Rixacam

Package leaflet: information for the patient

RIXACAM, 10 mg, film-coated tablets
Rivaroxaban
Read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient

• Keep this leaflet for future reference.
• If in doubt, consult your doctor or pharmacist. This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, they should inform their 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 and is used in adults to:

• prevent blood clots in veins after hip or knee replacement surgery. Your doctor has prescribed this medicine because the risk of developing blood clots 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 to prevent recurrence of blood clots in the blood vessels of the legs and/or lungs.

RIXACAM 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 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 is experiencing excessive bleeding,

• if the patient has a disease or organ condition leading to an increased risk of serious bleeding (e.g. gastric 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 clotting (e.g. warfarin,
  dabigatran, apixaban or heparin), except when switching anticoagulant therapy
  or if heparin is administered to maintain patency
  of a catheter in a vein or artery,

• if the patient has liver disease leading to an increased risk of bleeding,

• if the patient is pregnant or breastfeeding.

Do not use RIXACAM, and also inform the 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 special caution when taking RIXACAM

• if the patient has an increased risk of bleeding, such as: moderate or severe kidney disease, as kidney function may affect the amount of medicine acting in the patient's body, 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 patency of a catheter in a vein or artery (see section "RIXACAM with other medicines"), coagulation disorders, very high blood pressure not reduced despite medication, stomach or intestinal diseases that may cause bleeding, e.g. inflammation of the intestines and stomach or esophagitis (throat and esophagus), e.g. due to gastroesophageal reflux disease (backflow of stomach acid into the esophagus), or tumors located in the stomach, intestines, genital or urinary system, retinal vascular disease (retinopathy), lung disease with bronchiectasis (dilated bronchi filled with pus) or previous pulmonary bleeding,
• in patients with prosthetic heart valves,
• if the patient has a disorder called antiphospholipid syndrome (an immune system disorder causing increased risk of blood clots), the patient should inform the doctor, who will decide whether treatment adjustment is necessary,
• if the patient has been diagnosed with 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 should undergo particularly close monitoring.
If the patient needs to undergo surgery:

• strictly follow the doctor's instructions regarding the timing of taking RIXACAM before or after surgery,

• if during a surgical procedure the patient is scheduled to undergo a lumbar puncture

• or placement of a catheter into the spine (e.g. for epidural or spinal anesthesia or for pain relief):

• strictly follow the doctor's instructions regarding the timing of taking RIXACAM,

• immediately inform the doctor if, after anesthesia ends, the patient experiences symptoms such as: numbness, weakness in the lower limbs, disturbances in bowel movements or bladder function, as immediate treatment is required in such cases.

Children and adolescents
RIXACAM 10 mg tablets are not recommended for patients under 18 years of age.
There is insufficient data on the use of the medicine in children and adolescents.
RIXACAM with other medicines
RIXACAM Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines you plan 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,
• certain antidepressants (selective serotonin reuptake inhibitors (SSRI) or serotonin-noradrenaline reuptake inhibitors (SNRI)).

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 should undergo 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 antiepileptic medicines (phenytoin, carbamazepine, phenobarbital), St John's wort ( Hypericum perforatum ), an herbal medicine used for depression, or rifampicin, an antibiotic. 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 should undergo particularly close monitoring.

Pregnancy and breastfeeding
Do not take 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 this medicine, they should immediately inform the doctor, who will decide on further treatment.
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 a 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 as prescribed by the doctor. In case of any doubts,
contact your doctor or pharmacist.
How many tablets to take
To prevent the formation of blood clots in the veins after hip or knee replacement surgery:
The recommended dose is one tablet of RIXACAM 10 mg taken once daily.
For the treatment of blood clots in the leg veins, blood clots in the blood vessels of the lungs,
and to prevent recurrence of blood clots:
After at least 6 months of treatment for blood clots, the recommended dose is one tablet
of 10 mg once daily or one tablet of 20 mg once daily. Your doctor has prescribed
RIXACAM 10 mg once daily.
The tablet should be swallowed whole, preferably with water.
RIXACAM may be taken with or without food.
If you have difficulty swallowing the whole tablet, talk to your doctor about other ways
of taking RIXACAM. The tablet can be crushed and mixed with water or soft food, such as
apple puree, immediately before administration.
If necessary, your doctor may administer crushed RIXACAM tablets via a gastric tube.
When to take RIXACAM
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.
To prevent blood clots in the leg veins after hip or knee replacement surgery:
The first tablet should be taken between 6 and 10 hours after surgery.
For patients undergoing major hip surgery, treatment usually lasts 5 weeks.
For patients undergoing major knee surgery, treatment usually lasts 2 weeks.
Taking more RIXACAM than prescribed
If you have taken more RIXACAM than prescribed, contact your doctor immediately.
Taking too high a dose of RIXACAM increases the risk of bleeding.
If you miss a dose of RIXACAM
If you forget to take a dose, take the tablet as soon as you remember.
Take the next tablet the following day, and then continue taking the tablets as usual,
once daily.
Do not take a double dose to make up for a missed tablet.
Stopping RIXACAM treatment
Do not stop taking RIXACAM without first talking to your doctor, as RIXACAM helps prevent
a serious condition.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will
experience them.
As with other medicines with a similar anticoagulant effect, RIXACAM 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.
You should contact your doctor immediately 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 paralysis, vomiting, seizures, decreased level of consciousness and neck stiffness. A serious, acute 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, formation of blisters or mucosal lesions, e.g. in the mouth or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis).
  • drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), characterized by rash, fever, internal organ inflammation, hematological disorders and systemic involvement. The frequency of these adverse effects is very rare (occurring in up to 1 in 10,000 people).

• Signs of severe allergic reactions:

  • swelling of the face, lips, oral cavity, tongue or throat; difficulty swallowing; hives 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 up to 1 in 100 people).

General list of possible adverse effects:
Common ( may occur in 1 out of 10 people )

• 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 urinary or genital tract (including blood in urine and heavy menstrual bleeding), nosebleeds, gum bleeding,
• 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) during coughing,
• bleeding from the skin or subcutaneous bleeding,
• postoperative bleeding,
• oozing of blood or fluid from the 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, diarrhea,
• low blood pressure (symptoms may include dizziness or fainting upon standing),
• general loss of strength and energy (weakness, fatigue), headache, dizziness,
• rash, skin itching,
• 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,
• 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 (hives),
• liver function disorders (may be observed in tests performed by a doctor).

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),
• local swelling,
• blood accumulation (hematoma) in the groin area as a complication of cardiac catheterization procedure, when a 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 lung inflammation (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 impaired kidney function (drug-induced anticoagulant-related nephropathy),
• increased pressure in the muscles of the arms and legs following bleeding, which may lead to pain, swelling, altered sensation, numbness or paralysis ( compartment syndrome following bleeding ).

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, you should 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
Phone: +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 RIXACAM

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after: EXP and on each blister after: EXP. The expiry date refers to the last day of the stated month.
No special storage precautions 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 in use. Such measures help protect the environment.

6. Contents of the pack and other information

What RIXACAM contains

• The active substance is rivaroxaban. One coated tablet contains 10 mg of rivaroxaban.
• The other ingredients are:
  Tablet core: microcrystalline cellulose, monohydrate lactose, sodium croscarmellose, hypromellose, sodium lauryl sulfate, magnesium stearate.
  Coating: hypromellose, hydroxypropylcellulose, polyethylene glycol, titanium dioxide (E 171), iron oxide red (E 172).

What RIXACAM looks like and contents of the pack
RIXACAM 10 mg coated tablets are light pink, round, biconvex,
with the number "10" embossed on one side.
The tablets are packed in blisters placed in a cardboard box containing: 10, 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