Apixaban medical valley

Package leaflet: Information for the user

Apixaban Medical Valley, 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, as you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

1. What Apixaban Medical Valley is and what it is 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 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 called 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 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 flow to these organs (also known as systemic embolism). 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 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 age 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 has 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 arterial catheter in place and heparin is administered through this catheter to maintain its patency, or when the patient has a venous 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 disorders, including conditions leading to 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 liver function abnormalities;
• a tube (catheter) or injection into the spine (anaesthetic or pain relief), in which case the doctor will advise taking this medicine 5 or more hours after removal of the catheter;
• if the patient has a heart valve prosthesis;
• if the doctor considers the patient’s blood pressure to be unstable or if another treatment or surgical procedure to remove a blood clot from the lungs is planned.

When to exercise particular caution when using Apixaban Medical Valley

• if the patient has a disorder called 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, ask the
doctor.
Children and adolescents
This medicine is not recommended for use in children and adolescents with body weight less than 35 kg.
Apixaban Medical Valley 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 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 and 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 is planning 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. The patient should consult her doctor, pharmacist or nurse before taking 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
It has not been established that Apixaban Medical Valley affects the ability to drive
and 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 the 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 exactly as directed by your doctor or pharmacist. If you have any doubts,
you should consult your doctor, pharmacist, or nurse.
Dosage
The tablet should be swallowed with water. Apixaban Medical Valley may 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 the tablets whole, they should discuss alternative methods of taking
Apixaban Medical Valley with their doctor. The tablet may be crushed immediately before administration
and mixed with water or 5% glucose solution, juice, or apple puree.
Instructions for crushing tablets:

• Crush the tablet with a pestle in a mortar.
• 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.
• Swallow (drink) the resulting mixture.
• Rinse the pestle and mortar used to crush the tablets, as well as the container, with a small amount of water or another liquid (e.g., 30 mL), then swallow (drink) the rinsing liquid.

If necessary, your doctor may administer crushed Apixaban Medical Valley tablets mixed with 60 mL of
water or 5% glucose solution through a nasogastric tube.
Apixaban Medical Valley should be taken as directed for the following indications:
Prevention of blood clots in the heart in patients with irregular heartbeat and at least one additional
risk factor
The recommended dose is one tablet of Apixaban Medical Valley 5 mg twice daily.
The recommended dose is one tablet of Apixaban Medical Valley 2.5 mg 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 level of 1.5 mg/dL (133 micromoles/L) or higher);
• the patient is 80 years of age or older;
• the patient's body weight is 60 kg or less.

The recommended dose is one tablet twice daily, for example, one tablet in the morning and one in the
evening. Your doctor will decide how long treatment should continue.
Treatment of blood clots in the deep veins of the legs and blood clots in the blood vessels of the lungs
The recommended dose is two tablets of Apixaban Medical Valley 5 mg twice daily for the first 7 days,
for example, two tablets in the morning and two in the evening.
After 7 days, the recommended dose is one tablet of Apixaban Medical Valley 5 mg twice daily, for
example, one tablet in the morning and one in the evening.
Prevention of recurrent blood clots after completion of 6-month treatment
The recommended dose is one tablet of Apixaban Medical Valley 2.5 mg twice daily, for example, one
tablet in the morning and one in the evening.
Your doctor will decide how long treatment should continue.
Use in children and adolescents
Treatment of blood clots and prevention of recurrent blood clots in veins or in the blood vessels of the lungs.
This medicine should always be taken or administered exactly as directed by your doctor or pharmacist.
If you have any doubts, 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 two tablets
of Apixaban Medical Valley 5 mg administered twice daily for the first 7 days, for example, two tablets
in the morning and two in the evening. After 7 days, the recommended dose is one tablet of Apixaban
Medical Valley 5 mg administered twice daily, for example, one tablet in the morning and one in the
evening.
Advice for parents and caregivers: observe the child and ensure they take 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 treatment as follows:

• Switching from Apixaban Medical Valley to other anticoagulant medicines Discontinue taking Apixaban Medical Valley. Start treatment with anticoagulant medicines (e.g., heparin) at the time the next tablet was scheduled to be taken.
• Switching from anticoagulant medicines to Apixaban Medical Valley Discontinue taking anticoagulant medicines. Begin treatment with Apixaban Medical Valley at the time the next anticoagulant dose was scheduled, then continue regular dosing.
• Switching from anticoagulant treatment 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 treatment 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 the times specified by their doctor to prevent the formation of blood clots in the brain's
blood vessels and in other blood vessels throughout 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 is empty.
If a patient has taken more than the recommended dose of Apixaban Medical Valley, the risk of bleeding may
be increased. In case of bleeding, surgical treatment, blood transfusion, or other treatments that reverse
the effect of factor Xa inhibitors may be necessary.
Missed dose of Apixaban Medical Valley

• If a 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 a patient misses the evening dose, it may only be taken the same evening. Do not take a double dose the next morning; instead, continue taking the medicine as directed the next day, twice daily.

If you have any doubts about using the medicine or if you miss more than one dose, you should consult your
doctor, pharmacist, or nurse.
Stopping Apixaban Medical Valley
Do not stop taking this medicine without consulting your doctor, as stopping treatment prematurely may
increase the risk of developing blood clots.
If you have any further doubts about using this medicine, you should consult your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like any medicine, this medicine can cause adverse effects, although they do not occur in everyone.
The most common general adverse effect of this medicine is bleeding, which may potentially
be life-threatening and may require immediate medical attention.
The following adverse effects may occur when taking Apixaban Medical Valley to prevent blood clots
in the heart in patients with irregular heartbeat and at least one additional risk factor.
Common adverse effects (may occur in up to 1 in 10 people):

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

Uncommon adverse effects (may occur in up to 1 in 100 people):

• bleeding:
  • into the brain or spinal canal;
  • in the mouth or presence of blood in sputum when coughing;
  • into the abdominal cavity or from the vagina;
  • bright red blood in stool;
  • after surgery, including bruising and swelling, leakage of blood or other fluid from the surgical wound/incision (wound discharge) or injection site;
  • from haemorrhoids;
  • test results indicating presence of blood in stool or urine;
• decreased platelet count (which may affect blood clotting);
• blood test results may indicate:
  • abnormal liver function;
• 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;
  • skin rash;
  • itching;
  • hair loss;
  • allergic reactions (hypersensitivity), which may cause swelling of the face, lips, mouth, tongue and/or throat, and breathing difficulties. If any of these symptoms occur, seek immediate medical advice.

Rare adverse effects (may occur in up to 1 in 1,000 people):

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

Very rare adverse effects (may occur in up to 1 in 10,000 people):

• skin rash, with blister formation, resembling small bullseyes (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 under the skin surface or bruising;
• bleeding in the kidney, sometimes with blood in urine, leading to impaired kidney function (anticoagulant-related nephropathy).

The following adverse effects may occur when taking Apixaban Medical Valley for the treatment or prevention of recurrent venous blood clots in the lower limbs and blood clots in blood vessels of the lungs.
Common adverse effects (may occur in up to 1 in 10 people):

• bleeding, including:
  • nosebleeds;
  • bleeding from gums;
  • blood in urine;
  • subcutaneous haemorrhages (bruising) and swelling;
  • into the stomach, intestine or from the rectum;
  • in the mouth;
  • from the 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-glutamyl transferase (GGT) or alanine aminotransferase (AlAT) activity.

Uncommon adverse effects (may occur in up to 1 in 100 people):

• low blood pressure, which may lead to fainting or rapid heartbeat;
• bleeding:
  • into the eyes;
• in the 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 the 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, seek immediate medical advice.
  • blood test results may indicate:
• abnormal liver function;
• 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.

Rare adverse effects (may occur in up to 1 in 1,000 people):

• bleeding:
  • into the brain or spinal canal;
  • in the lungs.

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

• bleeding into the abdominal cavity or retroperitoneal space;
• skin rash, with blister formation, resembling small bullseyes (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 under the skin surface, or bruising;
• bleeding in the kidney, sometimes with blood in urine, leading to impaired kidney function (anticoagulant-related nephropathy).

Additional adverse effects in children and adolescents
Seek immediate medical advice if a child develops 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 adverse effects are common (may occur in up to 1 in 10 people).

In general, adverse effects observed in children and adolescents treated with Apixaban Medical Valley were similar to those in adults, and their severity was mild or moderate. Adverse effects observed more frequently in children and adolescents included nosebleeds and abnormal vaginal bleeding.
Very common adverse effects (may occur in more than 1 in 10 people):

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

Common (may occur in up to 1 in 10 people):

• bleeding, including:
  • from gums;
• blood in urine;
• subcutaneous haemorrhages (bruising) and swelling;
• into the intestine or from the rectum;
• bright red blood in stool;
• after surgery, including bruising and swelling, leakage of blood or other fluid from the surgical wound/incision (wound discharge) or injection site;
  • hair loss;
  • anaemia, which may cause fatigue or paleness;
  • decreased 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 indicate:
• liver function disorders;
• increased activity of certain liver enzymes;
• increased alanine aminotransferase (AlAT) activity.

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

• bleeding:
  • into the abdominal cavity or retroperitoneal space;
  • into the stomach;
  • into the eyes;
  • in the mouth or presence of blood in sputum when coughing;
  • from haemorrhoids;
  • into the brain or spinal canal;
  • in the lungs;
  • into muscles;
• skin rash, with blister formation, resembling small bullseyes (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 under the skin surface or bruising.
• blood test results may indicate:
  • 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 adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring of 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
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps provide more information on the safety of the medicine.

5. How to store Apixaban Medical Valley

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and carton after "EXP". The expiry date refers to the last day of the stated month.
No special storage instructions apply.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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, iron oxide red (E 172).

What Apixaban Medical Valley looks like and contents of the pack
Pink, oval film-coated tablets of approximately 10 x 5 mm in size.
The tablets are packed in blisters made of PCV/PVDC/Aluminium, PVC/PE/PVDC/Aluminium foil blisters, or in HDPE bottles, all contained in a cardboard box.
Pack sizes:
Blister packs: 16, 20, 32, 56, 60 and 120 film-coated tablets;
HDPE bottles: 56, 60, 63, 70, 112, 168, 200, 210 or 500 film-coated tablets;
Not all pack sizes may be marketed.

Patient Warning Card: information for use
Inside the Apixaban Medical Valley packaging, in addition to the patient leaflet, there is a Patient Warning Card, or the treating physician will provide the patient with a similar card.
The Patient Warning 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 of the card in the appropriate language (perforated edges make this easier).
3. Complete the following sections, or ask your doctor to complete them:
   • First name and surname:
   • 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 countries under the following names:
Denmark Apixaban Medical Valley
Netherlands Apixaban Xiromed 5 mg filmomhulde tabletten
Iceland Apixaban Medical Valley
Germany Apixaban AXiromed 5 mg Filmtabletten
Norway Apixaban Medical Valley
Poland Apixaban Medical Valley
Sweden Apixaban Medical Valley