Simlerid

Package Leaflet: Information for the Patient

Simlerid, 25 mg, coated tablets

Simlerid, 50 mg, coated tablets

Simlerid, 100 mg, 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.
In case of any doubts, consult a doctor or pharmacist.
This medicine has been prescribed to you by a doctor and should not be given to others.
The medicine may harm another person, even if their symptoms are the same.
If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

1. What is Simlerid and what is it used for

Simlerid 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. The medicine can be used alone or in combination with other medicines (insulin, metformin, sulfonylurea derivatives, or glitazones) that lower blood sugar levels, which may already be taken for diabetes, along with diet and a physical exercise program.
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 diseases, such as heart disease, kidney disease, vision loss, and limb amputation.

2. Important information before taking Simlerid

When not to take Simlerid

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

Warnings and precautions

Before starting to take Simlerid, the patient should discuss it with their doctor or pharmacist.
There have been reports of pancreatitis (see section 4) in patients taking Simlerid.
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 Simlerid.
The patient should inform their doctor if they have or have had:

• pancreatic disease (e.g., pancreatitis);
• gallstones, alcohol dependence, or very high triglyceride levels 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 Simlerid (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 derivative or insulin, it may cause low blood sugar levels (hypoglycemia). The doctor may reduce the dose of the sulfonylurea derivative 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.

Simlerid 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 diseases). When taking Simlerid with digoxin, the patient's digoxin blood levels should be monitored.

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 the medicine passes into breast milk. If the patient is breastfeeding or plans to breastfeed, they should not take Simlerid.

Driving and using machines

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

Simlerid 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 Simlerid

This medicine should always be taken exactly as prescribed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
The recommended dose is:

• one 100 mg coated tablet;
• once a day;
• taken orally.

If the patient has kidney problems, the doctor may prescribe a lower dose of Simlerid (e.g., 25 mg or 50 mg).
This medicine can be taken with or without food and drinks.
The doctor may recommend taking only this medicine or this medicine and certain other medicines that lower blood sugar levels. Diet and physical exercise help the body use sugar in the blood better. When taking Simlerid, it is essential to follow the diet and exercise recommended by the doctor.

Taking a higher dose of Simlerid than recommended

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

Missing a dose of Simlerid

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 to make up for the missed dose.

Stopping Simlerid treatment

To maintain control of blood sugar levels, the medicine should be taken for as long as prescribed by the doctor. 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 Simlerid 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
Some patients experienced various gastrointestinal symptoms after starting treatment with sitagliptin in combination with metformin (commonly).
In some patients who took sitagliptin in combination with a sulfonylurea derivative 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, pioglitazone, and metformin, the following side effects occurred:
Common: swelling of the hands or feet
In some patients who took sitagliptin and insulin (with or without metformin), the following side effects occurred:
Common: flu
Uncommon: dry mouth
In some patients who took sitagliptin alone or with other anti-diabetic medicines in clinical trials or after the medicine was marketed, the following side effects occurred:
Common: low blood sugar levels, headache, upper respiratory tract infections, stuffy nose or sinusitis, and sore throat, joint pain, arm or leg 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 (a disease of the lung tissue), bullous pemphigoid (a type of blisters on the skin).

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Medicinal Product 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 Simlerid

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month.
There are no special precautions for storing the medicine.
Open the blister just before taking the tablet.
Do not use this medicine if the packaging is damaged or shows signs of tampering.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Simlerid contains

The active substance is sitagliptin.
Simlerid, 25 mg, coated tablets
Each coated tablet contains sitagliptin phosphate monohydrate equivalent to 25 mg of sitagliptin.
Simlerid, 50 mg, coated tablets
Each coated tablet contains sitagliptin phosphate monohydrate equivalent to 50 mg of sitagliptin.
Simlerid, 100 mg, coated tablets
Each coated tablet contains sitagliptin phosphate monohydrate equivalent to 100 mg of sitagliptin.
The other ingredients are: calcium hydrogen phosphate, microcrystalline cellulose, sodium carmellose, magnesium stearate, sodium stearyl fumarate, hypromellose (type 2910, 6 mPa · s), hydroxypropylcellulose (470 mPa · s), macrogol 6000, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), talc.
In addition, Simlerid, 100 mg coated tablets:black iron oxide (E 172).

What Simlerid looks like and contents of the pack

Simlerid, 25 mg, coated tablets
Pink, round, biconvex coated tablet with the inscription "ST 25" on one side, with a diameter of 5.7 mm - 6.6 mm.
Simlerid, 50 mg, coated tablets
Light pink, round, biconvex coated tablet with the inscription "ST 50" on one side, with a diameter of 7.7 mm - 8.6 mm.
Simlerid, 100 mg, coated tablets
Light brown, round, biconvex coated tablet with the inscription "ST 100" on one side, with a diameter of 9.7 mm - 10.6 mm.
The medicine is available in blisters of OPA/Aluminum/PVC/Aluminum foil or transparent blisters of PVC/PE/PVDC/Aluminum foil, each containing 28 coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl
Austria
Manufacturer
Lek Pharmaceuticals d.d.
Trimlini 2D
9220 Lendava,
Slovenia
Lek S.A
ul. Podlipie 16
95-010 Stryków
Poland

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

Netherlands
Simlerid 25 mg, film-coated tablets
Simlerid 50 mg, film-coated tablets
Simlerid 100 mg, film-coated tablets
Poland
Simlerid
Romania
Simlerid 100 mg film-coated tablets

For further information about this medicine, the patient should contact their local representative of the marketing authorization holder:

Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00
Date of last revision of the leaflet:11/2022