Sitagliptin Adamed

Leaflet attached to the packaging: patient information

Sitagliptin Adamed, film-coated tablets, 25 mg

Sitagliptin Adamed, film-coated tablets, 50 mg

Sitagliptin Adamed, film-coated tablets, 100 mg

Sitagliptin

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your 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 Adamed and what is it used for
• 2. Important information before taking 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 is Sitagliptin Adamed and what is it 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 sugar levels in adults with type 2 diabetes.
This medicine helps increase the amount of insulin produced after a meal and also lowers the amount of sugar produced by the body.
Your doctor has prescribed this medicine to help lower your blood sugar levels, which are high because of your type 2 diabetes. This medicine can be used alone or in combination with other medicines that lower blood sugar levels (insulin, metformin, sulfonylurea derivatives, or glitazone), which you may already be taking for your diabetes, along with diet and exercise.

What is type 2 diabetes?
Type 2 diabetes is a condition where the body does not produce enough insulin, and the insulin produced does not work as well as it should. The body may also produce too much sugar. This can lead to serious health problems, such as heart disease, kidney disease, loss of vision, and amputation of limbs.

2. Important information before taking Sitagliptin Adamed

When not to 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

In patients taking sitagliptin, cases of pancreatitis (inflammation of the pancreas) have been observed (see section 4).
The appearance of blisters on the skin may be a sign of a disease called bullous pemphigoid.
Your doctor may advise you to stop taking Sitagliptin Adamed.
You should tell your doctor if you have or have had:

• pancreatic disease (such as 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 complication of diabetes associated with high blood sugar 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 work when blood sugar levels are low. However, if this medicine is taken in combination with a sulfonylurea or insulin, it may cause low blood sugar levels (hypoglycemia). 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 when used in children under 10 years of age.

Sitagliptin Adamed 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, tell your doctor if you are taking digoxin (a medicine used to treat irregular heartbeat and other heart problems). Your doctor may need to check the level of digoxin in your blood if you are taking it with Sitagliptin Adamed.

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.
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 influence on the ability to drive and use machines. However, dizziness and drowsiness have been observed, which may affect the ability to drive and use machines.
Taking this medicine in combination with medicines such as sulfonylurea and insulin may cause low blood sugar levels (hypoglycemia), which may affect the ability to drive and use machines or work without a safe support for your feet.

Sitagliptin Adamed 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 Adamed

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 (such as 25 mg or 50 mg). This medicine can be taken with or without food.

Your doctor may prescribe this medicine alone or in combination with other medicines that lower blood sugar levels.
Diet and exercise can help your body make better use of sugar. While taking Sitagliptin Adamed, it is important to continue with the diet and exercise plan recommended by your doctor.

Taking a higher dose of Sitagliptin Adamed than recommended

If you take more of this medicine than you should, contact your doctor immediately.

Missing a dose of Sitagliptin Adamed

If you miss a dose, take it as soon as you remember. However, if you do not remember until it is time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose of this medicine.

Stopping treatment with Sitagliptin Adamed

Take this medicine for as long as your doctor recommends, so you can keep your blood sugar levels under control. Do not stop taking this medicine without talking to your doctor first.
If you have any further questions on the use of this medicine, 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 Adamed and contact your doctor immediately if you experience any of the following serious side effects:

• severe and persistent stomach pain (in the abdomen), which may radiate to the back and may be accompanied by nausea and vomiting, as these can be symptoms of pancreatitis.

If you experience a severe allergic reaction (frequency not known), including rash, hives, blisters on the skin/peeling of the skin, and swelling of the face, lips, tongue, and throat, which may cause difficulty breathing and 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 your diabetes.
In some patients, the following side effects have been reported after adding sitagliptin to metformin treatment:
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, the following side effects have been reported after taking sitagliptin in combination with sulfonylurea and metformin:
Very common (may affect more than 1 in 10 people): low blood sugar levels
Common: constipation
In some patients, the following side effects have been reported after taking sitagliptin and pioglitazone:
Common: bloating, swelling of the hands or feet
In some patients, the following side effects have been reported after taking sitagliptin in combination with pioglitazone and metformin:
Common: swelling of the hands or feet
In some patients, the following side effects have been reported after taking sitagliptin in combination with insulin (with or without metformin):
Common: flu
Uncommon: dry mouth
In some patients, the following side effects have been reported after taking sitagliptin alone or in combination with other anti-diabetic medicines during clinical trials or after the medicine was marketed:
Common: low blood sugar levels, headache, upper respiratory tract infection, stuffy or runny nose and sore throat, osteoarthritis, pain in the upper or lower limbs
Uncommon: dizziness, constipation, itching
Rare: decreased blood platelet count
Frequency not known: kidney problems (sometimes requiring dialysis), vomiting, stomach pain, 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 any side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 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 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 and carton after 'EXP'. The expiry date refers to the last day of the month.
There are no special storage requirements 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 Adamed contains

• The active substance is sitagliptin. Each film-coated tablet contains sitagliptin phosphate monohydrate, equivalent to 25 mg, 50 mg, or 100 mg of sitagliptin.
• The other ingredients are: Tablet core: calcium hydrogen phosphate, microcrystalline cellulose, sodium carmellose, 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 '25' engraved on one side.
50 mg tablet: orange, round, biconvex film-coated tablet with '50' engraved on one side.
100 mg tablet: orange, round, biconvex film-coated tablet with '100' engraved on one side.

Packaging

Blisters (PVC/PVDC/Aluminium)
Pack sizes: 28, 98 film-coated tablets in blisters, packed in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization 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

Date of last revision of the leaflet: December 2020