Package leaflet: Information for the patient

Elihib, 5 mg, film-coated tablets
Apixabanum
Please read this leaflet carefully before taking this medicine, because it contains important information for you.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are identical.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

What Elihib is and what it is used for
Important information before taking Elihib
How to take Elihib
Possible side effects
How to store Elihib
Contents of the package and other information

1. What Elihib is and what it is used for

Elihib contains the active substance apixaban and belongs to a group of medicines called anticoagulants.
This medicine helps prevent blood clots by inhibiting Factor Xa, an important component of the blood coagulation system.
Elihib is used in adults:

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

Elihib is used in children aged from 28 days up to below 18 years, for the treatment of blood clots and prevention of recurrence of blood clots in veins or in the pulmonary blood vessels.
Information regarding body weight and the recommended dose can be found in section 3.

2. Information before using Elihib

When not to use 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 a disease that increases the risk of serious bleeding (such as active or recently diagnosed peptic ulcer or intestinal ulcer, or recent intracranial bleeding),
if the patient has a liver disease leading to an increased risk of bleeding (liver coagulopathy),
if the patient is taking anticoagulant medicines (e.g. warfarin, rivaroxaban, dabigatran or heparin), except when switching anticoagulant therapy, when a venous or arterial line has been inserted 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 heartbeat (arrhythmia).

Warnings and precautions
Before starting treatment with this medicine, discuss with your doctor, pharmacist or nurse if the patient has any of the following conditions:

increased risk of bleeding, for example:
- disorders associated with bleeding, including those causing reduced platelet function,
- very high blood pressure not controlled by medication,
- if the patient is over 75 years of age,
- if the patient weighs 60 kg or less,
severe kidney disease or if the patient is on dialysis,
liver disorders or history of liver problems. This medicine should be used with caution in patients showing signs of impaired liver function.
a spinal catheter or spinal injection (anaesthetic or pain-relieving). In such cases, the doctor will advise taking this medicine at least 5 hours or more after catheter removal,
if the patient has a heart valve prosthesis,
if the doctor determines that the patient's blood pressure is unstable or other treatment or a surgical procedure to remove a blood clot from the lungs is planned.

Special caution when using Elihib:

if the patient has a condition called antiphospholipid syndrome (an immune system disorder increasing the risk of blood clots), the patient should inform the doctor, who will decide whether a change in treatment is necessary.
if surgery or a procedure associated with bleeding risk is required, the doctor may ask the patient to temporarily stop taking this medicine for a short period. If in doubt whether a procedure may involve bleeding risk, consult the doctor.

Children and adolescents
This medicine is not recommended for use in children and adolescents with body weight below 35 kg.

Elihib and other medicines
Tell your doctor, pharmacist or nurse about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Some medicines may enhance the effect of Elihib, while others may reduce its effectiveness. The doctor will decide whether the patient should receive Elihib while taking other medicines and how closely monitoring should be performed.

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

certain antifungal medicines (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), particularly if the patient is over 75 years of age and taking acetylsalicylic acid, which may increase the risk of unwanted bleeding,
medicines used for high blood pressure or heart problems (e.g. diltiazem),
antidepressants known as selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors.

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

antiepileptic medicines (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, suspects she may be pregnant, or is planning to have a child, she should consult her doctor, pharmacist or nurse before using 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, she should contact her doctor immediately.
It is not known whether Elihib passes into human milk. The patient should consult her doctor, pharmacist or nurse before using this medicine while breastfeeding. The patient may be advised to stop breastfeeding or to discontinue/avoid starting treatment with this medicine.

Driving and operating machinery
Elihib has no or negligible effect on the ability to drive and operate machinery.

Elihib contains lactose (a type of sugar) and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult the doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, meaning the medicine is considered "sodium-free".

3. How to take Elihib

This medicine should always be taken according to the instructions given by your doctor or pharmacist. If you are unsure,
you should consult your doctor, pharmacist, or nurse.
Dosage
Swallow the tablet with water. Elihib may be taken with food or independently of meals. For optimal treatment results, it is recommended to take the tablets at the same times each day.
If a patient has difficulty swallowing tablets whole, they should discuss alternative methods of taking Elihib with their doctor. The tablet may be crushed immediately before administration and mixed with water or a 5% aqueous glucose solution, juice, or apple puree.
Instructions for crushing tablets:

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

If necessary, your doctor may administer crushed Elihib tablets mixed with 60 mL of water or 5% aqueous glucose solution via a nasogastric tube.
Elihib should be taken as directed in the following indications:

Prevention of blood clots 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 5 mg twice daily.

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

the patient has severe kidney function impairment,
two or more of the following conditions are met:
- blood test results suggest reduced kidney function (serum creatinine concentration of 1.5 mg/dL (133 micromoles/L) or higher),
- the patient is 80 years of age 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. Your doctor will decide how long treatment should continue.

Treatment of blood clots in the deep veins of the legs and blood clots in the blood vessels of the lungs The recommended dose is two tablets of Elihib 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 tablet of Elihib 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 tablet of Elihib 2.5 mg twice daily, for example, one tablet in the morning and one in the evening. Your doctor will decide how long treatment should continue.
Use in children and adolescents Treatment of blood clots and prevention of recurrence of blood clots in veins or in the blood vessels of the lungs.

This medicine should always be taken or administered according to the instructions given by your doctor or pharmacist. If you are unsure,
you should consult your doctor, pharmacist, or nurse.
To achieve the best treatment effect, the dose should be taken or administered at the same time every day.
The dose of Elihib depends on body weight and will be calculated by the doctor. The recommended dose for children and adolescents weighing at least 35 kg is two tablets of Elihib 5 mg, administered twice daily for the first 7 days, for example, two in the morning and two in the evening. After 7 days, the recommended dose is one tablet of Elihib 5 mg, administered twice daily, for example, one in the morning and one in the evening.
For parents and caregivers: you should observe the child to ensure the full dose has been taken.
It is important to attend scheduled doctor's appointments, as dose adjustments may be necessary with changes in the patient's body weight.

Your doctor may change anticoagulant therapy as follows:
- Switching from Elihib to anticoagulant medicines Discontinue taking Elihib. Start treatment with anticoagulant medicines (e.g., heparin) at the time the next tablet was scheduled to be taken.
- Switching from anticoagulant medicines to Elihib
  Discontinue taking anticoagulant medicines. Begin Elihib treatment at the time the next dose of anticoagulant medicine was scheduled, then continue regular dosing.
Switching from anticoagulant therapy including a vitamin K antagonist (e.g., warfarin) to Elihib Discontinue the vitamin K antagonist-containing medicine. Your doctor must perform blood tests and will inform you when to start taking Elihib.
Switching from Elihib to anticoagulant therapy including a vitamin K antagonist (e.g., warfarin) If your doctor informs you that you should start taking a vitamin K antagonist-containing medicine, continue taking Elihib for at least 2 days after taking the first dose of the vitamin K antagonist-containing medicine. Your doctor must perform blood tests and inform you when to stop taking Elihib.

Patients undergoing cardioversion
Patients who require cardioversion to restore normal heart rhythm should take this medicine at the times specified by their doctor to prevent the formation of blood clots in the blood vessels of the brain and other blood vessels in the body.
Taking more Elihib than recommended
If you have taken more Elihib than recommended, you must contact your doctor immediately. Bring the medicine packaging with you, even if it is empty.
If you have taken more Elihib than recommended, there may be an increased risk of bleeding. Surgical treatment, blood transfusion, or other treatments capable of reversing the effect on factor Xa may be necessary in case of bleeding.
Missed dose of Elihib

If a morning dose is missed, take it as soon as you remember, and you may take it together with the evening dose.
A missed evening dose may be taken only that same evening. Do not take two doses the next morning instead; instead, continue taking the medicine the next day as directed, twice daily.

If you have any doubts about using the medicine or if you miss more than one dose, you should consult your doctor, pharmacist, or nurse.
Stopping Elihib
Do not stop taking this medicine without consulting your doctor, as the risk of developing blood clots may be higher if Elihib is discontinued prematurely.
If you have any further doubts about using this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not in everyone.
The most common general adverse effect of this medicine is bleeding, which may potentially
be life-threatening and may require immediate medical attention.

The following adverse effects may occur when taking Elihib
to prevent blood clots in the heart in patients with irregular heart rhythm
and at least one additional risk factor.

Common adverse effects (may occur in more than 1 in 10 people)

Bleeding, including:
- into the eye;
- into the stomach or intestine;
- from the rectum;
- blood in urine;
- nosebleeds;
- bleeding from gums;
- subcutaneous haemorrhage and swelling;
Anaemia, which may cause fatigue or paleness;
Low blood pressure, which may lead to fainting or rapid heartbeat;
Nausea;
Blood test results may indicate: increased activity of gamma-glutamyltransferase (GGT).

Uncommon adverse effects (may occur in more than 1 in 100 people)

Bleeding:
- into the brain or spinal canal;
- in the mouth or coughing up blood;
- in the abdominal cavity or from the vagina;
- bright red blood in stool;
- bleeding occurring after surgery, including bruising and swelling, leakage of blood or fluid from the surgical wound/incision site (wound discharge) or injection site;
- from haemorrhoids;
- presence of blood in stool or urine detected in laboratory tests;
Decreased platelet count (which may affect blood clotting);
Blood test results may indicate:
- abnormal liver function;
- increased activity of certain liver enzymes;
- elevated bilirubin levels – a breakdown product of red blood cells that may cause yellowing of the skin and eyes (jaundice);
Skin rash;
Itching;
Hair loss;
Allergic reactions (hypersensitivity), which may cause: swelling of the face, lips, mouth, tongue and/or throat, and breathing difficulties. If any of these symptoms occur, seek medical advice immediately.

Rare adverse effects (may occur in more than 1 in 1,000 people)

Bleeding:
- in the lungs or throat;
- into the retroperitoneal space (behind the abdominal cavity);
- into muscles.

Very rare adverse effects (may occur in more than 1 in 10,000 people)

Skin rash, which may develop blisters and resembles small target-like lesions (dark spots in the centre surrounded by a lighter ring, with a dark ring around the edge) (erythema multiforme).

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

Vasculitis (inflammation of blood vessels), which may cause skin rash or raised, flat, red, circular spots under the skin surface, or bruising;
Bleeding in the kidneys, sometimes with blood in urine, leading to impaired kidney function (nephropathy associated with anticoagulant therapy).

The following adverse effects may occur when taking Elihib
to treat or prevent recurrence of blood clots in the veins of the lower limbs
and blood clots in the blood vessels of the lungs.

Common adverse effects (may occur in more than 1 in 10 people)

Bleeding, including:
- nosebleeds;
- bleeding from gums;
- blood in urine;
- subcutaneous haemorrhage and swelling;
- in the stomach, intestines, or from the rectum;
- in the mouth;
- from the vagina;
Anaemia, which may cause fatigue or paleness;
Decreased platelet count (which may affect blood clotting);
Nausea;
Skin rash;
Blood test results may indicate: increased activity of gamma-glutamyltransferase (GGT) or alanine aminotransferase (AlAT).

Uncommon adverse effects (may occur in more than 1 in 100 people)

Low blood pressure, which may lead to fainting or rapid heartbeat;
Bleeding:
- into the eyes;
- in the mouth or coughing up blood;
- bright red blood in stool;
- test results indicating blood in stool or urine;
- bleeding occurring after surgery, including bruising and swelling, leakage of blood or fluid from the surgical wound/incision site (wound discharge) or injection site;
- from haemorrhoids;
- into muscles;
Itching;
Hair loss;
Allergic reactions (hypersensitivity), which may cause: swelling of the face, lips, mouth, tongue and/or throat, and breathing difficulties. If any of these symptoms occur, seek medical advice immediately;
Blood test results may indicate:
- abnormal liver function;
- increased activity of certain liver enzymes;
- elevated bilirubin levels – a breakdown product of red blood cells that may cause yellowing of the skin and eyes (jaundice).

Rare adverse effects (may occur in more than 1 in 1,000 people)

Bleeding:
- in the brain or spinal canal;
- in the lungs.

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

Bleeding: into the abdominal cavity or retroperitoneal space.
Skin rash, which may develop blisters and resembles small target-like lesions (dark spots in the centre surrounded by a lighter ring, with a dark ring around the edge) (erythema multiforme);
Vasculitis (inflammation of blood vessels), which may cause skin rash or raised, flat, red, circular spots under the skin surface, or bruising;
Bleeding in the kidneys, sometimes with blood in urine, leading to impaired kidney function (nephropathy associated with anticoagulant therapy).

Additional adverse effects in children and adolescents
If any of the following symptoms occur, seek medical advice immediately:

Allergic reactions (hypersensitivity), which may cause: swelling of the face, lips, mouth, tongue and/or throat, and breathing difficulties. The frequency of these adverse effects is defined as "common" (may occur in more than 1 in 10 people).

Overall, adverse effects observed in children and adolescents taking Elihib were generally similar to those seen in adults, mostly mild or moderate in severity. Adverse effects occurring more frequently in children and adolescents include nosebleeds and abnormal vaginal bleeding.

Very common adverse effects (may occur in more than 1 in 10 people)

Bleeding, including:
- from the vagina;
- nosebleeds.

Common adverse effects (may occur in more than 1 in 10 people)

Bleeding, including:
- from gums;
- blood in urine;
- subcutaneous haemorrhages (bruising) and swelling; from the intestine or rectum;
- bright red blood in stool;
- postoperative bleeding, including subcutaneous haemorrhages (bruising) and swelling, leakage of blood or fluid (discharge) from the surgical wound or injection site;
Hair loss;
Anaemia, which may cause fatigue or paleness;
Decreased platelet count (which may affect clotting);
Nausea;
Skin rash;
Itching;
Low blood pressure, which may cause fainting or rapid heartbeat;
Blood test results may indicate:
- abnormal liver function;
- increased activity of certain liver enzymes;
- increased activity of alanine aminotransferase (ALT).

Frequency not known (cannot be estimated from available data)

Bleeding:
- into the abdominal cavity or retroperitoneal space;
- in the stomach;
- in the eyes;
- in the mouth;
- from haemorrhoids;
- in the mouth or blood in sputum when coughing;
- in the brain or spine;
- in the lungs;
- in muscles;
Skin rash, which may develop blisters and resembles small target-like lesions (dark spots in the centre surrounded by a lighter ring, with a dark ring around the edge) (erythema multiforme);
Vasculitis, which may cause skin rash or raised, flat, red, circular spots under the skin surface or bruising;
Blood test results may indicate:
- increased activity of gamma-glutamyltransferase (GGT);
presence of blood in stool or urine;
- Bleeding in the kidneys, sometimes with blood in urine, leading to impaired kidney function (nephropathy associated with anticoagulant therapy).

Reporting of adverse effects
If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps provide more information on the safety of this medicine.

5. How to store Elihib

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the outer carton after: "EXP". The expiry date refers to the last day of the specified month.
No special storage instructions apply.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures help protect the environment.

6. Contents of the pack and other information

What Elihib contains

The active substance is apixaban. Each tablet contains 5 mg of apixaban.
The other ingredients are:
- Core of the tablet: monohydrate lactose (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: monohydrate lactose (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, oblong film-coated tablet with dimensions of 5.2 x 10.3 mm.
Alu-PVC/PVdC foil blisters containing 7, 10, 14, 20, 28, 30, 56, 60 or 100 film-coated tablets
in a cardboard box.
Single-dose perforated blister in Alu-PVC/PVdC foil 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 cardboard box.
Not all pack sizes may be marketed.

Patient card: information on how to proceed
Inside the Elihib packaging, together with the patient leaflet, there is a Patient Card or a similar card which the patient may receive from the doctor.
This Patient Card contains information that will be helpful for the patient and will alert other physicians about the use of Elihib. This card should always be kept on hand.

Take the card.
Fill in the following details or ask your doctor to complete them:
- Name and surname:
- Date of birth:
- Indication:
- Dose:...........mg twice daily
- Name of physician:
- Physician's telephone number:
Fold the card and always keep it with you.

Marketing Authorisation Holder
G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria

Importers
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 medicinal product is authorised for marketing in the European Economic Area under the following names:
Finland: Elihib
Austria: Elihib 5 mg-Filmtabletten
Bulgaria: Elihib
Czech Republic: Elihib
Italy: Elihib
Poland: Elihib

For further information about this medicinal product, please contact the representative of the Marketing Authorisation 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]