SITAGLIPTIN STADA 25 mg FILM-COATED TABLETS

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

Do not take Sitagliptina Stada

• 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 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 disease of the pancreas (such as pancreatitis)
• gallstones, alcohol addiction, or very high levels of triglycerides 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 kidney problem you have now or have had in the past
• 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 Stada

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 the level of digoxin 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 have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not take this medicine during pregnancy.

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

Driving and using machines

The effect of this medicine on your ability to drive or use machines is negligible. 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 hypoglycemia, which may affect your ability to drive and use machines or work without a safe support.

Sitagliptina Stada contains sodium and lactose

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

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

3. How to take Sitagliptina Stada

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Dose

The recommended dose is 100 mg once a day.

Method of administration

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

Kidney problems

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

Other medicines and recommendations

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 Stada than you should

If you take more of this medicine than you should, 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 your 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 Stada

Continue taking this medicine while your doctor prescribes it for you to continue helping 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 immediately if you notice any of the following serious side effects:

Not known(frequency cannot be estimated from the available data)

? 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.

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

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

Some patients experienced the following side 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
• somnolence

Some patients experienced the following side effects when they started taking sitagliptin and metformin together.

Common

• different types of stomach discomfort

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

Common

• flatulence
• swelling of hands or feet

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

Common

• swelling of hands or feet

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

Common

• flu

Uncommon

• dry mouth

Some patients experienced the following side effects while taking sitagliptin alone during clinical trials or after approval, 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
• arthrosis
• pain in the arm or leg

Uncommon

• dizziness
• constipation
• itching

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

• reduction in the number of platelets

Not known

• kidney problems (which may 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 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 Medicines and Healthcare Products Agency (AEMPS) website (http://www.aemps.gob.es/). By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Sitagliptina Stada

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, label of the bottle, 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 Stada

• The active substance is sitagliptin. Each film-coated tablet (tablet) contains sitagliptin hydrochloride monohydrate, equivalent to 25 mg of sitagliptin.
• The other ingredients are: calcium hydrogen phosphate, microcrystalline cellulose, sodium croscarmellose, sodium stearyl fumarate, magnesium stearate.

The film coating contains: lactose monohydrate, hypromellose, titanium dioxide (E171), triacetin, iron oxide red (E172).

Appearance and packaging

The 25 mg film-coated tablets are round, biconvex, approximately 6 mm in diameter, pink, engraved with "LC" on one side.

Sitagliptina Stada 25 mg is available in packs of 14, 28, 30, 56, and 98 tablets and in bottles of 100 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder

Laboratorio STADA, S.L.

Frederic Mompou 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

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 medicine is authorised in the Member States of the European Economic Area under the following names:

Netherlands Sitagliptine CF 25 mg, filmomhulde tabletten

Austria Sitagliptin STADA 25 mg Filmtabletten

Belgium Sitagliptin EG 25 mg, filmomhulde tabletten

Greece σιταγλιπτ?νης STADA 25 mg επικαλυμμ?να με λεπτ? υμ?νιο δισκ?α (SITAGLIPTIN/STADA 25 mg film-coated tablets)

Germany Sitagliptin STADA 25 mg Filmtabletten

Denmark Sitagliptin STADA

Spain Sitagliptina STADA 25 mg comprimidos recubiertos con película EFG

Finland Sitagliptin STADA 25 mg kalvopäällysteiset tabletit

France Sitagliptine EG 25 mg, comprimé pelliculé

Iceland Sitagliptin STADA 25 mg filmuhúðaðar töflur

Luxembourg Sitagliptin EG 25 mg comprimés pelliculés

Portugal Sitagliptina Ciclum

Sweden Sitagliptin STADA 25 mg filmdragerad tablet

Date of last revision of this leaflet:May 2022

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