Patient leaflet - Rivaroxaban Umedica 10 mg film-coated tablets
1. What Rivaroxaban Umedica is and what it is used for
Rivaroxaban Umedica contains the active substance rivaroxaban and 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.
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 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.
2. What you need to know before you take Rivaroxaban Umedica
Do not take Rivaroxaban Umedica
if you are allergic to rivaroxaban or any of
the other ingredients of this medicine (listed in section 6)
- if you are bleeding excessively
if you have a disease or condition in an
organ of the body that increases the risk of serious bleeding (e.g. stomach ulcer, injury or bleeding in the brain, recent surgery of the brain or eyes)
if you are taking medicines to prevent
blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), except when changing anticoagulant treatment or while getting heparin through a venous or arterial line to keep it open
if you have a liver disease which leads to an
increased risk of bleeding
- if you are pregnant or breast-feeding Do not take Rivaroxaban Umedica and tell your doctor if any of these apply to you.
Warnings and precautions
Talk to your doctor or pharmacist before taking Rivaroxaban Umedica.
Take special care with Rivaroxaban Umedica
Ÿ 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 (e.g. warfarin, dabigatran, apixaban or heparin), when changing anticoagulant treatment or while getting heparin through a venous or arterial line to keep it open (see section “Other medicines and Rivaroxaban Umedica”)
§ bleeding disorders
§ very high blood pressure, not controlled by medical treatment
§ diseases of your stomach or bowel that might result in bleeding, e.g. inflammation of the bowels or stomach, or inflammation of the oesophagus (gullet), e.g. 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
Ÿ if you have a prosthetic heart valve Ÿ if you have cancer:
Some cancers, especially those in the stomach, intestines, bladder, or kidneys, may increase your risk of bleeding when taking this medicine.
Your doctor will carefully consider whether this medicine is suitable for you, depending on your type of cancer and treatment
Ÿ 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.
Ÿ 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 this medicine. 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
Ÿ it is very important to take this medicine
before and after the operation exactly at the times you have been told by your doctor. Ÿ if your operation involves a catheter or
injection into your spinal column (e.g. for epidural or spinal anaesthesia or pain reduction):
§ it is very important to take Rivaroxaban Umedica 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
Rivaroxaban Umedica are not recommended for people under 18 years of age. There is not enough information on their use in children and adolescents.
Other medicines and Rivaroxaban Umedica
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Ÿ If you are taking
§ some medicines for fungal infections (e.g. 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 (e.g. clarithromycin, erythromycin) § some anti-viral medicines for HIV / AIDS (e.g. ritonavir)
§ other medicines to reduce blood clotting (e.g. enoxaparin, clopidogrel or vitamin K antagonists such as warfarin and acenocoumarol)
§ anti-inflammatory and pain relieving medicines (e.g. 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 Rivaroxaban Umedica, because the effect of this medicine 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.
Ÿ If you are taking
§ some medicines for treatment of epilepsy (phenytoin, carbamazepine,
phenobarbital)
§ St John's Wort (Hypericum perforatum), a herbal product used for depression § rifampicin, an antibiotic
If any of the above apply to you, tell your doctor before taking Rivaroxaban Umedica, because the effect of this medicine may be reduced. Your doctor will decide, if you should be treated with Rivaroxaban Umedica and if you should be kept under closer observation.
Pregnancy and breast-feeding
Do not take this medicine 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 Rivaroxaban Umedica. 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
This medicine may cause dizziness (common side effect) or fainting (uncommon side effect) (see section 4 “Possible side effects”). You should not drive, ride a bicycle or use any tools or machines if you are affected by these symptoms.
Rivaroxaban Umedica contains lactose and sodium
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 less than 1 mmol sodium (23 mg) per tablet, that is to say essentially “sodium- free”.
3. How to take Rivaroxaban Umedica
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
How much to take
- To prevent blood clots in the veins after a hip or knee replacement operation. The recommended dose is one tablet Rivaroxaban Umedica once a day.
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
After at least 6 months blood clot treatment, the recommended dose is either one 10 mg tablet once a day or one 20 mg tablet once a day. Your doctor has prescribed you Rivaroxaban Umedica once a day. Swallow the tablet preferably with water. This medicine can be taken with or without food. If you have difficulty swallowing the tablet whole, talk to your doctor about other ways to take this medicine. The tablet may be crushed and mixed with water or apple puree immediately before you take it.
If necessary, your doctor may also give you the crushed Rivaroxaban Umedica through a stomach tube.
When to take Rivaroxaban Umedica
Take the tablet every day until your doctor tells you to stop.
Try to take the tablet 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 tablet 6 - 10 hours after your operation.
If you have had a major hip operation you will usually take the tablets for 5 weeks.
If you have had a major knee operation you will usually take the tablets for 2 weeks.
If you take more Rivaroxaban Umedica than you should
Contact your doctor immediately if you have taken too many Rivaroxaban Umedica. Taking too much Rivaroxaban Umedica increases the risk of bleeding.
Rivaroxaban Umedica 10 mg film-coated tablets
(PIL Size: 140x570 MM)
Rivaroxaban Umedica 10 mg film-coated tablets
r i v
a r o
x a b
a
nrivaroxaban
Package leaflet: Information for the user
Umedica Laboratories UK Ltd
If you forget to take Rivaroxaban Umedica
If you have missed a dose, take it as soon as you remember. Take the next tablet on the following day and then carry on taking a tablet once a day as normal.
Do not take a double dose to make up for a forgotten tablet.
If you stop taking Rivaroxaban Umedica
Do not stop taking this medicine without talking to your doctor first, because Rivaroxaban Umedica prevents the development of a serious condition.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Rivaroxaban Umedica can cause side effects, although not everybody gets them.
Like other similar medicines to reduce the formation of blood clots, this medicine 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 experience any of the following side effects:
Ÿ 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.
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. Ÿ 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).
Ÿ Signs of severe allergic reactions
- swelling of the face, lips, mouth, tongue or throat; difficulty swallowing; hives and breathing difficulties; 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 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 bleed, bleeding in the gum
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
wound
- 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, diarrhea
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 a muscle
cholestasis (decreased bile flow), hepatitis
incl. hepatocellular injury (inflamed liver incl. liver injury)
- yellowing of the skin and eye (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 a 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 a bleeding, which leads to pain, swelling, altered sensation, numbness or paralysis (compartment syndrome after a bleeding)
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, Website:
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 Umedica
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 carton and on each blister after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Crushed tablets
Crushed tablets are stable in water or apple puree for up to 4 hours.
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 Umedica contains
- The active substance is rivaroxaban. Each tablet contains 10 mg of rivaroxaban.
The other ingredients are:
Tablet core: Cellulose microcrystalline (E460); Croscarmellose sodium (E468); Lactose monohydrate; Hypromellose (E464); Sodium laurilsulfate (E487); Magnesium stearate (E470b)
See section 2 “Rivaroxaban Umedica 10 mg film-coated tablets contains lactose and sodium”.
Tablet film coat: Hypromellose-2910 (E464); Titanium dioxide (E171); Macrogol-3350 (E1521); Iron oxide red (E172)
What Rivaroxaban Umedica 10 mg film-coated tablets looks like and contents of the pack
Rivaroxaban Umedica 10 mg film-coated tablets are Pink, approx. 5.1 mm round shaped, film-coated tablets, debossed with 'RIV' on one side and '10' on other side.
They come
in PVC/PVDC Alu foil blisters in cartons of
5, 10, 14, 28, 30 or 98 film-coated tablets or
- in unit dose PVC/PVDC Alu foil blisters in cartons of 10 x 1 or 100 x 1 or
- in multipacks containing 10 packs, each containing 10 x 1 (100 film-coated tablets) Not all pack sizes may be marketed.
Marketing Authorisation Holder
Umedica Laboratories UK Ltd
Office No. G42
The Panorama Park Street
Ashford, England
TN24 8DF
Manufacturer
Elara Pharmaservices Limited
5 Garden Court,
Lockington Hall, Main Street,
Lockington Derby, United Kingdom, DE74 2RH
This medicinal product is authorised under the following names:
Rivaroxaban Umedica 10 mg film-coated tablets- PL 60528/0017
This leaflet was last revised in 03/2026
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