RIVAROXABAN MEDANA 2.5 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

Patient leaflet - RIVAROXABAN MEDANA 2.5 MG FILM-COATED TABLETS

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

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

You have been given Rivaroxaban Medana because you have been diagnosed with an acute coronary syndrome (a group of conditions that includes heart attack and unstable angina, a severe type of chest pain) and have been shown to have had an increase in certain cardiac blood tests.

Rivaroxaban Medana reduces the risk in adults of having another heart attack or reduces the risk of dying from a disease related to your heart or your blood vessels.

Rivaroxaban Medana will not be given to you on its own. Your doctor will also tell you to take either:

acetylsalicylic acid (also known as aspirin) or
acetylsalicylic acid plus clopidogrel or ticlopidine.

– you have been diagnosed with a high risk of getting a blood clot due to a coronary artery disease or peripheral artery disease which causes symptoms.

Rivaroxaban Medana reduces the risk in adults of getting blot clots (atherothrombotic events). Rivaroxaban Medana will not be given to you on its own. Your doctor will also tell you to take acetylsalicylic acid.

Rivaroxaban Medana contains the active substance rivaroxaban and 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 medana- 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 an acute coronary syndrome and previously had a bleeding or a blood clot in your brain (stroke)
– if you have coronary artery disease or peripheral artery disease and previously had a bleeding in your brain (stroke) or where there was a blockage of the small arteries providing blood to the brain's deep tissues (lacunar stroke) or if you had a blood clot in your brain (ischaemic, non-lacunar stroke) in the previous month
– 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 Medana and tell your doctor if any of these apply to you.

Warnings and precautions

Talk to your doctor or pharmacist before taking Rivaroxaban Medana.

Rivaroxaban Medana should not be used in combination with certain other medicines which reduce blood clotting such as prasugrel or ticagrelor other than acetylsalicylic acid and clopidogrel/ticlopidine.

Take special care with Rivaroxaban Medana

– 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 Medana”)
■ 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
■ you are older than 75 years
■ you weigh 60 kg or less
■ you have a coronary artery disease with severe symptomatic heart failure

– 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 any of the above apply to you, tell your doctor before you take Rivaroxaban Medana. 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 Medana 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 Medana 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 Medana 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 Medana

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, prasugrel and ticagrelor (see section „Warnings and Precautions“))
■ 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 Medana, because the effect of Rivaroxaban Medana 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.

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

Pregnancy and breast feeding

Do not take Rivaroxaban Medana 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 Medana. 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 Medana 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 Medana 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.

3. how to take rivaroxaban medana

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

How much to take

The recommended dose is one 2.5 mg tablet twice a day. Take Rivaroxaban Medana around the same time every 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, talk to your doctor about other ways to take Rivaroxaban Medana. 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 Rivaroxaban Medana tablet through a stomach tube.

Rivaroxaban Medana will not be given to you on its own. Your doctor will also tell you to take

acetylsalicylic acid. If you get Rivaroxaban Medana after an acute coronary syndrome, your doctor may tell you to also take clopidogrel or ticlopidine.

Your doctor will tell you how much of these to take (usually between 75 to 100 mg acetylsalicylic acid daily or a daily dose of 75 to 100 mg acetylsalicylic acid plus a daily dose of either 75 mg clopidogrel or a standard daily dose of ticlopidine).

When to start Rivaroxaban Medana

Treatment with Rivaroxaban Medana after an acute coronary syndrome should be started as soon as possible after stabilisation of the acute coronary syndrome, at the earliest 24 hours after admission to hospital and at the time when parenteral (via injection) anticoagulation therapy would normally be stopped.

Your doctor will tell you when to start treatment with Rivaroxaban Medana if you have been diagnosed with coronary artery disease or peripheral artery disease.

Your doctor will decide how long you must continue treatment.

If you take more Rivaroxaban Medana than you should

Contact your doctor immediately if you have taken too many Rivaroxaban Medana tablets.

Taking too much Rivaroxaban Medana increases the risk of bleeding.

If you forget to take Rivaroxaban Medana

Do not take a double dose to make up for a missed dose. If you miss a dose, take your next dose at the usual time.

If you stop taking Rivaroxaban Medana

Take Rivaroxaban Medana on a regular basis and for as long as your doctor keeps prescribing it.

Do not stop taking Rivaroxaban Medana without talking to your doctor first. If you stop taking this medicine, it may increase your risk of having another heart attack or stroke or dying from a disease related to your heart or your blood vessels.

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 (antithrombotic agents), Rivaroxaban Medana 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 reactions

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):

– 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

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
– 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

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)

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the 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.

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 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. contents of the pack and other information

What Rivaroxaban Medana contains

– The active substance is rivaroxaban. Each tablet contains 2.5 mg of rivaroxaban.
– The other ingredients are:

Tablet core: sodium laurilsulfate, lactose monohydrate, cellulose, microcrystalline, croscarmellose sodium, hypromellose, magnesium stearate.

Tablet film coat (Opadry Yellow 03F12967): hypromellose, titanium dioxide (E171), talc, macrogol 8000, iron oxide, yellow (E172).

What Rivaroxaban Medana looks like and contents of the pack

Rivaroxaban Medana 2.5 mg film-coated tablets are light yellow, round, biconvex and marked “2.5” on the one side.

They come in blisters in cartons of 28, 30, 56 or 196 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Medana Pharma SA

10 Wladyslawa Lokietka Street

Sieradz

98–200

Poland

Manufacturer

Zakfady Farmaceutyczne Polpharma S.A.

Ul. Pelplinska 19

Starogard Gdanski

Pomorskie

83–200

Poland

For any information about this medicine, please contact the local representative of the

Marketing Authorisation Holder:

This leaflet was last revised in 01/2020

Patient Alert Card

Rivaroxaban Medana 2.5 mg (tick next to the prescribed dose)

Rivaroxaban Medana 10 mg (tick next to the prescribed dose)

Rivaroxaban Medana 15 mg (tick next to the prescribed dose)

Rivaroxaban Medana 20 mg (tick next to the prescribed dose)

♦ Keep this card with you at all times
♦ Present this card to every physician or dentist prior to treatment

I am under anticoagulation treatment with Rivaroxaban Medana (rivaroxaban)

Name:

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Other medicines / conditions:

In case of emergency, please notify:

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Information for health care providers:

♦ INR values should not be used as they are not a dependable measure of the anticoagulant activity of Rivaroxaban Medana.

What should I know about Rivaroxaban Medana?

♦ Rivaroxaban Medana thins the blood, which prevents you from getting dangerous blood clots.
♦ Rivaroxaban Medana must be taken exactly as prescribed by your doctor. To ensure optimal protection from blood clots, never skip a dose.
♦ You must not stop taking Rivaroxaban Medana without first talking to your doctor as your risk of blood clots may increase.
♦ Tell your health care provider about any other medicines you are currently taking, took recently or intend to start taking, before you start Rivaroxaban Medana.
♦ Tell your health care provider that you are taking Rivaroxaban Medana before any surgery or invasive procedure.

When should I seek advice from my health care provider?

When taking a blood thinner such as Rivaroxaban Medana it is important to be aware of its possible side effects.

Bleeding is the most common side effect. Do not start taking Rivaroxaban Medana if you know you are at risk of bleeding, without first discussing this with your doctor. Tell your health care provider straight away if you have any signs or symptoms of bleeding such as the following: ♦ pain

♦ swelling or discomfort
♦ headache, dizziness or weakness
♦ unusual bruising, nosebleeds, bleeding of gums, cuts that take a long time to stop bleeding
♦ menstrual flow or vaginal bleeding that is heavier than normal
♦ blood in your urine which may be pink or brown, red or black stools
♦ coughing up blood, or vomiting blood or material that looks like coffee grounds

How do I take Rivaroxaban Medana?

♦ To ensure optimal protection, Rivaroxaban Medana
– 2.5 mg can be taken with or without food
– 10 mg can be taken with or without food
– 15 mg must be taken with food
– 20 mg must be taken with food