Sitagliptin Normon 100 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Sitagliptina Normon 100 mg film-coated tablets EFG

Sitagliptin

Read the entire leaflet carefully before you start taking this medicine, as 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 you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

1. What Sitagliptina Normon is and what it is used for
2. What you need to know before taking Sitagliptina Normon
3. How to take Sitagliptina Normon
4. Possible adverse effects
5. How to store 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 increase insulin levels produced after a meal and reduces the amount of sugar produced by the body.

Your doctor has prescribed this medicine to help you lower your blood sugar, which is too high due to your type 2 diabetes. This medicine may be used alone or in combination with other blood sugar-lowering medicines (insulin, metformin, sulfonylureas or glitazones) 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 condition in which your body does not produce enough insulin, and the insulin that is produced 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, kidney disease, blindness, and amputation.

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

Do not take Sitagliptina Normon

• If you are allergic to sitagliptin or to 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 sitagliptin.

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

Tell your doctor if you have or have had:

• A disease of the pancreas (such as pancreatitis).
• 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).
• Type 1 diabetes.
• Diabetic ketoacidosis (a complication of diabetes causing high blood sugar levels, rapid weight loss, nausea or vomiting).
• Any kidney problems currently or 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 act when blood sugar levels are low. However, when this medicine is used in combination with a medicine containing a sulfonylurea or with insulin, low blood sugar (hypoglycemia) may occur. Your doctor may reduce the dose of your sulfonylurea-containing medicine or insulin.

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 unknown whether 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 need to 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 digoxin blood levels may need to be monitored if you are taking sitagliptin.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

You should not take this medicine during pregnancy.

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

Driving and using machines

The effect of this medicine on the ability to drive or use machines is negligible or none. However, dizziness and somnolence have been reported, which may affect your ability to drive or use machines.

Also, taking this medicine together with medicines called sulfonylureas or with insulin may cause hypoglycemia, which could affect your ability to drive and use machines or work without a secure support point.

3. How to take Sitagliptina Normon

Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

• One 100 mg film-coated tablet.
• Once daily.
• Orally.

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

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

Your doctor may prescribe this medicine alone or in combination with other medicines that also lower blood sugar.

Diet and exercise can help your body use sugar more effectively. It is important that you follow the diet and exercise plan recommended by your doctor while taking sitagliptin.

If you take more Sitagliptina Normon than you should

If you take more of this medicine than prescribed, contact your doctor immediately or call the Toxicology Information Service at telephone number 91 562 04 20, stating the medicine and the amount ingested.

If you forget to take Sitagliptina Normon

If you miss a dose, take it as soon as you remember. If you do not remember until it is time for your next dose, then skip the missed dose and continue with your regular dosing schedule. Do not take a double dose of this medicine to make up for a missed dose.

If you stop taking Sitagliptina Normon

Keep taking this medicine for as long as your doctor continues to prescribe it, so that it can continue helping you control your blood sugar. You must not stop taking this medicine without first consulting your doctor.

If you have any further questions about the use of 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 sitagliptin 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).

If you have a severe allergic reaction (frequency not known), including rash, hives, skin blistering/skin peeling, and swelling of the face, lips, tongue, and throat which 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 experienced the following adverse effects after adding sitagliptin to 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, diarrhoea, constipation, drowsiness.

Some patients experienced various types of stomach discomfort when starting treatment with sitagliptin and metformin together (classified as common frequency).

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

• Common: flatulence, swelling of hands or legs.

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

• Common: swelling of hands or legs.

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

• Common: influenza.
• Uncommon: dry mouth.

Some patients experienced the following adverse effects while taking sitagliptin alone during clinical trials, or during post-approval use alone and/or in combination with other antidiabetic medicines:

• Common: low blood sugar, 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 rash).

Reporting of adverse effects

If you experience any type of 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 via 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 Sitagliptina Normon

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

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 dispose of medicines and containers you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Sitagliptina Normon

• The active substance is sitagliptin. Each film-coated tablet (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 stearyl fumarate, sodium croscarmellose (E468) and magnesium stearate (E470b). The tablet film coating contains: Opadry II White 85F18422, iron oxide red (E172), iron oxide yellow (E172) and talc (E553b).

Appearance of the product and contents of the pack

Film-coated tablet, beige, round, biconvex, with a break line and printed with "ST" on one side 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. Pack sizes of 28 and 56 film-coated tablets.

Date of the latest review of this leaflet: January 2021

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

You can access detailed and updated information about 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/85695/P_85695.html