Rixacam

Package leaflet: Information for the patient

RIXACAM, 10 mg, hard capsules
Rivaroxabanum
Read this leaflet carefully before taking this medicine, as it contains important information for the patient

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

Leaflet contents:

1. What RIXACAM is and what it is used for
2. What you need to know 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 condition of an organ that leads to an increased risk of serious bleeding (e.g. stomach ulcer, injury or bleeding into the brain, recent surgery on the brain or eyes),
• if the patient is taking other anticoagulant medicines (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 a 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 in the following conditions: moderate or severe kidney disease, as kidney function may affect the amount of active drug in the patient's body; if the patient is taking other anticoagulant medicines (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 (see section "RIXACAM with other medicines"); coagulation disorders; very high blood pressure that does not decrease despite medication; stomach or intestinal diseases that may cause bleeding, e.g. inflammatory bowel disease and gastritis or oesophagitis (e.g. due to gastro-oesophageal reflux disease (acid reflux into the oesophagus)) or tumours located in the stomach or intestines or in the genital or urinary system; vascular disease of the posterior part of the eyeball (retinopathy); lung disease with dilated bronchi 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 increased risk of clot formation), the patient should inform the doctor, who will decide whether treatment needs to be changed,
• 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, 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 surgery:
it is very important to take RIXACAM exactly at the times scheduled by the treating doctor, both before and after surgery;
if catheterisation or lumbar puncture of the spine is planned during surgery (e.g. for epidural or spinal anaesthesia or for pain relief):

• it is very important to take RIXACAM exactly at the times scheduled by the treating doctor, both before and after the puncture or catheter removal;
• inform the doctor immediately if, after the anaesthesia ends, numbness, weakness in the legs, or disturbances in bowel or bladder function occur, as immediate treatment will be necessary. Children and adolescents RIXACAM 10 mg capsules are not recommended for patients under 18 years of age. There is insufficient data on the use of this medicine in children and adolescents.

RIXACAM with 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 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 apply, 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 stomach or intestinal ulcers, preventive treatment for peptic ulcer disease may be prescribed.
• 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, 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 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, 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 monohydrate (a type of sugar) and sodium.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact the doctor before taking this medicine.
The medicine contains less than 1 mmol of sodium (23 mg) per capsule, meaning that the medicine is considered "sodium-free".

3. How to take RIXACAM

This medicine should always be taken as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
The capsule should be swallowed whole, preferably with water.
RIXACAM can be taken with or without food.
If a patient has difficulty swallowing the entire capsule, they should discuss alternative methods of taking RIXACAM with their doctor. The contents of the capsule may be mixed with water or apple puree immediately before administration. If necessary, a doctor may administer the contents of the RIXACAM capsule through a gastric tube.

How many capsules to take

For prevention of blood clots in veins following hip or knee replacement surgery
The recommended dose is one 10 mg RIXACAM capsule taken once daily.

For treatment of blood clots in the legs and blood clots in the blood vessels of the lungs, and for prevention of recurrence of blood clots
After at least 6 months of treatment for blood clots, the recommended dose is one 10 mg capsule once daily or one 20 mg capsule once daily. Your doctor has prescribed RIXACAM 10 mg once daily for you.

When to start treatment with RIXACAM
Take one capsule every day until your doctor decides to stop treatment.
It is best to take the capsule at the same time each day, as this makes it easier to remember.
Your doctor will decide how long treatment should continue.

For prevention of blood clots in the legs after hip or knee replacement surgery:
The first capsule should be taken 6 to 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 a patient has taken more RIXACAM than prescribed, they should contact their doctor immediately. Taking too high a dose of RIXACAM increases the risk of bleeding.

Missing a dose of RIXACAM
If a patient misses a dose, they should take it as soon as they remember. The next capsule should be taken the following day, and then continue taking the capsules as usual, once daily.
Do not take a double dose to make up for a missed capsule.

Stopping RIXACAM treatment
Do not stop taking RIXACAM without first talking to your doctor, as RIXACAM helps prevent serious illness.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicinal product can cause adverse reactions, although not everyone will experience them.
As with other medicines with a similar effect of reducing blood clot formation, RIXACAM
may cause bleeding, which 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 immediately inform your doctor if any of the following adverse reactions 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, sudden medical emergency. Immediate medical assistance must be sought!),
  • prolonged or excessive bleeding,
  • unusual weakness, fatigue, pallor, 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. on the tongue 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 reactions is very rare (up to 1 in 10,000 people).
• Signs of serious allergic reactions
  • swelling of the face, lips, mouth, tongue or throat; difficulty swallowing; 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 reactions
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
• bleeding from the stomach or intestine, 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 part 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
• bleeding after surgery
• 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 or vomiting, constipation, diarrhea
• low arterial 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 within the skull (see signs of bleeding above),
• bleeding into a joint causing pain and swelling,
• thrombocytopenia (low number of platelets, 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,
• dryness of the mouth,
• urticaria.

Rare (may occur in 1 out of 1000 people)

• bleeding into muscles,
• cholestasis (bile stasis), hepatitis including liver cell damage,
• yellowing of the skin and eyes (jaundice),
• local 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 white granulocytic blood cells, causing lung inflammation (eosinophilic pneumonia).

Frequency not known (cannot be estimated from available data)

• kidney failure following severe bleeding,
• bleeding in the kidneys, sometimes with presence of blood in urine, leading to inability of the kidneys to function properly (drug-induced nephropathy associated with anticoagulant medicines),
• increased pressure in the muscles of arms and legs occurring after bleeding, which may lead to pain, swelling, altered sensation, numbness or paralysis (compartment syndrome following bleeding).

Reporting of adverse reactions
If any adverse symptoms occur, including any possible adverse symptoms
not listed in this leaflet, you should inform your doctor or pharmacist. Adverse reactions
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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store RIXACAM

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton following: EXP or expiry date. The expiry date refers to the last day of the stated month.
PVC/PVDC/Alu foil blisters: Store below 30°C.
Keep in the original packaging to protect from moisture.
Aluminium/OPA/Aluminium/PVC foil blisters: No special storage precautions.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What RIXACAM contains

• The active substance is rivaroxaban. Each capsule contains 10 mg of rivaroxaban.
• Other ingredients are: capsule contents: monohydrate lactose, microcrystalline cellulose, sodium croscarmellose, hypromellose, sodium lauryl sulfate, magnesium stearate. capsule shell: gelatin, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), black iron oxide (E 172).

What RIXACAM looks like and contents of the pack
RIXACAM 10 mg: beige, opaque capsules filled with white or almost white powder, size "3" (approximately 16 mm in length).
Hard capsules are packed in blisters made of PVC/PVdC/Alu or Aluminium/OPA/Aluminium/PVC and cardboard outer packaging.
Available pack sizes: 10 or 30 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Tel: +48 22 732 77 00

Manufacturer:
Adamed Pharma S.A.
ul. Marszałka J. Piłsudskiego 5
95-200 Pabianice
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park, Paola
PLA3000
Malta
Zentiva S.A.
B-dul Theodor Pallady nr. 50, sector 3,
Bucharest, 032266
Romania

This medicinal product is authorised in the European Economic Area under the following names:
Czech Republic, Poland: RIXACAM
Spain: RIXACAM 10 mg cápsulas duras