Apixaban cipla

Package leaflet: Information for the user

Apixaban Cipla, 5 mg, film-coated tablets
Apixabanum
Please read all of 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 only. Do not pass it on to others. It may harm them, 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 you take 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 of the blood clotting process.
Apixaban Cipla is used in adults:

• To prevent blood clots forming in the heart in patients with an irregular heartbeat (atrial fibrillation) and at least one additional risk factor. Blood clots can break loose and travel to the brain, causing stroke, or to other organs, blocking 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 further blood clots from forming 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 excessive bleeding,
• if the patient has an organ disease 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 an intravenous or arterial line has been inserted 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 this medicine, 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 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.
• 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 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 unsure whether a procedure may involve bleeding, ask 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 performed.
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),
• especially 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 epilepsy or seizures (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 have a
child, 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 taken during pregnancy. If the patient becomes pregnant while taking this medicine, she should immediately contact her doctor.
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 stop/avoid starting treatment with this medicine.
Driving and using machines
No effects of Apixaban Cipla on the ability to drive and operate machinery have been observed.
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, meaning the medicine is considered “sodium-free”.

3. How to take Apixaban Cipla

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt,
consult a 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 outcomes, it is recommended to take the tablets at the same time
each day.
If a patient has difficulty swallowing tablets whole, they should speak with their doctor about
alternative ways of taking Apixaban Cipla. The tablet may be crushed and mixed with water or 5%
aqueous glucose solution, juice or apple puree immediately before administration.
Instructions for crushing tablets:

• Crush the tablet in a mortar using a 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 into the stomach via a nasogastric tube 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, a 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 in the heart in patients with irregular heartbeat (arrhythmia) and at least one additional risk factor
The recommended dose is one tablet of 5 mg twice daily.
The recommended dose is one tablet of Apixaban Cipla 2.5 mg twice daily if:

• the patient has severe renal impairment,
• two or more of the following conditions are met:
• blood test results suggest reduced kidney function (serum creatinine level is 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 veins of the legs and blood clots in the blood vessels of the lungs
The recommended dose is two tablets of Apixaban Cipla 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 Cipla 5 mg twice daily, 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 tablet of Apixaban Cipla 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 treatment as follows:

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

Patients undergoing cardioversion
Patients with irregular heartbeat who require a cardioversion procedure to restore normal heart rhythm should take this medicine at the times specified by the doctor to prevent the formation of blood clots in the blood vessels of the brain and other parts of the body.
Taking more Apixaban Cipla than recommended
If a patient takes more than the recommended dose of this medicine, they should immediately inform their doctor. The medicine packaging should be brought along, even if no tablets remain.
If a patient takes more than the recommended dose of Apixaban Cipla, the risk of bleeding may increase. In case of bleeding, surgical treatment, blood transfusion or other treatments to reverse the factor Xa inhibitor effect may be required.
Missing a dose of Apixaban Cipla

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

If in doubt about how to take the medicine or if more than one dose has been missed,
consult a doctor, pharmacist or nurse.
Stopping Apixaban Cipla
Do not stop taking this medicine without consulting a doctor, as the risk of developing blood clots may be higher if treatment is stopped prematurely.
If there are any further questions about the use of this medicine, consult a doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody 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 Cipla
to prevent blood clots in the heart in patients with irregular heartbeat and at least one additional risk factor.

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

• Bleeding, including:
• into the eyes;
• into the stomach or intestines;
• 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 show:
• increased activity of gamma-glutamyl transferase (GGT).

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

• Bleeding:
• into the brain or spinal cord;
• in the mouth or presence of blood in sputum when coughing;
• in the abdominal cavity or from the vagina;
• bright red blood in stool;
• bleeding occurring after any surgery, including subcutaneous haemorrhages (bruising) and swelling, leakage of blood or fluid from the surgical wound/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 blood 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 occur in up to 1 in 1,000 people)

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

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

• Skin rash, which may develop blisters and resembles target-like lesions (dark spots in the centre surrounded by a lighter ring, with a dark ring around the edge) (erythema multiforme).

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

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

The following side 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 side effects (may occur in up to 1 in 10 people)

• Bleeding, including:
• nosebleeds;
• bleeding from gums;
• blood in urine;
• subcutaneous haemorrhages (bruising) and swelling;
• in the stomach, intestines, 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 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;
• bleeding occurring after surgery, including subcutaneous haemorrhages (bruising) and swelling, leakage of blood or fluid from the surgical wound/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 occur in up to 1 in 1,000 people)
Bleeding:

• into the brain or spinal cord;
• in the lungs.

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

• Bleeding:
• into the abdominal cavity or retroperitoneal space (located at the back of the abdominal cavity).
• Skin rash, which may develop blisters and resembles target-like lesions (dark spots in the centre 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, round spots beneath the skin surface, or subcutaneous haemorrhages (bruising).

Reporting of side effects
If you experience any side effects, including any not listed
in this leaflet, tell your doctor, pharmacist or nurse. Side effects can also be reported directly to
Department of Monitoring of Adverse Drug Reactions, 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
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 Cipla

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton,
bottle and blister after: EXP. The expiry date refers to the last day of the stated month.
No special storage conditions apply for this medicine.
Medicines should 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 Cipla contains

• The active substance is apixaban. Each tablet contains 5 mg of apixaban.
• The other ingredients are:
  • Tablet core: monohydrate lactose, 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), yellow iron oxide (E 172).

What Apixaban Cipla looks like and contents of the pack
The coated tablets are pink, oval, biconvex, smooth on both sides [thickness: 4 mm, length: 10 mm and width: 5 mm].

• Available in blister packs in cardboard boxes containing 14 coated tablets.

Patient Alert Card: information on use
Inside the packaging of Apixaban Cipla, alongside the patient leaflet, there is a Patient Alert Card, or the treating physician may provide the patient with a similar card.
The Patient Alert Card contains helpful information for the patient and warns other physicians that the patient is taking Apixaban 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. Complete the following fields, 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 carry 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 countries under the following names: