Prospect: information for the user

Sitagliptin Stada 50 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 for 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 are not listed in this prospect. See section 4.

1.What is Sitagliptin Stada and for what it is used

2.What you need to know before starting to take Sitagliptin Stada

3.How to take Sitagliptin Stada

4.Possible adverse effects

5.Storage of Sitagliptin Stada

6.Contents of the package and additional information

Sitagliptina Stada contains the active ingredient sitagliptin, which belongs to a class of medications called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) that reduce 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 has prescribed this medication to help you reduce your blood sugar, which is too high due to your type 2 diabetes. This medication may be used alone or in combination with other medications (insulin, metformin, sulfonylureas, or thiazolidinediones) that reduce blood sugar, and which 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 disease that consists of your body not producing enough insulin, and the insulin it produces not working 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 Stada

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

Warnings and precautions

Cases of pancreatitis have been reported in patients treated with sitagliptin (see section 4).

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 sitagliptin.

Inform your doctor if you have or have had:

-pancreatitis (a disease of the pancreas)

-gallstones, alcohol addiction, or very high levels of triglycerides (a type of fat) in your 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 currently have or have had in the past

-an allergic reaction to sitagliptin (see section 4)

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

Children and adolescents

Children and adolescents under 18 years old should not use this medication. It is not effective in children and adolescents aged 10 to 17 years. The safety and efficacy of this medication in children under 10 years old are unknown.

Other medications and Sitagliptina Stada

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 heartbeat and other heart problems). Your doctor may need to check your digoxin blood levels 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.

The safety of this medication in breastfeeding women is unknown. 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 sulfonylureas or insulin may cause hypoglycemia, which may affect your ability to drive and operate machinery or work safely without support.

Sitagliptina Stada 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.

Dose

The recommended dose is 100 mg once a day.

Administration Form

It is taken orally. You can take this medication with or without food and drinks.

Kidney Problems

If you have kidney problems, your doctor may prescribe lower doses (such as 25 mg or 50 mg).

Other Medications and Recommendations

Your doctor may prescribe this medication alone or with other medications that also reduce 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 Stada Than You Should

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

If You Forget to Take Sitagliptina Stada

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 Stada

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 using this medication, ask your doctor or pharmacist.

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

STOP taking sitagliptin and see your doctor immediately if you notice any of the following serious side effects:

Unknown(the frequency cannot be estimated from the available data)

?intense and persistent abdominal pain (in the stomach area) that can reach the back with or without nausea and vomiting, as these can be signs of pancreatitis inflammation.

• severe allergic reaction, including skin rash, urticaria, skin blisters/peeling skin and swelling of the face, lips, tongue, and throat that can cause difficulty breathing or swallowing.

Your doctor will prescribe a medication to treat the allergic reaction and change your medication for diabetes treatment.

Some patients presented the following side effects afteradding sitagliptin to treatment with metformin:

Frequent(can affect up to 1 in 10 people)

• low blood sugar
• nausea
• flatulence
• vomiting

Poco frequent(can affect up to 1 in 100 people)

• stomach pain
• diarrhea
• constipation
• drowsiness.

Some patients presented the following side effects when initiating thecombination of sitagliptin and metforminconcurrently.

Frequent

• different types of stomach discomfort

Some patients presented the following side effectswhile taking sitagliptin in combination with a sulfonylurea and metformin:

Very frequent(can affect more than 1 in 10 people)

• low blood sugar

Frequent

• constipation

Some patients presented the following side effects whiletaking sitagliptin and pioglitazone:

Frequent

• flatulence
• swelling of hands or feet

Some patients presented the following side effects whiletaking sitagliptin in combination with pioglitazone and metformin:

Frequent

• swelling of hands or feet

Some patients presented the following side effects whiletaking sitagliptin in combination with insulin (with or without metformin):

Frequent

• flu

Poco frequent

• dry mouth

Some patients presented the following side effects whiletaking sitagliptin only during clinical trials, orduring use after approval alone and/or with other diabetes medications:

Frequent

• low blood sugar
• headache
• upper respiratory tract infection
• nasal congestion or mucous and sore throat
• arthritis
• arm or leg pain

Poco frequent

• dizziness
• constipation
• itching

Rare(can affect up to 1 in 1,000 people)

• reduction in platelet count

Unknown

• kidney problems (which sometimes require dialysis)
• vomiting
• joint pain
• muscle pain
• back pain
• interstitial lung disease
• bullous pemphigoid (a type of skin blister)

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 prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: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, bottle label, and carton 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 packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition of Sitagliptin Stada

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

-The other components are: calcium hydrogenphosphate, microcrystalline cellulose, sodium croscarmellose, sodium stearate fumarate, magnesium stearate.

The film-coating material contains: polyvinyl alcohol, titanium dioxide (E171), macrogol/polietilenglycol, talc, yellow iron oxide (E172), red iron oxide (E172).

Appearance of the product and contents of the package

The 50 mg film-coated tablets are round, biconvex, approximately 8 mm in diameter, orange in color, and engraved with "C" on one side.

Sitagliptin Stada 50 mg is available in packs of 14, 28, 30, 56, and 98 film-coated tablets and in bottles of 100 film-coated tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

STADA, S.L.

Frederic Mompou 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing

Laboratorios Liconsa S.A.

Avda. Miralcampo, Nº 7

Polígono Industrial Miralcampo

19200 Azuqueca de Henares (Guadalajara)

Spain

or

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

or

STADA Arzneimittel GmbH

Muthgasse 36/2

1190 Wien

Austria

or

Centrafarm Services B.V.

Van de Reijtstraat 31 E

NL-4814 Breda

Netherlands

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

NetherlandsSitagliptine CF 50 mg, filmomhulde tabletten

AustriaSitagliptin STADA 50 mg Filmtabletten

BelgiumSitagliptin EG 50 mg, filmomhulde tabletten

Greeceσιταγλιπτ?νης STADA 50 mg επικαλυμμ?να με λεπτ? υμ?νιο δισκ?α (SITAGLIPTIN/STADA 50 mg film-coated tablets)

GermanySitagliptin STADA 50 mg Filmtabletten

DenmarkSitagliptin STADA

SpainSitagliptina STADA 50 mg comprimidos recubiertos con película EFG

FinlandSitagliptin STADA 50mg kalvopäällysteiset tabletit

FranceSitagliptine EG 50 mg, comprimé pelliculé

IcelandSitagliptin STADA 50 mg filmuhúðaðar töflur

LuxembourgSitagliptin EG 50 mg comprimés pelliculés

PolandSitagliptin STADA

PortugalSitagliptina Ciclum

SwedenSitagliptin STADA 50 mg filmdragerad tablet

SloveniaSitagliptin STADA 50 mg filmsko obložene tablete

Last review date of this leaflet:May 2022

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