Apixaban cipla

Package leaflet: Information for the user

Apixaban Cipla, 2.5 mg, coated tablets
Apixabanum
Read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. 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 you personally. Do not share it with others. This medicine may harm other people, even if their symptoms are the same as yours.
• If you get any side effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of the leaflet

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

1. What Apixaban Cipla is and what it is used for

Apixaban Cipla contains the active substance apixaban and belongs to a group of medicines called anticoagulants. This medicine helps prevent blood clots by blocking factor Xa, which is an important component in the blood clotting process.

Apixaban Cipla is used in adults:

• To prevent blood clots (deep vein thrombosis) after hip or knee replacement surgery. After hip or knee surgery, patients have an increased risk of developing blood clots in the veins of the legs. This may lead to leg swelling, with or without pain. If a blood clot travels from the leg to the lungs, it may block blood flow through the lungs, causing breathlessness with or without chest pain. This condition (pulmonary embolism) can be life-threatening and requires immediate medical attention.
• To prevent blood clots in the heart in patients with an 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.

2. Important information before using Apixaban Cipla

When not to use Apixaban Cipla:

• if the patient is allergic to apixaban or any of the other ingredients of this medicine (listed in section 6),
• if the patient has active 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, recently diagnosed intracranial haemorrhage),
• 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 line and heparin is administered through the line to maintain its patency, or when the patient undergoes catheter ablation (a catheter is inserted into a vein) due to irregular heartbeat (arrhythmia).

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

• increased risk of bleeding, for example:
• conditions associated with bleeding, including those resulting in reduced platelet function,
• very high blood pressure that is not controlled with 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.
• spinal catheter or spinal injection (anaesthetic or pain relief), in which case the doctor will advise taking this medicine at least 5 hours or more after removal of the catheter,
• if the patient has a heart valve prosthesis,
• if the doctor determines that the patient's blood pressure is unstable or if other treatment or a surgical procedure to remove a blood clot from the lungs is planned.

When to exercise particular caution when using Apixaban Cipla

• if the patient has a disorder called antiphospholipid syndrome (an autoimmune disorder increasing the risk of blood clots), the patient should inform the doctor, who will decide whether a change in treatment is necessary.

If the patient needs to undergo surgery or a procedure that may cause bleeding,
the doctor may ask the patient to temporarily stop taking this medicine for a short period.
If in doubt whether a particular procedure may be associated with bleeding, consult the doctor.

Children and adolescents
This medicine is not recommended for use in children and adolescents under 18 years of age.

Apixaban Cipla 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 Cipla, while others may reduce its effect.
The doctor will decide whether the patient should receive Apixaban Cipla while taking other medicines and how closely monitoring should be.

The following medicines may enhance the effect of Apixaban Cipla 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),
• particularly if the patient is over 75 years of age and taking acetylsalicylic acid, the risk of unwanted bleeding may be increased,
• medicines used for high blood pressure or heart problems (e.g. diltiazem),
• antidepressant medicines known as selective serotonin reuptake inhibitors (SSRIs),
• or serotonin and noradrenaline reuptake inhibitors (SNRIs).

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

• medicines used to prevent seizures or convulsions (e.g. phenytoin and others),
• St. John’s wort (a herbal supplement used for depression),
• medicines used to treat tuberculosis or other infections (e.g. rifampicin).

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor, pharmacist or nurse before using this medicine.
The effect of Apixaban Cipla on pregnancy and the unborn child is unknown. This medicine should not be used during pregnancy. If the patient becomes pregnant while taking this medicine, she should contact her doctor immediately.
It is not known whether Apixaban Cipla passes into human milk. Before using this medicine during breastfeeding, consult a doctor, pharmacist or nurse. The patient may be advised to discontinue breastfeeding or to discontinue/avoid starting this medicine.

Driving and using machines
It has not been established that Apixaban Cipla affects the ability to drive or operate machinery.

Apixaban Cipla contains lactose (a type of sugar) and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet; therefore, this medicine is considered "sodium-free".

3. How to take Apixaban Cipla

This medicine should always be taken as prescribed 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 Cipla can be taken with or without food.
To achieve the best treatment results, it is recommended to take the tablets at the same times each day.
If you have difficulty swallowing tablets whole, you should discuss other ways of taking Apixaban Cipla with your doctor. The tablet may be crushed immediately before administration and mixed with water or 5% aqueous glucose solution, juice, or applesauce.
Instructions for crushing tablets:

• Crush the tablet using a mortar and pestle.
• Carefully transfer the entire powder into a suitable cup, then mix it with 60 mL of water or 5% glucose solution.
• Gently mix to fully disperse the mixture. Immediately administer the mixture via a nasogastric tube into the stomach using a polypropylene syringe.
• Rinse the empty cup with 5 mL of water or 5% glucose solution and flush the tube to deliver any remaining suspension.

If necessary, your doctor may administer crushed Apixaban Cipla tablets mixed with 60 mL of water or 5% glucose solution through a nasogastric tube.
Apixaban Cipla 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 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 replacement surgery, tablets are usually taken for 32 to 38 days.
If the patient has undergone major knee replacement surgery, tablets are usually taken for 10 to 14 days.
Prevention of blood clots in the heart in patients with irregular heartbeat (arrhythmia) and at least one additional risk factor
The recommended dose is one 5 mg tablet twice daily.
The recommended dose is one 2.5 mg tablet of Apixaban Cipla twice daily if:

• the patient has severe kidney function impairment,
• two or more of the following conditions are met:
• blood test results suggest 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 deep veins of the legs and blood clots in the blood vessels of the lungs
The recommended dose is two 5 mg tablets of Apixaban Cipla 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 Cipla 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 Cipla twice daily, for example one tablet in the morning and one in the evening.
Your doctor will decide how long treatment should continue.
Your doctor may switch anticoagulant therapy as follows:

• Switching from Apixaban Cipla to other anticoagulant medicines Discontinue Apixaban Cipla. Start treatment with anticoagulant medicines (e.g. heparin) at the time the next dose of Apixaban Cipla was scheduled.
• Switching from anticoagulant medicines to Apixaban Cipla Discontinue anticoagulant medicines. Start Apixaban Cipla at the time the next dose of the anticoagulant medicine was scheduled, then continue regular dosing.
• Switching from anticoagulant therapy including a vitamin K antagonist (e.g. warfarin) to Apixaban Cipla Discontinue the vitamin K antagonist medicine. Your doctor must perform blood tests and will inform you when to start taking Apixaban Cipla.
• Switching from Apixaban Cipla to anticoagulant therapy including a vitamin K antagonist (e.g. warfarin) If your doctor instructs you to start taking a vitamin K antagonist medicine, continue taking Apixaban Cipla for at least 2 days after taking the first dose of the vitamin K antagonist medicine. Your doctor must perform blood tests and will inform you when to stop taking Apixaban Cipla.

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 formation of blood clots in the brain's blood vessels and other blood vessels in the body.
Taking more Apixaban Cipla than recommended
If you have taken more than the recommended dose of this medicine, you should inform your doctor immediately.
Bring the medicine packaging with you, even if it is empty.
If you have taken more than the recommended dose of Apixaban Cipla, your risk of bleeding may be increased. In case of bleeding, surgical treatment, blood transfusion, or other treatments to reverse the effect directed against factor Xa may be required.
Missing a dose of Apixaban Cipla

• Take the missed dose as soon as you remember, and take the next dose at your usual time.
• then continue taking the medicine as usual.

If you have any doubts about using the medicine or if you miss more than one dose, consult your doctor, pharmacist, or nurse.
Stopping Apixaban Cipla
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 questions about using this medicine, 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.
Apixaban Cipla can be used in three different medical conditions. Known adverse effects and their frequency of occurrence in each of these medical conditions may differ and are listed separately below. In these conditions, 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 to prevent blood clots after hip or knee replacement surgery.

Common adverse effects (may occur in up to 1 in 10 people)

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

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

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

Rare adverse effects (may occur in up to 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 (cannot be estimated from the available data)

• Bleeding:

• into the brain or within the spinal column;

• in the lungs or throat;

• in the mouth;

• into the abdominal cavity or into the space located at the back of the abdominal cavity;

• from haemorrhoids;

• test results indicating presence of blood in stool or urine;

• Skin rash, which may develop blisters and resemble 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 (haematomas).

The following adverse effects may occur when taking Apixaban Cipla 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 no more than 1 in 10 people)

• Bleeding, including:
• into eyes;
• into stomach or intestine;
• from rectum
• blood in urine;
• nosebleeds;
• from gums;
• bruising (haematomas) and swelling;
• Anaemia, which may cause fatigue or paleness;
• Low blood pressure, which may lead to fainting or rapid heartbeat;
• Nausea (feeling sick);
• Blood test results may indicate:
• increased gamma-glutamyltransferase (GGT) activity.

Uncommon adverse effects (may occur in no more than 1 in 100 people)

• Bleeding:
• into brain or within spinal column;
• in mouth or presence of blood in sputum when coughing;
• in abdominal cavity or from vagina;
• bright red blood in stool;
• bleeding occurring after surgery, including bruising (haematomas) and swelling, leakage of blood or fluid from surgical wound/incision site (wound discharge) or injection site;
• from haemorrhoids;
• presence of blood in stool or urine detected in laboratory tests;
• Decreased platelet count (which may affect blood clotting);
• Blood test results may indicate:
• abnormal liver function;
• increased activity of certain liver enzymes;
• increased bilirubin levels – a breakdown product 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 are observed, contact your doctor immediately.

Rare adverse effects (may occur in no more than 1 in 1000 people)

• Bleeding:
• in lungs or throat;
• into the space located at the back of the abdominal cavity;
• into muscles.

Very rare adverse effects (may occur in no more than 1 in 10,000 people)

• Skin rash, which may develop blisters and resemble 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 the available data)

• Inflammation of blood vessels (vasculitis), which may cause skin rash or raised, flat, red, circular spots beneath the skin surface, or bruising (haematomas).

The following adverse effects may occur when taking Apixaban Cipla 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 adverse effects (may occur in no more than 1 in 10 people)

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

Uncommon adverse effects (may occur in no 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;
• bleeding occurring after surgery, including bruising (haematomas) and swelling, leakage of blood or fluid from surgical wound/incision site (wound discharge) or injection site;
• from haemorrhoids;
• into muscles;
• 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 are observed, contact your doctor immediately;
• Blood test results may indicate:
• abnormal liver function;
• increased activity of certain liver enzymes;
• increased bilirubin levels – a breakdown product of red blood cells, which may cause yellowing of skin and eyes.

Rare adverse effects (may occur in no more than 1 in 1000 people)
Bleeding:

• into brain or within spinal column;
• in lungs.

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

• Bleeding:
• into abdominal cavity or into the space located at the back of the abdominal cavity.
• Skin rash, which may develop blisters and resemble 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 (haematomas).

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-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.
By reporting adverse effects, additional information on the safety of the medicine’s use can be collected.

5. How to store Apixaban Cipla

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box, bottle, and blister 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 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 pack and other information

What Apixaban Cipla contains

• The active substance is apixaban. Each tablet contains 2.5 mg of apixaban.
• Other components are:
  • Tablet core: lactose monohydrate, microcrystalline cellulose (E 460), sodium croscarmellose (E 468), sodium lauryl sulfate (E 487), magnesium stearate (E 470b),
  • Coating: hypromellose (E 464), titanium dioxide (E 171), macrogol 400 (E 1521), iron oxide yellow (E 172)

What Apixaban Cipla looks like and contents of the pack
The coated tablets are yellow, round, biconvex, smooth on both sides [thickness: 3 mm,
diameter: 6 mm].

• Available in blisters packed in cardboard boxes containing 10 coated tablets.

Patient Warning Card: information on use
Inside the packaging of Apixaban Cipla, alongside the patient leaflet, there is a Patient Warning Card, or your doctor may provide you with a similar card.
The Patient Warning Card contains helpful information for the patient and warns other physicians that the patient is taking Apixaban Cipla. You should always carry this card with you.

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

Marketing Authorisation Holder
Cipla Europe NV
De Keyserlei 58-60,
Box-19, 2018
Antwerp
Belgium
tel: +32(0)32910101/ +32(0) 32910199
Manufacturer/Importer
Cipla Europe NV
De Keyserlei 58-60, Box-19, 2018 Antwerp,
Belgium
This medicinal product is authorised in the European Economic Area member states under the following names: