Ansifora Duo

Package Leaflet: Information for the Patient

Ansifora Duo, 50 mg + 1000 mg, Film-Coated Tablets

Sitagliptin+ Metformin Hydrochloride

Read the Package Leaflet Carefully Before Taking the Medication, 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, pharmacist, or nurse.
• This medication 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 those not listed in this package leaflet, please inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package Leaflet

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

1. What is Ansifora Duo and what is it used for

Ansifora Duo contains two different active substances called sitagliptin and metformin.

• Sitagliptin belongs to a group of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors).
• Metformin belongs to a group of medicines called biguanides.

The combined action of these medicines leads to the normalization of blood sugar levels in adult patients with a type of diabetes known as "type 2 diabetes". This medication helps to increase the amount of insulin released after a meal and reduces the amount of sugar produced by the body. When taken in combination with diet and exercise, this medication helps to reduce blood sugar levels. This medication can be used alone or in combination with certain other anti-diabetic medicines (insulin, sulfonylureas, or glitazones). What is type 2 diabetes? In type 2 diabetes, 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, vision loss, and limb amputation.

2. Important information before taking Ansifora Duo

When not to take Ansifora Duo

• if you are allergic to sitagliptin or metformin, or any of the other ingredients of this medication (listed in section 6),
• if you have severely reduced kidney function,
• if you have uncontrolled diabetes, such as severe hyperglycemia (high blood sugar), nausea, vomiting, diarrhea, rapid weight loss, lactic acidosis (see "Risk of lactic acidosis" below), or diabetic ketoacidosis. Diabetic ketoacidosis is a condition in which substances called ketones build up in the blood and can lead to diabetic coma. Symptoms include abdominal pain, rapid and deep breathing, drowsiness, or a fruity odor from the mouth.

Ketoacidosis is a condition in which substances called ketones build up in the blood and can lead to diabetic coma. Symptoms include abdominal pain, rapid and deep breathing, drowsiness, or a fruity odor from the mouth.

• if you have a severe infection or dehydration,
• if you are going to have a radiological examination with an intravascular contrast agent. You should stop taking Ansifora Duo before or at the time of the examination, and for 2 days or more after the examination, as recommended by your doctor, depending on your kidney function.
• if you have recently had a heart attack or have severe circulatory problems, such as shock or breathing difficulties,
• if you have liver disease,
• if you drink excessive amounts of alcohol (either regularly or from time to time),
• if you are breastfeeding.

Do not take Ansifora Duo if any of the above applies to you. Consult your doctor to determine other methods of controlling your diabetes. If you are unsure, consult your doctor, pharmacist, or nurse before taking Ansifora Duo.

Warnings and precautions

Patients taking sitagliptin in combination with metformin have reported cases of pancreatitis (see section 4). If you experience blisters on your skin, it may be a sign of a condition called bullous pemphigoid. Your doctor may advise you to stop taking Ansifora Duo.

Risk of lactic acidosis

Ansifora Duo may cause a very rare but very serious side effect called lactic acidosis, especially if you have kidney problems. The risk of lactic acidosis increases if you have uncontrolled diabetes, severe infection, prolonged fasting, or excessive alcohol consumption, dehydration (see below), liver problems, or any condition that reduces the oxygen supply to the body (e.g., severe heart disease). If any of these situations apply to you, consult your doctor for more detailed instructions.

Stop taking Ansifora Duo temporarily if you have a condition that may lead to dehydration

(significant loss of body water), such as severe vomiting, diarrhea, fever, high temperature, or if you drink less fluid than usual. Consult your doctor for more detailed instructions.

Stop taking Ansifora Duo and contact your doctor or the nearest hospital immediately if you experience any symptoms of lactic acidosis

, as this condition can lead to coma. Symptoms of lactic acidosis include vomiting, abdominal pain, muscle cramps, general feeling of being unwell with severe fatigue, difficulty breathing, decreased body temperature, and slow heart rate. Lactic acidosis is a medical emergency that requires immediate treatment in a hospital.

Before taking Ansifora Duo, discuss with your doctor or pharmacist:

• if you have or have had pancreatitis (inflammation of the pancreas),
• if you have or have had gallstones, alcohol dependence, or very high levels of triglycerides (a type of fat) in your blood. In these situations, the risk of pancreatitis (see section 4) may increase.
• if you have type 1 diabetes. This is sometimes called insulin-dependent diabetes.
• if you have or have had allergic reactions to sitagliptin, metformin, or Ansifora Duo (see section 4),
• if you are taking a sulfonylurea or insulin, anti-diabetic medicines, at the same time as Ansifora Duo, as this may lead to low blood sugar (hypoglycemia). Your doctor may reduce the dose of the sulfonylurea or insulin.

If you are going to have a major surgical procedure, you should not take Ansifora Duo during the procedure and for some time after it. Your doctor will decide when you should stop and restart Ansifora Duo. If any of the above situations apply to you, consult your doctor or pharmacist before taking Ansifora Duo. During treatment with Ansifora Duo, your doctor will check your kidney function at least once a year or more often if you are elderly and/or have worsening kidney function.

Children and adolescents

This medication should not be used in children and adolescents under the age of 18. This medication is not effective in children and adolescents aged 10 to 17. It is not known if this medication is safe and effective in children under the age of 10.

Ansifora Duo with other medicines

If you are going to have an intravascular contrast agent injected into your bloodstream, for example, for an X-ray examination or computed tomography, you should stop taking Ansifora Duo before or at the time of the injection. Your doctor will decide when you should stop and restart Ansifora Duo. Tell your doctor or pharmacist about all the medicines you are taking or have recently taken, as well as any medicines you plan to take. You may need more frequent blood glucose monitoring or kidney function tests, or your doctor may need to adjust the dose of Ansifora Duo. It is especially important to inform your doctor about the following medicines:

• medicines (taken orally, inhaled, or injected) used to treat inflammatory conditions, such as asthma or arthritis (corticosteroids),
• medicines that increase urine production (diuretics),
• medicines used to treat pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib),
• certain medicines used to treat high blood pressure (ACE inhibitors and angiotensin II receptor antagonists),
• specific medicines used to treat asthma (β-sympathomimetics),
• contrast agents containing iodine or medicines containing alcohol,
• certain medicines used to treat stomach disorders, such as cimetidine,
• ranolazine, a medicine used to treat angina pectoris,
• dolutegravir, a medicine used to treat HIV infection,
• vandetanib, a medicine used to treat a certain type of thyroid cancer (medullary thyroid carcinoma),
• digoxin (used to treat heart rhythm disorders and other heart conditions). When taking Ansifora Duo with digoxin, your doctor should monitor your digoxin blood levels.

Ansifora Duo with alcohol

Avoid excessive alcohol consumption while taking Ansifora Duo, as this may increase the risk of lactic acidosis (see "Warnings and precautions").

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medication. Do not take this medication during pregnancy or while breastfeeding. See section 2, "When not to take Ansifora Duo".

Driving and using machines

This medication has no or negligible influence on the ability to drive and use machines. However, while driving or operating machinery, you should take into account that dizziness and drowsiness have been reported with sitagliptin use, which may affect your ability to drive or operate machinery. Taking this medication with sulfonylureas or insulin may lead to low blood sugar (hypoglycemia), which may affect your ability to drive or operate machinery or work without safe foot support.

Ansifora Duo contains sodium

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

3. How to take Ansifora Duo

Always take this medication exactly as your doctor has told you. If you are unsure, ask your doctor or pharmacist.

• Take one tablet:
• twice a day, orally;
• with meals to reduce the likelihood of stomach upset.
• Your doctor may increase the dose of Ansifora Duo to control your blood sugar levels.
• If you have kidney problems, your doctor may prescribe a lower dose.

While taking this medication, continue to follow the diet recommended by your doctor and pay attention to evenly distributing your carbohydrate intake throughout the day. It is unlikely that taking this medication alone will lead to low blood sugar (hypoglycemia). Low blood sugar may occur if you take this medication with a sulfonylurea or insulin - in this case, your doctor may reduce the dose of the sulfonylurea or insulin.

What to do if you take more Ansifora Duo than you should

If you take more Ansifora Duo than you should, contact your doctor immediately. Go to the hospital if you experience symptoms of lactic acidosis, such as feeling cold or uncomfortable, severe nausea or vomiting, stomach pain, unexplained weight loss, muscle cramps, or rapid breathing (see "Warnings and precautions").

What to do if you forget to take Ansifora Duo

If you forget to take 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 of this medication.

What to do if you stop taking Ansifora Duo

To maintain control of your blood sugar levels, take this medication for as long as your doctor recommends. Do not stop taking this medication without consulting your doctor first. Stopping Ansifora Duo may lead to increased blood sugar levels. If you have any further questions about taking this medication, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Ansifora Duo can cause side effects, although not everybody gets them. If you experience any of the following side effects, stop taking Ansifora Duo and contact your doctor immediately:

• 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.

Ansifora Duo may very rarely cause (may affect up to 1 in 10,000 people) a very serious side effect called lactic acidosis (see "Warnings and precautions"). If this happens to you, stop taking Ansifora Duo and contact your doctor or the nearest hospital immediately, as lactic acidosis can lead to coma. In the event of a severe allergic reaction (frequency not known), including rash, hives, blisters, or peeling of the skin, and swelling of the face, lips, tongue, and throat, which may cause difficulty breathing or swallowing, stop taking Ansifora Duo and contact your doctor immediately. Your doctor may prescribe a medication to treat the allergic reaction and another medication to treat your diabetes. Some patients taking metformin after starting sitagliptin have reported the following side effects: 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, diarrhea, constipation, drowsiness Some patients have reported diarrhea, nausea, bloating, constipation, stomach pain, or vomiting after starting sitagliptin in combination with metformin (common). Some patients taking sitagliptin alone or in combination with other anti-diabetic medicines have reported the following side effects: Common: low blood sugar, headache, upper respiratory tract infection, stuffy or runny nose, sore throat, joint or muscle pain Uncommon: dizziness, constipation, itching Rare: reduced platelet count Frequency not known: kidney problems (sometimes requiring dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of blistering skin condition) Some patients taking metformin alone have reported the following side effects: Very common: nausea, vomiting, diarrhea, stomach pain, and loss of appetite. These symptoms usually occur after starting metformin and usually go away. Common: metallic taste Very rare: reduced vitamin B12 levels, liver inflammation (liver disease), hives, skin rash, or itching

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, please inform your doctor, pharmacist, or nurse. You can also report side effects directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl You can also report side effects to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medication.

5. How to store Ansifora Duo

Keep this medication out of the sight and reach of children. Do not use this medication after the expiry date stated on the blister and carton after "EXP"/"Expiry date (EXP)". The expiry date refers to the last day of the month. Store in a temperature below 30°C. Keep the medication in its original packaging to protect it from moisture. 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 Duo contains

• The active substances are sitagliptin and metformin. Each film-coated tablet of Ansifora Duo 50 mg + 1000 mg contains 50 mg of sitagliptin (as sitagliptin phosphate monohydrate) and 1000 mg of metformin hydrochloride.
• The other ingredients are: Tablet core: microcrystalline cellulose type 102, povidone K 29/32 (E1201), sodium lauryl sulfate, and sodium stearyl fumarate. Tablet coating: polyvinyl alcohol, macrogol 3350, talc (E553b), titanium dioxide (E171), red iron oxide (E172), and black iron oxide (E172).

What Ansifora Duo looks like and contents of the pack

Ansifora Duo 50 mg + 1000 mg film-coated tablets: red, capsule-shaped (21 mm x 8 mm), oval, biconvex, film-coated tablets. Non-transparent blisters (PVC/PE/PVDC/Aluminum). Packs of 14, 28, 56, 60, 112, 168, 180, and 196 film-coated tablets. Multipacks containing 196 (2 packs of 98) and 168 (2 packs of 84) film-coated tablets. Pack of 50 x 1 film-coated tablets in perforated unit dose blisters. Not all pack sizes may be marketed.

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: vipharm@vipharm.com.pl

Manufacturer

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: vipharm@vipharm.com.pl

This medication is authorized in the Member States of the European Economic Area under the following names:

Czech Republic: Ansifora Duo

Hungary: Ansifora Duo 50 mg/1 000 mg filmtabletta Poland: Ansifora Duo Slovakia: Ansifora Duo 50 mg/1 000 mg filmom obalené tablety

Date of last revision of the package leaflet: