Sitagliptin Olpha

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

Sitagliptin

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

Keep this package leaflet, you may need to read it again.
In case of any doubts, consult your doctor, pharmacist, or nurse.
This medicine has been prescribed to you by your doctor. 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 those not listed in this package leaflet, please inform your doctor, pharmacist, or nurse.
See section 4.

Table of Contents of the Package 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.
Your doctor has prescribed this medicine to reduce high blood sugar levels caused by type 2 diabetes. This medicine can be taken alone or in combination with certain other medicines (insulin, metformin, sulfonylureas, 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 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 health problems, such as heart disease, kidney disease, loss of vision, and limb amputation.

2. Important information before taking Sitagliptin Olpha

When not to take Sitagliptin Olpha

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 Olpha, cases of pancreatitis (see section 4) have been reported.
If you experience blisters on your skin, it may be a sign of a disease called bullous pemphigoid. Your doctor may advise you to stop taking sitagliptin.
Inform 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;
type 1 diabetes;
diabetic ketoacidosis (a complication of diabetes characterized by high blood sugar levels, rapid weight loss, nausea, or vomiting);
any kidney disease, past or present;
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 a sulfonylurea or insulin, low blood sugar levels (hypoglycemia) may occur. Your doctor may reduce the dose of the sulfonylurea or insulin.

Children and adolescents

Do not take this medicine if you are under 18 years old. This medicine is not effective in children and adolescents aged 10 to 17 years. It is not known if this medicine is safe and effective in children under 10 years of age.

Sitagliptin Olpha and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
In particular, inform your doctor if you are taking digoxin (a medicine used to treat heart rhythm disorders and other heart conditions). When taking Sitagliptin Olpha with digoxin, your doctor should monitor your digoxin blood levels.

Sitagliptin Olpha with food and drink

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan 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, when driving or operating machinery, consider that dizziness and drowsiness have been reported.
Taking this medicine with sulfonylureas or insulin may cause low blood sugar levels (hypoglycemia), which can affect your ability to drive or operate machinery or work without safe foot support.

Sitagliptin Olpha 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 Olpha

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The usual recommended dose is:
one 100 mg film-coated tablet;
once a day;
taken orally.
If you have kidney problems, your 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.
Your doctor may prescribe this medicine alone or with other medicines that lower blood sugar levels.
Diet and exercise help your body use the sugar in your blood. While taking Sitagliptin Olpha, it is important to follow the diet and exercise plan recommended by your doctor.

Taking a higher dose of Sitagliptin Olpha than recommended

If you take more of this medicine than you should, 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 your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose.

Stopping treatment with Sitagliptin Olpha

To maintain control of your blood sugar levels, you should continue to take this medicine for as long as your doctor tells you. Do not stop taking this medicine without first talking to your doctor.
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.
STOP taking Sitagliptin Olpha and contact your doctor immediately if you 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, stop taking this medicine and contact your doctor immediately. Your 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 were reported:
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 who started taking sitagliptin with metformin, various gastrointestinal symptoms were reported (commonly).
In some patients who took sitagliptin with a sulfonylurea and metformin, the following side effects were reported:
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 were reported:
Common: bloating, swelling of the hands or feet
In some patients who took sitagliptin with pioglitazone and metformin, the following side effects were reported:
Common: swelling of the hands or feet
In some patients who took sitagliptin with insulin (with or without metformin), the following side effects were reported:
Common: flu
Uncommon: dry mouth
In some patients who took sitagliptin alone in clinical trials or took sitagliptin with other anti-diabetic medicines after marketing authorization, the following side effects were reported:
Common: low blood sugar levels, headache, upper respiratory tract infections, stuffy or runny nose and sore throat, joint or muscle 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 blistering skin condition)

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. 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, 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sitagliptin Olpha

Keep this medicine out of the sight and reach of children.
Do not take this medicine after the expiry date 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. This will help protect the environment.

6. Contents of the pack and other information

What Sitagliptin Olpha contains

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

• 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.
Opaque 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 package leaflet: