Patient Information Leaflet

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

Equivalent medicine
Please read 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 or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Sitagliptin Sandoz and what is it used for?

Sitagliptin Sandoz contains the active substance sitagliptin, which belongs to a class of medicines
called dipeptidyl peptidase-4 (DPP-4) inhibitors that lower blood sugar levels in adult patients with
type 2 diabetes mellitus.
This medicine helps increase the levels of insulin released 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 may be used alone or together with other blood sugar-lowering
medicines (such as insulin, metformin, sulphonylureas or glitazones) that you may already be taking
to treat your diabetes, along with a diet and exercise programme.

What is type 2 diabetes?
Type 2 diabetes is a condition in which the body does not produce enough insulin, and the insulin that
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 limb amputations.

2. What you need to know before taking Sitagliptin Sandoz

Do not take Sitagliptin Sandoz

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Sitagliptin Sandoz.
Cases of inflammation of the pancreas (pancreatitis) have been observed in patients treated with Sitagliptin Sandoz (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 Sandoz.
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 Sandoz (see section 4)

It is unlikely that this medicine will cause low blood sugar levels (hypoglycaemia), as it does not act when blood sugar levels are low. However, when this medicine is taken together with a sulphonylurea or with insulin, low blood sugar levels (hypoglycaemia) may occur. Your doctor may reduce the dose of the sulphonylurea 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 Sandoz
Tell 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 when taken together with Sitagliptin Sandoz.

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 use 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 somnolence have been reported, which may affect your ability to drive and use machines. Taking this medicine together with other medicines called sulphonylureas or with insulin may cause hypoglycaemia, which could affect your ability to drive, use machines, or work without protective barriers.

Sitagliptin Sandoz contains sodium
Sitagliptin Sandoz contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take Sitagliptin Sandoz

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
by mouth

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 exercise can help your body use blood sugar more effectively. While taking Sitagliptin Sandoz, it is important to continue following the diet and exercise plan recommended by your doctor.
If you take more Sitagliptin Sandoz than you should
If you take more of this medicine than prescribed, contact your doctor immediately.
If you forget to take Sitagliptin Sandoz
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 usual time. Do not take a double dose to make up for a forgotten dose.
If you stop taking Sitagliptin Sandoz
Continue taking this medicine for as long as your doctor prescribes it, so that you can keep controlling your blood sugar levels. Do not stop taking this medicine without first talking to your doctor.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
STOP taking Sitagliptin Sandoz and contact your doctor immediately if you experience any of the following serious side effects:

Severe and persistent pain in the abdomen (stomach area), possibly radiating 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/skin peeling, and swelling of the face, lips, tongue, or throat, which may cause difficulty breathing or swallowing, stop 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-marketing use alone and/or with other diabetes 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 blister)

Reporting of side effects
If you get any side effects, including ones 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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sitagliptin 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 outer carton after
"EXP".
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Open the blister pack immediately before taking the tablets. Do not use this medicine if the packaging
shows any signs of tampering.
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. Package contents and other information

What Sitagliptin Sandoz contains

The active substance is sitagliptin.

Sitagliptin Sandoz 25 mg film-coated tablets
Each film-coated tablet contains sitagliptin hydrochloride monohydrate, equivalent to 25 mg of
sitagliptin.
Sitagliptin Sandoz 50 mg film-coated tablets
Each film-coated tablet contains sitagliptin hydrochloride monohydrate, equivalent to 50 mg of
sitagliptin.
Sitagliptin Sandoz 100 mg film-coated tablets
Each film-coated tablet contains sitagliptin hydrochloride monohydrate, equivalent to 100 mg of
sitagliptin.

The other components are: dibasic calcium phosphate (E341), microcrystalline cellulose (E460),
sodium croscarmellose (E468), magnesium stearate (E470b), sodium stearyl fumarate, hypromellose
(E464), hydroxypropylcellulose (E463), macrogol (E1521), titanium dioxide (E171), yellow iron oxide
(E172), red iron oxide (E172), black iron oxide (E172) (only applicable for the 100 mg strength), and talc (E553b).

Description of the appearance of Sitagliptin Sandoz and contents of the pack
Sitagliptin Sandoz 25 mg film-coated tablets
Round, biconvex, pink film-coated tablets, marked with "ST 25" on one side; diameter 5.7 – 6.6 mm.
Sitagliptin Sandoz 50 mg film-coated tablets
Round, biconvex, light pink film-coated tablets, marked with "ST 50" on one side; diameter 7.7 – 8.6 mm.
Sitagliptin Sandoz 100 mg film-coated tablets
Round, biconvex, light brown film-coated tablets, marked with "ST 100" on one side; diameter 9.7 – 10.6 mm.

Sitagliptin Sandoz is available in:
OPA/Alu/PVC//Alu blisters and transparent PVC/PE/PVDC//Aluminum blisters containing 28, 30, 50,
56, 60, 84, 90, 98, 100, 105, 108, 110, 112, 120, 168, 180, 196, 198 or 200 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sandoz S.p.A.,
L.go U. Boccioni 1,
21040 Origgio (VA),
Italy

Manufacturer
Lek Pharmaceuticals d.d.
Trimlini 2D
9220 Lendava, Slovenia