Prospect: information for the patient

Sitagliptin Adamed25 mg film-coated tablets EFG

Sitagliptin Adamed50 mg film-coated tablets EFG

Sitagliptin Adamed 100 mg film-coated tablets EFG

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
  If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this prospect. See section 4.

1. What isSitagliptin Adamedand for what it is used

2. What you need to know before starting to takeSitagliptin Adamed

3. How to takeSitagliptin Adamed

4. Possible adverse effects

5. Conservation ofSitagliptin Adamed

6. Contents of the package and additional information

Sitagliptina Adamedcontains the active ingredient sitagliptin, which is part of a class of medications called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) that reduces blood sugar levels in adult patients with type 2 diabetes mellitus.

This medication helps to increase insulin levels produced after a meal and decreases the amount of sugar produced by the body.

Your doctor prescribed this medication to help you reduce your blood sugar, which is too high due to your type 2 diabetes. This medication can be used alone or in combination with other medications (insulin, metformin, sulfonylureas, or thiazolidinediones) that reduce blood sugar, and that you may be taking for diabetes, along with a diet and exercise program.

What is type 2 diabetes?

Type 2 diabetes is a disease that consists of your body not producing enough insulin and the insulin produced by the body not functioning as well as it should. Your body may also produce too much sugar. When this happens, sugar (glucose) accumulates in the blood. This can cause serious medical problems, such as heart disease, kidney disease, blindness, and amputation.

Do not take Sitagliptina Adamed

-if you are allergic to sitagliptin or any of the other components of this medication (listed in section6).

Warnings and precautions

Cases of pancreatitis have been reported in patients treated with sitagliptin (see section4).

If you notice blisters on your skin, it may be a sign of a condition called bullous pemphigoid. Your doctor may ask you to stop taking this medication.

Inform your doctor if you have or have had:

• pancreatitis (such as pancreatitis)
• gallstones, alcohol addiction, or very high levels of triglycerides in your blood (a type of fat). These conditions may increase your risk of developing pancreatitis (see section4)
• type 1 diabetes
• diabetic ketoacidosis (a complication of diabetes that causes high blood sugar levels, rapid weight loss, nausea, or vomiting)
• any kidney problem you currently have or have had in the past
• an allergic reaction toSitagliptina Adamed(see section4).

It is unlikely that this medication will cause low blood sugar because it does not work when blood sugar levels are low. However, when this medication is used in combination with a medication that contains a sulfonylurea or with insulin, low blood sugar (hypoglycemia) may occur. Your doctor may reduce the dose of the medication that contains a sulfonylurea or insulin.

Children and adolescents

Children and adolescents under 18 years old should not use this medication.

This medication is not effective in children and adolescents aged 10 to 17 years. It is unknown if this medication is safe and effective when used in children under 10 years old.

Other medications and Sitagliptina Adamed

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Particularly, inform your doctor if you are taking digoxin (a medication used to treat irregular heartbeats and other heart problems). Your digoxin level in the blood may need to be checked if you are taking sitagliptin.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication. This medication should not be taken during pregnancy.

It is unknown if this medication passes into breast milk. Do not take this medication if you are breastfeeding or plan to breastfeed.

Driving and operating machinery

The influence of this medication on your ability to drive or operate machinery is negligible. However, dizziness and somnolence have been reported, which may affect your ability to drive or operate machinery.

Additionally, taking this medication with medications called sulfonylureas or with insulin may cause hypoglycemia, which may affect your ability to drive and operate machinery or work without a secure support point.

Sitagliptina Adamed contains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The usual recommended dose is:

• one film-coated tablet of 100 mg
• 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 medication with or without food and drinks.

Your doctor may prescribe this medication alone or with other medications that also lower blood sugar.

Diet and exercise can help your body use blood sugar better. It is essential that you follow the diet and exercise recommended by your doctor while taking sitagliptina.

If you take more Sitagliptina Adamed than you should

If you take more doses of this medication than prescribed, contact your doctor immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Sitagliptina Adamed

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 medication.

If you interrupt treatment with Sitagliptina Adamed

Continue taking this medication as long as your doctor prescribes it for you to continue helping control your blood sugar. You should not stop taking this medication without first consulting your doctor.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

STOP takingsitagliptinand seek medical attention immediately if you notice any of the following severe side effects:

• Severe and persistent abdominal pain (stomach area) that can reach the back, with or without nausea and vomiting, as these may be signs of pancreatitis (inflammation of the pancreas).

If you have a severe allergic reaction (unknown frequency), including skin rash, urticaria, blisters on the skin or 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 may prescribe a medicine to treat the allergic reaction and a different medicine for diabetes.

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

Frequent (may affect up to 1 in 10 people): low blood sugar, nausea, flatulence, vomiting.

Infrequent (may affect up to 1 in 100 people): stomach pain, diarrhea, constipation, drowsiness.

Some patients experienced different types of stomach discomfort when initiating the combination of sitagliptin and metformin together (classified as frequent).

Some patients experienced the following side effects while taking sitagliptin in combination with a sulfonylurea and metformin:

Very frequent (may affect more than 1 in 10 people): low blood sugar.

Frequent: constipation.

Some patients experienced the following side effects while taking sitagliptin and pioglitazone: Frequent: flatulence, swelling of hands or feet.

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

Frequent: swelling of hands or feet.

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

Frequent: flu.

Infrequent: dry mouth.

Some patients experienced the following side effects while taking sitagliptin alone during clinical trials or during use after authorization alone and/or with other medicines for diabetes:

Frequent: low blood sugar, headache, upper respiratory tract infection, congestion or nasal mucosity and throat pain, arthritis, arm or leg pain

Infrequent: dizziness, constipation, itching.

Rare: reduction in platelet count.

Unknown frequency: kidney problems (which sometimes 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 experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the blister pack and on the box after "CAD." The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and themedications that you no longer need at the SIGRE collection pointat the pharmacy.Ask your pharmacist how to dispose of the packaging and the medications that you no longer need. This will help protect the environment.

Composition of Sitagliptin Adamed

The active ingredient is sitagliptin.

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

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

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

The other components are:

In the tablet core: anhydrous calcium phosphate, microcrystalline cellulose, sodium croscarmellose, stearate of fumaric acid and sodium, magnesium stearate.

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

Appearance of the product and contents of the package

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

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

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

PVC/PVDC/Aluminum blisters included in an outer packaging.

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

Packages of 28 or 98 film-coated tablets.

Sitagliptin Adamed 100 mg film-coated tablets EFG

Packages of 28, 56, or 98 film-coated tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

Adamed Laboratorios, S.L.U.

c/ de las Rosas de Aravaca, 31 – 2nd floor

28023 Madrid

Spain

Responsible for manufacturing

Adamed Pharma S.A.

ul. Marszalka Józefa Pilsudskiego 5

95-200 Pabianice

Poland

Last review date of this leaflet: December 2020

Further information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://aemps.gob.es/