Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.
* Keep this leaflet. You may need to read it again.
* If you have any further questions, ask your doctor or
pharmacist.
* This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them, even if their
signs of illness are the same as yours.
* If you get any side effects talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.
as clopidogrel.
•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: The recommended dose is one tablet
XAVAROX-UBSA 15 mg twice a day for the first 3 weeks.
For treatment after 3 weeks, the recommended dose is one
tablet XAVAROX-UBSA 20 mg once a day. After at least 6 months
blood clot treatment your doctor may decide to continue
treatment with either one 10 mg tablet once a day or one 20 mg
tablet once a day.
If you have kidney problems and take one tablet XAVAROX-UBSA
20 mg once a day, your doctor may decide to reduce the dose
for the treatment after 3 weeks to one tablet XAVAROX-UBSA 15
mg once a day if the risk for bleeding is greater than the risk for
having another blood clot.
Children and adolescents
The dose of XAVAROX-UBSA depends on the body weight, and will
be calculated by the doctor.
The recommended dose for children and adolescents with a
body weight between 30 kg and less than 50kg is one
XAVAROX-UBSA 15 mg film-coated tablet once a day.
The recommended dose for children and adolescents with a
body weight of 50kg or more is one XAVAROX-UBSA 20 mg
film-coated tablet once a day.
Take the tablet(s) every day until your doctor tells you to stop. Try
to take the tablet(s) 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 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 XAVAROX-UBSA
at the times your doctor tells you.
If you take more XAVAROX-UBSA than you should Contact your
doctor immediately if you have taken too many XAVAROX-UBSA
tablets. Taking too much XAVAROX-UBSA increases the risk of
bleeding.
If you forget to take XAVAROX-UBSA If you are taking one 20 mg
tablet or one 15 mg tablet once a day and have missed a dose,
take it as soon as you remember. Do not take more than one
tablet in a single day to make up for a forgotten dose. Take the
next tablet on the following day and then carry on taking one
tablet once a day.
If you are taking one 15 mg tablet twice a day and have missed a
dose, take it as soon as you remember. Do not take more than
two 15 mg tablets in a single day. If you forget to take a dose you
can take two 15 mg tablets at the same time to get a total of two
tablets (30 mg) on one day. On the following day you should
carry on taking one 15 mg tablet twice a day.
If you stop taking XAVAROX-UBSA Do not stop taking
XAVAROX-UBSA without talking to your doctor first, because
XAVAROX-UBSA treats and prevents serious conditions. If you
have any further questions on the use of this medicine, ask your
doctor or pharmacist.
5-WARNINGS and PRECAUTIONS
Do not take XAVAROX-UBSA
- if you are allergic to rivaroxaban or any of the other ingredients
of this medicine (listed in section 2)
- 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 are breast-feeding Do not take
XAVAROX-UBSA and tell your doctor if any of these apply to you.
Take special care with XAVAROX-UBSA
•if you have an increased risk of bleeding, as could be the case
in situations such as:
•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 XAVAROX-UBSA”)
•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 esophagus (gullet), e.g. due to
gastroesophageal reflux disease (disease where stomach acid
goes upwards into the esophagus) or tumors 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 XAVAROX.-UBSA 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 XAVAROX-UBSA 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 (e.g. for epidural or spinal anaesthesia or pain
reduction):
•it is very important to take XAVAROX-UBSA before and after the
injection or removal of the catheter 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 anesthesia, because urgent care is necessary
6-SPECIFIC PATIENT POPULATIONS
Children and adolescents:
XAVAROX-UBSA is not recommended for people under 18 years
of age. There is not enough information on its use in children
and adolescents.
Pregnancy and breast-feeding
Do not take XAVAROX-UBSA 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
XAVAROX-UBSA. 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
XAVAROX-UBSA may cause dizziness (common side effect) or
fainting (uncommon side effect) (see section 7,” Possible side
effects”). You should not drive, ride a bicycle or use any tools or
machines if you are affected by these
symptoms.
7-SIDE EFFECTS
Like all medicines, XAVAROX-UBSA can
cause side effects, although not
everybody gets them.
Like other similar medicines to reduce
the formation of blood clots,
XAVAROX-UBSA may cause bleeding
which may potentially be life threatening.
Excessive bleeding may lead to a sudden
drop in blood pressure (shock). In some
case the bleeding may not be obvious.
Tell your doctor immediately if you
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. 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 (StevensJohnson 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; 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 (hematoma,
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)
– localized 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)
- 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)
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. By
reporting side effects, you can help provide more information on
the safety of this medicine
8-DRUG INTERACTIONS
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any of these medicines:
- 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))
-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
XAVAROX-UBSA, because the effect of XAVAROX-UBSA may be
reduced. Your doctor will decide, if you should be treated with
XAVAROX-UBSA and if you should be kept under closer
observation.
9-STORAGE CONDITIONS
Keep all medicine out of reach of children
Store in a dry place below 30°C
Keep your medicine in a cool dry place and away from light in
the original package to protect it from moisture
Don’t use this medicine after the expiry date which is stated on
the outer packaging. The expiry date refers to the last day of that
month.
Don’t use this medicine if you notice any visible signs of
deterioration.
Don’t throw away any medicines via wastewater. Ask your
pharmacist how to throw away medicines you no longer use.
These measures will help protect the environment.
Manufacturer:
UNIZA LIFECARE PRIVATE LIMITED , Kadi Detroj Road Balasar,
Mehsana Gujarat. India
Marketing Authorization Holder, Packed by:
Rivaroxaban 10/20 mg Film-coated tablets
1-DESCRIPTION:
XAVAROX-UBSA 10mg is a round pink film-coated tablet.
XAVARAOX-UBSA 20mg is a round pink film-coated tablet.
It 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-COMPOSITION:
Each film coated-tablet of XAVAROX-UBSA 10mg contains 10mg
of rivaroxaban
Each film coated-tablet of XAVARAOX-UBSA 20mg contains
20mg of rivaroxaban
Excipients: Microcrystalline Cellulose Powder 101, lactose
Monohydrate, HPMC E5, Sodium Lauryl sulphate, Croscarmellose
Sodium, Magnesium Stearate, Spraycel SC AQ 3882 Pink.
3-THERAPEUTIC INDICATIONS
•Adults:
- 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.
•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.
4-POSOLOGY
Adults:
•To prevent blood clots in brain (stroke) and other blood vessels
in your body: The recommended dose is one tablet XAVAROX 20
mg once a day.
If you have kidney problems, the dose may be reduced to one
tablet XAVAROX-UBSA 15 mg once a day. If you need a
procedure to treat blocked blood vessels in your heart (called a
percutaneous coronary intervention - PCI with an insertion of a
stent), there is limited evidence to reduce the dose to one tablet
XAVAROX-UBSA 15 mg once a day (or to one tablet
XAVAROX-UBSA 10 mg once a day in case your kidneys are not
working properly) in addition to an antiplatelet medicine such
This is a medicament:
- A medicament is a product which
affects your health and its consumption
contrary to instructions is dangerous for
you.
- Follow strictly the doctor's prescription,
the method of use and the instructions of
the pharmacist who sold the
medicament.
- The doctor and the pharmacist are the
experts in medicine, their benefits and
risks.
- Do not by yourself interrupt the period
of treatment prescribed.
- Do not repeat the same prescription
without consulting your doctor.
- Keep all medicaments out of reach of
children.
Council of Arab Health Ministers
Union of Arab pharmacists
as clopidogrel.
•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: The recommended dose is one tablet
XAVAROX-UBSA 15 mg twice a day for the first 3 weeks.
For treatment after 3 weeks, the recommended dose is one
tablet XAVAROX-UBSA 20 mg once a day. After at least 6 months
blood clot treatment your doctor may decide to continue
treatment with either one 10 mg tablet once a day or one 20 mg
tablet once a day.
If you have kidney problems and take one tablet XAVAROX-UBSA
20 mg once a day, your doctor may decide to reduce the dose
for the treatment after 3 weeks to one tablet XAVAROX-UBSA 15
mg once a day if the risk for bleeding is greater than the risk for
having another blood clot.
Children and adolescents
The dose of XAVAROX-UBSA depends on the body weight, and will
be calculated by the doctor.
The recommended dose for children and adolescents with a
body weight between 30 kg and less than 50kg is one
XAVAROX-UBSA 15 mg film-coated tablet once a day.
The recommended dose for children and adolescents with a
body weight of 50kg or more is one XAVAROX-UBSA 20 mg
film-coated tablet once a day.
Take the tablet(s) every day until your doctor tells you to stop. Try
to take the tablet(s) 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 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 XAVAROX-UBSA
at the times your doctor tells you.
If you take more XAVAROX-UBSA than you should Contact your
doctor immediately if you have taken too many XAVAROX-UBSA
tablets. Taking too much XAVAROX-UBSA increases the risk of
bleeding.
If you forget to take XAVAROX-UBSA If you are taking one 20 mg
tablet or one 15 mg tablet once a day and have missed a dose,
take it as soon as you remember. Do not take more than one
tablet in a single day to make up for a forgotten dose. Take the
next tablet on the following day and then carry on taking one
tablet once a day.
If you are taking one 15 mg tablet twice a day and have missed a
dose, take it as soon as you remember. Do not take more than
two 15 mg tablets in a single day. If you forget to take a dose you
can take two 15 mg tablets at the same time to get a total of two
tablets (30 mg) on one day. On the following day you should
carry on taking one 15 mg tablet twice a day.
If you stop taking XAVAROX-UBSA Do not stop taking
XAVAROX-UBSA without talking to your doctor first, because
XAVAROX-UBSA treats and prevents serious conditions. If you
have any further questions on the use of this medicine, ask your
doctor or pharmacist.
5-WARNINGS and PRECAUTIONS
Do not take XAVAROX-UBSA
- if you are allergic to rivaroxaban or any of the other ingredients
of this medicine (listed in section 2)
- 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 are breast-feeding Do not take
XAVAROX-UBSA and tell your doctor if any of these apply to you.
Take special care with XAVAROX-UBSA
•if you have an increased risk of bleeding, as could be the case
in situations such as:
•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 XAVAROX-UBSA”)
•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 esophagus (gullet), e.g. due to
gastroesophageal reflux disease (disease where stomach acid
goes upwards into the esophagus) or tumors 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 XAVAROX.-UBSA 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 XAVAROX-UBSA 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 (e.g. for epidural or spinal anaesthesia or pain
reduction):
•it is very important to take XAVAROX-UBSA before and after the
injection or removal of the catheter 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 anesthesia, because urgent care is necessary
6-SPECIFIC PATIENT POPULATIONS
Children and adolescents:
XAVAROX-UBSA is not recommended for people under 18 years
of age. There is not enough information on its use in children
and adolescents.
Pregnancy and breast-feeding
Do not take XAVAROX-UBSA 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
XAVAROX-UBSA. 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
XAVAROX-UBSA may cause dizziness (common side effect) or
fainting (uncommon side effect) (see section 7,” Possible side
effects”). You should not drive, ride a bicycle or use any tools or
machines if you are affected by these
symptoms.
7-SIDE EFFECTS
Like all medicines, XAVAROX-UBSA can
cause side effects, although not
everybody gets them.
Like other similar medicines to reduce
the formation of blood clots,
XAVAROX-UBSA may cause bleeding
which may potentially be life threatening.
Excessive bleeding may lead to a sudden
drop in blood pressure (shock). In some
case the bleeding may not be obvious.
Tell your doctor immediately if you
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. 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 (StevensJohnson 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; 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 (hematoma,
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)
– localized 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)
- 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)
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. By
reporting side effects, you can help provide more information on
the safety of this medicine
8-DRUG INTERACTIONS
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any of these medicines:
- 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))
-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
XAVAROX-UBSA, because the effect of XAVAROX-UBSA may be
reduced. Your doctor will decide, if you should be treated with
XAVAROX-UBSA and if you should be kept under closer
observation.
9-STORAGE CONDITIONS
Keep all medicine out of reach of children
Store in a dry place below 30°C
Keep your medicine in a cool dry place and away from light in
the original package to protect it from moisture
Don’t use this medicine after the expiry date which is stated on
the outer packaging. The expiry date refers to the last day of that
month.
Don’t use this medicine if you notice any visible signs of
deterioration.
Don’t throw away any medicines via wastewater. Ask your
pharmacist how to throw away medicines you no longer use.
These measures will help protect the environment.
Manufacturer:
UNIZA LIFECARE PRIVATE LIMITED , Kadi Detroj Road Balasar,
Mehsana Gujarat. India
Marketing Authorization Holder, Packed by:
Date of Revision: 06 October, 2025
1-DESCRIPTION:
XAVAROX-UBSA 10mg is a round pink film-coated tablet.
XAVARAOX-UBSA 20mg is a round pink film-coated tablet.
It 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-COMPOSITION:
Each film coated-tablet of XAVAROX-UBSA 10mg contains 10mg
of rivaroxaban
Each film coated-tablet of XAVARAOX-UBSA 20mg contains
20mg of rivaroxaban
Excipients: Microcrystalline Cellulose Powder 101, lactose
Monohydrate, HPMC E5, Sodium Lauryl sulphate, Croscarmellose
Sodium, Magnesium Stearate, Spraycel SC AQ 3882 Pink.
3-THERAPEUTIC INDICATIONS
•Adults:
- 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.
•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.
4-POSOLOGY
Adults:
•To prevent blood clots in brain (stroke) and other blood vessels
in your body: The recommended dose is one tablet XAVAROX 20
mg once a day.
If you have kidney problems, the dose may be reduced to one
tablet XAVAROX-UBSA 15 mg once a day. If you need a
procedure to treat blocked blood vessels in your heart (called a
percutaneous coronary intervention - PCI with an insertion of a
stent), there is limited evidence to reduce the dose to one tablet
XAVAROX-UBSA 15 mg once a day (or to one tablet
XAVAROX-UBSA 10 mg once a day in case your kidneys are not
working properly) in addition to an antiplatelet medicine such
PI030/01
