Apixaban medical valley

Poland
Brand name Apixaban medical valley
Form tablets, film-coated
Active substance / Dosage
apixaban · 2.5 mg
Prescription type Prescription only
ATC code
B01AF02
Registration number 100480848
Manufacturer Laboratorios Liconsa S.A. Zentiva S.A.
Apixaban medical valley tablets, film-coated

Table of Contents

Package leaflet: Information for the user

Apixaban Medical Valley, 2.5 mg, film-coated tablets
Apixabanum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

  • Keep this leaflet, so that you can read it again if necessary.
  • If you have any further questions, please ask your doctor, pharmacist or nurse.
  • This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
  • If you experience any adverse effects, including any not listed in this leaflet, please inform your doctor, pharmacist or nurse. See section 4.

Table of contents

  1. What Apixaban Medical Valley is and what it is used for
  2. What you need to know before taking Apixaban Medical Valley
  3. How to take Apixaban Medical Valley
  4. Possible side effects
  5. How to store Apixaban Medical Valley
  6. Contents of the pack and other information

1. What Apixaban Medical Valley is and what it is used for

Apixaban Medical Valley contains the active substance apixaban and belongs to a group of medicines known as anticoagulants. This medicine helps prevent blood clots by inhibiting Factor Xa, an important component in the blood clotting process. Apixaban Medical Valley is used in adults:

  • to prevent the formation of blood clots (deep vein thrombosis) after hip or knee replacement surgery. After hip or knee surgery, patients may have an increased risk of developing blood clots in the veins of the legs. This may lead to swelling of the legs, 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 the formation of blood clots in the heart in patients with irregular heartbeat (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 supply 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 blood vessels of the legs and/or lungs.

Apixaban Medical Valley is used in children from 28 days of life up to below 18 years of age for the treatment of blood clots and prevention of recurrence of blood clots in veins or in the blood vessels of the lungs.
The appropriate recommended dosage according to body weight is given in section 3.

2. Important information before taking Apixaban Medical Valley

When not to take Apixaban Medical Valley

  • if the patient is allergic to apixaban or any of the other ingredients of this medicine (listed in section 6);
  • if the patient is experiencing excessive bleeding;
  • if the patient has a disease of an organ that increases the risk of severe bleeding (such as active or recently diagnosed peptic ulcer of the stomach or intestine, recent bleeding into the brain);
  • if the patient has liver disease leading 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 of switching anticoagulant therapy, when the patient has an intravenous or intra-arterial catheter in place and heparin is administered through this catheter to maintain its patency, or when the patient has an intravenous catheter in place (undergoing catheter ablation) due to irregular heartbeat (arrhythmia).

Warnings and precautions
Before starting Apixaban Medical Valley, discuss with your doctor or
pharmacist if the patient has any of the following conditions:

  • increased risk of bleeding, for example:
    • bleeding-related disorders, including conditions resulting in reduced platelet activity;
    • very high blood pressure not controlled by medication;
    • if the patient is over 75 years of age;
    • if the patient's body weight is 60 kg or less;
  • severe kidney disease or if the patient is on dialysis;
  • liver disease or history of liver disease
    • this medicine should be used with caution in patients showing signs of impaired liver function;
  • a tube (catheter) or injection into the spine (anaesthetic or pain relief), in which case the doctor will advise taking this medicine at least 5 hours after catheter removal;
  • if the patient has a heart valve prosthesis;
  • if the doctor considers the patient's blood pressure to be unstable, or if other treatment or a surgical procedure to remove a blood clot from the lungs is planned.

When to exercise particular caution when taking Apixaban Medical Valley

  • if the patient has a disorder known as antiphospholipid syndrome (an immune system disorder causing increased 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 that may cause 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 cause bleeding, consult the
doctor.
Children and adolescents
This medicine is not recommended for use in children and adolescents weighing less than 35 kg.
Apixaban Medical Valley and other medicines
Tell your doctor, pharmacist or nurse about all medicines the patient is currently taking, has recently taken or plans to take.
Some medicines may enhance the effect of Apixaban Medical Valley, while others may reduce its effect. The doctor will decide whether the patient should be treated with Apixaban Medical Valley while taking other medicines and how closely monitoring should be performed.
The following medicines may enhance the effect of Apixaban Medical Valley and increase the risk of
unwanted bleeding:

  • certain medicines used to treat fungal infections (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). This is especially relevant for patients over 75 years of age and those taking acetylsalicylic acid, who may be at increased risk of unwanted bleeding;
  • medicines used for high blood pressure or heart problems (e.g. diltiazem);
  • antidepressant medicines known as selective serotonin reuptake inhibitors or serotonin-noradrenaline reuptake inhibitors.

The following medicines may reduce the ability of Apixaban Medical Valley to prevent blood clots:

  • medicines used to prevent epilepsy or seizures (e.g. phenytoin and others);
  • St John's wort (an 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 plans to become pregnant, she should consult her doctor, pharmacist or nurse before taking this medicine.
The effect of Apixaban Medical Valley 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 Apixaban Medical Valley passes into human milk. Consult your doctor, pharmacist or nurse before taking this medicine during breastfeeding.
The patient may be advised to discontinue breastfeeding or to discontinue/avoid taking this medicine.
Driving and operating machinery
Apixaban Medical Valley has not been shown to affect the ability to drive or operate machinery.
Apixaban Medical Valley contains lactose (a type of sugar) and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should
consult their doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Apixaban Medical Valley

This medicine should always be taken as instructed by your doctor or pharmacist. If you are unsure,
you should consult your doctor, pharmacist, or nurse.
Dosage
The tablet should be swallowed with water. Apixaban Medical Valley can be taken with food or
independently of meals. To achieve the best treatment outcomes, 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
Apixaban Medical Valley with their doctor. The tablet may be crushed immediately before intake and
mixed with water, 5% aqueous glucose solution, juice, or apple puree.
Instructions for crushing tablets:

  • Crush the tablet using a mortar and pestle.
  • Carefully transfer the entire powder into a suitable container and mix it with a small amount, e.g., 30 mL (2 tablespoons), of water or another liquid listed above to prepare a mixture.
  • The resulting mixture should be swallowed (drunk).
  • The mortar and pestle used to crush the tablets, as well as the container, should be rinsed with a small amount of water or another liquid (e.g., 30 mL), and the rinsing liquid should then be swallowed (drunk).

If necessary, your doctor may administer crushed Apixaban Medical Valley tablets mixed with
60 mL of water or 5% aqueous glucose solution via a nasogastric tube.
Apixaban Medical Valley should be taken as recommended for the following indications:
Prevention of blood clots after hip or knee replacement surgery
The recommended dose is one 2.5 mg tablet of Apixaban Medical Valley 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 the patient has undergone major hip joint surgery, they will usually take the tablets for 32 to 38 days.
If the patient has undergone major knee joint surgery, they will usually take the tablets for 10 to 14 days.
Prevention of blood clots in the heart in patients with irregular heartbeat and at least one additional
risk factor
The recommended dose is one 5 mg tablet of Apixaban Medical Valley twice daily.
The recommended dose is one 2.5 mg tablet of Apixaban Medical Valley twice daily if:

  • the patient has severe kidney function impairment, or
  • two or more of the following conditions are met :
  • blood test results indicate 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 veins of the legs and blood clots in blood vessels of the lungs
The recommended dose is two 5 mg tablets of Apixaban Medical Valley 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 tablet of Apixaban Medical Valley twice daily, for
example, 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 tablet of Apixaban Medical Valley 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 and prevention of recurrent blood clots in veins or in blood vessels of the lungs.
This medicine should always be taken or administered as instructed by your doctor or pharmacist.
If you are unsure, you should consult your doctor, pharmacist, or nurse.
To achieve the best treatment outcomes, the dose should be taken or administered at the same times
each day.
The dose of Apixaban Medical Valley depends on body weight and will be calculated by your doctor.
The recommended dose for children and adolescents with a body weight of at least 35 kg is four 2.5 mg
tablets of Apixaban Medical Valley administered twice daily for the first 7 days, for example, four
tablets in the morning and four in the evening.
After 7 days, the recommended dose is two 2.5 mg tablets of Apixaban Medical Valley administered
twice daily, for example, two tablets in the morning and two in the evening.
Advice for parents and caregivers: observe the child and ensure they have taken the full dose.
It is important to attend doctor’s appointments as recommended, because if the patient’s body weight
changes, the dose of medicine may need to be adjusted.
Your doctor may change anticoagulant therapy as follows:

  • Switching from Apixaban Medical Valley to anticoagulant medicines Discontinue Apixaban Medical Valley. Start anticoagulant treatment (e.g., heparin) at the time the next tablet was scheduled to be taken.
  • Switching from anticoagulant medicines to Apixaban Medical Valley Discontinue anticoagulant medicines. Begin Apixaban Medical Valley treatment at the time the next anticoagulant dose was scheduled, then continue regular dosing.
  • Switching from anticoagulant therapy including a vitamin K antagonist (e.g., warfarin) to Apixaban Medical Valley Discontinue the vitamin K antagonist medicine. Your doctor will order a blood test and inform you when to start taking Apixaban Medical Valley.
  • Switching from Apixaban Medical Valley 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 medicine, continue taking Apixaban Medical Valley for at least 2 days after taking the first dose of the vitamin K antagonist medicine. Your doctor will order a blood test and inform you when to stop taking Apixaban Medical Valley.

Patients undergoing cardioversion
Patients with irregular heartbeat who require cardioversion to restore normal heart rhythm should take
this medicine at times specified by their doctor to prevent the formation of blood clots in the brain’s
blood vessels and other blood vessels in the body.
Taking more than the recommended dose of Apixaban Medical Valley
If a patient has taken more than the recommended dose of this medicine, you should contact your
doctor immediately. Bring the medicine packaging with you, even if it no longer contains tablets.
If a patient has taken more than the recommended dose of Apixaban Medical Valley, there may be an
increased risk of bleeding. If bleeding occurs, surgical treatment, blood transfusion, or other treatment
to reverse the effect of factor Xa inhibitors may be necessary.
Missing a dose of Apixaban Medical Valley

  • If the patient forgets to take the morning dose, they should take it as soon as possible; the missed morning dose can be taken together with the evening dose.
  • If the patient misses the evening dose, it may only be taken on the same evening. Do not take a double dose the next morning; instead, continue taking the medicine as recommended, twice daily, from the following day.

If you have any doubts about using the medicine or if more than one dose is missed, you should consult
your doctor, pharmacist, or nurse.
Stopping treatment with Apixaban Medical Valley
Do not stop taking this medicine without consulting your doctor, as stopping treatment prematurely
may increase the risk of blood clots.
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 can cause side effects, although not everyone will experience them.
Apixaban Medical Valley can be used in three different medical conditions. Known side effects and their frequency of occurrence may vary for each of these medical conditions 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 Apixaban Medical Valley to prevent blood clots after hip or knee replacement surgery.

Common side effects (may occur in not more than 1 in 10 people):

  • anaemia, which may cause fatigue or paleness;
  • bleeding including:
    • subcutaneous haemorrhages (bruising) and swelling;
  • nausea (feeling sick).

Uncommon side effects (may occur in not more than 1 in 100 people):

  • reduced platelet count (which may affect blood clotting);
  • bleeding:
    • after surgery, including bruising and swelling, leakage of blood or other fluid from the surgical wound/incision (wound discharge) or injection site;
  • from stomach, intestines, or bright red blood in stool;
  • blood in urine;
  • nosebleeds;
  • vaginal bleeding;
    • low blood pressure, which may lead to fainting or rapid heartbeat;
    • blood tests may show:
  • liver function abnormalities;
  • increased activity of certain liver enzymes;
  • increased bilirubin levels, resulting from breakdown of red blood cells, which may cause yellowing of the skin and eyes;
    • itching.

Rare side effects (may occur in not 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 presence of blood in sputum when coughing;
    • from rectum;
  • hair loss.

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

  • bleeding:
    • into the brain or spinal cord;
    • in the lungs or throat;
    • in the mouth;
    • into the abdominal cavity or into the space behind the abdominal cavity (retroperitoneal space);
    • from haemorrhoids;
    • test results indicating presence of blood in stool or urine;
  • 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, round spots beneath the skin surface or bruising;
  • bleeding in the kidney, sometimes with blood in urine, leading to impaired kidney function (anticoagulant-related nephropathy).

The following side effects may occur when taking Apixaban Medical Valley 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 not more than 1 in 10 people):

  • bleeding, including:
    • into eyes;
    • into stomach or intestine;
    • from rectum;
    • blood in urine;
    • nosebleeds;
    • from gums;
    • subcutaneous haemorrhages (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 show:
    • increased gamma-glutamyl transferase (GGT) activity.

Uncommon side effects (may occur in not more than 1 in 100 people):

  • bleeding:
    • into brain or spinal cord;
    • in mouth or presence of blood in sputum when coughing;
    • into abdominal cavity or from vagina;
    • bright red blood in stool;
    • after surgery, including bruising and swelling, leakage of blood or other fluid from surgical wound/incision (wound discharge) or injection site;
    • from haemorrhoids;
    • test results indicating presence of blood in stool or urine;
  • reduced platelet count (which may affect clotting);
  • blood test results may show:
    • abnormal liver function;
    • increased activity of certain liver enzymes;
    • increased bilirubin levels resulting from breakdown of red blood cells, which may cause yellowing of skin and eyes;
  • 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, contact your doctor immediately.

Rare side effects (may occur in not more than 1 in 1000 people):

  • bleeding:
    • in lungs or throat;
    • into retroperitoneal space;
    • into muscle.

Very rare side effects (may occur in not 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, round spots beneath the skin surface or bruising;
  • bleeding in the kidney, sometimes with blood in urine, leading to impaired kidney function (anticoagulant-related nephropathy).

The following side effects may occur when taking Apixaban Medical Valley for the treatment or prevention of 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 not more than 1 in 10 people):

  • bleeding, including:
    • nosebleeds;
    • from gums;
    • blood in urine;
    • subcutaneous haemorrhages (bruising) and swelling;
    • into stomach, intestine, or from rectum;
    • in mouth;
    • from vagina;
    • anaemia, which may cause fatigue or paleness;
    • reduced platelet count (which may affect clotting);
    • nausea (feeling sick);
    • skin rash;
    • blood test results may show:
  • increased gamma-glutamyl transferase (GGT) or alanine aminotransferase (AlAT) activity.

Uncommon side effects (may occur in not more than 1 in 100 people):

  • low blood pressure, which may lead to fainting or rapid heartbeat;
  • bleeding:
    • into eyes;
    • in mouth or presence of blood in sputum when coughing;
    • bright red blood in stool;
    • test results indicating blood in stool or urine;
    • after surgery, including bruising and swelling, leakage of blood or other fluid from surgical wound/incision (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, contact your doctor immediately.
  • blood test results may show:
    • abnormal liver function;
    • increased activity of certain liver enzymes, increased bilirubin levels resulting from breakdown of red blood cells, which may cause yellowing of skin and eyes.

Rare side effects (may occur in not more than 1 in 1000 people):

  • bleeding:
    • into brain or spinal cord;
    • 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 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, round spots beneath the skin surface, or bruising;
  • bleeding in the kidney, sometimes with blood in urine, leading to impaired kidney function (anticoagulant-related nephropathy).

Additional side effects in children and adolescents
Contact your doctor immediately if a child experiences any of the following symptoms:

  • Allergic reactions (hypersensitivity), which may cause: swelling of the face, lips, mouth, tongue and (or) throat, and breathing difficulties. These side effects are common (may occur in not more than 1 in 10 people).

In general, side effects observed in children and adolescents treated with Apixaban Medical Valley were similar to those in adults, and their severity was mild or moderate. Side effects observed more frequently in children and adolescents included nosebleeds and abnormal vaginal bleeding.

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

  • bleeding, including:
    • from vagina;
    • nosebleeds.

Common side effects (may occur in not more than 1 in 10 people):

  • bleeding, including:
    • from gums;
    • blood in urine;
    • subcutaneous haemorrhages (bruising) and swelling;
    • into intestine or from rectum;
    • bright red blood in stool;
    • after surgery, including bruising and swelling, leakage of blood or other fluid from surgical wound/incision (wound discharge) or injection site;
  • hair loss;
  • anaemia, which may cause fatigue or paleness;
  • reduced platelet count in the child (which may affect clotting);
  • nausea (feeling sick);
  • skin rash;
  • itching;
  • low blood pressure, which may lead to fainting or rapid heartbeat in the child;
  • blood test results may show:
    • liver function abnormalities;
    • increased activity of certain liver enzymes;
    • increased alanine aminotransferase (AlAT) activity.

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

  • bleeding:

    • into abdominal cavity or retroperitoneal space;
    • into stomach;
    • into eyes;
    • in mouth or presence of blood in sputum when coughing;
    • from haemorrhoids;
    • into brain or spinal cord;
    • in lungs;
    • into 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 (inflammation of blood vessels), which may cause skin rash or raised, flat, red, round spots beneath the skin surface or bruising.

  • blood test results may show:

    • increased gamma-glutamyl transferase (GGT) activity;
    • presence of blood in stool or urine.

  • bleeding in the kidney, sometimes with blood in urine, leading to impaired kidney function (anticoagulant-related nephropathy).

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 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 responsible entity.
By reporting side effects, you help provide more information on the safety of this medicine.

5. How to store Apixaban Medical Valley

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton 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. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Apixaban Medical Valley contains

  • The active substance is apixaban. Each tablet contains 2.5 mg of apixaban.
  • The other ingredients are:
    Tablet core: microcrystalline cellulose, anhydrous lactose (see section 2 "Apixaban Medical Valley contains lactose (a type of sugar) and sodium"), sodium lauryl sulfate, sodium croscarmellose, magnesium stearate;
    Tablet coating: hypromellose (E 464), monohydrate lactose (see section 2 "Apixaban Medical Valley contains lactose (a type of sugar) and sodium"), titanium dioxide (E 171), triacetin, yellow iron oxide (E 172).

What Apixaban Medical Valley looks like and contents of the pack
Yellow, biconvex, film-coated tablets with a diameter of approximately 6 mm.
The tablets are packed in blisters made of PCV/PVDC/Aluminium, PVC/PE/PVDC/Aluminium blisters, or in HDPE bottles, all contained in a cardboard box.
Pack sizes:
Blisters: 10, 20, 21, 56 or 60 film-coated tablets;
HDPE bottle: 56, 60, 63, 70, 168, 200, 210 or 500 film-coated tablets;
Not all pack sizes may be marketed.

Patient Alert Card: information for users
Inside the packaging of Apixaban Medical Valley, in addition to the package leaflet, a Patient Alert Card is included, or the treating physician will provide the patient with a similar card.
The Patient Alert Card contains helpful information for the patient and warns other physicians that the patient is taking Apixaban Medical Valley. You should always carry this card with you.

  1. Take the card.
  2. If necessary, separate the section with the appropriate language (perforated edges make this easier).
  3. Fill in the following details, or ask your doctor to complete them:
    • Name:
    • Date of birth:
    • Indication for use of the medicine
    • Dose: mg twice daily
    • Doctor's name:
    • Doctor's telephone number:
  4. Fold the card and always carry it with you.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Medical Valley Invest AB
Brädgårdsvägen 28
236 32 Höllviken
Sweden
email: [email protected]

Manufacturer
Laboratorios Liconsa S.A.
Avenida De Miralcampo 7
Poligono Industrial Miralcampo
Azuqueca De Henares
19200 Guadalajara
Spain
Zentiva S.A.
Bulevardul Pallady Theodor Nr 50
032266 Bucharest
Romania

This medicinal product is authorised in the European Economic Area member states under the following names:
Denmark Apixaban Medical Valley
Netherlands Apixaban Xiromed 2.5 mg filmomhulde tabletten
Iceland Apixaban Medical Valley
Germany Apixaban AXiromed 2.5 mg Filmtabletten
Norway Apixaban Medical Valley
Poland Apixaban Medical Valley
Sweden Apixaban Medical Valley