ANSIFORA 50 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Ansifora, 50 mg, coated tablets
3. Ansifora, 100 mg, coated tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet
4. What is Ansifora and what is it used for
5. Important information before taking Ansifora
   1. When not to take Ansifora
   2. Warnings and precautions
   3. Children and adolescents
   4. Ansifora and other medicines
   5. Pregnancy and breastfeeding
   6. Driving and using machines
   7. Ansifora contains sodium
6. How to take Ansifora
   1. If you take more Ansifora than you should
   2. If you forget to take Ansifora
   3. If you stop taking Ansifora
7. Possible side effects
   1. Reporting side effects
8. How to store Ansifora
9. Contents of the pack and other information
   1. What Ansifora contains
   2. Ansifora, 50 mg
   3. Ansifora, 100 mg
   4. What Ansifora looks like and contents of the pack
   5. Marketing authorization holder and manufacturer
   6. This medicine is authorized in the Member States of the European Economic Area under the following names:
   7. Date of last revision of the leaflet:

Package Leaflet: Information for the Patient

Ansifora, 50 mg, coated tablets

Ansifora, 100 mg, coated tablets

Sitagliptin

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• 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, please tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is Ansifora and what is it used for
• 2. Important information 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 is Ansifora and what is it 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 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 produced by the body.
Your doctor has prescribed this medicine to reduce high blood sugar levels caused by type 2 diabetes. This medicine can be used alone or in combination with other medicines (insulin, metformin, sulfonylurea derivatives, or glitazones) that lower blood sugar levels, which you may already be taking for diabetes, along with diet and exercise.

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 Ansifora

When not to take Ansifora

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

Warnings and precautions

In patients taking Ansifora, cases of pancreatitis (see section 4) have been reported.
If you develop blisters on your skin, it may be a sign of a condition called bullous pemphigoid. Your doctor may advise you to stop taking Ansifora.
Tell your doctor if you have or have had:

• pancreatic disease (e.g., 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 problems, past or present;
• an allergic reaction to Ansifora (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 derivative or insulin, it may cause low blood sugar levels (hypoglycemia). Your 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 from 10 to 18 years of age. It is not known if this medicine is safe and effective when used in children under 10 years of age.

Ansifora and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might 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 Ansifora with digoxin, your doctor may need to check the level of digoxin in your blood.

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 if 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, when driving or using machines, consider that dizziness and drowsiness have been reported.
Taking this medicine with sulfonylurea derivatives or insulin may cause low blood sugar levels (hypoglycemia), which can affect your ability to drive and use machines or work without safe foot support.

Ansifora contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is essentially sodium-free.

3. How to take Ansifora

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

• one 100 mg coated tablet,
• once a day,
• taken orally.

If you have kidney problems, your doctor may prescribe a lower dose of this medicine (e.g., 25 mg or 50 mg).
A 25 mg strength of this medicine is available in another brand.
This medicine can be taken with or without food and drink.
Your doctor may advise you to take this medicine alone or with certain other medicines that lower blood sugar levels.
Diet and exercise help your body use the sugar in your blood. When taking Ansifora, it is important to follow the diet and exercise plan recommended by your doctor.

If you take more Ansifora than you should

If you have taken more than the recommended dose, contact your doctor immediately.

If you forget to take Ansifora

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

If you stop taking Ansifora

To maintain control of your blood sugar levels, you should continue taking this medicine for as long as your doctor recommends. Do not stop taking 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 everybody gets them.
STOP taking Ansifora and contact your doctor immediately if you experience any of the following serious side effects:

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

If you experience a severe allergic reaction (frequency not known), including rash, hives, blisters on the skin, or peeling skin, and 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 were reported:
Common (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, diarrhea, constipation, drowsiness.
Some patients experienced various stomach problems when they started taking sitagliptin with metformin (common).
In some patients taking sitagliptin with a sulfonylurea derivative and metformin, the following side effects were reported:
Very common (may affect more than 1 in 10 people): low blood sugar levels.
Common: constipation.
In some patients taking sitagliptin and pioglitazone, the following side effects were reported:
Common: bloating, swelling of the hands or feet.
In some patients taking sitagliptin with pioglitazone and metformin, the following side effects were reported:
Common: swelling of the hands or feet.
In some patients taking sitagliptin with insulin (with or without metformin), the following side effects were reported:
Common: flu.
Uncommon: dry mouth.
In some patients taking sitagliptin alone or with other diabetes medicines in clinical studies or after marketing authorization, the following side effects were reported:
Common: low blood sugar levels, headache, upper respiratory tract infections, stuffy or runny nose and sore throat, osteoarthritis, pain in the arm or leg.
Uncommon: dizziness, constipation, itching.
Rare (may affect up to 1 in 1,000 people): reduced platelet count.
Frequency not known (frequency cannot be estimated from the available data): kidney problems (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, please tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw, phone: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.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 Ansifora

Keep this medicine out of the 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.
Store in a temperature below 25°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Ansifora contains

Ansifora, 50 mg

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

Ansifora, 100 mg

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

What Ansifora looks like and contents of the pack

Ansifora, 50 mg
Round, light beige coated tablets, 8 mm in size, with "50" on one side.
Ansifora, 100 mg
Round, beige coated tablets, 10 mm in size, with "100" on one side.
Non-transparent blisters of PVC/PE/PVDC/Aluminum in a cardboard box. Packs of 14, 28, 30, 56, 84, 90, or 98 coated tablets.
Aluminum blisters of OPA/Aluminum/PVC/Aluminum in a cardboard box. Packs of 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.
A and F Radziwiłłów Street 9
05-850 Ożarów Mazowiecki
phone: +48 22 679 51 35
fax: +48 22 678 92 87
e-mail: [email protected]
Manufacturer
Vipharm S.A.
A and F Radziwiłłów Street 9
05-850 Ożarów Mazowiecki

This medicine is authorized in the Member States 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

Date of last revision of the leaflet: