Mantreda

Leaflet accompanying the packaging: information for the user

Mantreda, 15 mg, coated tablets

Mantreda, 20 mg, coated tablets

Rivaroxaban
You should carefully read the contents of the leaflet before taking the medicine, as it contains
important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you specifically. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Mantreda and what is it used for

Mantreda contains the active substance rivaroxaban and is used in adults to:

• prevent the formation of blood clots in the brain (stroke) and other blood vessels in the patient's body, if the patient has a form of irregular heart rhythm called non-valvular atrial fibrillation.
• treat blood clots in the veins of the legs (deep vein thrombosis) and blood vessels in the lungs (pulmonary embolism) and prevent the recurrence of blood clots in the blood vessels of the legs and/or lungs.

Mantreda is used in children and adolescents under 18 years of age and weighing 30 kg or more to:

• treat blood clots and prevent the recurrence of blood clots in the veins or blood vessels in the lungs after at least 5 days of initial treatment with injectable medicines used to treat blood clots.

Mantreda belongs to a group of medicines called anticoagulants. Its action is based on blocking the blood clotting factor (factor Xa) and thereby reducing the tendency to form blood clots.

2. Important information before taking Mantreda

When not to take Mantreda

• if the patient is allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6),
• if the patient has excessive bleeding,
• if the patient has a disease or condition of the body that leads to an increased risk of serious bleeding (e.g. stomach ulcer, injury or bleeding into the brain, recent surgical procedure on the brain or eyes),
• if the patient is taking other medicines that prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), except when changing anticoagulant treatment or when heparin is administered to maintain the patency of a vein or artery catheter,
• if the patient has liver disease that leads to an increased risk of bleeding,
• if the patient is pregnant or breastfeeding.

Do not take Mantreda, and inform your doctorif you suspect that you have any of the above conditions.

Warnings and precautions

Before starting to take Mantreda, you should discuss it with your doctor or pharmacist.

When to be particularly careful when taking Mantreda

• if the patient has an increased risk of bleeding, in such conditions as:
• severe kidney disease in adults and moderate or severe kidney disease in children and adolescents, as kidney function may affect the amount of medicine acting in the patient's body
• taking other medicines that prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin) when changing anticoagulant treatment or when heparin is administered to maintain the patency of a vein or artery catheter (see "Mantreda and other medicines")
• bleeding disorders
• very high blood pressure that does not decrease despite taking medicines
• stomach or intestinal diseases that may cause bleeding, e.g. inflammation of the intestines and stomach or inflammation of the esophagus (throat and esophagus) e.g. due to reflux disease of the esophagus (backflow of stomach acid into the esophagus) or tumors located in the stomach or intestines or genital or urinary system
• disease of the blood vessels in the back of the eyeballs (retinopathy)
• pulmonary disease in which the bronchi are dilated and filled with pus (bronchiectasis) or previous bleeding from the lungs
• in patients with prosthetic valves
• if the patient has a disorder called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), the patient should inform their doctor, who will decide on possible changes to the treatment
• if the patient has been diagnosed with abnormal blood pressure or a surgical procedure is planned to remove a blood clot from the lungs.

If the patient suspects that they have any of the above conditions, they should

inform their doctorbefore taking Mantreda. The doctor will decide whether to use this medicine and whether the patient should be subject to particularly close monitoring.

If the patient needs to undergo surgery:

• they should follow their doctor's instructions very carefully regarding the intake of Mantreda at a precisely specified time before or after surgery.
• if a spinal puncture or catheter insertion into the spine is planned during the surgical procedure (e.g. for spinal anesthesia or epidural anesthesia or to reduce pain):
• they should follow their doctor's instructions very carefully regarding the time of taking Mantreda before and after the puncture or catheter removal
• they should immediately inform their doctor if, after the anesthesia, they experience symptoms such as numbness, weakness of the lower limbs, disorders of bowel or bladder function, as in such a case, immediate treatment is necessary.

Children and adolescents

Mantreda tablets are not recommended for children with a body weight below 30 kg.There is a lack of sufficient data on the use of the medicine in children and adolescents for indications in adults.

Mantreda and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take, including those that are available without a prescription.

• -If you are taking:
• certain medicines used to treat fungal infections (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are used only locally on the skin
• ketokonazole in tablets (used to treat Cushing's syndrome, in which the body produces too much cortisol)
• certain medicines used to treat bacterial infections (e.g. clarithromycin, erythromycin)
• certain antiviral medicines used to treat HIV or AIDS (e.g. ritonavir)
• other medicines used to reduce blood clotting (e.g. enoxaparin, clopidogrel or vitamin K antagonists, such as warfarin or acenocoumarol)
• anti-inflammatory and pain-relieving medicines (e.g. naproxen or acetylsalicylic acid)
• dronedarone, a medicine used to treat heart rhythm disorders
• certain medicines used to treat depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs)).

If the patient suspects that they have any of the above conditions, they should

inform their doctorbefore taking Mantreda, as the effect of Mantreda may be enhanced. The doctor will decide whether to use this medicine and whether the patient should be subject to particularly close monitoring.
If the doctor believes that the patient is at increased risk of developing stomach or duodenal ulcers, they may use treatment to prevent ulcer disease.

• -If you are taking:
• certain medicines used to treat epilepsy (phenytoin, carbamazepine, phenobarbital)
• St. John's Wort ( Hypericum perforatum), a herbal medicine used to treat depression
• rifampicin, which belongs to a group of antibiotics.

If the patient suspects that they have any of the above conditions, they should

inform their doctorbefore taking Mantreda, as the effect of Mantreda may be reduced. The doctor will decide whether to use Mantreda and whether the patient should be subject to particularly close monitoring.

Pregnancy and breastfeeding

Do not take Mantreda if you are pregnant or breastfeeding. If there is a risk that you may become pregnant, you should use effective contraception while taking Mantreda. If you become pregnant while taking this medicine, you should immediately inform your doctor, who will decide on further treatment.

Driving and using machines

Mantreda may cause dizziness (frequent side effects) or fainting (uncommon side effects) (see section 4 "Possible side effects"). Patients who experience these side effects should not drive vehicles, ride bicycles, or operate tools or machines.

Mantreda contains lactose and sodium

If you have previously been diagnosed with intolerance to some sugars, you should contact your doctor before taking this medicine.
The medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means that the medicine is considered "sodium-free".

3. How to take Mantreda

This medicine should always be taken according to the doctor's instructions. If you have any doubts, you should consult a doctor or pharmacist.
Mantreda should be taken with food.
The tablet(s) should be swallowed, preferably with water.
If you have difficulty swallowing the whole tablet, you should talk to your doctor about other ways of taking Mantreda. The tablet can be crushed and mixed with water or soft food, such as apple puree, immediately before administration. After such a mixture, you should eat a meal immediately.
If necessary, your doctor may also administer the crushed Mantreda tablet through a gastric tube.

How many tablets to take

• Adults
• In the prevention of blood clot formation in the brain (stroke) and other blood vessels in the body, the recommended dose is one 20 mg Mantreda tablet taken once a day. If you have kidney problems, the dose may be reduced to one 15 mg Mantreda tablet once a day.

If the patient requires a procedure to clear the blood vessels in the heart (called percutaneous coronary intervention - PCI with stent placement), there is limited evidence to support a dose reduction to one 15 mg Mantreda tablet once a day (or one 10 mg Mantreda tablet once a day in case of kidney function impairment) in combination with an antiplatelet medicine such as clopidogrel.

• In the treatment of blood clots in the veins of the legs, blood clots in the blood vessels of the lungs, and to prevent the recurrence of blood clots, the recommended dose is one 15 mg Mantreda tablet twice a day for the first 3 weeks. For treatment after 3 weeks, the recommended dose is one 20 mg Mantreda tablet once a day. After at least 6 months of treatment for blood clots, your doctor may decide to continue treatment using one 10 mg tablet once a day or one 20 mg tablet once a day. If you have kidney problems and are taking one 20 mg Mantreda tablet once a day, your doctor may decide to reduce the dose after 3 weeks of treatment to one 15 mg Mantreda tablet once a day, if the risk of bleeding is greater than the risk of further blood clots.
• Children and adolescentsThe dose of Mantreda depends on body weight and will be calculated by your doctor.
• The recommended dose for children and adolescents with a body weight from 30 kg to less than 50 kgis one Mantreda 15 mg tabletonce a day.
• The recommended dose for children and adolescents with a body weight of 50 kg or moreis one Mantreda 20 mg tabletonce a day. Each dose of Mantreda should be taken with a meal, with a drink (e.g. water or juice). Tablets should be taken daily at approximately the same time. It's a good idea to set an alarm to remind you. For parents or caregivers: you should observe the child to make sure they take the entire dose.

The dose of Mantreda depends on body weight, so it's essential to come to scheduled doctor's appointments, as it may be necessary to adjust the dose due to weight changes.
Never adjust the dose yourself.If necessary, your doctor will adjust the dose. Do not divide the tablet to get a partial dose. If a smaller dose is needed, you should use a different pharmaceutical form of rivaroxaban, such as a granule for oral suspension. For children and adolescents who are unable to swallow whole tablets, rivaroxaban should be used in the form of granules for oral suspension.
If the oral suspension is not available, you can crush the tablet and mix it with water or apple puree immediately before administration. After this mixture, you should eat a meal immediately.
If necessary, your doctor may also administer the crushed Mantreda tablet through a gastric tube.

In case of spitting out the dose or vomiting

• less than 30 minutes after taking Mantreda, you should take a new dose.
• more than 30 minutes after taking Mantreda, do not takea new dose. In this case, the next dose of Mantreda should be taken at the usual time.

You should contact your doctor in case of repeated spitting out of the dose or vomiting after taking Mantreda.

When to take Mantreda

You should take one tablet(s) every day until your doctor decides to stop the treatment.
It's best to take the tablet(s) at the same time every day, as it's easier to remember.
Your doctor will decide how long to continue the treatment.
Prevention of blood clot formation in the brain (stroke) and other blood vessels in the body:
If the heart rhythm needs to be restored to normal using a procedure called cardioversion, you should take Mantreda as directed by your doctor.

Missing a dose of Mantreda

• -Adults, children, and adolescents: If you take one 20 mg or one 15 mg tablet once a day and you miss a dose, you should take it as soon as possible. Do not take more than one tablet in one day to make up for the missed dose. The next tablet should be taken the next day, and then one tablet should be taken once a day.
• Adults: If you take one 15 mg tablet twice a day and you miss a dose, you should take it as soon as possible. Do not take more than two 15 mg tablets in one day. If you forget to take a dose, you can take two 15 mg tablets at the same time to get a total of two tablets (30 mg) taken in one day. The next day, you should continue taking one 15 mg tablet twice a day.

Taking more than the recommended dose of Mantreda

If you take more than the recommended dose of Mantreda, you should contact your doctor immediately. Taking too much Mantreda increases the risk of bleeding.

Stopping the treatment with Mantreda

You should not stop taking Mantreda without first consulting your doctor, as Mantreda treats and prevents serious illnesses.
If you have any further doubts about the use of this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Like other medicines with similar effects, reducing blood clot formation, Mantreda may cause bleeding, which can be life-threatening. Excessive bleeding can lead to a sudden drop in blood pressure (shock). These may not always be obvious or visible signs of bleeding.

You should immediately inform your doctor if you or your child experience any of the following side effects:

• Signs of bleeding
• bleeding into the brain or skull (symptoms may include headache, one-sided weakness, vomiting, seizures, decreased level of consciousness, and stiffness of the neck. This is a serious medical emergency. You should seek medical help immediately!)
• prolonged or excessive bleeding
• unusual weakness, fatigue, pallor, dizziness, headache, unexplained swelling, shortness of breath, chest pain, or angina pectoris. Your doctor may decide to monitor you very closely or change the treatment.
• Signs of severe skin reactions
• widespread, acute skin rash, blistering, or changes to the mucous membranes, e.g. in the mouth or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• a drug reaction causing rash, fever, inflammation of internal organs, blood disorders, and systemic symptoms (DRESS syndrome). The frequency of these side effects is very rare (may occur in less than 1 in 10,000 people).
• •Signs of severe allergic reactions
• swelling of the face, lips, mouth, tongue, or throat; difficulty swallowing; hives, and difficulty breathing; sudden drop in blood pressure. Severe allergic reactions are very rare (anaphylactic reactions, including anaphylactic shock; may occur in less than 1 in 10,000 people) and uncommon (angioedema and allergic edema; may occur in less than 1 in 100 people).

General list of possible side effects in adults and children and adolescents

Common(may affect up to 1 in 10 people)

• reduced red blood cell count, which may cause pallor and be the cause of weakness or shortness of breath
• bleeding from the stomach or intestine, bleeding from the urinary tract (including blood in the urine and heavy menstrual bleeding), nosebleeds, bleeding from the gums
• bleeding into the eye (including bleeding from the sclera)
• bleeding into tissues or body cavities (hematoma, bruising)
• presence of blood in sputum (hemoptysis) when coughing
• bleeding from the skin or subcutaneous bleeding
• bleeding after surgery
• oozing of blood or fluid from the wound after surgery
• swelling of the limbs
• limb pain
• kidney function disorders (can be observed in tests performed by the doctor)
• fever
• stomach pain, nausea (nausea), vomiting, constipation, diarrhea
• low blood pressure (symptoms may include dizziness or fainting when standing up)
• general weakness and lack of energy (weakness, fatigue), headache, dizziness
• rash, itching
• increased activity of certain liver enzymes, which can be seen in blood test results.

Uncommon(may affect up to 1 in 100 people)

• bleeding into the brain or skull (see above, signs of bleeding)
• bleeding into the joint, causing pain and swelling
• thrombocytopenia (low platelet count - cells involved in blood clotting)
• allergic reactions, including allergic skin reactions
• liver function disorders (can be observed in tests performed by the doctor)
• blood test results may show increased bilirubin levels, activity of certain pancreatic or liver enzymes, or platelet count
• fainting
• malaise
• rapid heartbeat
• dry mouth
• hives.

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

• bleeding into the muscles
• cholestasis (bile stasis), hepatitis, including liver cell damage
• jaundice (yellowing of the skin and eyes)
• local swelling
• blood accumulation (hematoma) in the groin as a complication of heart catheterization, when the catheter is inserted into the artery in the leg (pseudoaneurysm).

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

• accumulation of eosinophils, a type of white granular blood cells, which can cause inflammation in the lungs (eosinophilic pneumonia).

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

• kidney failure after severe bleeding
• bleeding in the kidneys, sometimes with the presence of blood in the urine, leading to kidney failure (nephropathy associated with the use of anticoagulant medicines)
• increased pressure in the muscles of the legs and arms, occurring after bleeding, which can lead to pain, swelling, changes in sensation, numbness, or paralysis (compartment syndrome after bleeding).

Side effects in children and adolescents

Generally, the side effects observed in children and adolescents treated with Mantreda were similar in type to those observed in adults and were mainly mild to moderate.
Side effects observed more frequently in children and adolescents:
Very common(may affect more than 1 in 10 people)

• headache
• fever
• nosebleeds, vomiting

Common(may affect up to 1 in 10 people)

• rapid heartbeat
• blood test results may show increased bilirubin levels
• thrombocytopenia (low platelet count - cells involved in blood clotting)
• excessive menstrual bleeding

Uncommon(may affect up to 1 in 100 people)

• blood test results may show increased direct bilirubin levels

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. 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,
Al. Jerozolimskie 181 C
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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Mantreda

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on each blister after: EXP. The expiry date refers to the last day of the month.
There are no special precautions for the storage of the medicinal product.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Mantreda contains

• The active substance of Mantreda is rivaroxaban. Each tablet contains 15 mg or 20 mg of rivaroxaban.
• Other ingredients are: Tablet core: sodium lauryl sulfate, lactose monohydrate, hypromellose 2910, croscarmellose sodium, magnesium stearate. Coating for 15 mg tablets: polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc), iron oxide yellow (E 172), iron oxide red (E 172). Coating for 15 mg tablets: polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc), iron oxide red (E 172).

What Mantreda looks like and contents of the pack

Mantreda 15 mg, coated tablets, are orange, approximately 7 mm in diameter, with "T" embossed on one side and "3R" on the other side.
Mantreda 20 mg, coated tablets, are red, approximately 8 mm in diameter, with "T" embossed on one side and "7R" on the other side.
Mantreda 15 mg: single-dose blisters, containing 14 x 1, 28 x 1, 42 x 1, or 100 x 1 tablets.
Mantreda 20 mg: single-dose blisters, containing 14 x 1, 28 x 1, or 100 x 1 tablets.

Marketing authorization holder:

Sigillata Limited
Inniscarra
Main Street
Rathcoole
Co. Dublin D24 E029
Ireland

Importer:

Balkanpharma - Dupnitsa AD
3 Samokovsko Shosse Str.
2600 Dupnitsa
Bulgaria

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Germany: Mantreda 15 mg, 20 mg, filmtabletten
Poland: Mantreda
Date of last revision of the leaflet:11/2023