Package leaflet: Information for the patient

Lynxaram, 5 mg, film-coated tablets
Linagliptinum
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 questions, ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

What Lynxaram is and what it is used for
Important information before taking Lynxaram
How to take Lynxaram
Possible side effects
How to store Lynxaram
Contents of the pack and other information

1. What Lynxaram is and what it is used for

Lynxaram 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 the body reduce the amount of sugar in the blood.
Lynxaram is used to treat type 2 diabetes in adults when the disease cannot be adequately controlled
by a single oral antidiabetic agent (metformin or sulfonylurea derivatives) or by diet and exercise alone.
Lynxaram 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 following the diet and exercise regimen recommended by your doctor or nurse.

2. Important information before using Lynxaram

When not to use Lynxaram

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

Warnings and precautions
Before starting treatment with Lynxaram, discuss with your doctor or pharmacist:

if the patient has type 1 diabetes (the patient's body does not produce insulin) or diabetic ketoacidosis (a complication of diabetes characterized by high blood sugar levels, rapid weight loss, nausea or vomiting). Lynxaram must not be used to treat these conditions.
if the patient is taking an antidiabetic medicine called a "sulfonylurea" (e.g. glimepiride, glipizide), the doctor may recommend reducing the dose of the sulfonylurea when Lynxaram is taken 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 had a history of pancreatic disease. If the patient experiences symptoms of acute pancreatitis, such as severe and persistent abdominal pain, contact a doctor.

If the patient develops blisters on the skin, this may be a sign of a condition called bullous pemphigoid. The doctor may advise the patient to stop taking Lynxaram.
Diabetic skin changes are common complications of diabetes. The patient should follow the skin and foot care recommendations provided by the doctor or nurse.

Children and adolescents
Lynxaram must not be used in children and adolescents under 18 years of age. 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.

Lynxaram with 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 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 become pregnant, she should consult her doctor or pharmacist before using this medicine.
It is not known whether linagliptin is harmful to unborn children; therefore, use of Lynxaram during pregnancy is not recommended.
It is not known whether linagliptin passes into human milk. The doctor must decide whether to discontinue breastfeeding or to discontinue/withhold treatment with Lynxaram.

Driving and operating machinery
Lynxaram has no or negligible influence on the ability to drive and operate machinery.
However, taking Lynxaram 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 secure footing. It is therefore recommended to monitor blood glucose levels more frequently to minimize the risk of hypoglycaemia, especially when Lynxaram is used in combination with sulfonylureas and/or insulin.

3. How to take Lynxaram

This medicine should always be taken as instructed by your doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.
The recommended dose of Lynxaram is one 5 mg tablet once daily.
Lynxaram may be taken with or without food.
Your doctor may prescribe Lynxaram together with another oral antidiabetic medicine.
All medicines should be taken as directed by your doctor to achieve the best possible treatment outcome.

Taking more Lynxaram than prescribed
If you take more Lynxaram than prescribed, contact your doctor immediately.

If you forget to take Lynxaram

If you forget to take a dose of Lynxaram, 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 missed dose. Never take two doses on the same day.

Stopping Lynxaram
Do not stop taking Lynxaram without first consulting your doctor. Stopping Lynxaram may lead to increased blood sugar levels.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Some symptoms require immediate medical attention.
You should stop taking Lynxaram and contact your doctor immediately if you experience any of the following symptoms associated with low blood sugar levels:
tremor, sweating, anxiety, blurred vision, tingling of the lips, pallor, mood changes, or confusion (hypoglycaemia). Hypoglycaemia (frequency: very common, may occur in more than 1 in 10 people) is a known adverse effect of linagliptin when taken together with metformin and a sulphonylurea derivative.
Allergic reactions (hypersensitivity; frequency: not common, may occur in up to 1 in 100 people) have occurred in some patients during treatment with linagliptin, either as monotherapy or in combination with other antidiabetic medicines, which may be severe, including wheezing and shortness of breath (bronchospasm; frequency: not known, frequency cannot be estimated from available data). Some patients have experienced rash (frequency: not common), urticaria (frequency: rare, may occur in up to 1 in 1,000 people), and swelling of the face, lips, tongue, and throat, which may cause difficulty in breathing or swallowing (angioedema; frequency: rare). If any of the above signs of illness occur, you should stop taking Lynxaram and contact your doctor immediately.
Your doctor may prescribe a medicine to treat the allergic reaction and switch you to another medicine for diabetes treatment.
Pancreatitis (inflammation of the pancreas; frequency: rare, occurs in up to 1 in 1,000 people) has occurred in some patients during treatment with linagliptin, either as monotherapy or in combination with other antidiabetic medicines.
You should STOP taking Lynxaram and contact your doctor immediately if you experience any of the following serious adverse reactions:

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.

During treatment with linagliptin as monotherapy or in combination with other antidiabetic medicines, the following adverse reactions have occurred in some patients:

Common: increased lipase activity in blood.
Not common: nasopharyngitis (inflammation of the nose and throat), cough, constipation (in combination with insulin), increased amylase activity in blood.
Rare: 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 or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Lynxaram

Keep this medicine out of 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 storage conditions are required for this medicine.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures help protect the environment.

6. Contents of the pack and other information

What Lynxaram contains

The active substance is linagliptin. Each coated tablet contains 5 mg of linagliptin.
The other ingredients (excipients) are: mannitol (E 421), pregelatinized starch, corn starch and magnesium stearate in the tablet core; and hypromellose (type 2910, 6 mPa·s), titanium dioxide (E 171), talc, propylene glycol and iron oxide red (E 172) in the tablet coating.

What Lynxaram looks like and contents of the pack
Lynxaram is a dark pink, round, biconvex coated tablet. The tablet diameter is approximately 8 mm.
Lynxaram is available in packs containing:

7, 10, 14, 15, 28, 30, 56, 60, 84, 90, 98, 100 or 120 coated tablets in blister packs within a cardboard box.
7 x 1, 10 x 1, 14 x 1, 15 x 1, 28 x 1, 30 x 1, 56 x 1, 60 x 1, 84 x 1, 90 x 1, 98 x 1, 100 x 1 or 120 x 1 coated tablet in single-dose, perforated blisters within a cardboard box.
7, 14, 28, 56, 84 or 98 coated tablets in calendar blister packs within a cardboard box.
7 x 1, 14 x 1, 28 x 1, 56 x 1, 84 x 1 or 98 x 1 coated tablet in calendar blister packs, single-dose, perforated, within a cardboard box.

Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warszawa
tel. 22 57 37 500