LINAGLIPTIN 5 mg Tabletki Powlekane

Treść ulotki

1. Linagliptin Sandoz 5 mg film-coated tablets
   1. What is Linagliptin Sandoz and what is it used for
   2. What you need to know before taking Linagliptin Sandoz
   3. How to take Linagliptin Sandoz
   4. Possible side effects
   5. How to store Linagliptin Sandoz
   6. Package contents and other information

Linagliptin Sandoz 5 mg film-coated tablets

Generic medicine

Read this leaflet carefully before you start taking this medicine as 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 Sandoz is and what it is used for
• 2. What you need to know before you take Linagliptin Sandoz
• 3. How to take Linagliptin Sandoz
• 4. Possible side effects
• 5. How to store Linagliptin Sandoz
• 6. Contents of the pack and other information

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

Linagliptin Sandoz 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 blood sugar
levels.
Linagliptin Sandoz 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 Sandoz can be used together with other antidiabetic
medicines, for example metformin, sulfonylureas (e.g. glimepiride, glipizide) 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 taking Linagliptin Sandoz

Do not take Linagliptin Sandoz:

• 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 Sandoz 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 Sandoz 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 Sandoz, 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 Sandoz.
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 Sandoz 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 Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
In particular, you should inform your doctor if you are taking medicines containing one of the following
active substances:

• carbamazepine, phenobarbital or phenytoin. These can 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 Sandoz is dangerous for the fetus. Therefore, it is preferable to avoid
taking Linagliptin Sandoz if you are pregnant.
It is not known whether Linagliptin Sandoz passes into human breast milk. The doctor must make the decision
whether to discontinue breastfeeding or discontinue/avoid therapy with Linagliptin Sandoz.

Driving and using machines
Linagliptin Sandoz does not alter or alters negligibly the ability to drive vehicles and operate
machinery.
Taking Linagliptin Sandoz in combination with medicines called sulfonylureas and/or insulin
can 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 combined with sulfonylureas and/or insulin

3. How to take Linagliptin Sandoz

Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult your
doctor or pharmacist.
The recommended dose of Linagliptin Sandoz is one 5 mg tablet once a day.
You can take Linagliptin Sandoz independently of food.
Your doctor may prescribe Linagliptin Sandoz in association with another oral antidiabetic medicine.
Take this medicine following your doctor's instructions in order to obtain the best results
for your health.

If you take more Linagliptin Sandoz than you should
If you take more Linagliptin Sandoz than you should, consult your doctor immediately.

If you forget to take Linagliptin Sandoz

• If you forget to take a dose of Linagliptin Sandoz, take it as soon as you remember. However, if it is almost time to take the next dose, skip the dose you had forgotten.
• 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 Sandoz
Do not stop the treatment with Linagliptin Sandoz without first consulting your doctor. Blood sugar
levels may increase when you stop the treatment with Linagliptin Sandoz..
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

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 Sandoz 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 Sandoz 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 Sandoz 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 the available data). Some patients have experienced skin rash (frequency uncommon), urticaria (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 Sandoz 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 experienced inflammation of the pancreas (pancreatitis; frequency rare, may
affect up to 1 in 1,000 people) while taking Linagliptin Sandoz alone or in
combination with other medicines for the treatment of diabetes.
STOP taking Linagliptin Sandoz and contact a doctor immediately if you notice any
of the following serious side effects:

• Severe and persistent abdominal (stomach) pain, which may spread to the back, as well as nausea and vomiting, as these could be signs of an inflamed pancreas (pancreatitis).

Some patients have experienced the following side effects when taking Linagliptin Sandoz
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
on the safety of this medicine.

5. How to store Linagliptin Sandoz

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 and the packaging, after
“Exp.”. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
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. Package contents and other information

What Linagliptin Sandoz contains

• The active ingredient is linagliptin. Each film-coated tablet contains 5 mg of linagliptin
• Other ingredients are: Tablet core:mannitol (E421), crospovidone (E1202), hypromellose (E464), anhydrous colloidal silica (E551) and magnesium stearate (E470b).

Film coating:hypromellose (E464), titanium dioxide (E171), talc (E553b), macrogol
(E1521) and red iron oxide (E172).

Description of the appearance of Linagliptin Sandoz and package contents
Linagliptin Sandoz are light pink, round, biconvex, film-coated tablets with
an approximate diameter of 8 mm and imprinted with “5” on one side.
Linagliptin Sandoz is available in aluminum blisters. The pack contains 28 tablets.
Linagliptin Sandoz is available in aluminum blisters divisible for unit dose. The pack contains 28
x1 tablets.
Not all pack sizes may be marketed.

Marketing authorisation holder
Sandoz S.p.A.,
Viale Luigi Sturzo, 43
20154 Milan
Italy

Manufacturer
Lek Pharmaceuticals d.d.
Verovškova ulica 57,
1526 Ljubljana
Slovenia
PharOS MT Ltd.
HF62X, Qasam Industrijali Hal Far,
Hal Far, Birzebbuga BBG3000,
Malta
PharOS Pharmaceutical Oriented Services Ltd.
Lesvou Street End, Thesi Loggos Industrial Zone
Metamorfossi, 14452
Greece

This medicinal product is authorised in the member states of the European Economic Area with the
following denominations:
Italy Linagliptin Sandoz
Hungary Linagliptin 1A Pharma 5 mg filmtabletta