Apixaban Cipla

Leaflet attached to the packaging: information for the user

Apixaban Cipla, 5 mg, film-coated tablets

Apixaban

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your 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 side effects 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 Cipla and what is it used for
• 2. Important information 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 is Apixaban Cipla and what is it used for

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

Apixaban Cipla is used in adults:

• to prevent the formation of blood clots in the heart in patients with irregular heart rhythm (atrial fibrillation) and at least one additional risk factor. Blood clots can break loose and move 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 legs (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 legs and/or lungs.

2. Important information before taking Apixaban Cipla

When not to take Apixaban Cipla:

• 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 ulcersor recent brain bleeding),
• if the patient has liver diseasethat leads to an increased risk of bleeding (hepatic coagulopathy),
• if the patient is taking anticoagulant medicines(e.g., warfarin, rivaroxaban, dabigatran, or heparin), except in cases where the anticoagulant treatment is changed, and the patient has a venous or arterial access 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 their vein) due to irregular heart rhythm (arrhythmia).

In the case of needing 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 time. If there is any uncertainty as to whether a given procedure may be associated with bleeding, the doctor should be consulted.

Warnings and precautions

Before starting treatment, the patient should discuss with their doctor, pharmacist, or nurse if they have any of the following conditions:

• increased risk of bleeding, for example:
• bleeding disorders, including those resulting in decreased platelet activity,
• very high blood pressurethat is not controlled 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 determines 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 exercise special caution when taking Apixaban Cipla

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

In the event of needing 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 time. If there is any uncertainty as to whether a given procedure may be associated with bleeding, the doctor should be consulted.

Children and adolescents

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

Apixaban Cipla and other medicines

The patient should tell their doctor, pharmacist, or nurse about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Some medicines may enhance the effect of Apixaban Cipla, and some may weaken its effect.

The doctor will decide whether the patient should receive Apixaban Cipla while taking other medicines and how closely they should be monitored.

The following medicines may enhance the effect of Apixaban Cipla 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-inflammatoryor pain-relieving medicines(e.g., acetylsalicylic acid or naproxen),
• especially if the patient is over 75 years old and taking acetylsalicylic acid, they may be at increased risk of unwanted bleeding
• medicines used to treat high blood pressure or heart problems(e.g., diltiazem)
• antidepressant medicinesknown as selective serotonin reuptake inhibitors
• or serotonin and norepinephrine reuptake inhibitors.

The following medicines may reduce the ability of Apixaban Cipla 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 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, they should contact their doctor immediately.

It is not known whether Apixaban Cipla passes into breast milk. Before taking this medicine while breastfeeding, the patient should consult their doctor, pharmacist, or nurse. The patient may be advised to stop breastfeeding or stop/take this medicine.

Driving and using machines

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

Apixaban Cipla 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 this medicine.

The 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 Cipla

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor, pharmacist, or nurse.

Dose

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 time every day.

If the patient has problems swallowing the tablets whole, they should discuss other ways of taking Apixaban Cipla with their doctor. The tablet can be crushed immediately before administration and mixed with water or a 5% glucose solution, juice, or apple sauce.

Instructions for crushing tablets:

• Crush the tablet with a pestle in a mortar.
• Carefully transfer the entire powder to a suitable cup, then mix it with 60 mL of water or a 5% glucose solution.
• Gently mix to completely disperse the mixture. Using a polypropylene syringe, immediately administer the mixture through a nasogastric tube into the stomach.
• Rinse the empty cup with 5 mL of water or a 5% glucose solution and rinse the tube to administer the remaining suspension.

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

Apixaban Cipla should be taken as follows:

Prevention of blood clot formation in the heart in patients with irregular heart rhythm (arrhythmia) and at least one additional risk factor

The recommended dose is one 5 mg tablet twice a day.

The recommended dose is one Apixaban Cipla 2.5 mg 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 suggest decreased kidney function (serum creatinine level of 1.5 mg/dL (133 micromoles/L) or higher),
• the patient is 80 years old or older,
• 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 to continue treatment.

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 Apixaban Cipla 5 mg 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 one Apixaban Cipla 5 mg tablet twice a day, for example, one tablet in the morning and one in the evening.

Prevention of recurrent blood clot formation after completing 6 months of treatment

The recommended dose is one Apixaban Cipla 2.5 mg tablet twice a day, for example, one tablet in the morning and one in the evening.

The doctor will decide how long to continue treatment.

The doctor may change the anticoagulant treatment as follows:

• Changing from Apixaban Cipla to anticoagulant medicinesStop taking Apixaban Cipla. Anticoagulant treatment (e.g., heparin) should be started at the time of the scheduled intake of the next tablet.
• Changing from anticoagulant medicines to Apixaban CiplaStop taking anticoagulant medicines. Apixaban Cipla treatment should be started at the time of the scheduled intake of the next dose of anticoagulant medicine, and then continue with its usual intake.
• Changing from treatment with a vitamin K antagonist (e.g., warfarin) to Apixaban CiplaStop taking the vitamin K antagonist. The doctor must perform blood tests, and the patient will be informed when to start taking Apixaban Cipla.
• Changing from Apixaban Cipla 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, they should continue taking Apixaban Cipla for at least 2 days after taking the first dose of the vitamin K antagonist. The doctor must perform blood tests, and the patient will be informed when to stop taking Apixaban Cipla.

Patients undergoing cardioversion

Patients with irregular heart rhythm who need to undergo a cardioversion procedure to restore a normal heart rhythm should take this medicine at the times specified by the doctor to prevent blood clot formation in the brain and other blood vessels.

Taking a higher dose of Apixaban Cipla than recommended

If the patient has taken a higher dose of this medicine than recommended, they should contact their doctor immediately.

If the patient has taken a higher dose of Apixaban Cipla, they may be at increased risk of bleeding. If bleeding occurs, surgical treatment, blood transfusion, or other treatment that can reverse the effect of factor Xa inhibition may be necessary.

Missing a dose of Apixaban Cipla

• Take the dose as soon as possible, and then take the next dose at the usual time.
• Continue taking the medicine as usual.

In case of doubts about taking the medicine or if more than one dose is missed

Consult the doctor, pharmacist, or nurse.

Stopping Apixaban Cipla treatment

Do not stop taking this medicine without consulting the doctor, as the risk of blood clot formation may be higher if treatment is stopped prematurely.

If the patient has any further doubts about taking this medicine, they should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Apixaban Cipla 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 Cipla to prevent blood clot formation in the heart in patients with irregular heart rhythm and at least one additional risk factor.

Common side effects (may occur in 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 pale skin;
• Low blood pressure, which can lead to fainting or rapid heartbeat;
• Nausea (vomiting);
• Blood test results may indicate:
• increased gamma-glutamyltransferase (GGT) activity.

Uncommon side effects (may occur in 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 from the vagina;
• bright red blood in the stool;
• bleeding after surgery, including bruising and swelling, bleeding or fluid from the surgical wound or injection site;
• from hemorrhoids;
• presence of blood in the stool or urine detected in laboratory tests;
• decreased platelet count in the blood (which can 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 that 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 are observed, the patient should contact their doctor immediately.

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

• Bleeding:
• in the lungs or throat;
• in the abdominal cavity or retroperitoneal space.

Very rare side effects (may occur in 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 elevated, flat, red, round patches under the skin, or bruising.

The following side effects may occur when taking Apixaban Cipla to treat or prevent recurrent blood clot formation in the veins of the legs and blood clots in the blood vessels of the lungs.

Common side effects (may occur in 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 pale skin;
• Decreased platelet count in the blood (which can affect blood clotting);
• Nausea (vomiting);
• Skin rash;
• Blood test results may indicate:
• increased gamma-glutamyltransferase (GGT) or alanine aminotransferase (ALT) activity.

Uncommon side effects (may occur in 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;
• bleeding after surgery, including bruising and swelling, bleeding or fluid from the surgical wound or injection site;
• from hemorrhoids;
• in the muscles;
• 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 are observed, the patient should contact their 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 that can cause yellowing of the skin and eyes.

Rare side effects (may occur in 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:
• in the abdominal cavity or retroperitoneal space.
• 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 elevated, flat, red, round patches under the skin, or bruising.

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor, pharmacist, or nurse.

Side effects can be reported directly to the Department of Drug Safety Monitoring 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

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Apixaban Cipla

Keep the medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton, bottle, and blister after EXP. The expiry date refers to the last day of the month stated.

There are no special storage instructions for the medicine.

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 Cipla contains

• The active substance of the medicine is apixaban. Each tablet contains 5 mg of apixaban.
• Other ingredients 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), yellow iron oxide (E 172).

What Apixaban Cipla looks like and contents of the pack

The film-coated tablets are pink, oval, biconvex, smooth on both sides [thickness: 4 mm, length: 10 mm, and width: 5 mm].

• Available in blisters in cardboard boxes of 14 film-coated tablets.

Patient Alert Card: information for use

Inside the Apixaban Cipla packaging, next to the patient information leaflet, there is a Patient Alert Card or the doctor may give the patient a similar card.

The Patient Alert Card contains information that helps the patient and warns other doctors that the patient is taking Apixaban Cipla. The patient should always carry this card with them.

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

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

Date of last revision of the leaflet: