SANSIK 5 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Sansik, 5 mg, film-coated tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for you.
   2. Contents of the pack
3. What is Sansik and what is it used for
4. Important information before taking Sansik
   1. When not to take Sansik
   2. Warnings and precautions
   3. Children and adolescents
   4. Sansik with other medicines
   5. Pregnancy and breast-feeding
   6. Driving and using machines
5. How to take Sansik
   1. If you take more Sansik than you should
   2. If you forget to take Sansik
   3. If you stop taking Sansik
6. Possible side effects
   1. Some symptoms require immediate medical attention
   2. Reporting of side effects
7. How to store Sansik
8. Contents of the pack and other information
   1. What Sansik contains
   2. What Sansik looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer/Importer
   5. This medicine is authorized in the Member States of the European Economic Area under the following names:

Package Leaflet: Information for the User

Sansik, 5 mg, film-coated tablets

Linagliptin

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

• You should 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 them, 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 possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Sansik and what is it used for

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

2. Important information before taking Sansik

When not to take Sansik

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

Warnings and precautions

Before taking Sansik, talk to your doctor, pharmacist, or nurse if:

• you have type 1 diabetes (your body does not produce insulin) or diabetic ketoacidosis (a complication of diabetes characterized by high blood sugar levels, rapid weight loss, nausea, or vomiting). Sansik should not be used to treat these conditions.
• you are taking a sulfonylurea medicine (e.g. glimepiride, glipizide), your doctor may advise you to reduce the dose of the sulfonylurea medicine if you are taking Sansik, to avoid too low blood sugar levels.
• you have had an allergic reaction to any other medicine used to lower blood sugar levels.
• you have or have had pancreatitis (inflammation of the pancreas).

If you get symptoms of acute pancreatitis, such as severe and persistent stomach pain (abdominal pain), contact your doctor.
If you get blisters on your skin, it may be a sign of a condition called bullous pemphigoid. Your doctor may advise you to stop taking Sansik.
Diabetic skin changes are common complications of diabetes. You should follow the advice on skin and foot care given by your doctor or nurse.

Children and adolescents

Sansik is not recommended for use in children and adolescents below 18 years of age. It is not effective in children and adolescents aged 10 to 17 years. It is not known if this medicine is safe and effective when used in children below 10 years of age.

Sansik with other medicines

Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, and about any medicines you plan to take.
In particular, tell your doctor if you are taking medicines containing any of the following active substances:

• carbamazepine, phenobarbital, or phenytoin. These medicines are used to treat epilepsy or chronic pain.
• rifampicin. This is an antibiotic used to treat infections, such as tuberculosis.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
It is not known if Sansik is harmful to the unborn baby. Therefore, it is recommended to avoid taking Sansik during pregnancy.
It is not known if Sansik passes into breast milk. Your doctor will decide whether you should stop breast-feeding or stop/withhold Sansik therapy.

Driving and using machines

Sansik has no or negligible influence on the ability to drive and use machines.
Taking Sansik in combination with sulfonylurea and/or insulin may cause too low blood sugar levels (hypoglycemia), which may affect your ability to drive and use machines or work without strong support for your legs.
However, it is recommended to check your blood sugar levels more frequently to minimize the risk of hypoglycemia, especially when taking Sansik in combination with sulfonylurea and/or insulin.

3. How to take Sansik

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose of Sansik is one 5 mg tablet once a day.
Sansik can be taken with or without food.
Your doctor may advise you to take Sansik in combination with another oral anti-diabetic medicine. You should take all your medicines as advised by your doctor to get the best results.

If you take more Sansik than you should

If you take more Sansik than you should, contact your doctor immediately.

If you forget to take Sansik

• If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, do not take the missed dose.
• Do not take a double dose to make up for a forgotten dose. Never take two doses on the same day.

If you stop taking Sansik

Do not stop taking Sansik without talking to your doctor first. If you stop taking Sansik, your blood sugar levels may increase.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some symptoms require immediate medical attention

STOP taking Sansik and contact your doctor immediately if you notice any of the following side effects:
Very common (may affect more than 1 in 10 people)

• symptoms of low blood sugar: shaking, sweating, anxiety, blurred vision, tingling of the lips, pallor, mood changes, or confusion (hypoglycemia). Hypoglycemia is a known side effect of Sansik when taken in combination with metformin and sulfonylurea.
• severe and persistent stomach pain (in the abdomen), which may radiate to the back, as well as nausea and vomiting, as these may be symptoms of pancreatitis.

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

• allergic reactions (hypersensitivity), which can be serious, including wheezing and shortness of breath (bronchospasm) when taking linagliptin alone or in combination with other diabetes medicines,
• rash.

Rare (may affect up to 1 in 1,000 people)

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

Your doctor may prescribe a medicine to treat an allergic reaction and prescribe another medicine to treat diabetes.
Other side effects
When taking Sansik alone or in combination with other diabetes medicines, some patients have reported the following side effects:
Common (may affect up to 1 in 10 people)

• increased activity of lipase in the blood.

Uncommon (may affect up to 1 in 100 people)

• nasopharyngitis (inflammation of the nose and throat),
• cough,
• constipation (when taken in combination with insulin),
• increased activity of amylase in the blood.

Rare (may affect up to 1 in 1,000 people)

• formation of blisters on the skin (bullous pemphigoid).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet.
Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to 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
Side effects can also be reported 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 Sansik

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month.
There are no special storage conditions for this medicine. Store in the original package to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will 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.
• The 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.
Packaged in OPA/Alu/PVC//Alu blisters in a carton 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 single-dose blisters.
Not all pack sizes may be marketed.

Marketing authorization holder

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

Manufacturer/Importer

Zentiva, k.s.,
U kabelovny 130
Dolní Měcholupy
102 37 Prague 10
Czech Republic
To obtain more detailed information on this medicine, contact the local representative of the marketing authorization holder:
Zentiva Polska Sp. z o.o.
Bonifraterska 17
00-203 Warsaw
tel.: +48 22 375 92 00

This medicine is authorized in the Member States of the European Economic Area under the following names:

Austria, Bulgaria, Croatia, Estonia, Lithuania, Latvia, Poland, Czech Republic, Romania, Slovakia, Hungary: Sansik
Date of last revision of the leaflet:November 2023