Rivaroxaban Tecnigen: detailed information

Patient Information Leaflet: Information for the User

Rivaroxaban Tecnigen 10 mg film-coated tablets

rivaroxaban
Generic medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

What Rivaroxaban Tecnigen is and what it is used for.
What you need to know before taking Rivaroxaban Tecnigen.
How to take Rivaroxaban Tecnigen.
Possible side effects.
How to store Rivaroxaban Tecnigen.
Contents of the pack and other information.

1. What Rivaroxaban Tecnigen is and what it is used for

Rivaroxaban Tecnigen contains the active substance rivaroxaban and is used in adults for:

preventing blood clots in the veins after hip or knee replacement surgery. Your doctor has prescribed this medicine because there is an increased risk of blood clots forming after surgery.
treating blood clots in the veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism), and preventing the recurrence of blood clots in the blood vessels of the legs and/or lungs.

Rivaroxaban Tecnigen belongs to a group of medicines called antithrombotic agents. It works by
blocking a blood clotting factor (factor Xa), thereby reducing the blood's tendency to form clots.

2. What you need to know before taking Rivaroxaban Tecnigen

Do not take Rivaroxaban Tecnigen

if you are allergic to rivaroxaban or to any of the other ingredients of this medicine (listed in section 6);
if you have excessive bleeding (haemorrhage);
if you have a disease or condition affecting an organ in the body that increases the risk of serious bleeding (e.g. stomach ulcer, injuries or bleeding in the brain, recent surgery on the brain or eyes);
if you are taking medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), except when switching anticoagulant therapy or while receiving heparin through a venous or arterial catheter to keep it open;
if you have a liver disease that increases the risk of bleeding;
during pregnancy or breastfeeding.

Do not take Rivaroxaban Tecnigen and consult your doctor if any of the conditions described above apply to you.
Warnings and precautions
Talk to your doctor or pharmacist before taking Rivaroxaban Tecnigen
Take special care with Rivaroxaban Tecnigen

if you have an increased risk of bleeding, such as in the following situations:
- moderate or severe kidney disease, as kidney function may affect the amount of medicine active in your body;
- if you are taking other medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), if you are switching anticoagulant therapy, or during administration of heparin through a venous or arterial catheter to keep it open (see section "Other medicines and Rivaroxaban Tecnigen");
- coagulation disorders;
- very high blood pressure that is not controlled by medical treatment;
- diseases of the stomach or intestines that could cause bleeding, e.g. inflammation of the intestine or stomach, or inflammation of the oesophagus, e.g. due to gastroesophageal reflux disease (a condition in which stomach acid flows back into the oesophagus);
- a blood vessel disorder in the back of the eye (retinopathy);
- a lung disease in which the bronchi are dilated and filled with pus (bronchiectasis), or previous bleeding from your lung;
if you have a prosthetic heart valve;
if you know you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor, who will decide whether a change in therapy may be necessary;
if your doctor determines that your blood pressure is unstable or if another treatment or surgical procedure to remove a blood clot from the lungs is planned.

If any of the conditions described above apply to you, inform your doctor before taking Rivaroxaban Tecnigen. Your doctor will decide whether you should be treated with this medicine and whether you need to be closely monitored.
If you are due to undergo surgery

it is very important to take Rivaroxaban Tecnigen exactly at the times indicated by your doctor, both before and after surgery.
if the surgery involves a catheter or injection into the spine (e.g. for epidural or spinal anaesthesia or pain relief):
it is very important to take Rivaroxaban Tecnigen exactly at the times indicated by your doctor;
inform your doctor immediately if you experience numbness or weakness in the legs, or bowel or bladder problems after the anaesthesia, as urgent intervention may be required.

Children and adolescents
Rivaroxaban Tecnigen is not recommended for people under 18 years of age. There is insufficient information on its use in children and adolescents.
Other medicines and Rivaroxaban Tecnigen
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.

If you are taking:
certain antifungal medicines (e.g. fluconazole, itraconazole, voriconazole,
posaconazole), unless they are applied only to the skin;
ketoconazole tablets (used to treat Cushing's syndrome – a condition in which the body produces too much cortisol);
certain antibiotics (e.g. clarithromycin, erythromycin);
certain antiviral medicines for HIV/AIDS (e.g. ritonavir);
other medicines to reduce blood clotting (e.g. enoxaparin, clopidogrel, vitamin K antagonists such as warfarin and acenocoumarol, prasugrel and ticagrelor (see section "Warnings and precautions"));
anti-inflammatory and pain-relief medicines (e.g. naproxen or acetylsalicylic acid);
dronedarone, a medicine used to treat abnormal heart rhythm;
certain antidepressants (selective serotonin reuptake inhibitors (SSRIs) or serotonin-noradrenaline reuptake inhibitors (SNRIs)).

If any of the conditions described above apply to you, inform your doctor before taking Rivaroxaban Tecnigen, as the effect of Rivaroxaban Tecnigen may be enhanced. Your doctor will decide whether you should be treated with this medicine and whether you need to be closely monitored.
If your doctor considers that you have an increased risk of developing stomach or intestinal ulcers, they may also prescribe preventive ulcer treatment.

If you are taking:
certain antiepileptic medicines (phenytoin, carbamazepine, phenobarbital);
St John's wort (Hypericum perforatum), a herbal remedy used for depression;
rifampicin, an antibiotic.

If any of the conditions described above apply to you, inform your doctor before taking Rivaroxaban Tecnigen, as the effect of Rivaroxaban Tecnigen may be reduced. Your doctor will decide whether you should be treated with Rivaroxaban Tecnigen and whether you need to be closely monitored.
Pregnancy and breastfeeding
Do not take Rivaroxaban Tecnigen during pregnancy or breastfeeding. If you could become pregnant, use a reliable contraceptive method while taking Rivaroxaban Tecnigen. If you become pregnant while taking this medicine, inform your doctor immediately. Your doctor will decide on the appropriate course of treatment.
Driving and using machines
Rivaroxaban Tecnigen may cause dizziness (a common side effect) or fainting (an uncommon side effect) (see section 4, "Possible side effects"). Do not drive or operate machinery if you experience these symptoms.
Rivaroxaban Tecnigen contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
Rivaroxaban Tecnigen contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially "sodium-free".

3. How to take Rivaroxaban Tecnigen

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.

What dose to take

To prevent blood clots in the veins after hip or knee replacement surgery:
The recommended dose is one 10 mg Rivaroxaban Tecnigen tablet once daily.
For the treatment of blood clots in the leg veins and blood clots in the lung blood vessels, and to prevent recurrence of blood clots:
After at least 6 months of treatment for the blood clot, the recommended dose is one 10 mg tablet once daily or one 20 mg tablet once daily. Your doctor has prescribed Rivaroxaban Tecnigen 10 mg once daily.

Swallow the tablet preferably with water.
Rivaroxaban Tecnigen may be taken with or without food.
If you have difficulty swallowing the tablet whole, consult your doctor for alternative ways of taking Rivaroxaban Tecnigen. The tablet can be crushed and mixed with water or apple puree immediately before taking.
If necessary, your doctor may also administer crushed Rivaroxaban Tecnigen tablets through a tube inserted into the stomach.

To prevent blood clots in the veins after hip or knee replacement surgery:
Take the first tablet 6–10 hours after surgery.
If you have undergone major hip surgery, you will usually need to take the tablets for 5 weeks.
If you have undergone major knee surgery, you will usually need to take the tablets for 2 weeks.

If you take more Rivaroxaban Tecnigen than you should
Contact your doctor immediately if you have taken too many Rivaroxaban Tecnigen tablets.
Taking an excessive amount of Rivaroxaban Tecnigen increases the risk of bleeding.

If you forget to take Rivaroxaban Tecnigen
If you forget to take a dose, take it as soon as you remember. Take the next dose the following day at the usual time and continue taking one tablet once daily as before.
Do not take a double dose to make up for the forgotten tablet.

If you stop taking Rivaroxaban Tecnigen
Do not stop taking Rivaroxaban Tecnigen without first consulting your doctor, as Rivaroxaban Tecnigen helps prevent serious conditions from developing.

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

4. Possible side effects

Like all medicines, Rivaroxaban Tecnigen can cause side effects, although not everybody gets them.
Like other similar medicines that reduce blood clot formation, Rivaroxaban Tecnigen can cause bleeding, which may potentially be life-threatening. Excessive bleeding can lead to a sudden drop in blood pressure (shock). In some cases, bleeding may not be obvious.
Contact your doctor immediately if you experience any of the following side effects:

Signs of bleeding
- bleeding in the brain or within the skull (symptoms may include headache, one-sided weakness, vomiting, seizures, decreased level of consciousness, and neck stiffness. A serious medical emergency. Seek immediate medical attention!).
prolonged or excessive bleeding.
unusual weakness, fatigue, paleness, dizziness, headache, unexplained swelling, shortness of breath, chest pain or angina pectoris. Your doctor may decide to monitor you closely or adjust your treatment.
- Signs of severe skin reactions
widespread and intense rash, blisters or mucosal lesions, e.g. in the mouth or eyes (Stevens-Johnson syndrome/toxic epidermal necrolysis).
a drug reaction causing rash, fever, internal organ inflammation, 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 edema; may affect up to 1 in 100 people).

Complete list of possible side effects
Common (may affect up to 1 in 10 people)

reduction in red blood cells that may cause pale skin, weakness or shortness of breath;
bleeding in the stomach or intestines, urogenital bleeding (including blood in urine and heavy menstrual bleeding), nosebleeds, bleeding from the gums;
bleeding in the eye (including bleeding from the white of the eye);
bleeding into tissues or body cavities (hematoma, bruising);
coughing up blood;
bleeding from the skin or under the skin;
bleeding after surgery;
loss of blood or fluid from a surgical wound;
swelling of limbs;
limb pain;
impaired kidney function (may be detected through tests performed by your doctor);
fever;
stomach ache, indigestion, nausea or vomiting, constipation, diarrhoea;
low blood pressure (symptoms may include dizziness or feeling faint when standing up);
decreased general strength and energy (weakness, fatigue), headache, dizziness;
skin rash, itchy skin;
blood tests may show increased levels of certain liver enzymes.

Uncommon (may affect up to 1 in 100 people)

bleeding in the brain or within the skull (see above, signs of bleeding);
bleeding into a joint causing pain and swelling;
thrombocytopenia (low platelet count; platelets are cells that help blood to clot);
allergic reactions, including skin allergic reactions;
impaired liver function (may be detected through tests performed by your doctor);
blood tests may show increased levels of bilirubin, certain pancreatic or liver enzymes, or increased platelet count;
fainting;
feeling unwell;
rapid heartbeat;
dry mouth;
hives.

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

muscle bleeding;
cholestasis (reduced bile flow), hepatitis including hepatocellular injury (inflamed liver including liver damage);
yellowing of the skin and eyes (jaundice);
localized swelling;
formation of a blood collection (hematoma) in the groin as a complication of cardiac procedures involving insertion of a catheter into the leg artery (pseudoaneurysm).

Frequency not known (cannot be estimated from the available data)

kidney failure following severe bleeding;
increased pressure within the muscles of the arms or legs after bleeding, causing pain, swelling, altered sensation, numbness or paralysis (compartment syndrome after bleeding).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Rivaroxaban Tecnigen

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date 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 dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

Contents of Rivaroxaban Tecnigen:

The active substance is rivaroxaban. Each film-coated tablet contains 10 mg of rivaroxaban.
The other components are: Tablet core: microcrystalline cellulose, sodium croscarmellose, lactose monohydrate, hypromellose, sodium lauryl sulfate, magnesium stearate, calcium silicate, maize starch. See section 2 "Rivaroxaban Tecnigen contains lactose and sodium". Film coating of the tablet: macrogol, lactose monohydrate, hypromellose (E464), titanium dioxide (E 171), red iron oxide (E 172), yellow iron oxide (E 172).

Description of the appearance of Rivaroxaban Tecnigen and package contents
The 10 mg film-coated tablets of Rivaroxaban Tecnigen are pink, round and biconvex, with a diameter of 6.0 mm.
Rivaroxaban Tecnigen 10 mg film-coated tablets are available in packages containing 5, 10, 30 or 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Tecnigen S.r.l.,
via Galileo Galilei 40,
20092, Cinisello Balsamo,
Milan, Italy.

Manufacturer
Atlantic Pharma – Produções Farmacêuticas, S.A.
Rua da Tapada Grande, nº 2,
Abrunheira, 2710-089 Sintra,
Portugal.

This medicinal product is authorised in the European Economic Area countries under the following names:
Cyprus: Rivaroxaban Farmoz Genéricos
Italy: Rivaroxaban Tecnigen
Portugal: Rivaroxabano Farmoz Genéricos

Patient Information Leaflet: information for the user

Rivaroxaban Tecnigen 15 mg film-coated tablets, 20 mg film-coated tablets

rivaroxaban
Generic medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

What Rivaroxaban Tecnigen is and what it is used for.
What you need to know before taking Rivaroxaban Tecnigen.
How to take Rivaroxaban Tecnigen.
Possible side effects.
How to store Rivaroxaban Tecnigen.
Contents of the pack and other information.

1. What Rivaroxaban Tecnigen is and what it is used for

Rivaroxaban Tecnigen contains the active substance rivaroxaban.
Rivaroxaban Tecnigen is used in adults for:

preventing blood clots in the brain (stroke) and in other blood vessels in the body if you have an irregular type of heart rhythm called non-valvular atrial fibrillation.
treating blood clots in the veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism), and for preventing recurrence of blood clots in the blood vessels of the legs and/or lungs. Rivaroxaban Tecnigen is used in children and adolescents under 18 years of age and with body weight equal to or greater than 30 kg for:
treating blood clots and preventing their recurrence in the veins or blood vessels of the lungs, after an initial treatment of at least 5 days with injectable medicines used to treat blood clots.

Rivaroxaban Tecnigen belongs to a group of medicines called antithrombotic agents. It works
by blocking a blood clotting factor (factor Xa), thereby reducing the tendency of the blood to
form clots.

2. What you need to know before taking Rivaroxaban Tecnigen

Do not take Rivaroxaban Tecnigen

if you are allergic to rivaroxaban or to any of the other ingredients of this medicine (listed in section 6);
if you have excessive bleeding (haemorrhage);
if you have a disease or condition affecting an organ in the body that increases the risk of serious bleeding (e.g. stomach ulcer, lesions or bleeding in the brain, recent brain or eye surgery);
if you are taking medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), except when switching anticoagulant treatment or while receiving heparin through a venous or arterial catheter to keep it open;
if you have liver disease that increases the risk of bleeding;
during pregnancy or breastfeeding.

if you have an increased risk of bleeding, as may occur in situations such as:
- moderate or severe kidney disease in adults, kidney disease and moderate or severe in children and adolescents since renal function can affect the amount of medicine active in the body;
- if you are taking other medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), if you are switching anticoagulant treatment or while taking heparin through a venous or arterial catheter to keep it open (see section "Other medicines and Rivaroxaban Tecnigen");
- coagulation disorders;
- very high blood pressure not controlled by medical treatment;
- stomach or intestinal diseases that could cause bleeding, e.g. inflammation of the stomach or intestine that could cause bleeding, such as intestinal or stomach inflammation or oesophagitis, e.g. due to gastroesophageal reflux disease (a condition in which stomach acid flows back into the oesophagus);
- a blood vessel disorder at the back of the eye (retinopathy);
- a lung disease in which the bronchi are dilated and filled with pus (bronchiectasis), or previous bleeding from the lung;
if you have a prosthetic heart valve;
if you know you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor who will decide whether a change in therapy may be needed;
if your doctor determines that your blood pressure is unstable or if another treatment or surgical procedure to remove a blood clot from the lungs is planned.

If any of the conditions described above apply to you, inform your doctor before taking Rivaroxaban
Tecnigen. Your doctor will decide whether you should be treated with this medicine and whether you should be
closely monitored.
If you are scheduled for surgery

it is very important to take Rivaroxaban Tecnigen before and after surgery exactly as directed by your doctor.
if the procedure involves a catheter or injection into the spinal column (e.g. for epidural or spinal anaesthesia or pain relief):
it is very important to take Rivaroxaban Tecnigen before and after the injection or catheter removal exactly as directed by your doctor;
inform your doctor immediately if you experience numbness or weakness in the legs or bowel or bladder problems after the anaesthesia, as urgent intervention is required.

Children and adolescents
Rivaroxaban Tecnigen tablets are not recommended in children weighing less than
30 kg. There is insufficient information available on the use of rivaroxaban in children and adolescents for the indications approved in adults.
Other medicines and Rivaroxaban Tecnigen
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines without a prescription.

If you are taking:
certain antifungal medicines (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are applied only to the skin;
ketoconazole tablets (used to treat Cushing's syndrome – a condition in which the body produces too much cortisol);
certain antibiotics (e.g. clarithromycin, erythromycin);
certain antiviral medicines for HIV/AIDS (e.g. ritonavir);
certain 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 used to treat abnormal heart rhythm;
medicines used to treat depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin-noradrenaline reuptake inhibitors (SNRIs)).

If any of the conditions described above apply to you, inform your doctor before taking Rivaroxaban
Tecnigen, because the effect of Rivaroxaban Tecnigen may be enhanced. Your doctor will decide whether
you should be treated with this medicine and whether you should be closely monitored.
If your doctor considers that you have an increased risk of developing stomach or intestinal ulcers,
he or she may also prescribe preventive ulcer treatment.

If you are taking:
certain medicines for epilepsy (phenytoin, carbamazepine, phenobarbital);
St John's wort (Hypericum perforatum), a herbal remedy used for depression;
rifampicin, an antibiotic.

If any of the conditions described above apply to you, inform your doctor before taking Rivaroxaban
Tecnigen, because the effect of Rivaroxaban Tecnigen may be reduced. Your doctor will decide whether you
should be treated with Rivaroxaban Tecnigen and whether you should be closely monitored.
Pregnancy and breastfeeding
Do not take Rivaroxaban Tecnigen during pregnancy or breastfeeding. If there is a possibility you could become
pregnant, use a reliable contraceptive method while taking Rivaroxaban Tecnigen. If you become
pregnant while taking this medicine, inform your doctor immediately, who will decide on the appropriate
course of treatment.
Driving and using machines
Rivaroxaban Tecnigen may cause dizziness (a common side effect) or fainting (an uncommon side effect) (see section 4, "Possible side effects"). You must not drive or operate machinery if you experience these symptoms.
Rivaroxaban Tecnigen contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this
medicine.
Rivaroxaban Tecnigen contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially "sodium-free".

3. How to take Rivaroxaban Tecnigen

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Rivaroxaban Tecnigen should be taken with food.
Swallow the tablet or tablets preferably with some water.
If you have difficulty swallowing the tablet whole, ask your doctor how to take Rivaroxaban Tecnigen in another way. The tablet may be crushed and mixed with water or apple puree immediately before administration. The mixture should be taken immediately followed by food. If necessary, your doctor may administer crushed Rivaroxaban Tecnigen through a tube inserted into the stomach.

What dose to take

Adults
To prevent blood clots in the brain (stroke) and in other blood vessels of the body: The recommended dose is one 20 mg Rivaroxaban Tecnigen tablet once daily. If you have kidney problems, the dose may be reduced to one 15 mg Rivaroxaban Tecnigen tablet once daily.

If you need to undergo a procedure to treat blocked blood vessels in your heart (called PCI - Percutaneous Coronary Intervention with stent placement), there is limited evidence supporting dose reduction to one 15 mg Rivaroxaban Tecnigen tablet once daily (or one 10 mg Rivaroxaban Tecnigen tablet once daily if your kidneys are not functioning properly), in addition to an antiplatelet medicine such as clopidogrel.

To treat blood clots in the veins of the legs and in the blood vessels of the lungs, and to prevent recurrence of clots: The recommended dose is one 15 mg Rivaroxaban Tecnigen tablet twice daily for the first 3 weeks. After 3 weeks, the recommended dose is one 20 mg Rivaroxaban Tecnigen tablet once daily. After at least 6 months of treatment for blood clots, your doctor may decide to continue treatment with either one 10 mg tablet once daily or one 20 mg tablet once daily. If you have kidney problems and are taking one 20 mg Rivaroxaban Tecnigen tablet once daily, your doctor may decide to reduce the dose after 3 weeks to one 15 mg Rivaroxaban Tecnigen tablet once daily if the risk of bleeding is greater than the risk of developing a new blood clot.
Children and adolescents
The dose of Rivaroxaban Tecnigen depends on body weight and will be calculated by your doctor.
The recommended dose for children and adolescents with a body weight between 30 kg and 50 kg is one 15 mg Rivaroxaban Tecnigen tablet once daily.
The recommended dose for children and adolescents with a body weight equal to or above 50 kg is one 20 mg Rivaroxaban Tecnigen tablet once daily.
Take each dose of Rivaroxaban TecniGen with a drink (e.g. water or juice) during a meal. Take the tablets at approximately the same time every day. Consider setting an alarm to help you remember. For parents or caregivers: please observe the child to ensure the full dose is taken.

Since the dose of Rivaroxaban TecniGen is based on body weight, it is important to attend scheduled appointments with your doctor, as the dose may need to be adjusted as weight changes.
Never adjust the dose of Rivaroxaban Tecnigen by yourself. If necessary, your doctor will adjust the dose.
Do not split the tablet in an attempt to divide the dose.
You may crush the Rivaroxaban Tecnigen tablet and mix it with water or apple puree immediately before administration. Take food after taking this mixture. If necessary, your doctor may also administer crushed Rivaroxaban Tecnigen via a gastric tube.

If you spit out the dose or vomit

If this happens less than 30 minutes after taking Rivaroxaban Tecnigen, take a new dose.
If this happens more than 30 minutes after taking Rivaroxaban Tecnigen, do not take a new dose. In this case, take the next dose of Rivaroxaban Tecnigen at your usual time.

Contact your doctor if you spit out the dose or vomit repeatedly after taking Rivaroxaban Tecnigen.

When to take Rivaroxaban Tecnigen
Take the tablet every day until your doctor tells you to stop.
Try to take the tablet at the same time each day to help you remember.
Your doctor will decide how long you should continue treatment.
To prevent the formation of blood clots in the brain (stroke) and in other blood vessels in the body:
If your heartbeat is to be restored to normal by a procedure called cardioversion, take Rivaroxaban Tecnigen at the time indicated by your doctor.

If you forget to take Rivaroxaban Tecnigen

Adults, children and adolescents: If you are taking one 20 mg tablet or one 15 mg tablet once daily and you miss a dose, take it as soon as you remember. Do not take more than one tablet in the same day to make up for the missed dose. Take the next tablet the following day and continue with one tablet once daily.
Adults: If you are taking one 15 mg tablet twice daily and you miss a dose, take it as soon as you remember. Do not take more than two 15 mg tablets in the same day. If you miss a dose, you may take two 15 mg tablets together to achieve a total of two tablets (30 mg) in one day. The following day, continue with one 15 mg tablet twice daily.

If you stop taking Rivaroxaban Tecnigen
Do not stop taking Rivaroxaban Tecnigen without first consulting your doctor, because Rivaroxaban Tecnigen helps prevent serious conditions.
If you have any questions about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Rivaroxaban Tecnigen may cause side effects, although not everyone experiences them.
Like other similar medicines that reduce blood clot formation, Rivaroxaban Tecnigen may cause bleeding, which can potentially be life-threatening. Excessive bleeding may lead to a sudden drop in blood pressure (shock). In some cases, bleeding may not be obvious.
Contact your doctor immediately if you or the child experience any of the following side effects:

Signs of bleeding
- bleeding in the brain or within the skull (symptoms may include headache, one-sided weakness, vomiting, seizures, decreased level of consciousness, and neck stiffness. A serious medical emergency. Seek immediate medical attention!).
- prolonged or excessive bleeding.
- unusual weakness, fatigue, paleness, dizziness, headache, unexplained swelling, shortness of breath, chest pain, or angina pectoris. Your doctor may decide to monitor you closely or adjust your treatment.
Signs of severe skin reactions
- widespread and severe rash, blisters or mucosal lesions, e.g., in the mouth or eyes (Stevens-Johnson syndrome/toxic epidermal necrolysis).
- a drug reaction causing rash, fever, internal organ inflammation, 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; 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 edema; may affect up to 1 in 100 people).

Complete list of possible side effects
Common (may affect up to 1 in 10 people)

reduced red blood cells, which may cause pale skin, weakness, or shortness of breath;
bleeding in the stomach or intestines, urogenital bleeding (including blood in urine and heavy menstrual bleeding), nosebleeds, bleeding gums;
bleeding in the eye (including bleeding from the white of the eye);
bleeding into tissues or body cavities (hematoma, bruising);
coughing up blood;
bleeding from or under the skin;
bleeding after surgery;
loss of blood or fluid from a surgical wound;
swelling of limbs;
limb pain;
impaired kidney function (may be detected through blood tests performed by your doctor);
fever;
stomach ache, indigestion, nausea or vomiting, constipation, diarrhoea;
low blood pressure (symptoms may include dizziness or feeling faint when standing up);
decreased general strength and energy (weakness, fatigue), headache, dizziness;
rash, itchy skin;
blood tests may show increased levels of certain liver enzymes.

Uncommon (may affect up to 1 in 100 people)

bleeding in the brain or within the skull (see above, signs of bleeding);
bleeding into a joint causing pain and swelling;
thrombocytopenia (low platelet count; platelets are cells that help blood to clot);
allergic reactions, including skin allergic reactions;
impaired liver function (may be detected through blood tests performed by your doctor);
blood tests may show increased levels of bilirubin, certain pancreatic or liver enzymes, or increased platelet count;
fainting;
feeling unwell;
rapid heartbeat;
dry mouth;
hives.

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

muscle bleeding;
cholestasis (reduced bile flow), hepatitis including hepatocellular injury (inflamed liver including liver damage);
yellowing of the skin and eyes (jaundice);
localized swelling;
formation of a blood collection (hematoma) in the groin as a complication of a cardiac procedure where a catheter is inserted into the leg artery (pseudoaneurysm).

Frequency not known (frequency cannot be estimated from the available data)

kidney failure following severe bleeding;
increased pressure within the muscles of the legs or arms after bleeding, causing pain, swelling, altered sensation, numbness, or paralysis (compartment syndrome following bleeding).

Side effects in children and adolescents
In general, the side effects observed in children and adolescents treated with Rivaroxaban Tecnigen have been similar in type to those observed in adults and have mainly been mild to moderate in severity.
Side effects observed more frequently in children and adolescents:
Very common (may affect more than 1 in 10 people)

headache;
fever;
nosebleeds;
vomiting.
Common (may affect up to 1 in 10 people)
increased heart rate;
blood tests may show increased bilirubin (bile pigment);
thrombocytopenia (reduced platelet count; platelets are cells that allow blood to clot);
heavy menstrual bleeding.
Uncommon (may affect up to 1 in 100 people)
blood tests may show increased levels of a subcategory of bilirubin (direct bilirubin, bile pigment).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Rivaroxaban Tecnigen

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date 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 dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

Contents of the Rivaroxaban Tecnigen pack

The active substance is rivaroxaban: Each film-coated tablet contains 15 mg of rivaroxaban. Each film-coated tablet contains 20 mg of rivaroxaban.
Other components are: Tablet core: microcrystalline cellulose, sodium croscarmellose, lactose monohydrate, hypromellose, sodium lauryl sulfate, magnesium stearate, calcium silicate, maize starch. See section 2 "Rivaroxaban Tecnigen contains lactose and sodium". Film coating of the tablet: macrogol, lactose monohydrate, hypromellose (E464), titanium dioxide (E 171), red iron oxide (E 172), yellow iron oxide (E 172).
Other components are: Tablet core: microcrystalline cellulose, sodium croscarmellose, lactose monohydrate, hypromellose, sodium lauryl sulfate, magnesium stearate, calcium silicate, maize starch. See section 2 "Rivaroxaban Tecnigen contains lactose and sodium". Film coating of the tablet: macrogol, lactose monohydrate, hypromellose (E464), titanium dioxide (E 171), red iron oxide (E 172).

Description of the appearance of Rivaroxaban Tecnigen and contents of the pack
The 15 mg film-coated tablets of Rivaroxaban Tecnigen are dark pink, round and biconvex with a diameter of 5.0 mm.
Rivaroxaban Tecnigen 15 mg film-coated tablets are available in packs of 10, 14, 28, 42, 98 or 100 film-coated tablets.
The 20 mg film-coated tablets of Rivaroxaban Tecnigen are red-brown, round and biconvex with a diameter of 6.0 mm.
Rivaroxaban Tecnigen 20 mg film-coated tablets are available in packs of 10, 14, 28, 98 or 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Tecnigen S.r.l.,
via Galileo Galilei 40,
20092, Cinisello Balsamo,
Milan, Italy.

Manufacturer
Atlantic Pharma – Produções Farmacêuticas, S.A.
Rua da Tapada Grande, nº 2,
Abrunheira, 2710-089 Sintra,
Portugal.

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Cyprus: Rivaroxaban Farmoz Genéricos.
Italy: Rivaroxaban Tecnigen.
Portugal: Rivaroxabano Farmoz Genéricos.

Patient card
Patient Card
Tecnigen (logo)
Rivaroxaban Tecnigen 10 mg (check the box corresponding to the prescribed dose)
Rivaroxaban Tecnigen 15 mg (check the box corresponding to the prescribed dose)
Rivaroxaban Tecnigen 20 mg (check the box corresponding to the prescribed dose)

Always keep this card with you
Show this card to every doctor or dentist before any treatment

I am on anticoagulant therapy with Rivaroxaban Tecnigen (rivaroxaban)
Name:
Address:
Date of birth:
Weight:
Other medicines / conditions:

In case of emergency, please inform:
Name of physician:
Physician's telephone number:
Physician's stamp:

Please also inform:
Name:
Telephone number:
Relationship:

Information for healthcare professionals:

INR values should not be considered, as they are not a reliable measure of the anticoagulant effect of Rivaroxaban Tecnigen.

What should I know about Rivaroxaban Tecnigen?

Rivaroxaban Tecnigen thins the blood, preventing the formation of dangerous clots.
Rivaroxaban Tecnigen must be taken exactly as prescribed by your doctor. To ensure optimal protection against clots, never miss a dose.
You must never stop taking Rivaroxaban Tecnigen without first discussing it with your doctor, as the risk of clot formation may increase.
Inform healthcare professionals if you are taking, have recently taken, or plan to take any other medicines before starting Rivaroxaban Tecnigen.
Inform healthcare professionals that you are taking Rivaroxaban Tecnigen before any surgical procedure or invasive intervention.

When should I seek advice from healthcare professionals?
When taking a blood thinner such as Rivaroxaban Tecnigen, it is important to be aware of possible side effects. Bleeding is the most common side effect. Do not start taking Rivaroxaban Tecnigen if you know you are at risk of unusual bleeding without first discussing it with your doctor. Immediately inform healthcare professionals if you experience any signs or symptoms of bleeding, such as:

pain;
swelling or discomfort;
headache, dizziness or weakness;
unusual bruising, nosebleeds, bleeding from gums or cuts that take a long time to stop;
heavier than normal menstrual flow or vaginal bleeding;
blood in the urine (which may appear pink or brown), red or black stools;
coughing up blood, or vomiting blood or material that looks like coffee grounds.

How do I take Rivaroxaban Tecnigen?

To ensure optimal protection, Rivaroxaban Tecnigen:
- 10 mg can be taken with or without food;
- 15 mg must be taken with food;
- 20 mg must be taken with food.