SITAGLIPTIN NORMON 100 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Sitagliptina Normon 100mg film-coated tablets EFG

Sitagliptina

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 further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

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

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

Your doctor has prescribed this medicine to help you reduce your blood sugar level, which is too high due to your type 2 diabetes. This medicine can be used alone or in combination with other medicines (insulin, metformin, sulfonylureas, or glitazones) that reduce blood sugar levels, which you may already be taking for your diabetes, along with your 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) builds up in the blood. This can cause serious medical problems, such as heart disease, kidney disease, blindness, and amputation.

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 sitagliptina (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 dependence, 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 current or past kidney problems.
• An allergic reaction to sitagliptina (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.

Do not take this medicine during pregnancy.

It is not known if this medicine passes into breast milk. Do 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 low blood sugar, 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.
• Orally.

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 Poison 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 to 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 see a 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 talk to your doctor immediately. Your doctor will prescribe a medicine to treat the allergic reaction and change your diabetes medicine.

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.
• 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 it is possible that 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 refers to 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 100 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, iron oxide red (E172), iron oxide yellow (E172), and talc (E553b).

Appearance of the product and pack contents

Film-coated tablet, beige, round, biconvex, with a break line and engraved 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%.

Aluminum/Polyamide-Aluminum-PVC or Aluminum/PVC (white)-PE-PVDC (90) blister packs. Packs of 28 and 56 film-coated tablets.

Date of last revision of this leaflet: January 2021

Detailed and up-to-date 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 up-to-date information about 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