MODYLAN 5 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Modylan, 5 mg, Film-Coated Tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet
3. What is Modylan and what is it used for
4. Important information before taking Modylan
   1. When not to take Modylan:
   2. Warnings and precautions
   3. Children and adolescents
   4. Modylan and other medicines
   5. The following medicines may increase the effect of Modylan and increase the risk of unwanted bleeding:
   6. The following medicines may reduce the ability of Modylan to prevent blood clots:
   7. Pregnancy and breastfeeding
   8. Driving and using machines
   9. Modylan contains lactose (a type of sugar) and sodium
5. How to take Modylan
   1. Dose
   2. Instructions for crushing tablets:
   3. Modylan should be taken as follows in the following indications:
   4. Use in patients undergoing cardioversion
   5. Taking a higher dose of Modylan than recommended
   6. Missing a dose of Modylan
   7. If you have any doubts about taking the medicine or have missed more than
   8. Stopping Modylan treatment
6. Possible side effects
   1. The following side effects are known to occur when taking Modylan to prevent blood clots in the heart in patients with
   2. irregular heart rhythm and at least one additional risk factor.
   3. Common side effects (may affect up to 1 in 10 people)
   4. Uncommon side effects (may affect up to 1 in 100 people)
   5. Rare side effects (may affect up to 1 in 1000 people)
   6. Frequency not known (cannot be estimated from the available data)
   7. The following side effects are known to occur when taking Modylan to prevent the recurrence of blood clots in the veins of the legs and in the blood vessels of the lungs.
   8. Prevention of recurrence of blood clots in the veins of the legs and in the blood vessels of the lungs.
   9. Common side effects (may affect up to 1 in 10 people)
   10. Uncommon side effects (may affect up to 1 in 100 people)
   11. Rare side effects (may affect up to 1 in 1000 people)
   12. Frequency not known (cannot be estimated from the available data)
   13. Reporting side effects
7. How to store Modylan
8. Contents of the pack and other information
   1. What Modylan contains
   2. What Modylan looks like and contents of the pack
   3. Patient Alert Card: Information for Use
   4. Marketing Authorization Holder:
   5. Importer:
   6. Date of last revision of the leaflet:

Package Leaflet: Information for the User

Modylan, 5 mg, Film-Coated Tablets

Apixaban

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is Modylan and what is it used for
• 2. Important information before taking Modylan
• 3. How to take Modylan
• 4. Possible side effects
• 5. How to store Modylan
• 6. Contents of the pack and other information

1. What is Modylan and what is it used for

Modylan contains apixaban as the active substance and belongs to a group of medicines called anticoagulants. It helps prevent blood clots by blocking factor Xa, which is an important part of the blood clotting process.
This medicine 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 can break loose and travel to the brain, leading to a stroke, or to other organs, blocking blood flow to these organs (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 the recurrence of blood clots in the veins of the legs and/or lungs.

2. Important information before taking Modylan

When not to take Modylan:

• if you are allergic to apixaban or any of the other ingredients of this medicine (listed in section 6);
• if you have excessive bleeding;
• if you have a disease of an organ that increases the risk of severe bleeding (e.g., active or recent stomach or intestinal ulcer, bleeding in the brain);
• if you have liver disease that increases the risk of bleeding (hepatic coagulopathy);
• if you are taking medicines that prevent blood clotting (such as warfarin, rivaroxaban, dabigatran, or heparin), except in situations where one anticoagulant is being switched for another, when you have a permanent venous or arterial catheter and are receiving heparin through this catheter to maintain its patency, or when you have a catheter inserted into a blood vessel (during catheter ablation) to treat irregular heart rhythm (arrhythmia).

Warnings and precautions

Before starting treatment, discuss with your doctor, pharmacist, or nurse:

• if you have an increased risk of bleeding, such as:
• bleeding disorders, including conditions with decreased platelet activity;
• very high, uncontrolled blood pressure;
• if you are over 75 years old;
• if your body weight is 60 kg or less;
• if you have severe kidney disease or are on dialysis;
• if you have or have had liver disease. The use of this medicine requires caution in patients with signs of liver dysfunction.
• if you have a heart valve replacement;
• if your doctor considers that your blood pressure is unstable or if you are scheduled to undergo surgery to remove a blood clot from your lungs.

When to be particularly careful when taking Modylan

• if you have a disease called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), you should inform your doctor, who will decide whether a change in treatment is necessary.
• if you need to undergo surgery or a procedure that may involve bleeding, your doctor may ask you to temporarily stop taking this medicine. 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.

Modylan and 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 Modylan, while others may reduce its effect. Your doctor will decide whether you should take Modylan while being treated with other medicines and how closely you should be monitored.

The following medicines may increase the effect of Modylan 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 and 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 a higher risk of bleeding;
• medicines used to treat high blood pressure or heart disease (e.g., diltiazem);
• antidepressant medicines called selective serotonin reuptake inhibitors or serotonin and noradrenaline reuptake inhibitors.

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

• medicines used to prevent seizures or fits (e.g., phenytoin and others);
• St. John's Wort (a herbal supplement used in 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 plan to have a baby, ask your doctor, pharmacist, or nurse for advice before taking this medicine.
The effect of Modylan on pregnancy and the unborn child is not known. This medicine should not be used during pregnancy. If you become pregnant while taking this medicine, you should contact your doctor immediately.
It is not known whether this medicine passes into breast milk. Before taking this medicine while breastfeeding, ask your doctor, pharmacist, or nurse for advice. They will decide whether you should stop breastfeeding, stop, or not start taking this medicine.

Driving and using machines

It has not been found that Modylan affects the ability to drive or use machines.

Modylan contains lactose (a type of sugar) and sodium

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

3. How to take Modylan

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. Modylan can be taken with or without food.
It is recommended to take the tablets at the same time every day to get the best results from the treatment.
If you have difficulty swallowing whole tablets, you should talk to your doctor about other ways to take Modylan. The tablet can be crushed just before taking and mixed with water, 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 then mix it with a small amount, for example, 30 mL (2 tablespoons), of water or one of the above-mentioned liquids to obtain a mixture.
• Swallow (drink) the resulting mixture.
• Rinse the pestle and mortar used to crush the tablet and the container in which the mixture was prepared with a small amount of water or one of the above-mentioned liquids (e.g., 30 mL), and then swallow (drink) the rinse liquid.

If necessary, your doctor may give you a crushed Modylan tablet mixed with 60 mL of water or 5% aqueous glucose solution through a nasogastric tube.

Modylan should be taken as follows in the following indications:

• -Prevention of blood clots in the heart in patients with irregular heart rhythm and at least one additional risk factor:The recommended dose is one Modylan 5 mg tablet twice a day.

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

• you have severe kidney problems;
• at least 2 of the following criteria are met:
• your blood test results show decreased kidney function (serum creatinine level of 1.5 mg/dL (133 μmol/L) or higher);
• you are 80 years old or older;
• your body weight is 60 kg or less.

The recommended dose is one tablet twice a day, for example, one tablet in the morning and one tablet 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 blood vessels of the lungsThe recommended dose is twoModylan 5 mg tablets twice a day for the first 7 days, for example, two tablets in the morning and two tablets in the evening. After 7 days, the recommended dose is oneModylan 5 mg tablet twice a day, for example, one tablet in the morning and one tablet in the evening.
• -Prevention of recurrence of blood clots after completing 6 months of treatmentThe recommended dose is one Modylan 2.5 mg tablet twice a day, for example, one tablet in the morning and one tablet in the evening. Your doctor will decide how long you should continue treatment.
• -Your doctor may switch your anticoagulant treatment as follows:
• •Switching from Modylan to other anticoagulantsYou should stop taking Modylan. At the time when you would take the next scheduled dose, you should start treatment with another anticoagulant (e.g., heparin).
• •Switching from other anticoagulants to ModylanYou should stop taking the anticoagulant. At the time when you would take the next scheduled dose of the anticoagulant, you should start treatment with Modylan and continue its usual intake.
• •Switching from treatment with a vitamin K antagonist (e.g., warfarin) to ModylanYou should stop taking the vitamin K antagonist. Your doctor will order blood tests and tell you when you can start taking Modylan.
• •Switching from Modylan to treatment with a vitamin K antagonist (e.g., warfarin)If your doctor advises you to start taking a vitamin K antagonist, you should continue taking Modylan for at least 2 days after taking the first dose of the vitamin K antagonist. Your doctor will order blood tests and tell you when you can stop taking Modylan.

Use in patients undergoing cardioversion

If a procedure called cardioversion is needed to restore a normal heart rhythm due to irregular heart rhythm, you should take the medicine at the times strictly specified by your doctor to prevent blood clots in the blood vessels of the brain and other blood vessels in the body.

Taking a higher dose of Modylan than recommended

If you have taken more Modylan than recommended, you should immediately
inform your doctor.You should take the package with you, even if it is empty.
Taking more Modylan than recommended may increase the risk of bleeding. If bleeding occurs, surgical treatment, blood transfusion, or other treatment that can reverse the effect of factor Xa inhibition may be necessary.

Missing a dose of Modylan

You should take the dose as soon as you remember and:

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

If you have any doubts about taking the medicine or have missed more than

one dose, you should ask your doctor, pharmacist, or nurse.

Stopping Modylan treatment

You should not stop taking this medicine without consulting your doctor, as stopping treatment too early may increase the risk of blood clots.
If you have any further doubts about taking this medicine, you should ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most common general side effect of this medicine is bleeding, which can potentially be life-threatening and may require immediate medical attention.

The following side effects are known to occur when taking Modylan to prevent blood clots in the heart in patients with

irregular heart rhythm and at least one additional risk factor.

Irregular heart rhythm and at least one additional risk factor.

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

• bleeding, including:
• in the eyes;
• in the stomach or intestines;
• from the rectum;
• presence of blood in the urine;
• from the nose;
• from the gums;
• bruising and swelling;
• anemia, which can cause fatigue or pale skin;
• low blood pressure, which can lead to fainting or rapid heart rate;
• nausea (vomiting);
• blood tests showing increased gamma-glutamyltransferase (GGTP) activity.

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

• bleeding:
• in the brain or spinal cord;
• in the mouth or presence of blood in sputum when coughing;
• in the abdominal cavity or from the vagina;
• presence of clear/red blood in the stool;
• bleeding after surgery, including bruising and swelling, and oozing of blood or fluid from the wound/surgical incision site or injection site;
• from hemorrhoids;
• in the muscles;
• decreased platelet count (which can affect blood clotting);
• blood tests may show:
• abnormal liver function;
• increased activity of certain liver enzymes;
• increased bilirubin levels, a product of broken-down red blood cells, which 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, you should immediately contact your doctor.

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

• bleeding:
• in the lungs or throat;
• in the abdominal cavity or retroperitoneal space.

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

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

The following side effects are known to occur when taking Modylan to prevent the recurrence of blood clots in the veins of the legs and in the blood vessels of the lungs.

Prevention of recurrence of blood clots in the veins of the legs and in the blood vessels of the lungs.

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

• bleeding, including:
• from the nose;
• from the gums;
• presence of blood in the urine;
• bruising and swelling;
• from the stomach, intestines, rectum;
• in the mouth;
• from the vagina;
• anemia, which can cause fatigue or pale skin;
• decreased platelet count (which can affect blood clotting);
• nausea (vomiting);
• skin rash;
• blood tests may show increased gamma-glutamyltransferase (GGTP) or alanine aminotransferase (AlAT) activity.

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

• low blood pressure, which can lead to fainting or rapid heart rate
• bleeding:
• in the eyes;
• in the mouth or presence of blood in sputum when coughing;
• presence of clear/red blood in the stool;
• blood tests showing presence of blood in the stool or urine;
• bleeding after surgery, including bruising and swelling, and oozing of blood or fluid from the wound/surgical incision site or injection site;
• from hemorrhoids;
• in the muscles;
• 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, you should immediately contact your doctor;
• blood tests may show:
• abnormal liver function;
• increased activity of certain liver enzymes;
• increased bilirubin levels, a product of broken-down red blood cells, which can cause yellowing of the skin and eyes.

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

• bleeding:
• in the brain or spinal cord;
• in the lungs.

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

• bleeding in the abdominal cavity or retroperitoneal space.
• skin rash, which can cause blisters and looks like small targets (dark spots surrounded by a lighter area, with a dark border on the edge) (erythema multiforme);
• vasculitis (inflammation of blood vessels), which can cause skin rash or pinpoint, flat, red, round spots under the skin surface or bruising.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Modylan

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.
There are no special storage instructions 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. This will help protect the environment.

6. Contents of the pack and other information

What Modylan contains

• The active substance is apixaban. Each tablet contains 5 mg of apixaban.
• The other ingredients are:
• Tablet core: lactose monohydrate (see section 2. Modylan contains lactose (a type of sugar) and sodium), microcrystalline cellulose (E 460), Povidone K-30, Crospovidone (type A), sodium lauryl sulfate, and sodium stearyl fumarate
• Coating: lactose monohydrate (see section 2. Modylan contains lactose (a type of sugar) and sodium), hypromellose, titanium dioxide (E171), triacetin (E 1518), iron oxide red (E172).

What Modylan looks like and contents of the pack

Prolonged-release tablets are pink, 5.2 mm wide, and 10.3 mm long.
This medicine is available in blisters of aluminum/PVC/PVdC or in single-dose blisters with perforations, packaged in cardboard boxes.
Pack sizes: 7, 10, 14, 20, 28, 30, 56, 60, or 100 film-coated tablets (in blisters)
Pack sizes: 7 x 1, 10 x 1, 14 x 1, 20 x 1, 28 x 1, 30 x 1, 56 x 1, 60 x 1, or 100 x 1 film-coated tablets (in single-dose blisters with perforations)
Not all pack sizes may be marketed.

Patient Alert Card: Information for Use

Inside the Modylan package, in addition to the package leaflet, there is a patient alert card. Your doctor may also give you such a card.
The patient alert card contains information that will be useful for you and will inform other doctors that you are taking Modylan. You should always carry this card with you.

• 1. Take the card.
• 2. Fill in the following or ask your doctor to fill them in:
• Name and surname:
• Date of birth:
• Indication:
• Dose: ........mg twice a day
• Doctor's name and surname:
• Doctor's phone number:
• 3. Fold the card and carry it with you at all times.

Marketing Authorization Holder:

Egis Pharmaceuticals PLC
Keresztúri út 30-38
1106 Budapest
Hungary

Importer:

Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park
Paola PLA 3000
Malta
Adalvo Limited
Malta Life Sciences Park, Building 1, Level 4, Sir Temi Zammit Buildings,
San Gwann SGN 3000
Malta
This medicine is authorized in the Member States of the European Economic Area under the following names:
Finland
Modylan
Bulgaria
Modylan 2.5 mg, 5 mg film-coated tablets
Модилан 2.5 mg, 5 mg филмирани таблетки
Czech Republic
Modylan
Lithuania
Modylan 2.5 mg, 5 mg plėvele dengtos tabletės
Latvia
Modylan 2.5 mg, 5 mg apvalkotās tabletes
Poland
Modylan
Romania
Modylan 2.5 mg, 5 mg comprimate filmate
Slovakia
Modylan
To obtain more detailed information on this medicine, please contact the local representative of the marketing authorization holder:
EGIS Polska Sp. z o.o.
ul. Komitetu Obrony Robotników 45D
02-146 Warsaw
Phone: +48 22 417 92 00

Date of last revision of the leaflet: