Adimuplan

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.
In case of any doubts, consult your doctor or pharmacist.
This medicine has been prescribed to you personally. Do not give it to others.
The medicine may harm another person, even if their symptoms are the same.
If you experience any side effects, including those not listed in this package leaflet, tell 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. Package contents 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 produced by the body.
Your 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 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, vision loss, 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 it with your doctor or pharmacist.
Patients taking Adimuplan have reported cases of pancreatitis (see section 4).
If you experience blisters on your skin, it may be a sign of a disease 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 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, past or present;
• allergic reaction to Adimuplan (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 sulfonylurea derivatives or insulin, it may cause low blood sugar levels (hypoglycemia). Your doctor may reduce the dose of sulfonylurea derivatives 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.

Adimuplan and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
In particular, tell your doctor if you are taking digoxin (a medicine used to treat heart rhythm disorders and other heart diseases). 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, consult your doctor or pharmacist before taking this medicine. Do not take this medicine during pregnancy.
It is not known whether the 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 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 lower blood sugar levels. Diet and physical exercise help your body use the sugar in your blood. While taking Adimuplan, it is important to follow the diet and exercise program recommended by your doctor.

Taking a higher dose of Adimuplan than recommended

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

Missing a dose of Adimuplan

If you miss a dose, take it as soon as possible. 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 missed dose.

Stopping treatment with 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 consulting 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 Adimuplan and contact your doctor immediately if you 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, 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 who added sitagliptin to metformin, the following side effects were 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 experienced various stomach problems after starting treatment with sitagliptin in combination with metformin (common).
In some patients who took sitagliptin in combination with sulfonylurea derivatives and metformin, the following side effects were reported:
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 were reported:
Common: bloating, swelling of the hands or feet
In some patients who took sitagliptin, pioglitazone, and metformin, the following side effects were reported:
Common: swelling of the hands or feet
In some patients who took sitagliptin and insulin (with or without metformin), the following side effects were reported:
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 were reported:
Common: low blood sugar levels, headache, upper respiratory tract infections, stuffy nose or sinusitis, and sore throat, joint or muscle 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 condition affecting the tissue and space around the air sacs of the lungs), 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, tell 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 precautions for storage.
Open the blister just before taking the tablet.
Do not use the 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. Package contents 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 the inscription "ST 25" 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 the inscription "ST 50" 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 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 PVC/PE/PVDC/Aluminum foil blisters, 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 more information about this medicine, contact the 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 package leaflet:11/2022