Rixacam

Package leaflet: Information for the patient

RIXACAM, 15 mg, coated tablets
RIXACAM, 20 mg, coated tablets
Rivaroxaban
Read the entire leaflet before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist. This medicine has been prescribed for a specific individual. Do not pass it on to others.
• This medicine may harm another person, even if their symptoms appear identical.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor. See section 4.

Leaflet contents:

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

1. What RIXACAM is and what it is used for

RIXACAM contains the active substance rivaroxaban.
RIXACAM is used in adults to:

• prevent the formation of blood clots in the brain (stroke) and other blood vessels in the body in patients with a type of irregular heartbeat known as non-valvular atrial fibrillation.
• 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 recurrence of blood clots in the veins of the legs and/or lungs.

RIXACAM 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 pulmonary blood vessels, after at least 5 days of initial treatment with injectable medicines used to treat blood clots.

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

2. Important information before taking RIXACAM

When not to take RIXACAM

• 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, trauma or bleeding into the brain, recent surgical procedure on the brain or eyes),
• if the patient is taking other medicines that prevent blood clots (e.g. warfarin, dabigatran, apixaban or heparin), except when switching anticoagulant therapy or if heparin is administered to maintain catheter patency in a vein or artery,
• if the patient has liver disease that leads to an increased risk of bleeding,
• if the patient is pregnant or breastfeeding.

Do not use RIXACAM and inform your doctor if the patient
suspects that any of the above circumstances apply.
Warnings and precautions
Before starting to take RIXACAM, consult a doctor or
pharmacist.
When to exercise particular caution when taking RIXACAM

• if the patient has an increased risk of bleeding, such 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, coagulation 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 catheter patency in a vein or artery (see section "RIXACAM with other medicines"), very high blood pressure that does not decrease despite medication, diseases of the stomach or intestines that may cause bleeding, e.g. inflammation of the intestines and stomach or oesophagus (e.g. due to gastroesophageal reflux disease (acid reflux into the oesophagus) or tumours located in the stomach or intestines or in the genital or urinary system), blood vessel disease of the posterior part of the eyeball (retinopathy), lung disease in which bronchi are dilated and filled with pus (bronchiectasis) or previous pulmonary haemorrhage,
• 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 if surgery or another treatment to remove a pulmonary clot is planned.

If the patient suspects that any of the above conditions apply, they should
inform the doctor before taking RIXACAM. The doctor will decide whether
to use this medicine and whether the patient requires particularly close monitoring.
If the patient needs to undergo surgery:

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

Children and adolescents
RIXACAM tablets are not recommended for children weighing less than 30 kg.
There is insufficient data on the use of RIXACAM in children and adolescents for the indications approved in adults.
RIXACAM with other medicines
Inform your doctor or pharmacist about all medicines currently taken or taken recently,
as well as any medicines the patient plans to take, including those available without a prescription.

• If the patient is taking certain antifungal medicines (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), certain antibiotics (e.g. clarithromycin, erythromycin), certain antiviral medicines used in HIV infection or AIDS treatment (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, or certain antidepressants (selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs)).

If the patient suspects that any of the above conditions apply, they should
inform the doctor before taking RIXACAM, as the effect of RIXACAM 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 gastric or duodenal ulcer, they may prescribe treatment to prevent peptic ulcer disease.

• If the patient is taking certain medicines used to treat epilepsy (phenytoin, carbamazepine, phenobarbital), St. John's wort Hypericum perforatum, an herbal remedy used for depression,
  or rifampicin, which belongs to the group of antibiotics.
  If the patient suspects that any of the above conditions apply, they should
  inform the doctor before taking RIXACAM, as the effect of RIXACAM may be reduced. The doctor will decide whether to use RIXACAM and whether the patient requires particularly close monitoring.
  Pregnancy and breastfeeding
  Do not use RIXACAM 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 RIXACAM. If the patient becomes pregnant while taking RIXACAM, she must inform the doctor immediately, who will decide on further management.
  Driving and operating machinery
  RIXACAM may cause dizziness (common side effects)
  and fainting (uncommon side effects) (see section 4 "Possible side effects"). Patients experiencing these side effects should not drive, ride a bicycle, or operate tools or machinery.
  RIXACAM 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, meaning the medicine is considered "sodium-free".

3. How to take RIXACAM

This medicine should always be taken exactly as your doctor has instructed. If you are unsure,
contact your doctor or pharmacist.
RIXACAM should be taken with food.
Swallow the tablet(s) whole, preferably with water.
If you have difficulty swallowing the whole tablet, talk to your doctor about other ways of taking RIXACAM. 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 promptly.
If necessary, your doctor may administer crushed RIXACAM tablets via a gastric tube.

How many tablets to take

Adults

• For prevention of blood clots in the brain (stroke) and other blood vessels in the body: The recommended dose is one 20 mg RIXACAM tablet once daily. If you have kidney problems, the dose may be reduced to one 15 mg RIXACAM tablet once daily.

If you require a procedure to open narrowed blood vessels in the heart (called percutaneous coronary intervention - PCI with stent placement), there is limited evidence supporting a reduced dose of one 15 mg RIXACAM tablet once daily (or one 10 mg RIXACAM tablet once daily if you have kidney problems), in combination with an antiplatelet medicine such as clopidogrel.

• For treatment of blood clots in the veins of the legs, blood clots in the blood vessels of the lungs, and to prevent recurrence of blood clots: The recommended dose is one 15 mg RIXACAM tablet twice daily for the first 3 weeks. After 3 weeks of treatment, the recommended dose is one 20 mg RIXACAM 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 you have kidney problems and are taking one 20 mg RIXACAM tablet once daily, your doctor may decide to reduce the dose after 3 weeks of treatment to one 15 mg RIXACAM tablet once daily, if the risk of bleeding is greater than the risk of developing further blood clots.

Children and adolescents
The dose of RIXACAM depends on body weight and will be calculated by your doctor.

• The recommended dose for children and adolescents with a body weight of 30 kg to below 50 kg is one 15 mg RIXACAM tablet once daily.
• The recommended dose for children and adolescents with a body weight of 50 kg or more is one 20 mg RIXACAM tablet once daily.

Each dose of RIXACAM should be taken with a meal and with a drink (e.g. water or juice). Tablets should be taken every day at approximately the same time. Consider setting an alarm to remind you.
For parents or caregivers: observe your child to ensure they have taken the full dose.
The dose of RIXACAM depends on body weight, so it is important to attend scheduled doctor’s appointments, as dose adjustments may be needed due to changes in weight.
Never adjust the dose on your own. If necessary, your doctor will adjust the dose.
Do not split the tablet to achieve a partial dose. If a lower dose is required, another medicine containing rivaroxaban in the form of granules for oral suspension should be used. For children and adolescents who cannot swallow whole tablets, rivaroxaban in the form of granules for oral suspension should be used.
If the oral suspension is not available, the RIXACAM 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 crushed RIXACAM tablets via a gastric tube.

If a dose is vomited or spat out

• Less than 30 minutes after taking RIXACAM, take a new dose.
• More than 30 minutes after taking RIXACAM, 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 RIXACAM.

When to take RIXACAM
Take the tablet(s) every day until your doctor decides to stop treatment. It is best to take the tablet(s) at the same time each day, as this makes it easier to remember. Your doctor will decide how long you should continue treatment.
Prevention of 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 RIXACAM as directed by your doctor.

Missed dose of RIXACAM
Adults, children and adolescents:
If you take one 20 mg tablet or one 15 mg tablet once daily and you miss a dose, take it as soon as possible. Do not take more than one tablet in one day to make up for the missed dose. Take the next tablet the following day, then continue with one tablet once daily.

Adults:
If you take one 15 mg tablet twice daily and you miss a dose, 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 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, continue taking one 15 mg tablet twice daily.

Taking more RIXACAM than prescribed
If you take too many RIXACAM tablets, contact your doctor immediately. Taking too high a dose of RIXACAM increases the risk of bleeding.

Stopping RIXACAM treatment
Do not stop taking RIXACAM without first consulting your doctor, as RIXACAM treats and prevents serious medical conditions.
If you have any further questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like any medicine, this medicine can cause adverse effects, although not everyone will
experience them.
As with other medicines with a similar action of reducing blood clot formation, RIXACAM
may cause bleeding, which potentially could be life-threatening.
Excessive bleeding may lead to a sudden drop in blood pressure (shock). Signs of bleeding
are not always obvious or visible.
You should immediately inform your doctor if any of the following adverse effects occur:

• Signs of bleeding:

  • bleeding into the brain or inside the skull (symptoms may include headache, one-sided weakness, vomiting, seizures, reduced level of consciousness and
    neck stiffness. A serious, sudden medical emergency. Seek immediate medical help!),

• prolonged or excessive bleeding,

• unusual weakness, fatigue, paleness, dizziness, headache, unexplained swelling, shortness of breath, chest pain or angina. Your doctor may decide that close monitoring of the patient or a change in treatment is necessary.

  • Signs of severe skin reactions

• widespread, acute skin rash, blistering or mucosal lesions, e.g. in the mouth or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis).

• drug reaction causing rash, fever, internal organ inflammation, hematological and systemic disorders (DRESS syndrome). The frequency of these adverse effects is very rare (up to 1 in 10,000 people).

  • Signs of severe allergic reactions

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

General list of possible adverse effects in adults, children and adolescents:
Common (may occur in 1 out of 10 people)

• reduction in red blood cells, which may cause paleness of the skin and lead to weakness or shortness of breath,
• bleeding from the stomach or intestines, bleeding from the urinary or genital tract (including blood in urine and severe menstrual bleeding), nosebleeds, bleeding from the gums,
• bleeding into the eye (including bleeding from the conjunctiva),
• bleeding into tissues or body cavities (hematoma, bruising),
• presence of blood in sputum (hemoptysis) during coughing,
• bleeding from the skin or under the skin,
• bleeding after surgery,
• oozing of blood or fluid from a surgical wound,
• limb swelling,
• limb pain,
• kidney function disorders (may be observed in tests performed by a doctor),
• fever,
• stomach pain, indigestion, nausea or vomiting, constipation, diarrhoea,
• low blood pressure (symptoms may include dizziness or fainting upon standing),
• general loss of 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 people)

• bleeding into the brain or inside the skull (see signs of bleeding above),
• 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,
• dry mouth,
• urticaria.

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

• bleeding into muscles,
• cholestasis (bile stasis), hepatitis including liver cell damage,
• yellowing of the skin and eyes (jaundice),
• localized swelling,
• blood collection (hematoma) in the groin as a complication of cardiac catheterization procedure 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 granular white blood cells, causing lung inflammation (eosinophilic pneumonia).

Frequency unknown (frequency cannot be determined from available data)

• kidney failure following severe bleeding,
• bleeding in the kidneys, sometimes with blood in urine, leading to impaired kidney function (drug-induced anticoagulant-related 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).

Adverse effects in children and adolescents
In general, adverse effects observed in children and adolescents treated with RIXACAM
were similar in type to those observed in adults and were mostly mild to moderate in severity.
Adverse 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 tests may show increased bilirubin levels (a bile pigment)
• thrombocytopenia (low platelet count, platelets being cells that help blood clot)
• excessive menstrual bleeding

Uncommon (may occur in 1 out of 100 people)

• blood tests may show increased levels of a subcategory of bilirubin (direct bilirubin, a bile pigment).

Reporting adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or
pharmacist. Adverse effects can be reported directly to the Department of Monitoring
Adverse Drug Reactions, 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
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store the medicine RIXACAM

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box after: Expiry date and on each blister after: EXP. The expiry date refers to the last day of the stated month.
No special precautions for storage of the medicine are required.
Crushed tablets
Crushed tablets are stable in water or apple puree for up to 4 hours.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What RIXACAM contains

• The active substance is rivaroxaban. One coated tablet contains 15 mg or 20 mg of rivaroxaban.
• The other ingredients are: Core of the tablet: microcrystalline cellulose, sodium croscarmellose, lactose monohydrate, hypromellose, sodium lauryl sulfate, magnesium stearate. Coating: hydroxypropyl cellulose, macrogol, hypromellose, titanium dioxide (E 171),
  iron oxide red (E 172).

What RIXACAM looks like and contents of the pack
RIXACAM 15 mg coated tablets are pink, round, biconvex tablets, with the number "15" embossed on one side.
The tablets are packed in blisters placed in a cardboard box containing: 14, 28,
30, 42, 98 or 100 coated tablets.

RIXACAM 20 mg coated tablets are brick-brown, round, biconvex
tablets, with the number "20" embossed on one side.
The tablets are packed in blisters placed in a cardboard box containing: 14, 28,
30, 98 or 100 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów

Manufacturer / Importer:
Adamed Pharma S.A.
ul. Marszałka J. Piłsudskiego 5
95-200 Pabianice