Package leaflet: Information for the user

Linagliptin Aurobindo 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 give it to other people, even if they have the same symptoms as you, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Linagliptin Aurobindo contains the active substance linagliptin, which belongs to a class of medicines
called "oral antidiabetics". Oral antidiabetics are used to treat high blood sugar levels. These medicines
work by helping the body to reduce blood sugar levels.
Linagliptin Aurobindo 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 Aurobindo may be used together with other antidiabetic medicines, for example
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 need to know before taking Linagliptin Aurobindo

Do not take Linagliptin Aurobindo

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 or pharmacist before taking Linagliptin Aurobindo if:

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

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 could be a sign of a condition called bullous pemphigoid. Your doctor may ask you to stop treatment with Linagliptin Aurobindo.
Diabetic skin lesions are a common complication of this disease. It is recommended that you follow the advice provided by your doctor or nurse regarding skin and foot care.

Children and adolescents
Linagliptin Aurobindo is not recommended for children and adolescents under 18 years of age. It is not effective in children and adolescents aged between 10 and 17 years. It is unknown whether this medicine is safe and effective when used in children under 10 years of age.

Other medicines and Linagliptin Aurobindo
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, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
It is not known whether Linagliptin Aurobindo is harmful to the unborn baby. Therefore, it is preferable to avoid taking Linagliptin Aurobindo during pregnancy.
It is not known whether Linagliptin Aurobindo passes into human breast milk. Your doctor will decide whether to discontinue breastfeeding or to discontinue/forego treatment with Linagliptin Aurobindo.

Driving and using machines
Linagliptin Aurobindo has no effect or only a negligible effect on the ability to drive and use machines.
However, taking Linagliptin Aurobindo in combination with medicines called sulfonylureas and/or insulin may cause blood sugar levels to become too low (hypoglycaemia), which may affect your ability to drive and use machines or to work without protective barriers. In such cases, it may be advisable to monitor your blood glucose levels more frequently to minimize the risk of hypoglycaemia, especially when used in combination with sulfonylureas and/or insulin.

3. How to take Linagliptin Aurobindo

Take this medicine exactly as your doctor has told you. If you are unsure, consult your
doctor or pharmacist.
The recommended dose of Linagliptin Aurobindo is one 5 mg tablet once daily.
You may take Linagliptin Aurobindo regardless of meals.
Your doctor may prescribe Linagliptin Aurobindo 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 Aurobindo than you should
If you take more Linagliptin Aurobindo than you should, contact your doctor immediately.

If you forget to take Linagliptin Aurobindo

If you forget to take a dose of Linagliptin Aurobindo, 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 Aurobindo
Do not stop treatment with Linagliptin Aurobindo without first consulting your doctor. Blood sugar levels may increase when you stop treatment with Linagliptin Aurobindo.
If you have any doubts about how to use 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 Aurobindo 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, paleness, mood changes or confusion (hypoglycaemia).
Hypoglycaemia (frequency: very common, may affect more than 1 in 10 people) is a known side effect when Linagliptin Aurobindo 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 Aurobindo 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 experience any of the above signs of illness, stop taking Linagliptin Aurobindo 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 Aurobindo alone or in combination with other medicines for the treatment of diabetes.

STOP taking Linagliptin Aurobindo and contact your 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, as well as nausea and vomiting, as these may be signs of an inflamed pancreas (pancreatitis).

Some patients experienced the following side effects when taking Linagliptin Aurobindo alone or in combination with other medicines for the treatment of diabetes:

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

Reporting of side effects
If you get any side effects, including any 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 Aurobindo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after “EXP”.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Linagliptin Aurobindo contains

The active substance is linagliptin. Each film-coated tablet contains 5 mg of linagliptin.
The other components are:
Tablet core: Mannitol, maize starch, copovidone (K-28) and magnesium stearate.
Tablet coating: Hypromellose 2910 (6 mPa·s) (E464), titanium dioxide (E171), macrogol 6000 (E1521), talc (E553b), iron oxide red (E172).

Description of the appearance of Linagliptin Aurobindo and package contents
Film-coated tablet.
Light red, round, approximately 8.1 mm, biconvex, film-coated tablets with bevelled edges, marked with 'LN' on one side and '5' on the other.
Linagliptin Aurobindo is available in blister packs containing 28, 30 or 56 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Aurobindo Pharma (Italia) Srl
Via San Giuseppe, 102 - 21047 Saronno (VA), Italy

Manufacturer
APL Swift Services (Malta) Ltd
Hf26, Hal Far Industrial Estate, Hal Far, Birzebbugia, BBG 3000, Malta
Generis Farmacêutica SA
Rua João de Deus, n. 19, Venda Nova, Amadora, 2700-487, Portugal

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Italy: Linagliptin Aurobindo
Netherlands: Linagliptine Aurobindo 5 mg, filmomhulde tabletten
Portugal: Linagliptina Generis Phar
Spain: Linagliptina Aurovitas 5 mg comprimidos recubiertos con película EFG