Avassan

Package Leaflet: Information for the User

AVASSAN 5 mg, film-coated tablets

Apixaban

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

1. What Avassan is and what it is used for

Avassan 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 an important part of the blood clotting process.

Avassan is used in adults to:

• prevent blood clots forming in the heart in patients with irregular heartbeats (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, blocking blood flow to those organs (also known as systemic embolism). A stroke can be life-threatening and requires immediate medical attention.
• treat blood clots in the veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism), as well as prevent new blood clots from forming in the blood vessels of the legs and/or lungs.

Avassan is used in children from 28 days to less than 18 years of age to treat and prevent blood clots in the veins or lungs.

2. What you need to know before you take Avassan

Do not take Avassan

• if you are allergicto apixaban or any of the other ingredients of this medicine (listed in section 6),
• if you have active bleeding,
• if you have liver diseasewhich leads to an increased risk of bleeding (hepatic coagulopathy),
• if you are taking medicines to 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 Avassan, tell your doctor, pharmacist, or nurse if you have any of the following conditions:

• increased risk of bleeding, for example:
• bleeding disorders, including those that affect the blood's ability to clot,
• very high blood pressurethat is not controlled with medication,
• if you are over 75 years old,
• if your body weight is 60 kg or less,
• severe kidney disease or if you are on dialysis,
• if you have or have had liver disease,
• This medicine should be used with caution in patients with signs of liver dysfunction,
• if you have a prosthetic heart valve,
• if your doctor determines that your blood pressure is unstable or if you are scheduled for surgery to remove a blood clot from your lungs.

When to be extra careful when taking Avassan

• 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 Avassan 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 children and adolescents with a body weight below 35 kg.

Avassan and other medicines

Tell your doctor, pharmacist, or nurse about all the medicines you are taking, have recently taken, or might take.

Some medicines may increase the effects of Avassan and increase the risk of bleeding. Your doctor will decide whether you should take Avassan while taking other medicines and how closely you should be monitored.

The following medicines may increase the effects of Avassan and increase the risk of bleeding:

• certain antifungal medicines(e.g. itraconazole, voriconazole, posaconazole, and others)
• certain medicines used to treat Cushing's syndrome(e.g. ketoconazole)
• certain antiviral medicines used to treat HIV/AIDS(e.g. ritonavir)
• other medicines used to prevent blood clotting(e.g. enoxaparin and others)
• anti-inflammatory or pain-relieving medicines(e.g. acetylsalicylic acid or naproxen), especially if you are over 75 years old and taking acetylsalicylic acid, you may be at increased risk of bleeding
• medicines used to treat high blood pressure or heart conditions(e.g. diltiazem)
• antidepressant medicinesknown as selective serotonin reuptake inhibitorsor serotonin-norepinephrine reuptake inhibitors

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

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, 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 Avassan on pregnancy and the unborn child is not known. You should not take Avassan during pregnancy. If you become pregnant while taking Avassan, you should contact your doctor immediately.

It is not known whether Avassan passes into breast milk. Before taking Avassan while breastfeeding, ask your doctor, pharmacist, or nurse for advice. You may be advised to stop breastfeeding or stop/ not start taking Avassan.

Driving and using machines

Avassan has not been shown to affect the ability to drive or use machines.

Avassan 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 Avassan.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, which is essentially 'sodium-free'.

3. How to take Avassan

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 with water. You can take Avassan with or without food.

To get the best effect, try to take the tablets at the same time every day.

If you have problems swallowing the tablets whole, talk to your doctor about other ways to take Avassan. You can crush the tablet and mix it with water, 5% glucose solution, juice, or apple puree just before taking it.

Instructions for crushing tablets:

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

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

Take Avassan as directed in the following indications:

Prevention of blood clots in the heart in patients with irregular heartbeats and at least one additional risk factor

The recommended dose is one 5 mg Avassan tablet twice daily.

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

• you have severe kidney problems
• two or more of the following conditions apply:
• your blood test results indicate reduced kidney function (serum creatinine level of 1.5 mg/dL or more)
• you are 80 years old or older
• your body weight is 60 kg or less

Take 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 veins of the legs and blood clots in the lungs

The recommended dose is two 5 mg Avassan 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 Avassan 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 2.5 mg Avassan 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

Treatment and prevention of blood clots in the veins or lungs

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

To get the best effect, try to take or give the tablets at the same time every day.

The dose of Avassan is based on body weight and will be calculated by your doctor.

The recommended dose for children and adolescents weighing 35 kg or more is two 5 mg Avassan 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 Avassan tablet twice daily, for example, one tablet in the morning and one in the evening.

For parents and caregivers: observe the child to ensure they take the full dose.

It is important to follow the scheduled doctor's visits, as the dose may need to be adjusted with changes in the patient's body weight.

Your doctor may switch your anticoagulant treatment as follows:

• Switching from Avassan to other anticoagulantsStop taking Avassan. Start treatment with other anticoagulants (e.g. heparin) when the next Avassan tablet is due.
• Switching from other anticoagulants to AvassanStop taking other anticoagulants. Start taking Avassan 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 AvassanStop taking the vitamin K antagonist. Your doctor will order blood tests and tell you when to start taking Avassan.
• Switching from Avassan 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 Avassan for at least 2 days after the first dose of the vitamin K antagonist. Your doctor will order blood tests and tell you when to stop taking Avassan.

Patients undergoing cardioversion

Patients with irregular heartbeats who require cardioversion to restore a normal heart rhythm should take Avassan 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 Avassan than you should

If you take more Avassan than you should, contact your doctor immediately. Take the package and any remaining tablets with you. If you take more Avassan 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 effects of Avassan.

If you forget to take Avassan

• If you miss a morning dose, take it as soon as you remember and take the evening dose as usual. You can take the missed morning dose at the same time as the evening dose.
• If you miss an evening dose, you can only take it on the same evening. Do not take two doses on the next day, instead, continue taking your tablets as usual, twice a day.

If you have any further questions on the use of this product, or if you have missed more than one dose

ask your doctor, pharmacist, or nurse.

Stopping Avassan

Do not stop taking Avassan without talking to your doctor first, as this may increase the risk of blood clots.

If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Avassan can cause side effects, although not everybody gets them.

The most common side effect of Avassan is bleeding, which can be serious and potentially life-threatening, requiring immediate medical attention.

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

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

• Bleeding, including:
• eye bleeding;
• stomach or intestine bleeding;
• rectal bleeding;
• blood in urine;
• nosebleeds;
• gum bleeding;
• bruising and swelling;
• Anemia, which can cause tiredness or pale skin;
• Low blood pressure, which can cause fainting or rapid heartbeat;
• 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:
• brain or spinal bleeding;
• mouth or throat bleeding, or blood in sputum when coughing;
• abdominal or vaginal bleeding;
• blood in stool;
• bleeding after surgery, including bruising and swelling, bleeding or fluid from the wound or injection site;
• hemorrhoids bleeding;
• blood in urine or stool (detected by laboratory tests);
• Reduced platelet count (which can affect blood clotting);
• Blood test results may show:
• abnormal liver function;
• 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 1,000 people)

• Bleeding:
• lung or throat bleeding;
• abdominal or retroperitoneal bleeding;
• muscle bleeding.

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

• 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).

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

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

The following side effects may occur when taking Avassan to treat or prevent new blood clots in the veins of the legs and lungs.

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

• Bleeding, including:
• nosebleeds;
• gum bleeding;
• blood in urine;
• bruising and swelling;
• stomach or intestine bleeding;
• mouth bleeding;
• vaginal bleeding;
• 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 fainting or rapid heartbeat;
• Bleeding:
• eye bleeding;
• mouth or throat bleeding, or blood in sputum when coughing;
• blood in stool;
• blood test results showing blood in stool or urine;
• bleeding after surgery, including bruising and swelling, bleeding or fluid from the wound or injection site;
• hemorrhoids bleeding;
• muscle bleeding;
• 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:
• abnormal liver function;
• 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 1,000 people)

• Bleeding:
• brain or spinal bleeding;
• lung bleeding.

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

• Bleeding:
• abdominal or retroperitoneal bleeding;
• 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);
• Vasculitis (inflammation of blood vessels), which can cause skin rash or raised, flat, red, round patches under the skin, or bruising.

Additional side effects in children and adolescents

If you experience any of the following symptoms, contact your doctor immediately:

• Allergic reactions (hypersensitivity), which can 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).

Generally, side effects in children and adolescents treated with Avassan are similar to those in adults and are mostly mild to moderate.

Side effects that are more common in children and adolescents include nosebleeds and unusual vaginal bleeding.

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

• Bleeding, including:
• vaginal bleeding;
• nosebleeds.

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

• Bleeding, including:
• gum bleeding;
• blood in urine;
• bruising and swelling;
• stomach or intestine bleeding;
• rectal bleeding;
• blood in stool;
• bleeding after surgery, including bruising and swelling, bleeding or fluid from the wound or injection site;
• Hair loss;
• Anemia, which can cause tiredness or pale skin;
• Reduced platelet count (which can affect blood clotting);
• Nausea (feeling sick);
• Skin rash;
• Itching;
• Low blood pressure, which can cause fainting or rapid heartbeat in the child;
• Blood test results may show:
• abnormal liver function;
• increased activity of certain liver enzymes;
• increased alanine aminotransferase (ALT) activity.

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

• Bleeding:
• abdominal or retroperitoneal bleeding;
• stomach bleeding;
• eye bleeding;
• mouth or throat bleeding, or blood in sputum when coughing;
• brain or spinal bleeding;
• lung bleeding;
• muscle bleeding;
• 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);
• Vasculitis (inflammation of blood vessels), which can cause skin rash or raised, flat, red, round patches under the skin, or bruising;
• Blood test results may show:
• increased gamma-glutamyltransferase (GGT) activity;
• blood in stool or urine.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet.

Side effects can be reported to the national reporting system listed below.

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Avassan

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 blister after "EXP". The expiry date refers to the last day of that month.

No special storage conditions are required.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Avassan contains

The active substance is apixaban. Each tablet contains 5 mg of apixaban.

The other ingredients are:

• Tablet core: lactose monohydrate[see section 2 "Avassan contains lactose (a type of sugar) and sodium"], microcrystalline cellulose, sodium croscarmellose [see section 2 "Avassan contains lactose (a type of sugar) and sodium"], sodium lauryl sulfate, povidone, magnesium stearate (E 470b),
• Coating: lactose monohydrate[see section 2 "Avassan contains lactose (a type of sugar) and sodium"], hypromellose (E 464), titanium dioxide (E 171), triacetin, iron oxide red (E 172).

What Avassan looks like and contents of the pack

Oval, film-coated tablets, pink to light pink in color, approximately 10 mm in length and 5 mm in width, with "A3" engraved on one side and smooth on the other side.

• Avassan, film-coated tablets are available in blisters of aluminum/PVC/PVDC in cartons of 10, 20, 60, 100, and 200 tablets.
• Avassan, film-coated tablets are available in perforated blisters of aluminum/PVC/PVDC in cartons of 10x1, 20x1, 60x1, 100x1, and 200x1 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Ranbaxy (Poland) Sp. z o.o.

ul. Idzikowskiego 16

00-710 Warszawa

tel. 22 642 07 75

Manufacturer/Importer

Terapia SA

124 Fabricii Street

400632, Cluj-Napoca

Romania

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH, Hoofddorp

Netherlands

Date of last revision of the leaflet:

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Patient Alert Card: Information for use

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

The Patient Alert Card contains information that is helpful to you and warns other doctors that you are taking Avassan.

Always carry this card with you.

• 1. Take the card.
• 2. If necessary, separate the relevant language (this is made easier by the 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 always carry it with you.