GLIPTERIN 25 mg Tabletki Powlekane

Treść ulotki

1. Glipterin 25 mg film-coated tablets, 50 mg film-coated tablets, 100 mg film-coated tablets
   1. What is Glipterin and what is it used for
   2. What you need to know before taking Glipterin
   3. How to take Glipterin
   4. Possible side effects
   5. How to store Glipterin
   6. Package Contents and Other Information

Glipterin 25 mg film-coated tablets, 50 mg film-coated tablets, 100 mg film-coated tablets

Sitagliptin
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 their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Glipterin and what is it used for

Glipterin contains the active substance sitagliptin which belongs to a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) that lower blood sugar levels in adult patients with type 2 diabetes mellitus.
This medicine helps to increase the levels of insulin produced after a meal and decreases the amount of sugar produced by the body.
Your doctor has prescribed this medicine to help lower your blood sugar level, which is too high due to type 2 diabetes. This medicine can be used alone or together with other medicines (insulin, metformin, sulfonylurea or glitazones) that lower blood sugar and that you may already be taking to treat your diabetes along with a diet and exercise program.
What is type 2 diabetes?
Type 2 diabetes is a condition in which the body does not produce enough insulin, and the insulin produced by the body does not work as well as it should. The body may also produce too much sugar.
When this happens, sugar (glucose) builds up in the blood. This can lead to serious medical problems such as heart disease, kidney disease, blindness and amputations.

2. What you need to know before taking Glipterin

Do not take Glipterin

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

Warnings and precautions
Cases of inflammation of the pancreas (pancreatitis) have been observed in patients treated with Glipterin (see
section 4).
If you develop blisters on the skin, this may be a sign of a condition called bullous pemphigoid.
Your doctor may ask you to stop taking Glipterin.
Tell your doctor if you have or have had:

• a disease of the pancreas (such as pancreatitis)
• gallstones, alcohol dependence or very high levels of triglycerides (a type of fat) in the blood. These medical conditions may increase your risk of developing pancreatitis (see section 4).
• type 1 diabetes
• diabetic ketoacidosis (a complication of diabetes with high blood sugar levels, rapid weight loss, nausea or vomiting)
• any kidney problems, past or present
• an allergic reaction to Glipterin (see section 4).

It is unlikely that this medicine will cause low blood sugar levels because it does not work when
blood sugar levels are low. However, when this medicine is taken with a sulfonylurea or
with insulin, a decrease in blood sugar levels (hypoglycemia) may occur. Your doctor may
reduce the dose of sulfonylurea or insulin.

Children and adolescents
Children and adolescents under 18 years of age should not use this medicine. 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 when used in children under 10 years of age.

Other medicines and Glipterin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
In particular, tell your doctor if you are taking digoxin (a medicine used to treat irregular heartbeat and other heart problems). It may be necessary to check your digoxin level in the blood if it is taken with Glipterin.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
You should not take this medicine during pregnancy.
It is not known whether this medicine passes into breast milk. You should not take this medicine if you are
breastfeeding or intend to breastfeed.

Driving and using machines
This medicine has no or negligible influence on the ability to drive and
operate machines. However, dizziness and drowsiness have been reported, which may affect your
ability to drive and operate machines.
Taking this medicine with other medicines called sulfonylureas or with insulin can cause
hypoglycemia, which can affect your ability to drive, operate machines or work without
safety precautions.

Glipterin contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Glipterin

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
The usual recommended dose is:

• one film-coated tablet of 100 mg
• once a day
• by mouth

If you have kidney problems, your doctor may prescribe lower doses (such as 25 mg or 50 mg).
You can take this medicine with or without food and beverages.
Your doctor may prescribe this medicine alone or together with other medicines that lower blood
sugar levels.
Diet and exercise can help your body use blood sugar better.
While taking Glipterin, it is important to follow the diet and exercise plan recommended by
your doctor.

If you take more Glipterin than you should
If you take a dose of this medicine higher than that prescribed to you, contact your doctor immediately.

If you forget to take Glipterin
If you forget a dose, take it as soon as you remember. If you do not remember until it is time to take
the next dose, skip the forgotten dose and continue with your normal dose. Do not take a double
dose of this medicine.

If you stop taking Glipterin
Continue to take this medicine until your doctor prescribes it, so that you can continue
to control your blood sugar level. Do not stop taking this medicine without first talking to your doctor.
If you have any further questions on 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.
STOP taking Glipterin and contact your doctor immediately if you notice any of the following
serious side effects:

• Severe and persistent abdominal pain (stomach area) that may spread to your back with or without nausea and vomiting, as these can be signs of inflammation of the pancreas (pancreatitis).

If you have a serious allergic reaction (frequency not known), including skin rash, hives, blisters on the
skin/skin peeling and swelling of the face, lips, tongue and throat, which can cause difficulty
breathing or swallowing, stop treatment with this medicine and contact your doctor immediately.
Your doctor may prescribe you a medicine to treat your allergic reaction and a different medicine for
your diabetes.
Some patients have experienced the following side effects following the addition of sitagliptin to
metformin:
Common (may affect up to 1 in 10 people): low blood sugar, nausea, flatulence,
vomiting
Uncommon (may affect up to 1 in 100 people): stomach pain, diarrhoea, constipation, drowsiness
Some patients have experienced different types of stomach discomfort when they started treatment
with sitagliptin and metformin together (the frequency is common).
Some patients have experienced the following side effects when taking sitagliptin in
combination with a sulfonylurea and metformin:
Very common (may affect more than 1 in 10 people): low blood sugar
Common: constipation
Some patients have experienced the following side effects when taking sitagliptin and
pioglitazone:
Common: flatulence, swelling of the hands or legs
Some patients have experienced the following side effects when taking sitagliptin in
combination with pioglitazone and metformin:
Common: swelling of the hands or legs
Some patients have experienced the following side effects when taking sitagliptin in
combination with insulin (with or without metformin):
Common: influenza
Uncommon: dry mouth
Some patients have experienced the following side effects when taking sitagliptin alone in
clinical studies, or during post-approval use alone and/or with other medicines for diabetes:
Common: low blood sugar, headache, upper respiratory tract infection, stuffy or runny nose and sore throat, osteoarthritis, pain in the arms or legs
Uncommon: dizziness, constipation, itching
Rare: reduced number of platelets
Frequency not known: kidney problems (sometimes requiring dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of skin blister).

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 Glipterin

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 special 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 Glipterin contains

• The active ingredient is sitagliptin. Glipterin 25 mg film-coated tabletsEach film-coated tablet (tablet) contains sitagliptin monohydrate hydrochloride, equivalent to 25 mg of sitagliptin.

Glipterin 50 mg film-coated tablets
Each film-coated tablet (tablet) contains sitagliptin monohydrate hydrochloride, equivalent to
50 mg of sitagliptin.

Glipterin 100 mg film-coated tablets
Each film-coated tablet (tablet) contains sitagliptin monohydrate hydrochloride, equivalent to
100 mg of sitagliptin.

• The other ingredients are:
• in the tablet core: microcrystalline cellulose (E460), dibasic calcium phosphate (E 341(ii)), sodium carboxymethylamide, magnesium stearate (E470b)

The tablet coating contains:

Glipterin 25 mg film-coated tablets
polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b), yellow iron oxide
(E172), red iron oxide (E172)

Glipterin 50 mg film-coated tablets
polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b), yellow iron oxide
(E172), red iron oxide (E172), black iron oxide (E172)

Glipterin 100 mg film-coated tablets
polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b), yellow iron oxide
(72), red iron oxide (E172)

Description of the appearance of Glipterin and contents of the pack

Glipterin 25 mg film-coated tablets
Pink, round film-coated tablet, with “25” engraved on one side, with dimensions of 6.2 ± 0.2 mm.

Glipterin 50 mg film-coated tablets
Light beige, round film-coated tablet, with “50” engraved on one side, with dimensions of 8.0 ± 0.2 mm.

Glipterin 100 mg film-coated tablets
Beige, round film-coated tablet, with “100” engraved on one side, with dimensions of 9.9 ± 0.2 mm.
Opaque PVC/PE/PVDC-aluminum or OPA/Al/PVC-aluminum blisters.

25 mg
Packs of 28 film-coated tablets.

50 mg
Packs of 28 film-coated tablets.

100 mg
Packs of 28 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
PHARMEXTRACTA S.P.A
Via G. Natta 28
29010 Pontenure (PC)
Italy

Manufacturers
Rontis Hellas Medical and Pharmaceutical Products S.A.
P.O. Box 3012 Larisa Industrial Area
Larisa 41004
Greece
PharOS MT Ltd.
HF62X, Hal Far Industrial Estate
Birzebbugia BBG3000
Malta

This medicinal product is authorised in the Member States of the European Economic Area under the
following names: