RIVAROXABAN SANDOZ 20 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

Package leaflet: Information for the user

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 is and what it is used for

• 2. What you need to know before you take Rivaroxaban

• 3. How to take Rivaroxaban

• 4. Possible side effects

• 5. How to store Rivaroxaban

• 6. Contents of the pack and other information

1.

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

• – prevent blood clots in brain (stroke) and other blood vessels in your body if you have a form of irregular heart rhythm called non-valvular atrial fibrillation.

• – 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 reoccurring in the blood vessels of your legs and/or lungs.

Rivaroxaban 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.

Do not take Rivaroxaban

• – 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 and tell your doctor if any of these apply to you.

Warnings and precautions

Talk to your doctor or pharmacist before taking Rivaroxaban.

Take special care with Rivaroxaban

• – 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”)
• 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 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 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 any of the above apply to you, tell your doctor before you take Rivaroxaban. 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 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 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 is not recommended for people under 18 years of age. There is not enough information on its use in children and adolescents.

Other medicines and Rivaroxaban

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

-

• 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, because the effect of Rivaroxaban 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, because the effect of Rivaroxaban may be reduced. Your doctor will decide, if you should be treated with Rivaroxaban and if you should be kept under closer observation.

Pregnancy and breast feeding

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

Rivaroxaban contains lactose

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

Rivaroxaban contains sodium

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

Rivaroxaban contains azo colouring agent, sunset yellow FCF aluminium lake (E110) This excipient may cause allergic reactions.

3.

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 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. 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 tablet through a stomach tube.

How much to take

• – To prevent blood clots in brain (stroke) and other blood vessels in your body

The recommended dose is one 20 mg tablet once a day.

If you have kidney problems, the dose may be reduced to one 15 mg tablet once a day.

If you need a procedure to treat blocked blood vessels in your heart (called a percutaneous coronary intervention – PCI with an insertion of a stent), there is limited evidence to reduce the dose to one tablet Rivaroxaban 15 mg once a day (or to one tablet Rivaroxaban 10 mg once a day in case your kidneys are not working properly) in addition to an antiplatelet medicine such as clopidogrel.

• – To treat blood clots in the veins of your legs and blood clots in the blood vessels of your lungs, and for preventing blood clots from re-occurring.

The recommended dose is one 15 mg tablet twice a day for the first 3 weeks. For treatment after 3 weeks, the recommended dose is one 20 mg tablet once a day. After at least 6 months blood clot treatment your doctor may decide to continue treatment with either one 10 mg tablet once a day or one 20 mg tablet once a day. If you have kidney problems and take one 20 mg tablet once a day, your doctor may decide to reduce the dose for the treatment after 3 weeks to one 15 mg tablet once a day if the risk for bleeding is greater than the risk for having another blood clot.

When to take Rivaroxaban

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.

To prevent blood clots in the brain (stroke) and other blood vessels in your body:

If your heart beat needs to be restored to normal by a procedure called cardioversion, take Rivaroxaban at the times your doctor tells you.

If you take more Rivaroxaban than you should

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

If you forget to take Rivaroxaban

• – If you are taking one 20 mg tablet or one 15 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 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 stop taking Rivaroxaban

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

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

4.

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

Like other similar medicines (antithrombotic agents), this medicine 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:

• - long or excessive bleeding

• – exceptional weakness, tiredness, paleness, dizziness, headache, unexplained swelling, breathlessness, chest pain or angina pectoris, which may be signs of bleeding.

Your doctor may decide to keep you under closer observation or change how you should be treated.

Possible side effects which may be a sign of severe skin reaction:

Tell your doctor immediately if you experience skin reactions such as:

• – spreading intense skin rash, blisters or mucosal lesions, e.g. in the mouth or eyes (Stevens-Johnson syndrome/Toxic Epidermal Necrolysis). The frequency of this side effect is very rare (up to 1 in 10,000).

• – a drug reaction that causes rash, fever, inflammation of internal organs, hematologic abnormalities and systemic illness (DRESS syndrome). The frequency of this side effect is very rare (up to 1 in 10,000).

Possible side effects which may be a sign of severe allergic reaction:

Tell your doctor immediately if you experience any of the following side effects: – swelling of the face, lips, mouth, tongue or throat; difficulty swallowing; hives and breathing difficulties; sudden drop in blood pressure. The frequencies of these side effects 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):

• – 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

• – fever

• – reduction in red blood cells which can make the skin pale and cause weakness or breathlessness

• – stomach ache, indigestion, feeling or being sick, constipation, diarrhea

• – 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

• – impaired function of the kidneys (may be seen in tests performed by your doctor)

• – blood tests may show an increase in some liver enzymes

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

• – bleeding into the brain or inside the skull

• – bleeding into a joint causing pain and swelling

• – fainting

• – feeling unwell

• – dry mouth

• – faster heartbeat

• – allergic reactions, including allergic skin reactions

• – hives

• – 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

• – thrombocytopenia (low number of platelets, which are cells that help blood to clot)

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

• – bleeding into a muscle

• – localised swelling

• – yellowing of the skin and eye (jaundice)

• – collection of blood (haematoma) in the groin as a complication of the cardiac procedure where a catheter is inserted in your leg artery (pseudoaneurysm)

• – cholestasis (decreased bile flow), hepatitis incl. hepatocellular injury (inflamed liver incl. liver injury)

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

• – 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)

• – kidney failure after a severe bleeding

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 Yellow Card Scheme. By reporting side effects you can help provide more information on the safety of this medicine.

5.

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, blister and container 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.

6.

Rivaroxaban 15 mg film-coated tablets

• – The active substance is rivaroxaban. Each film-coated tablet contains 15 mg of rivaroxaban.

• – The other ingredients are:

Tablet core: Lactose Monohydrate, Sodium Laurilsulfate, Hypromellose, Croscarmellose Sodium, Magnesium stearate, Cellulose Microcrystalline, Silica Colloidal Anhydrous.

Tablet film coat: Hypromellose, Titanium dioxide (E 171), Macrogol, Sunset yellow FCF aluminium lake ( E 110), Iron oxide red (E 172).

Rivaroxaban 20 mg film-coated tablets

• – The active substance is rivaroxaban. Each tablet contains 20 mg of rivaroxaban.

• – The other ingredients are:

What Rivaroxaban looks like and contents of the pack

Rivaroxaban 15 mg film-coated tablets are light orange coloured, round, biconvex film coated tablets marked with ‘15’ on one side.

Rivaroxaban 20 mg film-coated tablets are orange coloured, round, biconvex film coated tablets marked with ‘20’ on one side.

The tablets are available in blister packs (OPA/Aluminium/PVC/A­luminium foil; Transparent or opaque PVCPVDC/Aluminium foil) of 5, 10, 14, 20, 28, 30, 42, 50, 98, 100 film-coated tablets

The tablets are available in perforated unit dose blister packs (OPA/Aluminium/PVC/A­luminium foil; Transparent or opaque PVCPVDC/Aluminium foil) of 5×1, 10×1, 14×1, 28×1, 30×1, 42×1, 56×1, 98×1, 100×1 film-coated tablets.

The tablets are available in tablet containers (HDPE), with child resistant screw cap containing desiccant, of 56, 100, 112 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Marketing Authorisation Holder

Sandoz Limited

Frimley Business Park,

Frimley,

Camberley,

Surrey,

GU16 7SR

United Kingdom

Manufacturer

Manufacturer

Pharmacare Premium Ltd

HHF 003, Hal Far Industrial Estate,

Birzebbugia, BBG 3000,

Malta

Salutas Pharma GmbH

Otto-von-Guericke Allee 1

D-39179 Barleben

Germany

This leaflet was last revised in 10/2019

PIL.1491–92.007.0d

V012: PI in line with reference product

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