Package leaflet: Information for the patient

Linagliptin Mylan 5 mg film-coated tablets

linagliptin
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, pharmacist or nurse.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

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

Linagliptin Mylan contains the active substance linagliptin, which belongs to a class of medicines known as "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 Mylan is used in adults with "type 2 diabetes" when the disease cannot be adequately controlled with a single oral antidiabetic medicine (metformin or sulphonylureas) or with diet and exercise alone. Linagliptin Mylan 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 Mylan

Do not take Linagliptin Mylan

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 Mylan 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 Mylan 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 the sulfonylurea when taken together with Linagliptin Mylan 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 or have previously had a disease of the pancreas.

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 Mylan.
Skin lesions typical of diabetes 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 Mylan 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 in children under 10 years of age.

Other medicines and Linagliptin Mylan
Inform 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, ask your doctor or pharmacist for advice before taking this medicine.
It is not known whether Linagliptin Mylan is harmful to the unborn baby. Therefore, it is preferable to avoid taking Linagliptin Mylan during pregnancy.
It is not known whether Linagliptin Mylan passes into human breast milk. Your doctor will decide whether to discontinue breastfeeding or to discontinue/forego treatment with Linagliptin Mylan.

Driving and using machines
Linagliptin Mylan has no effect or has a negligible effect on the ability to drive vehicles and use machines.
However, taking Linagliptin Mylan 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 work without protective barriers. Therefore, you may be advised to monitor your blood glucose levels more frequently to minimize the risk of hypoglycaemia, especially when Linagliptin Mylan is used in combination with sulfonylureas and/or insulin.

3. How to take Linagliptin Mylan

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended dose of Linagliptin Mylan is one 5 mg tablet once daily.
You may take Linagliptin Mylan with or without food.
Your doctor may prescribe Linagliptin Mylan 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 Mylan than you should
If you take more Linagliptin Mylan than prescribed, contact your doctor immediately.

If you forget to take Linagliptin Mylan

If you forget to take a dose of Linagliptin Mylan, 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 Mylan
Do not stop treatment with Linagliptin Mylan without first consulting your doctor. Your blood sugar levels may increase when you stop treatment with Linagliptin Mylan.
If you have any questions 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 everyone gets them.

Some symptoms require immediate medical attention.
You must stop taking Linagliptin Mylan and contact your doctor immediately if you experience the following symptoms due to low blood sugar levels: trembling, 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 Mylan 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 Mylan 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 (urticaria; 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 Mylan 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 Mylan alone or in combination with other medicines for the treatment of diabetes.

STOP taking Linagliptin Mylan 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 extend to the back, together with nausea and vomiting, as these may be signs of an inflamed pancreas (pancreatitis).

Some patients experienced the following side effects when taking Linagliptin Mylan 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 the 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 experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. 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 Mylan

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, the bottle, and 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 use Linagliptin Mylan if you notice that the packaging is damaged or shows signs of tampering.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Linagliptin Mylan contains

The active substance is linagliptin. Each film-coated tablet contains 5 mg of linagliptin.
Other components are:
Tablet core: mannitol (E421), maize starch (E1404), copovidone, magnesium stearate (E572).
Film coating: hypromellose (type 2910), titanium dioxide (E171), macrogol 3350, talc, iron oxide red (E172).

Description of the appearance of Linagliptin Mylan and contents of the pack
Film-coated pink, round, biconvex tablet, with "M" engraved on one side and "LI" on the other side, approximately 7.6 mm in diameter.
Available in:
PVC/OPA/Alu blister packs containing 14, 28, 30, 90 and 100 film-coated tablets.
Divided unit-dose PVC/OPA/Alu blister packs containing 10 x 1, 30 x 1 and 90 x 1 film-coated tablets.
HDPE bottle with screw cap made of polypropylene (PP) and silica gel desiccant, available in packs of 30, 90, 100 and 120 film-coated tablets, supplied in a cardboard box or without a box.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milan
Italy

Manufacturer
Mylan Hungary Kft./Mylan Hungary Ltd.
Mylan utca 1., Komarom,
2900, Hungary