Sitagliptin stada

Package leaflet: Information for the user

Sitagliptin STADA, 50 mg, film-coated tablets
Sitagliptin STADA, 100 mg, film-coated tablets
Sitagliptinum
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• 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 a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

1. What Sitagliptin STADA is and what it is used for
2. What you need to know 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 Sitagliptin STADA is and what it is 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 glucose levels in adults with type 2 diabetes.
This medicine helps increase the amount of insulin released after meals and reduces the amount of glucose
produced by the body.
Your doctor has prescribed this medicine to lower high blood glucose levels caused by type 2 diabetes.
This medicine may be used alone or in combination with other glucose-lowering medicines (such as insulin,
metformin, sulfonylureas, or glitazones) that you may already be taking for diabetes, along with an appropriate diet
and an exercise programme.

What is type 2 diabetes?
Type 2 diabetes is a condition in which the body does not produce enough insulin, the insulin produced does not work properly, or the body may also produce too much glucose. When this happens, sugar (glucose) builds up in the blood. This can lead to serious health problems such as heart disease, kidney disease, loss of vision, and limb amputations.

2. Information before using Sitagliptin STADA

When not to use Sitagliptin STADA

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

Warnings and precautions
Pancreatitis has been reported in patients taking sitagliptin (see section 4).
If the patient develops blisters on the skin, this may be a sign of a disease called bullous pemphigoid.
The doctor may advise the patient to stop taking Sitagliptin STADA.
Inform the doctor if the patient has had or currently has:

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

Since this medicine does not work when blood sugar is low, it is unlikely to cause excessively low blood sugar. However, if this medicine is used together with a sulfonylurea or insulin, low blood sugar (hypoglycaemia) may occur. The 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 aged 10 to 17 years. It is not known whether this medicine is safe and effective in children under 10 years of age.
Sitagliptin STADA with other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
In particular, inform the doctor if the patient is taking digoxin (a medicine used to treat heart rhythm disorders and other heart conditions). When Sitagliptin STADA is taken with digoxin, blood digoxin levels should be monitored.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
This medicine should not be used during pregnancy.
It is not known whether this medicine passes into human breast milk. This medicine should not be used during breastfeeding or if breastfeeding is planned.
Driving and operating machinery
This medicine has no effect or a negligible effect on the ability to drive and operate machinery. However, dizziness and drowsiness have been reported, which may affect the ability to drive and operate machinery.
Taking this medicine together with medicines called sulfonylureas or with insulin may lead to hypoglycaemia, which in turn may affect the ability to drive and operate machinery or work without safe foot support.
Sitagliptin STADA contains sodium.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".

3. How to take Sitagliptin STADA

This medicine should always be taken as directed by your doctor. If in doubt, consult your
doctor or pharmacist.
Dosage
The recommended dose is 100 mg once daily.
Method of administration
For oral use. Sitagliptin STADA may be taken regardless of meals or drinks.
Renal function disorders
If the patient has impaired renal function, the doctor may recommend a lower dose of the medicine
(such as 25 mg or 50 mg).
Other medicines and recommendations
The doctor may prescribe this medicine alone or together with certain other blood glucose-lowering medicines.
Diet and physical exercise help the body use blood sugar more effectively.
While taking Sitagliptin STADA, it is important to follow the diet and physical activity regimen recommended by your doctor.
Taking more Sitagliptin STADA than recommended
If you take more than the recommended dose of this medicine, contact your doctor immediately.
Missing a dose of Sitagliptin STADA
If you miss a dose, take it as soon as possible. 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 missed dose.
Stopping treatment with Sitagliptin STADA
To maintain blood sugar control, take this medicine for as long as your doctor has instructed. Do not stop taking this medicine without first consulting your doctor.
If you have any further questions about the use of this medicine, consult 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:
You must stop taking Sitagliptin STADA and contact your doctor immediately if you experience any of
the following serious side effects:
Frequency unknown (frequency cannot be estimated from the available data)

• severe and persistent pain in the stomach area which may spread to the back, with or without nausea and vomiting – these may be symptoms of pancreatitis
• severe allergic reaction, including rash, hives, skin blisters or peeling skin, and swelling of the face, lips, tongue, or throat which may cause difficulty in breathing or swallowing.

Your doctor may prescribe medication to treat the allergic reaction and another medicine to treat diabetes.
The following side effects have been reported in some patients when sitagliptin was added to metformin:
Common (may affect up to 1 in 10 people)

• low blood sugar
• nausea
• bloating
• vomiting

Uncommon (may affect up to 1 in 100 people)

• stomach pain
• diarrhoea
• constipation
• drowsiness

The following side effects have been reported in some patients after starting treatment with sitagliptin in combination with metformin:
Common

• various gastrointestinal disorders

The following side effects have been reported in some patients taking sitagliptin in combination with a sulfonylurea and metformin:
Very common (may affect more than 1 in 10 people)

• low blood sugar

Common

• constipation

The following side effects have been reported in some patients taking sitagliptin with pioglitazone:
Common

• bloating
• swelling of hands or feet

The following side effects have been reported in some patients taking sitagliptin in combination with pioglitazone and metformin:
Common

• swelling of hands or feet

The following side effects have been reported in some patients taking sitagliptin in combination with insulin (with or without metformin):
Common

• influenza-like illness

Uncommon

• dry mouth

The following side effects have been reported in some patients taking sitagliptin alone in clinical trials or after marketing when sitagliptin was used alone and/or with other antidiabetic medicines:
Common

• low blood sugar
• headache
• upper respiratory tract infections
• stuffy or runny nose and sore throat
• bone and joint inflammation
• pain in arms or legs

Uncommon

• dizziness
• constipation
• itching

Rare

• decreased platelet count

Unknown frequency

• kidney disorders (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 worsen or if you experience any side effects not listed in this leaflet, you should inform your doctor.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 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.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store the medicine Sitagliptin STADA

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the cardboard box
after: EXP. The expiry date refers to the last day of the stated month.
No special requirements for the storage of this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What the medicine contains
The active substance is sitagliptin.
Sitagliptin STADA 50 mg: each film-coated tablet contains sitagliptin hydrochloride monohydrate equivalent to 50 mg of sitagliptin.
Sitagliptin STADA 100 mg: each film-coated tablet contains sitagliptin hydrochloride monohydrate equivalent to 100 mg of sitagliptin.
The other ingredients are: calcium hydrogen phosphate, microcrystalline cellulose, sodium croscarmellose, sodium stearyl fumarate, magnesium stearate.
The film-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 in colour, with the letter "C" engraved on one side.
Sitagliptin STADA 100 mg are round, biconvex, film-coated tablets approximately 9.8 mm in diameter, beige in colour, with the letter "L" engraved on one side.
Carton packs containing blisters have 14, 28, 30, 56 or 98 film-coated tablets.
Carton packs containing a bottle have 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
(logo of the marketing authorisation holder)

Manufacturers:
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
The Netherlands

This medicinal product is authorised in the following names in the Member States of the European Economic Area:
Netherlands: Sitagliptine CF 25 mg, filmomhulde tabletten
Sitagliptine CF 50 mg, filmomhulde tabletten
Sitagliptine CF 100 mg, filmomhulde tabletten

Austria: Sitagliptin STADA 25 mg Filmtabletten
Sitagliptin STADA 50 mg Filmtabletten
Sitagliptin STADA 100 mg Filmtabletten

Belgium: Sitagliptin EG 25 mg, filmomhulde tabletten
Sitagliptin EG 50 mg, filmomhulde tabletten
Sitagliptin EG 100 mg, filmomhulde tabletten

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 Filmtabletten
Sitagliptin STADA 50 mg Filmtabletten
Sitagliptin STADA 100 mg Filmtabletten

Denmark: Sitagliptin STADA

Spain: Sitagliptina STADA 25 mg comprimidos recubiertos con película EFG
Sitagliptina STADA 50 mg comprimidos recubiertos con película EFG
Sitagliptina STADA 100 mg comprimidos recubiertos con película EFG

Finland: Sitagliptin STADA 25 mg kalvopäällysteiset tabletit
Sitagliptin STADA 50 mg kalvopäällysteiset tabletit
Sitagliptin STADA 100 mg kalvopäällysteiset tabletit

France: Sitagliptine EG 25 mg, comprimé pelliculé
Sitagliptine EG 50 mg, comprimé pelliculé
Sitagliptine EG 100 mg, comprimé pelliculé

Iceland: Sitagliptin STADA 25 mg filmuhúðaðar töflur
Sitagliptin STADA 50 mg filmuhúðaðar töflur
Sitagliptin STADA 100 mg filmuhúðaðar töflur

Luxembourg: Sitagliptin EG 25 mg comprimés pelliculés
Sitagliptin EG 50 mg comprimés pelliculés
Sitagliptin EG 100 mg comprimés pelliculés

Poland: Sitagliptin STADA

Portugal: Sitagliptina Ciclum

Sweden: Sitagliptin STADA 25 mg filmdragerad tablet
Sitagliptin STADA 50 mg filmdragerad tablet
Sitagliptin STADA 100 mg filmdragerad tablet

Slovenia: Sitagliptin STADA 50 mg filmsko obložene tablete
Sitagliptin STADA 100 mg filmsko obložene tablete

Slovakia: Sitagliptin STADA 100 mg filmom obalené tablety