SITAGLIPTIN OLPHA 25 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Sitagliptina Olpha 25mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, 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 Package Leaflet

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

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

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

This medicine helps to increase the amounts 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, and that you may already be taking for your diabetes, together with a diet and exercise program.

What is type 2 diabetes?

Type 2 diabetes is a condition where your body does not produce enough insulin, and the insulin that it does produce 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 you take Sitagliptina Olpha

Do not take Sitagliptina Olpha

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

Warnings and precautions

Consult your doctor or pharmacist before you start taking this medicine.

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:

• pancreatitis (inflammation of the pancreas)
• 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 kidney problems you have now or have had in the past
• 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 your 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.

Children and adolescents

Children and adolescents under 18 years 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.

Other medicines and Sitagliptina Olpha

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 the level of digoxin in your blood if you are taking sitagliptina.

Taking Sitagliptina Olpha with food and drinks

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

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, 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 breast-feeding or planning to breast-feed.

Driving and using machines

This medicine has no or negligible influence on the ability to drive and use machines. However, dizziness and somnolence have been reported, which may affect your ability to drive or use machines.

Taking this medicine with the medicines called sulfonylureas or with insulin may cause low blood sugar, which may affect your ability to drive or use machines or work without a safe support.

Sitagliptina Olpha contains sodium

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

3. How to take Sitagliptina Olpha

Follow exactly the instructions of your doctor for taking this medicine. 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 may 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 Olpha than you should

If you take more of this medicine than you should, contact your doctor immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Sitagliptina Olpha

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

If you stop taking Sitagliptina Olpha

Keep taking this medicine as long as your doctor tells you to, so that you can continue 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 contact a doctor immediatelyif 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, urticaria, blisters on the skin/peeling of the skin, and swelling of the face, lips, tongue, and throat that may 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 your medicine for the treatment of diabetes.

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 number of platelets

Frequency not known: kidney problems (which may 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

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Sitagliptina Olpha

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 blister and 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 Olpha

• The active substance is sitagliptin:
• • Each film-coated tablet contains sitagliptin hydrochloride monohydrate, equivalent to 25 mg of sitagliptin.

• The other ingredients (excipients) are:

Core of the tablet: calcium hydrogen phosphate, microcrystalline cellulose 102 (E460), sodium croscarmellose (E468), anhydrous colloidal silica, sodium stearyl fumarate, and magnesium stearate (E470b).

Coating material: poly(vinyl alcohol) (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b), yellow iron oxide (E172), red iron oxide (E172), and black iron oxide (E172).

Appearance of the product and contents of the pack

Film-coated tablets, round and pink.

Opaque blisters (PVC/PE/PVDC and aluminum). Packs of 28, 30, 56, 98 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Olpha AS,

Rupnicu iela 5,

Olaine, Olaines novads, LV-2114,

Latvia

Manufacturer

SAG MANUFACTURING S.L.U

Carretera Nacional 1, km.36

San Agustín del Guadalix

28750 Madrid, Spain

or

Galenicum Healthcare S.L.U

Carrer de Sant Gabriel, 50

Esplugues de Llobregat

08950 Barcelona, Spain

Date of last revision of this leaflet:12/2024.

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