Adimuplan

Package leaflet: Information for the patient

Adimuplan, 25 mg, film-coated tablets
Adimuplan, 50 mg, film-coated tablets
Adimuplan, 100 mg, film-coated tablets
Sitagliptin
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
Keep this leaflet, as you may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not share it with others.
This medicine may harm another person, even if their symptoms are the same as yours.
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 Adimuplan is and what it is 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 Adimuplan is and what it is 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 glucose levels in adult patients with type 2 diabetes.
This medicine helps increase the amount of insulin 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 (such as insulin, metformin, sulfonylureas, or glitazones) that you may already be taking, 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 properly. The body may also produce too much glucose. When this happens, 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. Information before taking Adimuplan

When not to take Adimuplan

• 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 to take Adimuplan, discuss this with your doctor or pharmacist.
Cases of pancreatitis have been reported in patients taking Adimuplan (see section 4).
If the patient develops blisters on the skin, this may be a symptom of a disease known as bullous pemphigoid. The doctor may advise the patient to stop taking Adimuplan.
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 complication of diabetes characterized by high blood sugar levels, rapid weight loss, nausea or vomiting);
• any kidney diseases, either currently or in the past;
• an allergic reaction to Adimuplan (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 or insulin, it may lead to low blood sugar (hypoglycaemia). The 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.
Adimuplan and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or 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 Adimuplan together 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 child, she should consult her doctor or pharmacist before taking this medicine. This medicine should not be used during pregnancy.
It is not known whether the medicine passes into breast milk. If the patient is breastfeeding or plans to breastfeed, she should not take Adimuplan.
Driving and operating machinery
This medicine has no effect or a negligible effect on the ability to drive and operate machinery. However, dizziness and somnolence have been reported, which may affect the ability to drive and operate machinery.
Taking this medicine together with medicines called sulfonylureas or with insulin may lead to low blood sugar (hypoglycaemia), which may affect the ability to drive and operate machinery or working without secure foot support.
Adimuplan 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 Adimuplan

This medicine should always be taken as directed by the physician. In case of doubt, please
consult a 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 recommend a lower dose of
Adimuplan (e.g. 25 mg or 50 mg).
This medicine can be taken regardless of meals or drinks.
The doctor may recommend treatment with this medicine alone or in combination with other
medicines that reduce blood sugar levels. Diet and physical exercise help the body to use
blood sugar more effectively. While taking Adimuplan, it is important to follow the diet and
exercise regimen recommended by the physician.
Taking more than the recommended dose of Adimuplan
If more than the recommended dose of this medicine is taken, contact a doctor immediately.
Missing a dose of Adimuplan
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 Adimuplan
To maintain control of blood sugar levels, this medicine should be taken for as long as directed
by the physician. Do not stop taking this medicine without first consulting the doctor.
If there are any further doubts regarding the use of this medicine, consult a 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 Adimuplan and contact your doctor immediately if any of the following severe adverse reactions occur:
Severe and persistent abdominal pain (in the stomach area), possibly radiating to the back, with or without nausea and vomiting – these may be symptoms of pancreatitis.
In case of a severe allergic reaction (frequency unknown), including rash, hives, skin blisters or skin peeling, and swelling of the face, lips, tongue or throat, which may cause difficulty in breathing or swallowing, the medicine should be discontinued and medical advice should be sought immediately. The doctor may prescribe a medicine to treat the allergic reaction and another medicine to treat diabetes.
The following adverse reactions have been reported in some patients when sitagliptin was added to metformin:
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, diarrhoea, constipation, drowsiness.
Some patients experienced various gastrointestinal symptoms after starting treatment with sitagliptin in combination with metformin (common).
The following adverse reactions have been reported in some patients when sitagliptin was used 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 when sitagliptin was used in combination with pioglitazone:
Common: bloating, swelling of hands or feet
The following adverse reactions have been reported in some patients when sitagliptin was used in combination with pioglitazone and metformin:
Common: swelling of hands or feet
The following adverse reactions have been reported in some patients when sitagliptin was used 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 when sitagliptin was used alone or in combination with other antidiabetic medicines in clinical trials or after marketing authorization:
Common: low blood sugar levels, headache, upper respiratory tract infections, nasal congestion 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, lung inflammation (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 to provide more information on the safety of the medicine.

5. How to store Adimuplan

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard package and
blister pack after EXP. The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Open the blister pack immediately before taking the tablet.
Do not use the medicine if the packaging is damaged or shows signs of prior opening.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer in use. This will help protect
the environment.

6. Contents of the packaging and other information

What the medicine Adimuplan contains
The active substance is sitagliptin.
Adimuplan 25 mg, film-coated tablets
Each film-coated tablet contains sitagliptin hydrochloride monohydrate equivalent to 25 mg of sitagliptin.
Adimuplan 50 mg, film-coated tablets
Each film-coated tablet contains sitagliptin hydrochloride monohydrate equivalent to 50 mg of sitagliptin.
Adimuplan 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),
hydroxypropyl cellulose (470 mPa  s), macrogol 6000, titanium dioxide (E 171), yellow iron oxide (E 172),
red iron oxide (E 172), black iron oxide (E 172), talc.
Additionally, Adimuplan 100 mg, film-coated tablets contain: black iron oxide (E 172).

What Adimuplan looks like and contents of the pack
Adimuplan 25 mg, film-coated tablets
Pink, round, biconvex film-coated tablet with the imprint “ST 25” on one side, with a diameter of 5.7 mm – 6.6 mm.
Adimuplan 50 mg, film-coated tablets
Light pink, round, biconvex film-coated tablet with the imprint “ST 50” on one side, with a diameter of 7.7 mm – 8.6 mm.
Adimuplan 100 mg, film-coated tablets
Light brown, round, biconvex film-coated tablet with the imprint “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 or transparent blisters made of PVC/PE/PVDC/Aluminium, 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 European Economic Area countries under the following names:
Netherlands Adimuplan 25 mg, filmomhulde tabletten
Adimuplan 50 mg, filmomhulde tabletten
Adimuplan 100 mg, filmomhulde tabletten
Estonia ADIMUPLAN
Greece ADIMUPLAN
Croatia ADIMUPLAN 25 mg filmom obložene tablete
ADIMUPLAN 50 mg filmom obložene tablete
ADIMUPLAN 100 mg filmom obložene tablete
Spain ALTUXERIN
Lithuania ADIMUPLAN 25 mg plėvele dengtos tabletės
ADIMUPLAN 50 mg plėvele dengtos tabletės
ADIMUPLAN 100 mg plėvele dengtos tabletės
Latvia ADIMUPLAN 25 mg apvalkotās tabletes
ADIMUPLAN 50 mg apvalkotās tabletes
ADIMUPLAN 100 mg apvalkotās tabletes
Poland ADIMUPLAN
Romania ADIMUPLAN 100 mg comprimate filmate
Slovenia ADIMUPLAN 50 mg filmsko obložene tablete
ADIMUPLAN 100 mg filmsko obložene tablete
Slovakia ADIMUPLAN 50 mg
ADIMUPLAN 100 mg

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