Dovequa

Package Leaflet: Information for the Patient

Dovequa, 15 mg, Film-Coated Tablets

Dovequa, 20 mg, Film-Coated Tablets

Rivaroxaban

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this package leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medication has been prescribed for a specific person. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. See section 4.

Package Leaflet Contents

• 1. What is Dovequa and What is it Used For
• 2. Important Information Before Taking Dovequa
• 3. How to Take Dovequa
• 4. Possible Side Effects
• 5. How to Store Dovequa
• 6. Package Contents and Other Information

1. What is Dovequa and What is it Used For

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

• prevent the formation of blood clots in the brain (stroke) and other blood vessels in the body, if the patient has a type of irregular heartbeat called atrial fibrillation not caused by heart valve problems;
• treat blood clots in the veins of the legs (deep vein thrombosis) and blood vessels in the lungs (pulmonary embolism) and prevent the recurrence of blood clots in the blood vessels 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 and prevent blood clots in the veins or blood vessels in the lungs, after at least 5 days of initial treatment with injectable medications used to treat blood clots.

Dovequa belongs to a group of medicines called anticoagulants. Its action is based on
blocking the blood clotting factor (factor Xa) and thereby reducing the tendency to form
blood clots.

2. Important Information Before Taking Dovequa

When Not to Take 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 excessive bleeding,
• if the patient has a disease or condition of the body that leads to an increased risk of significant bleeding (e.g., stomach ulcer, injury or bleeding into the brain, recent brain or eye surgery),

or recent spinal or epidural injection.

• if the patient is taking other medications that prevent blood clotting (e.g., warfarin, dabigatran, apixaban, or heparin), except when changing anticoagulant treatment or when heparin is given to maintain the patency of a venous or arterial catheter,
• if the patient has liver disease that leads to an increased risk of bleeding,
• if the patient is pregnant or breastfeeding.

Do not take Dovequa, and inform your doctorif you suspect that any of the above conditions apply to you.

Warnings and Precautions

Discuss taking Dovequa with your doctor or pharmacist before starting treatment.

Be Particularly Careful When Taking Dovequa:

• if the patient has an increased risk of bleeding, such as:
• severe kidney disease in adults and moderate or severe kidney disease in children and adolescents, as kidney function may affect the amount of medication in the patient's body,
• taking other medications that prevent blood clotting (e.g., warfarin, dabigatran, apixaban, or heparin) when changing anticoagulant treatment or when heparin is given to maintain the patency of a venous or arterial catheter (see "Dovequa and Other Medications"),
• bleeding disorders,
• very high blood pressure that does not decrease despite medication,
• stomach or intestinal diseases that may cause bleeding, e.g., inflammation of the intestines and stomach or esophageal inflammation (e.g., due to gastroesophageal reflux disease) or tumors located in the stomach, intestines, genital, or urinary system,
• vascular disease in the back of the eye (retinopathy),
• pulmonary disease with dilated bronchi filled with pus (bronchiectasis) or previous lung bleeding,
• in patients with prosthetic heart valves,
• if the patient has a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), the patient should inform the doctor, who will decide on possible changes to the treatment,
• if the patient has been diagnosed with abnormal blood pressure or is scheduled for surgery or other treatment to remove a blood clot from the lungs.

If You Suspect That You Have Any of the Above Conditions, Inform

your doctorbefore taking Dovequa. The doctor will decide whether to use this medication and whether the patient should be closely monitored.

If You Need to Undergo Surgery:

• follow your doctor's instructions carefully regarding taking Dovequa at a specific time before and after surgery,
• if a procedure to open up blood vessels in the heart (called percutaneous coronary intervention with stent placement) is planned:
• it is very important to take Dovequa before and after the procedure, as instructed by your doctor
• due to the need for caution, immediately inform your doctor if you experience numbness or weakness in your legs, bowel or bladder dysfunction, or back pain after the procedure.

Children and Adolescents

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

Dovequa and Other Medications

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

• If you are taking: certain medications used to treat fungal infections (e.g., fluconazole, itraconazole, voriconazole, posaconazole), unless they are used only locally on the skin, ketoconazole tablets (used to treat Cushing's syndrome, in which the body produces too much cortisol), certain medications used to treat bacterial infections (e.g., clarithromycin, erythromycin), certain antiviral medications used to treat HIV or AIDS (e.g., ritonavir), other medications used to reduce blood clotting (e.g., enoxaparin, clopidogrel, or vitamin K antagonists, such as warfarin or acenocoumarol), anti-inflammatory and pain medications (e.g., naproxen or acetylsalicylic acid), dronedarone, a medication used to treat heart rhythm disorders, certain medications used to treat depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs)).

If You Suspect That You Have Any of the Above Conditions, Inform

your doctorbefore taking Dovequa, as the effect of Dovequa may be increased. The doctor will decide whether to use this medication and whether the patient should be closely monitored.
If the doctor believes that the patient is at increased risk of developing stomach or intestinal ulcers, they may use preventive treatment.

• If you are taking: certain medications used to treat epilepsy (phenytoin, carbamazepine, phenobarbital), St. John's Wort (Hypericum perforatum), a herbal remedy used to treat depression, rifampicin, which belongs to a group of antibiotics.

If You Suspect That You Have Any of the Above Conditions, Inform

your doctorbefore taking Dovequa, as the effect of Dovequa may be reduced. The doctor will decide whether to use Dovequa and whether the patient should be closely monitored.

Pregnancy and Breastfeeding

Do not take Dovequa if you are pregnant or breastfeeding. If there is a risk that you may become pregnant, use effective contraception while taking Dovequa. If you become pregnant while taking this medication, immediately inform your doctor, who will decide on further treatment.

Driving and Using Machines

Dovequa may cause dizziness (frequent side effects) or fainting (uncommon side effects) (see section 4 "Possible Side Effects"). Patients who experience these side effects should not drive, ride a bicycle, or operate tools or machines.

Dovequa Contains Lactose and Sodium

If you have previously been diagnosed with intolerance to some sugars, contact your doctor before taking the medication.
The medication contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to Take Dovequa

Always take this medication exactly as your doctor has told you. If you are unsure, ask your doctor or pharmacist.
Take Dovequa with food.
Swallow the tablet(s) whole, preferably with water.
If you have difficulty swallowing whole tablets, talk to your doctor about other ways to take Dovequa. The tablet can be crushed and mixed with water or apple sauce, just before taking. After such a mixture, eat a meal immediately.
If necessary, your doctor may also give you a crushed tablet through a gastric tube.

How Many Tablets to Take

• Adults
• In preventing the formation 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 you have kidney disease, the dose may be reduced to one 15 mg Dovequa tablet once daily.

If you need a procedure to open up blood vessels in the heart (called percutaneous coronary intervention with stent placement), there is limited evidence to support a dose reduction to one 15 mg Dovequa tablet once daily (or one 10 mg Dovequa tablet once daily in case of kidney disease) in combination with an antiplatelet medication such as clopidogrel.

• In treating blood clots in the veins of the legs, blood clots in the lungs, and preventing the recurrence of blood clots: The recommended dose is one 15 mg Dovequa tablet twice daily for the first 3 weeks. After 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 you have kidney disease and are taking one 20 mg Dovequa tablet once daily, your doctor may decide to reduce the dose to one 15 mg Dovequa tablet once daily after 3 weeks of treatment, if the risk of bleeding is higher than the risk of recurrent blood clots.
• Children and AdolescentsThe dose of Dovequa depends on body weight and will be calculated by your doctor. o The recommended dose for children and adolescents with a body weight of 30 kg to less than 50 kgis one Dovequa 15 mgtablet once daily. o The recommended dose for children and adolescents with a body weight of 50 kg or moreis one Dovequa 20 mgtablet once daily.

Take each dose of Dovequa with food, and drink a liquid (e.g., water or juice).
Take the tablets 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 entire dose.
The dose of Dovequa is based on body weight, so it is essential to attend scheduled doctor's appointments, as the dose may need to be adjusted based on weight changes.
Never adjust the dose yourself.If necessary, your doctor will adjust the dose.
Do not split the tablet to achieve a partial dose. If a smaller dose is needed, use other medications in the form of granules for oral suspension.
For children and adolescents who are unable to swallow whole tablets, use other medications in the form of granules for oral suspension.
If an oral suspension is not available, you can crush the Dovequa tablet and mix it with water or apple sauce, just before taking. After such a mixture, eat a meal immediately.
If necessary, your doctor may also give you a crushed tablet through a gastric tube.

If You Spit Out a Dose or Vomit

• less than 30 minutes after taking Dovequa, take a new dose.
• more than 30 minutes after taking Dovequa, do nottake a new dose. In this case, take the next dose of Dovequa at the usual time.

Contact your doctor if you spit out a dose or vomit 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 every day, as it will be easier to remember.
Your doctor will decide how long to continue treatment.
Preventing the formation of blood clots in the brain (stroke) and other blood vessels in the body:
If your heart rhythm needs to be restored with a procedure called cardioversion, take Dovequa as instructed by your doctor.

Missing a Dose of Dovequa

• Adults, children, and adolescents: If you take one 20 mg or one 15 mg tablet oncedaily and miss a dose, take it as soon as possible. Do not take more than one tablet in a 24-hour period to make up for the missed dose. Take the next tablet at the usual time the next day, then continue taking one tablet once daily.
• Adults: If you take one 15 mg tablet twicedaily and miss a dose, take it as soon as possible. Do not take more than two 15 mg tablets in a 24-hour period. If you miss a dose, you can take two 15 mg tablets at the same time to get a total of two tablets (30 mg) in a 24-hour period. The next day, continue taking one 15 mg tablet twice daily.

Taking More Than the Recommended Dose of Dovequa

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

Stopping Treatment with Dovequa

Do not stop taking Dovequa without consulting your doctor, as this medication prevents serious illness.
If you have any further questions about taking this medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, Dovequa can cause side effects, although not everybody gets them.
Like other medications with similar effects that reduce blood clotting, Dovequa can cause bleeding, which can be life-threatening. Excessive bleeding can lead to a sudden drop in blood pressure (shock). Not all signs of bleeding will be obvious or visible.

Immediately Inform Your Doctor if You Experience Any of the Following Side Effects:

• Signs of Bleeding:
• bleeding into the brain or skull (symptoms may include headache, one-sided weakness, vomiting, seizures, decreased level of consciousness, and stiffness in the neck. This is a serious medical emergency. Seek medical help immediately!),
• prolonged or excessive bleeding,
• unusual weakness, fatigue, pallor, dizziness, headache, unexplained swelling, shortness of breath, chest pain, or angina. Your doctor may decide to monitor you closely or change your treatment.
• Signs of Severe Skin Reactions:
• widespread, severe skin rash, blistering, or changes to the mucous membranes, e.g., on the tongue or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• a drug reaction that causes a rash, fever, inflammation of internal organs, hematologic disorders, and systemic disorders (DRESS syndrome). The frequency of these side effects is very rare (less than 1 in 10,000 people).
• Signs of Severe Allergic Reactions:
• swelling of the face, lips, mouth, tongue, or throat; difficulty swallowing; hives and difficulty breathing; sudden drop in blood pressure. The frequency of severe allergic reactions is very rare (anaphylactic reactions, including anaphylactic shock, may occur in less than 1 in 10,000 people) and uncommon (angioedema and allergic edema may occur in 1 in 100 people).

General List of Possible Side Effects in Adults, Children, and Adolescents:

Common(may affect up to 1 in 10 people):

• reduced red blood cell count, which can cause pallor and be the cause of weakness or shortness of breath,
• bleeding from the stomach or intestines, bleeding from the urinary or reproductive system (including blood in the urine and heavy menstrual bleeding), nosebleeds, bleeding from the gums,
• bleeding into the eye (including bleeding from the conjunctiva),
• bleeding into tissues or body cavities (hematoma, bruising),
• presence of blood in sputum (hemoptysis) when coughing,
• bleeding from the skin or subcutaneous bleeding,
• bleeding after surgery,
• oozing of blood or fluid from the wound after surgery,
• swelling of the limbs,
• limb pain,
• kidney function disorders (can be observed in tests performed by your doctor),
• fever,
• stomach pain, nausea (nausea) or vomiting, constipation, diarrhea,
• low blood pressure (symptoms may include dizziness or fainting when standing),
• general weakness and lack of energy (weakness, fatigue), headache, dizziness,
• rash, itching,
• increased activity of certain liver enzymes, which can be seen in blood test results. Uncommon(may affect up to 1 in 100 people):
• bleeding into the brain or skull (see above signs of bleeding),
• bleeding into a joint, causing pain and swelling,
• thrombocytopenia (low platelet count, cells involved in blood clotting),
• allergic reactions, including allergic skin reactions,
• liver function disorders (can be observed in tests performed by your doctor),
• blood test results may show increased bilirubin levels, certain liver or pancreatic enzyme activity, or platelet count,
• fainting,
• malaise,
• rapid heartbeat,
• dry mouth,
• hives.

Rare(may affect up to 1 in 1,000 people):

• bleeding into the muscles,
• cholestasis (bile stasis), hepatitis, including liver cell damage,
• jaundice (yellowing of the skin and eyes),
• local swelling,
• pseudoaneurysm (a complication of coronary catheterization, where the catheter is inserted into an artery in the leg). Very Rare(may affect up to 1 in 10,000 people):
• eosinophil accumulation, a type of white granular blood cell that causes inflammation in the lungs (eosinophilic pneumonia).

Frequency Not Known(frequency cannot be estimated from the available data):

• kidney failure after severe bleeding,
• kidney bleeding, sometimes with blood in the urine, leading to kidney failure (nephropathy associated with anticoagulant therapy),
• increased pressure in the muscles of the legs and arms, occurring after bleeding, which can lead to pain, swelling, changes in sensation, numbness, or paralysis (compartment syndrome after bleeding).

Side Effects in Children and Adolescents

Overall, the side effects observed in children and adolescents treated with Dovequa were similar in type to those observed in adults and were mostly mild to moderate.
Side effects observed more frequently in children and adolescents:
Very Common(may affect more than 1 in 10 people):

• headache,
• fever,
• nosebleeds,
• vomiting.

Common(may affect up to 1 in 10 people):

• rapid heartbeat,
• blood test results may show increased bilirubin levels,
• thrombocytopenia (low platelet count, cells involved in blood clotting),
• excessive menstrual bleeding.

Uncommon(may affect up to 1 in 100 people):

• blood test results may show increased direct bilirubin levels.

Reporting Side Effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medication.

5. How to Store Dovequa

Keep this medication out of the sight and reach of children.
Do not use this medication after the expiry date stated on the carton and blister. The expiry date refers to the last day of the month.
The notation on the packaging after the "EXP" abbreviation indicates the expiry date.
There are no special storage instructions for this medication.
Crushed Tablets
Crushed tablets are stable in water or apple sauce for up to 4 hours.
Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Package Contents 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, lactose monohydrate, microcrystalline cellulose (E460), sodium croscarmellose (E468), hypromellose type 2910 (5 mPas) (E464), magnesium stearate (E572). See section 2 "Dovequa contains lactose and sodium". Film coating 15 mg (Opadry II Pink 33G240024): hypromellose type 2910 (6 mPas) (E464), titanium dioxide (E 171), lactose monohydrate, macrogol 3350 (E1521), triacetin (E1518), iron oxide red (E 172), iron oxide black (E 172); Film coating 20 mg (Opadry II Red 33G250007): hypromellose type 2910 (6 mPas) (E464), titanium dioxide (E 171), lactose monohydrate, macrogol 3350 (E1521), triacetin (E1518), iron oxide red (E 172), iron oxide yellow (E 172).

What Dovequa Looks Like and Contents of the Package

Dovequa 15 mg is a pink, round, biconvex film-coated tablet with a diameter of 6 mm, with "15" engraved on one side.
The tablets are in transparent blisters made of PVC/PVDC/Aluminum, packaged in cardboard boxes containing 14, 28, 42, or 100 film-coated tablets.
Dovequa 20 mg is a reddish-brown, round, biconvex film-coated tablet with a diameter of 7 mm, with "20" engraved on one side.
The tablets are in transparent blisters made of PVC/PVDC/Aluminum, packaged in cardboard boxes containing 10, 14, 28, or 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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.
ul. Pelplińska 19
83-200 Starogard Gdański
Polska
tel. + 48 22 364 61 01

Date of Last Revision of the Package Leaflet: