RIVAROXABAN 10 mg Film-Coated Tablets

Зміст інструкції

1. Rivaroxaban Tecnigen 10 mg film-coated tablets
   1. What is Rivaroxaban Tecnigen and what it is used for
   2. What you need to know before taking Rivaroxaban Tecnigen
   3. How to take Rivaroxaban Tecnigen
   4. Possible side effects
   5. How to store Rivaroxaban Tecnigen
   6. Contents of the pack and other information
2. Rivaroxaban Tecnigen 15 mg film-coated tablets, 20 mg film-coated tablets
   1. What is Rivaroxaban Tecnigen and what it is used for
   2. What you need to know before taking Rivaroxaban Tecnigen
3. Rivaroxaban Tecnigen tablets are not recommended in children with a body weight less than
   1. How to take Rivaroxaban Tecnigen
   2. Possible side effects
   3. How to store Rivaroxaban Tecnigen
   4. Package Contents and Other Information

Rivaroxaban Tecnigen 10 mg film-coated tablets

rivaroxaban

Generic medicine

Read this leaflet carefully before you start taking this medicine because it contains
importantinformation 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Rivaroxaban Tecnigen is and what it is used for.
• 2. What you need to know before you take Rivaroxaban Tecnigen.
• 3. How to take Rivaroxaban Tecnigen.
• 4. Possible side effects.
• 5. How to store Rivaroxaban Tecnigen.
• 6. Contents of the pack and other information.

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

Rivaroxaban Tecnigen contains the active ingredient 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 after surgery the risk of blood clots forming in the blood increases.
• 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) and thus 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 any of the other ingredients of this medicine (listed in section 6);
• if you have excessive bleeding (haemorrhages);
• if you have a disease or condition of a body organ that increases the risk of serious bleeding (e.g. stomach ulcer, injuries 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 in the case of changing anticoagulant treatment or while receiving heparin through a venous or arterial catheter to keep it open;
• if you have a liver disease that involves an increased risk of bleeding;
• during pregnancy or breastfeeding.

Do not take Rivaroxaban Tecnigen and consult your doctorif any of the conditions described apply to you.

Warnings and precautions
Talk to your doctor, pharmacist before taking Rivaroxaban Tecnigen

Take special care with Rivaroxaban Tecnigen

• if you have an increased risk of bleeding, as may be the case in situations such as:
• moderate or severe kidney disease, because kidney function can affect the amount of medicine that works in the body
• if you are taking other medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), if you are changing anticoagulant therapy or during the administration of heparin through a venous or arterial catheter to keep it open (see section "Other medicines and Rivaroxaban Tecnigen");
• blood clotting disorders;
• very high blood pressure, 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 esophagus, e.g. due to gastroesophageal reflux disease (a condition in which stomach acid rises into the esophagus);
• a disorder of the blood vessels in the back of the eye (retinopathy);
• a lung disease in which the bronchi are dilated and full of 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 causes an increased risk of blood clots), tell your doctor who will decide if you may need to change therapy;
• if your doctor determines that blood pressure is unstable or if another treatment or surgery is planned to remove the blood clot from the lungs.

If any of the conditions described apply to you, tell your doctor,inform your doctor before taking Rivaroxaban Tecnigen. The doctor will decide if you should be treated with this medicine and if you should be kept under close observation.

If you are going to have surgery

• it is very important to take Rivaroxaban Tecnigen before and after surgery exactly at the times indicated by your doctor.
• if the surgery involves a catheter or an injection into the spine (e.g. for epidural or spinal anesthesia or pain relief):
• it is very important to take Rivaroxaban Tecnigen exactly at the times indicated by your doctor;
• immediately inform your doctor if you experience numbness or weakness in your legs or disturbances in the bowel or bladder at the end of anesthesia, because urgent intervention is necessary.

Children and adolescents
Rivaroxaban Tecnigen is not recommended for people under 18 years of age. There is not enough information about its use in children and adolescents.

Other medicines and Rivaroxaban Tecnigen
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including over-the-counter medicines.

• If you are taking:
• some medicines for fungal infections (e.g. fluconazole, itraconazole, voriconazole,

posaconazole), unless they are applied only to the skin;

• ketoconazole tablets (used to treat Cushing's syndrome - in which the body produces an excess of cortisol);
• some medicines for bacterial infections (e.g. clarithromycin, erythromycin);
• some antiviral 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, prasugrel and ticagrelor (see section "Warnings and precautions"));
• anti-inflammatory and pain-relieving medicines (e.g. naproxen or acetylsalicylic acid);
• dronedarone, a medicine for the treatment of abnormal heartbeat;
• some medicines for the treatment of depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin noradrenaline reuptake inhibitors (SNRIs)).

If any of the conditions described apply to you, tell your doctorbefore taking Rivaroxaban Tecnigen, because the effect of Rivaroxaban Tecnigen may be increased. The doctor will decide if you should be treated with this medicine and if you should be kept under close observation. If the doctor believes you have an increased risk of developing stomach or intestinal ulcers, they may also prescribe you preventive ulcer treatment.

• If you are taking:
• some medicines for the treatment of epilepsy (phenytoin, carbamazepine, phenobarbital);
• St. John's Wort (Hypericum perforatum), a herbal medicine used for depression;
• rifampicin, an antibiotic.

If any of the conditions described apply to you, tell your doctorbefore taking Rivaroxaban Tecnigen, because the effect of Rivaroxaban Tecnigen may be reduced. The doctor will decide if you should be treated with Rivaroxaban Tecnigen and if you should be kept under close observation.

Pregnancy and breastfeeding
Do not take Rivaroxaban Tecnigen during pregnancy or breastfeeding. If there is a possibility of becoming pregnant, use reliable contraception while taking Rivaroxaban Tecnigen. If you become pregnant during the intake of this medicine, inform your doctor immediately, who will decide on the treatment modalities.

Driving and using machines
Rivaroxaban Tecnigen can cause dizziness (a common side effect) or lightheadedness (an uncommon side effect) (see section 4, "Possible side effects"). Do not drive or use machines if you are affected by 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 your doctor has told you. If you have any doubts, ask your doctor or pharmacist.

What dose to take

• To prevent blood clots from forming in the veins after hip or knee replacement surgery.

The recommended dose is one 10 mg Rivaroxaban Tecnigen tablet once a day.

• For the treatment of blood clots in the veins of the legs and blood clots in the blood vessels of the lungs, and to prevent the recurrence of blood clots. After at least 6 months of treatment for the blood clot, the recommended dose is one 10 mg tablet once a day or one 20 mg tablet once a day. Your doctor has prescribed Rivaroxaban Tecnigen 10 mg once a day.

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

When to take Rivaroxaban Tecnigen
Take the tablet every day until your doctor tells you to stop taking it.
Try to take the tablet at the same time each day to help you remember.
Your doctor will decide how long you need to continue treatment.
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 had major hip surgery, you will generally need to take the tablets for 5 weeks.
If you have had major knee surgery, you will generally 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 tablet
the following day and continue to take one tablet once a day, as before.
Do not take a double dose to make up for a missed tablet.

If you stop taking Rivaroxaban Tecnigen
Do not stop taking Rivaroxaban Tecnigen without consulting your doctor first, because
Rivaroxaban Tecnigen prevents a serious condition from developing.
If you have any questions about using this medicine, ask your doctor or 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 can be potentially life-threatening. Excessive bleeding can lead to a sudden drop in blood pressure (shock). In some cases the
bleeding may not be obvious.

Immediately inform your doctor if you experience any of the following side effects:

• Signs of bleeding
• bleeding in the brain or inside the skull (symptoms may include headache, one-sided weakness, vomiting, convulsions, decreased level of consciousness and stiffness of the

neck. A serious medical emergency. Seek medical attention immediately!).

• 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 change your treatment.
• Signs of severe skin reactions
• widespread and severe rash, blisters or lesions of the mucous membranes, 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 diseases (DRESS syndrome). The frequency of these side effects is very rare (up to 1 in 10,000).
• Signs of severe allergic reactions
• swelling of the face, lips, mouth, tongue or throat; difficulty swallowing; hives and difficulty breathing; 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) and uncommon (angioedema and allergic edema; may affect up to 1 in 100).

Complete 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 shortness of breath;
• bleeding in the stomach or intestine, urogenital bleeding (including blood in the urine and heavy menstrual flow), nosebleeds, bleeding gums;
• bleeding in the eye (including bleeding from the white of the eye);
• bleeding into tissues or a cavity of the body (hematoma, bruising);
• coughing up blood;
• bleeding from the skin or under the skin;
• bleeding after a surgical procedure;
• loss of blood or fluid from a surgical wound;
• swelling of the limbs;
• pain in the limbs;
• impaired kidney function (can be detected with tests performed by your doctor);
• fever;
• stomach pain, indigestion, nausea or vomiting, constipation, diarrhea;
• low blood pressure (symptoms may include feeling dizzy or faint when standing up);
• decreased general strength and energy (weakness, fatigue), headache, dizziness;
• rash, itchy skin;
• blood tests may show an increase in certain liver enzymes.

Uncommon(may affect up to 1 in 100 people)

• bleeding in 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 the cells that help the blood to clot);
• allergic reactions, including allergic skin reactions;
• impaired liver function (can be detected with tests performed by your doctor);
• blood tests may show an increase in bilirubin, certain pancreas or liver enzymes or the number of platelets;
• fainting;
• feeling unwell;
• fast heartbeat;
• dry mouth;
• hives.

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

• muscle bleeding;
• cholestasis (decreased 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 in which a catheter is inserted into the artery of the leg (pseudoaneurysm).

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

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

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 indicated 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 particular storage conditions
Crushed tablets
Crushed tablets are stable in water or applesauce for up to 4 hours.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

Contents of Rivaroxaban Tecnigen:

• The active ingredient is rivaroxaban. Each film-coated tablet contains 10 mg of rivaroxaban.
• The other ingredients are: Tablet core: microcrystalline cellulose, croscarmellose sodium, lactose monohydrate, hypromellose, sodium lauryl sulfate, magnesium stearate, calcium silicate, corn starch. See section 2 "Rivaroxaban Tecnigen contains lactose and sodium". Tablet film coating: 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 contents of the pack
Rivaroxaban Tecnigen 10 mg film-coated tablets are pink, round and biconvex with a
diameter of 6.0 mm.
Rivaroxaban Tecnigen film-coated tablets 10 mg are available in packs of 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,
Milano, 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 Member States of the European Economic Area under the
following denominations:
Cyprus: Rivaroxaban Farmoz Genéricos
Italy: Rivaroxaban Tecnigen.
Portugal: Rivaroxabano Farmoz Genéricos

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

rivaroxaban

Generic medicine

Read 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Rivaroxaban Tecnigen is and what it is used for.
• 2. What you need to know before you take Rivaroxaban Tecnigen.
• 3. How to take Rivaroxaban Tecnigen.
• 4. Possible side effects.
• 5. How to store Rivaroxaban Tecnigen.
• 6. Contents of the pack and other information.

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

Rivaroxaban Tecnigen contains the active ingredient 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 a type of irregular heartbeat called non-valvular atrial fibrillation.
• treating blood clots in the leg veins (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism), and to prevent the recurrence of blood clots in the leg and/or lung blood vessels. Rivaroxaban Tecnigen is used in children and adolescents under 18 years of age and with a body weight of 30 kg or more 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) and thus 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 any of the other ingredients of this medicine (listed in section 6);
• if you have excessive bleeding (haemorrhages);
• if you have a disease or condition of an organ in your body that increases the risk of serious bleeding (e.g. stomach ulcer, injuries 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 receiving heparin through a venous or arterial catheter to keep it open;
• if you have a liver disease that involves an increased risk of bleeding;
• during pregnancy or breastfeeding.

Do not take Rivaroxaban Tecnigen and consult your doctorif any of the conditions described apply to you.

Warnings and precautions
Talk to your doctor or pharmacist before taking Rivaroxaban Tecnigen

Pay particular attention with Rivaroxaban Tecnigen

• if you have an increased risk of bleeding, as may be the case in situations such as:
• moderate or severe kidney disease in adults, kidney disease and moderate or severe in children and adolescents because kidney function can affect the amount of medicine that acts in the body
• if you are taking other medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), if you are changing anticoagulant treatment or while you are taking heparin through a venous or arterial catheter to keep it open (see section "Other medicines and Rivaroxaban Tecnigen");
• blood clotting disorders;
• very high blood pressure, not controlled by medical treatment;
• diseases of the stomach or intestines that could cause bleeding, e.g. inflammation of the stomach or intestines that could cause bleeding, for example inflammation of the intestine or stomach or inflammation of the esophagus, e.g. due to gastroesophageal reflux disease (a condition in which stomach acid rises into the esophagus);
• a disorder of the blood vessels in the back of the eye (retinopathy);
• a lung disease in which the bronchi are dilated and full of 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 autoimmune disorder that causes an increased risk of blood clots), tell your doctor who will decide if you may need to change therapy;
• if your doctor determines that your blood pressure is unstable or if another treatment or surgery is planned to remove the blood clot from the lungs.

If any of the conditions described apply to you,tell your doctor before taking Rivaroxaban
Tecnigen. The doctor will decide whether you should be treated with this medicine and whether you should be
closely monitored.

If you are going to have surgery

• it is very important to take Rivaroxaban Tecnigen before and after surgery exactly at the times indicated by your doctor.
• if the surgery involves a catheter or an injection into the spine (e.g. for epidural or spinal anesthesia or pain reduction):
• it is very important to take Rivaroxaban Tecnigen before and after the injection or removal of the catheter exactly at the times indicated by your doctor;
• immediately inform your doctor if you experience numbness or weakness in your legs or bowel or bladder problems at the end of anesthesia, because urgent intervention is necessary.

Children and adolescents

Rivaroxaban Tecnigen tablets are not recommended in children with a body weight less than

30 kg.There is not sufficient information available on the use of rivaroxaban in children and
adolescents in adult indications.

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:
• some medicines for fungal infections (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are applied only to the skin;
• ketoconazole tablets (used to treat Cushing's syndrome - where the body produces too much cortisol);
• some medicines for bacterial infections (e.g. clarithromycin, erythromycin);
• some antiviral medicines for HIV/AIDS (e.g. ritonavir);
• some 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 for the treatment of abnormal heartbeat;
• medicines for the treatment of depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin noradrenaline reuptake inhibitors (SNRIs)).

If any of the conditions described apply to you, tell your doctorbefore taking Rivaroxaban
Tecnigen, because the effect of Rivaroxaban Tecnigen may be increased. The doctor will decide if
you should be treated with this medicine and if you should be kept under close observation.
If the doctor believes that you have an increased risk of developing stomach or intestinal ulcers,
they may also prescribe you preventive ulcer treatment.

• If you are taking:
• some medicines for the treatment of epilepsy (phenytoin, carbamazepine, phenobarbital);
• St John's Wort ( Hypericum perforatum), a herbal medicine used for depression;
• rifampicin, an antibiotic.

If any of the conditions described apply to you, tell your doctorbefore taking Rivaroxaban
Tecnigen, because the effect of Rivaroxaban Tecnigen may be reduced. The doctor will decide if you should
be treated with Rivaroxaban Tecnigen and if you should be kept under close observation.

Pregnancy and breastfeeding
Do not take Rivaroxaban Tecnigen during pregnancy or breastfeeding. If there is a possibility that you might
become pregnant, use reliable contraception while taking Rivaroxaban Tecnigen. If you become
pregnant while taking this medicine, tell your doctor immediately, who will decide on the
treatment method.

Driving and using machines
Rivaroxaban Tecnigen can cause dizziness (a common side effect) or lightheadedness (an uncommon side
effect) (see section 4, "Possible side effects"). You should not drive vehicles or use machines if you
experience these symptoms.

Rivaroxaban Tecnigen contains lactose
If you have been diagnosed with intolerance to some sugars, contact your doctor 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 following exactly the instructions of your doctor. If you have doubts, consult your doctor or pharmacist.
Rivaroxaban TecnigGen must be taken with a meal.
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 can be crushed and mixed with some water or with applesauce immediately before taking it. Taking the mixture should be immediately followed by taking food. If necessary, your doctor may administer the crushed Rivaroxaban TecnigGen tablet 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 Rivaroxaban TecnigGen 20 mg tablet once a day. If you have kidney problems, the dose may be reduced to one Rivaroxaban TecnigGen 15 mg tablet once a day.

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

• To treat blood clots in the legs and blood vessels in the lungs and to prevent the recurrence of clots, the recommended dose is one Rivaroxaban Tecnigen 15 mg tablet twice a day for the first 3 weeks. After 3 weeks, the recommended dose is one Rivaroxaban Tecnigen 20 mg tablet once a day. After at least 6 months of treatment for blood clots, your doctor may decide to continue treatment with a 10 mg tablet once a day or a 20 mg tablet once a day. If you have kidney problems and are taking a Rivaroxaban Tecnigen 20 mg tablet once a day, your doctor may decide to reduce the dosage for treatment after 3 weeks to a Rivaroxaban Tecnigen 15 mg tablet once a day if the risk of bleeding is greater than the risk of having a new blood clot.
• Children and adolescentsThe 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 Rivaroxaban Tecnigen 15 mg tabletonce a day.
• The recommended dose for children and adolescents with a body weight of 50 kg or more is one Rivaroxaban Tecnigen 20 mg tabletonce a day. Take each dose of Rivaroxaban TecniGen with a drink (e.g. water or juice) during a meal. Take the tablets every day at approximately the same time. Consider setting an alarm to remind yourself. For parents or caregivers: please observe the child to ensure that the entire dose is taken.

Because the dose of Rivaroxaban TecniGen is based on body weight, it is important to go to scheduled visits with your doctor because the dose may need to be adjusted as the weight changes.

Never adjust the dose of Rivaroxaban Tecnigen on your own. If necessary, your doctor will adjust the dose.
Do not split the tablet in an attempt to fraction a dose.
You can crush the Rivaroxaban Tecnigen tablet and mix it with water or applesauce immediately before taking it. Take food after taking this mixture. If necessary, your doctor may also administer the crushed Rivaroxaban Tecnigen tablet via a gastric tube.

If you spit out the dose or vomit

• less than 30 minutes after taking Rivaroxaban Tecnigen, take a new dose;
• more than 30 minutes after taking Rivaroxaban Tecnigen, do nottake a new dose. In this case, take the next dose of Rivaroxaban Tecnigen at the usual time.

Contact your doctor if you repeatedly spit out the dose or vomit after taking Rivaroxaban Tecnigen .
When to take Rivaroxaban Tecnigen
Take the tablet every day until your doctor tells you to stop taking it.
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 needs 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 a 20 mg or 15 mg tablet once a day and have forgotten 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 then continue with one tablet once a day.
• Adults: if you are taking a 15 mg tablet twice a day and have forgotten a dose, take it as soon as you remember. Do not take more than two 15 mg tablets in the same day. If you forget a dose, you can take two 15 mg tablets at the same time to take a total of two tablets (30 mg) in one day. The next day, continue with one 15 mg tablet twice a day

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 stop taking Rivaroxaban Tecnigen
Do not stop taking Rivaroxaban Tecnigen without first consulting your doctor, because
Rivaroxaban Tecnigen prevents a serious condition from developing.
If you have any doubts about the use of this medicine, contact your doctor or pharmacist or

the 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 can be potentially life-threatening. Excessive bleeding can 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 your child experience any of the following side
effects:

• Signs of bleeding
• bleeding in the brain or inside the skull (symptoms may include headache, one-sided weakness, vomiting, convulsions, decreased level of consciousness and stiff neck. A serious medical emergency. Seek medical attention immediately!).
• 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 change your treatment.
• Signs of severe skin reactions
• widespread and severe rash, blisters or lesions of the mucous membranes, 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 diseases (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 difficulty breathing; 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 which can make the skin pale and cause weakness or shortness of breath;
• bleeding in the stomach or intestines, urogenital bleeding (including blood in the urine and heavy menstrual flow), nosebleeds, bleeding gums;
• bleeding in the eye (including bleeding from the white of the eye);
• bleeding into tissues or a cavity of the body (hematoma, bruising);
• coughing up blood;
• bleeding from the skin or under the skin;
• bleeding after a surgical procedure;
• loss of blood or fluid from a surgical wound;
• swelling of the limbs;
• pain in the limbs;
• impaired kidney function (can be detected with tests performed by your doctor);
• fever;
• stomach pain, indigestion, nausea or vomiting, constipation, diarrhea;
• low blood pressure (symptoms may include feeling dizzy or faint when standing up);
• decreased general strength and energy (weakness, fatigue), headache, dizziness;
• skin rash, itchy skin;
• blood tests may show an increase in certain liver enzymes.

Uncommon(may affect up to 1 in 100 people)

• bleeding in 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 the cells that help the blood to clot);
• allergic reactions, including allergic skin reactions;
• impaired liver function (can be detected with tests performed by your doctor);
• blood tests may show an increase in bilirubin, certain pancreatic or liver enzymes, or the number of platelets;
• fainting;
• feeling unwell;
• fast heartbeat;
• dry mouth;
• hives.

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

• muscle bleeding;
• cholestasis (decreased flow of bile), hepatitis incl. 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 in which a catheter is inserted into the artery in the leg (pseudoaneurysm).

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

• kidney failure after severe bleeding;
• increased pressure inside the muscles of the legs or arms after bleeding, causing 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
Tecnigen have been similar to those observed in adults and have been mainly of mild to moderate severity.
Side effects that have been 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 an increase in bilirubin (bile pigment);
• thrombocytopenia (reduced platelets, which are the cells that allow the blood to clot);
• heavy menstrual flow. Uncommon(may affect up to 1 in 100 people)
• blood tests may show an increase in a subclass of bilirubin (direct bilirubin, bile pigment).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed
in this leaflet. You can also report side effects directly through 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 indicated 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 particular storage conditions
Crushed tablets
Crushed tablets are stable in water or applesauce for up to 4 hours.
Do not dispose of any medicine in 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 ingredient 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, anhydrous lactose, hypromellose, sodium lauryl sulfate, magnesium stearate, calcium silicate, corn starch. See paragraph 2 "Rivaroxaban Tecnigen contains lactose and sodium". Tablet film coating: macrogol, anhydrous lactose, hypromellosa (E464), titanium dioxide (E 171), red iron oxide (E 172), yellow iron oxide (E 172).
• Other components are: Tablet core: microcrystalline cellulose, sodium croscarmellose, anhydrous lactose, hypromellose, sodium lauryl sulfate, magnesium stearate, calcium silicate, corn starch. See paragraph 2 Rivaroxaban Tecnigen contains lactose and sodium”. Tablet film coating: macrogol, anhydrous lactose, hypromellosa (E464), titanium dioxide (E 171), red iron oxide (E 172).

Description of the appearance of Rivaroxaban Tecnigen and package contents
Rivaroxaban Tecnigen 15 mg film-coated tablets 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.
Rivaroxaban Tecnigen 20 mg film-coated tablets are reddish-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 Authorisation Holder
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 Member States of the European Economic Area under the
following denominations:
Cyprus: Rivaroxaban Farmoz Genéricos.
Italy: Rivaroxaban Tecnigen.
Portugal: Rivaroxabano Farmoz Genéricos

Patient Card
Patient Card
Tecnigen (logo)

Rivaroxaban Tecnigen 10 mg(tick the box to mark the prescribed dose)

Rivaroxaban Tecnigen 15 mg(tick the box to mark the prescribed dose)

Rivaroxaban Tecnigen 20 mg(tick the box to mark the prescribed dose)

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

I am undergoing anticoagulant treatment with Rivaroxaban Tecnigen (rivaroxaban)
Name:
Address:
Date of birth:
Weight:
Other medications / conditions:

In case of emergency please inform:
Doctor's name:
Doctor's telephone number:
Doctor's stamp:

Please also inform:
Name:
Telephone number:
Type of relationship:

Information for healthcare professionals:

• INR values should not be considered as they are not a value dependent on the anticoagulant activity of Rivaroxaban Tecnigen.

What do I need to 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 should never stop taking Rivaroxaban Tecnigen without first talking to your doctor, as the risk of clot formation may increase.
• Inform healthcare professionals if you are taking, have recently taken or intend to take any other medicines, before taking Rivaroxaban Tecnigen.
• Inform healthcare professionals that you are taking Rivaroxaban Tecnigen before any surgery or invasive procedure.

When should I ask for advice from healthcare professionals?
When taking a blood thinner such as Rivaroxaban Tecnigen, it is important to be informed
about 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 this with your doctor. Immediately inform healthcare professionals if you have signs or symptoms of
bleeding such as:

• pain;
• swelling or discomfort;
• headache, dizziness or weakness;
• unusual bruising, nosebleeds, gum bleeding or cuts that take a long time to stop bleeding;
• heavier than usual 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 meals;
• 20 mg must be taken with meals.