Sitagliptin sandoz

Package leaflet: Information for the patient

Sitagliptin Sandoz, 25 mg, film-coated tablets
Sitagliptin Sandoz, 50 mg, film-coated tablets
Sitagliptin Sandoz, 100 mg, film-coated tablets
Sitagliptinum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.
Keep this leaflet, as you may need to read it again.
If you have any further questions, please consult your doctor, pharmacist, or nurse.
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 effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse.
See section 4.

Contents of the leaflet:

1. What Sitagliptin Sandoz is 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

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

Sitagliptin Sandoz 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 adult patients with type 2 diabetes.
This medicine helps increase the amount of insulin released after a meal and reduces the amount of sugar produced by the body.
Your doctor has prescribed this medicine to help lower high blood sugar levels caused by type 2 diabetes. It may be used alone or in combination with other blood sugar-lowering medicines (such as insulin, metformin, sulfonylureas, or glitazones) that you may already be taking, along with diet and an 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 sugar. When this happens, sugar (glucose) builds up in the blood. This can lead to serious health problems such as heart disease, kidney disease, vision loss, and limb amputations.

2. Information before taking Sitagliptin Sandoz

When not to take Sitagliptin Sandoz

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

Warnings and precautions
Cases of pancreatitis have been reported in patients taking Sitagliptin Sandoz (see section 4).
If the patient develops blisters on the skin, this may be a sign of a disease called bullous pemphigoid. The doctor may advise the patient to stop taking Sitagliptin Sandoz.
Inform the doctor if the patient has or has had in the past:

• pancreatic disease (e.g. pancreatitis);
• gallstones, alcohol dependence, or very high levels of triglycerides (a type of fat) in the blood. In such 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 levels, rapid weight loss, nausea or vomiting);
• any kidney disease in the past or currently;
• an allergic reaction to Sitagliptin Sandoz (see section 4).

Since this medicine does not work when blood sugar levels are low, it is unlikely to cause excessively low blood sugar. However, if this medicine is taken together with a sulfonylurea or insulin, low blood sugar (hypoglycaemia) may occur. The doctor may reduce the dose of the sulfonylurea or insulin.
Children and adolescents
This medicine should not be used in children and adolescents under 18 years of age. 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 in children under 10 years of age.
Sitagliptin Sandoz and 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 Sandoz with digoxin, blood levels of digoxin should be monitored.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
This medicine should not be used during pregnancy.
It is not known whether this medicine passes into human breast milk. This medicine should not be used during breastfeeding or if breastfeeding is planned.
Driving and using machines
This medicine has no effect or a negligible effect 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 together with medicines called sulfonylureas or with insulin may lead to low blood sugar (hypoglycaemia), which may affect the ability to drive and use machines or working without secure foot support.
Sitagliptin Sandoz contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. this medicine is considered "sodium-free".

3. How to take Sitagliptin Sandoz

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 prescribe a lower dose of
Sitagliptin Sandoz (e.g. 25 mg or 50 mg).
This medicine can be taken independently of meals and drinks.
The doctor may recommend taking only this medicine or this medicine together with certain other
medicines that reduce blood sugar levels. Diet and physical exercise help the body to use blood
sugar more effectively. While taking Sitagliptin Sandoz, it is important to follow the diet and perform
the physical activities recommended by your doctor.
Taking more Sitagliptin Sandoz than recommended
If you take more of this medicine than prescribed, contact your doctor immediately.
Missing a dose of Sitagliptin Sandoz
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 of this medicine.
Stopping Sitagliptin Sandoz
To maintain control of blood sugar levels, this medicine should be taken for as long as your doctor
recommends. 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 everybody will experience them.
You should DISCONTINUE Sitagliptin Sandoz and contact your doctor immediately if any of the following serious adverse reactions occur:
Severe and persistent pain in the stomach area which may spread to the back, with or without nausea and vomiting – these may be symptoms of pancreatitis.
In case of a severe allergic reaction (frequency not known), including rash, hives, blistering or peeling of the skin, and swelling of the face, lips, tongue or throat which may cause difficulty in breathing or swallowing, treatment with the medicine should be stopped and immediate medical advice sought. Your doctor may prescribe a medicine to treat the allergic reaction and another medicine to treat diabetes.

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

In some patients, gastrointestinal symptoms of various kinds occurred after starting treatment with sitagliptin in combination with metformin (common).

In some patients, the following adverse reactions occurred when sitagliptin was used in combination with a sulfonylurea and metformin:
Very common (may affect more than 1 in 10 people): low blood sugar
Common: constipation

In some patients, the following adverse reactions occurred when sitagliptin was used with pioglitazone:
Common: bloating, swelling of hands or feet

In some patients, the following adverse reactions occurred when sitagliptin was used in combination with pioglitazone and metformin:
Common: swelling of hands or feet

In some patients, the following adverse reactions occurred when sitagliptin was used in combination with insulin (with or without metformin):
Common: influenza-like illness
Uncommon: dry mouth

In some patients, the following adverse reactions occurred during clinical trials with sitagliptin alone, or during post-marketing use of sitagliptin alone and/or with other antidiabetic medicines:
Common: low blood sugar, headache, upper respiratory tract infections, nasal congestion or runny nose and sore throat, bone and joint pain, pain in arms or legs
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 blistering skin condition).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Sitagliptin Sandoz

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the cardboard
pack after "EXP". The expiry date refers to the last day of the stated month.
There are no special storage instructions for this medicine. Medicines must not be
disposed of via wastewater or household waste. Ask your pharmacist how to dispose
of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Sitagliptin Sandoz contains
The active substance is sitagliptin.
Sitagliptin Sandoz 25 mg, film-coated tablets
Each film-coated tablet contains sitagliptin hydrochloride monohydrate equivalent to 25 mg of sitagliptin.
Sitagliptin Sandoz 50 mg, film-coated tablets
Each film-coated tablet contains sitagliptin hydrochloride monohydrate equivalent to 50 mg of sitagliptin.
Sitagliptin Sandoz 100 mg, film-coated tablets
Each film-coated tablet contains sitagliptin hydrochloride monohydrate equivalent to 100 mg of sitagliptin.

The other ingredients are:
Tablet core: microcrystalline cellulose, calcium hydrogen phosphate, sodium carboxymethyl starch (type A), magnesium stearate.
Tablet coating:
Sitagliptin Sandoz 25 mg, film-coated tablets; Sitagliptin Sandoz 100 mg, film-coated tablets
polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, yellow iron oxide (E 172), red iron oxide (E 172).
Sitagliptin Sandoz 50 mg, film-coated tablets
polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, yellow iron oxide (E 172), red iron oxide (E 172), black iron oxide (E 172).

What Sitagliptin Sandoz looks like and contents of the pack
Sitagliptin Sandoz 25 mg, film-coated tablets
Pink, round film-coated tablets with the inscription "25" debossed on one side, 6.2 mm ± 0.2 mm in diameter.
Sitagliptin Sandoz 50 mg, film-coated tablets
Light beige, round film-coated tablets with the inscription "50" debossed on one side, 8.0 mm ± 0.2 mm in diameter.
Sitagliptin Sandoz 100 mg, film-coated tablets
Beige, round film-coated tablets with the inscription "100" debossed on one side, 9.9 mm ± 0.2 mm in diameter.

Opaque blister pack made of PVC/PE/PVDC/Aluminum or OPA/Aluminum/PVC/Aluminum, perforated or non-perforated.
Packaging contains 28 film-coated tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl
Austria

Manufacturers
PharOS MT Ltd
HF62X, Hal Far Industrial Estate
BBG3000 Birzebbugia
Malta
Rontis Hellas Medical and Pharmaceutical Products S.A
P.O Box 3012 Larissa Industrial Area
41500 Larissa
Greece
Lek Pharmaceuticals d.d.
Verovškova Ulica 57
1526 Ljubljana
Slovenia

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Netherlands Sitagliptin Sandoz 25 mg, filmomhulde tabletten
Sitagliptin Sandoz 50 mg, filmomhulde tabletten
Sitagliptin Sandoz 100 mg, filmomhulde tabletten
Poland Sitagliptin Sandoz
Romania Sitagliptină Sandoz 100 mg comprimate filmate

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00