Sitagliptin Stada

Package Leaflet: Information for the User

Sitagliptin STADA, 50 mg, film-coated tablets
Sitagliptin STADA, 100 mg, film-coated tablets
Sitagliptin

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

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

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

Sitagliptin STADA contains the active substance sitagliptin, which belongs to a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors), which reduce blood sugar levels in adults with type 2 diabetes.
This medicine helps to increase the amount of insulin released after a meal and decrease the amount of sugar produced by the body.
Your doctor has prescribed this medicine to reduce high blood sugar levels caused by type 2 diabetes. The medicine can be used alone or in combination with other medicines that reduce blood sugar levels (insulin, metformin, sulfonylureas, or glitazones) that you are already taking for diabetes, along with a suitable diet and exercise program.
What is type 2 diabetes
Type 2 diabetes is a condition where the body does not produce enough insulin, and the insulin produced does not work as it should. The body may also produce too much sugar. If this happens, sugar (glucose) builds up in the blood. This can lead to serious diseases such as heart disease, kidney disease, loss of vision, and limb amputation.

2. Important information before taking Sitagliptin STADA

When not to take Sitagliptin STADA

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

Warnings and precautions

In patients taking sitagliptin, cases of pancreatitis (see section 4) have been reported.
If you experience blisters on your skin, this may be a sign of a condition called bullous pemphigoid. Your doctor may advise you to stop taking Sitagliptin STADA.
Tell your doctor if you have or have had:

• pancreatic disease (e.g., pancreatitis);
• gallstones, alcohol dependence, or very high levels of triglycerides (a type of fat) in the blood. In these situations, the risk of pancreatitis (see section 4) may increase;
• 4);
• type 1 diabetes;
• diabetic ketoacidosis (a complication of diabetes characterized by high blood sugar levels, rapid weight loss, nausea, or vomiting);
• any kidney disease that has occurred in the past or is present;
• an allergic reaction to Sitagliptin STADA (see section 4).

Because this medicine does not work when blood sugar levels are low, it is unlikely to cause low blood sugar levels. However, if this medicine is taken with a sulfonylurea or insulin, it may cause low blood sugar levels (hypoglycemia). Your doctor may reduce the dose of the sulfonylurea or insulin.

Children and adolescents

Children and adolescents under 18 years of age should not take this medicine. This medicine is not effective in children and adolescents from 10 to 17 years of age. It is not known if this medicine is safe and effective when used in children under 10 years of age.

Sitagliptin STADA and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take.
In particular, tell your doctor if you are taking digoxin (a medicine used to treat heart rhythm disorders and other heart conditions). When taking Sitagliptin STADA with digoxin, your doctor should check your digoxin blood levels.

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 while breastfeeding or if you plan to breastfeed.

Driving and using machines

This medicine has no or negligible influence on the ability to drive and use machines. However, dizziness and drowsiness have been reported, which may affect the ability to drive and use machines.
Taking this medicine with sulfonylureas or insulin may cause low blood sugar levels (hypoglycemia), which can affect the ability to drive and use machines or work without safe foot support.

Sitagliptin STADA contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially 'sodium-free'.

3. How to take Sitagliptin STADA

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Dosage
The recommended dose is 100 mg once a day.
Method of administration
Oral use. Sitagliptin STADA can be taken with or without food and drink.
Kidney problems
If you have kidney problems, your doctor may prescribe a lower dose of the medicine (such as 25 mg or 50 mg).
Other medicines and advice
Your doctor may prescribe this medicine alone or with other medicines that reduce blood sugar levels.
Diet and exercise help your body use blood sugar better. While taking Sitagliptin STADA, it is important to follow the diet and exercise program recommended by your doctor.

What to do if you take more Sitagliptin STADA than you should

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

What to do if you forget to take Sitagliptin STADA

If you forget to take a dose, take it as soon as you remember. If it is almost 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 forgotten dose.

What to do if you stop taking Sitagliptin STADA

To keep your blood sugar levels under control, you should keep taking this medicine for as long as your doctor tells you to. Do not stop taking this medicine without talking to your doctor first.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects may be serious and require immediate medical attention:

Stop taking Sitagliptin STADA and contact your doctor immediately if you experience any of the following serious side effects:

Frequency not known(frequency cannot be estimated from the available data)

• severe and persistent abdominal pain (in the stomach area), which may radiate to the back, with or without nausea and vomiting - this may be a sign of pancreatitis
• severe allergic reaction, including rash, hives, blisters on the skin, or peeling skin, as well as swelling of the face, lips, tongue, and throat, which may cause difficulty breathing or swallowing.

Your doctor may prescribe a medicine to treat an allergic reaction and another medicine to treat diabetes.
In some patients, after adding sitagliptin to metformin, the following side effects have occurred:
Common(may affect up to 1 in 10 people)

• low blood sugar levels
• nausea
• bloating
• vomiting

Uncommon(may affect up to 1 in 100 people)

• stomach pain
• diarrhea
• constipation
• drowsiness

Some patients have experienced the following side effects after starting treatment with sitagliptin in combination with metformin:

Common

• various stomach problems

In some patients, after taking sitagliptin in combination with a sulfonylurea and metformin, the following side effects have occurred:
Very common(may affect more than 1 in 10 people)

• low blood sugar levels

Common

• constipation

In some patients, after taking sitagliptin and pioglitazone, the following side effects have occurred:

Common

• bloating
• swelling of the hands or feet

In some patients, after taking sitagliptin in combination with pioglitazone and metformin, the following side effects have occurred:

Common

• swelling of the hands or feet

In some patients, after taking sitagliptin in combination with insulin (with or without metformin), the following side effects have occurred:

Common

• flu

Uncommon

• dry mouth

In some patients, after taking sitagliptin alone in clinical trials or after taking sitagliptin alone and/or with other anti-diabetic medicines after marketing authorization, the following side effects have occurred:

Common

• low blood sugar levels
• headache
• upper respiratory tract infections
• stuffy or runny nose and sore throat
• inflammation of the bones and joints
• hand or foot pain

Uncommon

• dizziness
• constipation
• itching

Rare

• reduced number of blood platelets

Frequency not known

• kidney disease (sometimes requiring dialysis)
• vomiting
• joint pain
• muscle pain
• back pain
• interstitial lung disease
• bullous pemphigoid (a type of blistering skin condition)

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sitagliptin 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 and carton after EXP. The expiry date refers to the last day of that month.
There are no special storage instructions for this medicine.
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

What Sitagliptin STADA contains

The active substance is sitagliptin.
Sitagliptin STADA, 50 mg: each film-coated tablet contains sitagliptin phosphate monohydrate equivalent to 50 mg sitagliptin.
Sitagliptin STADA, 100 mg: each film-coated tablet contains sitagliptin phosphate monohydrate equivalent to 100 mg sitagliptin.
The other ingredients are: calcium hydrogen phosphate, microcrystalline cellulose, sodium carboxymethylcellulose, sodium stearyl fumarate, magnesium stearate.
The coating contains: polyvinyl alcohol, titanium dioxide (E 171), macrogol, talc, yellow iron oxide (E 172), red iron oxide (E 172).

What Sitagliptin STADA looks like and contents of the pack

Sitagliptin STADA, 50 mg, are round, biconvex, film-coated tablets, approximately 8 mm in diameter, orange, with "C" engraved on one side.
Sitagliptin STADA, 100 mg, are round, biconvex, film-coated tablets, approximately 9.8 mm in diameter, beige, with "L" engraved on one side.
Each carton with blisters contains 14, 28, 30, 56, or 98 film-coated tablets.
Each carton with a bottle contains 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
(logo of the marketing authorization holder)
Manufacturer:
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
LABORATORIOS LICONSA S.A.
Avenida Miralcampo 7
Polígono Industrial Miralcampo
19200 Azuqueca de Henares (Guadalajara)
Spain
STADA Arzneimittel GmbH
Muthgasse 36/2
1190 Vienna
Austria
Centrafarm Services B.V.
Van de Reijtstraat 31 E
4814 NL Breda
Netherlands

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

Netherlands:
Sitagliptine CF 25 mg, film-coated tablets
Sitagliptine CF 50 mg, film-coated tablets
Sitagliptine CF 100 mg, film-coated tablets
Austria
Sitagliptin STADA 25 mg film-coated tablets
Sitagliptin STADA 50 mg film-coated tablets
Sitagliptin STADA 100 mg film-coated tablets
Belgium:
Sitagliptin EG 25 mg, film-coated tablets
Sitagliptin EG 50 mg, film-coated tablets
Sitagliptin EG 100 mg, film-coated tablets
Greece:
σιταγλιπτίνης STADA 25 mg επικαλυμμένα με λεπτό υμένιο δισκία (SITAGLIPTIN/STADA 25mg film-coated tablets)
σιταγλιπτίνης STADA 50 mg επικαλυμμένα με λεπτό υμένιο δισκία (SITAGLIPTIN/STADA 50 mg film-coated tablets)
σιταγλιπτίνης STADA 100 mg επικαλυμμένα με λεπτό υμένιο δισκία (SITAGLIPTIN/STADA 100 mg film-coated tablets)
Czech Republic
Sitagliptin STADA
Germany:
Sitagliptin STADA 25 mg film-coated tablets
Sitagliptin STADA 50 mg film-coated tablets
Sitagliptin STADA 100 mg film-coated tablets
Denmark:
Sitagliptin STADA
Spain:
Sitagliptina STADA 25 mg film-coated tablets EFG
Sitagliptina STADA 50 mg film-coated tablets EFG
Sitagliptina STADA 100 mg film-coated tablets EFG
Finland:
Sitagliptin STADA 25 mg film-coated tablets
Sitagliptin STADA 50 mg film-coated tablets
Sitagliptin STADA 100 mg film-coated tablets
France:
Sitagliptine EG 25 mg, film-coated tablets
Sitagliptine EG 50 mg, film-coated tablets
Sitagliptine EG 100 mg, film-coated tablets
Iceland:
Sitagliptin STADA 25 mg film-coated tablets
Sitagliptin STADA 50 mg film-coated tablets
Sitagliptin STADA 100 mg film-coated tablets
Luxembourg
Sitagliptin EG 25 mg film-coated tablets
Sitagliptin EG 50 mg film-coated tablets
Sitagliptin EG 100 mg film-coated tablets
Poland
Sitagliptin STADA
Portugal:
Sitagliptina Ciclum
Sweden:
Sitagliptin STADA 25 mg film-coated tablets
Sitagliptin STADA 50 mg film-coated tablets
Sitagliptin STADA 100 mg film-coated tablets
Slovenia:
Sitagliptin STADA 50 mg film-coated tablets
Sitagliptin STADA 100 mg film-coated tablets
Slovakia:
Sitagliptin STADA 100 mg film-coated tablets
Date of last revision of the leaflet:05/2022