Medicine guide
Svariya (previously Rivaroxaban Koanaa)
·
- Prescription status not stated
- Blood, clotting and anaemia
- Active substance
- Rivaroxaban
- Used in
- Blood, clotting and anaemia
- Made by
- Koanaa Healthcare GmbH
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
- Svariya contains the active substance rivaroxaban and is used in adults to
- - prevent blood clots in the veins after a hip or knee replacement operation. Your doctor has prescribed this medicine for you because after an operation you are at an increased risk of getting blood clots.
- - 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.
- Svariya 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.
From the package leaflet in EMA’s product information, p. 105 · 2026-08-25
How it works
This product’s leaflet is published as a scanned document. This section quotes the US prescribing label for the same active substance (rivaroxaban). It describes the substance, not this Bulgarian product — its uses and doses can differ.
XARELTO is a selective inhibitor of FXa.
It does not require a cofactor (such as Anti-thrombin III) for activity.
Peak level after2–4 h
Half-life5–9 h
Mostly cleared after≈ 35 hfive half-lives — our arithmetic
How it leaves the body
Unchanged drug is excreted into urine, mainly via active tubular secretion and to a lesser extent via glomerular filtration (approximate 5:1 ratio).
With food
For the 2.5 mg and 10 mg dose, it is estimated to be 80% to 100% and is not affected by food.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-09-10
Do not take it if
- 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 Svariya and tell your doctor if any of these apply to you.
From the package leaflet in EMA’s product information, p. 105.
How to take it
These directions are for this exact strength and form. Another one is different.
- Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
- Svariya 10 mg Orodispersible films are for the oral use and can be taken with or without food and also with or without water. Allow the film to disintegrate in your mouth before you swallow it with saliva.
- Instructions on handling Svariya Important: Do not handle the orodispersible film with wet hands.
- a) Take a sachet, locate the arrow mark at one of the shorter sides and hold the sachet with this side facing up.
- b) Gently peel both parts of the sachet apart at the arrow mark. Now you can hold each part between your thumb and your index finger using one hand for each part.
- c) Carefully tear both parts of the sachet into opposite directions until they are separated. The orodispersible film is now visible and placed on one of the separated sachet parts.
- d) Take the orodispersible film with dry fingers out of the sachet and put it in your mouth directly on your tongue. It will disperse rapidly, so that it can be easily swallowed.
- The orodispersible film should be placed in mouth, on the tongue. Your mouth should be empty and your fingers dry before placing orodispersible film on to the tongue. It should be taken immediately once the sachet is open.
- How much to take
- To prevent blood clots in the veins after a hip or knee replacement operation The recommended dose is one Svariya 10 mg Orodispersible film once a day.
- 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 After at least 6 months blood clot treatment, the recommended dose is either one 10 mg orodispersible film once a day or one 20 mg orodispersible film once a day. Your doctor has prescribed you Svariya 10 mg Orodispersible film once a day.
- Svariya 10 mg Orodispersible film can be taken with or without food.
- When to take Svariya Take the orodispersible film every day until your doctor tells you to stop.
- Try to take the orodispersible film 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 veins after a hip or knee replacement operation:
- Take the first orodispersible film 6 - 10 hours after your operation.
- If you have had a major hip operation you will usually take the orodispersible film for 5 weeks.
- If you have had a major knee operation you will usually take the orodispersible film for 2 weeks.
- If you take more Svariya than you should Contact your doctor immediately if you have taken too many Svariya Orodispersible film. Taking too much Svariya increases the risk of bleeding.
- If you forget to take Svariya If you have missed a dose, take it as soon as you remember. Take the next orodispersible film on the following day and then carry on taking a orodispersible film once a day as normal.
- Do not take a double dose to make up for a forgotten orodispersible film.
- If you stop taking Svariya Do not stop taking Svariya without talking to your doctor first, because Svariya prevents the development of a serious condition.
- If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
From the package leaflet in EMA’s product information, p. 107–109.
Warnings and precautions
- Talk to your doctor or pharmacist before taking Svariya.
- Take special care with Svariya
- if you have an increased risk of bleeding, as could be the case in situations such as:
- moderate or 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 Svariya”)
- 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) or tumours located in the stomach or bowels or genital tract or urinary tract 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 Svariya. 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 Svariya 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 Svariya 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 Svariya 10 mg Orodispersible film are not recommended for people under 18 years of age. There is not enough information on their use in children and adolescents.
From the package leaflet in EMA’s product information, p. 106.
Pregnancy and breastfeeding
Do not take Svariya 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 Svariya. If you become pregnant while you are taking this medicine, tell your doctor immediately, who will decide how you should be treated.
From the package leaflet in EMA’s product information, p. 107.
Other medicines
- 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 Svariya, because the effect of Svariya 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 Svariya, because the effect of Svariya may be reduced. Your doctor will decide, if you should be treated with Svariya and if you should be kept under closer observation.
From the package leaflet in EMA’s product information, p. 106–107.
Driving and using machines
- Svariya 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.
- Svariya contains macrogolglycerol hydroxystearate and sodium Macrogolglycerol hydroxystearate may cause stomach upset and diarrhea.
- This medicine contains less than 1 mmol sodium (23 mg) per film, that is to say essentially ”sodium- free”.
From the package leaflet in EMA’s product information, p. 107.
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, Svariya 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.
- 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, blood abnormalities and systemic illness (DRESS syndrome).
- The frequency of these side effects 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 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 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)
- Very rare (may affect up to 1 in 10,000 people)
- accumulation of eosinophils, a type of white granulocytic blood cells that cause inflammation in the lung (eosinophilic pneumonia)
- Not known (frequency cannot be estimated from the available data)
- kidney failure after a severe bleeding
- bleeding in the kidney sometimes with presence of blood in urine leading to inability of the kidneys to work properly (anticoagulant-related nephropathy)
- 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 national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
From the package leaflet in EMA’s product information, p. 110–111.
How to store it
- 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 sachet after EXP. The expiry date refers to the last day of that month.
- The product should be stored in the original package and this medicinal product does not require any special temperature 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.
From the package leaflet in EMA’s product information, p. 111–112.
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
United StatesNo exact match for this strength and form
BulgariaNo exact match for this strength and form
SpainNo exact match for this strength and form
FranceNo exact match for this strength and form
CanadaNo exact match for this strength and form
NetherlandsNo exact match for this strength and form
SwitzerlandNo exact match for this strength and form
Details
| Made by | Koanaa Healthcare GmbH |
|---|---|
| Active substance | Rivaroxaban |
| Used in | Blood, clotting and anaemia |
| Classification | B01AF01 · Blood, clotting and anaemia |
| Generic | Yes — a generic medicine, according to the register |
| Authorised on | 2025-11-21 |
| Last updated by the regulator | 2026-08-25 |
| EMA product number | EMEA/H/C/006643 |
Source: European Medicines Agency — medicine data · 2026-09-30 · not reviewed by a clinician
Source: European Medicines Agency (EMA). Product information as published by EMA. Reuse terms: EMA legal notice (reproduction authorised).
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.