SITAGLIPTIN ALENICUM 100 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Sitagliptina Alenicum 100 mg 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.
• 1. 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 symptoms 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 and other information

1. What is Sitagliptina Alenicum and what is it used for
2. What you need to know before you take Sitagliptina Alenicum
3. How to take Sitagliptina Alenicum
4. Possible side effects

5 Storage of Sitagliptina Alenicum

1. Contents of the pack and other information

1. What is Sitagliptina Alenicum 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, 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 condition where your body does not produce enough insulin, and the insulin 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 cause serious medical problems, such as heart disease, kidney disease, blindness, and amputation.

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

Do not take Sitagliptina Alenicum

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

Warnings and precautions

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 sitagliptin.

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 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.

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 10 to 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 Alenicum

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 sitagliptin.

Taking Sitagliptina Alenicum with food and drinks

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

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

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.

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

Sitagliptina Alenicum 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 Alenicum

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

If you take more Sitagliptina Alenicum 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 Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Sitagliptina Alenicum

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.

If you stop taking Sitagliptina Alenicum

Continue taking this medicine as long as your doctor prescribes it to you to help control your blood sugar levels. You should not stop taking this medicine without first consulting 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 sitagliptin 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, hives, blisters on the skin/exfoliative skin conditions, 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 diabetes medicine.

Some patients reported the following side effects after adding sitagliptin 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 reported different types of stomach discomfort when starting the combination of sitagliptina and metformina together (frequency classified as common).

Some patients reported the following side 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 reported the following side effects while taking sitagliptin and pioglitazone:

Common: flatulence, swelling of hands or feet

Some patients reported the following side effects while taking sitagliptin in combination with pioglitazone and metformin:

Common: swelling of hands or feet

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

Common: flu

Uncommon: dry mouth

Some patients reported the following side effects while taking sitagliptin 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.

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 Alenicum

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 Alenicum

The active substance is sitagliptin. Each film-coated tablet (tablet)

• contains sitagliptin hydrochloride monohydrate equivalent to 100 mg of sitagliptin.
• The other ingredients (excipients) are:

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

Coating: partially hydrolyzed polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol/PEG (E1521), talc (E553b), yellow iron oxide (E172), and red iron oxide (E172).

Appearance of the product and pack contents

Film-coated tablet, round, beige in color.

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

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Galenicum Health, S.L.U

Sant Gabriel, 50

08950 Esplugues de Llobregat (Barcelona)

Spain

Manufacturer

SAG MANUFACTURING, S.L.U.

Crta. N-I, Km 36, San Agustín de Guadalix

28750 Madrid

Spain

Or

GALENICUM HEALTH, S.L.

Avda. Cornella, 144 7º- 1ª Edificio LEKLA

08950 Esplugues de Llobregat (Barcelona)

Spain

This medicine is authorized in the Member States of the European Economic Area under the following names

Date of last revision of this leaflet:March 2023

Other sources of information

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/