Sitagliptin Olpha

Leaflet attached to the packaging: patient information

Sitagliptin Olpha, 25 mg, film-coated tablets

Sitagliptin Olpha, 50 mg, film-coated tablets

Sitagliptin Olpha, 100 mg, film-coated tablets

Sitagliptin

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

Keep this leaflet, you may need to read it again.
In case of any doubts, consult a doctor, pharmacist, or nurse.
This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse.
See section 4.

Table of contents of the leaflet

• 1. What is Sitagliptin Olpha and what is it used for
• 2. Important information before taking Sitagliptin Olpha
• 3. How to take Sitagliptin Olpha
• 4. Possible side effects
• 5. How to store Sitagliptin Olpha
• 6. 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 to increase the amount of insulin released after a meal and decrease the amount of sugar produced by the body.
The doctor has prescribed this medicine to reduce high blood sugar levels caused by type 2 diabetes. This medicine can be used alone or in combination with certain other medicines (insulin, metformin, sulfonylurea derivatives, or glitazones) that lower blood sugar levels, which may already be taken for diabetes, along with diet and exercise.
What is type 2 diabetes?
Type 2 diabetes is a disease in which the body does not produce enough insulin, and the insulin produced does not work properly. The body may also produce too much sugar.
If 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 amputation.

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

In patients taking Sitagliptin Olpha, cases of pancreatitis (see section 4) have been reported.
If the patient develops blisters on the skin, it may be a sign of a disease called bullous pemphigoid. The doctor may advise the patient to stop taking sitagliptin.
The patient should inform their doctor if they have or have 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 (see section 4) may increase;
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 currently present;
an allergic reaction to sitagliptin (see section 4).
Since 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 sulfonylurea derivatives or insulin, it may cause low blood sugar levels (hypoglycemia). The doctor may reduce the dose of sulfonylurea derivatives 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 when used in children under 10 years of age.

Sitagliptin Olpha and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
In particular, the patient should inform their doctor if they are taking digoxin (a medicine used to treat heart rhythm disorders and other heart conditions). When taking Sitagliptin Olpha with digoxin, the patient's digoxin blood levels should be monitored.

Sitagliptin Olpha with food and drink

This medicine can be taken with or without food and drink.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
This medicine should not be used during pregnancy.
It is not known whether this medicine passes into breast milk. This medicine should not be used during breastfeeding or if the patient plans to breastfeed.

Driving and using machines

This medicine has no or negligible influence on the ability to drive and use machines. However, when driving or using machines, the patient should take into account that dizziness and drowsiness have been reported.
Taking this medicine with sulfonylurea derivatives or insulin may cause low blood sugar levels (hypoglycemia), which can affect the ability to drive and use machines or work without safe support for their feet.

Sitagliptin Olpha contains sodium

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

3. How to take Sitagliptin Olpha

This medicine should always be taken exactly as prescribed by the doctor. In case of doubt, the patient should consult their doctor or pharmacist.
The recommended dose is:
one 100 mg film-coated tablet;
once a day;
taken orally.
If the patient has kidney problems, 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 and drink.
The doctor may prescribe this medicine alone or with other medicines that lower blood sugar levels.
Diet and exercise help the body use the sugar in the blood better. When taking Sitagliptin Olpha, it is important to follow the diet and exercise prescribed by the doctor.

Taking a higher dose of Sitagliptin Olpha than recommended

In case of taking a higher dose of this medicine than recommended, the patient should contact their doctor immediately.

Missing a dose of Sitagliptin Olpha

In case of missing a dose, the patient should take it as soon as possible. If it is almost time for the next dose, the patient should skip the missed dose and continue taking the medicine as usual.
The patient should not take a double dose.

Stopping treatment with Sitagliptin Olpha

To maintain control of blood sugar levels, the patient should take this medicine for as long as their doctor prescribes it. The patient should not stop taking this medicine without consulting their doctor first.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The patient should STOP taking Sitagliptin Olpha and contact their doctor immediately if they experience any of the following serious side effects:
Severe and persistent abdominal pain (in the stomach area), which may radiate to the back, with or without nausea and vomiting - these may be symptoms of pancreatitis.
In case of a severe allergic reaction (frequency not known), including rash, hives, blisters on the skin, or peeling skin, and swelling of the face, lips, tongue, and throat, which may cause difficulty breathing or swallowing, the patient should stop taking the medicine and contact their doctor immediately. The doctor may prescribe a medicine to treat the allergic reaction and another medicine to treat diabetes.
In some patients who added sitagliptin to metformin, the following side effects 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
In some patients, various gastrointestinal symptoms occurred after starting treatment with sitagliptin in combination with metformin (common).
In some patients who took sitagliptin in combination with sulfonylurea derivatives and metformin, the following side effects occurred:
Very common (may affect more than 1 in 10 people): low blood sugar levels
Common: constipation
In some patients who took sitagliptin and pioglitazone, the following side effects occurred:
Common: bloating, swelling of the hands or feet
In some patients who took sitagliptin in combination with pioglitazone and metformin, the following side effects occurred:
Common: swelling of the hands or feet
In some patients who took sitagliptin in combination with insulin (with or without metformin), the following side effects occurred:
Common: flu
Uncommon: dry mouth
In some patients who took sitagliptin alone in clinical trials or took sitagliptin alone and/or with other anti-diabetic medicines after marketing authorization, the following side effects occurred:
Common: low blood sugar levels, headache, upper respiratory tract infections, stuffy nose or sinusitis, and sore throat, joint or limb pain
Uncommon: dizziness, constipation, itching
Rare: decreased platelet count
Frequency not known: kidney disease (sometimes requiring dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of blisters on the skin)

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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 will help to gather more information on the safety of this medicine.

5. How to store Sitagliptin Olpha

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after "EXP". The expiry date refers to the last day of the month.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Sitagliptin Olpha contains

The active substance of the medicine is sitagliptin:
Each 25 mg film-coated tablet of Sitagliptin Olpha contains sitagliptin hydrochloride monohydrate, equivalent to 25 mg of sitagliptin.
Each 50 mg film-coated tablet of Sitagliptin Olpha contains sitagliptin hydrochloride monohydrate, equivalent to 50 mg of sitagliptin.
Each 100 mg film-coated tablet of Sitagliptin Olpha contains sitagliptin hydrochloride monohydrate, equivalent to 100 mg of sitagliptin.
­
The other ingredients (excipients) are:
Core of the tablet:
Calcium hydrogen phosphate, microcrystalline cellulose 102 (E460), sodium carmellose (E468), colloidal anhydrous silica, sodium stearyl fumarate, magnesium stearate (E470b).
Coating of the tablet:

• Sitagliptin Olpha, 25 mg, film-coated tabletspolyvinyl 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 tabletspolyvinyl 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 "S" marked on one side.
­ Sitagliptin Olpha, 100 mg, film-coated tablets: round, beige film-coated tablets.
Non-transparent blisters (PVC/PE/PVDC and aluminum) in a carton, containing 28, 30, 56, and 98 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization 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 medicine is authorized 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 pellicule
Latvia: Sitagliptin Olpha 25 mg, 50 mg, 100 mg apvalkotās tabletes
Lithuania: Sitagliptin Olpha 25 mg, 50 mg, 100 mg plėvele dengtos tabletės
Slovakia: Sitagliptin Olpha Filmom obalené tablet
Spain: Sitagliptina Olpha 25 mg, 50 mg, 100 mg comprimidos recubiertos con película

Date of last revision of the leaflet: