ADIMUPLAN 50 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Adimuplan, 25 mg, coated tablets
3. Adimuplan, 50 mg, coated tablets
4. Adimuplan, 100 mg, coated tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for you.
   2. Package Leaflet Contents:
5. What is Adimuplan and what is it used for
6. Important information before taking Adimuplan
   1. When not to take Adimuplan
   2. Warnings and precautions
   3. Children and adolescents
   4. Adimuplan and other medicines
   5. Pregnancy and breastfeeding
   6. Driving and using machines
   7. Adimuplan contains sodium
7. How to take Adimuplan
   1. If you take more Adimuplan than you should
   2. If you forget to take Adimuplan
   3. If you stop taking Adimuplan
8. Possible side effects
   1. Reporting side effects
9. How to store Adimuplan
10. Contents of the pack and other information
    1. What Adimuplan contains
    2. What Adimuplan looks like and contents of the pack
    3. Marketing authorization holder and manufacturer
    4. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
    5. For further information about this medicine, please contact the local representative of the marketing authorization holder:

Package Leaflet: Information for the Patient

Adimuplan, 25 mg, coated tablets

Adimuplan, 50 mg, coated tablets

Adimuplan, 100 mg, 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.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you. 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 or pharmacist. See section 4.

Package Leaflet Contents:

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

1. What is Adimuplan and what is it used for

Adimuplan 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 made by the body.
Your doctor has prescribed this medicine to reduce high blood sugar levels caused by type 2 diabetes. This medicine can be used alone or in combination with other medicines that reduce blood sugar levels (insulin, metformin, sulfonylurea derivatives, or glitazones) that you are already taking for type 2 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 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, loss of vision, and limb amputation.

2. Important information before taking Adimuplan

When not to take Adimuplan

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

Warnings and precautions

Before taking Adimuplan, discuss this with your doctor or pharmacist.
There have been reports of pancreatitis (see section 4) in patients taking Adimuplan.
If you develop blisters on your skin, this may be a sign of a condition called bullous pemphigoid. Your doctor may advise you to stop taking Adimuplan.
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. 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;
• an allergic reaction to Adimuplan (see section 4).

Because 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). Your 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 when used in children under 10 years of age.

Adimuplan and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, and about 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 Adimuplan with digoxin, your doctor should monitor your digoxin blood levels.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before taking this medicine. Do not take this medicine during pregnancy.
It is not known whether this medicine passes into breast milk. If you are breastfeeding or plan to breastfeed, do not take Adimuplan.

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 reported, 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.

Adimuplan 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 Adimuplan

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 coated tablet;
• once a day;
• taken orally.

If you have kidney problems, your doctor may prescribe a lower dose of Adimuplan (e.g., 25 mg or 50 mg).
This medicine can be taken with or without food and drink.
Your doctor may advise you to take only this medicine or this medicine and certain other medicines that reduce blood sugar levels. Diet and exercise help your body make better use of the sugar in your blood. While taking Adimuplan, it is important to follow the diet and exercise plan recommended by your doctor.

If you take more Adimuplan than you should

If you have taken more Adimuplan than you should, contact your doctor immediately.

If you forget to take Adimuplan

If you miss a dose, take it as soon as you remember. 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 to make up for a forgotten dose.

If you stop taking Adimuplan

To maintain control of your blood sugar levels, you should continue to take this medicine for as long as your doctor recommends. Do not stop taking this medicine without first talking to your doctor.
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 Adimuplan 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, 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 your diabetes.
In some patients, the following side effects have been 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
Some patients have experienced various stomach problems after starting treatment with sitagliptin in combination with metformin (common).
In some patients taking sitagliptin in combination with a sulfonylurea derivative and metformin, the following side effects have been reported:
Very common (may affect more than 1 in 10 people): low blood sugar levels
Common: constipation
In some patients taking sitagliptin and pioglitazone, the following side effects have been reported:
Common: bloating, swelling of the hands or feet
In some patients taking sitagliptin, pioglitazone, and metformin, the following side effects have been reported:
Common: swelling of the hands or feet
In some patients taking sitagliptin and insulin (with or without metformin), the following side effects have been reported:
Common: flu
Uncommon: dry mouth
In some patients taking sitagliptin alone or with other anti-diabetic medicines in clinical studies or after the medicine was marketed, the following side effects have been reported:
Common: low blood sugar levels, headache, upper respiratory tract infections, stuffy nose or sinusitis, and sore throat, osteoarthritis, arm or leg pain
Uncommon: dizziness, constipation, itching
Rare: reduced platelet count
Frequency not known: kidney disease (sometimes requiring dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease (a condition in which the tissue and space around the air sacs of the lungs become inflamed), 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, pharmacist, or nurse. You can also report side effects directly to the Department of Drug Safety 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.
You can also report side effects 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 Adimuplan

Keep this medicine out of the 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 storage instructions for this medicine.
The blister should be opened immediately before taking the tablet.
Do not use this medicine if the packaging is damaged or shows signs of opening.
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 Adimuplan contains

The active substance is sitagliptin.
Adimuplan, 25 mg, coated tablets
Each coated tablet contains sitagliptin phosphate monohydrate equivalent to 25 mg of sitagliptin.
Adimuplan, 50 mg, coated tablets
Each coated tablet contains sitagliptin phosphate monohydrate equivalent to 50 mg of sitagliptin.
Adimuplan, 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), hydroxypropyl cellulose (470 mPa·s), macrogol 6000, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), talc.
In addition, Adimuplan, 100 mg coated tablets: black iron oxide (E 172).

What Adimuplan looks like and contents of the pack

Adimuplan, 25 mg, coated tablets
Pink, round, biconvex coated tablet with "ST 25" engraved on one side, with a diameter of 5.7 mm - 6.6 mm.
Adimuplan, 50 mg, coated tablets
Light pink, round, biconvex coated tablet with "ST 50" engraved on one side, with a diameter of 7.7 mm - 8.6 mm.
Adimuplan, 100 mg, coated tablets
Light brown, round, biconvex coated tablet with "ST 100" engraved 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
Adimuplan 25 mg, film-coated tablets
Adimuplan 50 mg, film-coated tablets
Adimuplan 100 mg, film-coated tablets
Estonia
ADIMUPLAN
Greece
ADIMUPLAN
Croatia
ADIMUPLAN 25 mg film-coated tablets
ADIMUPLAN 50 mg film-coated tablets
ADIMUPLAN 100 mg film-coated tablets
Spain
ALTUXERIN
Lithuania
ADIMUPLAN 25 mg film-coated tablets
ADIMUPLAN 50 mg film-coated tablets
ADIMUPLAN 100 mg film-coated tablets
Latvia
ADIMUPLAN 25 mg coated tablets
ADIMUPLAN 50 mg coated tablets
ADIMUPLAN 100 mg coated tablets
Poland
ADIMUPLAN
Romania
ADIMUPLAN 100 mg film-coated tablets
Slovenia
ADIMUPLAN 50 mg film-coated tablets
ADIMUPLAN 100 mg film-coated tablets
Slovakia
ADIMUPLAN 50 mg
ADIMUPLAN 100 mg

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

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