Package leaflet: Information for the patient

Adaglip 25 mg film-coated tablets
Adaglip 50 mg film-coated tablets
Adaglip 100 mg film-coated tablets
Sitagliptin
Generic 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, 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, because it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

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

1. What Adaglip is and what it is used for

Adaglip 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 insulin levels 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) accumulates 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 Adaglip

Do not take Adaglip

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 Adaglip (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 treatment with Adaglip.
Inform your doctor if you have or have had:

a pancreatic disease (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 Adaglip (see section 4).

It is unlikely that this medicine will cause low blood sugar levels (hypoglycaemia) because it does not act when blood sugar is low. However, when this medicine is taken together with a sulphonylurea or insulin, low blood sugar (hypoglycaemia) may occur. Your doctor may reduce the dose of 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 Adaglip
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 Adaglip.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are 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 has a 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 sulphonylureas or with insulin may cause hypoglycaemia, which could affect your ability to drive, operate machinery, or work without protective barriers.
Adaglip contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially "sodium-free".

3. How to take Adaglip

Take this medicine exactly as your doctor has instructed you. If you have any doubts, 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 physical exercise can help your body use blood sugar more effectively.
While taking Adaglip, it is important to continue the diet and exercise plan recommended by your doctor.
If you take more Adaglip than you should
If you take a dose of this medicine higher than prescribed, contact your doctor immediately.
If you forget to take Adaglip
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 of this medicine.
If you stop taking Adaglip
Continue taking this medicine for as long as your doctor prescribes it, so that you can keep your blood sugar level under control.
Do not stop taking this medicine without first talking to your doctor.
If you have any questions 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 everybody will experience them.
STOP taking Adaglip and contact a 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 blisters/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 a 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 experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at http://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 Adaglip

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack 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 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 Adaglip contains
The active substance is sitagliptin.
Each 25 mg tablet contains sitagliptin hydrochloride monohydrate, equivalent to 25 mg of sitagliptin.
Each 50 mg tablet contains sitagliptin hydrochloride monohydrate, equivalent to 50 mg of sitagliptin.
Each 100 mg tablet contains sitagliptin hydrochloride monohydrate, equivalent to 100 mg of sitagliptin.
The other components are: in the tablet core: microcrystalline cellulose, anhydrous calcium phosphate,
sodium croscarmellose, magnesium stearate and sodium stearyl fumarate. The tablet coating contains:
polyvinyl alcohol, macrogol 4000, talc, titanium dioxide (E171), red iron oxide (E172), and yellow iron oxide (E172).

Description of the appearance of Adaglip and the contents of the pack
25 mg tablet: orange film-coated, round, biconvex tablet with "25" on one side. The tablet diameter is 6 mm.
50 mg tablet: orange film-coated, round, biconvex tablet with "50" on one side. The tablet diameter is 8 mm.
100 mg tablet: orange film-coated, round, biconvex tablet with "100" on one side. The tablet diameter is 10 mm.
Packs of 28 and 98 film-coated tablets in PVC/PVDC-aluminium blisters.
Not all pack sizes may be marketed.

Marketing Authorization Holder:
Adamed s.r.l.
Via G. Mazzini, 20
20123 – Milan
(Italy)

Manufacturer
Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice
Poland

This medicinal product is authorized in the European Economic Area countries under the following names:
Finland: Sitagliptin APC Instytut 25 mg kalvopäällysteiset tabletit
Sitagliptin APC Instytut 50 mg kalvopäällysteiset tabletit
Sitagliptin APC Instytut 100 mg kalvopäällysteiset tabletit
Italy: Adaglip
Bulgaria: Ситаглиптин Адамед 25 mg филмирани таблетки
Ситаглиптин Адамед 50 mg филмирани таблетки
Ситаглиптин Адамед 100 mg филмирани таблетки
Spain: Sitagliptina APC Instytut 25 mg comprimidos recubiertos con película EFG
Sitagliptina APC Instytut 50 mg comprimidos recubiertos con película EFG
Sitagliptina APC Instytut 100 mg comprimidos recubiertos con película EFG