Apixaban Cipla

Package Leaflet: Information for the User

Apixaban Cipla, 2.5 mg, Film-Coated Tablets

Apixaban

Read All of This Leaflet Carefully Before You Start Taking This Medicine Because It Contains Important Information for You.

• You should keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Pack and Other Information

• 1. What Apixaban Cipla is and What It is Used For
• 2. What You Need to Know Before You Take Apixaban Cipla
• 3. How to Take Apixaban Cipla
• 4. Possible Side Effects
• 5. How to Store Apixaban Cipla
• 6. Contents of the Pack and Other Information

1. What Apixaban Cipla is and What It is Used For

Apixaban Cipla contains the active substance apixaban and belongs to a group of medicines called anticoagulants. It helps to prevent blood clots from forming by blocking factor Xa, which is involved in the blood clotting process.

Apixaban Cipla is used in adults to:

• prevent blood clots from forming after hip or knee replacement surgery. After hip or knee surgery, you are at a higher risk of getting blood clots in your legs. This can lead to swelling of your legs, with or without pain. If a blood clot breaks loose from your leg, it can travel to your lungs, which can be life-threatening and requires immediate medical attention.
• prevent blood clots from forming in the heart in patients with irregular heart rhythm (atrial fibrillation) and at least one additional risk factor. Blood clots can break loose and travel to the brain, causing a stroke, or to other organs, reducing blood flow to these organs.
• treat blood clots in the deep veins of the legs (deep vein thrombosis) and blood clots in the lungs (pulmonary embolism), as well as prevent new blood clots from forming in the legs and/or lungs.

2. What You Need to Know Before You Take Apixaban Cipla

Do Not Take Apixaban Cipla:

• if you are allergic to apixaban or any of the other ingredients of this medicine (listed in section 6),
• if you have active bleeding,
• if you have a liver disease that increases the risk of bleeding (hepatic coagulopathy),
• if you are taking other medicines that prevent blood clotting (e.g. warfarin, rivaroxaban, dabigatran, or heparin), except when switching from these medicines to apixaban under the guidance of your doctor.

Warnings and Precautions

Before taking Apixaban Cipla, tell your doctor if you have any of the following conditions:

• increased risk of bleeding, for example:
• bleeding disorders, including those that affect platelet function,
• high blood pressure that is not controlled with medication,
• if you are 75 years old or older,
• if your body weight is 60 kg or less,
• severe kidney disease or if you are on dialysis,
• liver disease or a history of liver disease.
• This medicine should be used with caution in patients with signs of liver dysfunction.
• Tubing (catheter) or injection into the spine (anesthetic or pain relief), in which case your doctor will advise you to take this medicine 5 or more hours after the catheter is removed.
• if you have a prosthetic heart valve,
• if your doctor determines that your blood pressure is unstable or if you are scheduled for another treatment or surgery to remove a blood clot from your lungs.

When to Be Extra Careful When Taking Apixaban Cipla

• if you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), you should inform your doctor, who will decide whether to change your treatment.

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

Children and Adolescents

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

Apixaban Cipla with Other Medicines

Tell your doctor, pharmacist, or nurse about all medicines you are taking or have recently taken, as well as any medicines you plan to take. Some medicines may increase the effect of Apixaban Cipla, while others may reduce its effect. Your doctor will decide whether you should take Apixaban Cipla while taking other medicines and how closely you should be monitored.

The following medicines may increase the effect of Apixaban Cipla 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 (e.g. ritonavir),
• other medicines used to reduce blood clotting (e.g. enoxaparin and others),
• anti-inflammatory or pain-relieving medicines (e.g. aspirin or naproxen),
• especially if you are over 75 years old and taking aspirin, you may be at increased risk of unwanted bleeding,
• medicines used to treat high blood pressure or heart problems (e.g. diltiazem),
• antidepressant medicines called selective serotonin reuptake inhibitors (SSRIs),
• or serotonin-norepinephrine reuptake inhibitors (SNRIs).

The following medicines may reduce the ability of Apixaban Cipla to prevent blood clots:

• medicines used to prevent seizures or fits (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 Breast-Feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor, pharmacist, or nurse for advice before taking this medicine. The effect of Apixaban Cipla on pregnancy and the unborn child is not known. This medicine should not be taken during pregnancy. If you become pregnant while taking this medicine, you should contact your doctor immediately.

It is not known whether Apixaban Cipla passes into breast milk. Before taking this medicine while breast-feeding, ask your doctor, pharmacist, or nurse for advice. You may be advised to stop breast-feeding or stop/ not start taking this medicine.

Driving and Using Machines

Apixaban Cipla has not been shown to affect your ability to drive or use machines.

Apixaban Cipla Contains Lactose and Sodium

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is essentially sodium-free.

3. How to Take Apixaban Cipla

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor, pharmacist, or nurse.

Dose

Swallow the tablet whole with water. Apixaban Cipla can be taken with or without food. To get the best results, take the tablets at the same time every day.

If you have difficulty swallowing the tablets whole, talk to your doctor about other ways to take Apixaban Cipla. The tablet can be crushed and mixed with water, 5% glucose solution, juice, or apple puree just before taking.

Instructions for Crushing the Tablets:

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

Your doctor may give you a crushed Apixaban Cipla tablet mixed with 60 mL of water or 5% glucose solution through a nasogastric tube.

Take Apixaban Cipla as Directed in the Following Indications:

Prevention of blood clots after hip or knee replacement surgery

The recommended dose is one 2.5 mg tablet twice daily. For example, one tablet in the morning and one in the evening.

Take the first tablet 12 to 24 hours after surgery.

If you have had major hip surgery, you will usually take the tablets for 32 to 38 days.

If you have had major knee surgery, you will usually take the tablets for 10 to 14 days.

Prevention of blood clots in the heart in patients with irregular heart rhythm (atrial fibrillation) and at least one additional risk factor

The recommended dose is one 5 mg tablet twice daily.

The recommended dose is one Apixaban Cipla 2.5 mg tablet twice daily if:

• you have severe kidney problems,
• you meet two or more of the following conditions:
• your blood test results show reduced kidney function (serum creatinine level of 1.5 mg/dL (133 micromoles/L) or more),
• you are 80 years old 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.

Treatment of blood clots in the deep veins of the legs and blood clots in the lungs

The recommended dose is two Apixaban Cipla 5 mg 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 Apixaban Cipla 5 mg tablet twice daily, for example, one tablet in the morning and one in the evening.

Prevention of new blood clots after completing 6 months of treatment

The recommended dose is one Apixaban Cipla 2.5 mg 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.

Your Doctor May Switch Your Anticoagulant Treatment as Follows:

• Switching from Apixaban Cipla to Other AnticoagulantsStop taking Apixaban Cipla. Start taking other anticoagulants (e.g. heparin) when the next dose of Apixaban Cipla is due.
• Switching from Other Anticoagulants to Apixaban CiplaStop taking other anticoagulants. Start taking Apixaban Cipla when the next dose of the other anticoagulant is due, and then continue with the usual dosing schedule.
• Switching from Treatment with a Vitamin K Antagonist (e.g. Warfarin) to Apixaban CiplaStop taking the vitamin K antagonist. Your doctor will perform blood tests and tell you when to start taking Apixaban Cipla.
• Switching from Apixaban Cipla to Treatment with a Vitamin K Antagonist (e.g. Warfarin)If your doctor tells you to start taking a vitamin K antagonist, you should continue taking Apixaban Cipla for at least 2 days after taking the first dose of the vitamin K antagonist. Your doctor will perform blood tests and tell you when to stop taking Apixaban Cipla.

Patients Undergoing Cardioversion

Patients with irregular heart rhythm who need to undergo a procedure to restore a normal heart rhythm (cardioversion) should take this medicine at the times specified by their doctor to prevent blood clots from forming in the blood vessels of the brain and other parts of the body.

If You Take More Apixaban Cipla Than You Should

If you take more Apixaban Cipla than you should, contact your doctor immediately. Take the package with you, even if it is empty. If you take more Apixaban Cipla than you should, you may be at increased risk of bleeding. If bleeding occurs, you may need surgical treatment, blood transfusion, or other treatment to reverse the effect of Apixaban Cipla.

If You Forget to Take Apixaban Cipla

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

If You Have Any Further Questions on the Use of This Product, Ask Your Doctor, Pharmacist, or Nurse.

Do not stop taking Apixaban Cipla without consulting your doctor, as the risk of blood clots may be higher if you stop taking this medicine too early.

4. Possible Side Effects

Like all medicines, Apixaban Cipla can cause side effects, although not everybody gets them. Apixaban Cipla can be used in three different medical conditions. The known side effects and their frequency may vary depending on the condition and are listed separately below. In these conditions, the most common overall side effect of this medicine is bleeding, which can be life-threatening and may require immediate medical attention.

The following side effects may occur when taking Apixaban Cipla to prevent blood clots after hip or knee replacement surgery.

Common Side Effects (May Affect Up to 1 in 10 People)

• Anemia, which can cause tiredness or pale skin,
• Bleeding, including:
• bruises and swelling,
• nausea (feeling sick),

Uncommon Side Effects (May Affect Up to 1 in 100 People)

• Reduced platelet count (which can affect blood clotting),
• Bleeding:
• after surgery, including bruises and swelling, bleeding or fluid leakage from the wound or injection site,
• from the stomach or intestines, or black stools,
• blood in the urine,
• from the nose,
• from the vagina,
• Low blood pressure, which can cause dizziness or fainting,
• Blood test results may show:
• liver problems,
• increased activity of certain liver enzymes,
• increased bilirubin levels, a product of red blood cell breakdown that can cause yellowing of the skin and eyes,
• itching,

Rare Side Effects (May Affect Up to 1 in 1000 People)

• Allergic reactions (hypersensitivity), which can cause:
• swelling of the face, lips, mouth, tongue, and/or throat, and difficulty breathing. If you experience any of these symptoms, contact your doctor immediately.
• Bleeding:
• into the muscle,
• into the eyes,
• from the gums and blood in the sputum when coughing,
• from the rectum,
• hair loss,

Frequency Not Known (Cannot Be Estimated from the Available Data)

• Bleeding:
• into the brain or spinal cord;
• into the lungs or throat;
• into the mouth;
• into the abdominal cavity or the space behind the abdominal cavity;
• from hemorrhoids;
• blood test results showing blood in the stool or urine;
• a skin rash that may have blisters and looks like small targets (dark spots in the center surrounded by a lighter ring, with a dark ring around the edge) (erythema multiforme);
• inflammation of blood vessels (vasculitis), which can cause a skin rash or raised, flat, red, round patches under the skin, or bruises.

The following side effects may occur when taking Apixaban Cipla to prevent blood clots in the heart in patients with irregular heart rhythm and at least one additional risk factor.

Common Side Effects (May Affect Up to 1 in 10 People)

• Bleeding, including:
• into the eyes,
• from the stomach or intestines,
• from the rectum,
• blood in the urine,
• from the nose,
• from the gums,
• bruises and swelling,
• Anemia, which can cause tiredness or pale skin,
• Low blood pressure, which can cause dizziness or fainting,
• nausea (feeling sick),
• Blood test results may show:
• increased gamma-glutamyltransferase (GGT) activity.

Uncommon Side Effects (May Affect Up to 1 in 100 People)

• Bleeding:
• into the brain or spinal cord;
• into the mouth or blood in the sputum when coughing;
• into the abdominal cavity or from the vagina;
• black stools;
• bleeding after surgery, including bruises and swelling, bleeding or fluid leakage from the wound or injection site;
• from hemorrhoids;
• blood test results showing blood in the stool or urine;
• reduced platelet count (which can affect blood clotting);
• Blood test results may show:
• liver problems,
• increased activity of certain liver enzymes,
• increased bilirubin levels, a product of red blood cell breakdown that can cause yellowing of the skin and eyes,
• skin rash,
• itching,
• hair loss,
• Allergic reactions (hypersensitivity), which can cause:
• swelling of the face, lips, mouth, tongue, and/or throat, and difficulty breathing. If you experience any of these symptoms, contact your doctor immediately.

Rare Side Effects (May Affect Up to 1 in 1000 People)

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

Frequency Not Known (Cannot Be Estimated from the Available Data)

• a skin rash that may have blisters and looks like small targets (dark spots in the center surrounded by a lighter ring, with a dark ring around the edge) (erythema multiforme);
• inflammation of blood vessels (vasculitis), which can cause a skin rash or raised, flat, red, round patches under the skin, or bruises.

The following side effects may occur when taking Apixaban Cipla to treat or prevent new blood clots in the deep veins of the legs and blood clots in 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,
• bruises and swelling,
• from the stomach or intestines, or from the rectum,
• from the mouth,
• from the vagina,
• Anemia, which can cause tiredness or pale skin,
• reduced platelet count (which can affect blood clotting),
• nausea (feeling sick),
• skin rash,
• Blood test results may show:
• increased gamma-glutamyltransferase (GGT) or alanine aminotransferase (ALT) activity.

Uncommon Side Effects (May Affect Up to 1 in 100 People)

• Low blood pressure, which can cause dizziness or fainting,
• Bleeding:
• into the eyes,
• into the mouth or blood in the sputum when coughing;
• black stools;
• blood test results showing blood in the stool or urine;
• bleeding after surgery, including bruises and swelling, bleeding or fluid leakage from the wound or injection site;
• from hemorrhoids;
• into the muscle;
• itching,
• hair loss,
• Allergic reactions (hypersensitivity), which can cause:
• swelling of the face, lips, mouth, tongue, and/or throat, and difficulty breathing. If you experience any of these symptoms, contact your doctor immediately;
• Blood test results may show:
• liver problems,
• increased activity of certain liver enzymes,
• increased bilirubin levels, a product of red blood cell breakdown that can cause yellowing of the skin and eyes.

Rare Side Effects (May Affect Up to 1 in 1000 People)

Bleeding:

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

Frequency Not Known (Cannot Be Estimated from the Available Data)

• Bleeding:
• into the abdominal cavity or the space behind the abdominal cavity.
• a skin rash that may have blisters and looks like small targets (dark spots in the center surrounded by a lighter ring, with a dark ring around the edge) (erythema multiforme);
• inflammation of blood vessels (vasculitis), which can cause a skin rash or raised, flat, red, round patches under the skin, or bruises.

Reporting of Side Effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the national reporting system via the contact details below. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to Store Apixaban Cipla

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, bottle, and blister after EXP. The expiry date refers to the last day of that month.

There are no special storage conditions 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. These measures will help protect the environment.

6. Contents of the Pack and Other Information

What Apixaban Cipla Contains

• The active substance is apixaban. Each tablet contains 2.5 mg of apixaban.
• The other ingredients are:
• tablet core: lactose monohydrate, microcrystalline cellulose (E 460), sodium croscarmellose (E 468), sodium lauryl sulfate (E 487), magnesium stearate (E 470b),
• coating: hypromellose (E 464), titanium dioxide (E 171), macrogol 400 (E 1521), yellow iron oxide (E 172)

What Apixaban Cipla Looks Like and Contents of the Pack

The film-coated tablets are yellow, round, biconvex, and smooth on both sides [thickness: 3 mm, diameter: 6 mm].

• They are available in blisters in cardboard boxes of 10 film-coated tablets.

Patient Alert Card: Information for Use

Inside the Apixaban Cipla package, along with the patient leaflet, you will find a Patient Alert Card or your doctor may give you a similar card.

The Patient Alert Card contains information to help you and to alert other doctors that you are taking Apixaban Cipla. You should always carry this card with you.

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

Marketing Authorisation Holder

Cipla Europe NV

De Keyserlei 58-60, Box-19, 2018 Antwerp, Belgium, tel: +32(0)32910101/ +32(0)32910199

Manufacturer/Importer

Cipla Europe NV

De Keyserlei 58-60, Box-19, 2018 Antwerp, Belgium

This Medicinal Product is Authorised in the Member States of the European Economic Area Under the Following Names:

Date of Last Revision of the Leaflet: