Package leaflet: Information for the patient

Sitagliptin Abdi 25 mg film-coated tablets, 50 mg film-coated tablets, 100 mg film-coated tablets

Sitagliptin
Equivalent medicine
Please read all of this leaflet carefully before 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 they have the same symptoms as yours, because it may 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 Sitagliptin Abdi is and what it is used for
What you need to know before taking Sitagliptin Abdi
How to take Sitagliptin Abdi
Possible side effects
How to store Sitagliptin Abdi
Contents of the pack and other information

1. What Sitagliptin Abdi is and what it is used for

Sitagliptin Abdi 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 together 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
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) accumulates in the blood. This can lead to serious medical problems such as heart disease, kidney disease, blindness, and amputations.

2. What you should know before taking Sitagliptin Abdi

Do not take Sitagliptin Abdi
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 Sitagliptin Abdi (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 Sitagliptin.
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 Sitagliptin (see section 4).

It is unlikely that this medicine will cause low blood sugar levels because it does not act when blood sugar levels are low. However, when this medicine is taken with a sulfonylurea or insulin, low blood sugar levels (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 Sitagliptin Abdi
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 taken together with Sitagliptin.
Pregnancy and breastfeeding
If you are pregnant, think you may 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 machines, or work without protective barriers.
Sitagliptin Abdi contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Sitagliptin Abdi

Take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.
The usual recommended dose is:

one 100 mg film-coated tablet
once daily
by mouth

If you have kidney problems, your doctor may prescribe a lower dose (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 Sitagliptin, it is important to continue the diet and exercise plan recommended by your doctor.

If you take more Sitagliptin Abdi than you should
If you take more of this medicine than prescribed, contact your doctor immediately.

If you forget to take Sitagliptin Abdi
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 the next dose at the regular time.
Do not take a double dose of this medicine.

If you stop taking Sitagliptin Abdi
Continue taking this medicine for as long as your doctor prescribes it, so that you can keep controlling your blood sugar level. Do not stop taking this medicine without first talking to your doctor.

If you have any doubts about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
STOP taking Sitagliptin and contact your doctor immediately if you notice 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 experience 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, discontinue treatment with this medicine and contact your doctor immediately. Your doctor may prescribe 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 sitagliptin and metformin together as combination therapy (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 diabetes medicines:
Common: low blood sugar level, headache, upper respiratory tract infection, nasal congestion or runny nose, 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 blister)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform 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 Sitagliptin Abdi

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 carton 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 via 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 Sitagliptin Abdi contains

The active substance is sitagliptin:
o Each film-coated tablet of Sitagliptin Abdi 25 mg contains sitagliptin hydrochloride, equivalent to 25 mg of sitagliptin.
o Each film-coated tablet of Sitagliptin Abdi 50 mg contains sitagliptin hydrochloride, equivalent to 50 mg of sitagliptin.
o Each film-coated tablet of Sitagliptin Abdi 100 mg contains sitagliptin hydrochloride, equivalent to 100 mg of sitagliptin.
The other components are:
o Tablet core: microcrystalline cellulose, calcium hydrogen phosphate (anhydrous), sodium croscarmellose, and sodium stearyl fumarate.
o Tablet coating: polyvinyl alcohol (E1203), polyethylene glycol (E1521), talc, titanium dioxide (E171), red iron oxide (E172), and yellow iron oxide (E172).

Description of the appearance of Sitagliptin Abdi and contents of the pack

Sitagliptin Abdi 25 mg film-coated tablets are round, pink, film-coated tablets, marked “SH1” on one side and plain on the other. The tablet dimensions are approximately 6 x 3 mm.
Sitagliptin Abdi 50 mg film-coated tablets are round, light beige, film-coated tablets, marked “SH2” on one side and plain on the other. The tablet dimensions are approximately 8 x 3.5 mm.
Sitagliptin Abdi 100 mg film-coated tablets are round, beige, film-coated tablets, marked “SH3” on one side and plain on the other. The tablet dimensions are approximately 10 x 4 mm.

Clear PVC/PVDC and Al blister packs. Packs containing 28, 56, and 98 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Abdi Farma GmbH
Donnersbergstraße 4
64646 Heppenheim
Germany

Manufacturer:
FLAVINE PHARMA FRANCE
3 voie d’Allemagne, 13127, VITROLLES,
France

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Germany Sitagliptin Abdi 25 mg Filmtabletten
Sitagliptin Abdi 50 mg Filmtabletten
Sitagliptin Abdi 100 mg Filmtabletten
Italy Sitagliptin Abdi 25 mg film-coated tablets
Sitagliptin Abdi 50 mg film-coated tablets
Sitagliptin Abdi 100 mg film-coated tablets