Sitagliptin Aurovitas

Package Leaflet: Information for the User

Sitagliptin Aurovitas, 100 mg, Film-Coated Tablets

Sitagliptin

Read the package leaflet carefully before taking the medicine, as it contains important information for you.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

• 1. What Sitagliptin Aurovitas is and what it is used for
• 2. Important information before taking Sitagliptin Aurovitas
• 3. How to take Sitagliptin Aurovitas
• 4. Possible side effects
• 5. How to store Sitagliptin Aurovitas
• 6. Contents of the pack and other information

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

The medicine contains the active substance sitagliptin, which belongs to a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors), which reduce blood sugar levels in adults with type 2 diabetes.
This medicine helps to increase the amount of insulin produced after a meal and decreases the amount of sugar produced by the body.
Your doctor has prescribed this medicine to lower your blood sugar, which is too high because of your type 2 diabetes. This medicine can be used alone or in combination with other medicines (insulin, metformin, sulfonylureas, or glitazones) that lower blood sugar, which you may already be taking, along with diet and exercise.

What is type 2 diabetes?
Type 2 diabetes is a condition where the body does not produce enough insulin, and the insulin that it does produce does not work properly. The body may also produce too much sugar. If this happens, sugar (glucose) builds up in the blood. This can lead to serious health problems, such as heart disease, kidney disease, loss of vision, and amputation of limbs.

2. Important information before taking Sitagliptin Aurovitas

When not to take Sitagliptin Aurovitas

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

Warnings and precautions

Before taking Sitagliptin Aurovitas, talk to your doctor or pharmacist.
There have been reports of pancreatitis (inflammation of the pancreas) in patients taking Sitagliptin Aurovitas (see section 4).
If you get blisters on your skin, it may be a sign of a condition called bullous pemphigoid. Your doctor may tell you to stop taking Sitagliptin Aurovitas.
Tell your doctor if you have or have had:

• pancreatitis (inflammation of the pancreas)
• gallstones, alcohol dependence, or very high levels of triglycerides (a type of fat) in the blood. In these cases, the risk of pancreatitis may be increased (see section 4)
• type 1 diabetes
• diabetic ketoacidosis (a complication of diabetes characterized by high blood sugar, rapid weight loss, nausea, or vomiting)
• any kidney problems, now or in the past
• an allergic reaction to sitagliptin (see section 4).

Because this medicine does not work when your blood sugar is low, it is unlikely to cause low blood sugar. However, when taken with a sulfonylurea or insulin, it may cause low blood sugar (hypoglycemia). Your doctor may reduce the dose of the sulfonylurea or insulin.

Children and adolescents

Children and adolescents under 18 years of age should not take this medicine. This medicine is not effective in children and adolescents aged 10 to 17 years. It is not known if this medicine is safe and effective in children under 10 years of age.

Sitagliptin Aurovitas with other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take.
In particular, tell your doctor if you are taking digoxin (a medicine used to treat heart rhythm disorders and other heart conditions). When taking Sitagliptin Aurovitas with digoxin, it may be necessary to check the level of digoxin in your blood.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Do not take this medicine if you are pregnant.
It is not known if this medicine passes into breast milk. Do not take this medicine if you are breastfeeding or plan to breastfeed.

Driving and using machines

This medicine has no or negligible influence on the ability to drive and use machines. However, when driving or using machines, consider that dizziness and drowsiness have been reported.

Sitagliptin Aurovitas contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is essentially sodium-free.

3. How to take Sitagliptin Aurovitas

Always take this medicine exactly as your doctor or pharmacist has told you.
The usual recommended dose is:

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

If you have kidney problems, your doctor may prescribe a lower dose (such as 25 mg or 50 mg).
This medicine can be taken with or without food and drink.
Your doctor may prescribe this medicine alone or with certain other medicines that lower blood sugar.
Diet and exercise help your body use blood sugar better. When taking Sitagliptin Aurovitas, it is important to follow the diet and exercise plan recommended by your doctor.

If you take more Sitagliptin Aurovitas than you should

If you take more than the recommended dose, contact your doctor immediately.

If you forget to take Sitagliptin Aurovitas

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a forgotten dose.

If you stop taking Sitagliptin Aurovitas

To maintain control of your blood sugar, you should continue taking this medicine for as long as your doctor tells you.
Do not stop taking this medicine without talking to your doctor first.
If you have any further questions on the use of this product, 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 Sitagliptin Aurovitas and contact your doctor immediately if you experience any of the following serious side effects:

• Severe and persistent stomach pain (in the abdomen), which may radiate to the back, with or without nausea and vomiting - these may be signs of pancreatitis.

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

In some patients, when sitagliptin was added to metformin, the following side effects were reported:
Common (may affect up to 1 in 10 people): low blood sugar, nausea, bloating, vomiting.
Uncommon (may affect up to 1 in 100 people): stomach pain, diarrhea, constipation, drowsiness.
Some patients experienced various stomach problems when they started taking sitagliptin with metformin (commonly).

In some patients, when sitagliptin was taken with a sulfonylurea and metformin, the following side effects were reported:
Very common (may affect more than 1 in 10 people): low blood sugar.
Common: constipation.
In some patients, when sitagliptin was taken with pioglitazone, the following side effects were reported:
Common: bloating, swelling of the hands or feet.
In some patients, when sitagliptin was taken with pioglitazone and metformin, the following side effects were reported:
Common: swelling of the hands or feet.
In some patients, when sitagliptin was taken with insulin (with or without metformin), the following side effects were reported:
Common: flu.
Uncommon: dry mouth.
In some patients, when sitagliptin was taken alone or with other diabetes medicines in clinical studies or after marketing, the following side effects were reported:
Common: low blood sugar, headache, upper respiratory tract infections, stuffy or runny nose and sore throat, and pain in the bones or joints.
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 blistering skin condition).

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
Side effects can be reported to the national reporting system listed below.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sitagliptin Aurovitas

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 carton, blister, or bottle after EXP. The expiry date refers to the last day of that month.
There are no special storage conditions for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Sitagliptin Aurovitas contains

• The active substance is sitagliptin.

Each film-coated tablet contains sitagliptin phosphate monohydrate equivalent to 100 mg of sitagliptin.

• The other ingredients are: Tablet core:microcrystalline cellulose (Type-102), calcium hydrogen phosphate, croscarmellose sodium, sodium stearyl fumarate, magnesium stearate. Tablet coating:polyvinyl alcohol (E 1203), titanium dioxide (E 171), macrogol 3350 (E 1521), talc (E 553b), yellow iron oxide (E 172), red iron oxide (E 172).

What Sitagliptin Aurovitas looks like and contents of the pack

Film-coated tablet.

Sitagliptin Aurovitas, 100 mg, film-coated tablets

Beige, round, biconvex film-coated tablet with "SG" engraved on one side and "100" on the other.
Sitagliptin Aurovitas, 100 mg, film-coated tablets are available in blisters and HDPE bottles.

Pack sizes:

Blister:10, 14, 28, 30, 56, 60, 84, 90, 98, 100, 112, and 120 film-coated tablets
HDPE bottle:30, 500, and 1000 film-coated tablets
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warszawa
e-mail: medicalinformation@aurovitas.pl

Manufacturer/Importer:

APL Swift Services (Malta) Ltd.
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus 19, Venda Nova
2700-487 Amadora
Portugal
Arrow Génériques
26 Avenue Tony Garnier
69007 Lyon
France

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

Belgium:
Sitagliptine AB 25 mg/50 mg/100 mg film-coated tablets / comprimés pelliculés /
Filmtabletten
France:
Sitagliptine Arrow 50 mg/100 mg comprimé pelliculé
Germany:
Sitagliptin PUREN 25 mg/50 mg/100 mg Filmtabletten
Netherlands:
Sitagliptine Aurobindo 25 mg/50 mg/100 mg, filmomhulde tabletten
Poland:
Sitagliptin Aurovitas
Romania:
Sitagliptină Aurobindo 50 mg/ 100 mg comprimate filmate
Spain:
Sitagliptina Aurovitas 25 mg/50 mg/100 mg comprimidos recubiertos con película EFG

Date of last revision of the package leaflet: