Rivaroxaban 5 mg/ml Oral Suspension – patient leaflet, side effects, dosage

1. What Rivaroxaban 5 mg/ml Oral Suspension is and what it is used for

Rivaroxaban 5 mg/ml oral suspension contains the active substance rivaroxaban and belongs to a group of medicines called antithrombotic agents. It works by blocking a blood clotting factor (factor Xa) and thus reducing the tendency of the blood to form clots.

Rivaroxaban 5 mg/ml oral suspension is used in adults to:

• prevent blood clots in the veins after a hip or knee replacement operation. Your doctor has prescribed this medicine for you because after an operation you are at an increased risk of getting blood clots.
• prevent blood clots in brain (stroke) and other blood vessels in your body if you have a form of irregular heart rhythm called non-valvular atrial fibrillation.
• treat blood clots in the veins of your legs (deep vein thrombosis) and in the blood vessels of your lungs (pulmonary embolism), and to prevent blood clots from re-occurring in the blood vessels of your legs and/or lungs. This medicine is used in children and adolescents below 18 years and with a body weight of 30 kg or more to:
• treat blood clots and prevent re-occurrence of blood clots in the veins or in the blood vessels of the lungs, following initial treatment of at least 5 days with injectable medicines used to treat blood clots.

2. What you need to know before you take Rivaroxaban 5 mg/ml Oral Suspension

Do not take Rivaroxaban 5 mg/ml Oral Suspension if you:

• are allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6)
• are bleeding excessively
• have a disease or condition in an organ of the body that increases the risk of serious bleeding (such as a stomach ulcer, injury or bleeding in the brain, recent surgery of the brain or eyes)
• are taking medicines to prevent blood clotting (such as warfarin, dabigatran, apixaban or heparin), except when changing anticoagulant treatment or while getting heparin through a venous or arterial line to keep it open
• have a liver disease which leads to an increased risk of bleeding
• are pregnant or breast-feeding

Do not take this medicine and tell your doctor if any of these apply to you.

Warnings and precautions

Talk to your doctor or pharmacist before taking Rivaroxaban 5 mg/ml oral suspension.

Take special care with Rivaroxaban 5 mg/ml Oral Suspension

• if you have an increased risk of bleeding, as could be the case in situations such as:

  • moderate or severe kidney disease, since your kidney function may affect the amount of medicine that works in your body
  • if you are taking other medicines to prevent blood clotting (such as warfarin, dabigatran, apixaban or heparin), when changing anticoagulant treatment or while getting heparin through a venous or arterial line to keep it open (see the section “Other medicines and Rivaroxaban 5 mg/ml oral suspension”)
  • bleeding disorders
  • very high blood pressure, not controlled by medical treatment
  • diseases of your stomach or bowel that might result in bleeding, such as inflammation of the bowels or stomach, or inflammation of the oesophagus (gullet), due to gastroesophageal reflux disease (disease where stomach acid goes upwards into the oesophagus) or tumours located in the stomach or bowels or genital tract or urinary tract
  • a problem with the blood vessels in the back of your eyes (retinopathy)
  • a lung disease where your bronchi are widened and filled with pus (bronchiectasis), or previous bleeding from your lung

• if you have a prosthetic heart valve

  • if you know that you have a disease called antiphospholipid syndrome (a disorder of the immune system that causes an increased risk of blood clots), tell your doctor who will decide if the treatment may need to be changed
  • if your doctor determines that your blood pressure is unstable or another treatment or surgical procedure to remove the blood clot from your lungs is planned. If any of the above apply to you, tell your doctor before you take Rivaroxaban 5 mg/ml oral suspension. Your doctor will decide if you should be treated with this medicine and if you should be kept under closer observation.

If you need to have an operation

• it is very important to take Rivaroxaban 5 mg/ml oral suspension before and after the operation exactly at the times you have been told by your doctor.

• if your operation involves a catheter or injection into your spinal column (such as for epidural or spinal anaesthesia or pain reduction):

  • it is very important to take Rivaroxaban 5 mg/ml oral suspension exactly at the times you have been told by your doctor
  • tell your doctor immediately if you get numbness or weakness of your legs or problems with your bowel or bladder after the end of anaesthesia, because urgent care is necessary.

Children and adolescents

This medicine is not recommended for children with a body weight below 30 kg.

There is not enough information on the use of rivaroxaban in children and adolescents in the adult indications. Other medicines and Rivaroxaban 5 mg/ml Oral Suspension

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

• If you are taking:

  • some medicines for fungal infections (for example, fluconazole, itraconazole, voriconazole, posaconazole), unless they are only applied to the skin
  • ketoconazole tablets (used to treat Cushing’s syndrome when the body produces an excess of cortisol)
  • some medicines for bacterial infections (for example, clarithromycin, erythromycin)
  • some anti-viral medicines for HIV/AIDS (e.g. ritonavir)
  • other medicines to reduce blood clotting (for example, enoxaparin, clopidogrel or vitamin K antagonists such as warfarin and acenocoumarol, prasugrel and ticagrelor (see the section “Warnings and Precautions”)

  • anti-inflammatory and pain relieving medicines (for example, naproxen or acetylsalicylic acid)

    • dronedarone, a medicine to treat abnormal heart beat
    • some medicines to treat depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs))

If any of the above apply to you, tell your doctor before taking this medicine, because its effect may be increased. Your doctor will decide, if you should be treated with this medicine and if you should be kept under closer observation. If your doctor thinks that you are at increased risk of developing stomach or bowel ulcers, he may also use a preventative ulcer treatment.

• If you are taking:

  • some medicines for the treatment of epilepsy (phenytoin, carbamazepine, phenobarbital)
  • St John’s Wort (Hypericum perforatum), a herbal product used for depression or rifampicin, an antibiotic If any of the above apply to you, tell your doctor before taking this medicine, because its effect may be reduced. Your doctor will decide, if you should be treated with Rivaroxaban 5 mg/ml oral suspension and if you should be kept under closer observation.

Pregnancy and breast-feeding

Do not take Rivaroxaban 5 mg/ml oral suspension if you are pregnant or breast-feeding. If there is a chance that you could become pregnant, use a reliable contraceptive while you are taking this medicine. If you become pregnant while you are taking this medicine, tell your doctor immediately, who will decide how you should be treated.

Driving and using machines

Rivaroxaban 5 mg/ml oral suspension may cause dizziness (common side effect) or fainting (uncommon side effect) (see section 4, ‘Possible side effects’). Do not drive, ride a bicycle or use any tools or machines if you are affected by these symptoms.

Rivaroxaban 5 mg/ml Oral Suspension contains sodium, sodium benzoate, propylene glycol, maltitol and sorbitol.

• This medicine contains 37 mg propylene glycol and 2.5 mg sodium benzoate in each ml.
• This medicine contains less than 1 mmol sodium (23 mg) per the highest individual dose (6 ml), that is to say essentially ‘sodium-free’.
• This medicines contain maltitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
• This medicine contains 50 mg sorbitol in each ml. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine.

3. How to take Rivaroxaban 5 mg/ml Oral Suspension

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. In order for Rivaroxaban 5 mg/ml oral suspension to work well, it is important that you follow the instructions below regarding correct method of administration:

Dose of Rivaroxaban

5 mg/ml oral suspension How to take

2 ml (10 mg of rivaroxaban) With water (note: you can

take with or without food) 3 ml (15 mg of rivaroxaban) With food

4 ml (20 mg of rivaroxaban)

This medicine is a “ready for-use” oral suspension. You may take the suspension directly into the mouth. The dose should be measured using the graduated oral dosing syringe, see “Instructions for use”.

Take your dose every day at approximately the same time. Consider setting an alarm to remind you.

If necessary, your doctor may also give the suspension via a stomach tube.

Instructions for the use of the oral dosing syringe

Shake the bottle before each use for five seconds. Check the prescribed dose

1. 1. Place the syringe in the opening of the bottle adaptor and turn the bottle upside down. Then pull the plunger slowly down to the volume you need for your dose.
2. 2. Check the syringe for any bubbles. If there are any, empty the syringe back into the bottle and repeat the step 1. Double check the dose.
3. 3.

   Turn the bottle back again and remove the syringe.

   1. 4. You can give the liquid directly into the patient’s mouth or apply the liquid to a kitchen spoon.
   1. 5. Cleaning: It is recommended to use only cold tap water for cleaning the syringe.

How much to take

Adults

Indication Dosage

To prevent blood clots in the veins after a hip or knee replacement operation

2 ml of suspension (10 mg rivaroxaban) once daily with water

(note: you can take with or without food)

To prevent blood clots in the brain (stroke) and other blood vessels in your body

4 ml of suspension (20 mg rivaroxaban) once daily with food

In certain cases, the dose may be reduced by your doctor.

To treat blood clots in the veins of your legs and blood clots in the blood vessels of your lungs, and for preventing blood clots from re-occurring

3 ml of suspension (15 mg rivaroxaban) twice daily with food for the first three weeks 4 ml of suspension (20 mg rivaroxaban) once daily with food after three weeks

Your doctor may reduce the dose if you have kidney problems.

To prevent blood clots in the veins of your legs and blood clots in the blood vessels of your lungs from re-occurring after at least 6 months blood clot treatment

2 ml of suspension (10 mg rivaroxaban) once daily with water

(note: you can take with or without food)

or

4 ml of suspension (20 mg rivaroxaban) once daily with food Use in children and adolescents

When to take Rivaroxaban 5 mg/ml Oral Suspension

Take the suspension every day until your doctor tells you to stop.

Try to take the dose at the same time every day to help you to remember it. Your doctor will decide how long you must continue treatment.

To prevent blood clots in the veins after a hip or knee replacement operation:

• Take the first dose 6 – 10 hours after your operation.
• If you have had a major hip operation you will usually take the suspension for 5 weeks.

• If you have had a major knee operation you will usually take the suspension for 2 weeks.

  To prevent blood clots in the brain (stroke) and other blood vessels in your body:

  If your heart beat needs to be restored to normal by a procedure called cardioversion, take Rivaroxaban 5 mg/ml oral suspension at the times your doctor tells you. If you take more Rivaroxaban 5 mg/ml Oral Suspension than you should

  Contact your doctor immediately if you have taken too much of this medicine. Taking too much Rivaroxaban 5 mg/ml oral suspension increases the risk of bleeding.

  If you forget to take Rivaroxaban 5 mg/ml Oral Suspension

  • While taking one dose a day (adults, children and adolescents):

    If you are taking one dose a day and have missed a dose, take it as soon as you remember.

    Do not take a double dose in a single day to make up for a forgotten dose.

    Take the next dose on the following day and then carry on taking one dose once a day.

  • While taking a dose twice daily (adults only): If you are taking 3 ml of suspension (15 mg of rivaroxaban) twice a day and have missed a dose, take it as soon as you remember to get a total daily dose of 6 ml of suspension (30 mg of rivaroxaban).

    If you forget to take a dose you can take 6 ml of suspension (30 mg of rivaroxaban) at the same time. Do not take more than 6 ml of suspension (30 mg of rivaroxaban) in a single day.

    On the following day you should carry on taking 3 ml of suspension (15 mg of rivaroxaban) twice a day. If you stop taking Rivaroxaban 5 mg/ml Oral Suspension

Do not stop taking this medicine without talking to your doctor first, because Rivaroxaban 5 mg/ml oral suspension treats and prevents serious conditions.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Like other similar medicines to reduce the formation of blood clots, Rivaroxaban 5 mg/ml oral suspension may cause bleeding which may potentially be life threatening. Excessive bleeding may lead to a sudden drop in blood pressure (shock). In some cases the bleeding may not be obvious. Tell your doctor immediately if you or the child experience any of the following side effects:

• Signs of bleeding

  • bleeding into the brain or inside the skull (symptoms

    can include headache, one-sided weakness, vomiting, seizures, decreased level of consciousness, and neck stiffness. This is a serious medical emergency. Seek medical attention immediately!)

    • long or excessive bleeding.
    • exceptional weakness, tiredness, paleness, dizziness, headache, unexplained swelling, breathlessness, chest pain or angina pectoris.

Your doctor may decide to keep you under closer observation or change the treatment.

• Signs of severe skin reactions

  • spreading intense skin rash, blisters or mucosal lesions, e.g. in the mouth or eyes (Stevens-Johnson syndrome/ toxic epidermal necrolysis).
  • a drug reaction that causes rash, fever, inflammation of internal organs, blood abnormalities and systemic illness (DRESS syndrome).

The frequency of these side 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; difficulty swallowing; hives and breathing difficulties; a sudden drop in blood pressure.

The frequencies of severe allergic reactions are very rare (anaphylactic reactions, including anaphylactic shock; may affect up to 1 in 10,000 people) and uncommon (angioedema and allergic oedema; may affect up to 1 in 100 people). Overall list of possible side effects found in adults, children and adolescents

Common (may affect up to 1 in 10 people):

• reduction in red blood cells which can make the skin pale and cause weakness or breathlessness
• bleeding in the stomach or bowel, urogenital bleeding (including blood in the urine and heavy menstrual bleeding), nose bleeds, bleeding of the gums
• bleeding into the eye (including bleeding from the whites of the eyes)
• bleeding into tissue or a cavity of the body (haematoma, bruising)
• coughing up blood
• bleeding from the skin or under the skin
• bleeding following an operation
• oozing of blood or fluid from surgical wounds
• swelling in the limbs
• pain in the limbs
• impaired function of the kidneys (may be seen in tests performed by your doctor)
• fever
• stomach ache, indigestion, feeling or being sick, constipation, diarrhoea

• low blood pressure (symptoms may be feeling dizzy or fainting when standing up)

  • decreased general strength and energy (weakness, tiredness), headache, dizziness
  • rash, itchy skin
  • blood tests may show an increase in some liver enzymes Uncommon (may affect up to 1 in 100 people):
  • bleeding into the brain or inside the skull (see above, signs of bleeding)
  • bleeding into a joint causing pain and swelling
  • thrombocytopenia (low number of platelets, which are cells that help blood to clot)
  • allergic reactions, including allergic skin reactions
  • impaired function of the liver (may be seen in tests performed by your doctor)
  • blood tests may show an increase in bilirubin, some pancreatic or liver enzymes or in the number of platelets
  • fainting
  • feeling unwell
  • faster heartbeat
  • dry mouth
  • hives

Rare (may affect up to 1 in 1,000 people):

• bleeding into the muscles
• cholestasis (decreased bile flow), hepatitis including hepatocellular injury (inflamed liver including liver injury)
• yellowing of the skin and eyes (jaundice)
• localised swelling
• collection of blood (haematoma) in the groin as a complication of the cardiac procedure where a catheter is inserted in your leg artery (pseudoaneurysm) Very rare (may affect up to 1 in 10,000 people):
• accumulation of eosinophils, a type of white granulocytic blood cells that cause inflammation in the lung (eosinophilic pneumonia)

Not known (frequency cannot be estimated from the available data):

• kidney failure after severe bleeding
• bleeding in the kidney sometimes with presence of blood in urine leading to inability of the kidneys to work properly (anticoagulant-related nephropathy)
• increased pressure within muscles of the legs or arms after bleeding, which leads to pain, swelling, altered sensation, numbness or paralysis (compartment syndrome after bleeding)

Side effects in children and adolescents

In general, the side effects observed in children and adolescents treated with rivaroxaban were similar in type to those observed in adults and were primarily mild to moderate in severity.

Side effects that were observed more often in children and adolescents:

Very common (may affect more than 1 in 10 people):

• headache
• fever
• nose bleeding
• vomiting

Common (may affect up to 1 in 10 people):

• raised heartbeat
• blood tests may show an increase in bilirubin (bile pigment)
• thrombocytopenia (low number of platelets which are cells that help blood to clot)
• heavy menstrual bleeding

Uncommon (may affect up to 1 in 100 people):

• blood tests may show an increase in a subcategory of bilirubin (direct bilirubin, bile pigment)

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Rivaroxaban 5 mg/ml Oral Suspension

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the bottle label and carton after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions. Use within 100 days of first opening.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Rivaroxaban 5 mg/ml Oral Suspension contains

• The active substance is rivaroxaban. Each ml of the oral suspension contains 5 mg of rivaroxaban.

• The other ingredients are: xanthan gum, propylene glycol (E1520), sodium benzoate (E211), potassium sorbate (E212), disodium hydrogen phosphate heptahydrate, sucralose, xylitol, liquid maltitol (E965), glycerol (E422), liquid sorbitol (non-crystallising) (E420), citric acid monohydrate, sodium laurilsulfate, purified water and Strawberry RS1 flavouring agent (contains propylene glycol, nature identical flavouring substances, natural flavouring substances).

  What Rivaroxaban 5 mg/ml Oral Suspension looks like and contents of the pack

  A white to off-white, aqueous suspension with a strawberry aroma in an amber glass bottle with a child-resistant closure (PP) with sealing insert (LDPE). The pack contains a 5 ml oral dosing syringe (PP barrel, LDPE plunger) and press in bottle LDPE adaptor for graduated dosing of 2, 3 and 4 ml.

  Pack size: 1x 200 ml

  Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder:

  Zentiva Pharma UK Limited,

  12 New Fetter Lane,

  London, EC4A 1JP, United Kingdom

  Manufacturer:

  Zakłady Farmaceutyczne POLPHARMA S.A. Oddział Medana w Sieradzu ul. Władysława Łokietka 10, 98-200 Sieradz, POLAND

  This leaflet was last revised in January 2025.

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