• New

Roteas 60 mg. 30 tablets

€168
Tax included

Roteas contains the active substance edoxaban and belongs to a group of medicines called anticoagulants. This medicine helps prevent blood clots. It works by blocking the activity of factor Xa, which is an important component of blood clotting.

Quantity

1. What Roteas is and what it is used for

Roteas contains the active substance edoxaban and belongs to a group of medicines called anticoagulants. This medicine helps prevent blood clots. It works by blocking the activity of factor Xa, which is an important component of blood clotting.

Roteas is used in adults:

to prevent blood clots from forming in the brain (stroke) and other blood vessels in the body if you have a certain type of irregular heart rhythm called non-valvular atrial fibrillation and at least one additional risk factor such as heart failure, previous stroke or high blood pressure;

to 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 blood clots from forming again in the blood vessels of the legs and/or lungs.

2. What you need to know before you take Roteas

Do not take Roteas

if you are allergic to edoxaban or any of the other ingredients of this medicine (listed in section 6);

if you have active bleeding;

if you have a disease or condition that increases the risk of serious bleeding (for example, a stomach ulcer, injury or bleeding in the brain, recent brain or eye surgery);

if you are taking other medicines to prevent blood clots (eg warfarin, dabigatran, rivaroxaban, apixaban or heparin), except when changing anticoagulant treatment or while receiving heparin through a venous or arterial catheter to maintain its patency;

if you suffer from liver disease which leads to an increased risk of bleeding;

if you have uncontrolled high blood pressure;

if you are pregnant or breastfeeding.

Warnings and precautions

Talk to your doctor or pharmacist before taking Roteas,

if you are at risk of bleeding, which may be the case if you have any of the following conditions:

end stage renal failure or if you are on dialysis;

severe liver disease;

bleeding disorders;

a problem with the blood vessels in the back of the eyes (retinopathy);

recent bleeding in the brain (intracranial or intracerebral bleeding);

problems with the blood vessels of the brain or spine;

if you have a mechanical heart valve.

Roteas 15 mg should only be used when switching from Roteas 30 mg to a vitamin K antagonist (eg, warfarin) (see section 3. "How to take Roteas").

Take special care when using Roteas

if you know you have a condition called antiphospholipid syndrome (a disorder of the immune system that causes an increased risk of blood clots), tell your doctor, who will decide whether you need to change your treatment.

If you are about to have surgery:

it is very important that you take Roteas before and after surgery exactly at the times prescribed by your doctor. If possible, Roteas should be stopped at least 24 hours before surgery. Your doctor will decide when to resume taking Roteas.

In emergency situations, your doctor will help determine the appropriate course of action regarding Roteas.

Children and adolescents

Roteas is not recommended for children and adolescents under 18 years of age. There is no information on its use in children and adolescents.

Other medicines and Roteas

You should tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

If you are taking any of the following:

certain medicines for fungal infections (eg ketoconazole);

medicines to treat an irregular heart rhythm (eg, dronedarone, quinidine, verapamil);

other medicines that reduce blood clotting (eg heparin, clopidogrel or vitamin K antagonists such as warfarin, acenocoumarol, phenprocoumon or dabigatran, rivaroxaban, apixaban);

antibiotics (eg erythromycin);

medicines to prevent rejection of organs after a transplant (for example, cyclosporine);

anti-inflammatory and pain-relieving drugs (for example, naproxen or acetylsalicylic acid);

medicines to treat depression called selective serotonin reuptake inhibitors or serotonin norepinephrine reuptake inhibitors.

If any of the above apply to you, tell your doctor before taking Roteas, as these medicines may increase the effects of Roteas and the chance of unwanted bleeding. Your doctor will decide whether to treat you with Roteas and whether you should be monitored.

If you are taking any of the following:

certain medicines to treat epilepsy (eg, phenytoin, carbamazepine, phenobarbital);

St. John's wort, an herbal product used for anxiety and mild depression;

rifampicin, an antibiotic.

If any of the above apply to you, tell your doctor before taking Roteas, as the effect of Roteas may be reduced. Your doctor will decide whether to treat you with Roteas and whether you should be monitored.

Pregnancy and breastfeeding

Do not take Roteas if you are pregnant or breastfeeding. If you are likely to become pregnant, use reliable contraception while taking Roteas. If you become pregnant while taking Roteas, tell your doctor immediately, who will decide how you should be treated.

Driving and using machines

Roteas has no or negligible influence on the ability to drive or use machines.

3. How to take Roteas

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

What dose to take

The recommended dose is one 60 mg tablet once daily,

if you have impaired kidney function, the dose may be reduced to one 30 mg tablet once daily by your doctor.

if your body weight is 60 kg or less, the recommended dose is one 30 mg tablet once a day.

if your doctor has prescribed medicines known as P-gp inhibitors:

cyclosporine, dronedarone, erythromycin or ketoconazole, the recommended dose is one 30 mg tablet once daily.

How to take the tablet

Swallow the tablet preferably with water.

Roteas can be taken with or without food.

If you have difficulty swallowing the tablet whole, talk to your doctor about other possible ways of taking Roteas. The tablet can be crushed and mixed with water or applesauce immediately before taking it. If necessary, your doctor may also give you the crushed Roteas tablet through a stomach tube.

Your doctor may change your anticoagulant treatment as follows:

Switching from vitamin K antagonists (eg warfarin) to Roteas

Stop taking the vitamin K antagonist (eg, warfarin). Your doctor will need to do blood tests and let you know when to start taking Roteas.

Switching from oral anticoagulants that are not vitamin K antagonists (dabigatran, rivaroxaban or apixaban) to Roteas

Stop taking the previous medicines (eg dabigatran, rivaroxaban or apixaban) and start taking Roteas at the time of the next scheduled dose.

Switching from parenteral anticoagulants (eg heparin) to Roteas Stop taking the anticoagulant (eg heparin) and start Roteas at the time of the next scheduled anticoagulant dose.

Switching from Roteas to vitamin K antagonists (eg warfarin) If you are currently taking 60 mg Roteas:

Your doctor will tell you to reduce the dose of Roteas to one 30 mg tablet once a day and to take it together with a vitamin K antagonist (eg warfarin). Your doctor will need to do blood tests and tell you when to stop taking Roteas. If you are currently taking 30 mg (reduced dose) Roteas:

Your doctor will tell you to reduce your dose of Roteas to one 15 mg tablet once a day and take it with a vitamin K antagonist (eg warfarin). Your doctor will need to do blood tests and tell you when to stop taking Roteas.

Switching from Roteas to oral anticoagulants that are not vitamin K antagonists (dabigatran, rivaroxaban or apixaban)

Stop taking Roteas and start an anticoagulant that is not a vitamin K antagonist (eg, dabigatran, rivaroxaban, or apixaban) at the time of the next scheduled dose of Roteas.

Switching from Roteas to parenteral anticoagulants (e.g. heparin)

Stop taking Roteas and start the parenteral anticoagulant (eg, heparin) at the time of the next scheduled dose of Roteas.

Patients undergoing cardioversion

If your abnormal heart rhythm needs to be normalized by a procedure called cardioversion, take Roteas at the time prescribed by your doctor to prevent blood clots from forming in your brain and other blood vessels in your body.

If you take more Roteas than you should

Tell your doctor immediately if you have taken too many Roteas tablets.

If you have taken more Roteas than recommended, you may have an increased risk of bleeding.

If you forget to take Roteas

You should take the tablet immediately and then continue the next day with the tablet once a day as usual. Do not take a double dose on the same day to make up for a missed dose.

If you have stopped taking Roteas

Do not stop taking Roteas without first talking to your doctor, as Roteas treats and protects against serious diseases.

If you have any further questions related to the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Like other similar medicines (medicines to reduce the formation of blood clots), Roteas can cause bleeding, which can be potentially life-threatening. In some cases, the bleeding may not be obvious.

If you have any

General list of possible side effects:

Common (may affect up to 1 in 10 people):

stomachache;

deviations in liver function indicators;

bleeding from the skin or subcutaneous hemorrhage;

anemia (low level of red blood cells);

bleeding from the nose;

vaginal bleeding;

rash;

bleeding in the intestines;

bleeding from the mouth and/or throat;

blood in your urine;

bleeding from an injury (puncture);

bleeding in the stomach;

dizziness;

nausea;

headache;

itching.

Uncommon (may affect up to 1 in 100 people):

hemorrhage in the eye;

bleeding from a surgical wound after surgery;

blood in sputum after coughing;

hemorrhage in the brain;

other types of bleeding;

reduced number of platelets in the blood (which can affect blood clotting);

alergic reaction;

urticaria.

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

bleeding into the muscles;

bleeding in the joints;

bleeding in the abdomen;

hemorrhage in the heart;

hemorrhage in the skull;

bleeding after surgery;

allergic shock;

swelling of any part of the body due to an allergic reaction

5. How to store Roteas

Keep out of the reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP and on each blister or bottle after EXP. The expiration date corresponds to the last day of the specified month.

This medicine does not require special storage conditions.

Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Contents of the package and additional information

What Roteas contains

Active substance: edoxaban (as tosylate).

Roteas 15 mg film-coated tablets

Each tablet contains 15 mg edoxaban (as tosylate).

Roteas 30 mg film-coated tablets

Each tablet contains 30 mg of edoxaban (as tosylate).

Roteas 60 mg film-coated tablets

Each tablet contains 60 mg of edoxaban (as tosylate).

Other ingredients:

Roteas 15 mg film-coated tablets

Tablet core: mannitol (E421), pregelatinized starch, crospovidone (E1202), hydroxypropylcellulose (E463), magnesium stearate (E470b).

Film coating: hypromellose (E464), macrogol (8000), titanium dioxide (E171), talc (E553b), carnauba wax, red iron oxide (E172), yellow iron oxide (E172).

Roteas 30 mg film-coated tablets

Tablet core: mannitol (E421), pregelatinized starch, crospovidone (E1202), hydroxypropylcellulose (E463), magnesium stearate (E470b).

Film coating: hypromellose (E464), macrogol (8000), titanium dioxide (E171), talc (E553b), carnauba wax, red iron oxide (E172).

Roteas 60 mg film-coated tablets

Tablet core: mannitol (E421), pregelatinized starch, crospovidone (E1202), hydroxypropylcellulose (E463), magnesium stearate (E470b).

Film coating: hypromellose (E464), macrogol (8000), titanium dioxide (E171), talc (E553b), carnauba wax, yellow iron oxide (E172).

What Roteas looks like and contents of the pack

Roteas 15 mg film-coated tablets are orange, round (6.7 mm in diameter) and debossed with "DSC L15" on one side.

They are available in blisters in cardboard boxes of 10 film-coated tablets or single-dose blisters in cardboard boxes of 10 x 1 film-coated tablets.

Roteas 30 mg film-coated tablets are pink, round (8.5 mm in diameter) and debossed with "DSC L30" on one side.

They are available in blisters in cartons of 10, 14, 28, 30, 56, 60, 84, 90, 98 or 100 film-coated tablets or single-dose blisters in cartons of 10 x 1, 50 x 1 or 100 x 1 film-coated tablets tablets or in bottles of 90 film-coated tablets.

Roteas 60 mg film-coated tablets are yellow, round (10.5 mm in diameter) and debossed with "DSC L60" on one side.

They are available in blisters in cartons of 10, 14, 28, 30, 56, 60, 84, 90, 98 or 100 film-coated tablets or single-dose blisters in cartons of 10 x 1, 50 x 1 or 100 x 1 film-coated tablets tablets or in bottles of 90 film-coated tablets.

Not all types of packaging can be marketed.

1000 Items