Label: information for the user

Sitagliptin Normon 100mg film-coated tablets EFG

Sitagliptin

Read this label carefully before starting to take this medication, as it contains important information for you.

• Keep this label, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this label. See section4.

1.What is Sitagliptin Normon and for what it is used

2.What you need to know before starting to takeSitagliptin Normon

3.How to takeSitagliptin Normon

4.Possible adverse effects

5.Storage ofSitagliptin Normon

6. Contents of the package and additional information

Sitagliptina Normon contains the active ingredient sitagliptin, which belongs to a class of medications called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors), which reduce blood sugar levels in adult patients with type 2 diabetes.

This medication helps to increase insulin levels produced after a meal and decreases the amount of sugar produced by the body.

Your doctor has prescribed this medication to help you reduce your blood sugar, which is too high due to your type 2 diabetes. This medication can be used alone or in combination with other medications (insulin, metformin, sulfonylureas, or thiazolidinediones) that reduce blood sugar, and which you may already be taking for your diabetes along with a diet and exercise program.

What is type 2 diabetes?

Type 2 diabetes is a disease that consists of your body not producing enough insulin, and the insulin it produces not working as well as it should. Your body may also produce too much sugar. When this happens, sugar (glucose) accumulates in the blood. This can cause serious medical problems, such as heart disease, kidney disease, blindness, and amputation.

Do not take Sitagliptina Normon

-If you are allergic to sitagliptin or any of the other components of this medication (listed in section6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take sitagliptin.

Cases of pancreatitis (inflammation of the pancreas) have been reported in patients treated with sitagliptin (see section4).

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.

Inform your doctor if you have or have had:

-A pancreatic disease (such as pancreatitis).

-Gallstones, alcohol addiction, or very high levels of triglycerides in the blood. These medical conditions may increase your risk of developing pancreatitis (see section4).

-Type 1 diabetes.

-Diabetic ketoacidosis (a complication of diabetes that causes high blood sugar levels, rapid weight loss, nausea, or vomiting).

-Any kidney problems you currently have or have had in the past.

-An allergic reaction to sitagliptin (see section4).

It is unlikely that this medication will cause low blood sugar because it does not work when blood sugar levels are low. However, when this medication is used in combination with a medication that contains a sulfonylurea or with insulin, low blood sugar (hypoglycemia) may occur. Your doctor may reduce the dose of your sulfonylurea or insulin medication.

Sitagliptina Normon contains sodium

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

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 Normon

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Particularly, inform your doctor if you are taking digoxin (a medication used to treat irregular heartbeat and other heart problems). Your doctor may need to check your digoxin blood level if you are taking sitagliptin.

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.

This medication should not be taken during pregnancy.

The safety of this medication in breastfeeding women is unknown. Do not take this medication if you are breastfeeding or plan to breastfeed.

Driving and operating machinery

The influence of this medication on the ability to drive or operate machinery is negligible or insignificant.However,dizziness and somnolence have been reported, which may affect your ability to drive or operate machinery.

Additionally, taking this medication with sulfonylureas or insulin may cause hypoglycemia, which may affect your ability to drive and operate machinery or work safely without support.

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

The recommended dose is:

• One film-coated tablet of 100 mg.
• Once a day.
• Orally.

If you have kidney problems, your doctor may prescribe lower doses (such as 25 mg or 50 mg).

You can take this medication with or without food and drinks.

Your doctor may prescribe this medication alone or with other medications that also reduce blood sugar.

Diet and exercise can help your body use sugar better. It is essential that you follow the diet and exercise recommended by your doctor while taking sitagliptina.

If you take more Sitagliptina Normon than you should

If you take more doses of this medication than prescribed, contact your doctor immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Sitagliptina Normon

If you forget a dose, take it as soon as you remember. If you do not remember until the time of the next dose, then skip the missed dose and continue with your regular schedule. Do not take a double dose of this medication to compensate for the missed doses.

If you interrupt treatment with Sitagliptina Normon

Continue taking this medication as long as your doctor prescribes it for you to continue helping control your blood sugar. You should not stop taking this medication without first consulting your doctor.

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 and see your doctor immediately if you notice any of the following severe side effects:

• Intense and persistent abdominal pain (stomach area) that can reach the back with or without nausea and vomiting, as these may be signs of pancreatitis (inflammation of the pancreas).

If you have a severe allergic reaction (unknown frequency), 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, stop taking this medicine and consult your doctor immediately.Your doctor will prescribe a medicine to treat the allergic reaction and change the medicine for diabetes treatment..

Some patients experienced the following side effects after adding sitagliptin to treatment with metformin:

• Frequent (can affect up to 1 in 10 people): low blood sugar, nausea, flatulence, vomiting.
• Infrequent (can affect up to 1 in 100 people): stomach pain, diarrhea, constipation, drowsiness.

Some patients experienced different types of stomach discomfort when they started taking sitagliptin and metformin together (classified as frequent).

Some patients experienced the following side effects while taking sitagliptin in combination with a sulfonylurea and metformin:

• Very frequent (can affect more than 1 in 10 people): low blood sugar.
• Frequent: constipation.

Some patients experienced the following side effects while taking sitagliptin and pioglitazone:

• Frequent: flatulence, swelling of hands or feet.

Some patients experienced the following side effects while taking sitagliptin in combination with pioglitazone and metformin:

• Frequent: swelling of hands or feet.

Some patients experienced the following side effects while taking sitagliptin in combination with insulin (with or without metformin):

• Frequent: flu.
• Infrequent: dry mouth.

Some patients experienced the following side effects while taking sitagliptin only during clinical trials, orafter approval onlyand/or with other diabetes medications:

• Frequent: low blood sugar, headache, upper respiratory tract infection, congestion or nasal mucosity and sore throat, arthritis, arm or leg pain.
• Infrequent: dizziness, constipation, itching.
• Rare: reduction in platelet count.
• Unknown frequency: kidney problems (which sometimes require dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of blister on the skin).

Reporting of side effects

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

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

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

Composition of Sitagliptina Normon

• The active ingredient is sitagliptin. Each film-coated tablet contains sitagliptin hydrochloride equivalent to 100 mg of sitagliptin.

• The other components are: in the tablet core: colloidal anhydrous silica, microcrystalline cellulose (E460), calcium hydrogen phosphate (E341), sodium stearoyl fumarate, sodium croscarmellose (E468), and magnesium stearate (E470b). The film coating of the tablet contains: opadry II white 85F18422, red iron oxide (E172), yellow iron oxide (E172), and talc (E553b).

Appearance of the product and contents of the packaging

Film-coated tablet, beige, round, biconvex, with a breaking bar and printed with “ST” on one face and smooth on the other, with a diameter of 10.0 mm ± 25% and a thickness of 4.0 mm ± 25%.

Aluminium/Polyamide-Aluminium-PVC or Aluminium/PVC (white)-PE-PVDC (90) blister. Pack sizes of 28 and 56 film-coated tablets.

Last review date of this leaflet: January 2021

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

You can access detailed and updated information on this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/85695/P_85695.html