Sitagliptin adamed

Package leaflet: Information for the patient

Sitagliptin Adamed, film-coated tablets, 25 mg
Sitagliptin Adamed, film-coated tablets, 50 mg
Sitagliptin Adamed, film-coated tablets, 100 mg
Sitagliptinum
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. 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 any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

1. What Sitagliptin Adamed is and what it is used for
2. Before you take Sitagliptin Adamed
3. How to take Sitagliptin Adamed
4. Possible side effects
5. How to store Sitagliptin Adamed
6. Contents of the pack and other information

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

Sitagliptin Adamed contains the active substance sitagliptin, which belongs to a group of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors), which lower blood glucose levels in adult patients with type 2 diabetes.
This medicine helps increase the amount of insulin released after a meal and also reduces the amount of sugar produced by the body.
Your doctor has prescribed this medicine to help lower your blood sugar levels caused by type 2 diabetes. This medicine may be used alone or in combination with certain other medicines (insulin, metformin, sulfonylureas, or glitazones) that lower blood sugar (glucose) levels, which 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, and the insulin produced does not work as well as it should. Your body may also produce too much sugar. In this situation, glucose (sugar) builds up in the blood. This may lead to serious health problems such as heart disease, kidney disease, vision loss, and limb amputation.

2. Before you take Sitagliptin Adamed

Do not take Sitagliptin Adamed

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

Warnings and precautions

Pancreatitis (inflammation of the pancreas) has been observed in patients taking sitagliptin (see section 4).
The appearance of blisters on the skin may be a sign of a disease known as bullous pemphigoid. Your doctor may advise you to stop taking Sitagliptin Adamed.
Tell 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; these conditions may increase the risk of pancreatitis (see section 4);
• type 1 diabetes;
• diabetic ketoacidosis (a diabetes complication associated with high glucose levels, rapid weight loss, nausea, or vomiting);
• current or past kidney problems;
• allergic reaction to Sitagliptin Adamed (see section 4).

It is unlikely that this medicine will cause low blood sugar levels, as it does not act when blood sugar is low. However, if this medicine is used in combination with a sulfonylurea or insulin, low blood sugar (hypoglycaemia) may occur. Your doctor may reduce the dose of the sulfonylurea 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.

Sitagliptin Adamed with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, tell your doctor if you are taking digoxin (a medicine used to treat irregular heartbeat and other heart problems). It may be necessary to monitor digoxin levels in your blood if it is taken together with Sitagliptin Adamed.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your 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 if you are breastfeeding or plan to breastfeed.

Driving and using machines
This medicine has no or 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 in combination with medicines such as sulfonylureas and insulin may cause hypoglycaemia, which may affect the ability to drive and use machines or work without safe foot support.

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

3. How to take Sitagliptin Adamed

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 kidney problems, the doctor may prescribe a lower dose (e.g. 25 mg
or 50 mg).
This medicine can be taken with or without food.
Your doctor may prescribe this medicine to be taken alone or in combination with other
specific blood glucose-lowering medicines.
Diet and physical activity may help your body use glucose more effectively. While taking
Sitagliptin Adamed, it is important to continue following the diet and physical activity plan
recommended by your doctor.
Taking more Sitagliptin Adamed than prescribed
If you take more of this medicine than prescribed, contact your doctor immediately.
Missing a dose of Sitagliptin Adamed
If a dose is missed, take it as soon as you remember. However, if it is almost time for the
next dose, skip the missed dose and return to your regular dosing schedule. Do not take a
double dose of this medicine.
Stopping Sitagliptin Adamed
This medicine should be taken for the duration prescribed by your doctor in order to
continuously help control blood glucose levels. Do not stop taking this medicine without
consulting your doctor first.
If you have any further doubts about how to use 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.
YOU MUST STOP taking Sitagliptin Adamed and contact your doctor IMMEDIATELY if the patient notices any of the following serious adverse reactions:

• severe and persistent abdominal pain (in the stomach area), which may radiate to the back and may, but need not, be accompanied by nausea and vomiting, as these may be symptoms of pancreatitis.

In case of a severe allergic reaction (frequency unknown), including rash, hives, skin blisters/skin peeling, and swelling of the face, lips, tongue, and throat, which may cause difficulty breathing or swallowing, you must stop taking this medicine and contact your doctor immediately. Your doctor may prescribe a medicine to treat the allergic reaction, as well as another medicine to treat diabetes.

The following adverse reactions have been reported in some patients when sitagliptin was added to metformin therapy:

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): abdominal pain, diarrhoea, constipation, drowsiness

Various types of stomach discomfort occurred in some patients when starting combination therapy with sitagliptin and metformin (frequency: common).

The following adverse reactions have been reported in some patients taking sitagliptin in combination with a sulfonylurea and metformin:

Very common (may affect more than 1 in 10 people): low blood sugar levels
Common: constipation

The following adverse reactions have been reported in some patients taking sitagliptin and pioglitazone:

Common: bloating, swelling of hands or feet

The following adverse reactions have been reported in some patients taking sitagliptin in combination with pioglitazone and metformin:

Common: swelling of hands or feet

The following adverse reactions have been reported in some patients taking sitagliptin in combination with insulin (with or without metformin):

Common: influenza-like illness
Uncommon: dry mouth

The following adverse reactions have been reported in some patients taking sitagliptin alone and/or in combination with other antidiabetic medicines during clinical trials or after marketing authorization:

Common: low blood sugar levels, headache, upper respiratory tract infections, nasal congestion or runny nose, sore throat, osteoarthritis, pain in upper or lower limb
Uncommon: dizziness, constipation, itching
Rare: decreased platelet count
Frequency not known: kidney problems (sometimes requiring dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of blistering skin condition).

Reporting of adverse reactions

If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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.

By reporting adverse reactions, more information can be gathered about the safety of this medicine.

5. How to store Sitagliptin Adamed

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 carton after "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. These measures will help protect the environment.

6. Contents of the package and other information

What Sitagliptin Adamed contains

• The active substance is sitagliptin. Each film-coated tablet contains sitagliptin hydrochloride monohydrate, corresponding to 25 mg, 50 mg or 100 mg of sitagliptin, respectively.
• Other ingredients are:
  Tablet core: calcium hydrogen phosphate, microcrystalline cellulose, sodium croscarmellose, sodium stearyl fumarate, magnesium stearate.
  Tablet coating: polyvinyl alcohol, macrogol 4000, titanium dioxide (E 171), talc, iron oxide red (E 172) and iron oxide yellow (E 172).

What Sitagliptin Adamed looks like and contents of the pack
25 mg tablet: orange, round, biconvex film-coated tablet with the number "25" embossed on one side.
50 mg tablet: orange, round, biconvex film-coated tablet with the number "50" embossed on one side.
100 mg tablet: orange, round, biconvex film-coated tablet with the number "100" embossed on one side.
Packaging
Blister packs (PVC/PVDC/Aluminium)
Packages contain 28 or 98 film-coated tablets in blisters, placed in a cardboard box.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Manufacturer
Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice