Rivaroxaban Olpha: detailed information

Package leaflet: Information for the user

Rivaroxaban Olpha 2.5 mg film-coated tablets

rivaroxaban
Generic medicine
Please 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 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, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

You have been given Rivaroxaban Olpha because:

you have been diagnosed with acute coronary syndrome (a group of conditions including heart attack and unstable angina, a severe form of chest pain) and an increase in certain cardiac markers has been detected in blood tests. In adults, Rivaroxaban Olpha reduces the risk of another heart attack or the risk of dying from a heart- or blood vessel-related disease. Rivaroxaban Olpha will not be given to you alone. Your doctor will also prescribe one of the following:
- acetylsalicylic acid, or
- acetylsalicylic acid plus clopidogrel or ticlopidine.

you have been diagnosed with a high risk of developing blood clots due to coronary artery disease or peripheral artery disease causing symptoms. In adults, Rivaroxaban Olpha reduces the risk of clot formation (atherothrombotic events). Rivaroxaban Olpha will not be given to you alone. Your doctor will also prescribe acetylsalicylic acid. In some cases, if you are taking Rivaroxaban Olpha following a procedure used to widen a narrowed or blocked artery in the leg in order to restore blood flow, your doctor may also prescribe clopidogrel, which you will take for a short period in combination with acetylsalicylic acid.

Rivaroxaban Olpha contains the active substance rivaroxaban and belongs to a group of medicines
called antithrombotic agents. Its action is due to the inhibition of a clotting factor
(factor Xa), resulting in reduced tendency of the blood to form clots.

2. What you need to know before taking Rivaroxaban Olpha

Do not take Rivaroxaban Olpha

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 (bleeding)
if you have a disease or condition in any part of the body that increases the risk of serious bleeding (e.g. stomach ulcers, wounds 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 heparins), except when switching anticoagulant therapy or when receiving heparins through a venous or arterial catheter to keep it open
if you have acute coronary syndrome and have previously had bleeding or a blood clot in the brain (stroke)
if you have coronary artery disease or peripheral artery disease and have previously had bleeding in the brain (stroke), or if you have had a blockage of the small arteries supplying blood to the deep tissues of the brain (lacunar stroke) or a blood clot in the brain (non-lacunar ischemic stroke) within the previous month
if you have a liver disease that increases the risk of bleeding
during pregnancy or breastfeeding Do not take Rivaroxaban Olpha and inform your doctor if any of the conditions described above apply to you.

Warnings and precautions
Talk to your doctor or pharmacist before taking Rivaroxaban Olpha.
Rivaroxaban Olpha must not be used in combination with certain medicines that reduce blood clotting, such as prasugrel or ticagrelor, except acetylsalicylic acid and clopidogrel/ticlopidine.
Be especially careful with Rivaroxaban Olpha

if you have an increased risk of bleeding, such as in the following cases:
 severe kidney disease, because kidney function may alter the amount of active medicine in the body
 if you are taking other medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), when switching anticoagulant therapy or when receiving heparins through a venous or arterial catheter to keep it open (see section “Other medicines and Rivaroxaban Olpha”)
 coagulation disorders
 very high blood pressure not controlled with medication
 diseases of the stomach or intestine that may cause bleeding, for example inflammation of the intestine or stomach, or inflammation of the esophagus, such as caused by gastroesophageal reflux disease (a condition in which stomach acid flows back into the esophagus), or tumors located in the stomach, intestine, genital tract, or urinary tract
 a blood vessel disorder at the back of the eye (retinopathy)
 a lung disease with dilated bronchi filled with pus (bronchiectasis), or previous bleeding from the lungs
 you are over 75 years old
 you weigh less than 60 kg
 you suffer from coronary artery disease with severe symptomatic heart failure
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 is needed.

If any of the conditions described above apply to you, inform your doctor before taking Rivaroxaban Olpha. 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 Olpha before and after surgery exactly as directed by your doctor.
If the surgical procedure involves the use of a catheter or an injection into the spine (e.g. for epidural or spinal anaesthesia to reduce pain):
 it is very important to take Rivaroxaban Olpha before and after the injection or removal of the catheter exactly as directed by your doctor
 inform your doctor immediately if you experience numbness or weakness in your legs or problems with your bowel or bladder after the anaesthesia, as urgent intervention may be required.

Children and adolescents
Rivaroxaban Olpha 2.5 mg film-coated tablets are not recommended for people under 18 years of
age. There is insufficient information available on its use in children and adolescents.
Other medicines and Rivaroxaban Olpha
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, in which the body produces excess cortisol)
 certain antibiotics for bacterial infections (e.g. clarithromycin, erythromycin)
 certain antiviral medicines for HIV/AIDS (e.g. ritonavir)
 other medicines used to inhibit 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 used in the treatment of atrial fibrillation
 certain medicines for the treatment of depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs))

If any of the conditions described above apply to you, inform your doctor before taking Rivaroxaban Olpha, as the effect of Rivaroxaban Olpha 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 prescribe preventive treatment for ulcers.

If you are taking
 certain medicines for 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 above apply to you, inform your doctor before taking Rivaroxaban Olpha, as the effect of Rivaroxaban Olpha may be reduced. Your doctor will decide whether you should be treated with Rivaroxaban Olpha and whether you need to be closely monitored.

Pregnancy and breastfeeding
Do not take Rivaroxaban Olpha during pregnancy or breastfeeding. If there is a possibility of becoming pregnant, use a reliable method of contraception while taking Rivaroxaban Olpha. If you become pregnant while taking this medicine, inform your doctor immediately, who will decide how to proceed with treatment.
Driving and using machines
Rivaroxaban Olpha may cause dizziness (a common side effect) or fainting (an uncommon side effect) (see section 4, “Possible side effects”). If these symptoms occur, do not drive, ride a bicycle, or use tools or machinery.
Rivaroxaban Olpha contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. essentially “sodium-free”.

3. How to take Rivaroxaban Olpha

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

What dose to take
The recommended dose is one 2.5 mg tablet taken twice daily. Take Rivaroxaban Olpha at the same times each day (for example, one tablet in the morning and one in the evening). This medicine can be taken with or without food.

If you have difficulty swallowing the tablet whole, ask your doctor how to take Rivaroxaban Olpha in another way. The tablet may be crushed and mixed with a small amount of water or apple puree immediately before administration.

If necessary, your doctor may administer the crushed Rivaroxaban Olpha tablet through a tube inserted into the stomach.

Rivaroxaban Olpha will not be given to you alone.
Your doctor will also prescribe acetylsalicylic acid for you.

If you are taking Rivaroxaban Olpha after an acute coronary syndrome, your doctor may also prescribe clopidogrel or ticlopidine.

If you are taking Rivaroxaban Olpha following a procedure to dilate a narrowed or blocked artery in the leg to restore blood flow, your doctor may also prescribe clopidogrel, which you will take for a short period in combination with acetylsalicylic acid.

Your doctor will prescribe the correct dose of these medicines (generally 75 to 100 mg of acetylsalicylic acid daily, or a daily dose of 75–100 mg acetylsalicylic acid plus a daily dose of 75 mg clopidogrel, or a standard daily dose of ticlopidine).

When to start Rivaroxaban Olpha
Treatment with Rivaroxaban Olpha after an acute coronary syndrome should begin as soon as possible after stabilization of the acute coronary syndrome, but not earlier than 24 hours after hospital admission and at the time when parenteral anticoagulant therapy (by injection) would normally be discontinued. If you have been diagnosed with coronary artery disease or peripheral artery disease, your doctor will advise you when to start treatment with Rivaroxaban Olpha.
Your doctor will decide how long your treatment should continue.

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

If you forget to take Rivaroxaban Olpha
Do not take a double dose to make up for a forgotten dose. If you forget a dose, take the next dose at your usual time.

If you stop taking Rivaroxaban Olpha
Take Rivaroxaban Olpha regularly for the entire duration prescribed by your doctor.
Do not stop taking Rivaroxaban Olpha without first discussing it with your doctor. If you stop taking this medicine, your risk of having another heart attack or stroke, or of dying from heart or blood vessel disease, may increase.

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

4. Possible adverse effects

Like all medicines, Rivaroxaban Olpha can cause adverse effects, although not everyone experiences them.
Like other similar medicines used to reduce the formation of blood clots, Rivaroxaban Olpha can cause bleeding which may potentially be life-threatening. Severe 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 notice any of the following adverse effects:

Signs of bleeding
- bleeding in the brain or skull (symptoms may include headache, weakness on one side of the body, vomiting, seizures, reduced level of consciousness, and neck stiffness. This is a serious medical emergency. Seek immediate medical attention!)
- prolonged or excessive blood loss
- 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 modify your treatment.
Signs of severe skin reactions
- widespread and severe rash, blisters or mucosal lesions, for example in the mouth or eyes (Stevens-Johnson syndrome/toxic epidermal necrolysis).
- a drug reaction causing rash, fever, inflammation of internal organs, blood abnormalities and systemic illness (DRESS syndrome). The frequency of these adverse effects is very rare (may occur in up to 1 in 10,000 people).
Signs of severe allergic reactions
- swelling of the face, lips, mouth, tongue or throat; difficulty swallowing; urticaria and breathing difficulties; sudden drop in blood pressure. The frequencies of severe allergic reactions are very rare (anaphylactic reactions, including anaphylactic shock; may occur in up to 1 in 10,000 people) and not common (angioedema and allergic edema; may occur in up to 1 in 100 people).

Complete list of possible adverse effects
Common (may occur in up to 1 in 10 people)

reduced number of 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 in the white part of the eye)
bleeding into tissues or body cavities (haematoma, bruising)
coughing up blood
bleeding from or under the skin
bleeding after surgery
loss of blood or fluid from the surgical wound
swelling in limbs
limb pain
kidney dysfunction (can be detected by tests performed by your doctor)
fever
stomach ache, indigestion, feeling of discomfort or malaise, constipation, diarrhoea
low blood pressure (symptoms include dizziness or fainting when standing up)
general decrease in strength and energy (weakness, fatigue), headache, dizziness
rash, itchy skin
increased levels of certain liver enzymes in blood tests

Uncommon (may occur in up to 1 in 100 people)

bleeding in the brain or within the skull (see above, signs of bleeding)
joint bleeding, causing pain and swelling
thrombocytopenia (reduced number of platelets, which are the cells that help blood to clot)
allergic reactions, including allergic skin reactions
liver dysfunction (can be detected by tests performed by your doctor)
blood tests may show increased bilirubin, increased pancreatic or liver enzymes, or increased platelet count
fainting
feeling unwell
rapid heartbeat
dry mouth
urticaria

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

muscle bleeding
cholestasis (reduced flow of bile, a substance produced by the liver), hepatitis, including hepatocellular injury (liver inflammation including liver damage)
yellowing of the skin and eyes (jaundice)
localized swelling
formation of a blood collection (haematoma) in the groin as a complication of a cardiac procedure involving insertion of a catheter into the leg artery (pseudoaneurysm)

Very rare (may occur in up to 1 in 10,000 people)

accumulation of eosinophils, a type of granulocyte white blood cell causing lung inflammation (eosinophilic pneumonia)

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

kidney failure following severe bleeding
kidney bleeding sometimes with blood in urine leading to kidney dysfunction (Anticoagulant-related nephropathy)
increased pressure in the muscles of the legs or arms after bleeding, causing pain, swelling, altered sensation, numbness or paralysis (compartment syndrome after bleeding)

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

5. How to store Rivaroxaban Olpha

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and carton after
EXP/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 no longer required. This will help protect the environment.

6. Package contents and other information

What Rivaroxaban Olpha contains

The active substance is rivaroxaban. Each film-coated tablet contains 2.5 mg of rivaroxaban.
The other ingredients are: Tablet core: microcrystalline cellulose (E460i), lactose monohydrate, croscarmellose sodium (E468), sodium lauryl sulfate (E487), hypromellose 2910 (E464), magnesium stearate (E470b). See section 2 “Rivaroxaban Olpha contains lactose and sodium”. Tablet coating: hypromellose 2910 (E464), titanium dioxide (E171), macrogol 3350 (E1521), yellow iron oxide (E172).

Description of the appearance of Rivaroxaban Olpha and contents of the pack
Rivaroxaban Olpha 2.5 mg film-coated tablets are biconvex, light yellow, round, film-coated tablets, marked with the letter "A" on one side and "2.5" on the other (diameter 6.10 ± 0.20 mm, thickness 3.20 ± 0.30 mm).
Transparent PVC/PVdC//Alu or oPa/Alu/PVC//Alu blister packs containing 14 film-coated tablets.
Each cardboard carton contains 56 film-coated tablets (4 blisters) or 196 film-coated tablets (14 blisters).
Not all pack sizes may be marketed.

Marketing Authorization Holder
Olpha AS,
Rupnicu iela 5,
Olaine, Olaines novads, LV-2114,
Latvia

Manufacturer
Olpha AS,
Rupnicu iela 5,
Olaine, Olaines novads, LV-2114,
Latvia
or
Pharmadox Healthcare Ltd.,
KW20A Kordin Industrial Park,
Paola PLA 3000,
Malta

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Lithuania: Rivaroxaban Olpha 2.5 mg plėvele dengtos tabletės
Latvia: Rivaroxaban Olpha 2.5 mg apvalkotās tabletes
Estonia, Czech Republic, Slovakia, Poland, Germany, Italy, Spain: Rivaroxaban Olpha
France: RIVAROXABAN OLPHA 2.5 mg, comprimé pelliculé

Package leaflet: information for the user

Rivaroxaban Olpha 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, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Rivaroxaban Olpha contains the active substance rivaroxaban and is used in adults to

prevent the formation of blood clots in the veins after hip or knee replacement surgery. Your doctor has prescribed this medicine because the risk of blood clots forming in your bloodstream increases after surgery.
treat blood clots in the veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism), and to prevent the recurrence of blood clots in the blood vessels of the legs and/or lungs.

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

2. What you should know before taking Rivaroxaban Olpha

Do not take Rivaroxaban Olpha

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
if you have a disease or condition in any part of your body that increases the risk of serious bleeding (e.g. stomach ulcers, wounds 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 heparins), except when switching anticoagulant therapy or when receiving heparins 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 Olpha and inform your doctor if any of the conditions listed above apply to you.

Warnings and precautions
Talk to your doctor or pharmacist before taking Rivaroxaban Olpha.
Be especially careful with Rivaroxaban Olpha

if you have a high risk of bleeding, which may occur in situations such as:
moderate or severe kidney disease, because kidney function can affect the amount of active medicine in your body
if you are taking other medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban, or heparin), when switching anticoagulant treatment, or while receiving heparin through a venous or arterial catheter to keep it open (see section “Other medicines and Rivaroxaban Olpha”)
coagulation disorders
very high blood pressure not controlled by medication
stomach or intestinal diseases that may cause bleeding, such as inflammation of the intestine or stomach, or inflammation of the oesophagus (e.g. due to gastro-oesophageal reflux disease (a condition in which stomach acid flows back into the oesophagus)) or tumours located in the stomach, intestine, genital tract, or urinary tract
a blood vessel disorder in the back of the eye (retinopathy)
a lung disease with dilated bronchi filled with pus (bronchiectasis), or a history of bleeding from your lungs
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 your treatment needs to be changed
if your doctor finds your blood pressure is unstable or if another treatment or surgical procedure to remove blood clots from your lungs is planned.

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

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

Children and adolescents
Rivaroxaban Olpha 10 mg tablets are not recommended for patients under 18 years of age.
There is insufficient information available on its use in children and adolescents.
Other medicines and Rivaroxaban Olpha
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.

If you are taking certain antifungal medicines (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless ketoconazole tablets are applied only to the skin; ketoconazole tablets (used to treat Cushing's syndrome, in which the body produces too much cortisol); certain antibacterial medicines (e.g. clarithromycin, erythromycin)

certain antiviral medicines for HIV/AIDS (e.g. ritonavir)
other medicines used to inhibit 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 atrial fibrillation
certain medicines used to treat depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs))
If any of the conditions described above apply to you, inform your doctor before taking Rivaroxaban Olpha, as the effect of Rivaroxaban Olpha 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 you to be at increased risk of developing stomach or intestinal ulcers, they may prescribe preventive treatment for ulcers.

If you are taking certain medicines for epilepsy (phenytoin, carbamazepine, phenobarbital), St John's wort (Hypericum perforatum), a herbal medicine for depression, or rifampicin, an antibiotic

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

3. How to take Rivaroxaban Olpha

Take this medicine exactly as your doctor has told you. If you are unsure, 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 Olpha tablet once daily.
To treat blood clots in the veins of the legs and in the blood vessels of the lungs, and to prevent recurrence of clots:

After at least 6 months of treatment for blood clots, the recommended dose is one 10 mg tablet once daily or one 20 mg tablet once daily. Your doctor has prescribed Rivaroxaban Olpha 10 mg once daily.

Swallow the tablet preferably with some water.
Rivaroxaban Olpha can be taken regardless of meals.
If you have difficulty swallowing the tablet whole, ask your doctor how to take Rivaroxaban Olpha in another way. The tablet may be crushed and mixed with water or apple puree immediately before taking.
If necessary, your doctor may administer the crushed Rivaroxaban Olpha tablet through a tube inserted into the stomach.

When to take Rivaroxaban Olpha
Take the tablet every day until your doctor tells you to stop.
Try to take the tablets at the same time each day to help you remember. Your doctor will decide how long your treatment should continue.

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 forget to take Rivaroxaban Olpha
If you forget a dose, take it as soon as you remember. Take the next tablet the following day, and then continue as before with one tablet daily.
Do not take a double dose to make up for the forgotten tablet.

If you stop taking Rivaroxaban Olpha
Do not stop taking Rivaroxaban Olpha without first talking to your doctor, because Rivaroxaban Olpha prevents the occurrence of a serious condition.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Rivaroxaban Olpha can cause side effects, although not everyone experiences them.
Like other similar medicines used to reduce blood clot formation, Rivaroxaban Olpha can cause bleeding, which may potentially be life-threatening. Major 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 notice any of the following side effects:

Signs of bleeding
- bleeding in the brain or skull (symptoms may include headache, weakness on one side of the body, vomiting, seizures, reduced level of consciousness, and neck stiffness. This is a serious medical emergency. Seek immediate medical help!)
prolonged or excessive blood loss
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, for example 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 (may occur in 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 occur in up to 1 in 10,000 people) and uncommon (angioedema and allergic edema; may occur in up to 1 in 100 people).

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

reduced number of 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 in the white part of the eye)
bleeding into tissues or body cavities (haematoma, bruising)
coughing up blood
bleeding from or under the skin
bleeding after surgery
blood or fluid leakage from surgical wound
swelling in limbs
limb pain
kidney dysfunction (can be detected through tests performed by your doctor)
fever
stomach ache, indigestion, feeling unwell, constipation, diarrhoea
low blood pressure (symptoms include dizziness or fainting when standing up)
general loss of strength and energy (weakness, fatigue), headache, dizziness
skin rash, itchy skin
increased levels of certain liver enzymes in blood tests

Uncommon (may occur in up to 1 in 100 people)

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

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

muscle bleeding
cholestasis (reduced flow of bile, a substance produced by the liver), hepatitis including hepatocellular injury (liver inflammation including liver damage)
yellowing of the skin and eyes (jaundice)
localized swelling
formation of a blood collection (haematoma) in the groin as a complication of a heart procedure involving insertion of a catheter into the leg artery (pseudoaneurysm)

Very rare (may occur in up to 1 in 10,000 people)

accumulation of eosinophils, a type of granulocyte white blood cell causing lung inflammation (eosinophilic pneumonia)

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

kidney impairment following severe bleeding
kidney bleeding sometimes with blood in urine, leading to kidney dysfunction (Anticoagulant-related nephropathy)
increased pressure in the muscles of the legs or arms after bleeding, causing pain, swelling, altered sensation, numbness or paralysis (compartment syndrome following 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 Olpha

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after
EXP/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. Contents of the pack and other information

What Rivaroxaban Olpha contains

The active substance is rivaroxaban. Each film-coated tablet contains 10 mg of rivaroxaban.
The other components are: Tablet core: microcrystalline cellulose (E460i), lactose monohydrate, sodium croscarmellose (E468), sodium lauryl sulfate (E487), hypromellose 2910 (E464), magnesium stearate (E470b). See section 2 “Rivaroxaban Olpha contains lactose and sodium”. Tablet coating: hypromellose 2910 (E464), titanium dioxide (E171), macrogol 3350 (E1521), iron oxide red (E172).

Description of the appearance of Rivaroxaban Olpha and pack contents
The 10 mg film-coated tablets of Rivaroxaban Olpha are light red, round, biconvex tablets, marked with “A” on one side and “10” on the other (diameter 5.10 ± 0.20 mm; thickness 2.40 ± 0.30 mm).
Transparent PVC/PVdC//Alu or oPa/Alu/PVC//Alu blisters containing 10 or 14 film-coated tablets.
Each carton contains 30 film-coated tablets (3 blisters) or 98 film-coated tablets (7 blisters).
Not all pack sizes may be marketed.

Marketing Authorization Holder
Olpha AS,
Rupnicu iela 5,
Olaine, Olaines novads, LV-2114,
Latvia

Manufacturer
Olpha AS,
Rupnicu iela 5,
Olaine, Olaines novads, LV-2114,
Latvia
or
Pharmadox Healthcare Ltd.,
KW20A Kordin Industrial Park,
Paola PLA 3000,
Malta

This medicinal product is authorized in the European Economic Area countries under the following names:
Lithuania: Rivaroxaban Olpha 10 mg plėvele dengtos tabletės
Latvia: Rivaroxaban Olpha 10 mg apvalkotās tabletes
Estonia, Czech Republic, Slovakia, Poland, Germany, Italy, Spain: Rivaroxaban Olpha
France: RIVAROXABAN OLPHA 10 mg, comprimé pelliculé

Package leaflet: information for the user

Rivaroxaban Olpha 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 side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

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

preventing the formation of blood clots in the brain (stroke) and in other blood vessels of the body if you have a type of irregular heartbeat 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 preventing the recurrence of blood clots in the blood vessels of the legs and/or lungs.

Rivaroxaban Olpha 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 veins or in the blood vessels of the lungs, after an initial treatment of at least 5 days with injectable medicines used to treat blood clots.

Rivaroxaban Olpha belongs to a group of medicines called antithrombotic agents. Its action
is due to the inhibition of a clotting factor (factor Xa), resulting in reduced tendency of
the blood to form clots.

2. What you should know before taking Rivaroxaban Olpha

Do not take Rivaroxaban Olpha

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
if you have a disease or condition in any part of the body that increases the risk of serious bleeding (e.g. stomach ulcers, wounds 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 heparins), except when switching anticoagulant therapy or when 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 Olpha and inform your doctor if any of the conditions described above apply to you.

Warnings and precautions
Talk to your doctor or pharmacist before taking Rivaroxaban Olpha
Be especially careful with Rivaroxaban Olpha

if you have an increased risk of bleeding, such as in the following cases:
severe kidney disease in adults or moderate to severe kidney disease in children and adolescents, because kidney function may affect the amount of active medicine 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 while receiving heparin through a venous or arterial catheter to keep it open (see section “Other medicines and Rivaroxaban Olpha”)
coagulation disorders
very high blood pressure, uncontrolled with medication
stomach or intestinal diseases that may cause bleeding, such as inflammation of the intestine or stomach, or inflammation of the esophagus, for example caused by gastroesophageal reflux disease (a condition in which stomach acid flows back into the esophagus), or tumors located in the stomach, intestine, genital tract, or urinary tract
a blood vessel disorder in the back of the eye (retinopathy)
a lung disease with dilated bronchi filled with pus (bronchiectasis), or a history of bleeding from the lungs
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 is needed
if your doctor finds that your blood pressure is unstable or if another treatment or surgical procedure to remove blood clots from the lungs is planned

it is very important to take Rivaroxaban Olpha before and after surgery exactly as directed by your doctor.
If the surgical procedure involves the use of a catheter or an injection into the spine (e.g. for epidural or spinal anaesthesia for pain relief):
it is very important to take Rivaroxaban Olpha before and after the injection or removal of the catheter 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 medical intervention may be required.

Children and adolescents
Rivaroxaban Olpha tablets are not recommended for children weighing less than 30 kg. There is insufficient information on the use of Rivaroxaban Olpha in children and adolescents for the adult indications.
Other medicines and Rivaroxaban Olpha
Tell 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 ketoconazole tablets are used only topically (used to treat Cushing's syndrome, a condition in which the body produces too much cortisol) certain antibacterial medicines (e.g. clarithromycin, erythromycin) certain antiviral medicines for HIV/AIDS (e.g. ritonavir) other medicines used to inhibit 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 atrial fibrillation certain medicines used to treat depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs))

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 Olpha, as the effect of Rivaroxaban Olpha may be reduced. Your doctor will decide whether you should be treated with Rivaroxaban Olpha and whether you need to be closely monitored.
Pregnancy and breastfeeding
Do not take Rivaroxaban Olpha during pregnancy or breastfeeding. If there is a possibility you may become pregnant, use a reliable method of contraception while taking Rivaroxaban Olpha. If you become pregnant while taking this medicine, inform your doctor immediately, who will decide how to proceed with treatment.
Driving and using machines
Rivaroxaban Olpha may cause dizziness (a common side effect) or fainting (an uncommon side effect) (see section 4, “Possible side effects”). If you experience these symptoms, do not drive, ride a bicycle, or use tools or machinery.
Rivaroxaban Olpha contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. essentially “sodium-free”.

3. How to take Rivaroxaban Olpha

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Rivaroxaban Olpha 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 Olpha 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 Olpha tablets 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 in the body: The recommended dose is one 20 mg Rivaroxaban Olpha tablet once daily. If you have kidney problems, the dose may be reduced to one 15 mg Rivaroxaban Olpha 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 Olpha tablet once daily (or one 10 mg Rivaroxaban Olpha tablet 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 Olpha tablet twice daily for the first 3 weeks. After 3 weeks, the recommended dose is one 20 mg Rivaroxaban Olpha 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 Olpha tablet once daily, your doctor may decide to reduce the dose after 3 weeks to one 15 mg Rivaroxaban Olpha 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 Olpha 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 Olpha tablet once daily.
- The recommended dose for children and adolescents with a body weight equal to or greater than 50 kg is one 20 mg Rivaroxaban Olpha tablet once daily.
- Take each dose of Rivaroxaban Olpha with a drink (e.g. water or juice) during a meal. Take the tablets at approximately the same time each day. Consider setting an alarm to help you remember.
- For parents or caregivers: please observe the child to ensure the entire dose is taken.

Since the dose of Rivaroxaban Olpha 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 Olpha on your own. If adjustment is needed, your doctor will do so.
Do not split the tablet in an attempt to divide the dose. If a lower dose is required, use an alternative formulation of rivaroxaban. For children and adolescents who cannot swallow whole tablets, use alternative formulations of rivaroxaban.
If the oral suspension is not available, the Rivaroxaban Olpha tablet may be crushed and mixed with water or apple puree immediately before administration. Food should be taken after administering this mixture. If necessary, your doctor may also administer crushed Rivaroxaban Olpha tablets via a gastric tube.

If you spit out the dose or vomit

Within less than 30 minutes after taking Rivaroxaban Olpha, take a new dose.
More than 30 minutes after taking Rivaroxaban Olpha, do not take a new dose. In this case, take your next dose at the usual time.

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

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

If you forget to take Rivaroxaban Olpha
Adults, children and adolescents:
If you are taking one 20 mg 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 only:
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 one 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 next day, continue with one 15 mg tablet twice daily.

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

If you stop taking Rivaroxaban Olpha
Do not stop taking Rivaroxaban Olpha without first talking to your doctor, as Rivaroxaban Olpha treats serious conditions and helps prevent their occurrence.

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

4. Possible side effects

Like all medicines, Rivaroxaban Olpha can cause side effects, although not everyone experiences them.
Like other similar medicines used to reduce blood clot formation, Rivaroxaban Olpha can cause bleeding that may potentially be life-threatening. Severe bleeding can cause a sudden drop in blood pressure (shock). In some cases, bleeding may not be obvious.
Immediately inform your doctor if you notice any of the following side effects in yourself or your child:

Signs of bleeding
- bleeding in the brain or skull (symptoms may include headache, weakness on one side of the body, vomiting, seizures, reduced level of consciousness, and neck stiffness. This is a serious medical emergency. Seek immediate medical help!)
- prolonged or excessive blood loss
- 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 intense rash, blisters or mucosal lesions, for example in the mouth or eyes (Stevens-Johnson syndrome/toxic epidermal necrolysis).
- a drug reaction causing rash, fever, inflammation of internal organs, blood abnormalities, and systemic diseases (DRESS syndrome). The frequency of these side effects is very rare (may occur in 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 occur in up to 1 in 10,000 people) and uncommon (angioedema and allergic edema; may occur in up to 1 in 100 people).

Complete list of possible side effects reported in adults, children and adolescents
Common (may affect up to 1 in 10 people)

reduced number of 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 in 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
blood or fluid leakage from a surgical wound
swelling of limbs
limb pain
kidney dysfunction (can be detected through tests performed by your doctor)
fever
stomach pain, indigestion, feeling unwell, constipation, diarrhea
low blood pressure (symptoms include dizziness or fainting when standing)
general lack of energy and strength (weakness, fatigue), headache, dizziness
skin rash, itchy skin
increased liver enzymes in blood tests

Uncommon (may affect up to 1 in 100 people)

bleeding in the brain or within the skull (see above, signs of bleeding)
joint bleeding, causing pain and swelling
thrombocytopenia (reduced number of platelets, which are the cells that allow blood to clot)
allergic reactions, including allergic skin reactions
liver dysfunction (can be detected through tests performed by your doctor)
blood tests may show increased bilirubin, increased 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 flow of bile, a substance produced by the liver), hepatitis including hepatocellular injury (liver inflammation 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 involving insertion of a catheter into the leg artery (pseudoaneurysm)

Very rare (may affect up to 1 in 10,000 people)

accumulation of eosinophils, a type of granulocyte white blood cell causing lung inflammation (eosinophilic pneumonia)

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

kidney failure following severe bleeding
kidney bleeding sometimes with blood in the urine leading to impaired kidney function (Anticoagulant-related nephropathy)
increased pressure in the muscles of the arms or legs 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 Olpha have been similar 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 (a bile pigment)
thrombocytopenia (reduced platelet count, which are the cells that allow blood to clot)
heavy menstrual periods

Uncommon (may affect up to 1 in 100 people)

blood tests may show increased levels of a subcategory of bilirubin (direct bilirubin, a bile pigment)

5. How to store Rivaroxaban Olpha

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after
EXP/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 no longer used. This will help protect the environment.

6. Package contents and other information

What Rivaroxaban Olpha contains
Rivaroxaban Olpha 15 mg film-coated tablets

The active substance is rivaroxaban. Each film-coated tablet contains 15 mg of rivaroxaban.
The other components are: Tablet core: microcrystalline cellulose (E460i), lactose monohydrate, sodium croscarmellose (E468), sodium lauryl sulfate (E487), hypromellose 2910 (E464), magnesium stearate (E470b). See section 2 “Rivaroxaban Olpha contains lactose and sodium”. Tablet coating: hypromellose 2910 (E464), titanium dioxide (E171), macrogol 3350 (E1521), iron oxide red (E172).

Rivaroxaban Olpha 20 mg film-coated tablets

The active substance is rivaroxaban. Each film-coated tablet contains 20 mg of rivaroxaban.
The other ingredients are: Tablet core: microcrystalline cellulose (E460i), lactose monohydrate, sodium croscarmellose (E468), sodium lauryl sulfate (E487), hypromellose 2910 (E464), magnesium stearate (E470b). See section 2 “Rivaroxaban Olpha contains lactose and sodium”. Tablet coating: hypromellose 2910 (E464), titanium dioxide (E171), macrogol 3350 (E1521), iron oxide red (E172).

Description of the appearance of Rivaroxaban Olpha and package contents
Rivaroxaban Olpha 15 mg film-coated tablets
Rivaroxaban Olpha 15 mg film-coated tablets are red, round, biconvex, film-coated tablets, marked with “A” on one side and “15” on the other (diameter 6.10 ± 0.20 mm; thickness 2.60 ± 0.30 mm).
Transparent PVC/PVdC//Alu or oPa/Alu/PVC//Alu blister packs containing 14 film-coated tablets.
Each carton contains 28 film-coated tablets (2 blisters), 42 film-coated tablets (3 blisters) or 98 film-coated tablets (7 blisters).

Rivaroxaban Olpha 20 mg film-coated tablets
Rivaroxaban Olpha 20 mg film-coated tablets are red-brown, round, biconvex, film-coated tablets, marked with “A” on one side and “20” on the other (diameter 6.10 ± 0.30 mm; thickness 3.20 ± 0.30 mm).
Transparent PVC/PVdC//Alu or oPa/Alu/PVC//Alu blister packs containing 14 film-coated tablets.
Each cardboard carton contains 28 film-coated tablets (2 blisters) or 98 film-coated tablets (7 blisters).
Not all pack sizes may be marketed.

Marketing Authorization Holder
Olpha AS,
Rupnicu iela 5,
Olaine, Olaines novads, LV-2114,
Latvia

Manufacturer
Olpha AS,
Rupnicu iela 5,
Olaine, Olaines novads, LV-2114,
Latvia
or
Pharmadox Healthcare Ltd.,
KW20A Kordin Industrial Park,
Paola PLA 3000,
Malta

This medicinal product is authorized in the European Economic Area countries under the following names:
Lithuania: Rivaroxaban Olpha 15 mg plėvele dengtos tabletės
Rivaroxaban Olpha 20 mg plėvele dengtos tabletės
Latvia: Rivaroxaban Olpha 15 mg apvalkotās tabletes
Rivaroxaban Olpha 20 mg apvalkotās tabletes
Estonia, Czech Republic, Slovakia, Poland, Germany, Italy, Spain: Rivaroxaban Olpha
France: RIVAROXABAN OLPHA 15 mg, comprimé pelliculé
RIVAROXABAN OLPHA 20 mg, comprimé pelliculé