Dovequa

Package Leaflet: Information for the Patient

Dovequa, 15 mg, film-coated tablets

Dovequa, 20 mg, film-coated tablets

Rivaroxaban

Read all of this leaflet carefully before 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.

Contents of the pack and other information

• 1. What Dovequa is and what it is used for
• 2. What you need to know before you take Dovequa
• 3. How to take Dovequa
• 4. Possible side effects
• 5. How to store Dovequa
• 6. 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, if you have a form of irregular heart rhythm called atrial fibrillation not caused by a heart valve problem;
• treat blood clots in the veins of the legs (deep vein thrombosis) and blood vessels in the lungs (pulmonary embolism) and prevent blood clots from forming again in the blood vessels of the legs and/or lungs. Dovequa is used in children and adolescents aged below 18 years and weighing 30 kg or more to:
• treat and prevent blood clots from forming again in the veins or blood vessels in the lungs, after at least 5 days of initial treatment with injectable medicines used to treat blood clots.

Dovequa belongs to a group of medicines called anticoagulants. Its action is to block the blood clotting factor (factor Xa) and thus reduce the tendency to form blood clots.

2. What you need to know before you take Dovequa

Do not take Dovequa:

• if you are allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6),
• if you have bleeding that is not under control,
• if you have a disease or condition of an organ that increases the risk of major bleeding (e.g. stomach ulcer, injury or bleeding in the brain, recent brain or eye surgery),

if you are taking other medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), except when switching to a different anticoagulant treatment or when heparin is given to maintain a catheter in a vein or artery,

Do not take Dovequa and inform your doctorif you think any of the above applies to you.

Warnings and precautions

Before taking Dovequa, discuss this with your doctor or pharmacist.

Be particularly careful when taking Dovequa:

• if you have 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 medicine in the body,
• taking other medicines that prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin) when switching to a different anticoagulant treatment or when heparin is given to maintain a catheter in a vein or artery (see section "Dovequa and other medicines"),
• bleeding disorders,
• very high blood pressure that does not decrease despite treatment,
• stomach or intestinal diseases that may cause bleeding, such as inflammation of the intestines and stomach or inflammation of the esophagus (throat and esophagus) due to gastroesophageal reflux disease (backflow of stomach acid into the esophagus) or tumors located in the stomach or intestines or genital or urinary system,
• disease of the blood vessels in the back of the eyeballs (retinopathy),
• pulmonary disease where the airways are dilated and filled with pus (bronchiectasis) or previous bleeding from the lungs,
• in patients with prosthetic heart valves,
• if you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), you should inform your doctor, who will decide whether to change the treatment,
• if you have abnormal blood pressure or a surgical procedure is planned to remove a blood clot from the lungs.

If you think any of the above conditions apply to you, inform your

doctorbefore taking Dovequa. Your doctor will decide whether to use this medicine and whether you should be closely monitored.

If you need to have surgery:

• you must carefully follow your doctor's instructions regarding the intake of 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 special caution, you should immediately inform your doctor if you experience numbness or weakness in your legs, bowel or bladder problems after anesthesia.

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 medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including those obtained without a prescription.

• If you are taking: certain medicines 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 medicines used to treat bacterial infections (e.g. clarithromycin, erythromycin), certain antiviral medicines used to treat HIV or AIDS (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 and norepinephrine reuptake inhibitors (SNRIs)).

If you think any of the above conditions apply to you, inform your

doctorbefore taking Dovequa, as the effect of Dovequa may be increased. Your doctor will decide whether to use this medicine and whether you should be closely monitored.
If your doctor thinks you are at increased risk of developing stomach or intestinal ulcers, they may use a treatment to prevent ulcers.

• If you are taking: certain medicines used to treat epilepsy (phenytoin, carbamazepine, phenobarbital), St. John's Wort (Hypericum perforatum), a herbal medicine used to treat depression, rifampicin, which is an antibiotic.

If you think any of the above conditions apply to you, inform your

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

Pregnancy and breast-feeding

Do not take Dovequa if you are pregnant or breast-feeding. If there is a risk that you may become pregnant, you should use effective contraception during treatment with Dovequa. If you become pregnant during treatment with this medicine, you should inform your doctor immediately, who will decide on further treatment.

Driving and using machines

Dovequa may cause dizziness (common 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 been told that you have an intolerance to some sugars, you should contact your doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Dovequa

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Dovequa should be taken with food.
Swallow the tablet(s) whole, with water if possible.
If you have difficulty swallowing whole tablets, you should talk to your doctor about other ways to take Dovequa. The tablet can be crushed and mixed with water or apple puree, just before taking it. After such a mixture, you should eat a meal immediately.
If necessary, your doctor may also administer the crushed tablet through a gastric tube.

How many tablets to take

• Adults
• In preventing blood clots in the brain (stroke) and other blood vessels in the body: The recommended dose is one 20 mg Dovequa tablet once a day. If you have kidney disease, the dose may be reduced to one 15 mg Dovequa tablet once a day.

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

• In treating blood clots in the veins of the legs, blood clots in the lungs, and preventing blood clots from forming again: The recommended dose is one 15 mg Dovequa tablet twice a day for the first 3 weeks. For treatment after 3 weeks, the recommended dose is one 20 mg Dovequa tablet once a day. After at least 6 months of treatment for blood clots, your doctor may decide to continue treatment with either one 10 mg tablet once a day or one 20 mg tablet once a day. If you have kidney disease and are taking one 20 mg Dovequa tablet once a day, your doctor may decide to reduce the dose to one 15 mg Dovequa tablet once a day after 3 weeks of treatment, if the risk of bleeding is higher than the risk of further 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 from 30 kg to less than 50 kgis one Dovequa 15 mgtablet once a day. o The recommended dose for children and adolescents with a body weight of 50 kgor more is one Dovequa 20 mgtablet once a day.

Each dose of Dovequa should be taken with food, with a drink (e.g. water or juice).
Tablets should be taken every day at about the same time. It's a good idea to set an alarm to remind you.
For parents or caregivers: you should observe the child to make sure they take the whole dose.
The dose of Dovequa is based on body weight, so it's essential to attend scheduled doctor's appointments, as the dose may need to be adjusted due to weight changes.
Never adjust the dose yourself.If necessary, your doctor will adjust the dose.
Do not split the tablet to get a partial dose. If a smaller dose is needed, you should use other medicines in the form of granules for oral suspension.
For children and adolescents who are unable to swallow whole tablets, you should use other medicines 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 puree, just before taking it. After such a mixture, you should eat a meal immediately.
If necessary, your doctor may also administer the crushed tablet through a gastric tube.

If you spit out a dose or vomit

• less than 30 minutes after taking Dovequa, you should 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.

You should 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 the treatment.
It's 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 you should continue the treatment.
Preventing blood clots in the brain (stroke) and other blood vessels in the body:
If your heart rhythm needs to be restored to normal using a procedure called cardioversion, you should 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 oncea day and you miss a dose, you should take it as soon as possible. Do not take more than one tablet in a 24-hour period to make up for a missed dose. Take the next tablet at the usual time the next day, then continue taking one tablet once a day.
• Adults: If you take one 15 mg tablet twicea day and you miss a dose, you should 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 may 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 a day.

Taking more Dovequa than you should

If you take more Dovequa than you should, you should contact your doctor immediately. Taking more Dovequa than recommended may increase the risk of bleeding.

Stopping Dovequa

You should not stop taking Dovequa without first talking to your doctor, as Dovequa prevents a serious condition.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Seek medical help immediately if you experience any of the following side effects:

• 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 stiffness of the neck. This is a serious medical emergency. You should 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 closely monitor you or change the treatment.
• Signs of severe skin reactions:
• widespread, severe skin rash, blistering, or peeling of the skin (Stevens-Johnson syndrome, toxic epidermal necrolysis),
• a reaction to the medicine that causes a rash, fever, inflammation of internal organs, blood disorders, and systemic symptoms (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 may cause pallor and be the cause of weakness or shortness of breath,
• bleeding from the stomach or intestines, bleeding from the urinary tract (including blood in the urine and heavy menstrual bleeding), nosebleeds,
• bleeding into the eye (including bleeding from the conjunctiva),
• bleeding into tissues or body cavities (hematoma, bruising),
• appearance of blood in sputum when coughing,
• bleeding from the skin or subcutaneous bleeding,
• bleeding after surgery,
• oozing of blood or fluid from a wound after surgery,
• swelling of the limbs,
• limb pain,
• kidney problems (which can be seen in tests performed by your doctor),
• fever,
• stomach pain, nausea (nausea), 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 inside the 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 problems (which can be seen in tests performed by your doctor),
• blood test results may show increased levels of bilirubin, certain liver enzymes, 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 stagnation), hepatitis, including liver cell damage,
• jaundice (yellowing of the skin and eyes),
• local swelling,
• hematoma (collection of blood) in the groin as a complication of heart catheterization, when a catheter is inserted into an artery in the leg (pseudoaneurysm). Very rare(may affect up to 1 in 10,000 people):
• accumulation of eosinophils, a type of white blood cell, which can cause inflammation in the lungs (eosinophilic pneumonia).

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

• kidney failure after severe bleeding,
• bleeding in the kidneys, 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 seen in children and adolescents treated with Dovequa were similar in type to those seen in adults and were mainly mild to moderate.
Side effects seen 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 levels of bilirubin,
• thrombocytopenia (low platelet count),
• excessive menstrual bleeding.

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

• blood test results may show increased levels of a bilirubin subtype (direct bilirubin).

Reporting side effects

If you experience any side effects, talk to your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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 medicine.

5. How to store Dovequa

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 blister. The expiry date refers to the last day of that month.
The inscription on the packaging after the abbreviation EXP means the expiry date.
There are no special precautions for storage.
Crushed tablets
Crushed tablets are stable in water or apple puree for up to 4 hours.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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.
• The 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". 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); 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 pack

Dovequa 15 mg is a pink, round, biconvex film-coated tablet with a diameter of 6 mm, with the number "15" embossed on one side.
The tablets are packed in transparent blisters of PVC/PVDC/Aluminum, placed 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 the number "20" embossed on one side.
The tablets are packed in transparent blisters of PVC/PVDC/Aluminum, placed 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
phone: +48 17 865 51 00

Manufacturer

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

Date of last revision of the leaflet: