SITAGLIPTIN NORMON 50 mg FILM-COATED TABLETS

2. What you need to know before you take Sitagliptina Normon

Do not take Sitagliptina Normon

• If you are allergic to sitagliptin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take sitagliptina.

There have been reports of pancreatitis (inflammation of the pancreas) in patients treated with sitagliptin (see section 4).

If you notice blisters on your skin, it may be a sign of a disease called bullous pemphigoid. Your doctor may ask you to stop taking sitagliptina.

Tell your doctor if you have or have had:

• A pancreatic disease (such as pancreatitis).
• Gallstones, alcohol addiction, or very high levels of triglycerides (a type of fat) in the blood. These medical conditions may increase your risk of developing pancreatitis (see section 4).
• Type 1 diabetes.
• Diabetic ketoacidosis (a complication of diabetes that causes high blood sugar levels, rapid weight loss, nausea, or vomiting).
• Any kidney problem you have now or have had in the past.
• An allergic reaction to sitagliptin (see section 4).

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

Sitagliptina Normon contains sodium

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

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 not known if this medicine is safe and effective when used in children under 10 years of age.

Other medicines and Sitagliptina Normon

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

In particular, tell your doctor if you are taking digoxin (a medicine used to treat irregular heartbeat and other heart problems). Your doctor may need to check your digoxin levels if you are taking sitagliptina.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

This medicine should not be taken during pregnancy.

It is not known if this medicine passes into breast milk. You should not take this medicine if you are breastfeeding or planning to breastfeed.

Driving and using machines

The effect of this medicine on your ability to drive or use machines is negligible. However, dizziness and somnolence have been reported, which may affect your ability to drive or use machines.

Also, taking this medicine with sulfonylureas or insulin may cause hypoglycemia, which may affect your ability to drive or use machines or work without a safe support.

3. How to take Sitagliptina Normon

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist again.

The recommended dose is:

• One 100 mg film-coated tablet.
• Once a day.
• By mouth.

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

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

Your doctor may prescribe this medicine alone or with other medicines that also reduce blood sugar levels.

Diet and exercise can help your body use sugar better. It is important 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 of this medicine than you should, contact your doctor immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

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 medicine to make up for missed doses.

If you stop taking Sitagliptina Normon

Keep taking this medicine while your doctor prescribes it for you to continue helping control your blood sugar levels. You should not stop taking this medicine without first talking to your doctor.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking sitagliptina and contact your doctor immediately if you notice any of the following serious side effects:

• Severe and persistent abdominal pain (in the stomach area) that may radiate to the back with or without nausea and vomiting, as these may be signs of pancreatitis.

If you have a severe allergic reaction (frequency not known), including skin rash, hives, blisters on the skin/exfoliative skin, and swelling of the face, lips, tongue, and 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 change your medicine for diabetes treatment.

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

• Common (may affect up to 1 in 10 people): low blood sugar, nausea, flatulence, vomiting.
• Uncommon (may affect up to 1 in 100 people): stomach pain, diarrhea, constipation, somnolence.

Some patients experienced different types of stomach discomfort when starting the combination of sitagliptina and metformin together (frequency classified as common).

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

• Very common (may affect more than 1 in 10 people): low blood sugar levels.
• Common: constipation.

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

• Common: flatulence, swelling of hands or feet.

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

• Common: swelling of hands or feet.

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

• Common: flu.
• Uncommon: dry mouth.

Some patients experienced the following side effects while taking sitagliptina alone during clinical trials or after approval, alone and/or with other diabetes medicines:

• Common: low blood sugar, headache, upper respiratory tract infection, nasal congestion or runny nose, and sore throat, arthrosis, pain in the arm or leg.
• Uncommon: dizziness, constipation, itching.
• Rare: reduced platelet count.
• Frequency not known: kidney problems (which may require dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of skin blister).

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Sitagliptina Normon

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Sitagliptina Normon

• The active substance is sitagliptin. Each film-coated tablet contains sitagliptin hydrochloride equivalent to 50 mg of sitagliptin.

• The other ingredients are: in the tablet core: anhydrous colloidal silica, microcrystalline cellulose (E460), calcium hydrogen phosphate (E341), sodium stearyl 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 productand pack contents

Film-coated tablet, light beige, round, biconvex, with a break line and engraved with "ST" on one side 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 packs. Packs of 28 film-coated tablets.

Date of last revision of this leaflet:January 2021

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (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/85697/P85697.html