Rivaroxaban tzf

Package leaflet: Information for the patient

Rywaroksaban TZF, 15 mg, film-coated tablets
Rywaroksaban TZF, 20 mg, film-coated tablets
Rivaroxabanum
Please read this leaflet carefully before using this medicine, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual only. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

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

1. What Rywaroksaban TZF is and what it is used for

Rywaroksaban TZF 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 body in patients who have a type of irregular heartbeat known as non-valvular atrial fibrillation.
• treat blood clots in the veins of the legs (deep vein thrombosis) and blood vessels of the lungs (pulmonary embolism), and to prevent recurrence of blood clots in the blood vessels of the legs and/or lungs.

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

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

Rywaroksaban TZF belongs to a group of medicines called anticoagulants. It works by blocking a blood clotting factor (factor Xa), thereby reducing the tendency for blood clots to form.

2. Important information before using Rywaroksaban TZF

When not to use Rywaroksaban TZF:

• 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 an organ that leads to an increased risk of serious bleeding (e.g. stomach ulcer, injury or bleeding in the brain, recent surgery 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 switching anticoagulant therapy or if heparin is administered to maintain the patency of a venous or arterial catheter;
• if the patient has a liver disease that leads to an increased risk of bleeding;
• if the patient is pregnant or breastfeeding.

Do not use Rywaroksaban TZF and inform your doctor if you suspect any of the above-mentioned conditions apply.

Warnings and precautions

Before starting treatment with Rywaroksaban TZF, discuss this with your doctor or pharmacist.

When to exercise special caution when using Rywaroksaban TZF

• if the patient has an increased risk of bleeding, such as in the following conditions:
  • severe kidney disease in adults, or moderate to severe kidney disease in children and adolescents, as kidney function may affect the amount of medicine acting in the patient's body;
  • blood clotting disorders;
  • taking other medicines that prevent blood clots (e.g. warfarin, etexilate dabigatran, apixaban or heparin) when switching anticoagulant therapy or when heparin is administered to maintain the patency of a venous or arterial catheter (see section "Rywaroksaban TZF and other medicines");
  • very high blood pressure that does not decrease despite medication;
  • stomach or intestinal diseases that may cause bleeding, e.g. inflammation of the intestines and stomach or oesophagitis (throat and oesophagus), e.g. due to gastroesophageal reflux disease (backflow of stomach acid into the oesophagus), or tumours located in the stomach, intestines, genital or urinary system;
  • blood vessel disease in the back of the eye (retinopathy);
  • lung disease in which the bronchi are dilated and filled with pus (bronchiectasis) or previous lung bleeding;
• in patients with prosthetic heart valves;
• if the patient has a disorder called antiphospholipid syndrome (an immune system disorder causing an increased risk of blood clots), the patient should inform the doctor, who will decide whether a change in treatment is necessary;
• if the patient has abnormal blood pressure or is scheduled for surgery or other treatment aimed at removing a blood clot from the lungs. If the patient suspects any of the above-mentioned conditions, they should inform the doctor before using Rywaroksaban TZF. The doctor will decide whether to use this medicine and whether the patient requires particularly close monitoring.

If the patient needs surgery:

• strictly follow the doctor's instructions regarding the timing of taking Rywaroksaban TZF before or after surgery;
• if during surgery a catheter or spinal puncture is planned (e.g. for epidural or intrathecal anaesthesia or pain relief):
  • it is very important to take Rywaroksaban TZF before and after the puncture or catheter removal, as directed by the doctor;
  • due to the need for special caution, immediately inform the doctor if, after the anaesthesia ends, numbness or weakness in the legs, or disturbances in bowel or bladder function occur.

Children and adolescents

Rywaroksaban TZF is not recommended for children weighing less than 30 kg. There is insufficient data on the use of the medicine in children and adolescents for indications approved in adults.

Rywaroksaban TZF and other medicines

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 available without a prescription.

If the patient is taking: some medicines used to treat fungal infections (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are used only topically on the skin; ketoconazole tablets (used in the treatment of Cushing's syndrome, in which the body produces too much cortisol); some antibiotics used to treat bacterial infections (e.g. clarithromycin, erythromycin); some antiviral medicines used to treat HIV infection 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; some medicines used to treat depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin-noradrenaline reuptake inhibitors (SNRIs)).

If the patient suspects any of the above-mentioned conditions, they should inform the doctor before using Rywaroksaban TZF, as the effect of Rywaroksaban TZF may be enhanced. The doctor will decide whether to use this medicine and whether the patient requires particularly close monitoring.

If the doctor considers that the patient has an increased risk of developing stomach or duodenal ulcers, they may prescribe treatment to prevent peptic ulcer disease.

If the patient is taking: some medicines used to treat epilepsy (phenytoin, carbamazepine, phenobarbital); St. John's wort (Hypericum perforatum) – an herbal medicine used for depression; rifampicin, which belongs to the group of antibiotics.

If the patient suspects any of the above-mentioned conditions, they should inform the doctor before using Rywaroksaban TZF, as the effect of Rywaroksaban TZF may be reduced when taken together with the above-mentioned medicines. The doctor will decide whether to use Rywaroksaban TZF and whether the patient requires particularly close monitoring.

Pregnancy and breastfeeding

Do not use Rywaroksaban TZF if the patient is pregnant or breastfeeding.

If there is a risk that the patient may become pregnant, an effective method of contraception should be used during treatment with Rywaroksaban TZF. If the patient becomes pregnant while taking this medicine, she should inform the doctor immediately, who will decide on further treatment.

Driving and operating machinery

Rywaroksaban TZF may cause dizziness (common side effects) or fainting (uncommon side effects) (see section 4 "Possible side effects"). Patients experiencing these side effects should not drive or operate machinery.

Rywaroksaban TZF contains lactose and sodium

If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.

The medicine contains less than 1 mmol of sodium (23 mg) per tablet; therefore, the medicine is considered "sodium-free".

3. How to take Rywaroksaban TZF

This medicine should always be taken exactly as prescribed by your doctor. If you have any doubts,
please consult your doctor or pharmacist.
The tablet(s) should be swallowed whole, preferably with water.
Rywaroksaban TZF should be taken with food.
If a patient has difficulty swallowing the whole tablet, discuss alternative methods of taking
Rywaroksaban TZF with your doctor. The tablet may be crushed and mixed with water or soft food,
such as apple puree, immediately before administration. After taking this mixture, a meal should
be consumed immediately.
If necessary, your doctor may administer crushed Rywaroksaban TZF tablets through a gastric tube.

How many tablets to take
Adults

• To prevent blood clots in the brain (stroke) and other blood vessels in the body: The recommended dose is one 20 mg Rywaroksaban TZF tablet taken once daily. If the patient has kidney problems, the dose may be reduced to one 15 mg Rywaroksaban TZF tablet once daily.

If the patient requires a heart blood vessel clearance procedure (called percutaneous coronary intervention – PCI with stent placement), there is limited evidence supporting dose reduction to one 15 mg Rywaroksaban TZF tablet once daily (or one 10 mg Rywaroksaban TZF tablet once daily in case of renal impairment), in combination with an antiplatelet medicine such as clopidogrel.

• For the treatment of blood clots in the leg veins, blood clots in the lung blood vessels, and to prevent recurrence of blood clots: The recommended dose is one 15 mg Rywaroksaban TZF tablet twice daily for the first 3 weeks. For treatment after 3 weeks, the recommended dose is one 20 mg Rywaroksaban TZF tablet once daily. After at least 6 months of treatment for blood clots, your doctor may decide to continue treatment with either one 10 mg tablet once daily or one 20 mg tablet once daily. If the patient has kidney problems and is taking one 20 mg Rywaroksaban TZF tablet once daily, the doctor may decide to reduce the dose after 3 weeks of treatment to one 15 mg Rywaroksaban TZF tablet once daily, if the risk of bleeding is greater than the risk of further blood clots.

Children and adolescents
The dose of Rywaroksaban TZF depends on body weight and will be calculated by the doctor.

• Recommended dose for children and adolescents weighing 30 kg to less than 50 kg: one 15 mg Rywaroksaban TZF tablet once daily.
• Recommended dose for children and adolescents weighing 50 kg or more: one 20 mg Rywaroksaban TZF tablet once daily.

Each dose of Rywaroksaban TZF should be taken with a meal, accompanied by a drink (e.g. water or juice). Tablets should be taken daily at approximately the same time. Consider setting an alarm to remind you.
For parents or caregivers: observe the child to ensure the full dose has been taken.
The dose of Rywaroksaban TZF is based on body weight, so it is important to attend scheduled doctor’s appointments, as dose adjustments may be necessary due to weight changes.
Never adjust the dose independently. Your doctor will adjust the dose if needed.
Do not split the tablet to achieve a partial dose. If a lower dose is required, use another formulation containing rivaroxaban: granules for oral suspension. For children and adolescents unable to swallow whole tablets, rivaroxaban granules for oral suspension should be used.
If the oral suspension is not available, the Rywaroksaban TZF tablet may be crushed and mixed with water or apple puree immediately before administration. After taking this mixture, a meal should be consumed. If necessary, your doctor may also administer the crushed tablet via a gastric tube.

If a dose is vomited or spat out

• Less than 30 minutes after taking Rywaroksaban TZF, take a new dose.
• More than 30 minutes after taking Rywaroksaban TZF, do not take a new dose. In this case, take the next dose at the usual time.

Contact your doctor if you repeatedly spit out or vomit the dose after taking Rywaroksaban TZF.

When to take Rywaroksaban TZF
Take one tablet every day until your doctor decides to stop treatment.
It is best to take the tablet at the same time each day, as this makes it easier to remember.
Your doctor will decide how long treatment should continue.
Preventing blood clots in the brain (stroke) and other blood vessels in the body:
If a procedure to restore normal heart rhythm (cardioversion) is required, take Rywaroksaban TZF as directed by your doctor.

Taking more than the recommended dose of Rywaroksaban TZF
If a patient has taken more than the recommended dose of Rywaroksaban TZF, contact your doctor immediately. Taking too high a dose of Rywaroksaban TZF increases the risk of bleeding.

Missing a dose of Rywaroksaban TZF

• Adults, children, adolescents: If the patient takes one 20 mg tablet or one 15 mg tablet once daily and a dose is missed, take the tablet as soon as possible. Do not take more than one tablet in a single day to make up for the missed dose. Take the next tablet the following day, then continue taking one tablet once daily.
• Adults: If the patient takes one 15 mg tablet twice daily and a dose is missed, take the tablet as soon as possible. Do not take more than two 15 mg tablets in one day. If a dose is forgotten, the patient may take two 15 mg tablets at the same time to achieve a total of two tablets (30 mg) taken within one day. The next day, resume taking one 15 mg tablet twice daily.

Stopping Rywaroksaban TZF
Do not stop taking Rywaroksaban TZF without first consulting your doctor, as Rywaroksaban TZF treats and prevents serious medical conditions.
If you have any further questions about the use of this medicine, please consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
As with other medicines of similar action (anticoagulants), Rywaroksaban TZF may cause bleeding, which potentially can be life-threatening. Excessive bleeding may lead to a sudden drop in blood pressure (shock). Signs of bleeding are not always obvious or visible.

Possible side effects which may indicate bleeding:
Immediately contact a doctor if any of the following side effects occur:

• Bleeding into the brain or inside the skull (symptoms may include headache, one-sided paralysis, vomiting, seizures, decreased level of consciousness, and neck stiffness. A serious, acute medical emergency. Immediate medical assistance must be sought!);
• Prolonged or excessive bleeding;
• Unusual weakness, fatigue, paleness, dizziness, headache, unexplained swelling, shortness of breath, chest pain, or angina, which may indicate bleeding. The doctor may decide that close monitoring of the patient or a change in treatment is necessary.

Possible side effects which may indicate skin reactions:
Immediately inform your doctor if the following skin reactions occur, such as:

• Widespread, acute skin rash, blistering, or mucosal lesions, e.g., in the mouth or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis). The frequency of these side effects is very rare (up to 1 in 10,000 patients);
• Drug reaction causing rash, fever, internal organ inflammation, hematological and systemic disorders (DRESS syndrome). The frequency of these side effects is very rare (up to 1 in 10,000 patients).

Possible side effects which may indicate a serious allergic reaction:
Immediately inform your doctor if the following side effects occur:

• Swelling of the face, lips, mouth, tongue, or throat; urticaria and breathing difficulties; sudden drop in blood pressure. The frequency of these reactions is very rare (anaphylactic reactions, including anaphylactic shock, may occur in up to 1 in 10,000 patients) and uncommon (angioedema and allergic edema may occur in 1 in 100 patients).

General list of possible side effects:
Common (may occur in 1 out of 10 patients)

• Decrease in red blood cell count, which may cause paleness of the skin and lead to weakness or shortness of breath;
• Gastrointestinal or intestinal bleeding, bleeding from the genitourinary system (including blood in urine and heavy menstrual bleeding), nosebleeds, gum bleeding;
• Bleeding into the eye (including bleeding from the sclera);
• Bleeding into tissues or body cavities (hematoma, bruising);
• Presence of blood in sputum (hemoptysis) during coughing;
• Bleeding from the skin or subcutaneous bleeding;
• Postoperative bleeding;
• Oozing of blood or fluid from the surgical wound;
• Swelling of limbs;
• Limb pain;
• Kidney function disorders (may be observed in tests performed by a doctor);
• Fever;
• Stomach pain, indigestion, nausea (nausea) or vomiting, constipation, diarrhea;
• Low blood pressure (symptoms may include dizziness or fainting upon standing);
• General decrease in strength and energy (weakness, fatigue), headache, dizziness;
• Rash, itching of the skin;
• Increased activity of certain liver enzymes, which may be evident in blood test results.

Uncommon (may occur in 1 out of 100 patients)

• Bleeding into the brain or inside the skull;
• Bleeding into a joint causing pain and swelling;
• Thrombocytopenia (low platelet count, blood cells involved in blood clotting);
• Allergic reactions, including allergic skin reactions;
• Liver function disorders (may be observed in tests performed by a doctor);
• Blood tests may show increased levels of bilirubin, increased activity of certain pancreatic or liver enzymes, or increased platelet count;
• Fainting;
• Malaise;
• Rapid heartbeat;
• Dryness of the mouth;
• Urticaria.

Rare (may occur in 1 out of 1,000 patients)

• Bleeding into muscles;
• Cholestasis (bile stasis), hepatitis including liver cell damage;
• Yellowing of the skin and eyes (jaundice);
• Localized swelling;
• Collection of blood (hematoma) in the groin as a complication of cardiac catheterization when the catheter is inserted into an artery in the leg (pseudoaneurysm).

Very rare (may occur in 1 out of 10,000 people)

• Accumulation of eosinophils, a type of white granulocytic blood cells, causing inflammation in the lungs (eosinophilic pneumonia).

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

• Kidney failure following severe bleeding;
• Bleeding in the kidneys, sometimes with presence of blood in urine, leading to kidneys being unable to function properly (anticoagulant-associated nephropathy);
• Increased pressure in the muscles of arms and legs following bleeding, which may lead to pain, swelling, altered sensation, numbness, or paralysis (compartment syndrome following bleeding).

Side effects in children and adolescents
In general, side effects observed in children and adolescents treated with Rywaroksaban TZF were similar in type to those observed in adults and were mainly mild to moderate in severity.
Side effects observed more frequently in children and adolescents:
Very common (may occur in more than 1 out of 10 people)

• Headache;
• Fever;
• Nosebleeds, vomiting.

Common (may occur in 1 out of 10 people)

• Rapid heartbeat;
• Blood test results may show increased bilirubin concentration (a bile pigment);
• Thrombocytopenia (low platelet count, blood cells that help in blood clotting);
• Excessive menstrual bleeding.

Uncommon (may occur in 1 out of 100 people)

• Blood test results may show increased levels of a subcategory of bilirubin (direct bilirubin, a bile pigment).

Reporting of side effects
If any side effects occur, including any side effects not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: +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 helps provide more information on the safety of the medicine.

5. How to store the medicine Rywaroksaban TZF

Keep this medicine out of the sight and reach of children.
No special storage conditions apply for this medicine.
Do not use this medicine after the expiry date (EXP) stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Following this advice helps protect the environment.

6. Contents of the packaging and other information

What Rywaroksaban TZF contains

• The active substance is rivaroxaban. Each coated tablet contains 15 mg or 20 mg of rivaroxaban.
• The other ingredients are: tablet core: hypromellose, microcrystalline cellulose, sodium lauryl sulfate, lactose monohydrate, sodium croscarmellose, magnesium stearate.
  Film coating: hypromellose type 2910, titanium dioxide (E171), polyethylene glycol 3350, iron oxide red (E172).

What Rywaroksaban TZF looks like and contents of the pack
Rywaroksaban TZF 15 mg are red, round, biconvex film-coated tablets, with the number "15" engraved on one side and smooth on the other, approximately 6.1 mm in diameter.
Rywaroksaban TZF 20 mg are brownish-red, round, biconvex film-coated tablets, with the number "20" engraved on one side and smooth on the other.

Rywaroksaban TZF 15 mg
The tablets are packed in PVC/aluminum blisters, placed in a cardboard carton. The pack contains 14 or 28 film-coated tablets.

Rywaroksaban TZF 20 mg
The tablets are packed in PVC/aluminum blisters, placed in a cardboard carton. The pack contains 14 or 28 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Tarchomińskie Zakłady Farmaceutyczne „Polfa” Spółka Akcyjna
ul. A. Fleminga 2
03-176 Warszawa
Tel: 22 811-18-14

Manufacturer
ELPEN Pharmaceutical Co., Inc.
Marathonos Ave. 95
19009 Pikermi Attiki
Greece