Package leaflet: Information for the user

Sansik, 5 mg, coated tablets
Linagliptin
Please read all of this leaflet carefully before taking this medicine because 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 other people, even if their symptoms are the same as yours.
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any side effects not listed in this leaflet. See section 4.

Contents of the leaflet

What Sansik is and what it is used for
What you need to know before taking Sansik
How to take Sansik
Possible side effects
How to store Sansik
Contents of the pack and other information

1. What Sansik is and what it is used for

Sansik contains the active substance linagliptin, which belongs to a group of medicines called
"oral antidiabetic agents". Oral antidiabetic agents are used to treat high blood sugar levels. These medicines help your body reduce the amount of sugar in the blood.
Sansik is used to treat type 2 diabetes in adults when the disease cannot be adequately controlled with a single oral antidiabetic medicine (metformin or sulfonylurea derivatives) or with diet and exercise alone. Sansik may be used together with other antidiabetic medicines such as metformin, sulfonylurea derivatives (e.g. glimepiride, glipizide), empagliflozin, or insulin.
It is important to continue the diet and exercise recommended by your doctor or nurse.

2. Important information before taking Sansik

When not to take Sansik

if the patient is allergic to linagliptin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting Sansik, discuss this with your doctor, pharmacist, or
nurse:

if the patient has type 1 diabetes (the patient's body does not produce insulin) or diabetic ketoacidosis (a diabetes complication characterized by high blood sugar levels, rapid weight loss, nausea, or vomiting). Sansik must not be used to treat these conditions.
if the patient is taking an antidiabetic medicine called a "sulfonylurea derivative" (e.g. glimepiride, glipizide), the doctor may recommend reducing the dose of the sulfonylurea derivative when Sansik is used concomitantly, to avoid excessively lowering blood sugar levels.
if the patient has had an allergic reaction to any other medicines previously used to lower blood sugar levels.
if the patient has or has previously had pancreas disease.

If the patient develops symptoms of acute pancreatitis, such as severe and persistent stomach pain (abdominal pain), contact a doctor.
If the patient develops blisters on the skin, this may be a sign of a disease called bullous pemphigoid. The doctor may advise the patient to stop taking Sansik.
Diabetic skin changes are common complications of diabetes. Follow the skin and foot care advice provided by the doctor or nurse.
Children and adolescents
Sansik is not recommended for use in children and adolescents under 18 years of age. It is not effective in children and adolescents aged 10 to 17 years. It is unknown whether this medicine is safe and effective when used in children under 10 years of age.
Sansik 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, tell the doctor if the patient is taking medicines containing any of the following active substances:

carbamazepine, phenobarbital, or phenytoin. These medicines may be used to treat seizures (epilepsy) or chronic pain.
rifampicin. This is an antibiotic used to treat infections such as tuberculosis.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
It is unknown whether Sansik is harmful to unborn children; therefore, it is recommended to avoid taking Sansik during pregnancy.
It is not known whether Sansik passes into human milk. The doctor must decide whether to discontinue breastfeeding or to discontinue/withhold Sansik therapy.
Driving and operating machinery
Sansik has no effect or has a negligible effect on the ability to drive and operate machinery.
However, taking Sansik in combination with sulfonylurea derivatives and/or insulin may cause blood sugar levels to become too low (hypoglycaemia), which may affect the ability to drive and operate machinery or work without strong support for the legs.
Nevertheless, more frequent monitoring of blood sugar (glucose) levels is recommended to minimize the risk of hypoglycaemia, especially when Sansik is used in combination with sulfonylurea derivatives and/or insulin.

3. How to take Sansik

This medicine should always be taken as directed by the physician. In case of doubts, consult
your doctor or pharmacist.
The recommended dose of Sansik is one 5 mg tablet once daily.
Sansik may be taken with or without food.
Your doctor may recommend taking Sansik together with another oral antidiabetic medicine.
All medicines should be used as directed by the physician to achieve the best possible treatment outcome.
Taking more than the recommended dose of Sansik
If more than the recommended dose of Sansik has been taken, contact your doctor immediately.
Missing a dose of Sansik

If a patient forgets to take a dose of Sansik, they should take it as soon as they remember. However, if it is almost time for the next dose, the missed dose should not be taken.
Do not take a double dose to make up for a missed dose. Never take two doses on the same day.

Stopping Sansik treatment
Do not stop taking Sansik without consulting your doctor. Discontinuation of Sansik may lead to increased blood glucose levels.
If you have any further questions regarding the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Some symptoms require immediate medical attention
You should STOP taking Sansik and immediately contact your doctor
if you notice any of the following adverse reactions:
Very common (may affect more than 1 in 10 people)

symptoms related to low blood sugar levels: tremor, sweating, anxiety, blurred vision, tingling of the lips, pallor, mood changes or confusion (hypoglycaemia). Hypoglycaemia is a known adverse reaction of treatment with Sansik when taken concomitantly with metformin and a sulfonylurea derivative.
Rare (may affect up to 1 in 1000 people taking Sansik alone or in combination with other medicinal products used in the treatment of diabetes)
severe and persistent abdominal pain (in the stomach area), which may radiate to the back, as well as nausea and vomiting, as these may be symptoms of pancreatitis.

You should STOP taking Sansik and immediately contact your doctor
if any of the following signs or symptoms of an allergic reaction occur:
Uncommon (may affect up to 1 in 100 people)

allergic reactions (hypersensitivity), which may be serious, including wheezing and shortness of breath (bronchospasm) during treatment with linagliptin as monotherapy or in combination with other medicinal products used in the treatment of diabetes,
rash.

Rare (may affect up to 1 in 1000 people)

urticaria,
swelling of the face, lips, tongue, and throat, which may cause difficulty in breathing or swallowing (angioedema).

Your doctor may prescribe a medicine to treat the allergic reaction and prescribe another medicine for the treatment of diabetes.
Other adverse reactions
During treatment with Sansik as monotherapy or in combination with other medicines used in the treatment of diabetes, the following adverse reactions have occurred in some patients:
Common (may affect up to 1 in 10 people)

increased lipase activity in blood.

Uncommon (may affect up to 1 in 100 people)

inflammation of the nose or throat,
cough,
constipation (in combination with insulin),
increased amylase activity in blood.

Rare (may affect up to 1 in 1000 people)

development of blisters on the skin (bullous pemphigoid).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions 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 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Sansik

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 stated month.
No special temperature storage requirements. Store in the original packaging to protect from moisture.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Sansik contains

The active substance is linagliptin. Each film-coated tablet contains 5 mg of linagliptin.
Other ingredients are:
Tablet core: mannitol, copovidone K25-31, crospovidone type A, magnesium stearate.
Tablet coating (Sheffcoat Pink 30644369): hypromellose 6 mPa*s (E464), titanium dioxide (E171), talc, macrogol (6000), iron oxide red (E172).

What Sansik looks like and contents of the pack
Round, biconvex, pink film-coated tablets with a diameter of 8.1 mm ± 0.5 mm.
Packed in blisters made of OPA/Alu/PVC//Alu foil, contained in a cardboard box.
Pack sizes:
10, 14, 28, 30, 56, 60, 90 and 100 film-coated tablets.
10, 14, 28, 30, 56, 60, 90, 100 film-coated tablets in unit-dose blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Zentiva, k.s.,
U kabelovny 130
Dolní Měcholupy
102 37 Prague 10
Czech Republic
(logo of the marketing authorisation holder)

Manufacturer/Importer
Zentiva, k.s.,
U kabelovny 130
Dolní Měcholupy
102 37 Prague 10
Czech Republic

For further information about this medicinal product, please contact the local representative of the marketing authorisation holder:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
tel.: +48 22 375 92 00

This medicinal product is authorised in the European Economic Area countries under the following names:
Austria, Bulgaria, Croatia, Estonia, Lithuania, Latvia, Poland, Czech Republic, Romania, Slovakia, Hungary: Sansik