MANTREDA 10 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Mantreda, 10 mg, Film-Coated Tablets
   1. Table of Contents of the Package Leaflet
3. What is Mantreda and what is it used for
4. Important information before taking Mantreda
   1. When not to take Mantreda
   2. Warnings and precautions
   3. Be particularly careful when taking Mantreda:
   4. If you suspect that you have any of the above conditions, inform
   5. If you need to have surgery:
   6. Children and adolescents
   7. Mantreda and other medicines
   8. If you suspect that you have any of the above conditions, inform
   9. If you suspect that you have any of the above conditions, inform
   10. Pregnancy and breastfeeding
   11. Driving and using machines
   12. Mantreda contains lactose and sodium
5. How to take Mantreda
   1. How many tablets to take
   2. When to take Mantreda
   3. Taking more Mantreda than prescribed
   4. Missing a dose of Mantreda
   5. Stopping treatment with Mantreda
6. Possible side effects
   1. General list of possible side effects
   2. Reporting side effects
7. How to store Mantreda
8. Contents of the pack and other information
   1. What Mantreda contains
   2. What Mantreda looks like and contents of the pack
   3. Marketing authorization holder
   4. Importer
   5. This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Package Leaflet: Information for the User

Mantreda, 10 mg, Film-Coated Tablets

Rivaroxaban
Read the package leaflet carefully before taking the medicine, as 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 or pharmacist.
• 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 or pharmacist. See section 4.

Table of Contents of the Package 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 veins after hip or knee replacement surgery. Your doctor has prescribed this medicine because the risk of blood clot formation is increased after surgery.
• treat blood clots in the veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism) and prevent the recurrence of blood clots in the veins of the legs and/or lungs.

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

2. Important information before taking Mantreda

When not to take Mantreda

• if you are allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6),
• if you have excessive bleeding,
• if you have 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 brain or eye surgery),
• if you are taking other medicines that prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), except when switching anticoagulant treatment or when heparin is given to maintain the patency of a vein or artery catheter,
• if you have liver disease that leads to an increased risk of bleeding,
• if you are 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 treatment with Mantreda, discuss it with your doctor or pharmacist.

Be particularly careful when taking Mantreda:

• if you have an increased risk of bleeding, in conditions such as:
• moderate or severe kidney disease, as kidney function may affect the amount of medicine that works in your body
• taking other medicines that prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin) when switching anticoagulant treatment or when heparin is given to maintain the patency of a vein or artery catheter (see section "Mantreda and other medicines")
• bleeding disorders
• very high blood pressure that does not decrease despite treatment
• 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 gastroesophageal reflux disease (backflow of stomach acid into the esophagus) or tumors located in the stomach or intestines or genital or urinary system
• vascular disease of the back of the eye (retinopathy)
• pulmonary disease in which the bronchi are dilated and filled with pus (bronchiectasis) or previous bleeding from the lungs
• in patients with artificial heart valves
• if you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clot formation), you should inform your doctor, who will decide whether to change the treatment
• if you have abnormal blood pressure or if surgery is planned to remove a blood clot from the lungs.

If you suspect that you have any of the above conditions, inform

your doctorbefore taking Mantreda. Your doctor will decide whether to use this medicine and whether you need to be closely monitored.

If you need to have surgery:

• you should carefully follow your doctor's instructions regarding the intake of Mantreda at a specific time before or after surgery
• if a spinal puncture or catheter insertion into the spine is planned during surgery (e.g. for epidural or spinal anesthesia or to relieve pain):
• you should carefully follow your doctor's instructions regarding the intake of Mantreda at a specific time,
• you should immediately inform your doctor if you experience symptoms such as numbness, weakness of the lower limbs, disorders of bowel or bladder function after anesthesia, as immediate treatment may be necessary.

Children and adolescents

Mantreda 10 mg tablets are not recommended for persons under 18 years of age.There is insufficient data on the use of the medicine in children and adolescents.

Mantreda and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take, including those 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 topically 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 you suspect that you have any of the above conditions, inform

your doctorbefore taking Mantreda, as the effect of Mantreda may be enhanced. Your doctor will decide whether to use this medicine and whether you need to be closely monitored.
If your doctor believes that you have an increased risk of stomach or duodenal ulcer, he or she 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 you suspect that you have any of the above conditions, inform

your doctorbefore taking Mantreda, as the effect of Mantreda may be reduced. Your doctor will decide whether to use Mantreda and whether you need to be closely monitored.

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 during treatment with Mantreda. If you become pregnant during treatment with 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, ride a bicycle 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 exactly as directed by your doctor. If you are unsure, ask your doctor or pharmacist.

How many tablets to take

• In the prevention of blood clots in the veins after hip or knee replacement surgery, the recommended dose is one 10 mg Mantreda tablet taken once daily.
• 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, after at least 6 months of treatment for blood clots, the recommended dose is one 10 mg tablet once daily or one 20 mg tablet once daily. Your doctor has prescribed Mantreda 10 mg once daily for you.

Swallow the tablet whole, preferably with water.
Mantreda can be taken with or without food.
If you have difficulty swallowing the whole tablet, talk to your doctor about other ways to take Mantreda. The tablet can be crushed and mixed with water or apple sauce, just before taking it.
If necessary, your doctor may administer the crushed Mantreda tablet through a gastric tube.

When to take Mantreda

Take one tablet every day until your doctor decides to stop treatment.
It is best to take the tablet at the same time every day, as this will help you remember to take it.
Your doctor will decide how long you should continue treatment.
To prevent blood clots in the veins of the legs after hip or knee replacement surgery:

The first tablet should be taken 6 to 10 hours after surgery.
For patients after major hip surgery, tablets are usually taken for a period of 5 weeks.
For patients after major knee surgery, tablets are usually taken for a period of 2 weeks.

Taking more Mantreda than prescribed

If you have taken more Mantreda than prescribed, contact your doctor immediately. Taking too much Mantreda increases the risk of bleeding.

Missing a dose of Mantreda

If you miss a dose, take a tablet as soon as you remember. Take the next tablet the next day, and then take the tablets as usual, once a day.
Do not take a double dose to make up for a missed dose.

Stopping treatment with Mantreda

Do not stop taking Mantreda without first consulting your doctor, as Mantreda prevents a serious disease.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Mantreda 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.
Tell your doctor immediatelyif you experience any of the following side effects:

• Signs of bleeding
• bleeding into the brain or inside the skull (symptoms may include headache, one-sided weakness, vomiting, seizures, decreased level of consciousness and stiffness of the neck. A serious medical emergency. Seek medical help immediately!)
• prolonged or excessive bleeding
• unusual weakness, fatigue, pallor, dizziness, headache, unexplained swelling, shortness of breath, chest pain or angina. Your doctor may decide to closely monitor you or change treatment.
• Signs of severe skin reactions
• widespread, acute skin rash, blistering or changes in the mucous membranes, e.g. in the mouth or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• 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

Common(may affect up to 1 in 10 people)

• reduction in 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 or genital system (including blood in the urine and heavy menstrual bleeding), nosebleeds, bleeding gums
• bleeding into the eye (including bleeding from the white of the eye)
• 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 your doctor)
• fever
• stomach pain, nausea (nausea) or 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 inside the 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 your 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 a catheter is inserted into an artery in the leg.

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 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).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform 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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Mantreda

Keep the medicine out of the 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 storage of the medicinal product.
Medicines should not be disposed of via wastewater or household waste. 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 10 mg of rivaroxaban.
• Other ingredients are: Tablet core: sodium lauryl sulfate, lactose monohydrate, hypromellose 2910, croscarmellose sodium, magnesium stearate. Coating: polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, carmine (E 120), yellow iron oxide (E 172), red iron oxide (E 172).

What Mantreda looks like and contents of the pack

Mantreda 10 mg, film-coated tablets, are pink, approximately 8 mm in diameter, with "T" embossed on one side and "1R" on the other side.
Tablets are available

• in single-dose blisters, packaged in cardboard boxes, containing 10 x 1 or 30 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 10 mg, film-coated tablets
Poland: Mantreda
Date of last revision of the leaflet:11/2023