Apixaban Reddi

Leaflet accompanying the packaging: information for the user

Apixaban Reddy, 2.5 mg, coated tablets

Apixaban

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a 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 Reddy and what is it used for
• 2. Important information before taking Apixaban Reddy
• 3. How to take Apixaban Reddy
• 4. Possible side effects
• 5. How to store Apixaban Reddy
• 6. Contents of the packaging and other information

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

Apixaban Reddy 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 Reddy is used in adults:

• to prevent the formation of blood clots (deep vein thrombosis) after hip or knee replacement surgery. After hip or knee surgery, the patient may be at increased risk of developing blood clots in the veins of the lower limbs. This can lead to swelling of the legs, with or without pain. If a blood clot moves from the legs to the lungs, it can block blood flow through the lungs, causing shortness of breath with chest pain or without. This condition (pulmonary embolism) can be life-threatening and requires immediate medical attention.
• 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 lower limbs (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 lower limbs and/or lungs.

2. Important information before taking Apixaban Reddy

When not to take Apixaban Reddy

• 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 an 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 treatment is being 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).

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 cases 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 kilograms 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.
• Tube (catheter) or injection into the spine(anesthetic or pain-relieving), in which case the doctor will recommend taking this medicine after 5 or more hours after the catheter is removed,
• If the patient has a heart valve prosthesis,
• If the doctor determines that the patient's blood pressure is unstable or plans other treatment or surgery to remove a blood clot from the lungs.

When to be particularly cautious when taking Apixaban Reddy

• 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 whether to change the treatment.

In case of the need for 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 about whether a given procedure may cause bleeding, the patient should ask their doctor about it.

Children and adolescents

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

Apixaban Reddy 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, and some may weaken its effect. The doctor will decide whether the patient should receive apixaban while taking other medicines and how closely they should be monitored.
The following medicines may enhance the effect of apixaban 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 anticoagulant medicines(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 old and taking acetylsalicylic acid, may be at increased risk of bleeding
• Medicines used to treat high blood pressure or heart problems(e.g., diltiazem)
• Antidepressant medicinescalled selective serotonin reuptake inhibitorsor serotonin and norepinephrine reuptake inhibitors.

The following medicines may reduce the ability of apixaban to prevent blood clot formation:

• 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, 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 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 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/not start taking this medicine.

Driving and using machines

It has not been found that apixaban affects the ability to drive or use machines.

Apixaban Reddy 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 the 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 Reddy

This medicine should always be taken as directed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor, pharmacist, or nurse.

Dose

The tablet should be swallowed with water. Apixaban Reddy 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 difficulty swallowing the tablet whole, they should talk to their doctor about other ways to take Apixaban Reddy. Just before taking the tablet, it can be crushed and mixed with water or a 50 mg/ml (5%) glucose solution, apple juice, or apple puree.

Instructions for crushing tablets:

• Crush the tablet with a pestle in a mortar.
• Carefully transfer the entire powder to a suitable container and then mix it with a small amount (e.g., 30 mL or 2 tablespoons) of water or one of the above-mentioned liquids to prepare a mixture.
• Swallow (drink) the resulting mixture.
• Rinse the pestle and mortar used to crush the tablets and the container with a small amount of water or another liquid (e.g., 30 mL) and then swallow (drink) the rinse liquid.

If necessary, the doctor may also administer the crushed Apixaban Reddy tablet mixed with 60 mL of water or a 50 mg/mL (5%) glucose solution through a nasogastric tube.

Apixaban Reddy should be taken as directed in the following indications:

Prevention of blood clot formation after hip or knee replacement surgery
The recommended dose is one Apixaban Reddy 2.5 mg tablet twice a day.
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, they will usually take the tablets for 32 to 38 days.
If the patient has undergone major knee replacement surgery, they will usually take the tablets for 10 to 14 days.
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 Apixaban Reddy 5 mgtablet twice a day.
The recommended dose is one Apixaban Reddy 2.5 mgtablet twice a day if:

• the patient has severe kidney problems,
• two or more of the following conditions are met:
• the patient's blood test results indicate 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 kilograms 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 lower limbs and blood clots in the blood vessels of the lungs
The recommended dose is twoApixaban Reddy 5 mgtablets 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 oneApixaban Reddy 5 mgtablet 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 Reddy 2.5 mgtablet 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 Reddy to anticoagulant medicinesThe patient should stop taking Apixaban Reddy. Treatment with anticoagulant medicines (e.g., heparin) should be started at the time of the scheduled intake of the next Apixaban Reddy tablet.
• Changing from anticoagulant medicines to Apixaban ReddyThe patient should stop taking anticoagulant medicines. Apixaban treatment should be started at the time of the scheduled intake of the next dose of anticoagulant medicine and then continued as usual.
• Changing from treatment with a vitamin K antagonist (e.g., warfarin) to Apixaban ReddyThe patient should stop taking the vitamin K antagonist. The doctor will perform blood tests and inform the patient when to start taking apixaban.
• Changing from Apixaban Reddy 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, the patient should continue taking apixaban for at least 2 days after taking the first dose of the vitamin K antagonist. The doctor will perform blood tests and inform the patient when to stop taking apixaban.

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 their doctor to prevent blood clot formation in the brain and other blood vessels.

Taking a higher dose of Apixaban Reddy than recommended

If the patient has taken a higher dose of this medicine than recommended, they should immediately inform their doctor.
The patient should take the packaging of the medicine with them, even if there are no more tablets in it.
If the patient has taken a higher dose of apixaban than recommended, they may be at increased risk of bleeding. In case of bleeding, surgical treatment, blood transfusion, or other treatment that can reverse the effect of factor Xa inhibition may be necessary.

Missing a dose of Apixaban Reddy

• The patient should take the dose as soon as they remember and:
• take the next dose of Apixaban Reddy at the usual time
• then take the medicine as before.

In case of doubts about taking the medicine or if more than one dosehas been missed

The patient should consult their doctor, pharmacist, or nurse.

Stopping Apixaban Reddy treatment

The patient should not stop taking this medicine without consulting their doctor, as the risk of blood clot formation may be higher if the patient stops taking apixaban too early.
In case of any further doubts about taking this medicine, the patient should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Apixaban can be used in three different medical conditions. The known side effects and their frequency in each of these medical conditions may be different and are listed separately below. In these conditions, the most common overall side effect of this medicine is bleeding, which can potentially be life-threatening and may require immediate medical attention.
The following side effects may occur when taking apixaban to prevent blood clot formation after hip or knee replacement surgery.

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

• Anemia, which can cause fatigue or pallor;
• Bleeding, including:
• bruises and swelling;
• Nausea (vomiting).

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

• Decreased platelet count (which can affect blood clotting);
• Bleeding:
• after surgery, including bruising and swelling, bleeding or fluid leakage from the surgical wound/incision (wound discharge) or injection site;
• from the stomach, intestines, or bright red blood in the stool;
• blood in the urine;
• from the nose;
• from the vagina;
• Low blood pressure, which can 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 of red blood cell breakdown, which can cause yellowing of the skin and eyes;
• Itching.

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

• Allergic reactions (hypersensitivity), which can cause: facial swelling, lip, mouth, tongue, and/or throat swelling, and difficulty breathing. If any of these symptoms occur, the patient should immediately contact their doctor;
• Bleeding:
• into the muscle;
• into the eyes;
• from the gums and presence of blood in sputum when coughing;
• from the rectum;
• Hair loss.

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

• Bleeding:
• into the brain or spinal cord;
• into the lungs or throat;
• into the abdominal cavity or into the space behind the abdominal cavity;
• from hemorrhoids;
• blood test results indicating blood in the stool or urine;
• A skin rash, which can form 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 raised, flat, red, round spots under the skin surface, or bruising.

The following side effects may occur when taking apixaban 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:
• into the eyes;
• into 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 pallor;
• 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:
• into the brain or spinal cord;
• into the mouth or presence of blood in sputum when coughing;
• into the abdominal cavity or from the vagina;
• bright red blood in the stool;
• bleeding after surgery, including bruising and swelling, bleeding or fluid leakage from the surgical wound/incision (wound discharge) or injection site;
• from hemorrhoids;
• blood test results indicating blood in the stool or urine;
• Decreased platelet count (which can affect blood clotting);
• Blood test results may indicate:
• liver function disorders;
• increased activity of certain liver enzymes;
• increased bilirubin levels, a product of red blood cell breakdown, which can cause yellowing of the skin and eyes;
• Skin rash;
• Itching;
• Hair loss;
• Allergic reactions (hypersensitivity), which can cause: facial swelling, lip, mouth, tongue, and/or throat swelling, and difficulty breathing. If any of these symptoms occur, the patient should immediately contact their doctor.

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

• Bleeding:
• into the lungs or throat;
• into the space behind the abdominal cavity;
• into the muscle.

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

• A skin rash, which can form 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 (cannot be estimated from the available data)

• Vasculitis (inflammation of blood vessels), which can cause skin rash or raised, flat, red, round spots under the skin surface, or bruising.

The following side effects may occur when taking apixaban to treat or prevent recurrent blood clot formation in the veins of the lower limbs 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;
• into the stomach, intestines, or rectum;
• into the mouth;
• from the vagina;
• Anemia, which can cause fatigue or pallor;
• Decreased platelet count (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:
• into the eyes;
• into the mouth or presence of blood in sputum when coughing;
• bright red blood in the stool;
• blood test results indicating blood in the stool or urine;
• bleeding after surgery, including bruising and swelling, bleeding or fluid leakage from the surgical wound/incision (wound discharge) or injection site;
• from hemorrhoids;
• into the muscle;
• Itching;
• Hair loss;
• Allergic reactions (hypersensitivity), which can cause: facial swelling, lip, mouth, tongue, and/or throat swelling, and difficulty breathing. If any of these symptoms occur, the patient should immediately contact their doctor;
• Blood test results may indicate:
• liver function disorders;
• increased activity of certain liver enzymes;
• increased bilirubin levels, a product of red blood cell breakdown, which can cause yellowing of the skin and eyes.

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

• Bleeding:
• into the brain or spinal cord;
• into the lungs.

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

• Bleeding:
• into the abdominal cavity or into the space behind the abdominal cavity.
• A skin rash, which can form 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 raised, flat, red, round spots under the skin surface, 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 Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C,
02-222 Warsaw,
phone: 22 49-21-301,
fax: 22 49-21-309,
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Apixaban Reddy

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month.
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Apixaban Reddy contains

• The active substance of the medicine is apixaban. Each tablet contains 2.5 mg of apixaban.
• Other ingredients are:
• Tablet core: lactose[see section 2 "Apixaban Reddy contains lactose (a type of sugar) and sodium"], microcrystalline cellulose, sodium croscarmellose [see section 2 "Apixaban Reddy contains lactose (a type of sugar) and sodium"], sodium lauryl sulfate, magnesium stearate (E 470b),
• Coating: lactose monohydrate[see section 2 "Apixaban Reddy contains lactose (a type of sugar) and sodium"], hypromellose (E 464), titanium dioxide (E 171), triacetin, iron oxide yellow (E 172).

What Apixaban Reddy looks like and contents of the packaging

The tablets are yellow, round (6 mm in diameter), and marked with "2.5" on one side and smooth on the other.
They are available in blisters in cardboard boxes containing 10, 20, 28, 56, 60, 100, 168, or 200 coated tablets or in bottles containing 20, 60, or 100 coated tablets.
Not all pack sizes may be marketed.

Patient Alert Card: information for use

Inside the Apixaban Reddy packaging, next to the patient 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 Reddy. 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:
• Date of birth:
• Indication:
• Dose: ........ mg twice a day
• Doctor's name:
• Doctor's phone number:
• 4. Fold the card and always carry it with you.

Marketing authorization holder

Reddy Holding GmbH
Kobelweg 95
86156 Augsburg
Germany
Phone: +49 821 74881 0
Fax: +49 0821 74881 20
[email protected]

Manufacturer/Importer

betapharm Arzneimittel GmbH
Kobelweg 95
86156 Augsburg
Germany
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park
Paola PLA 3000,
Malta
RUAL LABORATORIES S.R.L.
Splaiul Unirii nr.313, budova H, 1. patro, sektor 3
030138 Bucharest
Romania

This medicine is authorized in the EEA member states under the following names:

Germany:
Apixaban beta 2.5 mg film-coated tablets
Austria:
Apixaban Reddy 2.5 mg film-coated tablets
Italy:
Apixaban Dr. Reddy's 2.5 mg film-coated tablets
Netherlands:
Apixaban Reddy 2.5 mg film-coated tablets
Czech Republic:
Apixaban Reddy 2.5 mg coated tablets
Poland:
Apixaban Reddy 2.5 mg coated tablets
Sweden:
Apixaban Reddy 2.5 mg film-coated tablets
Slovakia: Apixaban Reddy 2.5 mg film-coated tablets

Date of last revision of the leaflet: