Package leaflet: Information for the patient

Sitagliptin Olpha, 25 mg, film-coated tablets
Sitagliptin Olpha, 50 mg, film-coated tablets
Sitagliptin Olpha, 100 mg, film-coated tablets
Sitagliptinum
Please read this leaflet carefully before taking this medicine, because it contains
important information for you.
Keep this leaflet so that you can read it again if necessary.
If you have any further questions, please consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse.
See section 4.

Contents of the leaflet

What is Sitagliptin Olpha and what is it used for
What you need to know before taking Sitagliptin Olpha
How to take Sitagliptin Olpha
Possible side effects
How to store Sitagliptin Olpha
Contents of the pack and other information

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

Sitagliptin Olpha 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 increase the levels of insulin released after meals and reduces the amount of sugar produced by the body.
Your doctor has prescribed this medicine to help lower high blood sugar levels caused by type 2 diabetes. This medicine may be used alone or in combination with certain other blood sugar-lowering medicines (insulin, metformin, sulfonylureas, or glitazones) that you may already be taking, along with diet and an exercise program.

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 produce too much sugar. When this happens, sugar (glucose) builds up in the blood. This can lead to serious health problems such as heart disease, kidney disease, vision loss, and limb amputations.

2. Important information before taking Sitagliptin Olpha

When not to take Sitagliptin Olpha
if the patient is allergic to sitagliptin or any of the other ingredients of this medicine
(listed in section 6).

Warnings and precautions
Cases of pancreatitis (see section 4) have been reported in patients taking Sitagliptin Olpha.
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.

Inform the doctor if the patient has or has had in the past:
pancreatic disease (e.g. pancreatitis);
gallstones, alcohol dependence, or very high levels of triglycerides (a type of fat) in the blood. In such cases, the risk of pancreatitis may be increased (see section 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 in the past or currently;
an allergic reaction to sitagliptin (see section 4).

Since this medicine does not work when blood sugar is low, it is unlikely to cause excessively low blood sugar levels. However, if this medicine is taken 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
This medicine should not be used in children and adolescents under 18 years of age. 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 Olpha and other medicines
Tell the doctor or pharmacist if the patient is taking, has recently taken or might take any other medicines.
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 Olpha is taken with digoxin, the concentration of digoxin in the blood should be monitored.

Sitagliptin Olpha with food and drink
This medicine can be taken regardless of meals and drinks.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, thinks she may be pregnant or is planning to have a baby, she should consult her doctor or pharmacist before taking 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 using machines
This medicine has no effect or has a negligible effect on the ability to drive and use machines. However, when driving and using machines, it should be borne in mind that dizziness and drowsiness have been reported.
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 use machines or work without safe foot support.

Sitagliptin Olpha contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. this medicine is considered "sodium-free".

3. How to use Sitagliptin Olpha

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
The usual recommended dose is:
one 100 mg coated tablet;
once daily;
taken orally.
If the patient has impaired kidney function, the doctor may prescribe a lower dose of Sitagliptin Olpha (e.g. 25 mg or 50 mg).
This medicine can be taken with or without food or drink.
Your doctor may recommend taking only this medicine or this medicine together with certain other medicines that lower blood sugar levels.
Diet and physical exercise help the body to use blood sugar more effectively.
While taking Sitagliptin Olpha, it is important to follow the diet and perform the physical exercises recommended by your doctor.
Taking more Sitagliptin Olpha than prescribed
If you take more than the prescribed dose of this medicine, contact your doctor immediately.
Missing a dose of Sitagliptin Olpha
If you miss a dose, take it as soon as possible. If it is almost time for the next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose.
Stopping Sitagliptin Olpha
To maintain control of blood sugar levels, continue taking this medicine for as long as your doctor recommends. 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 adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
DISCONTINUE Sitagliptin Olpha and contact your doctor immediately if any of the following severe adverse reactions occur:
Severe and persistent pain in the upper abdomen, possibly radiating to the back, with or without nausea and vomiting – these may be symptoms of pancreatitis.
In case of a severe allergic reaction (frequency unknown), 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, stop taking the medicine immediately and contact your doctor without delay. Your doctor may prescribe a medicine to treat the allergic reaction and another medicine to treat diabetes.

In some patients, the following adverse reactions occurred when sitagliptin was added to metformin:
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, diarrhoea, constipation, drowsiness

Gastrointestinal disorders of various types occurred in some patients after starting treatment with sitagliptin in combination with metformin (common).

In some patients taking sitagliptin in combination with a sulfonylurea and metformin, the following adverse reactions occurred:
Very common (may affect more than 1 in 10 people): low blood sugar levels
Common: constipation

In some patients taking sitagliptin and pioglitazone, the following adverse reactions occurred:
Common: bloating, swelling of hands or feet

In some patients taking sitagliptin in combination with pioglitazone and metformin, the following adverse reactions occurred:
Common: swelling of hands or feet

In some patients taking sitagliptin in combination with insulin (with or without metformin), the following adverse reactions occurred:
Common: influenza-like illness
Uncommon: dry mouth

In some patients taking sitagliptin alone in clinical trials or after marketing authorization, either alone or in combination with other antidiabetic medicines, the following adverse reactions occurred:
Common: low blood sugar levels, headache, upper respiratory tract infections, nasal congestion or runny nose and sore throat, bone and joint inflammation, pain in arm or leg
Uncommon: dizziness, constipation, itching
Rare: decreased platelet count
Frequency not known: kidney disorders (sometimes requiring dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of skin blistering)

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Sitagliptin Olpha

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and the cardboard box
following "EXP". The expiry date refers to the last day of the specified month.
No special storage conditions are required for 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 help protect the environment.

6. Contents of the pack and other information

What Sitagliptin Olpha contains
The active substance is sitagliptin:
Each coated tablet (tablet) of Sitagliptin Olpha 25 mg contains sitagliptin hydrochloride monohydrate equivalent to 25 mg of sitagliptin.
Each coated tablet (tablet) of Sitagliptin Olpha 50 mg contains sitagliptin hydrochloride monohydrate equivalent to 50 mg of sitagliptin.
Each coated tablet (tablet) of Sitagliptin Olpha 100 mg contains sitagliptin hydrochloride monohydrate equivalent to 100 mg of sitagliptin.
Other components (excipients):
Tablet core:
Calcium hydrogen phosphate, microcrystalline cellulose 102 (E460), sodium croscarmellose (E468), colloidal anhydrous silica, sodium stearyl fumarate, magnesium stearate (E470b).
Tablet coating:

Sitagliptin Olpha, 25 mg, film-coated tablets: polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b), black iron oxide (E172), yellow iron oxide (E172), red iron oxide (E172).
Sitagliptin Olpha, 50 mg, film-coated tablets; Sitagliptin Olpha, 100 mg, film-coated tablets: polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b), yellow iron oxide (E172), red iron oxide (E172).

What Sitagliptin Olpha looks like and contents of the pack
Sitagliptin Olpha, 25 mg, film-coated tablets: round, pink film-coated tablets.
Sitagliptin Olpha, 50 mg, film-coated tablets: round, light beige film-coated tablets with the imprint “S” on one side.
Sitagliptin Olpha, 100 mg, film-coated tablets: round, beige film-coated tablets.
Opaque blisters (PVC/PE/PVDC and aluminium) in cardboard boxes containing 28, 30, 56, and 98 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Olpha AS,
Rupnicu iela 5,
Olaine, Olaines novads, LV-2114,
Latvia
e-mail: [email protected]

Manufacturer
SAG MANUFACTURING, S.L.U.
Carretera Nacional 1 Km 36
28750 San Agustin de Guadalix, Madrid
Spain
GALENICUM HEALTH, S.L.U
Sant Gabriel 50
08950 Esplugues de Llobregat, Barcelona
Spain

This medicinal product is authorised in the member states of the European Economic Area under the following names:
Malta: Sitagliptin Olpha 25 mg, 50 mg, 100 mg film-coated tablets
Czech Republic, Estonia, Italy, Poland: Sitagliptin Olpha
Germany: Sitagliptin Olpha 25 mg, 50 mg, 100 mg Filmtabletten
France: Sitagliptine Olpha 25 mg, 50 mg, 100 mg comprimé pelliculé
Latvia: Sitagliptin Olpha 25 mg, 50 mg, 100 mg apvalkotas tabletes
Lithuania: Sitagliptin Olpha 25 mg, 50 mg, 100 mg plėvele dengtos tabletės
Slovakia: Sitagliptin Olpha Filmom obalené tablety
Spain: Sitagliptina Olpha 25 mg, 50 mg, 100 mg comprimidos recubiertos con película