Simlerid

Package leaflet: Information for the patient

Simlerid, 25 mg, film-coated tablets
Simlerid, 50 mg, film-coated tablets
Simlerid, 100 mg, film-coated tablets
Sitagliptinum
Please read this leaflet carefully before taking this medicine, as 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 or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others.
This medicine may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
Contents of the leaflet:

1. What Simlerid is and what it is used for
2. What you need to know 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 Simlerid is and what it is 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 glucose levels in adult patients with type 2 diabetes.
This medicine helps increase insulin levels 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. The medicine may be used alone or in combination with other glucose-lowering medicines (insulin, metformin, sulfonylureas, or glitazones) that you may already be taking for diabetes, along with diet and exercise.

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 produces too much glucose. When this occurs, sugar (glucose) accumulates in the blood. This may lead to serious health problems such as heart disease, kidney disease, vision loss, and limb amputations.

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 Simlerid, discuss this with your doctor or pharmacist.
Cases of pancreatitis have been reported in patients taking Simlerid (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 Simlerid.
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 diabetes complication characterized by high blood sugar levels, rapid weight loss, nausea or vomiting);
• any kidney problems in the past or currently;
• an allergic reaction to Simlerid (see section 4).

Since this medicine does not act when blood sugar levels are low, it is unlikely to cause excessively low blood sugar levels. However, if this medicine is taken together with a sulfonylurea derivative or insulin, low blood sugar (hypoglycaemia) may occur. 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 unknown whether this medicine is safe and effective for use in children under 10 years of age.
Simlerid with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient 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 taking Simlerid with digoxin, blood levels of digoxin 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 taking this medicine. This medicine should not be used during pregnancy.
It is unknown whether the medicine passes into breast milk. If the patient is breastfeeding or planning to breastfeed, she should not take Simlerid.
Driving and using machines
This medicine has no effect or a negligible effect on the ability to drive and use machines. However, dizziness and drowsiness have been reported, which may affect the ability to drive and use machines.
Taking this medicine together with medicines called sulfonylurea derivatives or with insulin may lead to low blood sugar (hypoglycaemia), which may affect the ability to drive and use machines or working without secure foot support.
Simlerid contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".

3. How to take Simlerid

This medicine should always be taken as directed by the doctor. If in doubt, consult
the 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
Simlerid (e.g. 25 mg or 50 mg).
This medicine can be taken independently of meals and drinks.
The doctor may recommend using only this medicine or this medicine together with certain other
medicines that reduce blood sugar levels. Diet and physical exercise help the body to use blood
sugar more effectively. While taking Simlerid, it is important to follow the diet and perform the
physical exercises recommended by the doctor.
Taking more Simlerid than recommended
If more than the recommended dose of this medicine is taken, contact the doctor immediately.
Missing a dose of Simlerid
If a dose is missed, take it as soon as possible. If it is almost time for the next dose, skip the
missed dose and continue with the regular dosing schedule. Do not take a double dose to make up
for a missed dose.
Stopping Simlerid
To maintain control of blood sugar levels, the medicine should be taken for as long as the doctor
prescribes. Do not stop taking this medicine without first consulting the doctor.
If there are any further doubts regarding the use of this medicine, consult the doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You should DISCONTINUE Simlerid and contact your doctor immediately if any of the following serious adverse reactions occur:
Severe and persistent abdominal pain (in the stomach area), possibly radiating towards 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, urticaria, skin blisters or skin peeling, and swelling of the face, lips, tongue or throat, which may cause difficulty in breathing or swallowing, you must stop taking the 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, the following adverse reactions occurred when sitagliptin was added to metformin:
Frequent (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.
Some patients experienced various gastrointestinal symptoms after starting treatment with sitagliptin in combination with metformin (commonly occurring).

In some patients using 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
Frequent: constipation

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

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

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

In some patients using sitagliptin alone and/or with other antidiabetic medicines in clinical trials or after marketing authorization, the following adverse reactions occurred:
Frequent: low blood sugar levels, headache, upper respiratory tract infections, stuffy 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, pneumonia (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, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Simlerid

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard packaging and blister, following EXP. The expiry date refers to the last day of the specified month.
No special storage conditions are required for this medicine.
Open the blister immediately before taking the tablet.
Do not use this medicine if the packaging is damaged or shows any signs of tampering.
Medicines must not be disposed of via the sewage system 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 Simlerid contains
The active substance is sitagliptin.
Simlerid 25 mg, film-coated tablets
Each film-coated tablet contains sitagliptin hydrochloride monohydrate equivalent to 25 mg of sitagliptin.
Simlerid 50 mg, film-coated tablets
Each film-coated tablet contains sitagliptin hydrochloride monohydrate equivalent to 50 mg of sitagliptin.
Simlerid 100 mg, film-coated tablets
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,
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.
Additionally, Simlerid 100 mg film-coated tablets contain black iron oxide (E 172).

What Simlerid looks like and contents of the pack
Simlerid 25 mg, film-coated tablets
Pink, round, biconvex film-coated tablet, engraved with "ST 25" on one side, with a diameter of 5.7 mm – 6.6 mm.
Simlerid 50 mg, film-coated tablets
Light pink, round, biconvex film-coated tablet, engraved with "ST 50" on one side, with a diameter of 7.7 mm – 8.6 mm.
Simlerid 100 mg, film-coated tablets
Light brown, round, biconvex film-coated tablet, engraved with "ST 100" on one side, with a diameter of 9.7 mm – 10.6 mm.
The medicine is available in blisters made of OPA/Aluminium/PVC/Aluminium foil or transparent blisters made of PVC/PE/PVDC/Aluminium foil, containing 28 film-coated tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl
Austria

Manufacturers
Lek Pharmaceuticals d.d.
Trimlini 2D
9220 Lendava,
Slovenia
Lek S.A.
ul. Podlipie 16
95-010 Stryków
Poland

This medicinal product is authorised in the member states of the European Economic Area under the following names:
Netherlands Simlerid 25 mg, filmomhulde tabletten
Simlerid 50 mg, filmomhulde tabletten
Simlerid 100 mg, filmomhulde tabletten
Poland Simlerid
Romania Simlerid 100 mg comprimate filmate

For further information about this medicine, contact the local representative of the Marketing Authorisation Holder:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00