Sitagliptin aurovitas

Package leaflet: Information for the user

Sitagliptin Aurovitas, 100 mg, film-coated tablets
Sitagliptinum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

1. What Sitagliptin Aurovitas is and what it is used for
2. What you need to know 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

This medicine contains the active substance sitagliptin, which belongs to a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors), which reduce blood glucose levels in adult patients with type 2 diabetes.
This medicine helps increase insulin levels released after meals and reduces the amount of glucose produced by the body.
Your doctor has prescribed this medicine to help lower high blood glucose levels caused by type 2 diabetes. This medicine may be used alone or in combination with other glucose-lowering medicines (such as insulin, metformin, sulfonylureas or glitazones) that you may already be taking, along with 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 is produced does not work properly. The body may also produce too much glucose. When this happens, sugar (glucose) builds up in the blood. This may lead to serious health problems such as heart disease, kidney disease, vision loss and limb amputations.

2. Important information before taking Sitagliptin Aurovitas

When not to take Sitagliptin Aurovitas

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

Warnings and precautions
Before starting treatment with Sitagliptin Aurovitas, discuss this with the doctor or
pharmacist.
Cases of pancreatitis (inflammation of the pancreas) have been reported in patients taking Sitagliptin Aurovitas (see
section 4).
If the patient develops blisters on the skin, this may be a symptom of a disease called bullous pemphigoid. The doctor may advise the patient to stop taking Sitagliptin Aurovitas.
Inform the doctor if the patient has or has had:

• pancreatic disease (e.g. pancreatitis)
• gallstones, alcohol dependence, or very high levels of triglycerides (a form of fat) in the blood. In such cases, the risk of pancreatitis may be increased (see section 4)
• type 1 diabetes
• diabetic ketoacidosis (a diabetes complication characterized by high blood sugar levels, rapid weight loss, nausea or vomiting)
• any kidney disease in the past or currently
• allergic reaction to sitagliptin (see section 4).

Since this medicine does not act when blood sugar levels are low, it is unlikely to cause excessively low blood sugar levels. However, if this medicine is taken together with a sulfonylurea derivative or insulin, low blood sugar levels (hypoglycaemia) may occur. The doctor may reduce the dose of the sulfonylurea derivative 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 whether this medicine is safe and effective when used in children under 10 years of age.
Sitagliptin Aurovitas with other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
In particular, inform the doctor if the patient is taking digoxin (a medicine used to treat heart rhythm disorders and other heart conditions). When taking Sitagliptin Aurovitas with digoxin, monitoring of digoxin blood levels may be necessary.
Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before taking this medicine.
This medicine should not be used during pregnancy.
It is not known whether this medicine passes into breast milk. This medicine should not be used during breastfeeding or when breastfeeding is planned.
Driving and using machines
This medicine has no effect or a negligible effect on the ability to drive and operate machinery. Nevertheless, when driving and operating machinery, it should be taken into account that dizziness and somnolence have been reported.
Taking this medicine together with medicines called sulfonylurea derivatives or with insulin may lead to hypoglycaemia, which in turn may affect the ability to drive and operate machinery or to work without safe foot support.
Sitagliptin Aurovitas contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Sitagliptin Aurovitas

This medicine should always be taken as directed by your doctor. If you have any doubts, you should
consult your doctor or pharmacist.
The usual recommended dose is:

• one 100 mg coated tablet
• once daily
• taken orally.

If the patient has impaired kidney function, the doctor may recommend lower doses (e.g. 25 mg
or 50 mg).
This medicine can be taken regardless of meals or drinks.
Your doctor may recommend taking only this medicine or this medicine together with other
medicines that lower blood sugar levels.
Diet and physical exercise help the body to use more effectively the sugar present in the blood.
While taking Sitagliptin Aurovitas, it is important to follow the diet and perform the physical
exercises recommended by your doctor.
Taking more Sitagliptin Aurovitas than prescribed
If you take more than the prescribed dose of this medicine, contact your doctor immediately.
Missing a dose of Sitagliptin Aurovitas
If you miss a dose, take it as soon as possible. If it is almost time for the next dose, skip the missed
dose and continue with your regular dosing schedule. Do not take a double dose to make up for
the missed dose.
Stopping Sitagliptin Aurovitas
To maintain control of blood sugar levels, the medicine should be taken for as long as directed by
your doctor. Do not stop taking this medicine without first consulting your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
You should DISCONTINUE treatment with Sitagliptin Aurovitas and contact your doctor immediately if
any of the following serious adverse reactions occur:

• Severe and persistent abdominal pain (in the stomach area), possibly radiating to the back, with or without nausea and vomiting – these may be symptoms of pancreatitis.

In case of a severe allergic reaction (frequency unknown), including rash, hives, skin blisters or peeling skin, and swelling of the face, lips, tongue or throat which may cause difficulty in breathing or swallowing, treatment should be stopped and immediate medical advice sought. Your doctor may prescribe medication to treat the allergic reaction and another medicine for diabetes.

In some patients, the following adverse reactions occurred when sitagliptin was added to metformin:

Frequent (may affect up to 1 in 10 people): low blood sugar levels, nausea, bloating, vomiting.
Uncommon (may affect up to 1 in 100 people): stomach pain, diarrhoea, constipation, drowsiness.

Some patients experienced various gastrointestinal symptoms after starting treatment with sitagliptin in combination with metformin (frequent).

In some patients taking sitagliptin in combination with a sulfonylurea and metformin, the following adverse reactions occurred:

Very common (may affect more than 1 in 10 people): low blood sugar levels.
Frequent: constipation.

In some patients taking sitagliptin and pioglitazone, the following adverse reactions occurred:

Frequent: bloating, swelling of hands or feet.

In some patients taking sitagliptin in combination with pioglitazone and metformin, the following adverse reactions occurred:

Frequent: swelling of hands or feet.

In some patients taking sitagliptin in combination with insulin (with or without metformin), the following adverse reactions occurred:

Frequent: influenza-like illness.
Uncommon: dry mouth.

In some patients taking sitagliptin alone and/or in combination with other antidiabetic medicines in clinical trials or during post-marketing use, the following adverse reactions occurred:

Frequent: low blood sugar levels, headache, upper respiratory tract infections, blocked or runny nose and sore throat, bone and joint infections, pain in arm or leg.
Uncommon: dizziness, constipation, itching.
Rare: decreased platelet count.
Frequency not known: kidney disorders (sometimes requiring dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of skin blistering).

Reporting of adverse reactions

If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl

Reporting adverse reactions helps provide more information on the safety of the medicine.
Adverse reactions may also be reported to the marketing authorization holder.

5. How to store Sitagliptin Aurovitas

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, container,
and blister after: EXP. The expiry date refers to the last day of the stated month.
No special storage conditions apply.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Such 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 hydrochloride monohydrate equivalent to
100 mg of sitagliptin.

• Other components are: Tablet core: microcrystalline cellulose (Type-102), calcium hydrogen phosphate, sodium croscarmellose, 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, embossed with the letter "SG" on one side and the number "100" on the other.
Sitagliptin Aurovitas 100 mg film-coated tablets are available in blisters and HDPE bottles.
Pack sizes:
Blisters: 10, 14, 28, 30, 56, 60, 84, 90, 98, 100, 112 and 120 film-coated tablets
HDPE bottles: 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.
Sokratesa 13D, local 27
01-909 Warsaw
e-mail: [email protected]

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 medicinal product is authorised in the European Economic Area countries under the following names:
Belgium: Sitagliptine AB 25 mg/50 mg/100 mg filmomhulde tabletten / 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