RIVAROXABAN ACCORD 15 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

Patient leaflet - RIVAROXABAN ACCORD 15 MG FILM-COATED TABLETS

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Package leaflet: Information for the user Rivaroxaban Accord 15 mg film-coated tablets Rivaroxaban Accord 20 mg film-coated tablets

Treatment Initiation Pack

Not for use in children.

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rivaroxaban

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 further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

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

1. what rivaroxaban accord is and what it is used for

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

treat blood clots in the veins of your legs (deep vein thrombosis) and in the blood vessels of your lungs (pulmonary embolism), and to prevent blood clots from re-occurring in the blood vessels of your legs and/or lungs.

Rivaroxaban Accord 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 you take rivaroxaban accord

Do not take Rivaroxaban Accord

if you are allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6)
if you are bleeding excessively
if you have a disease or condition in an organ of the body that increases the risk of serious bleeding (e.g., stomach ulcer, injury 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 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 are pregnant or breast-feeding

Do not take Rivaroxaban Accord and tell your doctor if any of these apply to you.

Warnings and precautions

Talk to your doctor or pharmacist before taking Rivaroxaban Accord.

Take special care with Rivaroxaban Accord

if you have an increased risk of bleeding, as could be the case in situations such as:
severe kidney disease, since your kidney function may affect the amount of medicine that works in your body
if you are taking other medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), when changing anticoagulant treatment or while getting heparin through a venous or arterial line to keep it open (see section ‘Other medicines and Rivaroxaban Accord’)
bleeding disorders
very high blood pressure, not controlled by medical treatment
diseases of your stomach or bowel that might result in bleeding, e.g. inflammation of the bowels or stomach, or inflammation of the oesophagus (gullet), e.g. due to gastroesophageal reflux disease (disease where stomach acid goes upwards into the oesophagus)
a problem with the blood vessels in the back of your eyes (retinopathy)
a lung disease where your bronchi are widened and filled with pus (bronchiectasis), or previous bleeding from your lung
if you have a prosthetic heart valve
if your doctor determines that your blood pressure is unstable or another treatment or surgical procedure to remove the blood clot from your lungs is planned.
if you know that you have a disease called antiphospholipid syndrome (a disorder of the immune system that causes an increased risk of blood clots), tell your doctor who will decide if the treatment may need to be changed.

If any of the above apply to you, tell your doctor before you take Rivaroxaban Accord. Your doctor will decide, if you should be treated with this medicine and if you should be kept under closer observation.

If you need to have an operation:

it is very important to take Rivaroxaban Accord before and after the operation exactly at the times you have been told by your doctor.
If your operation involves a catheter or injection into your spinal column (e.g. for epidural or spinal anaesthesia or pain reduction):
it is very important to take Rivaroxaban Accord before and after the injection or removal of the catheter exactly at the times you have been told by your doctor
tell your doctor immediately if you get numbness or weakness of your legs or problems with your bowel or bladder after the end of anaesthesia, because urgent care is necessary.

Children and adolescents

Rivaroxaban Accord treatment initiation pack is not recommended for people under 18 years of age as it is specifically designed for initiation of treatment in adult patients and is not appropriate for use in children and adolescents.

Other medicines and Rivaroxaban Accord

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. If you are taking

some medicines for fungal infections (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are only applied to the skin
ketoconazole tablets (used to treat Cushing’s syndrome – when the body produces an excess of cortisol)
some medicines for bacterial infections (e.g. clarithromycin, erythromycin)
some anti-viral 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)
anti-inflammatory and pain relieving medicines (e.g. naproxen or acetylsalicylic acid)
dronedarone, a medicine to treat abnormal heart beat
some medicines to treat depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs)).

If any of the above apply to you, tell your doctor before taking Rivaroxaban Accord, because the effect of Rivaroxaban Accord may be increased. Your doctor will decide, if you should be treated with this medicine and if you should be kept under closer observation.

If your doctor thinks that you are at increased risk of developing stomach or bowel ulcers, he may also use a preventative ulcer treatment.

If you are taking:

some medicines for treatment of epilepsy (phenytoin, carbamazepine, phenobarbital)
St John’s Wort (Hypericum perforatum), a herbal product used for depression
rifampicin, an antibiotic

If any of the above apply to you, tell your doctor before taking Rivaroxaban Accord, because the effect of Rivaroxaban Accord may be reduced. Your doctor will decide, if you should be treated with Rivaroxaban Accord and if you should be kept under closer observation.

Pregnancy and breast-feeding

Do not take Rivaroxaban Accord 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 Rivaroxaban Accord. If you become pregnant while you are taking this medicine, tell your doctor immediately, who will decide how you should be treated.

Driving and using machines

Rivaroxaban Accord may cause dizziness (common side effect) or fainting (uncommon side effect) (see section 4, ‘Possible side effects’). You should not drive, ride a bicycle or use any tools or machines if you are affected by these symptoms.

Rivaroxaban Accord contains lactose and sodium

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

This medicine contains less than 1 mmol sodium (23 mg) per tablet that is to say essentially “sodium-free”.

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3. how to take rivaroxaban accord

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

You must take Rivaroxaban Accord together with a meal.

Swallow the tablet(s) preferably with water.

If you have difficulty swallowing the tablet whole, talk to your doctor about other ways to take Rivaroxaban Accord. The tablet may be crushed and mixed with water or apple puree immediately before you take it. This mixture should be immediately followed by food. If necessary, your doctor may also give you the crushed Rivaroxaban Accord tablet through a stomach tube.

How much to take

The recommended dose is one tablet Rivaroxaban Accord 15 mg twice a day for the first 3 weeks. For treatment after 3 weeks, the recommended dose is one tablet Rivaroxaban Accord 20 mg once a day. This Rivaroxaban Accord 15 mg and 20 mg treatment initiation pack is only for the first 4 weeks of treatment. Upon completion of this pack, treatment will continue on Rivaroxaban Accord 20 mg once daily as your doctor has told you.

If you have kidney problems, your doctor may decide to reduce the dose for the treatment after 3 weeks to one tablet Rivaroxaban Accord 15 mg once a day if the risk for bleeding is greater than the risk for having another blood clot.

When to take Rivaroxaban Accord

Take the tablet(s) every day until your doctor tells you to stop.

Try to take the tablet(s) at the same time every day to help you to remember it.

Your doctor will decide how long you must continue treatment.

If you take more Rivaroxaban Accord than you should

Contact your doctor immediately if you have taken too many Rivaroxaban Accord tablets. Taking too much Rivaroxaban Accord increases the risk of bleeding.

If you forget to take Rivaroxaban Accord

If you are taking one 15 mg tablet twice a day and have missed a dose, take it as soon as you remember. Do not take more than two 15 mg tablets in a single day. If you forget to take a dose you can take two 15 mg tablets at the same time to get a total of two tablets (30 mg) on one day.

On the following day you should carry on taking one 15 mg tablet twice a day.

If you are taking one 20 mg tablet once a day and have missed a dose, take it as soon as you remember. Do not take more than one tablet in a single day to make up for a forgotten dose. Take the next tablet on the following day and then carry on taking one tablet once a day.

If you stop taking Rivaroxaban Accord

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

If you have any further questions on 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 to reduce the formation of blood clots, , Rivaroxaban Accord may cause bleeding which may potentially be life threatening. Excessive bleeding may lead to a sudden drop in blood pressure (shock). In some cases the bleeding may not be obvious.

Possible side effects which may be a sign of bleeding

Tell your doctor immediately if you experience any of the following side effects:

Signs of bleeding
– bleeding into the brain or inside the skull (symptoms can include headache, one-sided weakness, vomiting, seizures, decreased level of consciousness, and neck stiffness.

A serious medical emergency. Seek medical attention immediately!)

– long or excessive bleeding
– exceptional weakness, tiredness, paleness, dizziness, headache, unexplained swelling, breathlessness, chest pain or angina pectoris Your doctor may decide to keep you under closer observation or change the treatment.

Signs of severe skin reactions
– spreading intense skin rash, blisters or mucosal lesions, e.g. in the mouth or eyes (Stevens-Johnson syndrome/toxic epidermal necrolysis).

– a drug reaction that causes rash, fever, inflammation of internal organs, hematologic abnormalities and systemic illness (DRESS syndrome).

The frequency of these side effect is very rare (up to 1 in 10,000 people).

Signs of severe allergic reactions
– swelling of the face, lips, mouth, tongue or throat; difficulty swallowing; hives and breathing difficulties; sudden drop in blood pressure.

The frequencies of severe allergic reactions are very rare (anaphylactic reactions, including anaphylactic shock; may affect up to 1 in 10,000 people) and uncommon (angioedema and allergic oedema; may affect up to 1 in 100 people).

Overall 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 breathlessness
bleeding in the stomach or bowel, urogenital bleeding (including blood in the urine and heavy menstrual bleeding), nose bleed, bleeding in the gum
bleeding into the eye (including bleeding from the whites of the eyes)
bleeding into tissue or a cavity of the body (haematoma, bruising)
coughing up blood
bleeding from the skin or under the skin
bleeding following an operation
oozing of blood or fluid from surgical wound
swelling in the limbs
pain in the limbs
impaired function of the kidneys (may be seen in tests performed by your doctor)
fever
stomach ache, indigestion, feeling or being sick, constipation, diarrhoea
low blood pressure (symptoms may be feeling dizzy or fainting when standing up)
decreased general strength and energy (weakness, tiredness), headache, dizziness
rash, itchy skin
blood tests may show an increase in some liver enzymes

Yellow Card Scheme Website: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

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5. how to store rivaroxaban accord

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 blister after “EXP”. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Crushed tablets

Crushed tablets are stable in water or apple puree for up to 4 hours.

Do not 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.

6. contents of the pack and other information

What Rivaroxaban Accord contains

The active substance is rivaroxaban. Each tablet contains 15 mg or 20 mg of rivaroxaban respectively.
The other ingredients are:

Tablet core

Lactose monohydrate

Croscarmellose sodium (E468)

Sodium laurilsulfate (E487)

Hypromellose 2910 (nominal viscosity 5.1 mPa.S) (E464)

Cellulose, microcrystalline (E460)

Silica, colloidal anhydrous (E551)

Magnesium stearate (E572)

Film-coating

Macrogol 4000 (E1521)

Hypromellose 2910 (nominal viscosity 5.1 mPa.S) (E464)

Titanium dioxide (E171)

Iron oxide red (E172)

What Rivaroxaban Accord looks like and contents of the pack

Rivaroxaban Accord 15 mg: Red coloured, round, biconvex, approximately 5.00 mm in diameter, film coated tablets debossed with ‘‘IL’’ on one side and ‘‘2’’ on other side.

Rivaroxaban Accord 20 mg: Dark red coloured, round, biconvex, approximately 6.00 mm in diameter, film coated tablets debossed with ‘‘IL3’’ on one side and plain on other side.

First 4 weeks treatment initiation pack: each pack of 49 film-coated tablets for the first 4 weeks of treatment contains: 42 film-coated tablets of 15 mg rivaroxaban and 7 film-coated tablets of 20 mg rivaroxaban in a wallet.

Marketing Authorisation Holder

Accord Healthcare Limited

Sage House, 319 Pinner Road

North Harrow, Middlesex, HA1 4HF

United Kingdom

Manufacturer

Accord Healthcare Polska Sp. z o.o.

Ul. Lutomierska 50, 95–200 Pabianice, Poland

Pharmadox Healthcare Limited

KW20A Kordin Industrial Park, Paola

PLA 3000, Malta

Laboratori Fundacio DAU

C/ C, 12–14 Pol. Ind. Zona Franca, 08040 Barcelona, Spain

Accord Healthcare B.V

Winthontlaan 200, 3526KV Utrecht, Netherland

This leaflet was last revised in 08/2021.

Uncommon ( may affect up to 1 in 100 people)

bleeding into 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 cells that help blood to clot)
allergic reactions, including allergic skin reactions
impaired function of the liver (may be seen in tests performed by your doctor)
blood tests may show an increase in bilirubin, some pancreatic or liver enzymes or in the number of platelets
fainting
feeling unwell
faster heartbeat
dry mouth
hives i

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

bleeding into a muscle
cholestasis (decreased bile flow), hepatitis incl. hepatocellular injury (inflamed liver incl. liver injury)
yellowing of the skin and eye (jaundice)
localised swelling
collection of blood (haematoma) in the groin as a complication of the cardiac procedure where a catheter is inserted in your leg artery

(pseudoaneurysm)

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

kidney failure after a severe bleeding
increased pressure within muscles of the legs or arms after a bleeding, which leads to pain, swelling, altered sensation, numbness or paralysis (compartment syndrome after a bleeding)