Package leaflet: Information for the patient

Rekiva, 5 mg, film-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 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 side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

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

1. What Rekiva is and what it is used for

Rekiva contains the active substance linagliptin, which belongs to a group of medicines called
"oral antidiabetic medicines". Oral antidiabetic medicines are used in the treatment of high blood sugar levels.
These medicines help your body reduce the amount of sugar in the blood.
Rekiva 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. Rekiva 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 regimen recommended by your doctor or nurse.

2. Important information before taking Rekiva

When not to take Rekiva

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 to take Rekiva, discuss 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 complication of diabetes characterized by high blood sugar levels, rapid weight loss, nausea, or vomiting). Rekiva 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 Rekiva is taken concomitantly to avoid excessively low blood sugar levels.
if the patient has experienced an allergic reaction to any other medicines previously taken to lower blood sugar levels.
if the patient has or has had pancreas-related disease in the past.

If the patient develops symptoms of acute pancreatitis, such as severe and persistent abdominal pain,
contact a doctor immediately.
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 Rekiva.
Diabetic skin changes are common complications of diabetes. Follow the skin and foot care advice
provided by the doctor or nurse.
Children and adolescents
Rekiva 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.
Rekiva 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 have a
baby, she should consult her doctor or pharmacist before using this medicine.
It is not known whether Rekiva is harmful to unborn children, therefore use of Rekiva during pregnancy is not recommended.
It is not known whether Rekiva passes into human breast milk. The doctor must decide whether to discontinue breastfeeding or to discontinue/withhold treatment with Rekiva.
Driving and operating machinery
Rekiva has no effect or has a negligible effect on the ability to drive and
operate machinery.
Taking Rekiva 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.
However, more frequent monitoring of blood glucose levels is recommended to minimize the risk of hypoglycaemia, especially when Rekiva is used in combination with sulfonylurea derivatives and/or insulin.

3. How to take Rekiva

This medicine should always be taken as directed by the physician. In case of doubt, consult
your doctor or pharmacist.
The recommended dose of Rekiva is one 5 mg tablet once daily.
Rekiva may be taken with or without food.
Your doctor may recommend taking Rekiva together with another oral antidiabetic medicine.
All medicines should be taken in accordance with the doctor's instructions to achieve the best
treatment outcome.
Taking more Rekiva than recommended
If you take more Rekiva than recommended, contact your doctor immediately.
Missing a dose of Rekiva

If a patient forgets to take a dose of Rekiva, the dose should be taken as soon as remembered. 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 Rekiva treatment
Do not stop taking Rekiva without first consulting your doctor. Stopping Rekiva may lead to increased blood sugar levels.
If you have any further questions about 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 Rekiva and contact your doctor immediately if you experience any of the following symptoms related to low blood sugar levels:
tremor, sweating, anxiety, blurred vision, tingling of the lips, pallor, mood changes or confusion (hypoglycaemia). Hypoglycaemia (frequency: very common, occurs in more than 1 in 10 people) is a known adverse effect of treatment with Rekiva when taken concomitantly with metformin and a sulphonylurea derivative.
Some patients experienced allergic reactions (hypersensitivity; frequency: not very common, occurs in no more than 1 in 100 people) during treatment with Rekiva as monotherapy or in combination with other antidiabetic medicines, which may be severe, including wheezing and difficulty breathing (bronchospasm; frequency: not known, frequency cannot be estimated from available data). Some patients experienced rash (frequency: not very common), urticaria (urticaria; frequency: rare, occurs in no more than 1 in 1,000 people), and swelling of the face, lips, tongue, or throat, which may cause difficulty breathing or swallowing (angioedema; frequency: rare). If any of the above symptoms occur, the patient should stop taking Rekiva and contact their doctor immediately.
The doctor may prescribe a medicine for the treatment of allergic reactions and switch to another medicine for the treatment of diabetes.
Pancreatitis (pancreatitis; frequency: rare, occurs in no more than 1 in 1,000 people) has been observed in some patients during treatment with Rekiva as monotherapy or in combination with other antidiabetic medicines.
You should STOP taking Rekiva and contact your doctor immediately if any of the following serious adverse reactions occur:

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 Rekiva as monotherapy or in combination with other antidiabetic medicines, the following adverse reactions have been observed in some patients:

Common: increased lipase activity in blood.
Not very common: inflammation of the nose or throat (nasopharyngitis), cough, constipation (in combination with insulin), increased amylase activity in blood.
Rare: blistering skin rash (bullous pemphigoid).

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 of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C,
02-222 Warsaw,
tel.: 22 49-21-301,
fax: 22 49-21-309,
website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the responsible entity. Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Rekiva

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 instructions apply for this medicine.
Do not use Rekiva if the packaging is damaged or if there are signs of tampering.
Medicines must 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. Contents of the pack and other information

What Rekiva contains

The active substance is linagliptin. Each coated tablet (tablet) contains 5 mg of linagliptin.
Other ingredients are:
Core of the tablet: mannitol, pregelatinized starch (corn), povidone K-30, corn starch, magnesium stearate.
Tablet coating: hypromellose, titanium dioxide (E171), macrogol 400, iron oxide red (E172).

What Rekiva looks like and contents of the pack

Rekiva 5 mg are red, round, biconvex coated tablets, 8.1 mm in diameter, with the engraved symbol "5" on one side and smooth on the other side.
Rekiva is available in aluminum/OPA/PVC/aluminum foil blisters in cardboard boxes. Pack sizes are 10, 14, 28, 30, 56, 60, 84, 90, 98, 100 and 120 tablets. All pack sizes may be presented as unit-dose blisters in cardboard boxes containing 10×1, 14×1, 28×1, 30×1, 56×1, 60×1, 84×1, 90×1, 98×1, 100×1 and 120×1 coated tablet.

Not all pack sizes may be marketed.
Marketing Authorisation Holder
Farmak International Sp. z o.o.
Koszykowa 65 Street
00-667 Warsaw
Poland
Tel. +48 22 822 93 06
[email protected]
Manufacturer
Genepharm S.A.
18th Km Marathonos Avenue
153 51 Pallini
Greece
This medicinal product is authorised for marketing in the European Economic Area countries under the following names:
Czech Republic: Rekiva
Estonia: Rekiva
Poland: Rekiva
Slovakia: Rekiva