Package leaflet: Information for the user

Apixaban Dr. Reddy’s 2.5 mg film-coated tablets

apixaban
Generic medicine
Please read this leaflet carefully before you start taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

What Apixaban Dr. Reddy’s is and what it is used for
What you need to know before taking Apixaban Dr. Reddy’s
How to take Apixaban Dr. Reddy’s
Possible side effects
How to store Apixaban Dr. Reddy’s
Contents of the pack and other information

1. What Apixaban Dr. Reddy’s is and what it is used for

to prevent the formation of blood clots (deep vein thrombosis [DVT]) after hip or knee replacement surgery. Following surgery on the hip or knee, there may be an increased risk of developing blood clots in the leg veins. This can cause swelling of the legs, with or without pain. If a blood clot travels from the leg to the lungs, it can block blood flow, causing breathlessness, with or without chest pain. This condition (pulmonary embolism) can be life-threatening and requires immediate medical treatment.
to prevent the formation of blood clots in the heart in patients with irregular heartbeat (atrial fibrillation) and with at least one additional risk factor. Blood clots may break loose, travel to the brain and cause stroke, or reach other organs and block normal blood supply to these organs (also known as systemic embolism). A stroke can be life-threatening and requires immediate medical treatment.
to treat blood clots in the 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.

Apixaban Dr. Reddy’s is used in children aged from 28 days up to but less than 18 years for the treatment of blood clots and to prevent recurrence of blood clots in the veins or blood vessels of the lungs.
For the recommended dose according to body weight, see section 3.

2. What you need to know before taking Apixaban Dr. Reddy’s

Do not take Apixaban Dr. Reddy’s if:
you are allergic to apixaban or to any of the other ingredients of this medicine (listed in
section 6);
you are experiencing excessive bleeding;
you have a disease in a body organ that leads to an increased risk of life-threatening bleeding (such as
a recent or active ulcer of the stomach or intestine, or recent bleeding in the brain);
you have a liver disease that increases the risk of bleeding (hepatic coagulopathy);
you are taking medicines to prevent blood clots (e.g., warfarin, rivaroxaban, dabigatran, or heparin), except when switching anticoagulant therapy, while you have a venous or arterial catheter and are receiving heparin through it to keep it open, or if a catheter is inserted into one of your blood vessels (transcatheter ablation) to treat an irregular heartbeat (arrhythmia).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking this medicine if you have any of the
following conditions:
an increased risk of bleeding, such as:
bleeding disorders, including conditions leading to reduced platelet function;
very high blood pressure not controlled by medical treatment;
if you are over 75 years old;
body weight equal to or less than 60 kg;
severe kidney disease or if you are on dialysis;
liver problems or a history of liver problems;
This medicine will be used with caution in patients showing signs of impaired liver function.
you have a tube (catheter) or have received an injection into the spine (for anaesthesia or pain relief). Your doctor will advise you to take this medicine at least 5 hours or more after removal of the catheter;
you have a prosthetic heart valve;
if your doctor finds your blood pressure is unstable or if another treatment or surgical procedure to remove a blood clot from the lungs has been planned.

Be especially careful with Apixaban Dr. Reddy’s
if you know you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor, who will decide whether a change in therapy is needed.

If you are scheduled for surgery or a procedure that may cause bleeding, your doctor may ask you to temporarily stop taking this medicine for a short time. If you are unsure whether a procedure may cause bleeding, ask your doctor.

Children and adolescents
This medicine is not recommended for children and adolescents with a body weight below 35 kg.

Other medicines and Apixaban Dr. Reddy’s
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.

Some medicines can increase the effect of apixaban, while others can reduce it. Your doctor will decide whether you should be treated with apixaban while taking these medicines and how closely you need to be monitored.

The following medicines may increase the effect of apixaban and increase the risk of unwanted bleeding:
some medicines for fungal infections (e.g., ketoconazole, etc.);

some antiviral medicines for HIV/AIDS (e.g., ritonavir);
other medicines used to reduce blood clotting (e.g., enoxaparin, etc.);
anti-inflammatory drugs or painkillers (e.g., acetylsalicylic acid or naproxen). Particularly if you are over 75 years old and taking acetylsalicylic acid, your risk of bleeding may be higher;
medicines for high blood pressure or heart problems (e.g., diltiazem);
antidepressant medicines known as selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs).

The following medicines may reduce the effect of apixaban in helping to prevent blood clots:

medicines for epilepsy or seizures (e.g., phenytoin, etc.);
St. John’s wort (a herbal remedy used for depression);
medicines to treat tuberculosis or other infections (e.g., rifampicin).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor, pharmacist, or nurse for advice before taking this medicine.
The effect of apixaban during pregnancy and on the unborn child is unknown. You must not take this medicine if you are pregnant. Contact your doctor immediately if you become pregnant while taking this medicine.
It is not known whether apixaban passes into human breast milk. Consult your doctor, pharmacist, or nurse before taking this medicine while breastfeeding. They will advise you whether to stop breastfeeding or to stop/avoid starting treatment with this medicine.

Driving and using machines
Apixaban has not shown effects on the ability to drive vehicles or use machinery.

Apixaban Dr. Reddy’s contains lactose and sodium
If your doctor has told you that you have an intolerance to certain sugars, contact them before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially “sodium-free”.

3. How to take Apixaban Dr. Reddy’s

Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor, pharmacist, or nurse.

Dose
Swallow the tablet with some water. Apixaban Dr. Reddy’s may be taken with or without food.
Try to take the tablets at the same time each day to achieve the best effect from treatment.
If you have difficulty swallowing the tablet whole, ask your doctor about other ways to take Apixaban Dr. Reddy’s. The tablet can be crushed and mixed with water, or 50 mg/mL glucose in water, apple juice, or apple puree, immediately before administration.

Instructions for crushing the tablet:

Crush the tablets using a mortar and pestle.
Carefully transfer all the powder into a suitable container and mix it with a small amount, e.g., 30 mL (2 tablespoons), of water or one of the other liquids listed above to prepare a mixture.
Swallow the mixture.
Rinse the mortar and pestle used to crush the tablet and the container with a small amount of water (e.g., 30 mL) or one of the other liquids, and swallow the rinse.

If necessary, your doctor may also administer the crushed Apixaban Dr. Reddy’s tablet mixed with 60 mL of water or 50 mg/mL glucose in water through a nasogastric tube.

Take Apixaban Dr. Reddy’s as recommended:

To prevent blood clots after hip or knee replacement surgery:
The recommended dose is one 2.5 mg Apixaban Dr. Reddy’s tablet twice daily, for example, one tablet in the morning and one in the evening.
You should take the first dose between 12 and 24 hours after surgery.
If you have had major surgery on the hip, you will usually take the tablets for 32–38 days.
If you have had major surgery on the knee, you will usually take the tablets for 10–14 days.

To prevent blood clots in the heart in patients with irregular heartbeat (atrial fibrillation) and at least one additional risk factor:
The recommended dose is one 5 mg Apixaban Dr. Reddy’s tablet twice daily.
The recommended dose is one 2.5 mg Apixaban Dr. Reddy’s tablet twice daily if:

you have severely reduced kidney function;
you meet two or more of the following criteria: blood test results suggest poor kidney function (serum creatinine level is 1.5 mg/dL (133 micromoles/L) or higher); you are 80 years of age or older; your 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 you should continue treatment.

To treat blood clots in the veins of the legs and in the blood vessels of the lungs (pulmonary embolism):
The recommended dose is two 5 mg Apixaban Dr. Reddy’s tablets 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 Apixaban Dr. Reddy’s tablet twice daily, for example, one tablet in the morning and one in the evening.

To prevent recurrence of blood clots after completing 6 months of treatment:
The recommended dose is one 2.5 mg Apixaban Dr. Reddy’s tablet twice daily, for example, one tablet in the morning and one in the evening.
Your doctor will decide how long you should continue treatment.

Use in children and adolescents
To treat blood clots and to prevent recurrence of blood clots in veins or in blood vessels of the lungs:
Take or administer this medicine exactly as instructed by your doctor, the child’s doctor, or pharmacist. If you have any doubts, consult your doctor, the child’s doctor, pharmacist, or nurse.
Try to take or administer the dose at the same time each day to achieve the best effect from treatment.
The dose of Apixaban Dr. Reddy’s depends on body weight and will be calculated by the doctor.
The recommended dose for children and adolescents with body weight of at least 35 kg is four 2.5 mg Apixaban Dr. Reddy’s tablets twice daily for the first 7 days, for example, four in the morning and four in the evening.
After 7 days, the recommended dose is two 2.5 mg Apixaban Dr. Reddy’s tablets twice daily, for example, two in the morning and two in the evening.
For parents or caregivers: observe the child to ensure the full dose has been taken.
It is important to keep scheduled medical appointments, as the dose may need to be adjusted as body weight changes.

Your doctor may change your anticoagulant treatment as follows:

Switching from Apixaban Dr. Reddy’s to another anticoagulant medicine
Stop taking apixaban. Start treatment with the anticoagulant medicine (e.g., heparin) at the time you would have taken your next tablet.
Switching from another anticoagulant medicine to Apixaban Dr. Reddy’s
Stop taking the anticoagulant medicine. Start treatment with apixaban at the time you would have taken your next dose of the anticoagulant, then continue taking it as directed.
Switching from a vitamin K antagonist anticoagulant (e.g., warfarin) to Apixaban Dr. Reddy’s
Stop taking the vitamin K antagonist medicine. Your doctor will need to perform blood tests to determine when you should start apixaban treatment.
Switching from Apixaban Dr. Reddy’s to a vitamin K antagonist anticoagulant (e.g., warfarin)
If your doctor tells you to start taking a vitamin K antagonist medicine, continue taking apixaban for at least 2 days after the first dose of the vitamin K antagonist. Your doctor will need to perform blood tests before advising you when to stop apixaban treatment.

Patients undergoing cardioversion
If your abnormal heart rhythm needs to be restored to normal using a procedure called cardioversion, take this medicine exactly as directed by your doctor to prevent blood clots in blood vessels of the brain and elsewhere in your body.

If you take more Apixaban Dr. Reddy’s than you should
Contact your doctor immediately if you have taken more than the prescribed dose of this medicine.
Bring the medicine pack with you, even if the tablets are finished.
If you take more apixaban than recommended, you may have an increased risk of bleeding.
If bleeding occurs, you may require surgery, a blood transfusion, or other treatments to reverse the anticoagulant effect of factor Xa inhibitors.

If you forget to take Apixaban Dr. Reddy’s
If you forget to take your morning dose, take it as soon as you remember, and you may take it together with your evening dose.
A forgotten evening dose may only be taken the same evening. Do not take two doses the next morning; instead, resume your regular twice-daily dosing schedule the next day as recommended.
If you are unsure what to do or if you have missed more than one dose, consult your doctor, pharmacist, or nurse.

If you stop taking Apixaban Dr. Reddy’s
Do not stop taking this medicine without first talking to your doctor, as your risk of developing a blood clot may be higher if you stop treatment too early.
If you have any questions about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. Apixaban may be given for three different medical conditions. The known side effects and how frequently they occur may differ for each of these medical conditions and are listed separately below. For these conditions, the most common general side effect of this medicine is bleeding, which may potentially be life-threatening and requires immediate medical attention.

The following side effects are known to occur when apixaban is taken to prevent blood clots after hip or knee replacement surgery.

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

Anaemia, which may cause tiredness or pale skin;
Bleeding, including:
- Bruising and swelling;
Nausea (feeling unwell).

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

Reduction in the number of platelets in the blood (which may affect blood clotting);
Bleeding:
- Occurring after surgery, including bruising and swelling, leakage of blood or fluids from the surgical wound/incision (wound discharge) or from the injection site;
- From the stomach, intestine, or clear/red blood in the stools;
- Blood in the urine;
- Nosebleeds;
- Vaginal bleeding;
Low blood pressure, which may cause weakness or a rapid heartbeat;
Blood tests may show:
- Abnormal liver function;
- Increased levels of certain liver enzymes;
- Increased bilirubin, a product of red blood cell breakdown, which may cause yellowing of the skin and eyes;
Itching.

Rare side effects (may affect up to 1 in 1,000 people)

Allergic reactions (hypersensitivity) which may cause: swelling of the face, lips, mouth, tongue and/or throat, and difficulty breathing. Contact your doctor immediately if you experience any of these symptoms.
Bleeding:
- Into the muscle;
- Into the eyes;
- From the gums and blood in sputum when coughing;
- From the rectum;
Hair loss.

Not known (frequency cannot be estimated from available data)

Bleeding:
- In the brain or spinal cord;
- In the lungs or throat;
- In the mouth;
- In the abdomen or in the space behind the abdominal cavity;
- From haemorrhoids;
Blood tests showing blood in the stools or urine;
Skin rash that may form blisters and appear as small spots (dark central spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme);
Inflammation of blood vessels (vasculitis), which may present as skin rashes or small, flat, red, round spots under the skin surface or bruising.
Bleeding in the kidney, sometimes with blood in the urine, leading to impaired kidney function (anticoagulant-related nephropathy).

The following side effects are known when taking apixaban to prevent blood clots in the heart in patients with irregular heartbeat and at least one additional risk factor.

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

Bleeding, including:
- In the eyes;
- In the stomach or intestines;
- From the rectum;
- Blood in the urine;
- Nosebleeds;
- From the gums;
- Bruising and swelling;
Anaemia, which may cause tiredness or pale skin;
Low blood pressure, which may cause weakness or a rapid heartbeat;
Nausea (feeling unwell);
Blood tests may show:
- Increased gamma-glutamyl transferase (GGT) levels.

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

Bleeding:
- In the brain or spinal cord;
- In the mouth or blood in sputum when coughing;
- In the abdomen or from the vagina;
- Clear/red blood in the stools;
- Bleeding occurring after surgery, including bruising and swelling, leakage of blood or fluids from the surgical wound/incision (wound discharge) or from the injection site;
- From haemorrhoids;
- Blood tests showing blood in the stools or urine;
Reduction in the number of platelets in the blood (which may affect clotting);
Blood tests may show:
- Abnormal liver function;
- Increased levels of certain liver enzymes;
- Increased bilirubin, a product of red blood cell breakdown, which may cause yellowing of the 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 difficulty breathing. Contact your doctor immediately if you experience any of these symptoms.

Rare side effects (may affect up to 1 in 1,000 people)

Bleeding:
- In the lungs or throat;
- In the space behind the abdominal cavity;
- Into the muscle.

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

Skin rash that may form blisters and appear as small spots (dark central spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme).

Not known (frequency cannot be estimated from available data)

Inflammation of blood vessels (vasculitis), which may cause skin rashes or small, flat, red, round spots under the skin surface or bruising.
Bleeding in the kidney, sometimes with blood in the urine, leading to impaired kidney function (anticoagulant-related nephropathy).

The following side effects are known to occur when apixaban is taken to treat or prevent recurrence of blood clots in the veins of the legs and blood vessels of the lungs.

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

Bleeding, including:
- Nosebleeds;
- From the gums;
- Blood in the urine;
- Bruising and swelling;
- In the stomach, intestines, or from the rectum;
- In the mouth;
- From the vagina;
Anaemia, which may cause tiredness or pale skin;
Reduction in the number of platelets in the blood (which may affect clotting);
Nausea (feeling unwell);
Skin rash;
Blood tests may show:
- Increased gamma-glutamyl transferase (GGT) or alanine aminotransferase (ALT) levels.

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

Low blood pressure, which may cause weakness or a rapid heartbeat;
Bleeding:
- In the eyes;
- In the mouth or blood in sputum when coughing;
- Clear/red blood in the stools;
- Blood tests showing blood in the stools or urine;
- Bleeding occurring after any surgery, including bruising and swelling, leakage of blood or fluids from the surgical wound/incision (wound discharge) or from the injection site;
- From haemorrhoids;
- Into the muscle;
Itching;
Hair loss;
Allergic reactions (hypersensitivity) which may cause: swelling of the face, lips, mouth, tongue and/or throat, and difficulty breathing. Contact your doctor immediately if you experience any of these symptoms;
Blood tests may show:
- Abnormal liver function;
- Increased levels of certain liver enzymes;
- Increased bilirubin, a product of red blood cell breakdown, which may cause yellowing of the skin and eyes.

Rare side effects (may affect up to 1 in 1,000 people)

Bleeding:
- In the brain or spinal cord;
- In the lungs.

Not known (frequency cannot be estimated from available data)

Bleeding:
- In the abdomen or in the space behind the abdominal cavity.
Skin rash that may form blisters and appear as small spots (dark central spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme);
Inflammation of blood vessels (vasculitis), which may cause skin rashes or small, flat, red, round spots under the skin surface or bruising.
Bleeding in the kidney, sometimes with blood in the urine, leading to impaired kidney function (anticoagulant-related nephropathy).

Other side effects in children and adolescents
Contact the child’s doctor immediately if you notice any of these symptoms:

Allergic reactions (hypersensitivity) which may cause: swelling of the face, lips, mouth, tongue and/or throat, and difficulty breathing. The frequency of these side effects is common (may affect up to 1 in 10 people).

In general, the side effects observed in children and adolescents treated with Apixaban Dr. Reddy’s have been of a similar type to those observed in adults and have mainly been mild to moderate in severity. The side effects observed more frequently in children and adolescents were nosebleeds and abnormal vaginal bleeding.

Very common side effects (may affect more than 1 in 10 people)

Bleeding, including:
- From the vagina;
- Nosebleeds.

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

Bleeding, including:
- From the gums;
- Blood in the urine;
- Bruising and swelling;
- From the intestines or rectum;
- Clear/red blood in the stools;
- Bleeding occurring after any surgery, including bruising and swelling, leakage of blood or fluid from the surgical wound/incision (wound discharge) or from the injection site;
Hair loss;
Anaemia, which may cause tiredness or pale skin;
Reduction in the number of platelets in the child’s blood (which may affect clotting);
Nausea (feeling unwell);
Skin rash;
Itching;
Low blood pressure, which may cause the child to feel weak or have a rapid heartbeat;
Blood tests may show:
- Abnormal liver function;
- Increased levels of certain liver enzymes;
- Increased alanine aminotransferase (ALT).

Not known (frequency cannot be determined from available data)

Bleeding:
- In the abdomen or in the space behind the abdominal cavity;
- In the stomach;
- In the eyes;
- In the mouth;
- From haemorrhoids;
- In the mouth or blood in sputum when coughing;
- In the brain or spinal cord;
- In the lungs;
- Into the muscle;
Skin rash that may form blisters and appear as small targets (dark central spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme);
Inflammation of blood vessels (vasculitis), which may present as skin rashes or small, flat, red, round spots under the skin surface or bruising;
Blood tests may show:
- Increased gamma-glutamyl transferase (GGT) levels;
- Blood tests showing blood in the stools or urine.
Bleeding in the kidney, sometimes with blood in the urine, leading to impaired kidney function (anticoagulant-related nephropathy).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Apixaban Dr. Reddy's

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack after "Exp". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Apixaban Dr. Reddy's contains

The active substance is apixaban. Each tablet contains 2.5 mg of apixaban.
The other components are:
Tablet core: lactose (see section 2 "Apixaban Dr. Reddy's contains lactose (a type of sugar) and sodium"), microcrystalline cellulose, sodium croscarmellose (see section 2 "Apixaban Dr. Reddy's contains lactose (a type of sugar) and sodium"), sodium lauryl sulfate, magnesium stearate (E470b);
Coating: monohydrate lactose (see section 2 "Apixaban Dr. Reddy's contains lactose (a type of sugar) and sodium"), hypromellose (E464), titanium dioxide (E171), triacetin, yellow iron oxide (E172).

Description of the appearance of Apixaban Dr. Reddy's and pack contents
The film-coated tablets are yellow, round (6 mm in diameter), with "2.5" engraved on one side and smooth on the other.
They are available in blisters packed in cartons containing 10, 14, 20, 28, 56, 60, 100, 168 and 200 film-coated tablets, and in bottles containing 20, 60 or 100 film-coated tablets.
Not all pack sizes may be marketed.

Patient Card: information management
Inside the package of Apixaban Dr. Reddy’s, together with the package leaflet, you will find a Patient Card, or your doctor may provide you with a similar one. This Patient Card includes information that may be useful to you and alerts other physicians that you are taking Apixaban Dr. Reddy’s.
You must always carry this card with you.

Take the card.
Separate the text in your language as needed (this will be facilitated by the pre-perforated edge).
Complete the following sections or ask your doctor to do so:
- Name:
- Date of birth:
- Indication:
- Dose: ...... mg twice daily
- Doctor’s name:
- Doctor’s telephone number:
Fold the card and always keep it with you.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Dr. Reddy's S.r.l.
Piazza Santa Maria Beltrade 1
20123, Milan
Italy

Manufacturers
betapharm Arzneimittel GmbH
Kobelweg 95,
86156 Augsburg,
Germany
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park,
Paola PLA 3000,
Malta
Rual Laboratories SRL
313, Splaiul Unirii, Building H,
1st floor, sector 3
Bucuresti, 030138,
Romania

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Austria Apixaban Reddy 2.5 mg Filmtabletten
Germany Apixaban beta 2.5 mg Filmtabletten
Italy Apixaban Dr. Reddy’s
Netherlands Apixaban Reddy 2.5 mg filmomhulde tabletten
Poland Apixaban Reddy
Czech Republic Apixaban Reddy
Slovakia Apixaban Reddy 2.5 mg filmom obalené tablety
Sweden Apixaban Reddy 2.5 mg filmdragerade tabletter

Patient Information Leaflet: Information for the User

Apixaban Dr. Reddy’s 5 mg film-coated tablets

apixaban
Generic medicine
Please read this entire leaflet carefully before taking this medicine, as it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

What Apixaban Dr. Reddy’s is and what it is used for
What you need to know before taking Apixaban Dr. Reddy’s
How to take Apixaban Dr. Reddy’s
Possible side effects
How to store Apixaban Dr. Reddy’s
Contents of the pack and other information

1. What Apixaban Dr. Reddy’s is and what it is used for

Apixaban Dr. Reddy’s contains the active substance apixaban and belongs to a group of medicines called
anticoagulants. This medicine helps prevent the formation of blood clots by blocking Factor
Xa, which is an important component in blood clotting.
Apixaban Dr. Reddy’s is used in adults:
to prevent the formation of blood clots in the heart in patients with irregular heartbeats
(atrial fibrillation) and with at least one additional risk factor. Blood clots can break loose and
travel to the brain, causing stroke, or reach other organs, blocking normal blood flow to those organs (also known as systemic embolism). A stroke can be life-threatening and requires immediate medical treatment.
to treat blood clots in the veins of the legs (deep vein thrombosis) and in the blood vessels of the
lungs (pulmonary embolism), and to prevent the recurrence of blood clots in the blood vessels of the
legs and/or lungs.
Apixaban Dr. Reddy’s is used in children aged 28 days to less than 18 years to treat blood clots and to prevent the recurrence of blood clots in the veins or blood vessels of the lungs.
For the recommended dose according to body weight, see section 3.

2. What you should know before taking Apixaban Dr. Reddy’s

Do not take Apixaban Dr. Reddy’s if:
you are allergic to apixaban or to any of the other ingredients of this medicine (listed in
section 6);
you have excessive bleeding;
you have a disease in a body organ that leads to an increased risk of life-threatening bleeding (such as
a recent or active ulcer of the stomach or intestine, recent bleeding in the brain);
you have a liver disease that leads to an increased risk of bleeding (hepatic coagulopathy);
you are taking medicines to prevent blood clots (e.g.,
warfarin, rivaroxaban, dabigatran, or heparin), except when switching anticoagulant therapy, while having a venous or arterial catheter and receiving heparin through it to keep it open, or if a catheter is inserted into one of your blood vessels (transcatheter ablation) to treat an irregular heartbeat (arrhythmia).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking this medicine if you have any of the following conditions:
an increased risk of bleeding, such as:
bleeding disorders, including conditions leading to reduced platelet activity;
very high blood pressure not controlled by medical treatment;
if you are over 75 years of age;
body weight equal to or less than 60 kg;
severe kidney disease or if you are on dialysis;
liver problems or a history of liver problems;
this medicine should be used with caution in patients showing signs of impaired liver function.
you have had a tube (catheter) or an injection in your spine (for anaesthesia or pain relief). Your doctor will tell you when to start taking this medicine, at least 5 hours or more after removal of the catheter;
you have a prosthetic heart valve;
if your doctor finds that your blood pressure is unstable, or if another treatment or surgical procedure to remove a blood clot from the lungs has been planned.

If you are scheduled for surgery or a procedure that may cause bleeding, your doctor may ask you to temporarily stop taking this medicine for a short period. If you are unsure whether a procedure might cause bleeding, ask your doctor.

Children and adolescents
This medicine is not recommended for children and adolescents weighing less than 35 kg.

Other medicines and Apixaban Dr. Reddy’s
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.

Some medicines can increase the effect of apixaban, while others can reduce it. Your doctor will decide whether you should be treated with apixaban when taking these medicines and how closely you should be monitored.

The following medicines may increase the effect of apixaban and increase the risk of unwanted bleeding:

certain medicines for fungal infections (e.g., ketoconazole);
certain antiviral medicines for HIV/AIDS (e.g., ritonavir);
other medicines used to reduce blood clotting (e.g., enoxaparin, etc.);
anti-inflammatory drugs or painkillers (e.g., acetylsalicylic acid or naproxen). In particular, if you are over 75 years of age and taking acetylsalicylic acid, you may have a higher risk of bleeding;
medicines for high blood pressure or heart problems (e.g., diltiazem);
antidepressant medicines known as selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs).

The following medicines may reduce the effect of apixaban in helping to prevent blood clots:

medicines for epilepsy or seizures (e.g., phenytoin, etc.);
St. John's wort (a herbal product used for depression);
medicines for treating tuberculosis or other infections (e.g., rifampicin).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor, pharmacist, or nurse before taking this medicine.
The effect of apixaban during pregnancy and on the unborn child is unknown. You must not take this medicine if you are pregnant. Contact your doctor immediately if you become pregnant while taking this medicine.
It is not known whether apixaban passes into human breast milk. Consult your doctor, pharmacist, or nurse before taking this medicine while breastfeeding. They will advise you whether to stop breastfeeding or to stop or not start treatment with this medicine.

Driving and using machines
Apixaban has not shown effects on the ability to drive or use machinery.

Apixaban Dr. Reddy’s contains lactose and sodium
If your doctor has informed you that you have an intolerance to certain sugars, contact them before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially “sodium-free”.

3. How to take Apixaban Dr. Reddy’s

Take this medicine exactly as prescribed by your doctor or pharmacist. If you have
any doubts, consult your doctor, pharmacist, or nurse.
Dosage
Swallow the tablet with some water. Apixaban Dr. Reddy’s may be taken with or without
food. Try to take the tablets at the same time each day to achieve the best effect from
treatment.
If you have difficulty swallowing the tablet whole, ask your doctor about alternative ways to take
Apixaban Dr. Reddy’s. The tablet may be crushed and mixed with water, or 50 mg/mL glucose
(5%) in water, apple juice, or apple puree, immediately before administration.
Instructions for crushing the tablet:
Crush the tablets using a mortar and pestle.

Carefully transfer all the powder into a suitable container and then mix the powder with a small amount, e.g., 30 mL (2 tablespoons), of water or one of the other liquids listed above to prepare a mixture.
Swallow the mixture.
Rinse the mortar and pestle used to crush the tablet and the container with a small amount of water (e.g., 30 mL) or one of the other liquids, and swallow the rinse.

If necessary, your doctor may also administer the crushed Apixaban Dr. Reddy’s tablet mixed with 60 mL of water or 50 mg/mL glucose (5%) in water through a nasogastric tube.
Take Apixaban Dr. Reddy’s as recommended:
To prevent blood clots in the heart in patients with irregular heartbeat and at least one additional risk factor.
The recommended dose is one tablet of Apixaban Dr. Reddy’s 5 mg twice daily.
The recommended dose is one tablet of Apixaban Dr. Reddy’s 2.5 mg twice daily if:

you have severely reduced kidney function;
you meet two or more of the following conditions: blood test results suggest poor kidney function (serum creatinine level is 1.5 mg/dL (133 micromoles/L) or higher); you are 80 years of age or older; your 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 you should continue treatment.
For treating blood clots in the veins of the legs and in the blood vessels of the lungs
The recommended dose is two tablets of Apixaban Dr. Reddy’s 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 Dr. Reddy’s 5 mg twice daily,
for example, one tablet in the morning and one in the evening.
To prevent recurrence of blood clots after completing 6 months of treatment
The recommended dose is one tablet of Apixaban Dr. Reddy’s 2.5 mg twice daily, for example,
one tablet in the morning and one in the evening.
Your doctor will decide how long you should continue treatment.
Use in children and adolescents
For treating blood clots and to prevent blood clots from recurring in veins or
pulmonary blood vessels.
Take or administer this medicine exactly as instructed by your doctor or the child’s doctor or pharmacist. If you have any doubts, consult your doctor or the child’s doctor, pharmacist, or nurse.
Try to take or administer the dose at the same time each day to achieve the best effect from treatment.
The dose of Apixaban Dr. Reddy’s depends on body weight and will be calculated by the doctor.
The recommended dose for children and adolescents with body weight of at least 35 kg is two
tablets of Apixaban Dr. Reddy’s 5 mg twice daily for the first 7 days, for example, two in the
morning and two in the evening.
After 7 days, the recommended dose is one tablet of Apixaban Dr. Reddy’s 5 mg twice daily, for example, one in the morning and one in the evening.
For parents or caregivers: observe the child to ensure the full dose has been taken.
It is important to keep scheduled medical appointments, as the dose may need to be adjusted as body weight changes.
Your doctor may modify your anticoagulant treatment as follows:

Switching from Apixaban Dr. Reddy’s to another anticoagulant medicine Stop taking apixaban. Start treatment with the anticoagulant medicine (e.g., heparin) at the time you would have taken your next tablet.
Switching from another anticoagulant medicine to Apixaban Dr. Reddy’s Stop taking the anticoagulant medicine. Start treatment with apixaban at the time you would have taken your next dose of the anticoagulant, then continue taking it as directed.
Switching from a vitamin K antagonist anticoagulant (e.g., warfarin) to Apixaban Dr. Reddy’s Stop taking the vitamin K antagonist medicine. Your doctor will need to perform blood tests to determine when you should start apixaban treatment.
Switching from Apixaban Dr. Reddy’s to a vitamin K antagonist anticoagulant (e.g., warfarin)

If your doctor instructs you to start taking a vitamin K antagonist medicine,
continue taking apixaban for at least 2 days after the first dose of the vitamin K antagonist medicine. Your doctor will need to perform blood tests before advising you when to stop apixaban treatment.
Patients undergoing cardioversion
If your abnormal heartbeat needs to be restored to normal through a procedure called cardioversion, take this medicine exactly as directed by your doctor to prevent blood clots in blood vessels of the brain and elsewhere in your body.
If you take more Apixaban Dr. Reddy’s than you should
Inform your doctor immediately if you have taken more than the prescribed dose of apixaban.
Bring the medicine packaging with you, even if the tablets are finished.
If you take more apixaban than recommended, you may have an increased risk of bleeding.
If bleeding occurs, you may require surgery, a blood transfusion, or other treatments to reverse the anticoagulant activity of factor Xa.
If you forget to take Apixaban Dr. Reddy’s

If you forget a morning dose, take it as soon as you remember, and you may take it together with your evening dose.
A forgotten evening dose may only be taken the same evening. Do not take two doses the next morning; instead, continue following the twice-daily dosing schedule as recommended the following day.

If you are unsure what to do or if you have missed more than one dose, consult your doctor,
pharmacist, or nurse.
If you stop taking Apixaban Dr. Reddy’s
Do not stop taking this medicine without first talking to your doctor, as the risk of developing a blood clot may be higher if you stop treatment too early.
If you have any questions about the use of this medicine, consult your doctor,
pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The most common general side effect of this medicine is bleeding, which can potentially be life-threatening and requires immediate medical attention.

The following side effects are known when taking apixaban to prevent blood clots forming in the heart of patients with irregular heartbeat and at least one additional risk factor.

Common side effects (may affect 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;
bruising and swelling;
Anaemia, which may cause tiredness or pale skin;
Low blood pressure, which may cause weakness or a rapid heartbeat;
Nausea (feeling unwell);
Blood tests may show:
an increase in gamma-glutamyl transferase (GGT).

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

Bleeding:
in the brain or spinal cord;
in the mouth or blood in coughed-up mucus (sputum) when coughing;
in the abdomen or from the vagina;
bright red blood in stools;
bleeding occurring after surgery, including bruising and swelling, leakage of blood or fluid from the surgical wound/incision (wound discharge) or from the injection site;
from haemorrhoids;
tests showing blood in stools or urine;
Reduction in the number of platelets in the blood (which may affect blood clotting);
Blood tests may show:
abnormalities in liver function;
increase in certain liver enzymes;
increase in bilirubin, a product of red blood cell breakdown, which may cause yellowing of the skin and eyes;
Rash;
Itching;
Hair loss;
Allergic reactions (hypersensitivity) which may cause: swelling of the face, lips, mouth, tongue and/or throat and difficulty breathing. Contact your doctor immediately if you experience any of these symptoms.

Rare side effects (may affect up to 1 in 1,000 people)

Bleeding:
in the lungs or throat;
in the space behind the abdominal cavity (retroperitoneal space);
in the muscle.

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

Skin rash that may blister and appears as small target-like spots (dark central spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme).

Not known (frequency cannot be estimated from available data)

Inflammation of blood vessels (vasculitis), which may cause skin rashes or small, flat, red, round spots or bruising under the skin surface.
Bleeding in the kidney, sometimes with blood in the urine, leading to impaired kidney function (anticoagulant-related nephropathy).

The following side effects are known when apixaban is taken to treat or prevent recurrence of blood clots in the veins of the legs and in the blood vessels of the lungs.

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

Bleeding, including:
from the nose;
from the gums;
blood in the urine;
bruising and swelling;
in the stomach, intestines, or from the rectum;
in the mouth;
from the vagina;
Anaemia, which may cause tiredness or pale skin;
Reduction in the number of platelets in the blood (which may affect blood clotting);
Nausea (feeling unwell);
Rash;
Blood tests may show:
an increase in gamma-glutamyl transferase (GGT) or alanine aminotransferase (ALT).

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

Low blood pressure, which may cause weakness or a rapid heartbeat;
Bleeding:
in the eyes;
in the mouth or blood in coughed-up mucus (sputum) when coughing;
bright red blood in stools;
tests showing blood in stools or urine;
bleeding occurring after any surgical procedure, including bruising and swelling, leakage of blood or fluid from the surgical wound/incision (wound discharge) or from the injection site;
from haemorrhoids;
in the muscle;
Itching;
Hair loss;
Allergic reactions (hypersensitivity) which may cause: swelling of the face, lips, mouth, tongue and/or throat and difficulty breathing. Contact your doctor immediately if you experience any of these symptoms;
Blood tests may show:
abnormalities in liver function;
increase in certain liver enzymes;
increase in bilirubin, a product of red blood cell breakdown, which may cause yellowing of the skin and eyes.

Rare side effects (may affect up to 1 in 1,000 people)

Bleeding:
in the brain or spinal cord;
in the lungs.

Not known (frequency cannot be estimated from available data)

Bleeding:
in the abdomen or in the space behind the abdominal cavity (retroperitoneal space).
Skin rash that may blister and appears as small target-like spots (dark central spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme);
Inflammation of blood vessels (vasculitis), which may cause skin rashes or small, flat, red, round spots or bruising under the skin surface.
Bleeding in the kidney, sometimes with blood in the urine, leading to impaired kidney function (anticoagulant-related nephropathy).

Other side effects in children and adolescents
Contact your child’s doctor immediately if you notice any of the following symptoms:

Allergic reactions (hypersensitivity) which may cause: swelling of the face, lips, mouth, tongue and/or throat and difficulty breathing. The frequency of these side effects is common (may affect up to 1 in 10 people).

In general, side effects observed in children and adolescents treated with Apixaban Dr. Reddy’s have been similar to those seen in adults and have mainly been mild to moderate in severity. The side effects observed more frequently in children and adolescents were nosebleeds and abnormal vaginal bleeding.

Very common side effects (may affect more than 1 in 10 people)

Bleeding, including:
from the vagina;
from the nose.

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

Bleeding, including:
from the gums;
blood in the urine;
bruising and swelling;
from the intestine or rectum;
bright red blood in stools;
bleeding occurring after any surgical procedure, including bruising and swelling, leakage of blood or fluid from the surgical wound/incision (wound discharge) or from the injection site;
Hair loss;
Anaemia, which may cause tiredness or pale skin;
Reduction in the number of platelets in your child’s blood (which may affect blood clotting);
Nausea (feeling unwell);
Rash;
Itching;
Low blood pressure, which may cause your child to feel weak or have a rapid heartbeat;
Blood tests may show:
abnormalities in liver function;
increase in certain liver enzymes;
increase in alanine aminotransferase (ALT).

Not known (frequency cannot be estimated from available data)

Bleeding:
in the abdomen or in the space behind the abdominal cavity (retroperitoneal space);
in the stomach;
in the eyes;
in the mouth;
from haemorrhoids;
in the mouth or blood in coughed-up mucus (sputum) when coughing;
in the brain or spinal cord;
in the lungs;
in the muscle;
Skin rash that may blister and appears as small target-like spots (dark central spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme);
Inflammation of blood vessels (vasculitis), which may present as skin rashes or small, flat, red, round spots under the skin surface or bruising;
Blood tests may show:
an increase in gamma-glutamyl transferase (GGT);
tests showing blood in stools or urine.
Bleeding in the kidney, sometimes with blood in the urine, leading to impaired kidney function (anticoagulant-related nephropathy).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Apixaban Dr. Reddy's

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and on the blister
after "Exp". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Apixaban Dr. Reddy's contains

The active substance is apixaban. Each tablet contains 5 mg of apixaban.
Other components are:
a. Tablet core: lactose (see section 2 "Apixaban Dr. Reddy's contains lactose (a type of sugar) and sodium"), microcrystalline cellulose, sodium croscarmellose (see section 2 "Apixaban Dr. Reddy's contains lactose (a type of sugar) and sodium"), sodium lauryl sulfate, magnesium stearate (E470b);
b. Coating: monohydrate lactose (see section 2 "Apixaban Dr. Reddy's contains lactose (a type of sugar) and sodium"), hypromellose (E464), titanium dioxide (E171), triacetin, red iron oxide (E172).

Description of the appearance of Apixaban Dr. Reddy's and package contents
The film-coated tablets are pink, oval-shaped (approximately 11 mm x 6 mm), marked with "5" on one side and smooth on the other.
Available in blisters packed in cartons containing 10, 14, 20, 28, 56, 60, 100, 168 and 200 film-coated tablets, and in bottles containing 20, 60 and 200 film-coated tablets.
Not all pack sizes may be marketed.

Patient Card: information management
Inside the package of Apixaban Dr. Reddy’s, together with the package leaflet, you will find a Patient Card, or your doctor may provide you with a similar one.
This Patient Card includes information that may be helpful to you and alerts other physicians that you are taking Apixaban Dr. Reddy’s.
You must always carry this card with you.

Take the card.
Detach the text in your language as needed (this will be facilitated by the pre-perforated edge).
Complete the following sections, or ask your doctor to do so:
- Name:
- Date of birth:
- Indication:
- Dose ....... mg twice daily
- Doctor’s name:
- Doctor’s telephone number:
Fold the card and always keep it with you.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Dr. Reddy's S.r.l.
Piazza Santa Maria Beltrade 1
20123, Milan
Italy

Manufacturers
betapharm Arzneimittel GmbH
Kobelweg 95,
86156 Augsburg,
Germany
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park,
Paola PLA 3000,
Malta
Rual Laboratories SRL
313, Splaiul Unirii, Building H,
1st floor, sector 3
Bucuresti, 030138,
Romania

This medicinal product is authorised in the European Economic Area countries under the following names:
Austria Apixaban Reddy 5 mg Filmtabletten
Germany Apixaban beta 5 mg Filmtabletten
Italy Apixaban Dr. Reddy’s
Netherlands Apixaban Reddy 5 mg filmomhulde tabletten
Poland Apixaban Reddy
Czech Republic Apixaban Reddy
Slovakia Apixaban Reddy 5 mg filmom obalené tablety
Sweden Apixaban Reddy 5 mg filmdragerade tabletter