Elihib

Poland
Brand name Elihib
Form tablets, film-coated
Active substance / Dosage
apixaban · 2.5 mg
Prescription type Prescription only
ATC code
B01AF02
Registration number 100480172
Manufacturer Adalvo Limited, G.L. Pharma Limited, Pharmadox Healthcare Limited

Table of Contents

Package leaflet: Information for the user

Elihib, 2.5 mg, coated tablets
Apixabanum
Please read carefully the entire leaflet before using this medicine, as 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 you personally. 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.

Contents of the leaflet

  1. What Elihib is and what it is 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 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 blocking Factor Xa, an important component in the blood clotting process.
Elihib is used in adults:

  • to prevent blood clots (deep vein thrombosis) after hip or knee replacement surgery. After hip or knee surgery, patients have an increased risk of developing blood clots in the deep veins of the legs. This may lead to leg swelling, with or without pain. If a blood clot travels from the leg to the lungs, it may block blood flow through the lungs, causing breathlessness with or without chest pain. This condition (pulmonary embolism) may be life-threatening and requires immediate medical attention.
  • 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 a stroke, or to other organs, impairing blood flow to these organs (also known as systemic embolism). A stroke may be life-threatening and requires immediate medical intervention.
  • to treat blood clots in the deep veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism), as well as to prevent recurrence of blood clots in the blood vessels of the legs and/or lungs.

Elihib is used in children aged from 28 days 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 recommended dosage can be found in section 3.

2. Important 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 of an organ that increases the risk of serious bleeding (such as active or recently diagnosed peptic ulcer of the stomach or intestine, recently diagnosed bleeding into the brain),
  • if the patient has a liver disease that leads to an increased risk of bleeding (hepatic coagulopathy),
  • if the patient is taking anticoagulant medicines (e.g. warfarin, rivaroxaban, dabigatran or heparin), except in situations when switching anticoagulant therapy, when a venous or arterial access line has been established 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 conditions causing reduced platelet activity,
    • very high blood pressure, uncontrolled with 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,
  • if the patient has a spinal catheter inserted or has received a spinal injection (anaesthetic or pain-relieving), in which case the doctor will recommend taking this medicine 5 or more hours after removal of the catheter,
  • 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 a surgical procedure to remove a blood clot from the lungs is planned.

Exercise particular caution when using Elihib:

  • if the patient has a disorder called antiphospholipid syndrome (an autoimmune 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 is required, the doctor may ask the patient to temporarily stop taking this medicine for a short period. If in doubt whether a particular procedure may be associated with bleeding, consult the doctor.

Children and adolescents
Use of this medicine is not recommended 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 weaken its effect. 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 enhance 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 infection (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 and noradrenaline reuptake inhibitors.

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

  • antiepileptic medicines or medicines used to prevent seizures (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 during breastfeeding. The patient may be advised to discontinue breastfeeding or to discontinue/avoid starting treatment with this medicine.
Driving and operating machinery
Elihib has no effect or a 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 contact the doctor before taking this medicine.
This medicine contains less than 0.023 g sodium (less than 1 mmol) per tablet, i.e. the medicine is considered "sodium-free".

3. How to take Elihib

This medicine should always be taken as directed by a doctor or pharmacist. If you have any doubts,
you should consult your doctor, pharmacist, or nurse.

Dosage

The tablet should be swallowed with water. Elihib may be taken with food or independently
of meals. To achieve the best treatment results, it is recommended to take the tablets
at the same times each day.

If a patient has difficulty swallowing the tablet 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 an appropriate container, then mix it with a small amount (e.g., 30 mL [2 tablespoons]) of water or another liquid listed above to form 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, a 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 for the following indications:

  • Prevention of blood clots after hip or knee replacement surgery
    The recommended dose is one 2.5 mg Elihib tablet twice daily (e.g., one tablet in the morning and one in the evening). The first dose should be taken 12 to 24 hours after surgery.

    • If the patient underwent major hip replacement surgery, tablets are usually taken for 32 to 38 days.
    • If the patient underwent major knee replacement surgery, tablets are usually taken 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 factor
    The recommended dose is one 5 mg Elihib tablet twice daily.

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

    • the patient has severe kidney impairment, or
    • two or more of the following conditions are met:
      • blood test results indicate reduced kidney function (serum creatinine concentration ≥1.5 mg/dL [133 micromoles/L]),
      • 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 (e.g., one in the morning and one in the evening). The 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 5 mg Elihib tablets twice daily for the first 7 days (e.g., two tablets in the morning and two in the evening). After 7 days, the recommended dose is one 5 mg Elihib tablet twice daily (e.g., one tablet in the morning and one in the evening).

  • Prevention of recurrent blood clots after completing 6 months of treatment
    The recommended dose is one 2.5 mg Elihib tablet twice daily (e.g., one tablet in the morning and one in the evening). The doctor will decide how long treatment should continue.

  • Use in children and adolescents
    Treatment of blood clots and prevention of recurrent blood clots in veins or pulmonary blood vessels.

This medicine should always be taken or administered as directed by a doctor or pharmacist. If you have any doubts, you should consult your doctor, pharmacist, or nurse.

To achieve the best treatment effect, doses should be taken or administered at the same time each day.

The Elihib dose depends on body weight and will be calculated by the doctor. The recommended dose for children and adolescents weighing at least 35 kg is four 2.5 mg Elihib tablets, taken twice daily for the first 7 days (e.g., four in the morning and four in the evening).

After 7 days, the recommended dose is two 2.5 mg Elihib tablets, taken twice daily (e.g., two in the morning and two 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 body weight.

  • The doctor may change anticoagulant therapy as follows:
    • Switching from Elihib to anticoagulant medicines
      Stop taking Elihib. Start anticoagulant therapy (e.g., heparin) at the time the next tablet was scheduled.
    • Switching from anticoagulant medicines to Elihib
      Stop taking anticoagulant medicines. Start Elihib at the time the next dose of anticoagulant medicine was scheduled, then continue taking it as usual.
    • Switching from anticoagulant therapy including a vitamin K antagonist (e.g., warfarin) to Elihib
      Discontinue the vitamin K antagonist-containing medicine. The doctor must perform blood tests and will inform the patient when to start taking Elihib.
    • Switching from Elihib to anticoagulant therapy including a vitamin K antagonist (e.g., warfarin)
      If the doctor informs the patient to start taking a vitamin K antagonist-containing medicine, Elihib should be continued for at least 2 days after the first dose of the vitamin K antagonist-containing medicine. The doctor must perform blood tests and inform the patient 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 the doctor to prevent the formation of blood clots in the brain's blood vessels and in other blood vessels of the body.

Taking more Elihib than recommended
If a patient has taken more than the recommended dose of this medicine, they should contact their doctor immediately. They should bring the medicine packaging with them, even if it is empty.

If a patient has taken more than the recommended dose of Elihib, the risk of bleeding may be increased. In case of bleeding, surgical treatment, blood transfusion, or other treatment capable of reversing the anti-factor Xa effect may be required.

Missed dose of Elihib

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

If you have any doubts about using the medicine or if more than one dose has been missed, you should consult your doctor, pharmacist, or nurse.

Stopping Elihib treatment
Do not stop taking this medicine without consulting your doctor, as the risk of developing a blood clot may be higher if Elihib is stopped prematurely.

If you have any further questions about using this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine may cause side effects, although not everyone gets them.
Elihib may be used for three different medical conditions. The known side effects and their frequency in each of these medical conditions may differ and are listed separately below. In these conditions, the most common general side effect of this medicine is bleeding, which may potentially be life-threatening and may require immediate medical attention.

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

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

  • Anaemia, which may cause fatigue or paleness;
  • Bleeding, including: bruising and swelling;
  • Nausea (feeling sick).

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

  • Decreased platelet count (which may affect blood clotting);
  • Bleeding:
    • After surgery, including bruises and swelling, leakage of blood or other fluid from the surgical wound/incision site (wound discharge) or injection site;
    • From stomach, intestines, or bright red blood in stool;
    • In urine;
    • From nose;
    • From vagina;
  • Low blood pressure, which may lead to fainting or rapid heartbeat;
  • Blood test results may indicate:
    • Liver function abnormalities;
    • Increased activity of certain liver enzymes;
    • Increased bilirubin levels, a product formed from destroyed red blood cells, which may cause yellowing of the skin and eyes (jaundice);
  • Itching.

Rare side effects (may occur in more than 1 in 1000 people)

  • 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, contact your doctor immediately;
  • Bleeding:
    • Into muscle;
    • Into eyes;
    • From gums and coughing up blood;
    • From rectum;
  • Hair loss.

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

  • Bleeding:
    • Into the brain or spinal area;
    • In lungs or throat;
    • In mouth;
    • Into abdominal cavity or retroperitoneal space (area behind the abdominal cavity);
    • From haemorrhoids;
  • Test results indicating presence of blood in stool or urine;
    • Skin rash, which may develop blisters and resembles target-like lesions (dark spots in the center 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, round spots under the skin surface, or bruising;
    • Bleeding in kidneys, sometimes with blood in urine, leading to kidney function impairment (nephropathy associated with anticoagulant drugs).

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

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

  • Bleeding, including:
    • Into the eye;
    • Into stomach or intestine;
    • From rectum;
    • In urine;
    • From nose;
    • From gums;
    • Bruising and swelling;
  • Anaemia, which may cause fatigue or paleness;
  • Low blood pressure, which may lead to fainting or rapid heartbeat;
  • Nausea (feeling sick);
  • Blood test results may indicate: increased gamma-glutamyltransferase (GGT) activity.

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

  • Bleeding:
    • Into the brain or spinal area;
    • In mouth or coughing up blood;
    • In abdominal cavity or from vagina;
    • Bright red blood in stool;
    • Occurring after surgery, including bruising and swelling, leakage of blood or fluid from 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:
    • Liver function abnormalities;
    • Increased activity of certain liver enzymes;
    • Increased bilirubin levels – a breakdown product of red blood cells, which 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, you must contact your doctor immediately.

Rare side effects (may occur in more than 1 in 1000 people)

  • Bleeding:
    • In lungs or throat;
    • Into retroperitoneal space;
    • Into muscle.

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

  • Skin rash, which may develop blisters and resembles target-like lesions (dark spots in the center 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, round spots under the skin surface, or bruising.
  • Bleeding in kidneys, sometimes with blood in urine, leading to kidney function impairment (nephropathy associated with anticoagulant drugs).

The following side 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 blood vessels in the lungs.

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

  • Bleeding, including:
    • From nose;
    • From gums;
    • In urine;
    • Bruising and swelling;
    • In stomach, intestine, or from rectum;
    • In mouth;
    • From vagina;
  • Anaemia, which may cause fatigue or paleness;
  • Decreased platelet count (which may affect clotting);
  • Nausea (feeling sick);
  • Skin rash;
  • Blood test results may indicate: increased gamma-glutamyltransferase (GGT) or alanine aminotransferase (AlAT) activity.

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

  • Low blood pressure, which may lead to fainting or rapid heartbeat;
  • Bleeding:
    • Into eyes;
    • In mouth or coughing up blood;
    • Bright red blood in stool;
    • Test results indicating blood in stool or urine;
    • Occurring after surgery, including bruising and swelling, leakage of blood or fluid from surgical wound/incision site (wound discharge) or injection site;
    • From haemorrhoids;
    • Into muscle;
  • 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, you must contact your doctor immediately;
  • Blood test results may indicate:
    • Liver function abnormalities;
    • Increased activity of certain liver enzymes;
  • Increased bilirubin levels – a breakdown product of red blood cells, which may cause yellowing of the skin and eyes (jaundice).

Rare side effects (may occur in more than 1 in 1000 people)

  • Bleeding:
    • Into the brain or spinal area;
    • In lungs.

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

  • Bleeding: into abdominal cavity or retroperitoneal space;
  • Skin rash, which may develop blisters and resembles target-like lesions (dark spots in the center 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, round spots under the skin surface, or bruising;
  • Bleeding in kidneys, sometimes with blood in urine, leading to kidney function impairment (nephropathy associated with anticoagulant drugs).

Additional side effects in children and adolescents
If any of the following symptoms occur, you must contact your doctor immediately:

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

Overall, side effects observed in children and adolescents treated with Elihib were similar to those seen in adults and were mostly mild or moderate in severity. Side effects occurring more frequently in children and adolescents include nosebleeds and abnormal vaginal bleeding.

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

  • Bleeding, including:
    • From vagina;
    • From nose.

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

  • Bleeding, including:
    • From gums;
    • In urine;
    • Bruising (haematomas) and swelling; from intestine or rectum;
    • Bright red blood in stool;
    • After surgery, including bruising (haematomas) and swelling, leakage of blood or fluid (discharge) from surgical wound or injection site;
  • Hair loss;
  • Anaemia, which may cause fatigue or paleness;
  • Decreased platelet count (which may affect coagulability);
  • Nausea (feeling sick);
  • 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 alanine aminotransferase (ALT) activity.

Frequency not known (cannot be estimated from available data)

  • Bleeding:
    • Into abdominal cavity or retroperitoneal space;
    • In stomach;
    • In eyes;
    • In mouth;
    • From haemorrhoids;
    • In mouth or blood in sputum when coughing;
    • In brain or spine;
    • In lungs;
    • In muscle;
  • Skin rash, which may develop blisters and resembles target-like lesions (dark spots in the center surrounded by a lighter ring, with a dark ring around the edge) (erythema multiforme);
  • Vasculitis, which may cause skin rash or raised, flat, round, red spots under the skin surface or bruising;
  • Blood test results may indicate:
    • Increased gamma-glutamyltransferase (GGT) activity;
    • Presence of blood in stool or urine;
  • Bleeding in kidneys, sometimes with blood in urine, leading to kidney function impairment (nephropathy associated with anticoagulant drugs).

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

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 stated on the blister and the cardboard
pack after: "EXP". The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via wastewater or household waste. You should ask
your pharmacist how to dispose of medicines you no longer use. This 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: 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 sulphate, sodium stearyl fumarate.
    • Coating: monohydrate lactose (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 yellow, round, film-coated tablets with a diameter of 6.1 mm.
Alu-PVC/PVdC foil blister pack containing 7, 10, 14, 20, 28, 30, 56, 60 or 100 film-coated tablets
in a cardboard box.
Single-dose perforated blister made of 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 physician.
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 carried on the person.

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

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 for marketing in the Member States of the European Economic Area under the following names:
Finland: Elihib
Austria: Elihib 2.5 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]