Ansifora duo

Package leaflet: Information for the patient

Ansifora Duo, 50 mg + 1000 mg, film-coated tablets
Sitagliptin + Metformin hydrochloride
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet. You may need to read it again.
• 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. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

1. What Ansifora Duo is and what it is used for
2. What you need to know 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 Ansifora Duo is and what it is used for

Ansifora Duo contains two different active substances: 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 two medicines helps regulate blood glucose levels in adult patients with diabetes known as "type 2 diabetes." This medicine helps increase insulin release after meals and reduces the amount of glucose produced by the body. When used together with diet and physical exercise, it helps lower blood glucose levels. This medicine may be used alone as an antidiabetic treatment or in combination with certain other antidiabetic medicines (insulin, sulfonylureas, or glitazones).

What is type 2 diabetes?
In type 2 diabetes, the body does not produce enough insulin, and the insulin that is produced does not work properly. The body may also produce too much glucose. When this happens, 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 Duo

When not to use Ansifora Duo

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

• if the patient has significantly reduced kidney function,

• if the patient has uncontrolled diabetes, e.g. severe hyperglycaemia (high blood glucose levels), nausea, vomiting, diarrhoea, sudden weight loss, lactic acidosis (see "Risk of lactic acidosis" below) or ketoacidosis. Ketoacidosis
  is a condition in which substances called ketone bodies accumulate
  in the blood and which may lead to diabetic pre-coma. Symptoms
  include: abdominal pain, rapid and deep breathing, drowsiness or unusual fruity odour of the breath.

• if the patient has severe infection or dehydration,

• if the patient is scheduled for a radiological examination with intravascular administration of contrast agents. The use of Ansifora Duo must be discontinued during the radiological examination and for 2 or more days afterwards, according to the physician's instructions, depending on the patient's kidney function.

• if the patient has recently experienced a heart attack or has severe circulatory disorders such as shock or breathing difficulties,

• if the patient has liver disease,

• if the patient consumes excessive amounts of alcohol (either daily or occasionally),

• if the patient is breastfeeding.

Do not take Ansifora Duo if any of the above contraindications apply. Consult your doctor to determine alternative methods of diabetes control. If in doubt, discuss this with your doctor, pharmacist, or nurse before using Ansifora Duo.
Warnings and precautions
Cases of pancreatitis have been reported in patients taking sitagliptin in combination with metformin (see section 4).
If the patient develops skin blisters, this may be a symptom of a disease known as bullous pemphigoid. The doctor may advise the patient to discontinue taking Ansifora Duo.
Risk of lactic acidosis
Ansifora Duo may cause a very rare but serious adverse effect called lactic acidosis, especially if the patient has impaired kidney function. The risk of lactic acidosis increases in cases of uncontrolled diabetes, severe infection, prolonged fasting or alcohol consumption, dehydration (see more detailed information below), liver dysfunction, and any medical conditions in which part of the body is inadequately supplied with oxygen (e.g. acute severe heart disease).
If any of the above conditions apply to the patient, consult a doctor for further instructions.
Temporarily discontinue use of Ansifora Duo if the patient develops a medical condition that may involve dehydration (significant loss of water from the body), such as severe vomiting, diarrhoea, fever, exposure to high temperatures, or if the patient drinks less fluid than usual. Consult a doctor for further instructions.
Discontinue use of Ansifora Duo and contact a doctor or the nearest hospital immediately if any symptoms of lactic acidosis occur , as this condition may lead to coma.
Symptoms of lactic acidosis include:

• vomiting,
• abdominal pain,
• muscle cramps,
• general malaise combined with severe fatigue,
• difficulty breathing,
• decreased body temperature and slowed heart rate.

Lactic acidosis is an acute, life-threatening condition requiring immediate hospital treatment.
Contact a doctor immediately for further instructions if:

• the patient has a genetically inherited disease affecting mitochondria
  (cellular structures that produce energy), such as MELAS syndrome (mitochondrial encephalopathy, myopathy, lactic acidosis and stroke-like episodes) or maternally inherited diabetes and deafness (MIDD).

• after starting metformin, the patient experiences any of the following symptoms: seizures, worsening cognitive function, difficulty moving, symptoms indicating nerve damage (e.g. pain or numbness), migraine or deafness.

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

• if the patient has or has had pancreatic disease (e.g. pancreatitis),
• if the patient has or has had gallstones, alcohol dependence, or very high blood triglyceride levels (a type of fat). In such cases, the risk of pancreatitis may increase (see section 4).
• if the patient has type 1 diabetes. This is sometimes referred to as insulin-dependent diabetes.
• if the patient currently has or has had allergic reactions to sitagliptin, metformin, or Ansifora Duo (see section 4),
• if the patient is taking a sulfonylurea derivative or insulin, antidiabetic drugs together with Ansifora Duo, as this may lead to excessively low blood glucose levels (hypoglycaemia). The doctor may reduce the dose of the sulfonylurea derivative or insulin.

If the patient is undergoing major surgery, Ansifora Duo must not be used during the procedure and for some time afterwards. The doctor will decide when the patient should stop and restart treatment with Ansifora Duo.
If any of the above situations apply, discuss them with your doctor or pharmacist before using Ansifora Duo.
During treatment with Ansifora Duo, the doctor will monitor the patient's kidney function at least once a year, or more frequently if the patient is elderly and/or has worsening kidney function.
Children and adolescents
This medicine should not be used in children and adolescents under 18 years of age. The medicine 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.
Ansifora Duo and other medicines
If the patient is to receive an intravenous iodine-containing contrast agent, for example for an X-ray or CT scan, the patient must stop taking Ansifora Duo before or at the latest at the time of injection. The doctor will decide when the patient should stop and restart treatment with Ansifora Duo.
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. The patient may require more frequent monitoring of blood glucose levels and kidney function assessments, or dose adjustments of Ansifora Duo by the doctor. It is especially important to inform about the following medicines:

• medicines (taken orally, by inhalation, or by injection) used to treat inflammatory conditions such as asthma or arthritis (corticosteroids),
• diuretics (medicines that increase urine production),
• 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 bronchial asthma (β-sympathomimetics),
• iodine-containing contrast agents or medicines containing alcohol,
• some medicines used to treat gastrointestinal 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 specific type of thyroid cancer (medullary thyroid cancer),
• digoxin (used to treat heart rhythm disorders and other heart conditions). Blood digoxin levels should be monitored when taking Ansifora Duo with digoxin.

Ansifora Duo and alcohol
Avoid consuming excessive amounts of alcohol while taking Ansifora Duo, as this may increase the risk of lactic acidosis (see section "Warnings and precautions").
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before using this medicine. This medicine should not be used during pregnancy or while breastfeeding. See section 2, When not to use Ansifora Duo
Driving and operating machinery
This medicine has no effect or negligible effect on the ability to drive and operate machinery. However, when driving and operating machinery, consider that dizziness and drowsiness have been reported with sitagliptin use, which may affect the ability to drive and operate machinery.
Taking this medicine together with medicines called sulfonylurea derivatives or with insulin may lead to hypoglycaemia, which may affect the ability to drive and operate machinery or work without secure foot support.
Ansifora Duo contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Ansifora Duo

This medicine should always be taken as prescribed by the doctor. In case of doubt, consult a
doctor or pharmacist.

• Take one tablet:
  • twice daily, orally;
  • with meals to reduce the likelihood of stomach upset.
• To control blood sugar levels, the doctor may increase the dose of the medicine.
• If the patient has impaired kidney function, the doctor may prescribe a lower dose.

While taking this medicine, continue the diet recommended by the doctor and pay attention to
an even intake of carbohydrates throughout the day.
It is unlikely that using this medicine alone will lead to abnormally low blood sugar levels
(hypoglycaemia). Low blood sugar may occur when this medicine is used together with a
sulphonylurea derivative or insulin – in such a case, the doctor may reduce the dose of the
sulphonylurea derivative or insulin.
Taking more Ansifora Duo than prescribed
If more than the prescribed dose of this medicine is taken, contact a doctor immediately. Go to
hospital if symptoms of lactic acidosis occur, such as feeling cold or discomfort, severe nausea or
vomiting, stomach pain, unexplained weight loss, muscle cramps or rapid breathing (see section
"Warnings and precautions").
Missing a dose of Ansifora Duo
If a dose is missed, take it as soon as possible. If the next dose is approaching, skip the missed
dose and continue taking the medicine according to the usual schedule. Do not take a double dose
of this medicine.
Stopping Ansifora Duo
To maintain control of blood sugar levels, the medicine should be taken for as long as the doctor
advises. Do not stop taking this medicine without consulting the doctor first.
Stopping treatment with Ansifora Duo may cause an increase in blood sugar levels.
If there are any further doubts regarding the use of this medicine, consult a doctor, pharmacist or
nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
You should DISCONTINUE taking Ansifora Duo and immediately contact your doctor if any of the following 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.

Ansifora Duo may very rarely (may occur in up to 1 patient in 10,000) cause a very serious adverse reaction known as lactic acidosis (see section “Warnings and precautions”). If lactic acidosis occurs in a patient, Ansifora Duo must be discontinued immediately and medical advice must be sought immediately from a doctor or the nearest hospital, as lactic acidosis may lead to coma.
In case of a severe allergic reaction (frequency unknown), including rash, urticaria, skin blisters or skin peeling, and swelling of the face, lips, tongue or throat, which may cause difficulty breathing or swallowing, the medicine should be discontinued and immediate medical advice sought. The doctor may prescribe medication to treat the allergic reaction and another medicine (a different medicine) for the treatment of diabetes.
In some patients taking metformin, the following adverse reactions occurred after starting sitagliptin:

Common (may occur in up to 1 in 10 people): low blood sugar levels, nausea, bloating, vomiting
Uncommon (may occur in up to 1 in 100 people): stomach pain, diarrhoea, constipation, drowsiness

Diarrhoea, nausea, bloating, constipation, stomach pain or vomiting occurred in some patients after starting treatment with sitagliptin in combination with metformin (common).

In some patients taking this medicine in combination with a sulfonylurea derivative such as glimepiride, the following adverse reactions occurred:
Very common (may occur in more than 1 in 10 people): low blood sugar levels
Common: constipation

In some patients taking this medicine in combination with pioglitazone, the following adverse reactions occurred:
Common: swelling of hands or feet

In some patients taking this medicine in combination with insulin, the following adverse reactions occurred:
Very common: low blood sugar levels
Uncommon: dry mouth, headache

In clinical trials, the following adverse reactions occurred in some patients during treatment with sitagliptin alone (one of the active substances in this medicine) or after marketing authorization during treatment with sitagliptin alone, sitagliptin in combination with metformin, or with other antidiabetic medicines:
Common: low blood sugar levels, headache, upper respiratory tract infection, nasal congestion or runny nose and sore throat, bone and joint inflammation, 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)

The following adverse reactions occurred in some patients taking metformin alone:
Very common: nausea, vomiting, diarrhoea, stomach pain and loss of appetite. These symptoms may occur when starting metformin and usually resolve over time.
Common: metallic taste
Very rare: decreased vitamin B12 levels, hepatitis (liver disease), urticaria, skin redness (rash) or itching

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 Adverse Reactions of Medicinal Products at 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
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 Ansifora Duo

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and the outer carton
after: „EXP”/„Expiry date (EXP)”. The expiry date refers to the last day of the stated month.
Store below 30°C.
Keep in the original packaging to protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. These measures will help protect
the environment.

6. Contents of the packaging and other information

What Ansifora Duo contains

• The active substances in this medicine are sitagliptin and metformin.

Each Ansifora Duo 50 mg + 1000 mg film-coated tablet contains 50 mg of sitagliptin (as sitagliptin monohydrochloride monohydrate) and 1000 mg of metformin hydrochloride.

• Other components are:
  o Tablet core: microcrystalline cellulose type 102, povidone K 29/32 (E1201), sodium lauryl sulfate, and sodium stearyl fumarate.
  o 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 length x 8 mm width), oval, biconvex film-coated tablets.
Opaque blisters (PVC/PE/PVDC/Aluminium).
Pack sizes: 14, 28, 56, 60, 112, 168, 180, 196 film-coated tablets; multipacks containing 196 (2 x 98) and 168 (2 x 84) film-coated tablets.
Pack of 50 x 1 film-coated tablet 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: [email protected]

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: [email protected]

This medicinal product is authorized in the countries 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