Apixaban Medical Vallei

Leaflet attached to the packaging: information for the user

Apixaban Medical Valley, 5 mg, coated tablets

Apixabanum

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

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

Table of contents of the leaflet

• 1. What is Apixaban Medical Valley and what is it used for
• 2. Important information 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 is Apixaban Medical Valley and what is it used for

Apixaban Medical Valley contains the active substance apixaban and belongs to a group of medicines called anticoagulants. This medicine helps prevent the formation of blood clots by blocking factor Xa, which is an important element in the blood clotting process.
Apixaban Medical Valley is used in adults:

• 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 can break loose and travel to the brain, leading to a stroke, or to other organs, hindering blood flow to these organs (also known as systemic embolism). A stroke can be life-threatening and requires immediate medical attention.
• to treat blood clots in the veins of the lower limbs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism), as well as to prevent the recurrence of blood clots in the blood vessels of the lower limbs and/or lungs.

Apixaban Medical Valley is used in children from 28 days of age to less than 18 years
to treat blood clots and prevent the recurrence of blood clots in the veins or
in the blood vessels of the lungs.
The recommended dose depends on body weight, see section 3.

2. Important information before taking Apixaban Medical Valley

When not to take Apixaban Medical Valley

• if the patient is allergicto apixaban or any of the other ingredients of this medicine

(listed in section 6);

• if the patient has excessive bleeding;
• if the patient has organ diseasethat increases the risk of severe bleeding (such as active or recently diagnosed stomach or intestinal ulcers, recent bleeding in the brain);
• if the patient has liver diseasethat leads to an increased risk of bleeding (hepatic coagulopathy);
• if the patient is taking medicines that prevent blood clotting(e.g., warfarin, rivaroxaban, dabigatran, or heparin), except in situations where the anticoagulant treatment is changed, when the patient has an intravenous or intra-arterial catheter and heparin is administered through this catheter to maintain its patency or when the patient has a catheter inserted into a vein (is undergoing catheter ablation) due to irregular heartbeat (arrhythmia).

Warnings and precautions

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

• increased risk of bleeding, for example:
• bleeding disorders, including conditions that result in decreased platelet activity;
• very high blood pressure, uncontrolled with medication;
• if the patient is over 75 years old;
• if the patient's body weight is 60 kg or less;
• severe kidney disease or if the patient is on dialysis;
• liver disease or a history of liver disease
• this medicine should be used with caution in patients with signs of liver function changes;
• if the patient has a prosthetic heart valve;
• if the doctor considers that the patient's blood pressure is unstable or if other treatment or surgery is planned to remove a blood clot from the lungs.

When to be particularly careful when taking Apixaban Medical Valley

• if the patient has a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), the patient should tell their doctor, who will decide whether to change the treatment.

In case of surgery or a procedure that may cause bleeding,
the doctor may ask the patient to temporarily stop taking this medicine for a short time.
If there is any doubt whether a particular procedure may cause bleeding, the patient should ask their doctor.

Children and adolescents

This medicine is not recommended for use in children and adolescents with a body weight of less than 35 kg.

Apixaban Medical Valley and other medicines

The patient should tell their doctor, pharmacist, or nurse about all medicines they are taking or have recently taken, as well as any medicines they plan to take.
Some medicines may enhance the effect of Apixaban Medical Valley, and some 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 they should be monitored.
The following medicines may enhance the effect of Apixaban Medical Valley 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). This is especially true for patients over 75 years old and taking acetylsalicylic acid, who may be at increased risk of unwanted bleeding;
• medicines used to treat high blood pressure or heart problems(e.g., diltiazem);
• antidepressant medicinescalled selective serotonin reuptake inhibitorsor serotonin and noradrenaline reuptake inhibitors.

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

• medicines used to prevent seizures or fits(e.g., phenytoin and others);
• St. John's Wort(a herbal supplement used in depression);
• medicines used to treat tuberculosis or other infections(e.g., rifampicin).

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor, pharmacist, or nurse before taking this medicine.
The effect of 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, they should contact their doctor immediately.
It is not known whether Apixaban Medical Valley passes into breast milk. Before taking this medicine during breastfeeding, the patient should consult their doctor, pharmacist, or nurse. The patient may be advised to stop breastfeeding or stop/not start taking this medicine.

Driving and using machines

It has not been found that Apixaban Medical Valley affects the ability to drive and use machines.

Apixaban Medical Valley contains lactose (a type of sugar) and sodium

If the patient has previously been found to have intolerance to some sugars, they should contact their doctor before taking the medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Apixaban Medical Valley

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

Dose

The tablet should be swallowed with water. Apixaban Medical Valley can be taken with or without food. To achieve the best treatment results, it is recommended to take the tablets at the same time every day.
If the patient has problems swallowing the tablets whole, they should discuss this with their doctor. The tablet can be crushed just before taking and mixed with water or a 5% aqueous solution of glucose, juice, or apple puree.

Instructions for crushing tablets:

• The tablet should be crushed with a pestle in a mortar.
• Carefully transfer all the powder to a suitable container, then mix it with a small amount, e.g., 30 mL (2 tablespoons), of water or another liquid mentioned above to prepare a mixture.
• The resulting mixture should be swallowed (drunk).
• The pestle and mortar used to crush the tablets and the container should be rinsed with a small amount of water or another liquid (e.g., 30 mL) and then swallowed (drunk).

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

Apixaban Medical Valley should be taken as recommended in the following indications:

Prevention of blood clot formation in the heart in patients with irregular heartbeat and at least one additional risk factor
The recommended dose is one 5 mg Apixaban Medical Valley tablet twice a day.
The recommended dose is one 2.5 mg Apixaban Medical Valley tablet twice a day if:

• the patient has severe kidney function disorders
• two or more of the following conditions are met:
• the patient's blood test results indicate decreased kidney function (serum creatinine level of 1.5 mg/dL (133 micromoles/L) or more);
• the patient is 80 years old or more;
• the patient's body weight is 60 kg or less.

The recommended dose is one tablet twice a day, for example, one tablet in the morning and one in the evening. The doctor will decide how long the treatment should be continued.
Treatment of blood clots in the veins of the lower limbs and blood clots in the blood vessels of the lungs
The recommended dose is two5 mg Apixaban Medical Valley tablets twice a day for the first 7 days, for example, two tablets in the morning and two in the evening.
After 7 days, the recommended dose is one5 mg Apixaban Medical Valley tablet twice a day, 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 2.5 mg Apixaban Medical Valley tablet twice a day, for example, one tablet in the morning and one in the evening.
The doctor will decide how long the treatment should be continued.
Use in children and adolescents
Treatment of blood clots and prevention of recurrence of blood clots in the veins or
in the blood vessels of the lungs.
This medicine should always be taken or administered as recommended by the doctor or pharmacist. In case of doubts, the patient should consult their doctor, pharmacist, or nurse.
To achieve the best treatment results, the dose should be taken or administered at the same time every day.
The dose of Apixaban Medical Valley depends on body weight and will be calculated by the doctor.
The recommended dose for children and adolescents with a body weight of at least 35 kg is two5 mg Apixaban Medical Valley tablets administered twice a day for the first 7 days, for example, two tablets in the morning and two tablets in the evening. After 7 days, the recommended dose is one5 mg Apixaban Medical Valley tablet administered twice a day, for example, one tablet in the morning and one tablet in the evening.
Recommendations for parents and caregivers: they should observe the child and ensure that they have taken the full dose.
It is essential to follow the doctor's recommendations for follow-up visits, as changes in the patient's body weight may require dose adjustments.

The doctor may change the anticoagulant treatment as follows:

• -Changing from Apixaban Medical Valley to anticoagulant medicinesThe patient should stop taking Apixaban Medical Valley. Treatment with anticoagulant medicines (e.g., heparin) should be started at the time of the scheduled intake of the next Apixaban Medical Valley tablet.
• -Changing from anticoagulant medicines to Apixaban Medical ValleyThe patient should stop taking anticoagulant medicines. Treatment with Apixaban Medical Valley should be started at the time of the scheduled intake of the next dose of anticoagulant medicine, and then continued as usual.
• -Changing from treatment with a vitamin K antagonist (e.g., warfarin) to Apixaban Medical ValleyThe patient should stop taking the vitamin K antagonist. The doctor will order a blood test and inform the patient when to start taking Apixaban Medical Valley.
• Changing from Apixaban Medical Valley to treatment with a vitamin K antagonist (e.g., warfarin)If the doctor informs the patient that they should start taking a vitamin K antagonist, the patient should continue taking Apixaban Medical Valley for at least 2 days after taking the first dose of the vitamin K antagonist. The doctor will order a blood test and inform the patient when to stop taking Apixaban Medical Valley.

Patients undergoing cardioversion

Patients with irregular heartbeat who require a cardioversion procedure to restore a 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 a higher dose of Apixaban Medical Valley than recommended

If the patient has taken a higher dose of this medicine than recommended, they should immediately inform their doctor.
The patient should take the packaging of the medicine with them, even if there are no more tablets left.
If the patient has taken a higher dose of Apixaban Medical Valley than recommended, they may be at increased risk of bleeding. In case of bleeding, surgical treatment, blood transfusion, or other treatment to reverse the effect of factor Xa inhibition 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, and the missed morning dose can be taken with the evening dose.
• If the patient misses the evening dose, they can take it only on the same evening. The patient should not take a double dose the next morning, but instead continue taking the medicine as recommended, twice a day.

In case of doubts about taking the medicine or missing more than

one dose, the patient should consult their doctor, pharmacist, or nurse.

Stopping Apixaban Medical Valley

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

4. Possible side effects

Like all medicines, Apixaban Medical Valley can cause side effects, although not everybody gets them.
The most common general side effect of this medicine is bleeding, which can be life-threatening and may require immediate medical attention.
The following side effects may occur when taking Apixaban Medical Valley to prevent blood clot formation in the heart in patients with irregular heartbeat and at least one additional risk factor.

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

• bleeding, including:
• in the eyes;
• in the stomach or intestines;
• from the rectum;
• blood in the urine;
• from the nose;
• from the gums;
• bruises and swelling;
• anemia, which can cause fatigue or pallor;
• low blood pressure, which can lead to fainting or rapid heartbeat;
• nausea (vomiting);
• blood test results may indicate:
• increased activity of gamma-glutamyltransferase (GGT).

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

• bleeding:
• in the brain or spinal cord;
• in the mouth or presence of blood in sputum when coughing;
• in the abdominal cavity or in the space behind the abdominal cavity;
• bright red blood in the stool;
• after surgery, including bruising and swelling, bleeding or other fluid leakage from the surgical wound/incision or injection site;
• from hemorrhoids;
• into the muscle.
• decreased platelet count (which can affect blood clotting);
• blood test results may indicate:
• abnormal liver function;
• increased activity of certain liver enzymes;
• increased bilirubin levels resulting from the breakdown of 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/or throat, as well as difficulty breathing. If any of these symptoms occur, the patient should contact their doctor immediately.

Rare side effects (may affect up to 1 in 1000 people):

• bleeding:
• in the lungs or throat;
• in the space behind the abdominal cavity;
• into the muscle.

Very rare side effects (may affect up to 1 in 10,000 people):

• a skin rash that can cause blisters and resembles small targets (dark spots in the center surrounded by a lighter border, with a dark ring around the edge) (erythema multiforme).

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

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

The following side effects may occur when taking Apixaban Medical Valley to treat or prevent the recurrence of blood clots in the veins of the lower limbs 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;
• from the gums;
• blood in the urine;
• bruises and swelling;
• in the stomach, intestines, or rectum;
• in the mouth;
• from the vagina;
• anemia, which can cause fatigue or pallor;
• decreased platelet count (which can affect blood clotting);
• nausea (vomiting);
• skin rash;
• blood test results may indicate:
• 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 rapid heartbeat;
• bleeding:
• in the eyes,
• in the mouth or presence of blood in sputum when coughing;
• bright red blood in the stool;
• blood test results indicating the presence of blood in the stool or urine;
• after surgery, including bruising and swelling, bleeding or other fluid leakage from the surgical wound/incision or injection site;
• from hemorrhoids;
• into the muscle;
• itching;
• hair loss;
• allergic reactions (hypersensitivity), which can cause swelling of the face, lips, mouth, tongue, and/or throat, as well as difficulty breathing. If any of these symptoms occur, the patient should contact their doctor immediately;
• blood test results may indicate:
• abnormal liver function;
• increased activity of certain liver enzymes, increased bilirubin levels resulting from the breakdown of red blood cells, which can cause yellowing of the skin and eyes.

Rare side effects (may affect up to 1 in 1000 people):

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

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

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

Additional side effects in children and adolescents
The patient should immediately inform their doctor if their child experiences any of the following symptoms:

• Allergic reactions (hypersensitivity), which can cause swelling of the face, lips, mouth, tongue, and/or throat, as well as difficulty breathing. These side effects are common (may affect up to 1 in 10 people).

Generally, the 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. The side effects observed more frequently in children and adolescents were nosebleeds and abnormal vaginal bleeding.

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

• bleeding, including:
• from the vagina;
• from the nose.

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

• bleeding, including:
• from the gums;
• blood in the urine;
• bruises and swelling;
• in the intestines or rectum;
• bright red blood in the stool;
• after surgery, including bruising and swelling, bleeding or other fluid leakage from the surgical wound/incision or injection site;
• hair loss;
• anemia, which can cause fatigue or pallor;
• decreased platelet count in the child's blood (which can affect blood clotting);
• nausea (vomiting);
• skin rash;
• itching;
• low blood pressure, which can lead to fainting or rapid heartbeat in the child;
• blood test results may indicate:
• liver function disorders;
• increased activity of certain liver enzymes;
• increased activity of alanine aminotransferase (ALT).

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

• Bleeding:
• into the abdominal cavity or into the space behind the abdominal cavity;
• into the stomach;
• in the eyes;
• in the mouth or presence of blood in sputum when coughing;
• from hemorrhoids;
• in the brain or spinal cord;
• in the lungs;
• into the muscle;
• a skin rash that can cause blisters and resembles small targets (dark spots in the center surrounded by a lighter border, with a dark ring around the edge) (erythema multiforme);
• vasculitis (inflammation of blood vessels), which can cause skin rash or raised, flat, red, round patches under the skin surface, or bruising.
• Blood test results may indicate:
• increased activity of gamma-glutamyltransferase (GGT);
• presence of blood in the stool or urine.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, 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 marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Apixaban Medical Valley

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

6. Contents of the pack and other information

What Apixaban Medical Valley contains

• The active substance of the medicine 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, croscarmellose sodium, magnesium stearate; Tablet coating: hypromellose (E 464), lactose monohydrate(see section 2 "Apixaban Medical Valley contains lactose (a type of sugar) and sodium"), titanium dioxide (E 171), triacetin, iron oxide red (E 172).

What Apixaban Medical Valley looks like and contents of the pack

Pink, oval, coated tablets, approximately 10 x 5 mm in size.
The tablets are packaged in PVC/PE/PVDC/Aluminum or PVC/PE/PVDC/Aluminum blisters or HDPE bottles in a cardboard box.
Pack sizes:
Blisters: 16, 20, 32, 56, 60, and 120 coated tablets;
HDPE bottle: 56, 60, 63, 70, 112, 168, 200, 210, or 500 coated tablets;
Not all pack sizes may be marketed.

Patient Alert Card: information for use

Inside the packaging of Apixaban Medical Valley, in addition to the patient information leaflet, there is a Patient Alert Card or the doctor will provide the patient with a similar card.
The Patient Alert Card contains information that is useful for the patient and warns other doctors that the patient is taking Apixaban Medical Valley. The patient should always carry this card with them.

• 1. Take the card.
• 2. If necessary, separate the card with the correct language (the perforated edges of the card will facilitate this).
• 3. Fill in the following points or ask the doctor to fill them in:
• Name and surname:
• Date of birth:
• Indication for use
• Dose: mg twice a day
• Doctor's name:
• Doctor's phone number:
• 4. Fold the card and always carry it with you.

Marketing authorization holder and manufacturer

Marketing authorization holder

Medical Valley Invest AB
Brädgårdsvägen 28
236 32 Höllviken
Sweden
email: safety@medicalvalley.se

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

Denmark
Apixaban Medical Valley
Netherlands
Apixaban Xiromed 5 mg film-coated tablets
Iceland
Apixaban Medical Valley
Germany
Apixaban AXiromed 5 mg film-coated tablets
Norway
Apixaban Medical Valley
Poland
Apixaban Medical Valley
Sweden
Apixaban Medical Valley

Date of last revision of the leaflet: