Ansifora

Patient Information Leaflet

Ansifora, 50 mg, film-coated tablets
Ansifora, 100 mg, film-coated tablets
Sitagliptin
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet for future reference.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Leaflet Contents

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

1. What Ansifora is and what it is used for

Ansifora 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 adults with
type 2 diabetes.
This medicine helps increase insulin release after meals and reduces the amount of glucose
produced by the body.
Your doctor has prescribed this medicine to lower high blood glucose levels caused by type 2
diabetes. The medicine may be used alone or in combination with other glucose-lowering medicines
(insulin, metformin, sulfonylureas, or glitazones) that you may already be taking, together with 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 does not work as it should. The body may also produce too much glucose. When this
occurs, sugar (glucose) accumulates 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 using Ansifora

When not to use Ansifora

• 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 Ansifora (see section 4).
If the patient develops skin blisters, this may be a sign of a condition called bullous pemphigoid. The doctor may advise the patient to stop taking Ansifora.
Inform the doctor if the patient has or has had:

• pancreatic disease (e.g. pancreatitis);
• gallstones, alcohol dependence, or very high blood triglyceride levels (a type of fat). 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 problems in the past or currently;
• allergic reaction to Ansifora (see section 4).

Since this medicine does not act when blood sugar levels are low, it is unlikely to cause excessively low blood sugar. However, if this medicine is used together with a sulfonylurea derivative or insulin, blood sugar levels may decrease (hypoglycaemia). 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 18 years. It is not known whether this medicine is safe and effective for use in children under 10 years of age.
Ansifora 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 Ansifora with digoxin, blood digoxin levels should be monitored.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
Do not use this medicine during pregnancy.
It is not known whether this medicine passes into breast milk. Do not use this medicine during breastfeeding or if breastfeeding is planned.
Driving and operating machinery
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 secure foot support.
Ansifora contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".
3. How to use Ansifora
This medicine should always be used exactly as directed by the doctor or pharmacist. In case of doubt, consult the 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 of the medicine (e.g. 25 mg or 50 mg).
It is recommended to use another available medicine on the market with a 25 mg strength.
This medicine may be taken with or without food and drink.
The doctor may recommend using only this medicine or this medicine together with certain other medicines that lower blood sugar levels.
Diet and physical exercise help the body use sugar in the blood more effectively.
While taking Ansifora, it is important to follow the diet and physical activity recommended by the doctor.
Taking more Ansifora than recommended
If more than the recommended dose of this medicine is taken, contact the doctor immediately.
Missed dose of Ansifora
If a dose is missed, take it as soon as possible. If it is almost time for the next dose, skip the missed dose and continue with the regular dosing schedule. Do not take a double dose.
Stopping Ansifora
To maintain control of blood sugar levels, the medicine should be taken for as long as directed by the doctor. Do not stop taking this medicine without first consulting the doctor.
If there are any further questions about the use of this medicine, consult the 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 Ansifora 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 not known), including rash, hives, skin blisters or skin peeling, and swelling of the face, lips, tongue or throat, which may cause difficulty in breathing or swallowing, treatment with this medicine must be stopped and medical advice must be sought immediately. Your doctor may prescribe another medicine to treat the allergic reaction and a different medicine for the treatment of diabetes.

The following adverse reactions have been reported in some patients when sitagliptin was added to metformin:

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

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

The following adverse reactions have been reported in some patients taking sitagliptin in combination with a sulfonylurea and metformin:

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

The following adverse reactions have been reported in some patients taking sitagliptin with pioglitazone:

Frequent: flatulence, swelling of hands or feet.

The following adverse reactions have been reported in some patients taking sitagliptin in combination with pioglitazone and metformin:

Frequent: swelling of hands or feet.

The following adverse reactions have been reported in some patients taking sitagliptin in combination with insulin (with or without metformin):

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

The following adverse reactions have been reported in some patients taking sitagliptin alone and/or with other antidiabetic medicines in clinical trials or during post-marketing use:

Frequent: low blood sugar levels, headache, upper respiratory tract infections, nasal congestion or runny nose, sore throat, bone and joint pain, pain in arm or leg.
Uncommon: dizziness, constipation, itching.
Rare (may affect up to 1 in 1,000 people): decreased platelet count.
Frequency not known (frequency cannot be estimated from available data): 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, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring 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 may also be reported to the Marketing Authorisation Holder.

Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Ansifora

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after: EXP. The expiry date refers to the last day of the month indicated.
Store below 25°C.
Medicines must not be disposed of via sewage systems 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 Package and Other Information

What Ansifora contains
Ansifora, 50 mg

• The active substance is sitagliptin: Each coated tablet contains sitagliptin hydrochloride monohydrate equivalent to 50 mg of sitagliptin.
• Other ingredients are:
  Tablet core: microcrystalline cellulose (PH 102), calcium hydrogen phosphate, sodium croscarmellose, magnesium stearate.
  Tablet coating: polyvinyl alcohol, macrogol 4000, talc, titanium dioxide (E 171), red iron oxide (E 172), and yellow iron oxide (E 172).

Ansifora, 100 mg

• The active substance is sitagliptin: Each coated tablet contains sitagliptin hydrochloride monohydrate equivalent to 100 mg of sitagliptin.
• Other ingredients are:
  Tablet core: microcrystalline cellulose (PH 102), calcium hydrogen phosphate, sodium croscarmellose, magnesium stearate.
  Tablet coating: polyvinyl alcohol, macrogol 4000, talc, titanium dioxide (E 171), red iron oxide (E 172), and yellow iron oxide (E 172).

What Ansifora looks like and contents of the pack
Ansifora, 50 mg
Round, light beige coated tablets, 8 mm in size, marked with "50" on one side.
Ansifora, 100 mg
Round, beige coated tablets, 10 mm in size, marked with "100" on one side.
Opaque blisters made of PVC/PE/PVDC/Aluminum in cardboard boxes. Pack sizes: 14, 28, 30, 56, 84, 90 or 98 coated tablets.
Aluminum blisters made of OPA/Aluminum/PVC/Aluminum in cardboard boxes. Pack sizes: 14, 28, 30, 56, 84, 90 or 98 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Vipharm S.A.
ul. A i F Radziwiłłów 9
05-850 Ożarów Mazowiecki
tel.: +48 22 679 51 35
fax: +48 22 678 92 87
e-mail: [email protected]

Manufacturer
Vipharm S.A.
ul. A i F Radziwiłłów 9
05-850 Ożarów Mazowiecki

This medicinal product is authorized in the member countries of the European Economic Area under the following names:
Czech Republic Ansifora
Hungary Ansifora 50mg filmtabletta
Ansifora 100mg filmtabletta
Poland Ansifora
Slovakia Ansifora 50 mg
Ansifora 100 mg