SEWAB 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Sewab 5 mg film-coated tablets EFG

apixaban

Read all of 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 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:

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

1. What is Sewab and what is it used for

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

This medicine is used in adults:

• to prevent the formation of a blood clot in the heart in patients with an irregular heartbeat (atrial fibrillation) and at least one additional risk factor. Blood clots can break loose, travel to the brain, and cause a stroke, or travel to other organs and prevent proper irrigation of the organ (also known as systemic embolism). A stroke can be life-threatening and requires immediate medical attention.

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 these blood clots from happening again in the blood vessels of the legs and/or lungs.

2. What you need to know before you take Sewab

Do not take Sewab if:

• you are allergic to apixaban or any of the other ingredients of this medicine (listed in section 6),
• you have a condition that increases the risk of bleeding, such as a recent injury, surgery, or bleeding disorder,
• you have an active or recent stomach or intestinal ulcer, or a recent bleeding in the brain,
• you have a liver disease that increases the risk of bleeding (hepatic coagulopathy),
• you are taking other medicines to prevent blood clotting (e.g., warfarin, rivaroxaban, dabigatran, or heparin), except when switching from one anticoagulant to another, or when being treated with heparin to keep a venous or arterial line open, or when undergoing a procedure to treat an irregular heartbeat (ablation).

Warnings and precautions

Tell your doctor, pharmacist, or nurse before you start taking this medicine if you have any of the following conditions:

• a higher risk of bleeding, such as:
• • bleeding disorders, including conditions that result in a decrease in platelet activity,
  • very high blood pressure, not controlled by medical treatment,
  • you are over 75 years old,
  • you weigh 60 kg or less,
• a severe kidney disease or if you are on dialysis,
• a liver problem or a history of liver problems.
• This medicine will be used with caution in patients with signs of liver function impairment,
• you have a heart valve replacement,
• if your doctor determines that your blood pressure is unstable or you are scheduled to receive another treatment or undergo surgery to remove a blood clot from your lungs.

Be careful with Sewab

• if you know you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor to decide if it is necessary to modify the treatment.
• If you need to undergo surgery or a procedure that may cause bleeding, your doctor will tell you to temporarily stop taking this medicine for a while. If you are not sure if a procedure may cause bleeding, ask your doctor.

Children and adolescents

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

Other medicines and Sewab

Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.

Some medicines may increase the effects of Sewab and some medicines may decrease its effects. Your doctor will decide if you should be treated with Sewab if you are taking these medicines and if you should be monitored more closely.

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

• some medicines for fungal infections (e.g., ketoconazole),
• some antiviral medicines for HIV/AIDS (e.g., ritonavir),
• other medicines to reduce blood clotting (e.g., enoxaparin),
• anti-inflammatory or pain-relieving medicines (e.g., acetylsalicylic acid or naproxen). In particular, if you are over 75 years old and taking acetylsalicylic acid, there is a higher risk of bleeding,
• medicines for high blood pressure or heart problems (e.g., diltiazem),
• antidepressants called selective serotonin reuptake inhibitors or serotonin-noradrenaline reuptake inhibitors.

The following medicines may reduce the ability of apixaban to prevent blood clots.

• medicines for the treatment of epilepsy or seizures (e.g., phenytoin),
• St. John's Wort (a herbal medicine for the treatment of depression),
• medicines 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 or pharmacist for advice before taking this medicine.

The effects of this medicine on pregnancy and the fetus are not known. You should not take this medicine if you are pregnant. Tell your doctor immediatelyif you become pregnant while taking this medicine.

It is not known if this medicine is excreted in human milk. Ask your doctor or pharmacist for advice before taking this medicine during breastfeeding. They will tell you if you should stop breastfeeding or if you can continue to take or start taking this medicine.

Driving and using machines

Sewab has no influence on the ability to drive or use machines.

Sewab contains lactose (a type of sugar) and sodium

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is, essentially, “sodium-free”.

3. How to take Sewab

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

Take the tablet with water. This medicine can be taken with or without food.

Try to take the tablets at the same time each day to achieve a better effect of the treatment.

If you have difficulty swallowing the tablet whole, talk to your doctor about other possible ways to take Sewab. The tablet can be crushed and mixed with water, 5% glucose in water, apple juice, or apple puree, immediately before taking it.

Instructions for crushing:

• Crush the tablets with a mortar.
• Transfer all the powder carefully into a suitable container, mixing the powder with a small amount, e.g., 30 ml (2 tablespoons), of water or one of the other liquids mentioned to make the mixture.
• Take the mixture.
• Rinse the mortar and pestle used to crush the tablet and the container with a small amount of water or one of the other liquids (e.g., 30 ml), and take that liquid.

If necessary, your doctor may also administer the crushed Sewab tablet mixed in 60 ml of water or 5% glucose in water through a nasogastric tube.

Take Sewab according to the following recommendations:

• To prevent the formation of a blood clot in the heart in patients with an irregular heartbeat and at least one additional risk factor

The recommended dose of Sewab is one 5 mg tablet twice a day.

The recommended dose of Sewab is one 2.5 mg tablet twice a day if:

• you have severely reduced kidney function
• you have two or more of the following factors:
• • your blood test results suggest poor kidney function (a serum creatinine value of 1.5 mg/dl (133 micromoles/l) or higher),
  • you are 80 years old or older,
  • your weight is 60 kg or less.

The recommended dose is one tablet twice a day, e.g., take one tablet in the morning and one in the evening.

Your doctor will tell you how long you should continue the treatment.

• To treat blood clots in the veins of the legs and in the blood vessels of the lungs

The recommended dose of Sewab is two 5 mg tablets twice a day for the first 7 days, e.g., two tablets in the morning and two tablets in the evening.

After 7 days, the recommended dose of Sewab is one 5 mg tablet twice a day, e.g., one tablet in the morning and one in the evening.

• To prevent blood clots from happening again after 6 months of treatment

The recommended dose of Sewab is one 2.5 mg tablet twice a day, e.g., one tablet in the morning and one in the evening.

Your doctor will tell you how long you should continue the treatment.

Your doctor may change your anticoagulant treatment as follows:

• Switching from Sewab to other anticoagulant medicines

Stop taking Sewab. Start treatment with other anticoagulant medicines (e.g., heparin) at the time you would take the next Sewab tablet.

• Switching from other anticoagulant medicines to Sewab

Stop taking other anticoagulant medicines. Start treatment with Sewab at the time you would take the next dose of the other anticoagulant medicine, and then continue as usual.

• Switching from a treatment with anticoagulants that contain Vitamin K antagonists (e.g., warfarin) to Sewab

Stop taking the medicine that contains a Vitamin K antagonist. Your doctor will need to perform blood tests and tell you when to start taking Sewab.

• Switching from Sewab to a treatment with anticoagulants that contain Vitamin K antagonists (e.g., warfarin)

If your doctor tells you to start taking a medicine that contains a Vitamin K antagonist, continue taking Sewab for at least 2 days after your first dose of the medicine that contains a Vitamin K antagonist. Your doctor will need to perform blood tests and tell you when to stop taking Sewab.

Patients undergoing cardioversion

If your heartbeat needs to be restored through a procedure called cardioversion, take this medicine at the times your doctor tells you to prevent blood clots in the blood vessels of the brain and other blood vessels in the body.

If you take more Sewab than you should

Tell your doctor immediatelyif you have taken a dose higher than the prescribed dose of this medicine. Take the medicine pack to your doctor, even if there are no tablets left.

If you take more Sewab than the recommended dose, you may increase the risk of bleeding. If bleeding occurs, surgery, blood transfusions, or other treatments may be necessary to reverse the anti-Factor Xa activity.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Sewab

Take the dose as soon as you remember and:

• take the next dose of Sewab at the usual time
• then continue taking the medicine as usual.

If you are not sure what to do or if you forget to take more than one dose,ask your doctor, pharmacist, or nurse.

If you stop taking Sewab

Do not stop taking this medicine without talking to your doctor first, because the risk of developing a blood clot may be higher if you stop the treatment too soon.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them. The most frequent adverse effect of this medicine is bleeding, which can put the patient's life at risk and requires immediate medical attention.

The following adverse effects have been reported when taking apixaban to prevent the formation of blood clots in the heart in patients with irregular heart rhythm and at least one additional risk factor.

Frequent Adverse Effects (may affect up to 1 in 10 people)

• Bleeding, including:
• • in the eyes,
  • in the stomach or intestine,
  • from the rectum,
  • blood in the urine,
  • from the nose,
  • from the gums,
  • • bruising and swelling,
• Anemia, which can cause fatigue or paleness.
• Low blood pressure that can cause fainting or a faster heart rate.
• Nausea (general discomfort).
• Blood tests may show:
• • an increase in gamma glutamyl transferase (GGT).

Uncommon Adverse Effects (may affect up to 1 in 100 people)

• Bleeding:
• • in the brain or spinal cord,
  • in the mouth or coughing up blood,
  • in the abdomen, or vagina,
  • bright red blood in the stool,
  • bleeding after surgery that includes bruising and swelling, discharge of blood or fluid from the wound/surgical incision (suppuration) or injection site,
  • hemorrhoidal,
  • tests that show blood in the stool or urine.
• Decrease in the number of platelets in the blood (which can affect coagulation).
• Blood tests may show:
• • abnormal liver function,
  • increase in some liver enzymes,
  • increase in bilirubin, a byproduct of red blood cells, which can cause yellowing of the skin and eyes.
• Skin rash.
• Itching.
• Hair loss.
• Allergic reactions (hypersensitivity) that can cause: swelling of the face, lips, mouth, tongue, and/or throat, and difficulty breathing. Inform your doctor immediately if you experience any of these symptoms.

Rare Adverse Effects (may affect up to 1 in 1,000 people)

• Bleeding:
• • in the lungs or throat,
  • in the space behind the abdominal cavity,
  • in a muscle.

Very Rare Adverse Effects (may affect up to 1 in 10,000 people)

• Skin rash that can form blisters and resemble small targets (dark spots in the center surrounded by a paler area, with a dark ring around) (erythema multiforme).

Frequency Not Known (cannot be estimated from the available data)

• Inflammation of the blood vessels (vasculitis) that can cause skin rash or pinpoint, flat, red, and round spots under the skin surface or bruising.

The following adverse effects have been reported when taking Sewab to treat or prevent blood clots from forming again in the veins of the legs and in the blood vessels of the lungs.

Frequent Adverse 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, intestine, or rectum,
  • in the mouth,
  • from the vagina,
• Anemia, which can cause fatigue or paleness.
• Decrease in the number of platelets in the blood (which can affect coagulation).
• Nausea (general discomfort).
• Skin rash.
• Blood tests may show:
• • an increase in gamma glutamyl transferase (GGT) or alanine aminotransferase (ALT).

Uncommon Adverse Effects (may affect up to 1 in 100 people)

• Low blood pressure that can cause fainting or a faster heart rate,
• Bleeding:
• • in the eyes,
  • in the mouth or coughing up blood,
  • bright red blood in the stool,
  • tests that show blood in the stool or urine,
  • bleeding after surgery that includes bruising and swelling, discharge of blood or fluid from the wound/surgical incision (suppuration) or injection site;
  • hemorrhoidal,
  • in a muscle.
• Itching.
• Hair loss.
• Allergic reactions (hypersensitivity) that can cause: swelling of the face, lips, mouth, tongue, and/or throat, and difficulty breathing. Inform your doctor immediately if you experience any of these symptoms.
• Blood tests may show:
• • abnormal liver function,
  • increase in some liver enzymes,
  • increase in bilirubin, a byproduct of red blood cells, which can cause yellowing of the skin and eyes.

Rare Adverse Effects (may affect up to 1 in 1,000 people)

• Bleeding:
• • in the brain or spinal cord,
  • in the lungs.

Frequency Not Known (cannot be estimated from the available data)

• Bleeding:
• • in the abdomen or the space behind the abdominal cavity.
• Skin rash that can form blisters and resemble small targets (dark spots in the center surrounded by a paler area, with a dark ring around) (erythema multiforme),
• Inflammation of the blood vessels (vasculitis) that can cause skin rash or pinpoint, flat, red, and round spots under the skin surface or bruising.

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Sewab

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date that appears on the packaging and on each blister, after "CAD/EXP". The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Sewab

• The active ingredient is apixaban. Each film-coated tablet contains 5 mg of apixaban.
• The other ingredients are:

Core of the tablet: lactose monohydrate (see section 2 "Sewab contains lactose (a type of sugar) and sodium"), microcrystalline cellulose (E460), povidone K30, crospovidone (type A), sodium lauryl sulfate, and sodium stearyl fumarate.

• Coating: lactose monohydrate (see section 2 "Sewab contains lactose (a type of sugar) and sodium"), hypromellose, titanium dioxide (E171), triacetin (E 1518), red iron oxide (E172).

Appearance of the Product and Package Contents

Sewab 5 mg are film-coated tablets, pink, oblong, 5.2 cm high and 10.3 cm long.

The product is available in aluminum-PVC/PVdC blisters and unit-dose blisters in a cardboard box containing 20, 28, 30, 56, or 60 film-coated tablets (blister) or 20 x 1, 28 x 1, 30 x 1, 56 x 1, or 60 x 1 film-coated tablets (unit-dose blister).

Only some pack sizes may be marketed.

Patient Information Card: Information Management

Inside the Sewab packaging, along with the leaflet, you will find a Patient Information Card or your healthcare professional may give you a similar card.

This Patient Information Card includes useful information for you and will alert other doctors that you are being treated with Sewab. You must keep this card with you at all times.

1. Take the card
2. Complete the following sections or ask your doctor to complete them:

• Name:
• Date of birth:
• Indication:
• Dose: ......mg twice a day
• Doctor's name:
• Doctor's phone number:
• 1. Fold the card and carry it with you at all times

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Adalvo Limited

Malta Life Sciences Park,

Building 1, Level 4

Sir Temi Zammit Buildings

San Gwann Industrial Estate

San Gwann

SGN 3000

Malta

Manufacturer

Pharmadox Healthcare Ltd.

Address: KW20A Kordin Industrial Park

Paola PLA 300

Malta

O

Adalvo Limited

Address: Malta Life Sciences Park

Building 1, Level 4, Sir Temi Zammit Buildings

San Gwann, SGN 3000

Malta

Date of the Last Revision of this Leaflet: May 2024

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/