Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - roteas

Document Subject

Generated Narrative: MedicinalProductDefinition mpd3bf47e7430f03a3543b0c027649dc7a

identifier: http://ema.europa.eu/identifier/EU/1/16/1152/001-002

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Roteas 15 mg film-coated tablets

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-d3bf47e7430f03a3543b0c027649dc7a

identifier: http://ema.europa.eu/identifier/EU/1/16/1152/001-002

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - roteas

Attesters

What is in this leaflet

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

Roteas contains the active substance edoxaban and belongs to a group of medicines called anticoagulants. This medicine helps to prevent blood clots from forming. 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 in the brain (stroke) and other blood vessels in the body if you have a form of irregular heart rhythm called nonvalvular atrial fibrillation and at least one additional risk factor, such as heart failure, previous stroke or high blood pressure;
• treat blood clots in the veins of the legs (deep vein thrombosis) and in the blood vessels in the lungs (pulmonary embolism), and to prevent blood clots from re-occurring in the blood vessels in the legs and/or lungs.

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 are actively bleeding;
• if you have a disease or condition that increases the risk of serious bleeding (e.g. stomach ulcer, injury or bleeding in the brain, or recent surgery of the brain or eyes);
• if you are taking other medicines to prevent blood clotting (e.g. warfarin, dabigatran, rivaroxaban, apixaban or heparin), except when changing anticoagulant treatment or while getting heparin through a venous or arterial line to keep it open;
• if you have a liver disease which leads to an increased risk of bleeding;
• if you have uncontrolled high blood pressure;
• if you are pregnant or breast feeding.

Warnings and precautions

Talk to your doctor or pharmacist before taking Roteas,

• if you have an increased risk of bleeding, as could be the case if you have any of the following conditions:

• endstage kidney disease or if you are on dialysis;
• severe liver disease;
• bleeding disorders;
• a problem with the blood vessels in the back of your eyes (retinopathy);
• recent bleeding in your brain (intracranial or intracerebral bleeding);
• problems with the blood vessels in your brain or spinal column;

• if you have a mechanical heart valve.

Roteas 15 mg is only to be used when changing from Roteas 30 mg to a vitamin K antagonist (e.g. warfarin) (see section

Take special care with Roteas,

• if you know that you have a disease called antiphospholipid syndrome (a disorder of the immune system that causes an increased risk for blood clots), tell your doctor who will decide if the treatment may need to be changed.

If you need to have an operation,

• it is very important to take Roteas before and after the operation exactly at the times you have been told by your doctor. If possible, Roteas should be stopped at least 24 hours before an operation. Your doctor will determine when to restart Roteas. In emergency situations your physician will help determine the appropriate actions regarding Roteas.

Children and adolescents

Roteas is not recommended in children and adolescents under 18 years of age.

Other medicines and Roteas

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:

• some medicines for fungal infections (e.g. ketoconazole);
• medicines to treat abnormal heart beat (e.g. dronedarone, quinidine, verapamil);
• other medicines to reduce blood clotting (e.g. heparin, clopidogrel or vitamin K antagonists such as warfarin, acenocoumarol, phenprocoumon or dabigatran, rivaroxaban, apixaban);
• antibiotic medicines (e.g. erythromycin, clarithromycin);
• medicines to prevent organ rejection after transplantation (e.g. ciclosporin);
• anti-inflammatory and pain-relieving medicines (e.g. naproxen or acetylsalicylic acid);
• antidepressant medicines called selective serotonin reuptake inhibitors or serotonin- norepinephrine reuptake inhibitors;

If any of the above apply to you, tell your doctor before taking Roteas, because these medicines may increase the effects of Roteas and the chance of unwanted bleeding. Your doctor will decide, if you should be treated with Roteas and if you should be kept under observation.

If you are taking any of the following:

• some medicines for treatment of epilepsy (e.g. phenytoin, carbamazepine, phenobarbital);
• St John s Wort, a herbal product used for anxiety and mild depression;
• rifampicin, an antibiotic medicine. If any of the above apply to you, tell your doctor before taking Roteas, because the effect of Roteas may be reduced. Your doctor will decide if you should be treated with Roteas and if you should be kept under observation.

Pregnancy and breast-feeding

Do not take Roteas if you are pregnant or breast-feeding. If there is a chance that you could become pregnant, use a reliable contraceptive while you are taking Roteas. If you become pregnant while you are taking Roteas, immediately tell your doctor, who will decide how you should be treated.

Driving and using machines

Roteas has no or negligible effects on your ability to drive or use machines.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

How much 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 lower, the recommended dose is one 30 mg tablet once daily;
• if your doctor has prescribed medicines known as P-gp inhibitors: ciclosporin, 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 ways to take Roteas. The tablet may be crushed and mixed with water or apple puree immediately before you take it. If necessary, your doctor may also give you the crushed Roteas tablet through a tube via the nose (nasogastric tube) or a tube in the stomach (gastric feeding tube).

Your doctor may change your anticoagulant treatment as follows:

Changing from vitamin K antagonists (e.g. warfarin) to Roteas Stop taking the vitamin K antagonist (e.g. warfarin). Your doctor will need to do blood measurements and will instruct you when to start taking Roteas.

Changing from non-VKA oral anticoagulants (dabigatran, rivaroxaban, or apixaban) to Roteas Stop taking the previous medicines (e.g. dabigatran, rivaroxaban, or apixaban) and start Roteas at the time of the next scheduled dose.

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

Changing from Roteas to vitamin K antagonists (e.g. warfarin) If you currently take 60 mg Roteas: Your doctor will tell you to reduce your dose of Roteas to a 30 mg tablet once daily and to take it together with a vitamin K antagonist (e.g. warfarin). Your doctor will need to do blood measurements and will instruct you when to stop taking Roteas. If you currently take 30 mg (dose reduced) Roteas: Your doctor will tell you to reduce your dose of Roteas to a 15 mg tablet once daily and to take it together with a vitamin K antagonist (e.g. warfarin). Your doctor will need to do blood measurements and will instruct you when to stop taking Roteas.

Changing from Roteas to non-VKA oral anticoagulants (dabigatran, rivaroxaban, or apixaban) Stop taking Roteas and start the non-VKA anticoagulant (e.g. dabigatran, rivaroxaban, or apixaban) at the time of the next scheduled dose of Roteas.

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

Patients undergoing cardioversion:

If your abnormal heartbeat needs to be restored to normal by a procedure called cardioversion, take Roteas at the times your doctor tells you to prevent blood clots in the 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 take 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 following day with the once daily tablet as usual. Do not take a double dose on the same day to make up for a forgotten dose.

If you stop taking Roteas

Do not stop taking Roteas without talking to your doctor first, because Roteas treats and prevents serious conditions.

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

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

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

If you experience any bleeding event that does not stop by itself or if you experience signs of excessive bleeding (exceptional weakness, tiredness, paleness, dizziness, headache or unexplained swelling) consult your doctor immediately.
Your doctor may decide to keep you under closer observation or change your medicine.

Overall list of possible side effects:

Common (may affect up to 1 in 10 people)

• stomach ache;
• abnormal liver blood tests;
• bleeding from the skin or under the skin;
• anaemia (low levels of red blood cells);
• bleeding from the nose;
• bleeding from the vagina;
• rash;
• bleeding in the bowel;
• bleeding from the mouth and/or throat;
• blood found in your urine;
• bleeding following an injury (puncture);
• bleeding in the stomach;
• dizziness;
• feeling sick;
• headache;
• itching.

Uncommon (may affect up to 1 in 100 people)

• bleeding in the eyes;
• bleeding from a surgical wound following an operation;
• blood in the spit when coughing;
• bleeding in the brain;
• other types of bleeding;
• reduced number of platelets in your blood (which can affect clotting);
• allergic reaction;
• hives.

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

• bleeding in the muscles;
• bleeding in joints;
• bleeding in the abdomen;
• bleeding in the heart;
• bleeding inside the skull;
• bleeding following a surgical procedure;
• allergic shock;
• swelling of any part of the body due to allergic reaction.

Not known (frequency cannot be estimated from the available data)

• bleeding in the kidney sometimes with presence of blood in urine leading to inability of the kidneys to work properly (anticoagulant-related nephropathy).

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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 carton and on each blister or bottle after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.