Sitagliptin Adamed 50 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Sitagliptin Adamed 25 mg film-coated tablets EFG

Sitagliptin Adamed 50 mg film-coated tablets EFG

Sitagliptin Adamed 100 mg film-coated tablets EFG

Read the entire 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 questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you should not give it to others, 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 Sitagliptin Adamed is and what it is used for
2. What you need to know before taking Sitagliptin Adamed
3. How to take Sitagliptin Adamed
4. Possible side effects
5. How to store Sitagliptin Adamed
6. Contents of the pack and other information

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

Sitagliptina Adamed contains the active substance sitagliptin, which belongs to a group of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) that lower 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 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 (such as insulin, metformin, sulfonylureas, or glitazones) that you may already be taking for 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 amputations.

2. What you need to know before taking Sitagliptina Adamed

Do not take Sitagliptina Adamed

• 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 notice 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 disease of the pancreas (such as pancreatitis),
• gallstones, alcohol addiction, or very high blood levels of triglycerides (a type of fat). These 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 Sitagliptina Adamed (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 the medicine containing sulfonylurea or insulin.

Children and adolescents

Children and adolescents under 18 years of age must not take 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 Adamed

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). It may be necessary to monitor digoxin levels in your blood 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. This medicine should not be taken during pregnancy.

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

Driving and using machines

The effect of this medicine on the ability to drive or operate machinery is negligible or minor. However, dizziness and drowsiness have been reported, which may affect your ability to drive or operate machinery.

Also, 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 Adamed contains sodium

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

3. How to take Sitagliptina Adamed

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

The usual recommended dose is:

• one 100 mg film-coated tablet
• once daily
• taken 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 blood sugar more effectively. It is important that you follow the diet and exercise regimen recommended by your doctor while taking sitagliptin.

If you take more Sitagliptina Adamed 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 number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Sitagliptina Adamed

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, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed dose.

If you stop taking Sitagliptina Adamed

Keep taking this medicine for as long as your doctor continues to prescribe it, so that it can keep helping control your blood sugar. You should 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 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) which may radiate 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, skin blisters or peeling of the skin, and swelling of the face, lips, tongue or throat which may cause difficulty breathing or swallowing, stop taking this medicine and contact your doctor immediately. Your doctor may prescribe a medicine to treat the allergic reaction and a different medicine for your diabetes.

Some patients experienced the following adverse effects after adding sitagliptin to treatment with metformin:

Frequent (may affect up to 1 in 10 people): low blood sugar levels, 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 sitagliptin and metformin together (frequency classified as frequent).

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 level.

Frequent: constipation.

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

Frequent: flatulence, swelling of hands or legs.

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

Frequent: swelling of hands or legs.

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

Frequent: influenza-like illness.

Uncommon: dry mouth.

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

Frequent: low blood sugar level, 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 (which sometimes require 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 Adamed

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

Do not use this medicine after the expiry date stated on the blister pack and 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. Unused containers and medicines should be taken to the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Sitagliptin Adamed

• The active substance is sitagliptin.

Each 25 mg film-coated tablet contains sitagliptin hydrochloride monohydrate, equivalent to 25 mg of sitagliptin.

Each 50 mg film-coated tablet contains sitagliptin hydrochloride monohydrate, equivalent to 50 mg of sitagliptin.

Each 100 mg film-coated tablet contains sitagliptin hydrochloride monohydrate, equivalent to 100 mg of sitagliptin.

• The other components are:

Tablet core: anhydrous calcium phosphate, microcrystalline cellulose, sodium croscarmellose, stearoyl fumarate and sodium, magnesium stearate.

The film coating contains: polyvinyl alcohol, macrogol 4000, titanium dioxide (E171), talc, red iron oxide (E172), and yellow iron oxide (E172).

Appearance of the product and contents of the pack

25 mg tablet: film-coated tablet, round, orange-colored, convex, with the number “25” engraved in relief on one side.

50 mg tablet: film-coated tablet, round, orange-colored, convex, with the number “50” engraved in relief on one side.

100 mg tablet: film-coated tablet, round, orange-colored, convex, with the number “100” engraved in relief on one side.

PVC/PVDC/Aluminum blisters contained in the outer packaging.

Sitagliptin Adamed 25 mg and 50 mg film-coated tablets EFG

Packs containing 28 or 98 film-coated tablets.

Sitagliptin Adamed 100 mg film-coated tablets EFG

Packs containing 28, 56 or 98 film-coated tablets.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder

Adamed Laboratorios, S.L.U.

Calle de las Rosas de Aravaca, 31 – 2nd floor

28023 Madrid

Spain

Manufacturer

Adamed Pharma S.A.

ul. Marszalka Józefa Pilsudskiego 5

95-200 Pabianice

Poland

Date of the most recent review of this leaflet: December 2020

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