SITAGLIPTIN 25 mg Film-Coated Tablets

Зміст інструкції

1. Sitagliptin Sandoz 25 mg film-coated tablets, 50 mg film-coated tablets, 100 mg film-coated tablets
   1. What is Sitagliptin Sandoz and what it is used for
   2. What you need to know before taking Sitagliptin Sandoz
   3. How to take Sitagliptin Sandoz
   4. Possible side effects
   5. How to store Sitagliptin Sandoz
   6. Contents of the pack and other information

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

Generic medicine

Read this leaflet carefully before you start 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Sitagliptin Sandoz contains the active ingredient 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 to increase the levels of insulin produced after a meal and decreases the
amount of sugar produced by the body.
Your doctor has prescribed this medicine to help lower your blood sugar level,
which is too high due to type 2 diabetes. This medicine can be used alone or together
with other medicines (insulin, metformin, sulfonylurea or glitazones) that lower blood sugar
and 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
produced by the body 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 amputations.

2. What you need to know before taking Sitagliptin Sandoz

Do not take Sitagliptin Sandoz

• if you are allergic to sitagliptin or 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 the skin, this may be a sign of a condition called
bullous pemphigoid. Your doctor may ask you to stop taking Sitagliptin Sandoz.
Tell 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 complication of diabetes 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) This medicine is unlikely to cause low blood sugar (hypoglycemia) because it does not work when blood sugar levels are low. However, when this medicine is taken with a sulfonylurea or with insulin, a decrease in blood sugar levels (hypoglycemia) may occur. Your doctor may reduce the dose of sulfonylurea or insulin.

Children and adolescents
Children and adolescents under 18 years of age should not use this medicine. It 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.

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, tell your doctor if you are taking digoxin (a
medicine used to treat irregular heartbeats and other heart problems). It may
be necessary to check the level of digoxin in the blood if it is taken with Sitagliptin
Sandoz

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this medicine. You should not
use this medicine during pregnancy.
It is not known whether this medicine passes into breast milk. You should not take this medicine if you
are breastfeeding or plan to breastfeed.

Driving and using machines
This medicine does not affect or has a negligible effect on the ability to drive vehicles and
operate machines. However, dizziness and drowsiness have been reported, which may affect your
ability to drive vehicles and operate machines. Taking this medicine with other
medicines called sulfonylureas or with insulin can cause hypoglycemia, which may affect your
ability to drive, operate machinery 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 following exactly the instructions of your doctor. If you have any doubts
consult your doctor or pharmacist.
The usual recommended dose is:

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

If you have kidney problems, your doctor may prescribe lower doses (such as 25 mg or 50 mg).
You can take this medicine with or without food and beverages.
Your doctor may prescribe this medicine alone or together with other medicines that lower the
blood sugar level. Diet and exercise can help your body to
use blood sugar better. While taking Sitagliptin Sandoz, it is important
to continue the diet and exercise program recommended by your doctor.

If you take more Sitagliptin Sandoz than you should
If you take a dose of this medicine higher than that which has been prescribed for you, 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 to
take the next dose, skip the forgotten dose and continue with the next doses
as usual. Do not take a double dose of this medicine to make up for a missed dose.

If you stop taking Sitagliptin Sandoz
Continue to take this medicine as long as your doctor prescribes it so that you can
continue to control your blood sugar level. You should not stop treatment
with this medicine without first talking to your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

• Severe and persistent abdominal pain (stomach area) that may extend to the back with or without nausea and vomiting, as these may be signs of inflammation of the pancreas (pancreatitis). If you have a serious allergic reaction (frequency not known), including skin rash, hives, blisters on the skin/skin peeling and swelling of the face, lips, tongue and throat, which can cause difficulty breathing or swallowing, stop treatment with this medicine and contact your doctor immediately. Your doctor may prescribe you a medicine to treat your allergic reaction and a different medicine for your diabetes.

Some patients have experienced the following side effects following the addition of sitagliptin
to metformin:
Common (may affect up to 1 in 10 people): low blood sugar, nausea,
flatulence, vomiting
Uncommon (may affect up to 1 in 100 people): stomach pain, diarrhea, constipation,
drowsiness
Some patients have experienced different types of stomach upset when starting sitagliptin and metformin together as part of combination therapy (frequency is common).
Some patients have 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
Common: constipation
Some patients have experienced the following side effects when taking sitagliptin and
pioglitazone:
Common: flatulence, swelling of the hands or legs
Some patients have experienced the following side effects when taking sitagliptin in
combination with pioglitazone and metformin:
Common: swelling of the hands or legs
Some patients have experienced the following side effects when taking sitagliptin in
combination with insulin (with or without metformin):
Common: influenza
Uncommon: dry mouth
Some patients have experienced the following side effects when taking sitagliptin
alone in clinical trials, or during post-approval use alone and/or with other medicines
for diabetes:
Common: low blood sugar, headache, upper respiratory tract infection,
stuffy or runny nose and sore throat, osteoarthritis, arm or leg pain
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
skin blistering)

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects
directly through 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 box after
"EXP".
The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Open the blister just before taking the tablets. Do not use this medicine if the packaging
shows signs of tampering
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Sitagliptin Sandoz contains

• The active ingredient is sitagliptin.

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

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

Sitagliptin Sandoz 100 mg film-coated tablets
Each film-coated tablet contains sitagliptin monohydrate hydrochloride, equivalent to 100 mg of
sitagliptin
The other ingredients are: dibasic calcium phosphate (E341), microcrystalline cellulose (E460),
sodium croscarmellose (E468), magnesium stearate (E470b), sodium stearyl fumarate, hypromellose
(E464), hydroxypropyl cellulose (E463), macrogol (E1521), titanium dioxide (E 171), yellow iron
oxide (E172), red iron oxide (E172), black iron oxide (E172) (only applicable for the
100mg dosage) and talc (E553b)

Description of the appearance of Sitagliptin Sandoz and contents of the pack
Sitagliptin Sandoz 25 mg film-coated tablets
Film-coated tablets, round, biconvex, pink in colour, with “ST 25” imprinted on one
side; diameter 5.7 – 6.6 mm

Sitagliptin Sandoz 50 mg film-coated tablets
Film-coated tablets, round, biconvex, light pink in colour, with “ST 50”
imprinted on one side; diameter 7.7 – 8.6 mm

Sitagliptin Sandoz 100 mg film-coated tablets
Film-coated tablets, round, biconvex, light brown in colour, with “ST 100”
imprinted on one side; diameter 9.7 – 10.6 mm
Sitagliptin Sandoz is available in:
OPA/Alu/PVC//Alu 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