LINAGLIPTIN 5 mg Tabletki Powlekane

Treść ulotki

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

Linagliptin Mylan 5 mg film-coated tablets

linagliptin

Generic medicine

Read 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

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

Linagliptin Mylan contains the active ingredient linagliptin, which belongs to a class of medicines
called “oral antidiabetics”. Oral antidiabetics are used for the treatment of high
blood sugar levels. These medicines work by helping the body to reduce the level of
blood sugar.
Linagliptin Mylan is used in “type 2 diabetes” in adults if the disease cannot be
adequately controlled with an oral antidiabetic medicine (metformin or sulfonylureas) or only
with diet and exercise. Linagliptin Mylan can be used together with other antidiabetic
medicines, for example, metformin, sulfonylureas (e.g., glimepiride, glipizide), empagliflozin or
insulin.
It is important that you continue to follow the advice received from your doctor or nurse regarding
diet and exercise.

2. What you need to know before you take 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 complication of diabetes with a high level of sugar in the blood, rapid weight loss, nausea or vomiting). Linagliptin Mylan should not be used for the treatment of these conditions.
• you are taking a medicine for diabetes known as a “sulfonylurea” (e.g., glimepiride, glipizide), your doctor may decide to reduce the dose of sulfonylurea if you take it together with

Linagliptin Mylan, in order to avoid that the sugar in the blood reaches a level too
low.

• you have had allergic reactions to any other medicine you take to control the amount of sugar in the blood.
• you have a disease of the pancreas or have had it in the past.

If you experience symptoms of acute pancreatitis, such as persistent and
severe stomach pain (abdominal pain), you should 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 therapy with Linagliptin Mylan.
Skin lesions characteristic of diabetes are a common complication of this disease. It is
recommended to follow the recommendations given to you by your doctor or nurse for the care
of the skin and feet.

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 not known whether this
medicine is safe and effective if used in children under 10 years of age.

Other medicines and Linagliptin Mylan
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
In particular, you should 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 seizures (convulsions) 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 or are planning to become pregnant, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
It is not known whether Linagliptin Mylan is dangerous for the fetus. Therefore, it is preferable to avoid taking
Linagliptin Mylan if you are pregnant.
It is not known whether Linagliptin Mylan passes into human breast milk. The doctor must make the decision
whether to discontinue breastfeeding or discontinue/avoid therapy with Linagliptin Mylan.

Driving and using machines
Linagliptin Mylan does not alter or alters negligibly the ability to drive vehicles and operate
machinery.
Taking Linagliptin Mylan in combination with medicines called sulfonylureas and/or insulin
may cause levels of sugar in the blood that are too low (hypoglycemia), which can affect
the ability to drive vehicles and operate machinery or to work without protective barriers. However
it may be advisable to check blood glucose more frequently to minimize the risk of hypoglycemia, especially when combining Linagliptin Mylan with
sulfonylureas and/or insulin.

3. How to take Linagliptin Mylan

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
The recommended dose of Linagliptin Mylan is one 5 mg tablet once a day.
You can take Linagliptin Mylan with or without food.
Your doctor may prescribe Linagliptin Mylan in association with another oral antidiabetic medicine.
Remember to take all medicines as prescribed by your doctor in order to obtain the best
results for your health.

If you take more Linagliptin Mylan than you should
If you take more Linagliptin Mylan than you should, consult 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 to take the next dose, skip the dose you forgot.
• Do not take a double dose to make up for a missed dose. Never take two doses in the same day.

If you stop taking Linagliptin Mylan
Do not stop treatment with Linagliptin Mylan without first consulting your doctor. Blood sugar
levels may increase when you stop treatment with Linagliptin Mylan.
If you have any doubts about the use of this medicine, ask 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 Mylan and consult your doctor immediately if you
experience the following symptoms due to low blood sugar: tremor, sweating, anxiety,
blurred vision, tingling of the lips, paleness, mood changes or confusion (hypoglycemia).
Hypoglycemia (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 sulfonylurea.
Some patients have experienced allergic reactions (hypersensitivity; frequency uncommon, may affect
up to 1 in 100 people) while taking Linagliptin Mylan alone or in combination with other
medicines for the treatment of diabetes, which can be serious and may include wheezing and
shortness of breath (bronchial hyperreactivity; frequency not known, the frequency cannot
be estimated based on available data). Some patients have developed a skin rash
(frequency uncommon), hives (frequency rare, may affect up to 1 in 1,000 people) and
swelling of the face, lips, tongue and throat which can cause difficulty breathing or
swallowing (angioedema; frequency rare). If you experience any of the above mentioned signs of
illness, stop taking Linagliptin Mylan and contact your doctor immediately. The
doctor may prescribe a medicine to treat the allergic reaction and a different medicine for
diabetes.
Some patients have experienced 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 abdominal (stomach area) pain, which may spread to the back, as well as nausea and vomiting, as these may be signs of an inflamed pancreas (pancreatitis).

Some patients have 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.
• Uncommon: inflammation of the nose or throat (nasopharyngitis), cough, constipation (in combination with insulin), increased levels of the enzyme amylase in the blood.
• Rare: blistering skin rash (bullous pemphigoid).

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-
reazioni-avverse . By reporting side effects you can help provide more information
about 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 that is stated on the blister, the bottle and the
pack 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 in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Linagliptin Mylan contains

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

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

Marketing authorisation holder and manufacturer
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milano
Italy

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