XANIRVA 15 MG HARD CAPSULES - patient leaflet, side effects, dosage

Patient leaflet - XANIRVA 15 MG HARD CAPSULES

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

1. what xanirva is and what it is used for

Xanirva 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 re-occurring in the blood vessels of your legs and/or lungs.

Xanirva 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 xanirva 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 Xanirva and tell your doctor if any of these apply to you.

Warnings and precautions

Talk to your doctor or pharmacist before taking Xanirva.

Take special care with Xanirva:

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 Xanirva”);

– 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 Xanirva. 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 Xanirva 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):

o it is very important to take Xanirva before and after the injection or removal of the catheter exactly at the times you have been told by your doctor

o 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

Xanirva 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 Xanirva

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

o some medicines for fungal infections (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are only applied to the skin;
o ketoconazole tablets (used to treat Cushing’s syndrome – when the body produces an excess of cortisol);
o some medicines for bacterial infections (e.g. clarithromycin, erythromycin);
o some anti-viral medicines for HIV / AIDS (e.g. ritonavir);
o other medicines to reduce blood clotting (e.g. enoxaparin, clopidogrel or vitamin K antagonists such as warfarin and acenocoumarol);
o anti-inflammatory and pain relieving medicines (e.g. naproxen or acetylsalicylic acid);
o dronedarone, a medicine to treat abnormal heart beat;

o 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 Xanirva, because the effect of Xanirva 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.

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

o rifampicin, an antibiotic.

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

Pregnancy and breast-feeding

Do not take Xanirva 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 Xanirva. 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

Xanirva 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.

Xanirva 15 mg and 20 mg contain lactose monohydrate (a type of sugar) and sodium

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

This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’.

Xanirva 20 mg contain also carmoisine (E 122)

The excipient carmoisine (E 122) may cause allergic reactions.

3. how to take xanirva

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 Xanirva together with a meal.

Swallow the capsule(s) preferably with water.

If you have difficulty swallowing the capsule whole, talk to your doctor about other ways to take Xanirva. The content of capsule may be 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 sprinkled Xanirva capsule content through a stomach tube.

How much to take

The recommended dose is one capsule Xanirva 20 mg once a day.

If you have kidney problems, the dose may be reduced to one capsule Xanirva 15 mg 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 capsule Xanirva 15 mg once a day (or to one capsule Xanirva 10 mg once a day in case your kidneys are not working properly) in addition to an antiplatelet medicinal product such as clopidogrel.

When to take Xanirva

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

Try to take the capsule(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 Xanirva at the times your doctor tells you.

If you take more Xanirva than you should

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

If you forget to take Xanirva

If you are taking one 20 mg capsule or one 15 mg capsule once a day and have missed a dose,

take it as soon as you remember. Do not take more than one capsule in a single day to make up for a forgotten dose. Take the next capsule on the following day and then carry on taking one capsule once a day.

If you are taking one 15 mg capsule twice a day and have missed a dose, take it as soon as you

remember. Do not take more than two 15 mg capsules in a single day. If you forget to take a dose you can take two 15 mg capsules at the same time to get a total of two capsules (30 mg) on one day. On the following day you should carry on taking one 15 mg capsule twice a day.

If you stop taking Xanirva

Do not stop taking Xanirva without talking to your doctor first, because Xanirva 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 (antithrombotic agents), Xanirva 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, haematologic 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 or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the MHRA 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.

5. how to store xanirva

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

PVC/PVdC/Alu blisters: Store below 30 °C. Store in the original package in order to protect from moisture.

Alu/Alu blisters: This medicinal product 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- the active substance is rivaroxaban. each capsule contains 15 mg or 20 mg of rivaroxaban

– The other ingredients are lactose monohydrate, cellulose, microcrystalline, croscarmellose sodium, hypromellose, sodium laurilsulfate, magnesium stearate in capsules content.

What Xanirva looks like and contents of the pack

Xanirva 15 mg hard capsules are white to off-white powder filled in size “1” capsule (of 19.4 ± 0.3 mm length) with light brown opaque cap and body with imprint on cap “15” with white ink.

Xanirva 20 mg hard capsules are white to off-white powder filled in size “0” capsule (of 21.7 ± 0.3 mm length) with dark brown opaque cap and body with imprint on cap “20” with white ink.

The hard capsules are packed into PVC/PVdC/Alu or Alu/Alu blisters.

Xanirva 15 mg is available in packs of 14, 28, 30, 42, 98 or 100 hard capsules.

Xanirva 20 mg is available in packs of 14, 28, 30, 98 or 100 hard capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Zentiva Pharma UK Limited

12 New Fetter Lane

London

EC4A 1JP

United Kingdom

S.C. Zentiva S.A.

B-dul Theodor Pallady nr.50, sector 3,

Bucuresti,

cod 032266,

Romania

This leaflet was last revised in March 2020