Linagliptin Zentiva

Package leaflet: Information for the user

Linagliptin Zentiva 5 mg film-coated tablets

Generic medicine
Please read all of this leaflet carefully before you start 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 you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful to them.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Linagliptin Zentiva is and what it is used for
2. What you need to know before taking Linagliptin Zentiva
3. How to take Linagliptin Zentiva
4. Possible side effects
5. How to store Linagliptin Zentiva
6. Contents of the pack and other information

1. What Linagliptin Zentiva is and what it is used for

Linagliptin Zentiva contains the active substance linagliptin, which belongs to a class of medicines
called "oral antidiabetics". Oral antidiabetic medicines are used to treat high blood sugar levels.
These medicines work by helping the body to reduce blood sugar levels.
Linagliptin Zentiva is used in 'type 2 diabetes' in adults, when the disease cannot be adequately
controlled with a single oral antidiabetic medicine (metformin or sulphonylureas) or with diet and exercise
alone. Linagliptin Zentiva may be used together with other antidiabetic medicines, such as metformin,
sulphonylureas (e.g. glimepiride, glipizide), empagliflozin or insulin.
It is important that you continue to follow your doctor’s or nurse’s advice regarding diet and exercise.

2. What you should know before taking Linagliptin Zentiva

Do not take Linagliptin Zentiva

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

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Linagliptin Zentiva if:

• you have type 1 diabetes (your body does not produce insulin) or diabetic ketoacidosis (a diabetes complication with high blood sugar levels, rapid weight loss, nausea or vomiting). Linagliptin Zentiva must not be used to treat these conditions.
• you are taking an antidiabetic medicine known as a 'sulphonylurea' (e.g. glimepiride, glipizide), your doctor may decide to reduce the dose of the sulphonylurea when taken together with Linagliptin Zentiva, in order to avoid blood sugar levels becoming too low.
• you have had allergic reactions to any other medicine you take to control your blood sugar levels.
• you have a history of pancreatic disease or have had it in the past.

If you experience symptoms of acute pancreatitis, such as persistent and severe stomach pain (abdominal pain), you must consult a doctor.
If blisters appear on the skin, they may be a sign of a condition called bullous pemphigoid. Your doctor may ask you to stop treatment with Linagliptin Zentiva.
Skin lesions typical of diabetes are a common complication of this disease. It is recommended that you follow the advice given to you by your doctor or nurse regarding skin and foot care.
Children and adolescents
Linagliptin Zentiva is not recommended for children and adolescents under 18 years of age.
Other medicines and Linagliptin Zentiva
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, you must inform your doctor if you are taking medicines containing any of the following active substances:

• carbamazepine, phenobarbital, or phenytoin. These may be used to control epileptic seizures or chronic pain.
• rifampicin. This is an antibiotic used to treat infections such as tuberculosis.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
It is not known whether Linagliptin Zentiva is harmful to the unborn baby. Therefore, it is preferable to avoid taking Linagliptin Zentiva during pregnancy.
It is not known whether Linagliptin Zentiva passes into human breast milk. Your doctor will decide whether to discontinue breastfeeding or to discontinue/abstain from treatment with Linagliptin Zentiva.
Driving and using machines
Linagliptin Zentiva has no effect or has a negligible effect on the ability to drive and use machines.
However, taking Linagliptin Zentiva in combination with medicines called sulphonylureas and/or insulin may cause blood sugar levels to become too low (hypoglycaemia), which may affect the ability to drive and use machines or to work without protective barriers. You may therefore be advised to monitor your blood glucose levels more frequently to minimise the risk of hypoglycaemia, especially when Linagliptin Zentiva is used together with sulphonylureas and/or insulin.

3. How to take Linagliptin Zentiva

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended dose of Linagliptin Zentiva is one 5 mg tablet once daily.
You may take Linagliptin Zentiva with or without food.
Your doctor may prescribe Linagliptin Zentiva in combination with another oral antidiabetic medicine.
Remember to take all your medicines as prescribed by your doctor to achieve the best possible health outcomes.

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

If you forget to take Linagliptin Zentiva

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

If you stop taking Linagliptin Zentiva
Do not stop treatment with Linagliptin Zentiva without first consulting your doctor. Your blood sugar levels may increase when you stop treatment with Linagliptin Zentiva.
If you have any questions about the use of this medicine, consult 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
You must stop taking Linagliptin Zentiva and contact your doctor immediately if you experience the following symptoms due to low blood sugar levels: tremor, sweating, anxiety, blurred vision, tingling of the lips, pallor, mood changes or confusion (hypoglycaemia).
Hypoglycaemia (frequency: very common, may affect more than 1 in 10 people) is a known side effect when Linagliptin Zentiva is taken with metformin and a sulphonylurea.
Some patients have experienced allergic reactions (hypersensitivity; frequency: not common, may affect up to 1 in 100 people) while taking Linagliptin Zentiva alone or in combination with other diabetes medicines, which may be severe and may include wheezing and shortness of breath (bronchial hyperreactivity; frequency: not known, frequency cannot be estimated from the available data). Some patients have developed skin rash (frequency: not common), hives (frequency: rare, may affect up to 1 in 1,000 people), and swelling of the face, lips, tongue and throat which may cause difficulty breathing or swallowing (angioedema; frequency: rare). If you develop any of the above-mentioned signs of illness, stop taking Linagliptin Zentiva and contact your doctor immediately. Your doctor may prescribe a medicine to treat the allergic reaction and a different medicine for diabetes.
Some patients have developed inflammation of the pancreas (pancreatitis; frequency: rare, may affect up to 1 in 1,000 people) while taking Linagliptin Zentiva alone or in combination with other diabetes medicines.
STOP taking Linagliptin Zentiva and contact a doctor immediately if you notice any of the following serious side effects:

• severe and persistent pain in the stomach area (abdomen), which may spread to the back, along with nausea and vomiting, as these may be signs of an inflamed pancreas (pancreatitis).

Some patients experienced the following side effects while taking Linagliptin Zentiva alone or in combination with other diabetes medicines:

• common (may affect up to 1 in 10): increased levels of the enzyme lipase in the blood.
• not common (may affect up to 1 in 100): inflammation of nose or throat (nasopharyngitis), cough, constipation (in combination with insulin), increased levels of the enzyme amylase in the blood.
• rare (may affect up to 1 in 1,000): blisters on the skin (bullous pemphigoid).

Reporting of side effects
If you get any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Linagliptin Zentiva

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 that month.
This medicine does not require any special storage temperature. Store in the
original packaging to protect from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how
to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Linagliptin Zentiva contains

• The active substance is linagliptin. Each film-coated tablet contains 5 mg of linagliptin.
• The other components are:
  Tablet core: mannitol, copovidone, crospovidone, magnesium stearate
  Film coating: hypromellose (E464), titanium dioxide (E171), talc, macrogol, red iron oxide (E172)

Description of the appearance of Linagliptin Zentiva and package contents
Round, biconvex, pink, film-coated tablet with a diameter of approximately 8 mm.
Packaged in Alu-Alu blisters.
Packaging:
10, 14, 28, 30, 56, 60 and 90 film-coated tablets in blisters
10, 14, 28, 30, 56, 60 and 90 film-coated tablets in unit-dose divisible blisters
Not all pack sizes may be marketed.

Marketing Authorization Holder
Zentiva Italia S.r.l.
Via P. Paleocapa, 7
20121 Milano, Italy

Manufacturer
Zentiva, k.s.
U Kabelovny 130 Dolni Mecholupy
102 37 Prague 10, Czech Republic

This medicinal product is authorized in the European Economic Area countries under the following names:
Czech Republic, Germany, France, Italy, Portugal, Sweden: Linagliptin Zentiva