Patient leaflet - RIVAROXABAN POLPHARMA 15 MG + 20 MG FILM-COATED TABLETS
Package leaflet: Information for the user
Rivaroxaban Polpharma 15 mg film-coated tablets Rivaroxaban Polpharma 20 mg film-coated tablets
Treatment Initiation Pack
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 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:
-
– 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.
-
-
■ 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 20 mg contains Allura Red AC.
Rivaroxaban 15 mg contains Allura Red AC and Sunset Yellow FCF.
May cause allergic reactions.
3. how to take rivaroxaban
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Swallow the tablet(s) preferably with water. Take Rivaroxaban 5 mg or 20 mg film-coated tablets together with a meal.
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
The recommended dose is one tablet Rivaroxaban 15 mg twice a day for the first 3 weeks. For treatment after 3 weeks, the recommended dose is one tablet Rivaroxaban 20 mg once a day. This Rivaroxaban 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 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 15 mg 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.
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 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
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. possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Like other similar medicines (antithrombotic agents), Rivaroxaban 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 (less than 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 or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to Yellow Card Scheme via 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.
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.
– The active substance is rivaroxaban. Each tablet contains 15 mg or 20 mg of rivaroxaban, respectively.
-
– The other ingredients are:
Tablet core: sodium laurilsulfate, lactose monohydrate, cellulose, microcrystalline, croscarmellose sodium, hypromellose, magnesium stearate.
Rivaroxaban 15 mg film coat (Opadry II Pink 33G240016): hypromellose, titanium dioxide (E171), lactose monohydrate, macrogol 3000, triacetin, Allura Red AC, aluminum lake (E129), Sunset Yellow FCF, aluminum lake (E110), Indigo Carmine, aluminum lake (E132).
Rivaroxaban 20 mg film coat (Opadry II Red 33G250002): hypromellose, titanium dioxide (E171), lactose monohydrate, macrogol 3000, triacetin, Allura Red AC, aluminum lake (E129), iron oxide, yellow (E172).
What Rivaroxaban looks like and contents of the pack
Rivaroxaban 15 mg film-coated tablets are pink, round, biconvex and marked with “15” on the one side.
Rivaroxaban 20 mg film-coated tablets are red, round, biconvex and marked with “20” on the one 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.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zaklady Farmaceutyczne POLPHARMA S.A.
ul. Pelplinska 19, 83–200 Starogard Gdanski
Poland
Manufacturer
Zaklady Farmaceutyczne POLPHARMA S.A.
ul. Pelplinska 19, 83–200 Starogard Gdanski, Poland
This leaflet was last revised in 11/2021
Patient Alert Card
Rivaroxaban Polpharma 2.5 mg (tick next to the prescribed dose)
Rivaroxaban Polpharma 10 mg (tick next to the prescribed dose)
Rivaroxaban Polpharma 15 mg (tick next to the prescribed dose)
Rivaroxaban Polpharma 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 Polpharma (rivaroxaban)
Name:
Address:
Birth date:
Weight:
Other medicines / conditions:
In case of emergency, please notify:
Doctor’s name:
Doctor’s phone:
Doctor’s stamp:
Please also notify:
Name:
Phone:
Relationship:
Information for health care providers:
-
♦ INR values should not be used as they are not a dependable measure of the anticoagulant activity of Rivaroxaban Polpharma.
What should I know about Rivaroxaban Polpharma?
-
♦ Rivaroxaban Polpharma thins the blood, which prevents you from getting dangerous blood clots.
-
♦ Rivaroxaban Polpharma 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 Polpharma 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 Polpharma.
-
♦ Tell your health care provider that you are taking Rivaroxaban Polpharma before any surgery or invasive procedure.
When should I seek advice from my health care provider?
When taking a blood thinner such as Rivaroxaban Polpharma it is important to be aware of its possible side effects.
Bleeding is the most common side effect. Do not start taking Rivaroxaban Polpharma 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 Polpharma?
-
♦ To ensure optimal protection, Rivaroxaban Polpharma
-
– 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