Elihib

Leaflet included in the packaging: patient information

Elihib, 5 mg, film-coated tablets

Apixaban
Read carefully the contents of this leaflet before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to you by a doctor for a specific person. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any undesirable effects, including any undesirable effects not mentioned in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

1. What is Elihib and what is it used for

Elihib contains the active substance apixaban and belongs to a group of so-called anticoagulant medicines.
This medicine helps prevent the formation of blood clots by blocking factor Xa, which is an important factor in blood clotting.
Elihib 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 move 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 lower limbs (deep vein thrombosis) 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 lower limbs and/or lungs.

2. Important information before taking Elihib

When not to take Elihib:

• if the patient is allergic to 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 disease that increases the risk of severe bleeding (such as active or recently diagnosed stomach or intestinal ulcers, bleeding into the brain),
• if the patient has a liver disease that leads to an increased risk of bleeding (liver coagulopathy),
• if the patient is taking medicines that prevent blood clotting (e.g., warfarin, rivaroxaban, dabigatran, or heparin), except in situations where anticoagulant therapy is changed, when a venous or arterial access line is inserted in the patient and heparin is administered through this line to maintain its patency or when the patient is undergoing catheter ablation (a catheter is inserted into the vein) due to irregular heart rhythm (arrhythmia).

In the event of planned surgery or a procedure that may be associated with bleeding, the doctor may ask the patient to temporarily discontinue taking this medicine for a short period. If there is any uncertainty as to whether a given procedure may be associated with bleeding, the doctor should be consulted.

Warnings and precautions

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

• increased risk of bleeding, for example:
• bleeding disorders, including cases resulting in reduced platelet activity,
• very high blood pressure, uncontrolled with medication,
• if the patient is over 75 years old,
• if the patient weighs 60 kg or less,
• severe kidney disease or if the patient is on dialysis,
• liver disorders or a history of liver disorders. This medicine 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 if other treatment or surgical intervention is planned to remove a blood clot from the lungs.

When to exercise special caution when taking Elihib:

• 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 changes to the treatment.
• in the event of a need for surgery or a procedure that may be associated with bleeding, the doctor may ask the patient to temporarily discontinue taking this medicine for a short period. If there is any uncertainty as to whether a given procedure may be associated with bleeding, the doctor should be consulted.

Children and adolescents

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

Elihib and other medicines

The patient should tell their doctor, pharmacist, or nurse about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Some medicines may enhance the effect of Elihib, and some may weaken its effect. The doctor will decide whether the patient should receive Elihib while taking other medicines and how closely they should be monitored.

The following medicines may enhance the effect of Elihib and increase the risk of undesirable bleeding:

• certain medicines used to treat fungal infections (e.g., ketoconazole and others),
• certain 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, may be at increased risk of undesirable bleeding.
• medicines used for high blood pressure or heart problems (e.g., diltiazem),
• antidepressant medicines called selective serotonin reuptake inhibitors or serotonin and norepinephrine reuptake inhibitors.

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

• medicines used to prevent seizures or convulsions (e.g., phenytoin and others),
• St. John's wort (a herbal supplement used for depression),
• medicines used to treat tuberculosis or 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 Elihib on pregnancy and the unborn child is unknown. This medicine should not be taken during pregnancy. If the patient becomes pregnant while taking this medicine, they should contact their doctor immediately.
It is not known whether Elihib 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 or stop/take this medicine.

Driving and using machines

Elihib has no or negligible influence on the ability to drive and use machines.

Elihib contains lactose (a type of sugar) and sodium

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

3. How to take Elihib

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of any doubts, the patient should consult their doctor, pharmacist, or nurse.

Dose

The tablet should be swallowed with water. Elihib 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 other ways of taking Elihib with their doctor. The tablet can be crushed immediately before administration and mixed with water or a 5% aqueous solution of glucose, juice, or apple sauce.

Instructions for crushing tablets:

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

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

Elihib should be taken as follows in the following indications:

• Prevention of blood clot formation in the heart in patients with irregular heart rhythm (atrial fibrillation) and at least one additional risk factor.The recommended dose is one Elihib tablet of 5 mg twice daily.

The recommended dose is one Elihib tablet of 2.5 mg twice daily if:

• the patient has severe kidney function disorders,
• two or more of the following conditions are met:
• the patient's blood test results indicate reduced 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 body weight is 60 kg or less.

The recommended dose is one tablet twice daily, for example, 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 lower limbs and blood clots in the blood vessels of the lungs.The recommended dose is two Elihib tablets of 5 mg twice daily 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 Elihib tablet of 5 mg twice daily, for example, one tablet in the morning and one in the evening.
• Prevention of recurrence of blood clots after completion of 6-month treatment.The recommended dose is one Elihib tablet of 2.5 mg twice daily, for example, 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 Elihib to anticoagulant medicines.The patient should stop taking Elihib. Treatment with anticoagulant medicines (e.g., heparin) should be started at the time of the planned intake of the next Elihib tablet.
• Changing from anticoagulant medicines to Elihib.The patient should stop taking anticoagulant medicines. Treatment with Elihib should be started at the time of the planned intake of the next dose of anticoagulant medicine, and then continued as usual.
• Changing from treatment with a vitamin K antagonist (e.g., warfarin) to Elihib.The patient should stop taking the vitamin K antagonist. The doctor will perform blood tests and inform the patient when to start taking Elihib.
• Changing from Elihib to treatment with a vitamin K antagonist (e.g., warfarin).

K

If the doctor informs the patient that they should start taking a medicine containing a vitamin K antagonist, they should continue taking Elihib for at least 2 days after taking the first dose of the medicine containing a vitamin K antagonist.The doctor will perform blood tests and inform the patient when to stop taking Elihib.

Patients undergoing cardioversion

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

Taking a higher dose of Elihib than recommended

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

Missing a dose of Elihib

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

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

In case of any doubts related to the use of the medicine or if more than one dose has been missed

The patient should consult their doctor, pharmacist, or nurse.

Stopping Elihib treatment

The patient should not stop taking this medicine without consulting their doctor, as the risk of blood clot formation may be higher if the treatment is stopped prematurely.
In case of any further doubts related to the use of this medicine, the patient should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Elihib can cause side effects, although not everybody gets them.
The most common overall side effect of this medicine is bleeding, which can be life-threatening and may require immediate medical attention.

The following side effects may occur when taking Elihib to prevent blood clot formation in the heart in patients with irregular heart rhythm (atrial fibrillation) and at least one additional risk factor.

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

• bleeding, including:
• eye bleeding;
• stomach or intestinal bleeding;
• rectal bleeding;
• blood in the urine;
• nosebleeds;
• gum bleeding;
• bruising and swelling;
• anemia, which can cause fatigue or pallor;
• low blood pressure, which can lead to fainting or rapid heartbeat;
• nausea (vomiting);
• blood test results may indicate: increased activity of gamma-glutamyltransferase (GGT).

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

• bleeding:
• brain or spinal bleeding;
• mouth or coughing up blood;
• abdominal or vaginal bleeding;
• bright red blood in the stool;
• bleeding after surgery, including bruising and swelling, bleeding or fluid leakage from the surgical wound or puncture site, or bleeding from the injection site;
• anal bleeding;
• muscle bleeding;
• reduced platelet count in the blood (which can affect blood clotting);
• blood test results may indicate:
• abnormal liver function;
• increased activity of certain liver enzymes;
• increased bilirubin levels - a product of red blood cell breakdown, which 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 are observed, the patient should immediately contact their doctor;

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

• bleeding:
• lung or throat bleeding;
• bleeding into the abdominal cavity or the space behind the abdominal cavity.

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

• bleeding: into the abdominal cavity or the space behind the abdominal cavity;
• a skin rash, which can form blisters and resembles small targets (dark spots in the center surrounded by a lighter ring, with a dark border around the edge) (erythema multiforme);
• inflammation of blood vessels (vasculitis), which can cause skin rash or elevated, flat, red, round patches under the skin surface, or bruising.

Reporting side effects

If any side effects occur, including any side effects not mentioned in this leaflet, the patient should inform their doctor, pharmacist, or nurse.Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Elihib

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

6. Contents of the pack and other information

What Elihib contains

• The active substance of the medicine is apixaban. Each tablet contains 5 mg of apixaban.
• Other ingredients are:
• tablet core: lactose monohydrate (see section 2 "Elihib contains lactose (a type of sugar) and sodium"), microcrystalline cellulose (E 460), povidone K30, crospovidone (type A), sodium lauryl sulfate, sodium stearyl fumarate.
• coating: lactose monohydrate (see section 2 "Elihib contains lactose (a type of sugar) and sodium"), hypromellose, titanium dioxide (E 171), triacetin, iron oxide red (E 172).

What Elihib looks like and contents of the pack

Elihib is a pink, elongated, film-coated tablet with dimensions of 5.2 x 10.3 mm.
Alu-PVC/PVdC blister pack containing 7, 10, 14, 20, 28, 30, 56, 60, or 100 film-coated tablets in a carton.
Single-dose perforated Alu-PVC/PVdC blister pack containing 7 x 1, 10 x 1, 14 x 1, 20 x 1, 28 x 1, 30 x 1, 56 x 1, 60 x 1, or 100 x 1 film-coated tablets in a carton.
Not all pack sizes may be marketed.

Patient alert card: information on handling

Inside the packaging of Elihib, together with the patient information leaflet, there is a patient alert card or a similar card that the patient may receive from their doctor.
This patient alert card contains information that will be useful for the patient and will alert other doctors that the patient is taking Elihib. This card should always be carried with the patient.

• 1. Take the card.
• 2. Fill in the following points or ask the doctor to fill them in:
• Name and surname:
• Date of birth:
• Indication:
• Dose:...........mg twice daily
• Doctor's name and surname:
• Doctor's phone number:
• 3. Fold the card and always carry it with you.

Marketing authorization holder

G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria

Importer

Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park,
Paola PLA 3000,
Malta
Adalvo Limited
Malta Life Sciences Park,
Building 1, Level 4, Sir Temi Zammit Buildings,
San Gwann, SGN 3000,
Malta
G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach,
Austria

This medicine is authorized for marketing in the Member States of the European Economic Area under the following names:

Finland: Elihib
Austria: Elihib 5 mg film-coated tablets
Bulgaria: Elihib
Czech Republic: Elihib
Italy: Elihib
Poland: Elihib

For more information on this medicine, the patient should contact the representative of the marketing authorization holder:

G.L. PHARMA POLAND Sp. z o.o.
ul. Sienna 75; 00-833 Warsaw, Poland
Tel: 022/ 636 52 23; 636 53 02
[email protected]

Date of last revision of the leaflet: