Label: information for the user

Sitagliptin Normon 50mg film-coated tablets EFG

Sitagliptin

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

• Keep this label, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only for you, and you must 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 do not appear 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 known as 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 reduces 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 that 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 in which your body does not produce enough insulin, and the insulin it produces does not work 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 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:

-Pancreatitis (a disease of the pancreas).

-Gallstones, alcohol addiction, or very high levels of triglycerides (a type of fat) in your 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. It is unknown if this medication is safe and effective when used in children under 10 years old.

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 digoxin level may need to be checked if you are taking sitagliptin.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

This medication should not be taken during pregnancy.

It is unknown if this medication passes into breast milk. Do not take this medication if you are breastfeeding or plan to breastfeed.

Driving and operating machinery

The influence of this medication on your 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 medications called sulfonylureas or with 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 100 mg film-coated tablet.
• 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 serious side effects:

• Intense and persistent abdominal pain (stomach area) that can reach the back with or without nausea and vomiting, as these can 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 metformin treatment:

• 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 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 with pioglitazone and metformin:

• Frequent: swelling of hands or feet.

Some patients experienced the following side effects while taking sitagliptin 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 throat pain, 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 conditions for conservation.

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 the pharmacy. Ask your pharmacist how to dispose of the 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 containssitagliptin hydrochloride equivalent to 50mg 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) andmagnesium stearate(E470b). The film coating of the tablet contains: opadry II white 85F18422,red iron oxide(E172),yellow iron oxide(E172) and talc (E553b).

Appearanceof the productand contents of the packaging

Film-coated tablet, light beige, round, biconvex, with a breaking bar and printed with “ST” on one face and smooth on the other, with a diameter of 7.8 mm ± 25% and a thickness of 3.4 mm ± 25%.

Aluminum/Polyamide-Aluminum-PVC or Aluminum/PVC (white)-PE-PVDC (90) blister. Packets of 28 film-coated tablets.

Date of the last review of this leaflet:January 2021

Detailed and updated information on this medication 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 medication by scanning with your 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/85697/P85697.html