Apixaban sandoz
Poland
Table of Contents
Package leaflet: Information for the patient
Apixaban Sandoz, 5 mg, film-coated tablets
Apixabanum
Read the entire leaflet before using this medicine, as it contains important information
for the patient.
Keep this leaflet so that you can read it again if necessary.
If you have any questions, please consult 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 another person, even if their symptoms are the same.
If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse.
See section 4.
Table of contents
- What Apixaban Sandoz is and what it is used for
- What you need to know before taking Apixaban Sandoz
- How to take Apixaban Sandoz
- Possible side effects
- How to store Apixaban Sandoz
- Contents of the pack and other information
1. What Apixaban Sandoz is and what it is used for
Apixaban Sandoz 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.
This medicine is used in adults:
- to prevent blood clots forming 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 stroke, or to other organs, impairing blood flow 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.
2. Important information before using Apixaban Sandoz
When not to use Apixaban Sandoz
- 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 an organ disease that increases the risk of serious bleeding (such as active or recently diagnosed stomach or intestinal ulcer, or recent intracranial bleeding);
- if the patient has a liver disease leading to increased risk of bleeding (hepatic coagulopathy);
- if the patient is taking anticoagulant medicines (such as warfarin, rivaroxaban, dabigatran or heparin), except in situations of switching anticoagulant therapy, when the patient has an intravenous or intra-arterial line 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, discuss with your doctor, pharmacist or nurse if:
- the patient has an increased risk of bleeding, for example:
- conditions associated with bleeding, including those resulting in 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;
- the patient has severe kidney disease or is on dialysis;
- the patient has liver disease or a history of liver disease; This medicine should be used with caution in patients showing signs of liver function abnormalities.
- the patient has a heart valve prosthesis;
- the doctor determines that the patient's blood pressure is unstable or other treatment or a surgical procedure to remove a blood clot from the lungs is planned.
When to exercise particular caution when using Apixaban Sandoz
- if the patient has a disorder called antiphospholipid syndrome (an immune system disorder causing increased risk of blood clots), the patient should inform their doctor, who will decide whether treatment adjustment is necessary.
- if surgery or a procedure associated with bleeding risk is required, the doctor may ask the patient to temporarily stop taking this medicine for a short period. If unsure whether a given procedure may involve bleeding risk, consult the doctor.
Children and adolescents
Apixaban Sandoz is not recommended for patients under 18 years of age.
Apixaban Sandoz with 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 Sandoz, while others may reduce its effect.
The doctor will decide whether the patient should receive Apixaban Sandoz while taking other medicines and how closely monitoring should be performed.
The following medicines may enhance the effect of Apixaban Sandoz and increase the risk of
unwanted bleeding:
- certain antifungal medicines (such as ketoconazole and others);
- certain antiviral medicines used to treat HIV/AIDS infection (such as ritonavir);
- other medicines used to reduce blood clotting (such as enoxaparin and others);
- anti-inflammatory or pain-relieving medicines (such as acetylsalicylic acid or naproxen); particularly when the patient is over 75 years old and taking acetylsalicylic acid, the risk of unwanted bleeding may be increased;
- medicines used for high blood pressure or heart problems (such as diltiazem);
- antidepressant medicines known as selective serotonin reuptake inhibitors or serotonin and noradrenaline reuptake inhibitors.
The following medicines may reduce the ability of Apixaban Sandoz to prevent clot formation:
- antiepileptic or anticonvulsant medicines (such as phenytoin and others);
- St. John’s wort (an herbal supplement used for depression);
- medicines used to treat tuberculosis or other infections (such as rifampicin).
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult her doctor, pharmacist or nurse before using this medicine.
The effect of this medicine 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 this medicine passes into human milk. Before using this medicine during breastfeeding, consult your doctor, pharmacist or nurse. The patient may be advised to stop breastfeeding or to discontinue/avoid starting this medicine.
Driving and using machines
This medicine has no effect or a negligible effect on the ability to drive and operate machinery.
Apixaban Sandoz contains lactose (a type of sugar) and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact 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 use Apixaban Sandoz
This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If in doubt, consult your doctor, pharmacist or nurse.
Dosage
Swallow the tablet with water. This medicine can be taken with or without food.
For optimal treatment results, it is recommended to take the tablets at the same times each day.
If the patient has difficulty swallowing tablets whole, discuss alternative ways of taking Apixaban Sandoz with the 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 powder to 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 the mixture.
Rinse the pestle and mortar used to crush the tablet, 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, the doctor may administer crushed Apixaban Sandoz tablets mixed with 60 mL of water or 5% glucose solution via a nasogastric tube.
Apixaban Sandoz should be taken as directed for the following indications:
- 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 tablet of Apixaban Sandoz 5 mg twice daily.
The recommended dose is one tablet of Apixaban Sandoz 2.5 mg twice daily if:
- the patient has severe renal impairment;
- 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. 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 tablets of Apixaban Sandoz 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 Sandoz 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 Sandoz 2.5 mg twice daily, for example one tablet in the morning and one in the evening.
The doctor will decide how long treatment should continue.
The doctor may change anticoagulant therapy as follows:
-
Switching from Apixaban Sandoz to anticoagulant medicines
Discontinue Apixaban Sandoz. Begin anticoagulant treatment (e.g., heparin) at the time the next tablet was scheduled to be taken. -
Switching from anticoagulant medicines to Apixaban Sandoz
Discontinue anticoagulant medicines. Begin Apixaban Sandoz treatment at the time the next anticoagulant dose was scheduled, then continue regular dosing. -
Switching from vitamin K antagonist anticoagulant therapy (e.g., warfarin) to Apixaban Sandoz
Discontinue the vitamin K antagonist medicine. The doctor must perform blood tests and inform the patient when to start taking Apixaban Sandoz. -
Switching from Apixaban Sandoz to vitamin K antagonist anticoagulant therapy (e.g., warfarin)
If the doctor informs the patient to start taking a vitamin K antagonist medicine, continue taking Apixaban Sandoz for at least 2 days after the first dose of the vitamin K antagonist medicine. The doctor must perform blood tests and inform the patient when to stop taking Apixaban Sandoz.
Use in patients undergoing cardioversion
Patients who require a cardioversion procedure to restore normal heart rhythm should take this medicine at the times specified by the doctor to prevent formation of blood clots in the blood vessels of the brain and other blood vessels in the body.
Taking more than the recommended dose of Apixaban Sandoz
If the patient has taken more than the recommended dose of this medicine, contact the doctor immediately. Bring the medicine packaging, even if empty.
If the patient has taken more than the recommended dose of Apixaban Sandoz, the risk of bleeding may increase. In case of bleeding, surgical treatment, blood transfusion or other treatments to reverse the anti-factor Xa effect may be required.
Missed dose of Apixaban Sandoz
Take the missed dose as soon as the patient remembers and:
- take the next dose at the usual time;
- continue taking the medicine as before.
If in doubt about using the medicine or if more than one dose has been missed, consult the doctor, pharmacist or nurse.
Stopping Apixaban Sandoz
Do not stop taking this medicine without consulting the doctor, as stopping Apixaban Sandoz prematurely may increase the risk of blood clot formation.
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.
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 Sandoz to prevent blood clots in the heart in patients with irregular heart rhythm and at least one additional risk factor.
Common side effects (may affect up to 1 in 10 people)
- Bleeding, including:
- into the eye;
- into the stomach or intestine;
- from the rectum;
- blood in urine;
- nosebleeds;
- bleeding from gums;
- subcutaneous haemorrhage 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 activity of gamma-glutamyl transferase (GGT).
Uncommon side effects (may affect up to 1 in 100 people)
- Bleeding:
- into the brain or spinal canal;
- in the mouth or coughing up blood;
- in the abdominal cavity or from the vagina;
- bright red blood in stool;
- bleeding occurring after surgery, including bruising and swelling, leakage of blood or fluid from the surgical wound or tissue incision site (wound discharge) or injection site;
- from haemorrhoids;
- presence of blood in stool or urine detected in laboratory tests;
- Decreased platelet count in blood (which may affect clotting);
- Blood test results may show:
- abnormal liver function;
- 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;
- Skin rash;
- Itching;
- Hair loss;
- Allergic (hypersensitivity) reactions, 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 affect up to 1 in 1,000 people)
- Bleeding:
- in the lungs or throat;
- into the space located at the back of the abdominal cavity;
- into muscles.
Very rare side effects (may affect up to 1 in 10,000 people)
- Skin rash, during which blisters may form, resembling small 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)
- Inflammation of blood vessels (vasculitis), which may cause skin rash or raised, flat, red, circular 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 Sandoz to treat or prevent recurrence of blood clots in the veins of the lower limbs and blood clots in blood vessels of the lungs.
Common side effects (may affect up to 1 in 10 people)
- Bleeding, including:
- nosebleeds;
- bleeding from gums;
- blood in urine;
- subcutaneous haemorrhage and swelling;
- in the stomach, intestine, or from the rectum;
- in the mouth;
- from the vagina;
- Anaemia, which may cause fatigue or paleness;
- Decreased platelet count in blood (which may affect clotting);
- Nausea (feeling sick);
- Skin rash;
- Blood test results may show:
- increased activity of gamma-glutamyl transferase (GGT) or alanine aminotransferase (AlAT).
Uncommon side effects (may affect 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 coughing up blood;
- bright red blood in stool;
- test results indicating presence of blood in stool or urine;
- bleeding occurring after surgery, including bruising and swelling, leakage of blood or fluid from the surgical wound or tissue incision site (wound discharge) or injection site;
- from haemorrhoids;
- into muscles;
- Itching;
- Hair loss;
- Allergic (hypersensitivity) reactions, 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 – a breakdown product of red blood cells, which may cause yellowing of the skin and eyes.
Rare side effects (may affect up to 1 in 1,000 people)
- Bleeding:
- into the brain or spinal canal;
- in the lungs.
Frequency not known (frequency cannot be estimated from available data)
- Bleeding into the abdominal cavity or into the space located at the back of the abdominal cavity.
- Skin rash, during which blisters may form, resembling small target-like lesions (dark spots in the center surrounded by a lighter ring, with a dark ring around the edge) (erythema multiforme);
- Inflammation of blood vessels (vasculitis), which may cause skin rash or raised, flat, red, circular spots beneath the skin surface, or bruising.
- 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, inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the 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 authorisation holder.
Reporting side effects helps provide more information on the safety of this medicine.
5. How to store Apixaban Sandoz
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box and blister pack 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 the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.
6. Contents of the packaging and other information
What Apixaban Sandoz contains
The active substance is apixaban. Each coated tablet contains 5 mg of apixaban.
The other ingredients are:
- Tablet core: monohydrate lactose (see section “Apixaban Sandoz contains lactose (a type of sugar) and sodium”), microcrystalline cellulose, povidone K-30, crospovidone (Type A), sodium lauryl sulfate, sodium stearyl fumarate
- Coating: monohydrate lactose (see section “Apixaban Sandoz contains lactose (a type of sugar) and sodium”), hypromellose, titanium dioxide (E 171), triacetin, red iron oxide (E 172)
What Apixaban Sandoz looks like and contents of the pack
Pink, elongated coated tablets, 5.2 mm wide and 10.3 mm long.
They are packed in blisters or in unit-dose perforated blisters made of Aluminium/PVC/PVdC foil,
housed in a cardboard box.
Pack sizes:
- 20, 28, 30, 56, 60 or 168 coated tablets in blisters
- 20 x 1, 28 x 1, 30 x 1, 56 x 1, 60 x 1 or 168 x 1 coated tablets in unit-dose perforated blisters.
Not all pack sizes may be marketed.
Patient Alert Card: information for the user
Inside the packaging, together with the Patient Leaflet, a Patient Alert Card is provided.
An identical card can also be obtained from your doctor.
This Patient Alert Card contains information that may be helpful for the patient
and may serve as a warning to other physicians that the patient is taking Apixaban Sandoz. The card should always be carried on your person.
- Remove the card.
- Fill in the following details or ask your doctor for assistance:
- Name and surname
- Date of birth
- Indication
- Dosage: …. mg twice daily
- Name and surname of doctor
- Doctor’s telephone number
- Fold the card and always keep it with you
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00
Importer
Pharmadox Healthcare Limited
KW20A Kordin Industrial Park,
Paola
PLA 3000, Malta
Adalvo Limited
Malta Life Sciences Park,
Building 1, Level 4
Sir Temi Zammit Buildings
San Gwann Industrial Estate, San Gwann
SGN 3000, Malta
This medicinal product is authorised in the European Economic Area countries under the following names:
Finland Apixaban Hexal
Bulgaria Apixaban Sandoz
Cyprus Apixaban/Ebewe 5 mg
film-coated tablets
Greece Apixaban/Ebewe
Lithuania Apixaban Sandoz 5 mg plėvele dengtos tabletės
Latvia Apixaban Sandoz 5 mg apvalkotās tabletes
Poland Apixaban Sandoz
Romania Apixaban Sandoz 5 mg comprimate filmate
Slovakia Apixaban Sandoz GmbH 5 mg filmom obalené tablety