ELIHIB 2.5 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Elihib, 2.5 mg, Film-Coated Tablets
   1. Table of Contents of the Package Leaflet
3. What is Elihib and what is it used for
4. Important information before taking Elihib
   1. When not to take Elihib:
   2. Warnings and precautions
   3. When to be extra careful while taking Elihib:
   4. Children and adolescents
   5. Elihib and other medicines
   6. Medicines that may increase the effect of Elihib and increase the risk of bleeding:
   7. Medicines that may reduce the effect of Elihib:
   8. Pregnancy and breastfeeding
   9. Driving and using machines
   10. Elihib contains lactose and sodium
5. How to take Elihib
   1. Dose
   2. Instructions for crushing the tablets:
   3. Elihib should be taken as follows for the following indications:
   4. If you take more Elihib than you should
   5. If you forget to take Elihib
   6. If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
6. Possible side effects
   1. The following side effects may occur when taking Elihib to prevent blood clots after hip or knee replacement surgery.
   2. Common side effects (may affect up to 1 in 10 people)
   3. Uncommon side effects (may affect up to 1 in 100 people)
   4. Rare side effects (may affect up to 1 in 1,000 people)
   5. Frequency not known (frequency cannot be estimated from the available data)
   6. The following side effects may occur when taking Elihib to prevent blood clots in the heart in patients with irregular heart rhythm (atrial fibrillation) and at least one additional risk factor.
   7. Common side effects (may affect up to 1 in 10 people)
   8. Uncommon side effects (may affect up to 1 in 100 people)
   9. Rare side effects (may affect up to 1 in 1,000 people)
   10. Frequency not known (frequency cannot be estimated from the available data)
   11. The following side effects may occur when taking Elihib to treat or prevent recurrence of blood clots in the deep veins of the legs and blood clots in the blood vessels of the lungs.
   12. Common side effects (may affect up to 1 in 10 people)
   13. Uncommon side effects (may affect up to 1 in 100 people)
   14. Rare side effects (may affect up to 1 in 1,000 people)
   15. Frequency not known (frequency cannot be estimated from the available data)
   16. Reporting of side effects
7. How to store Elihib
8. Contents of the pack and other information
   1. What Elihib contains
   2. What Elihib looks like and contents of the pack
   3. Patient Alert Card: Information on handling
   4. Marketing Authorisation Holder
   5. Importer
   6. This medicinal product is authorised in the Member States of the European Economic Area under the following names:
   7. For further information on this medicine, please contact:
   8. Date of last revision of the leaflet:

Package Leaflet: Information for the Patient

Elihib, 2.5 mg, Film-Coated Tablets

Apixaban
You should carefully read the contents of this leaflet before taking this medicine, as it contains important information for you.

• You should keep this leaflet, so you can read it again later if you need to.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine 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 any not listed in this leaflet, please inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package 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 medicines called anticoagulants. This medicine helps prevent blood clots from forming by blocking factor Xa, which is an important factor in blood clotting.

Elihib is used in adults:

• to prevent blood clots (deep vein thrombosis) after hip or knee replacement surgery. After hip or knee surgery, you are at a higher risk of getting blood clots in the veins of your legs. This can lead to swelling of your legs, with or without pain. If a blood clot breaks loose from your leg, it can travel to your lungs, blocking the flow of blood, which can be life-threatening and requires immediate medical attention.
• to prevent 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, causing a stroke, or to other organs, reducing blood flow to those organs (also known as systemic embolism). A stroke can be life-threatening and requires immediate medical attention.
• to treat blood clots in the deep veins of the legs (deep vein thrombosis) and blood clots in the blood vessels of the lungs (pulmonary embolism), as well as to prevent the recurrence of blood clots in the deep veins of the legs and/or lungs.

2. Important information before taking Elihib

When not to take Elihib:

• if you are allergic to apixaban or any of the other ingredients of this medicine (listed in section 6),
• if you have active bleeding,
• if you have a condition that increases the risk of major bleeding (such as a recently active stomach or intestinal ulcer, or recent bleeding in the brain),
• if you have a liver disease that leads to an increased risk of bleeding (hepatic coagulopathy),
• if you are taking other medicines to prevent blood clotting (such as warfarin, rivaroxaban, dabigatran, or heparin), except when switching from these medicines to Elihib under the guidance of your doctor.

Warnings and precautions

Before taking this medicine, you should discuss with your doctor, pharmacist, or nurse if you:

• have an increased risk of bleeding, such as:
• bleeding disorders, including those that lead to reduced platelet activity,
• very high blood pressure that is not controlled with medication,
• are over 75 years old,
• weigh 60 kg or less,
• have severe kidney disease or are on dialysis,
• have liver disease or a history of liver disease. This medicine should be used with caution in patients with signs of liver dysfunction.
• have a catheter or have had an injection into the spinal canal, in which case your doctor will advise you to take this medicine 5 or more hours after the procedure,
• have a prosthetic heart valve,
• have been told by your doctor that your blood pressure is unstable or that you need another treatment or surgery to remove a blood clot from your lungs.

When to be extra careful while taking Elihib:

• if you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), you should inform your doctor, who will decide whether to change your treatment.
• if you need to have surgery or a procedure that may cause bleeding, your doctor may ask you to stop taking this medicine for a short time. If you are unsure whether a procedure may cause bleeding, you should ask your doctor.

Children and adolescents

This medicine is not recommended for children and adolescents under 18 years old.

Elihib and other medicines

You should tell your doctor, pharmacist, or nurse about all the medicines you are taking, have recently taken, or might take, including those you have bought without a prescription.

Medicines that may increase the effect of Elihib and increase the risk of bleeding:

• certain medicines used to treat fungal infections (such as ketoconazole and others),
• certain antiviral medicines used to treat HIV/AIDS (such as ritonavir),
• other medicines used to reduce blood clotting (such as enoxaparin and others),
• anti-inflammatory or pain-relieving medicines (such as aspirin or naproxen), especially if you are over 75 years old and taking aspirin,
• medicines used to treat high blood pressure or heart problems (such as diltiazem),
• antidepressant medicines called selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors.

Medicines that may reduce the effect of Elihib:

• medicines used to treat epilepsy or seizures (such as phenytoin and others),
• St. John's Wort (a herbal supplement used to treat depression),
• medicines used to treat tuberculosis or other infections (such as rifampicin).

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or plan to have a baby, you should ask your doctor, pharmacist, or nurse for advice before taking this medicine.

Driving and using machines

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

Elihib contains lactose and sodium

If you have been told by your doctor that you have an intolerance to some sugars, you should contact your doctor before taking this medicine.

3. How to take Elihib

You should always take this medicine exactly as your doctor or pharmacist has told you.

Dose

Swallow the tablet with water. You can take Elihib with or without food. To get the best results from your treatment, it is recommended that you take the tablets at the same time every day.

Instructions for crushing the tablets:

• Crush the tablet with a mortar.
• Carefully transfer the powder to a suitable container, then mix it with a small amount (e.g., 30 mL or 2 tablespoons) of water or another liquid mentioned above to make 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.

Your doctor may give you a crushed Elihib tablet mixed with 60 mL of water or 5% glucose solution through a nasogastric tube if needed.

Elihib should be taken as follows for the following indications:

• Prevention of blood clots after hip or knee replacement surgeryThe recommended dose is one 2.5 mg Elihib tablet twice daily. For example, one tablet in the morning and one in the evening. The first tablet should be taken 12 to 24 hours after surgery.
• If you have had major hip surgery, you will usually take the tablets for 32 to 38 days.
• If you have had major knee surgery, you will usually take the tablets for 10 to 14 days.
• Prevention of blood clots in the heart in patients with irregular heart rhythm (atrial fibrillation) and at least one additional risk factorThe recommended dose is one 5 mg Elihib tablet twice daily.

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

• you have severe kidney problems,
• you meet two or more of the following conditions:
• your blood test results indicate reduced kidney function (a serum creatinine level of 1.5 mg/dL or more),
• you are 80 years old or more,
• your 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 you should continue treatment.

• Treatment of blood clots in the deep veins of the legs and blood clots in the blood vessels of the lungsThe recommended dose is two 5 mg Elihib tablets 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 5 mg Elihib tablet twice daily, for example, one tablet in the morning and one in the evening.
• Prevention of recurrence of blood clots after completing 6 months of treatmentThe recommended dose is one 2.5 mg Elihib tablet twice daily, for example, one tablet in the morning and one in the evening. Your doctor will decide how long you should continue treatment.
• Your doctor may switch your anticoagulant treatment as follows:
• Switching from Elihib to other anticoagulantsYou should stop taking Elihib. Treatment with other anticoagulants (such as heparin) should be started when the next Elihib tablet is due to be taken.
• Switching from other anticoagulants to ElihibYou should stop taking other anticoagulants. Treatment with Elihib should be started when the next dose of the other anticoagulant is due to be taken, and then continue as usual.
• Switching from treatment with a vitamin K antagonist (such as warfarin) to ElihibYou should stop taking the vitamin K antagonist. Your doctor will perform blood tests and inform you when to start taking Elihib.

If you take more Elihib than you should

If you take more Elihib than you should, you should contact your doctor immediately. You should take the packaging with you, even if it is empty. If you take more Elihib than you should, you may be at risk of bleeding. In case of bleeding, you may need surgical treatment, blood transfusion, or other treatment to reverse the effect of factor Xa inhibition.

If you forget to take Elihib

You should take the dose as soon as you remember and then:

• take the next dose of Elihib at the usual time
• continue taking the medicine as you would normally.

If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects may occur when taking Elihib to prevent blood clots after hip or knee replacement surgery.

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

• anaemia, which can make you feel tired or pale;
• bleeding, including:
• bruising and swelling;
• nausea (feeling sick).

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

• reduced platelet count (which can affect blood clotting);
• bleeding:
• after surgery, including bruising and swelling, fluid leakage from the wound or injection site;
• from the stomach or intestines, or black stools;
• blood in the urine;
• from the nose;
• from the vagina;
• low blood pressure, which can lead to fainting or a fast heart rate;
• blood test results indicating:
• liver problems;
• increased activity of certain liver enzymes;
• increased bilirubin levels, a product of broken-down red blood cells, which can cause yellowing of the skin and eyes;
• itching.

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

• allergic reactions (hypersensitivity), which can cause:
• swelling of the face, lips, mouth, tongue, and throat, and difficulty breathing;
• bleeding:
• into the muscle;
• into the eyes;
• coughing up blood;
• from the rectum;
• hair loss.

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

• bleeding:
• into the brain or spinal cord;
• into the lungs or throat;
• into the mouth;
• into the abdominal cavity or the space behind the abdomen;
• from the rectum;
• blood in the stool or urine detected by laboratory tests;
• a skin rash that can cause blisters and looks like small targets (dark spots in the center surrounded by a lighter ring, with a dark ring around the edge) (erythema multiforme);
• inflammation of blood vessels (vasculitis), which can cause a skin rash or raised, flat, red, round patches under the skin, or bruising.

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

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

• bleeding, including:
• into the eye;
• from the stomach or intestines;
• from the rectum;
• blood in the urine;
• from the nose;
• coughing up blood;
• bruising and swelling;
• anaemia, which can make you feel tired or pale;
• low blood pressure, which can lead to fainting or a fast heart rate;
• nausea (feeling sick);
• blood test results indicating increased activity of gamma-glutamyltransferase (GGT).

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

• bleeding:
• into the brain or spinal cord;
• into the mouth or throat;
• into the abdominal cavity or from the vagina;
• black stools;
• bleeding after surgery, including bruising and swelling, fluid leakage from the wound or injection site;
• from the rectum;
• reduced platelet count (which can affect blood clotting);
• blood test results indicating:
• liver problems;
• increased activity of certain liver enzymes;
• increased bilirubin levels, a product of broken-down red blood cells, which can cause yellowing of the skin and eyes;
• skin rash;
• itching;
• hair loss;
• allergic reactions (hypersensitivity), which can cause:
• swelling of the face, lips, mouth, tongue, and throat, and difficulty breathing;

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

• bleeding:
• into the lungs or throat;
• into the muscle.

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

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

The following side effects may occur when taking Elihib to treat or prevent recurrence of blood clots in the deep 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;
• coughing up blood;
• blood in the urine;
• bruising and swelling;
• from the stomach or intestines;
• from the rectum;
• from the mouth;
• from the vagina;
• anaemia, which can make you feel tired or pale;
• reduced platelet count (which can affect blood clotting);
• nausea (feeling sick);
• skin rash;
• blood test results indicating increased activity of gamma-glutamyltransferase (GGT) or alanine aminotransferase (ALT).

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

• low blood pressure, which can lead to fainting or a fast heart rate;
• bleeding:
• into the eye;
• into the mouth or throat;
• black stools;
• blood test results indicating bleeding in the stool or urine;
• bleeding after surgery, including bruising and swelling, fluid leakage from the wound or injection site;
• from the rectum;
• into the muscle.
• itching;
• hair loss;
• allergic reactions (hypersensitivity), which can cause:
• swelling of the face, lips, mouth, tongue, and throat, and difficulty breathing;
• blood test results indicating:
• liver problems;
• increased activity of certain liver enzymes;
• increased bilirubin levels, a product of broken-down red blood cells, which can cause yellowing of the skin and eyes.

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

• bleeding:
• into the brain or spinal cord;
• into the lungs.

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

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

Reporting of side effects

If you experience any side effects, including any not listed in this leaflet, please inform your doctor, pharmacist, or nurse.

5. How to store Elihib

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister and carton after “EXP”. The expiry date refers to the last day of that month.

No special storage precautions are required.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Elihib contains

• The active substance is apixaban. Each tablet contains 2.5 mg of apixaban.
• The 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, yellow iron oxide (E 172).

What Elihib looks like and contents of the pack

Elihib is a yellow, round, film-coated tablet with a diameter of 6.1 mm.

Alu-PVC/PVdC blister pack containing 7, 10, 14, 20, 28, 30, 56, 60, or 100 film-coated tablets in a carton.

Perforated unit dose 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 Elihib packaging, together with this leaflet, you will find a Patient Alert Card or a similar card that your doctor may give you.

This Patient Alert Card contains information that will be useful to you and will alert other doctors that you are taking Elihib. You should always carry this card with you.

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

Marketing Authorisation 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 medicinal product is authorised in the Member States of the European Economic Area under the following names:

Finland: Elihib
Austria: Elihib 2.5 mg film-coated tablets
Bulgaria: Elihib
Czech Republic: Elihib
Italy: Elihib
Poland: Elihib

For further information on this medicine, please contact:

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

Date of last revision of the leaflet: