Apixaban reddy

Package leaflet: Information for the user

Apixaban Reddy, 5 mg, film-coated tablets
Apixabanum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

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

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

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

Apixaban Reddy is used in adults:

• to prevent blood clots in the heart in patients with irregular heart rhythm (atrial fibrillation) and at least one additional risk factor. Blood clots may break loose and travel to the brain, causing stroke, or to other organs, blocking blood flow to these organs (also known as systemic embolism). Stroke may be life-threatening and requires immediate medical attention.
• to treat blood clots in the deep veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism), and to prevent recurrence of blood clots in the blood vessels of the legs and/or lungs.

2. Important information before using Apixaban Reddy

When not to use Apixaban Reddy

• if the patient is allergic to apixaban or any of the other ingredients of this medicine (listed in section 6),
• if the patient has excessive bleeding,
• if the patient has an organ disease that increases the risk of severe bleeding (such as active or recently diagnosed peptic ulcer of the stomach or intestine, recently diagnosed intracranial haemorrhage),
• if the patient has liver disease leading to an increased risk of bleeding (hepatic coagulopathy),
• if the patient is taking anticoagulant medicines (e.g. warfarin, rivaroxaban, dabigatran or heparin), except in situations when switching anticoagulant therapy, when the patient has an intravenous or intra-arterial line in place and heparin is administered through this line to maintain its patency, or when the patient is undergoing catheter ablation (a catheter is inserted into the vein) due to irregular heartbeat (arrhythmia).

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

• increased risk of bleeding, for example:
• conditions involving bleeding, including those resulting in reduced platelet activity,
• very high blood pressure uncontrolled by medication,
• if the patient is over 75 years of age,
• if the patient's body weight is 60 kg or less,
• severe kidney disease or if the patient is on dialysis,
• liver disease or history of liver disorders,
• This medicine should be used with caution in patients showing signs of impaired liver function.
• if the patient has a heart valve prosthesis,
• if the doctor determines that the patient's blood pressure is unstable or if other treatment or a surgical procedure to remove a blood clot from the lungs is planned.

When to exercise particular caution when using Apixaban Reddy

• if the patient has a disorder called antiphospholipid syndrome (an immune system disorder causing increased risk of blood clots), the patient should inform the doctor, who will decide whether treatment needs to be changed. If surgery or a procedure that may cause bleeding is required, the doctor may ask the patient to temporarily stop taking this medicine for a short period. If in doubt whether a given procedure may cause bleeding, ask the doctor.

Children and adolescents
This medicine is not recommended for use in children and adolescents under 18 years of age.
Apixaban Reddy and other medicines
Tell your doctor, pharmacist or nurse about any medicines the patient is currently taking, has recently taken or plans to take.
Some medicines may enhance the effect of apixaban, while others may reduce its effect. The doctor will decide whether the patient should receive apixaban while taking other medicines and how closely monitoring should be performed.
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 infection (e.g. ritonavir)
• other medicines used to reduce blood clotting (e.g. enoxaparin and others)
• anti-inflammatory or pain-relieving medicines (e.g. acetylsalicylic acid or naproxen), particularly if the patient is over 75 years of age and taking acetylsalicylic acid, which may increase the risk of unwanted bleeding
• medicines used for high blood pressure or heart problems (e.g. diltiazem)
• antidepressant medicines known as selective serotonin reuptake inhibitors or serotonin and noradrenaline reuptake inhibitors.

The following medicines may reduce apixaban’s ability to prevent blood clots:

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

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a
child, she should consult her doctor, pharmacist or nurse before using this medicine.
The effect of apixaban on pregnancy and the unborn child is unknown. This medicine should not be used
during pregnancy. If the patient becomes pregnant while taking this medicine, she should contact her doctor immediately.
It is unknown whether apixaban passes into human milk. Before using this medicine during
breastfeeding, consult your doctor, pharmacist or nurse. The patient may be advised to discontinue breastfeeding or to stop/avoid starting this medicine.
Driving and operating machinery
No effects of apixaban on the ability to drive and operate machinery have been observed.
Apixaban Reddy contains lactose (a type of sugar) and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact
their doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Apixaban Reddy

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt, consult a doctor, pharmacist, or nurse.
Dosage
Swallow the tablet with water. Apixaban Reddy may be taken independently of meals. To achieve the best treatment results, it is recommended to take the tablets at the same times each day.
If you have difficulty swallowing the tablet whole, speak to your doctor about other ways of taking Apixaban Reddy. Immediately before administration, the tablet may be crushed and mixed with water or a 50 mg/mL (5%) aqueous 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 mix it with a small amount (e.g., 30 mL [2 tablespoons]) of water or one of the liquids listed above to prepare a mixture.
• Swallow (drink) the resulting mixture.
• Rinse the pestle and mortar used for crushing the tablets, as well as the container, with a small amount of water or another liquid (e.g., 30 mL), then swallow (drink) the rinsing liquid.

If necessary, your doctor may also administer crushed Apixaban Reddy tablets through a nasogastric tube, mixed with 60 mL of water or a 50 mg/mL (5%) aqueous glucose solution.
Apixaban Reddy should be taken as directed for the following indications:
Prevention of blood clots in the heart in patients with irregular heartbeat (arrhythmia) and at least one additional risk factor
The recommended dose is one tablet of Apixaban Reddy 5 mg twice daily.
The recommended dose is one tablet of Apixaban Reddy 2.5 mg twice daily if:

• the patient has severe renal impairment, or
• two or more of the following conditions are met:
• blood test results indicate reduced kidney function (serum creatinine level of 1.5 mg/dL [133 micromoles/L] or higher)
• the patient is 80 years of age or older
• the patient's body weight is 60 kilograms or less.

The recommended dose is one tablet twice daily, for example, one tablet in the morning and one in the evening.
Your doctor will decide how long treatment should continue.
Treatment of blood clots in the deep veins of the legs and blood clots in the blood vessels of the lungs
The recommended dose is two tablets of Apixaban Reddy 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 Reddy 5 mg twice daily, for example, one tablet in the morning and one in the evening.
Prevention of recurrent blood clots after completion of 6-month treatment
The recommended dose is one tablet of Apixaban Reddy 2.5 mg twice daily, for example, one tablet in the morning and one in the evening.
Your doctor will decide how long treatment should continue.
Your doctor may switch anticoagulant therapy as follows:

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

first dose of the vitamin K antagonist medicine. Your doctor must perform blood tests and inform you when to stop taking apixaban.
Patients undergoing cardioversion
Patients with irregular heartbeat who require a cardioversion procedure to restore normal heart rhythm should take this medicine at the times specified by their doctor to prevent the formation of blood clots in the brain's blood vessels and other blood vessels in the body.
Taking more than the recommended dose of Apixaban Reddy
If you have taken more than the recommended dose of apixaban, contact your doctor immediately. Bring the medicine packaging with you, even if no tablets remain.
If you have taken more than the recommended dose of apixaban, your risk of bleeding may increase. If bleeding occurs, surgical treatment, blood transfusion, or other treatment to reverse the effect of the factor Xa inhibitor may be necessary.
Missed dose of Apixaban Reddy

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

If you have any doubts about using the medicine or if you miss more than one dose, consult your doctor, pharmacist, or nurse.
Stopping Apixaban Reddy
Do not stop taking this medicine without consulting your doctor, as stopping apixaban treatment prematurely may increase the risk of developing a blood clot.
If you have any further 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 everyone will experience them.
The most common general side effect of this medicine is bleeding, which may potentially
be life-threatening and may require immediate medical attention.
The following side effects may occur when taking apixaban to
prevent blood clots in the heart in patients with irregular heartbeat and at least
one additional risk factor.

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

• Bleeding, including:
• into the eyes;
• into the stomach or intestine;
• from the rectum;
• blood in urine;
• nosebleeds;
• bleeding from gums;
• subcutaneous haemorrhage (bruising) and swelling;
• Anaemia, which may cause fatigue or paleness;
• Low blood pressure, which may lead to fainting or rapid heartbeat;
• Nausea;
• Blood test results may show:
• increased gamma-glutamyl transferase (GGT) activity.

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

• Bleeding:
• into the brain or spinal canal;
• in the mouth or presence of blood in sputum when coughing;
• in the abdominal cavity or from the vagina;
• bright red blood in stool;
• bleeding occurring after surgery, including bruising and swelling, leakage of blood or fluid from the surgical wound/incision site (wound discharge) or injection site;
• from haemorrhoids;
• presence of blood in stool or urine detected in laboratory tests;
• Decreased number of platelets in blood (which may affect blood clotting);
• Blood test results may show:
• abnormal liver function;
• increased activity of certain liver enzymes;
• increased bilirubin levels, a breakdown product of red blood cells, which may cause yellowing of the skin and eyes;
• Skin rash;
• Itching;
• Hair loss;
• Allergic (hypersensitivity) reactions, which may cause: swelling of the face, lips, mouth, tongue and/or throat, and breathing difficulties. If any of these symptoms occur, seek medical advice immediately.

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

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

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

• Skin rash with blister formation, appearing as target-like lesions (dark spots in the centre surrounded by a lighter ring, with a dark ring around the edge) (erythema multiforme).

Frequency not known (cannot be estimated from available data)

• Inflammation of blood vessels (vasculitis), which may cause skin rash or raised, flat, red, round spots beneath the skin surface, or bruising;
• Bleeding in the kidneys, sometimes with blood in urine, leading to impaired kidney function (anticoagulant-related nephropathy).

The following side effects may occur when taking apixaban to treat
or prevent recurrence of blood clots in the veins of the lower limbs and
blood clots in blood vessels of the lungs.

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

• Bleeding, including:
• nosebleeds;
• bleeding from gums;
• blood in urine;
• subcutaneous haemorrhage (bruising) and swelling;
• in the stomach, intestine, or from the rectum;
• in the mouth;
• from the vagina;
• Anaemia, which may cause fatigue or paleness;
• Decreased number of platelets in blood (which may affect blood clotting);
• Nausea;
• Skin rash;
• Blood test results may show:
• increased gamma-glutamyl transferase (GGT) or alanine aminotransferase (AlAT) activity.

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

• Low blood pressure, which may lead to fainting or rapid heartbeat;
• Bleeding:
• into the eyes;
• in the mouth or presence of blood in sputum when coughing;
• bright red blood in stool;
• test results indicating blood in stool or urine;
• bleeding occurring after surgery, including bruising and swelling, leakage of blood or fluid from the surgical wound/incision site (wound discharge) or injection site;
• from haemorrhoids;
• into muscles;
• Itching;
• Hair loss;
• Allergic (hypersensitivity) reactions, which may cause: swelling of the face, lips, mouth, tongue and/or throat, and breathing difficulties. If any of these symptoms occur, seek medical advice immediately;
• Blood test results may show:
• abnormal liver function;
• increased activity of certain liver enzymes;
• increased bilirubin levels, a breakdown product of red blood cells, which may cause yellowing of the skin and eyes.

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

• Bleeding:
• into the brain or spinal canal;
• in the lungs.

Frequency not known (cannot be estimated from available data)

• Bleeding:
• into the abdominal cavity or retroperitoneal space;
• Skin rash with blister formation, appearing as target-like lesions (dark spots in the centre surrounded by a lighter ring, with a dark ring around the edge) (erythema multiforme);
• Inflammation of blood vessels (vasculitis), which may cause skin rash or raised, flat, red, round spots beneath the skin surface, or bruising;
• Bleeding in the kidneys, sometimes with blood in urine, leading to impaired kidney function (anticoagulant-related nephropathy).

Reporting of side effects
If any side effects occur, including any not listed in
this leaflet, inform your doctor, pharmacist or nurse. Side effects can
be reported directly to the Department of Monitoring Adverse Drug Reactions
at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C,
02-222 Warsaw,
tel.: 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 helps provide more information on the
safety of this medicine.

5. How to store Apixaban Reddy

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box and blister pack after:
EXP. The expiry date refers to the last day of the stated month.
No special storage conditions apply for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Apixaban Reddy contains

• The active substance is apixaban. Each tablet contains 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: monohydrate lactose [see section 2 "Apixaban Reddy contains lactose (a type of sugar) and sodium *"], hypromellose (E 464), titanium dioxide (E 171), triacetin, iron oxide red (E 172).

What Apixaban Reddy looks like and contents of the pack
The film-coated tablets are pink, oval-shaped (approx. 11 mm x 6 mm), marked with the number "5" on one side and smooth on the other.
Available in blister packs contained in cardboard boxes of 10, 14, 20, 28, 56, 60, 100, 168 or 200 film-coated tablets, and in bottles containing 20, 60 or 200 film-coated tablets.
Not all pack sizes may be marketed.
Patient Alert Card: information on use
Inside the Apixaban Reddy packaging, alongside the patient leaflet, a Patient Alert Card is included, or your physician may provide you with a similar card.
The Patient Alert Card contains helpful information for the patient and warns other physicians that the patient is taking Apixaban Reddy. You should always carry this card with you.

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

Marketing Authorization Holder
Reddy Holding GmbH
Kobelweg 95
86156 Augsburg
Germany
Telephone: +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 authorised for use in EEA countries under the following names:
Germany: Apixaban beta 5 mg Filmtabletten
Austria: Apixaban Reddy 5 mg Filmtabletten
Italy: Apixaban Dr. Reddy’s 5 mg compresse rivestite con film
Netherlands: Apixaban Reddy 5 mg filmomhulde tabletten
Czech Republic: Apixaban Reddy 5 mg potahované tablet
Poland: Apixaban Reddy 5 mg tabletki powlekane
Sweden: Apixaban Reddy 5 mg filmdragerade tabletter
Slovakia: Apixaban Reddy 5 mg filmom obalené tablety