Treftenin

Package Leaflet: Information for the User

Treftenin, 5 mg, coated tablets

Apixaban

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 a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

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

1. What is Treftenin and what is it used for

Treftenin contains the active substance apixaban and belongs to a group of anticoagulant medicines.
This medicine helps prevent the formation of blood clots by blocking factor Xa, which is an
important factor in blood clotting.
Treftenin is used in adults:

• to prevent the formation of blood clots in the heart in patients with irregular heart rhythm (atrial fibrillation) and at least one additional risk factor. Blood clots can break loose and travel to the brain, leading to a stroke, or to other organs, hindering blood flow to these organs (also known as systemic embolism). A stroke can be life-threatening and requires immediate medical attention.
• to treat blood clots in the veins of the legs (deep vein thrombosis, DVT) and in the blood vessels of the lungs (pulmonary embolism), as well as to prevent the recurrence of blood clots in the blood vessels of the legs and/or lungs.

2. Important information before taking Treftenin

When not to take Treftenin:

• if the patient is allergicto apixaban or any of the other ingredients of this medicine (listed in section 6),
• if the patient has excessive bleeding,
• if the patient has an organ diseasethat increases the risk of significant bleeding (e.g., active or recently diagnosed stomach or intestinal ulcer, recently diagnosed bleeding in the brain),
• if the patient has liver diseasethat leads to an increased risk of bleeding (hepatic coagulopathy),
• if the patient takes medicines that prevent blood clotting(e.g., warfarin, rivaroxaban, dabigatran, or heparin), except in cases where the anticoagulant treatment is changed, when the patient has a venous or arterial access line and heparin is administered through this line to maintain its patency, or when the patient is undergoing catheter ablation (a catheter is inserted into their vein) due to irregular heart rhythm (arrhythmia).

Warnings and precautions

Before starting treatment, the patient should discuss with their doctor, pharmacist, or nurse if they have any of the following conditions:

• increased risk of bleeding, such as:
• bleeding disorders, including those that result in decreased platelet activity
• very high blood pressure, uncontrolled by medication
• patient's age - over 75 years
• patient's weight - 60 kg or less
• severe kidney disease or dialysis,
• liver function disorders or a history of liver function disorders; Treftenin should be used with caution in patients with signs of liver function changes,
• if the patient has a heart valve prosthesis,
• if the doctor determines that the patient's blood pressure is unstable or plans other treatment or surgery to remove a blood clot from the lungs.

The patient should be cautious when taking Treftenin:

• If the patient has a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), the patient should inform their doctor, who will decide on possible treatment changes.

In case of surgery or procedures that may be associated with bleeding, the doctor may ask the patient to temporarily stop taking this medicine for a short time. If there is any uncertainty about whether a procedure may be associated with bleeding, the patient should ask their doctor.

Children and adolescents

Treftenin is not recommended for use in children and adolescents under 18 years of age.

Treftenin and other medicines

The patient should tell their doctor, pharmacist, or nurse about all medicines they are taking, have recently taken, or might take.
Some medicines may enhance the effect of Treftenin, and some may reduce its effect. The doctor will decide whether the patient should receive Treftenin while taking other medicines and how closely they should be monitored.
The following medicines may enhance the effect of Treftenin and increase the risk of unwanted bleeding:

• some antifungal medicines(e.g., ketoconazole and others),
• some antiviral medicines used to treat HIV/AIDS(e.g., ritonavir),
• other medicines used to reduce blood clotting(e.g., enoxaparin and others),
• anti-inflammatory or pain-relieving medicines(e.g., acetylsalicylic acid or naproxen). Especially if the patient is over 75 years old and taking acetylsalicylic acid, they may be at increased risk of unwanted bleeding.
• medicines used for high blood pressure or heart problems(e.g., diltiazem),
• antidepressant medicinescalled selective serotonin reuptake inhibitorsor serotonin and noradrenaline reuptake inhibitors.

The following medicines may reduce the ability of Treftenin to prevent blood clot formation:

• medicines used to prevent seizures or fits(e.g., phenytoin and others),
• St. John's Wort(a herbal supplement used for depression),
• medicines used to treat tuberculosisor other infections(e.g., rifampicin)

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor, pharmacist, or nurse before taking this medicine.
The effect of apixaban on pregnancy and the unborn child is unknown. Treftenin should not be taken during pregnancy. If the patient becomes pregnant while taking Treftenin, they should contact their doctor immediately.
It is not known whether apixaban passes into breast milk. Before taking this medicine while breastfeeding, the patient should consult their doctor, pharmacist, or nurse. The patient may be advised to stop breastfeeding, stop, or not start taking Treftenin.

Driving and using machines

Apixaban does not affect the ability to drive or use machines.

Treftenin contains lactose (a type of sugar) and sodium

If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Treftenin

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If the patient has any doubts, they should ask their doctor, pharmacist, or nurse.

Dose

The tablet should be swallowed with water. Treftenin can be taken with or without food.
To achieve the best treatment results, it is recommended to take the tablets at the same time every day.
If the patient has problems swallowing the tablets whole, they should discuss this with their doctor. The tablet can be crushed and mixed with water or a 5% aqueous solution of dextrose, juice, or apple puree before taking.

Instructions for crushing tablets:

• Crush the tablet with a pestle in a mortar.
• Carefully transfer the powder to a suitable container and then mix it with a small amount (e.g., 30 mL or 2 tablespoons) of water or another liquid mentioned above to prepare a mixture.
• Swallow the mixture.
• Rinse the pestle and mortar used to crush the tablets and the container with a small amount of water or another liquid (e.g., 30 mL) and swallow the rinse liquid.

If necessary, the doctor may administer a crushed Treftenin tablet mixed with 60 mL of water or a 5% aqueous solution of dextrose through a nasogastric tube.

Treftenin should be taken as recommended in the following indications:

Prevention of blood clot formation in the heart in patients with irregular heart rhythm and at least one additional risk factor.
The recommended dose is one 5 mg tablettwice a day.
The recommended dose is one 2.5 mg tablettwice a day if:

• the patient has severe kidney function disorders
• two or more of the following conditions are met:
• the patient's blood test results indicate decreased kidney function (serum creatinine level of 1.5 mg/dL (133 micromoles/L) or higher)
• the patient is 80 years old or older,
• the patient's weight is 60 kg or less.

The recommended dose is one tablet twice a day, e.g., one tablet in the morning and one in the evening. The doctor will decide how long the treatment should be continued.
Treatment of blood clots in the veins of the legs and blood clots in the blood vessels of the lungs
The recommended dose is two 5 mg tabletstwice a day for the first 7 days, for example, two tablets in the morning and two in the evening.
After 7 days, the recommended dose is one 5 mg tablettwice a day, e.g., one tablet in the morning and one in the evening.
Prevention of recurrence of blood clots after completing 6 months of treatment
The recommended dose is one 2.5 mg tablettwice a day, e.g., one tablet in the morning and one in the evening.
The doctor will decide how long the treatment should be continued.
The doctor may change the anticoagulant treatment as follows:

• Changing from Treftenin to anticoagulant medicinesThe patient should stop taking Treftenin. Anticoagulant treatment (e.g., heparin) should be started at the time of the scheduled intake of the next Treftenin tablet.
• Changing from anticoagulant medicines to TrefteninThe patient should stop taking anticoagulant medicines. Treftenin treatment should be started at the time of the scheduled intake of the next dose of anticoagulant medicine and then continued as usual.
• Changing from anticoagulant treatment with a vitamin K antagonist (e.g., warfarin) to TrefteninThe patient should stop taking the vitamin K antagonist. The doctor will perform blood tests and inform the patient when to start taking Treftenin.
• Changing from Treftenin to anticoagulant treatment with a vitamin K antagonist (e.g., warfarin)If the doctor informs the patient that they should start taking a vitamin K antagonist, the patient should continue taking Treftenin for at least 2 days after taking the first dose of the vitamin K antagonist. The doctor will perform blood tests and inform the patient when to stop taking Treftenin.

Patients undergoing cardioversion

Patients who require cardioversion to restore a normal heart rhythm should take Treftenin at the times specified by their doctor to prevent blood clot formation in the blood vessels of the brain and other blood vessels.

Taking a higher dose of Treftenin than recommended

If the patient has taken a higher dose of Treftenin than recommended, they should immediately inform
their doctor. They should take the packaging with them, even if it is empty.
If the patient has taken a higher dose of Treftenin than recommended, they may be at increased risk of bleeding. In case of bleeding, surgical treatment, blood transfusion, or other treatment to reverse the effect of factor Xa inhibition may be necessary.

Missing a dose of Treftenin

The patient should take the missed dose as soon as they remember and:

• take the next dose of Treftenin at the usual time
• then continue taking the medicine as before.

In case of doubts about taking the medicine or missing more than

one dose, the patient should consult their doctor, pharmacist, or nurse.

Stopping Treftenin treatment

The patient should not stop taking Trefteninwithout consulting their doctor, as stopping treatment prematurely may increase the risk of blood clot formation.
If the patient has any further doubts about taking this medicine, they should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Treftenin can cause side effects, although not everybody gets them.
The most common general side effect of apixaban is bleeding, which can be life-threatening and may require immediate medical attention.
The following side effects may occur when taking apixaban to prevent blood clot formation in the heart in patients with irregular heart rhythm and at least one additional risk factor.

Common side effects (may affect up to 1 in 10 people)

• Bleeding, including:
• in the eyes
• in the stomach or intestines
• from the rectum
• blood in the urine
• from the nose
• from the gums
• bruises and swelling
• Anemia, which can cause fatigue or pale skin
• Low blood pressure, which can lead to fainting or rapid heartbeat
• Nausea (vomiting)
• Blood test results may indicate:
• increased gamma-glutamyltransferase (GGT) activity

Uncommon side effects (may affect up to 1 in 100 people)

• Bleeding:
• in the brain or spinal cord
• in the mouth or coughing up blood
• in the abdominal cavity or retroperitoneal space
• Decreased platelet count (which can affect blood clotting)
• Blood test results may indicate:
• liver function disorders
• increased activity of certain liver enzymes
• increased bilirubin levels - a breakdown product of red blood cells that can cause yellowing of the skin and eyes
• Skin rash
• Itching
• Hair loss
• Allergic reactions (hypersensitivity), which can cause: facial, lip, mouth, tongue, and/or throat swelling, as well as difficulty breathing. If any of these symptoms occur, the patient should immediately contact their doctor.

Rare side effects (may affect up to 1 in 1,000 people)

• Bleeding:
• in the lungs or throat
• in the abdominal cavity or retroperitoneal space
• in the muscle

Very rare side effects (may affect up to 1 in 10,000 people)

• Skin rash, which can cause blisters and resembles small targets (a dark spot in the center surrounded by a lighter border, with a dark ring around the edge) (erythema multiforme)

Frequency not known (frequency cannot be estimated from the available data)

• Vasculitis (inflammation of blood vessels), which can cause skin rash or raised, flat, red, round patches under the skin or bruising.

The following side effects may occur when taking apixaban to treat or prevent the recurrence of blood clots in the veins of the legs and blood clots in the blood vessels of the lungs.

Common side effects (may affect up to 1 in 10 people)

• Bleeding, including:
• from the nose
• from the gums
• blood in the urine
• bruises and swelling
• from the stomach, intestines, or rectum
• from the mouth
• from the vagina
• Anemia, which can cause fatigue or pale skin
• Decreased platelet count (which can affect blood clotting)
• Nausea (vomiting)
• Skin rash
• Blood test results may indicate:
• increased gamma-glutamyltransferase (GGT) or alanine aminotransferase (ALT) activity

Uncommon side effects (may affect up to 1 in 100 people)

• Low blood pressure, which can lead to fainting or rapid heartbeat
• Bleeding:
• in the eyes
• in the mouth or coughing up blood
• red blood in the stool
• blood in the stool or urine detected in laboratory tests
• bleeding after surgery, including bruising and swelling, bleeding or fluid leakage from the surgical wound/incision or injection site
• from hemorrhoids
• in the muscle
• Itching
• Hair loss
• Allergic reactions (hypersensitivity), which can cause: facial, lip, mouth, tongue, and/or throat swelling, as well as difficulty breathing. If any of these symptoms occur, the patient should immediately contact their doctor.
• Blood test results may indicate:
• liver function disorders
• increased activity of certain liver enzymes
• increased bilirubin levels - a breakdown product of red blood cells that can cause yellowing of the skin and eyes

Rare side effects (may affect up to 1 in 1,000 people)

• Bleeding:
• in the brain or spinal cord
• in the lungs

Frequency not known (frequency cannot be estimated from the available data)

• Bleeding:
• in the abdominal cavity or retroperitoneal space
• Skin rash, which can cause blisters and resembles small targets (a dark spot in the center surrounded by a lighter border, with a dark ring around the edge) (erythema multiforme)
• Vasculitis (inflammation of blood vessels), which can cause skin rash or raised, flat, red, round patches under the skin or bruising.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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.
Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Treftenin

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month.
There are no special storage instructions for this medicine.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Treftenin contains

• The active substance of Treftenin is apixaban. Each tablet contains 5 mg of apixaban.
• The other ingredients are:
• Tablet core: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, sodium lauryl sulfate, magnesium stearate.
• Tablet coating: lactose monohydrate (see section 2), hypromellose (E 464), titanium dioxide (E 171), macrogol 3350, triacetin, iron oxide red (E 172).

What Treftenin looks like and contents of the pack

Pale pink, oval, film-coated tablets with a modified shape, with the inscription "TV" on one side and "G2" on the other. Dimensions: length: 9.9 - 10.5 mm, width: 5.0 - 5.6 mm, thickness: 4.2 - 4.8 mm.
Treftenin is available in the following pack sizes:

• unit dose blisters containing 10 x 1, 14 x 1, 20 x 1, 28 x 1, 30 x 1, 56 x 1, 60 x 1, 100 x 1, 120 x 1, 168 x 1, or 200 x 1 film-coated tablets
• tablet containers containing 180, 200, or 500 film-coated tablets, and
• tablet containers containing 180, 200, or 500 film-coated tablets, with cotton.

Blisters and bottles are packaged in cartons with a leaflet inside the carton.
Not all pack sizes may be marketed.

Patient Alert Card: Information for Action

Inside the Treftenin package, along with the patient leaflet, there is a Patient Alert Card or a similar card may be issued by the doctor.
The Patient Alert Card contains information that will be helpful for the patient and may serve as a warning to other doctors that the patient is taking Treftenin. The patient should always carry this card with them.

• 1. Remove the card
• 2. The patient should fill in the following or ask their doctor to fill them in:
• Name and surname:
• Date of birth:
• Indication:
• Dose: ...... mg twice a day
• Doctor's name and surname:
• Doctor's phone number:
• 3. The patient should fold the card and always carry it with them.

Marketing Authorization Holder

Day Zero ehf
Reykjavíkurvegi 62
220 Hafnarfjördur
Iceland
Tel. +354 659 4144

Importer

Balkanpharma Dupnitsa AD
3 Samokovsko Shosse Str..
2600, Dupnitsa
Bulgaria
Teva Pharma B.V.
Swensweg 5
2031 GA Haarlem
Netherlands
Actavis International Ltd
4, Sqaq tal-Gidi off Valletta Road
Luqa LQA 6000
Malta
Actavis Group PTC ehf.
Dalshraun 1
IS-220 Hafnarfjördur
Iceland

This medicine is authorized in the European Economic Area (EEA) member states under the following names:

Germany:
Treftenin 5 mg film-coated tablets
Poland:
Treftenin

Date of the last revision of the leaflet: