing, stop taking this medicine and contact your doctor immediately. 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:

• 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 have experienced diarrhea, 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 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 this medicine or sitagliptin alone or in combination with other diabetes medicines:

• Frequent: low blood sugar levels, headache, upper respiratory tract infection, nasal congestion or runny nose, sore throat, osteoarthritis, pain in the arm or leg.
• 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 condition).

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

• Very common: nausea, vomiting, diarrhea, stomach pain, and loss of appetite. These symptoms may occur when you first start taking metformin and usually go away.
• Frequent: metallic taste.
• Very rare: decreased vitamin B12 levels, hepatitis (a liver problem), hives, skin redness (rash), or itching.

Reporting of adverse effects

If you experience any 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 through 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 Normon

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 on the packaging after EXP. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines must 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 will help protect the environment.

6. Contents of the pack and other information

Composition of Sitagliptina/Metformina Normon

• The active substances are sitagliptin and metformin. Each film-coated tablet (tablet) contains sitagliptine hydrochloride equivalent to 50 mg of sitagliptin and 1,000 mg of metformin hydrochloride.
• The other components (excipients) are:
  • Content of metformin hydrochloride DC 95% granules: sodium carboxymethyl starch from potato (type A), povidone, and colloidal anhydrous silica.
  • In the tablet core: povidone, microcrystalline cellulose (E460), crospovidone, sodium lauryl sulfate, and stearoyl fumarate sodium.
  • The film coating contains: Opadry II white 85F18422 (contains: polyvinyl alcohol, titanium dioxide (E171), macrogol, and talc (E553b)), iron oxide red (E172), and talc (E553b).

Appearance of the product and contents of the pack

Film-coated tablet, elliptical, biconvex, red in colour, printed with "SMF" on one side and blank on the other.

Blister (single-dose and non-single-dose) made of Aluminium/Polyamide-Aluminium-PVC, Aluminium/PVC-Aclar® (PCTFE), or Aluminium/PVC-PE-PVDC (90).

Pack sizes of 56 and 112 (clinical pack) film-coated tablets.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of the most recent revision of this leaflet: March 2025

Other sources of information

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

You can access detailed and up-to-date information on this medicine by scanning with your mobile phone (smartphone) the QR code included in the leaflet and packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/86437/P_86437.html