Sitagliptin Teva

Package Leaflet: Information for the Patient

Sitagliptin Teva, 25 mg Film-Coated Tablets

Sitagliptin Teva, 50 mg Film-Coated Tablets

Sitagliptin Teva, 100 mg Film-Coated Tablets

Sitagliptin

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

• 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 experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

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

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

Sitagliptin Teva contains the active substance sitagliptin, which belongs to a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) that reduce blood sugar levels in adults with type 2 diabetes.
This medicine helps to increase the amount of insulin released after a meal and decrease the amount of sugar made by the body.
Your doctor has prescribed this medicine to lower your blood sugar levels, which are too high due to type 2 diabetes. This medicine can be used alone or in combination with other medicines (insulin, metformin, sulfonylureas, or glitazones) that lower blood sugar levels, which you may already be taking with meals and a program of exercise and weight loss.
What is type 2 diabetes
Type 2 diabetes is a condition where the body does not produce enough insulin and the insulin produced does not work as it should. 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 limb amputation.

2. Important information before taking Sitagliptin Teva

When not to take Sitagliptin Teva

• 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 Teva, discuss this with your doctor or pharmacist.
Patients taking sitagliptin have reported cases of pancreatitis (see section 4).
If you experience blisters on your skin, this may be a sign of a condition called bullous pemphigoid. Your doctor may advise you to stop taking Sitagliptin Teva.

Tell your doctor if you have or have had

• pancreatic disease (such as pancreatitis)
• gallstones, alcohol dependence, or very high levels of triglycerides (a type of fat) in the blood. In these situations, the risk of pancreatitis (see section 4) may increase
• type 1 diabetes
• diabetic ketoacidosis (a complication of diabetes characterized by high blood sugar levels, rapid weight loss, nausea, or vomiting)
• any kidney disease that has occurred in the past or is present
• allergic reaction to sitagliptin (see section 4).

Because this medicine does not work when blood sugar levels are low, it is unlikely to cause low blood sugar levels. However, if this medicine is taken with a sulfonylurea or insulin, low blood sugar levels (hypoglycemia) may occur. 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 from 10 to 17 years of age. It is not known whether this medicine is safe and effective when used in children under 10 years of age.

Sitagliptin Teva and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to 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 Teva with digoxin, your doctor should monitor your digoxin levels.

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 during pregnancy.
It is not known whether this medicine passes into breast milk. Do not take this medicine while breastfeeding or if you plan to breastfeed.

Driving and using machines

This medicine has no or negligible influence on the ability to drive and use machines. However, dizziness and drowsiness have been reported, which may affect the ability to drive and use machines.
Taking this medicine with sulfonylureas or insulin may cause low blood sugar levels (hypoglycemia), which may affect the ability to drive and use machines or work without safe foot support.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially 'sodium-free'.

3. How to take Sitagliptin Teva

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

• one 100 mg film-coated tablet;
• once a day;
• taken orally. If you have kidney problems, your doctor may prescribe a lower dose of Sitagliptin Teva (e.g., 25 mg or 50 mg).

The 50 mg and 100 mg tablets can be divided into equal doses.
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 levels.
Diet and exercise help your body use sugar from your blood. While taking Sitagliptin Teva, it is important to follow the diet and exercise program recommended by your doctor.

Taking a higher dose of Sitagliptin Teva than recommended

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

Missing a dose of Sitagliptin Teva

If you miss a dose, take it as soon as possible. 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.

Stopping treatment with Sitagliptin Teva

To maintain control of your blood sugar levels, you should continue to take this medicine for as long as your doctor tells you.
Do not stop taking this medicine without first talking to your doctor.
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 Teva and contact your doctor immediatelyif 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 skin, as well as 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 another medicine to treat your diabetes.

In some patients, when sitagliptin was added to metformin, the following side effects occurred:

Side effects:
Common(may affect up to 1 in 10 people): low blood sugar levels, headache, upper respiratory tract infections, stuffy or runny nose, and sore throat, joint pain or stiffness
Uncommon(may affect up to 1 in 100 people): dizziness, constipation, itching
Rare(may affect up to 1 in 1,000 people): reduced number of platelets in the blood
Frequency not known(cannot be estimated from the available data): kidney disease (sometimes requiring dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of blistering skin condition)

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.edrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sitagliptin Teva

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 and blister or label of the bottle after:
“Expiry Date” or “EXP”. The expiry date refers to the last day of the month.
The batch number is stated on the packaging after the word “Lot”.
There are no special storage instructions 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 Teva contains

• The active substance is sitagliptin.

25 mg, film-coated tablets:
Each film-coated tablet contains 25 mg of sitagliptin, in the form of sitagliptin phosphate.
50 mg, film-coated tablets:
Each film-coated tablet contains 50 mg of sitagliptin, in the form of sitagliptin phosphate.
100 mg, film-coated tablets:
Each film-coated tablet contains 100 mg of sitagliptin, in the form of sitagliptin phosphate.

• Other ingredients are: microcrystalline cellulose, calcium hydrogen phosphate, sodium carmellose, magnesium stearate The tablet coating contains: partially hydrolyzed polyvinyl alcohol, macrogol 3350, talc, titanium dioxide (E 171), iron oxide red (E 172), and iron oxide yellow (E 172). The 25 mg film-coated tablets also contain iron oxide black (E172).

What Sitagliptin Teva looks like and contents of the pack

The 25 mg film-coated tablets are pink, round, with the inscription “S25” on one side, and smooth on the other side..
The 50 mg film-coated tablets are beige, round, with the inscription “S | 50” and a dividing line on one side, and a dividing line on the other side.
The 100 mg film-coated tablets are orange, round, with the inscription “S | 100” and a dividing line on one side, and a dividing line on the other side.
Sitagliptin Teva is available in blisters of 14, 28, 30, 56, 60, 84, 90, 98, 100, and 120 tablets, calendar packs of 14, 28, 56, and 98 tablets, and single-dose packs of 28x1, 50x1, 56x1, 98x1, 100x1, and 120x1 tablets, or a bottle (with a desiccant) containing 100 or 250 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53,
00-113 Warsaw

Manufacturer/Importer

TEVA Gyógyszergyár Zrt.
Debrecen, Pallagi út 13,
H-4042, Hungary
Teva Operations Poland Sp. z o.o
ul. Mogilska 80., Krakow 31-546
Poland
Merckle GmbH
Ludwig-Merckle-Straße 3, Blaubeuren, Baden-Wuerttemberg
DE- 89143, Germany
Teva Pharma B.V.
Swensweg 5, Haarlem
2031 GA, Netherlands

Date of last revision of the package leaflet: December 2022