Sitagliptin Pensa 25 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Sitagliptin pensa 25 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.
• 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. It could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if the effects are not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Sitagliptina pensa is and what it is 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 increase the levels 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 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 your body 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 taking Sitagliptina pensa

Do not take Sitagliptina pensa

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

Warnings and precautions

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 this medicine.

Tell your doctor if you have or have had:

• a pancreatic disease (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 diabetes complication causing high blood sugar levels, rapid weight loss, nausea, or vomiting)
• any kidney problems currently or in the past
• an allergic reaction to this medicine (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 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 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 pensa

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.

Taking Sitagliptina pensa with food, drinks and alcohol

You may 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 become pregnant, consult your doctor or pharmacist before using this medicine.

This medicine should not be taken 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 operate machinery is negligible or none. However, dizziness and drowsiness have been reported, which may affect your ability to drive or operate machinery.

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

Sitagliptina pensa contains sodium

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

3. How to take Sitagliptina pensa

Follow exactly the instructions for use of this medicine as given by your doctor. If you are unsure, consult your doctor or pharmacist again.

The recommended usual 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 together 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 pensa than you should

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Sitagliptina pensa

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

If you stop taking Sitagliptina pensa

Keep taking this medicine for as long as your doctor prescribes it so that it can continue helping 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 may cause adverse effects, although not everyone experiences 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 skin rash, hives, blistering or peeling of the skin, and swelling of the face, lips, tongue, or 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 will switch you to another 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, diarrhea, constipation, drowsiness

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

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 diabetes medicines:

• Common: low blood sugar, headache, upper respiratory tract infection, nasal congestion or runny nose and sore throat, osteoarthritis, pain in 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 condition)

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 Sitagliptin pensa

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

Do not use this medicine after the expiry date stated on the blister and the carton after EXP. The expiry date refers to 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 a SIGRE Point at your pharmacy. If you are in doubt, please consult your pharmacist on how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Sitagliptina pensa

• The active substance is sitagliptin. Each film-coated tablet (tablet) contains sitagliptine hydrochloride monohydrate equivalent to 25 mg of sitagliptin.
• The other components (excipients) are: In the tablet core: calcium hydrogen phosphate, microcrystalline cellulose (E460), sodium croscarmellose (E468), colloidal anhydrous silica, sodium stearyl fumarate, magnesium stearate (E470b). The film coating of the tablet contains: partially hydrolysed polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol/PEG (E1521), talc (E553b), yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172).

Appearance of the product and contents of the pack

Sitagliptina pensa are film-coated tablets, round, pink in colour.

They are available in packs of 14 and 28 film-coated tablets in opaque blisters (PVC/PE/PVDC and aluminium).

Only certain pack sizes may be marketed.

Marketing Authorisation Holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

SAG MANUFACTURING, S.L.U.

Ctra. N-I, Km 36

28750 San Agustin de Guadalix, Madrid

Spain

or

GALENICUM HEALTH, S.L.U.

Sant Gabriel, 50

08950 Esplugues de Llobregat, Barcelona

Spain

This medicinal product is authorised in the European Economic Area member states under the following names:

Spain: Sitagliptina pensa 25 mg film-coated tablets EFG

Portugal: Sitagliptina toLife

Italy: Sitagliptin Pensa

Date of the most recent revision of this leaflet: August 2021.

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).