Package leaflet: Information for the patient

Dovequa, 15 mg, film-coated tablets
Dovequa, 20 mg, film-coated tablets
Rivaroxaban
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

What Dovequa is and what it is used for
Important information before taking Dovequa
How to take Dovequa
Possible side effects
How to store Dovequa
Contents of the pack and other information

1. What Dovequa is and what it is used for

Dovequa contains the active substance rivaroxaban.
Dovequa is used in adults to:

prevent blood clots in the brain (stroke) and other blood vessels in the body in patients with a type of irregular heartbeat called non-valvular atrial fibrillation;
treat blood clots in the veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism), and to prevent recurrence of blood clots in the veins of the legs and/or lungs.

Dovequa is used in children and adolescents under 18 years of age and weighing 30 kg or more to:

treat blood clots and prevent recurrence of blood clots in the veins or in the blood vessels of the lungs, after at least 5 days of initial treatment with injectable anticoagulant medicines.

Dovequa belongs to a group of medicines called anticoagulants. It works by
blocking a blood clotting factor (Factor Xa), thereby reducing the tendency for blood clots to form.

2. Important information before using Dovequa

When not to use Dovequa:

if the patient is allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6),
if the patient has active bleeding,
if the patient has a disease or condition of an organ that leads to an increased risk of major bleeding (e.g. stomach ulcer, trauma or bleeding into the brain, recent surgery on the brain or eyes),
if the patient is taking other medicines that prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), except when switching anticoagulant therapy or if heparin is administered to maintain the patency of a venous or arterial catheter,
if the patient has a liver disease that leads to an increased risk of bleeding,
if the patient is pregnant or breastfeeding.

Do not use Dovequa, and inform your doctor if you suspect that any of the above circumstances apply to you.
Warnings and precautions
Talk to your doctor or pharmacist before taking Dovequa.
Exercise special caution when using Dovequa:

if the patient has an increased risk of bleeding, such as in the following conditions:
- severe kidney disease in adults, or moderate to severe kidney disease in children and adolescents, because kidney function may affect the amount of medicine acting in the patient's body,
- taking other medicines that prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin) when switching anticoagulant therapy or when heparin is administered to maintain the patency of a venous or arterial catheter (see section "Dovequa with other medicines"),
- bleeding disorders,
- very high blood pressure that does not decrease despite treatment with medicines,
- stomach or intestinal diseases that may cause bleeding, e.g. inflammation of the intestines and stomach or inflammation of the oesophagus (throat and oesophagus), e.g. due to gastro-oesophageal reflux disease (backflow of stomach acid into the oesophagus), or tumours located in the stomach, intestines, genital or urinary system,
- blood vessel disease in the back of the eye (retinopathy),
- lung disease with bronchiectasis (enlarged airways filled with pus) or previous lung bleeding,
in patients with heart valve prostheses,
if the patient has a disorder called antiphospholipid syndrome (an immune system disorder causing an increased risk of blood clots), the patient should inform their doctor, who will decide whether treatment needs to be changed,
if the patient has been diagnosed with abnormal blood pressure or if surgery or another treatment to remove a blood clot from the lungs is planned.

If you suspect that any of the above conditions apply to you, inform your doctor before taking Dovequa. The doctor will decide whether to use this medicine and whether the patient requires particularly close monitoring.
If the patient needs to undergo surgery:

strictly follow the doctor's instructions regarding the timing of taking Dovequa before and after surgery,
if spinal catheterisation or puncture (e.g. for epidural or spinal anaesthesia or pain relief) is planned during surgery:
- it is very important to take Dovequa before and after the puncture or catheter removal exactly as directed by the doctor,
- due to the need for special caution, inform the doctor immediately if numbness or weakness in the legs, or disturbances in bowel or bladder function occur after the anaesthesia ends.

Children and adolescents
Dovequa tablets are not recommended for children weighing less than 30 kg. There is insufficient data on the use of Dovequa in children and adolescents for the indications approved in adults.

Dovequa with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take, including those available without a prescription.

If the patient is taking: certain antifungal medicines (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are used only topically on the skin, ketoconazole tablets (used in the treatment of Cushing's syndrome, in which the body produces too much cortisol), certain antibiotics (e.g. clarithromycin, erythromycin), certain antiviral medicines used in HIV infection or AIDS treatment (e.g. ritonavir), other medicines used to reduce blood clotting (e.g. enoxaparin, clopidogrel or vitamin K antagonists such as warfarin or acenocoumarol), anti-inflammatory and pain-relieving medicines (e.g. naproxen or acetylsalicylic acid), dronedarone, a medicine used to treat heart rhythm disorders, certain medicines used to treat depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin-noradrenaline reuptake inhibitors (SNRIs)).

If you suspect that any of the above conditions apply to you, inform your doctor before taking Dovequa, because the effect of Dovequa may be increased. The doctor will decide whether to use this medicine and whether the patient requires particularly close monitoring.
If the doctor considers that the patient has an increased risk of developing stomach or intestinal ulcers, they may prescribe treatment to prevent ulcer formation.

If the patient is taking: certain medicines used to treat epilepsy (phenytoin, carbamazepine, phenobarbital), St John's wort (Hypericum perforatum), a herbal remedy used for depression, or rifampicin, an antibiotic.

If you suspect that any of the above conditions apply to you, inform your doctor before taking Dovequa, because the effect of Dovequa may be reduced. The doctor will decide whether to use Dovequa and whether the patient requires particularly close monitoring.

Pregnancy and breastfeeding
Do not use Dovequa if you are pregnant or breastfeeding. If there is a risk that the patient may become pregnant, an effective method of contraception should be used during treatment with Dovequa. If the patient becomes pregnant while taking this medicine, inform the doctor immediately. The doctor will decide on further management.

Driving and using machines
Dovequa may cause dizziness (common side effects) or fainting (uncommon side effects) (see section 4. "Possible side effects"). Patients experiencing these side effects should not drive, ride a bicycle, or operate tools or machinery.

Dovequa contains lactose and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet; this means the medicine is considered "sodium-free".

3. How to take Dovequa

This medicine should always be taken as instructed by your doctor. If you have any doubts,
consult your doctor or pharmacist.
Dovequa should be taken with food.
The tablet(s) should be swallowed whole, preferably with water.
If the patient has difficulty swallowing the whole tablet, discuss alternative ways of taking
Dovequa with your doctor. The tablet may be crushed and mixed with water or apple puree
immediately before administration. After taking this mixture, a meal should be consumed promptly.
If necessary, your doctor may administer crushed Dovequa tablets through a gastric tube.

How many tablets to take

Adults
- For prevention of blood clots in the brain (stroke) and other blood vessels in the body: The recommended dose is one 20 mg Dovequa tablet once daily. If the patient has kidney disease, the dose may be reduced to one 15 mg Dovequa tablet once daily.

If the patient requires a procedure to open blocked blood vessels in the heart (called percutaneous
coronary intervention – PCI with stent placement), limited evidence supports reducing the dose
to one 15 mg Dovequa tablet once daily (or one 10 mg Dovequa tablet once daily if the patient
has impaired kidney function), in combination with an antiplatelet medicine such as clopidogrel.

For treatment of blood clots in the veins of the legs, blood clots in the blood vessels of the lungs, and to prevent recurrence of blood clots: The recommended dose is one 15 mg Dovequa tablet twice daily for the first 3 weeks. For treatment beyond 3 weeks, the recommended dose is one 20 mg Dovequa tablet once daily. After at least 6 months of treatment for blood clots, your doctor may decide to continue treatment with either one 10 mg tablet once daily or one 20 mg tablet once daily. If the patient has kidney disease and is taking one 20 mg Dovequa tablet once daily, your doctor may decide to reduce the dose after 3 weeks of treatment to one 15 mg Dovequa tablet once daily, if the risk of bleeding is greater than the risk of further blood clots.
Children and adolescents The dose of Dovequa depends on body weight and will be calculated by the doctor.
- Recommended dose for children and adolescents with a body weight from 30 kg to below 50 kg is one 15 mg Dovequa tablet once daily.
- Recommended dose for children and adolescents with a body weight of 50 kg or more is one 20 mg Dovequa tablet once daily.

Each dose of Dovequa should be taken with a meal and a drink (e.g. water or juice).
Tablets should be taken every day at approximately the same time. Consider setting an alarm to
remind you.
For parents or caregivers: observe the child to ensure they have taken the full dose.
The dose of Dovequa depends on body weight, so it is important to attend scheduled doctor visits,
as dose adjustments may be needed due to changes in weight.
Never adjust the dose on your own. Your doctor will adjust the dose if necessary.
Do not split the tablet to achieve a partial dose. If a lower dose is required, use an alternative
medication in the form of granules for oral suspension.
For children and adolescents who cannot swallow whole tablets, an alternative medication in the
form of granules for oral suspension should be used.
If oral suspension is not available, the Dovequa tablet may be crushed and mixed with water or
apple puree immediately before administration. After taking this mixture, a meal should be consumed.
If necessary, your doctor may also administer the crushed tablet via a gastric tube.

If a dose is vomited or spat out

Within 30 minutes of taking Dovequa, take a new dose.
More than 30 minutes after taking Dovequa, do not take another dose. In this case, take the next dose at the usual time.

Contact your doctor if vomiting or spitting out the dose occurs repeatedly after taking Dovequa.

When to take Dovequa
Take the tablet(s) every day until your doctor decides to stop treatment.
It is best to take the tablet(s) at the same time each day, as this makes it easier to remember.
Your doctor will decide how long treatment should continue.
For prevention of blood clots in the brain (stroke) and other blood vessels in the body:
If restoration of normal heart rhythm is required by a procedure called cardioversion, Dovequa
should be taken as directed by your doctor.

Missed dose of Dovequa

Adults, children and adolescents: If the patient takes one 20 mg or one 15 mg tablet once daily and a dose is missed, take the tablet as soon as possible. Do not take more than one tablet in one day to make up for the missed dose. Take the next tablet the following day, then continue taking one tablet once daily.
Adults: If the patient takes one 15 mg tablet twice daily and a dose is missed, take the tablet as soon as possible. Do not take more than two 15 mg tablets in one day. If the patient forgot to take a dose, they may take two 15 mg tablets at the same time to achieve a total of two tablets (30 mg) taken within one day. The next day, continue taking one 15 mg tablet twice daily.

Taking more than the recommended dose of Dovequa
If the patient has taken more than the recommended dose of Dovequa, contact your doctor
immediately. Taking too much Dovequa increases the risk of bleeding.

Stopping Dovequa
Do not stop taking Dovequa without first consulting your doctor, as Dovequa helps prevent
serious illness.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, Dovequa may cause adverse reactions, although not everyone experiences them.
As with other medicines with a similar mechanism of action that reduce blood clot formation, Dovequa may cause bleeding, which potentially could be life-threatening. Excessive bleeding may lead to a sudden drop in blood pressure (shock). Signs of bleeding are not always obvious or visible.
You should immediately inform your doctor if any of the following adverse reactions occur:

Signs of bleeding:
- bleeding into the brain or inside the skull (symptoms may include headache, one-sided weakness, vomiting, seizures, decreased level of consciousness, and neck stiffness. This is a serious, acute medical emergency. Seek immediate medical help!),
- prolonged or excessive bleeding,
- unusual weakness, fatigue, paleness, dizziness, headache, unexplained swelling, shortness of breath, chest pain, or angina. Your doctor may decide that close monitoring or a change in treatment is necessary.
Signs of severe skin reactions:
- widespread, acute skin rash, blistering, or mucosal lesions (e.g. in the mouth or eyes) (Stevens-Johnson syndrome, toxic epidermal necrolysis).
- drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), characterized by rash, fever, internal organ inflammation, hematological abnormalities, and systemic involvement. The frequency of these adverse reactions is very rare (up to 1 in 10,000 people).
Signs of serious allergic reactions:
- swelling of the face, lips, mouth, tongue, or throat; difficulty swallowing; urticaria and breathing difficulties; sudden drop in blood pressure. The frequency of severe allergic reactions is very rare (anaphylactic reactions, including anaphylactic shock, may occur in up to 1 in 10,000 people) and uncommon (angioedema and allergic edema may occur in 1 in 100 people).

General list of possible adverse reactions in adults, children, and adolescents:
Common (may occur in up to 1 in 10 patients):

decreased number of red blood cells, which may cause paleness of the skin and lead to weakness or shortness of breath,
gastrointestinal or intestinal bleeding, bleeding from the urinary or genital tract (including blood in urine and heavy menstrual bleeding), nosebleeds, gum bleeding,
bleeding into the eye (including conjunctival hemorrhage),
bleeding into tissues or body cavities (hematoma, bruising),
presence of blood in sputum (hemoptysis) during coughing,
skin bleeding or subcutaneous bleeding,
postoperative bleeding,
oozing of blood or fluid from a surgical wound,
limb swelling,
limb pain,
kidney function disorders (may be observed in tests performed by a doctor),
fever,
stomach pain, indigestion, nausea or vomiting, constipation, diarrhea,
low blood pressure (symptoms may include dizziness or fainting upon standing),
general loss of strength and energy (weakness, fatigue), headache, dizziness,
rash, itching of the skin,
increased activity of certain liver enzymes, which may be evident in blood test results.

Uncommon (may occur in up to 1 in 100 patients):

intracranial or cerebral hemorrhage (see signs of bleeding above),
bleeding into a joint causing pain and swelling,
thrombocytopenia (low platelet count, the blood cells involved in blood clotting),
allergic reactions, including allergic skin reactions,
liver function disorders (may be observed in tests performed by a doctor),
blood tests may show increased levels of bilirubin, increased activity of certain pancreatic or liver enzymes, or increased platelet count,
fainting,
malaise,
rapid heartbeat,
dry mouth,
urticaria.

Rare (may occur in up to 1 in 1,000 patients):

bleeding into muscles,
cholestasis (bile stasis), hepatitis including liver cell damage,
yellowing of the skin and eyes (jaundice),
localized swelling,
blood collection (hematoma) in the groin area as a complication of cardiac catheterization when the catheter is inserted into an artery in the leg (pseudoaneurysm).

Very rare (may occur in up to 1 in 10,000 patients):

accumulation of eosinophils, a type of granular white blood cells, causing lung inflammation (eosinophilic pneumonia).

Frequency not known (frequency cannot be estimated from available data):

kidney failure following severe bleeding,
bleeding in the kidneys, sometimes with blood in the urine, leading to impaired kidney function (anticoagulant-related nephropathy),
increased pressure in the muscles of arms and legs after bleeding, which may lead to pain, swelling, altered sensation, numbness, or paralysis (compartment syndrome following bleeding).

Adverse reactions in children and adolescents
In general, adverse reactions observed in children and adolescents treated with the medicinal product Dovequa were similar in type to those observed in adults and were mainly mild to moderate in severity.

Adverse reactions observed more frequently in children and adolescents:
Very common (may occur in more than 1 in 10 patients):

headache,
fever,
nosebleeds,
vomiting.

Common (may occur in up to 1 in 10 patients):

rapid heartbeat,
blood tests may show increased bilirubin levels (a bile pigment),
thrombocytopenia (low platelet count, the cells that help blood to clot),
excessive menstrual bleeding.

Uncommon (may occur in up to 1 in 100 patients):

blood tests may show increased levels of a subcategory of bilirubin (direct bilirubin, a bile pigment).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Poland.
Tel: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Dovequa

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of the stated month.
The expiry date is indicated on the packaging following the abbreviation EXP.
There are no special storage instructions for this medicine.
Crushed tablets
Crushed tablets are stable in water or apple puree for up to 4 hours.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Dovequa contains

The active substance is rivaroxaban. Each film-coated tablet contains 15 mg or 20 mg of rivaroxaban.
Other ingredients are:
Tablet core: Sodium lauryl sulfate, monohydrate lactose, microcrystalline cellulose (E460), sodium croscarmellose (E468), hypromellose type 2910 (5 mPas) (E464), magnesium stearate (E572). See section 2 "Dovequa contains lactose and sodium".
Coating of the 15 mg tablet (Opadry II Pink 33G240024): Hypromellose type 2910 (6 mPas) (E464), titanium dioxide (E171), monohydrate lactose, macrogol 3350 (E1521), triacetin (E1518), iron oxide red (E172), iron oxide black (E172).
Coating of the 20 mg tablet (Opadry II Red 33G250007): Hypromellose type 2910 (6 mPas) (E464), titanium dioxide (E171), monohydrate lactose, macrogol 3350 (E1521), triacetin (E1518), iron oxide red (E172), iron oxide yellow (E172).

What Dovequa looks like and contents of the pack
Dovequa 15 mg are pink, round, biconvex film-coated tablets with a diameter of 6 mm, imprinted with the number "15" on one side. The tablets are contained in transparent blisters made of PVC/PVDC/Aluminium, packed in cardboard boxes containing 14, 28, 42 or 100 film-coated tablets.

Dovequa 20 mg are brown-red, round, biconvex film-coated tablets with a diameter of 7 mm, imprinted with the number "20" on one side. The tablets are contained in transparent blisters made of PVC/PVDC/Aluminium, packed in cardboard boxes containing 10, 14, 28 or 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland
Tel.: +48 17 865 51 00

Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
Pelplińska Street 19
83-200 Starogard Gdański
Poland
Tel.: +48 22 364 61 01