Package leaflet: Information for the patient

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

Sitagliptin
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 may be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Glipterin is and what it is 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 increase the levels of insulin produced after a meal and reduces the amount of sugar produced by the body.
Your doctor has prescribed this medicine to help you lower your blood sugar level, which is too high due to type 2 diabetes. This medicine can be used alone or in combination with other blood sugar-lowering medicines (insulin, metformin, sulfonylureas, or glitazones) 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 the body produces 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 to 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 your skin, this may be a sign of a condition called bullous pemphigoid. Your doctor may ask you to stop treatment with Glipterin.
Inform 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 diabetes complication 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 because it does not act when blood sugar levels are low. However, when this medicine is taken with a sulfonylurea or with insulin, low blood sugar (hypoglycaemia) may occur. Your doctor may reduce the dose of sulfonylurea or insulin.
Children and adolescents
Children and adolescents under 18 years of age must 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
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking digoxin (a medicine used to treat irregular heartbeat and other heart-related problems). It may be necessary to monitor digoxin levels in the blood if it is taken together with Glipterin.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
You must not take this medicine during pregnancy.
It is not known whether this medicine passes into breast milk. You must not take this medicine if you are breastfeeding or think you may need to breastfeed.
Driving and using machines
This medicine has no effect or negligible effect on the ability to drive and use machines. However, dizziness and drowsiness have been reported, which may affect your ability to drive and use machines.
Taking this medicine together with other medicines called sulfonylureas or with insulin may cause hypoglycaemia, which may affect your ability to drive, use machinery, or work without protective barriers.
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 exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
The usual recommended dose is:

one 100 mg film-coated tablet
once daily
orally

If you have kidney problems, your doctor may prescribe lower doses (such as 25 mg or 50 mg).
You may take this medicine with or without food and drinks.
Your doctor may prescribe this medicine alone or together with other medicines that lower blood sugar levels.
Diet and physical exercise can help your body use blood sugar more effectively.
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 more of this medicine than prescribed, 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 for your next dose, skip the missed dose and take your next dose at the regular time. Do not take a double dose of this medicine.

If you stop taking Glipterin
Keep taking this medicine for as long as your doctor prescribes it, so that you can continue to control your blood sugar levels. Do not stop taking this medicine without first talking to your doctor.

If you have any further questions 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.
STOP taking Glipterin and contact a doctor immediately if you experience any of the following serious side effects:

Severe and persistent pain in the abdomen (stomach area) which may extend to the back, with or without nausea and vomiting, as these may be signs of inflammation of the pancreas (pancreatitis).

If you have a severe allergic reaction (frequency not known), including rash, hives, skin blistering or peeling, and swelling of the face, lips, tongue, or throat, which may cause difficulty breathing or swallowing, stop treatment with this medicine and contact a doctor immediately.
Your doctor may prescribe you a medicine to treat your allergic reaction and a different medicine for your diabetes.

Some patients experienced the following side effects when sitagliptin was added to metformin:
Common (may affect up to 1 in 10 people): low blood sugar level, nausea, flatulence, vomiting
Uncommon (may affect up to 1 in 100 people): stomach pain, diarrhoea, constipation, drowsiness
Some patients experienced various types of stomach discomfort when starting treatment with sitagliptin and metformin together (frequency is common).

Some patients 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 level
Common: constipation

Some patients experienced the following side effects when taking sitagliptin and pioglitazone:
Common: flatulence, swelling of the hands or legs

Some patients experienced the following side effects when taking sitagliptin in combination with pioglitazone and metformin:
Common: swelling of the hands or legs

Some patients experienced the following side effects when taking sitagliptin in combination with insulin (with or without metformin):
Common: influenza
Uncommon: dry mouth

Some patients experienced the following side effects when taking sitagliptin alone in clinical studies, or during post-approval use alone and/or with other antidiabetic medicines:
Common: low blood sugar level, headache, upper respiratory tract infection, stuffy or runny nose and sore throat, osteoarthritis, pain in arms or legs
Uncommon: dizziness, constipation, itching
Rare: reduced platelet count
Frequency not known: kidney problems (sometimes requiring dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of skin blistering).

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 . Reporting side effects 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 stated on the blister and 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 medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Pack contents and other information

What Glipterin contains

The active substance is sitagliptin. Glipterin 25 mg film-coated tablets: Each film-coated tablet (tablet) contains sitagliptin monohydrochloride monohydrate, equivalent to 25 mg of sitagliptin.

Glipterin 50 mg film-coated tablets
Each film-coated tablet (tablet) contains sitagliptin monohydrochloride monohydrate, equivalent to
50 mg of sitagliptin.
Glipterin 100 mg film-coated tablets
Each film-coated tablet (tablet) contains sitagliptin monohydrochloride monohydrate, equivalent to
100 mg of sitagliptin.

The other components are:
In the tablet core: microcrystalline cellulose (E460), dibasic calcium phosphate (E 341(ii)), sodium carboxymethyl starch, magnesium stearate (E470b)

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 (E172), red iron oxide (E172)

Description of the appearance of Glipterin and pack contents
Glipterin 25 mg film-coated tablets
Pink, round, film-coated tablet, engraved with "25" on one side, size 6.2 ± 0.2 mm.
Glipterin 50 mg film-coated tablets
Light beige, round, film-coated tablet, engraved with "50" on one side, size 8.0 ± 0.2 mm.
Glipterin 100 mg film-coated tablets
Beige, round, film-coated tablet, engraved with "100" on one side, size 9.9 ± 0.2 mm.
Opaque PVC/PE/PVDC-aluminium or OPA/Al/PVC-aluminium blisters.
25 mg
Pack containing 28 film-coated tablets.
50 mg
Pack containing 28 film-coated tablets.
100 mg
Pack containing 28 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization 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 Larissa Industrial Area
Larissa 41500
Greece
PharOS MT Ltd.
HF62X, Hal Far Industrial Estate
Birzebbugia BBG3000
Malta

This medicinal product has been authorised in the European Economic Area Member States under the following names:
Italy:
Glipterin 25 mg, Glipterin 50 mg, Glipterin 100 mg film-coated tablets