Apixaban reddy

Poland
Brand name Apixaban reddy
Form tablets, film-coated
Active substance / Dosage
apixaban · 2.5 mg
Prescription type Prescription only
ATC code
B01AF02
Registration number 100481759
Manufacturer Betapharm Arzneimittel GmbH

Table of Contents

Package leaflet: Information for the user

Apixaban Reddy, 2.5 mg, coated tablets
Apixabanum
Please read 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 person. Do not pass it on to others. It may harm other people, 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 inhibiting factor Xa, an important component 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, patients have an increased risk of developing blood clots in the veins of the legs. This may lead to swelling of the legs, with or without pain. If a blood clot travels from the legs to the lungs, it may block blood flow through the lungs, causing breathlessness with or without chest pain. This condition (pulmonary embolism) may 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 may break loose and travel to the brain, causing a stroke, or to other organs, impairing 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), as well as 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 active bleeding,
  • if the patient has a disease that increases the risk of severe bleeding (such as active or recently diagnosed peptic ulcer of the stomach or intestine, recently diagnosed intracranial bleeding),
  • if the patient has liver disease that 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 situations of switching anticoagulant therapy, when a venous or arterial access line has been inserted and heparin is administered through the 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 associated with bleeding, including those resulting in reduced platelet activity,
  • very high blood pressure that is not controlled with medication,
  • if the patient is over 75 years of age,
  • if the patient's body weight is 60 kilograms or less,
  • severe kidney disease or if the patient is on dialysis,
  • liver disease or history of liver disease.
  • This medicine should be used with caution in patients showing signs of impaired liver function.
  • spinal catheter or spinal injection (anaesthetic or pain relief), in which case the doctor will advise taking this medicine 5 or more hours after catheter removal,
  • if the patient has a heart valve prosthesis,
  • if the doctor determines that the patient's blood pressure is unstable or other treatment is planned, or surgery to remove a blood clot from the lungs.

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 a change in treatment is necessary.

If surgery or a procedure that may cause bleeding is required,
the doctor may ask the patient to temporarily stop taking this medicine for a short period.
If in doubt whether a procedure may cause bleeding, consult 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 all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Some medicines may enhance the effect of apixaban, 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 medicines used to treat fungal infections (e.g. ketoconazole and others)
  • certain antiviral medicines used to treat HIV/AIDS infection (e.g. ritonavir)
  • other medicines used to reduce blood clotting (e.g. enoxaparin and others)
  • anti-inflammatory or pain-relieving medicines (e.g. acetylsalicylic acid or naproxen), especially if the patient is over 75 years of age and taking acetylsalicylic acid, the risk of bleeding may be increased
  • medicines used for high blood pressure or heart problems (e.g. diltiazem)
  • antidepressant medicines known as selective serotonin reuptake inhibitors or serotonin and norepinephrine 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 not known whether apixaban passes into human milk. Before using this medicine during breastfeeding, consult a doctor, pharmacist or nurse. The patient may be advised to discontinue breastfeeding or to discontinue/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 the doctor before taking the 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 exactly as directed by your doctor or pharmacist. If you have any doubts,
you should consult your doctor, pharmacist or nurse.
Dosage
The tablet should be swallowed 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, discuss alternative methods of taking Apixaban Reddy with your doctor. Immediately before administration, the tablet may be crushed and mixed with water or 5% glucose solution (50 mg/ml), apple juice or apple puree.
Instructions for crushing tablets:

  • Crush the tablet with a pestle in a mortar.
  • Carefully transfer the entire powder into 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 rinse liquid.

If necessary, your doctor may also administer crushed Apixaban Reddy tablets via a nasogastric tube, mixed with 60 mL of water or 5% glucose solution (50 mg/mL).
Apixaban Reddy should be taken as directed for the following indications:
Prevention of blood clots after hip or knee replacement surgery
The recommended dose is one 2.5 mg Apixaban Reddy tablet twice daily.
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 surgery, they will usually take the tablets for 32 to 38 days.
If the patient has undergone major knee surgery, they will usually take the tablets for 10 to 14 days.
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 5 mg Apixaban Reddy tablet twice daily.
The recommended dose is one 2.5 mg Apixaban Reddy tablet twice daily if:

  • the patient has severe renal impairment,
  • 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 5 mg Apixaban Reddy 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 Reddy tablet 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 2.5 mg Apixaban Reddy tablet 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 treatment as follows:

  • Switching from Apixaban Reddy to other anticoagulant medicines Discontinue taking Apixaban Reddy. Start treatment with anticoagulant medicines (e.g. heparin) at the time the next tablet was scheduled to be taken.
  • Switching from anticoagulant medicines to Apixaban Reddy Discontinue taking anticoagulant medicines. Begin apixaban treatment at the time the next dose of anticoagulant medicine was scheduled, then continue regular dosing.
  • Switching from anticoagulant treatment 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 treatment including a vitamin K antagonist (e.g. warfarin) If your doctor informs you that you should 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 cardioversion to restore normal heart rhythm should take this medicine at the times specified by the doctor to prevent formation of blood clots in the blood vessels of the brain 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 this medicine, you should contact your doctor immediately.
Take the medicine packaging with you, even if there are no tablets left in it.
If you have taken more than the recommended dose of apixaban, your risk of bleeding may be increased. If bleeding occurs, surgical treatment, blood transfusion or other treatments to reverse the effect of factor Xa inhibitors may be required.
Missing a dose of Apixaban Reddy

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

If you have any doubts about how to use 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 adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.
Apixaban may be used in three different medical conditions. Known adverse effects and their frequency of occurrence in each of these medical conditions may differ and are listed separately below. In these conditions, the most common general adverse effect of this medicine is bleeding, which may potentially be life-threatening and may require immediate medical attention.

The following adverse effects may occur when taking apixaban to prevent blood clots after hip or knee replacement surgery.

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

  • Anaemia, which may cause fatigue or paleness;
  • Bleeding including:
    • Subcutaneous haemorrhages (bruising) and swelling;
  • Nausea.

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

  • Decreased platelet count (which may affect blood clotting);
  • Bleeding:
    • After surgery, including bruising and swelling, leakage of blood or other fluid from the surgical wound/incision site (wound discharge) or injection site;
    • From the stomach, intestines, or bright red blood in stool;
    • Blood in urine;
    • Nosebleeds;
    • Vaginal bleeding;
  • Low blood pressure, which may 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 formed from destroyed red blood cells, which may cause yellowing of the skin and eyes;
  • Itching.

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

  • Hypersensitivity reactions, which may cause: swelling of the face, lips, mouth, tongue and/or throat, and breathing difficulties. If any of these symptoms occur, contact your doctor immediately;
  • Bleeding:
    • Into muscle tissue;
    • Into the eyes;
    • From gums and presence of blood in sputum when coughing;
    • From the rectum;
  • Hair loss.

Frequency unknown (cannot be estimated from available data)

  • Bleeding:
    • Into the brain or spinal canal;
    • In the lungs or throat;
    • In the mouth;
    • Into the abdominal cavity or retroperitoneal space;
    • From haemorrhoids;
    • Test results indicating presence of blood in stool or urine;
  • Skin rash, which may develop blisters and resemble small target lesions (dark spots in the centre surrounded by a lighter ring, with a dark ring around the edge) (erythema multiforme);
  • Vasculitis (inflammation of blood vessels), which may cause skin rash or raised, flat, red, circular spots beneath the skin surface, or bruising;
  • Bleeding in the kidney, sometimes with blood in urine, leading to impaired kidney function (anticoagulant-related nephropathy).

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

  • Bleeding, including:
    • Into the eyes;
    • In the stomach or intestines;
    • From the rectum;
    • Blood in urine;
    • Nosebleeds;
    • 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 indicate:
    • Increased gamma-glutamyltransferase (GGT) activity.

Uncommon adverse 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;
    • Postoperative bleeding, 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 platelet count (which may affect clotting);
  • Blood test results may indicate:
    • Abnormal liver function;
    • Increased activity of certain liver enzymes;
    • Increased bilirubin levels, a breakdown product of red blood cells, 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 breathing difficulties. If any of these symptoms are observed, contact your doctor immediately.

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

  • Bleeding:
    • In the lungs or throat;
    • Into the retroperitoneal space;
    • Into muscle tissue.

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

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

Frequency unknown (cannot be estimated from available data)

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

The following adverse effects may occur when taking apixaban for the treatment or prevention of recurrence of blood clots in the deep veins of the legs and blood clots in the blood vessels of the lungs.

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

  • Bleeding, including:
    • Nosebleeds;
    • From gums;
    • Blood in urine;
    • Subcutaneous haemorrhage (bruising) and swelling;
    • In the stomach, intestines, or from the rectum;
    • In the mouth;
    • Vaginal bleeding;
  • Anaemia, which may cause fatigue or paleness;
  • Decreased platelet count (which may affect clotting);
  • Nausea;
  • Skin rash;
  • Blood test results may indicate:
    • Increased gamma-glutamyltransferase (GGT) or alanine aminotransferase (AlAT) activity.

Uncommon adverse 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;
    • Postoperative bleeding, including bruising and swelling, leakage of blood or fluid from the surgical wound/incision site (wound discharge) or injection site;
    • From haemorrhoids;
    • Into muscle tissue;
  • Itching;
  • Hair loss;
  • Allergic reactions (hypersensitivity), which may cause: swelling of the face, lips, mouth, tongue and/or throat, and breathing difficulties. If any of these symptoms are observed, contact your doctor immediately;
  • Blood test results may indicate:
    • Abnormal liver function;
    • Increased activity of certain liver enzymes;
    • Increased bilirubin levels, a breakdown product of red blood cells, which may cause yellowing of the skin and eyes.

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

  • Bleeding:
    • Into the brain or spinal canal;
    • In the lungs.

Frequency unknown (cannot be estimated from available data)

  • Bleeding:
    • Into the abdominal cavity or retroperitoneal space.
  • Skin rash, which may develop blisters and resemble small target lesions (dark spots in the centre surrounded by a lighter ring, with a dark ring around the edge) (erythema multiforme);
  • Vasculitis (inflammation of blood vessels), which may cause skin rash or raised, flat, red, circular spots beneath the skin surface, or bruising;
  • Bleeding in the kidney, sometimes with blood in urine, leading to impaired kidney function (anticoagulant-related nephropathy).

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse 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
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Apixaban Reddy

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

6. Contents of the package and other information

What Apixaban Reddy contains

  • The active substance is apixaban. Each tablet contains 2.5 mg of apixaban.
  • The 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, yellow iron oxide (E 172).

What Apixaban Reddy looks like and contents of the pack
The film-coated tablets are yellow, round (6 mm in diameter) and marked with "2.5" on one side and smooth on the other side.
They are supplied in blister packs contained in cardboard boxes of 10, 20, 28, 56, 60, 100, 168 or 200 film-coated tablets or in bottles containing 20, 60 or 100 film-coated tablets.
Not all pack sizes may be marketed.
Patient Warning Card: information for use
Inside the packaging of Apixaban Reddy, alongside the patient leaflet, there is a Patient Warning Card, or your physician may provide you with a similar card.
The Patient Warning 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 (this is 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 Authorisation 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, 1st floor, sector 3
030138 Bucharest
Romania
This medicinal product is authorised in the EEA Member States under the following
names:
Germany: Apixaban beta 2.5 mg Filmtabletten
Austria: Apixaban Reddy 2.5 mg Filmtabletten
Italy: Apixaban Dr. Reddy’s 2.5 mg compresse rivestite con film
Netherlands: Apixaban Reddy 2.5 mg filmomhulde tabletten
Czech Republic: Apixaban Reddy 2.5 mg potahované tablety
Poland: Apixaban Reddy 2.5 mg tabletki powlekane
Sweden: Apixaban Reddy 2.5 mg filmdragerade tabletter
Slovakia: Apixaban Reddy 2.5 mg filmom obalené tablety