Dovequa

Package Leaflet: Information for the Patient

Dovequa, 2.5 mg, Film-Coated Tablets

Rivaroxaban

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 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. Contents of the pack and other information

1. What is Dovequa and what is it used for

You have been given Dovequa because:

• you have been diagnosed with acute coronary syndrome (a condition that includes heart attack and unstable angina, severe chest pain) and have elevated levels of cardiac biomarkers. Dovequa reduces the risk of another heart attack or reduces the risk of death due to heart or blood vessel disease in adults. Dovequa will not be given to you as the only medicine. Your doctor will also prescribe you to take:
• aspirin or
• aspirin and clopidogrel or ticlopidine.
• you have been diagnosed with a high risk of blood clots due to coronary artery disease or peripheral arterial disease, which causes symptoms. Dovequa reduces the risk of blood clots (atherothrombotic events) in adults. Dovequa will not be given to you as the only medicine. Your doctor will also prescribe you to take aspirin. In some cases, if you are taking Dovequa after a procedure to open up a narrowed or blocked artery in your leg to restore blood flow, your doctor may also prescribe clopidogrel for you to take for a short time in addition to aspirin. Dovequa contains the active substance rivaroxaban and belongs to a group of medicines called anticoagulants. Its action is to block a blood clotting factor (factor Xa) and thereby reduce the tendency to form blood clots.

2. Important information before taking Dovequa

When not to take Dovequa:

• if you are allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6),
• if you have excessive bleeding,
• if you have 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),
• if you are taking other medicines that prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), except when switching anticoagulant therapy or when heparin is given to maintain the patency of a venous or arterial catheter,
• if you have had acute coronary syndrome and have had bleeding or blood clots in the brain (stroke),
• if you have coronary artery disease or peripheral arterial disease and have had bleeding in the brain (stroke) or blockage of small arteries supplying blood to the brain tissues (cerebral sinus thrombosis), or if you have had a blood clot in the brain (ischemic stroke) in the last month,
• if you have liver disease that leads to an increased risk of bleeding,
• if you are pregnant or breastfeeding.

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

Warnings and precautions

Before starting treatment with Dovequa, discuss it with your doctor or pharmacist.
Dovequa should not be taken with other anticoagulant medicines, except for aspirin, clopidogrel or ticlopidine.

Be careful when taking Dovequa:

• if you have an increased risk of bleeding, such as:
• severe kidney disease, as kidney function may affect the amount of medicine that works in your body,
• taking other anticoagulant medicines (e.g. warfarin, dabigatran, apixaban or heparin) when switching anticoagulant therapy or when heparin is given to maintain the patency of a venous or arterial catheter (see "Dovequa and other medicines"),
• bleeding disorders,
• very high blood pressure that does not decrease despite taking medicines,
• stomach or intestinal diseases that may cause bleeding, e.g. inflammation of the intestines and stomach or inflammation of the esophagus (throat and esophagus) e.g. due to gastroesophageal reflux disease (stomach acid flowing back into the esophagus) or tumors located in the stomach or intestines or genital or urinary system,
• vascular disease of the back of the eye (retinopathy),
• pulmonary disease in which the airways are dilated and filled with pus (bronchiectasis) or previous bleeding from the lungs,
• if you are over 75 years old,
• if you weigh less than 60 kg,
• coronary artery disease with severe symptomatic heart failure,
• 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 your treatment.

If you suspect that you have any of the above conditions, inform

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

If you need to have surgery:

• you should carefully follow your doctor's instructions regarding taking Dovequa at a specific time before or after surgery,
• if catheterization or spinal puncture is planned (e.g. for epidural or spinal anesthesia or pain relief):
• it is very important to take Dovequa before and after the puncture or catheter removal, 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 2.5 mg tablets are not recommended for people under 18 years of age. There is a lack of sufficient data on the use of the medicine in children and adolescents.

Dovequa and other medicines

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

• If you are taking: certain antifungal medicines (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 antibacterial medicines (e.g. clarithromycin, erythromycin), certain antiviral medicines used to treat HIV or AIDS (e.g. ritonavir), other medicines that reduce blood clotting (e.g. enoxaparin, clopidogrel or vitamin K antagonists, such as warfarin or acenocoumarol, prasugrel and ticagrelor (see "Warnings and precautions")), non-steroidal anti-inflammatory and pain-relieving medicines (e.g. naproxen or aspirin), dronedarone, a medicine used to treat heart rhythm disorders, certain medicines used to treat depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin and noradrenaline 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. Your doctor will decide whether to prescribe this medicine and whether you should be closely monitored.
If your doctor thinks that you are at risk of developing stomach or intestinal ulcers, they may prescribe 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 suspect that you have any of the above conditions, inform

your doctorbefore taking Dovequa, as the effect of Dovequa may be reduced. Your doctor will decide whether to prescribe Dovequa and whether you 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, you should use effective contraception while taking Dovequa. If you become pregnant while taking this medicine, you should 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 bike, or operate tools or machines.

Dovequa contains lactose and sodium

If you have previously been diagnosed with 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 that the medicine is considered "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.

How many tablets to take

The recommended dose is one 2.5 mg tablet twice a day. Dovequa should be taken at the same time every day (e.g. one tablet in the morning and one in the evening). This medicine can be taken with or without food.
If you have difficulty swallowing whole tablets, you should talk to your doctor about other ways of taking Dovequa. The tablet can be crushed and mixed with water or apple sauce, just before taking it.
If necessary, your doctor may give you a crushed Dovequa tablet through a gastric tube.
Dovequa will not be given to you as the only medicine.
Your doctor will also prescribe you to take aspirin. If you are taking Dovequa after acute coronary syndrome, your doctor may also prescribe clopidogrel or ticlopidine for you to take.
If you are taking Dovequa after a procedure to open up a narrowed or blocked artery in your leg to restore blood flow, your doctor may prescribe clopidogrel for you to take for a short time in addition to aspirin.
Your doctor will tell you what dose of these medicines to take (usually 75-100 mg of aspirin per day or a daily dose of 75-100 mg of aspirin plus a daily dose of 75 mg of clopidogrel or a standard daily dose of ticlopidine).

When to start taking Dovequa

Treatment with Dovequa after acute coronary syndrome should be started as soon as possible after stabilization of acute coronary syndrome, at the earliest 24 hours after hospitalization and when parenteral (by injection) anticoagulant treatment would normally be discontinued.
Your doctor will tell you when to start treatment with Dovequa if you have been diagnosed with coronary artery disease or peripheral arterial disease.
Your doctor will decide how long to continue treatment.

Taking more Dovequa than prescribed

If you have taken more Dovequa than prescribed, you should immediately contact your doctor. Taking too much Dovequa increases the risk of bleeding.

Missing a dose of Dovequa

Do not take a double dose to make up for a missed dose. If you miss a dose, you should take the next dose at the scheduled time.

Stopping treatment with Dovequa

Dovequa should be taken regularly and for the time prescribed by your doctor.
Do not stop taking Dovequa without first consulting your doctor. If you stop taking this medicine, you may increase your risk of having another heart attack, stroke, or death due to heart or blood vessel disease.
If you have any further questions about taking 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 can cause bleeding, which can be life-threatening. Excessive bleeding can lead to a sudden drop in blood pressure (shock). These may not always be obvious or visible signs of bleeding.

Immediately inform your doctor 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. 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 closely monitor you or change your treatment.
• Signs of severe skin reactions:
• widespread, acute skin rash, blistering or changes to the mucous membranes, e.g. on the tongue or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis),
• drug reaction that causes rash, fever, inflammation of internal organs, hematological disorders, and systemic disorders (DRESS syndrome). The frequency of these side effects is very rare (maximum 1 in 10,000 people).
• Signs of serious 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 up to 1 in 10,000 people) and uncommon (angioedema and allergic edema may occur in 1 in 100 people).

General list of possible side effects:

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

• decrease in red blood cell count, which can cause pallor and be the cause of weakness or shortness of breath,
• bleeding from the stomach or intestine, bleeding from the urinary or genital 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),
• appearance of blood in sputum (hemoptysis) 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 (can be observed in tests performed by your doctor),
• fever,
• stomach pain, nausea, feeling sick (nausea) or vomiting, constipation, diarrhea,
• low blood pressure (symptoms may include dizziness or fainting when standing up),
• general weakness and lack of energy (weakness, fatigue), headache, dizziness,
• rash, itching of the skin,
• 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 (can be observed in tests performed by your doctor),
• blood test results may show increased levels of bilirubin, activity of certain pancreatic or liver enzymes, or platelet count,
• fainting,
• malaise,
• rapid heartbeat,
• dry mouth,
• hives.

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

• bleeding into muscles,
• cholestasis (bile flow obstruction), hepatitis, including liver cell damage,
• jaundice (yellowing of the skin and eyes),
• local swelling,
• blood accumulation (hematoma) in the groin as a complication of heart catheterization, when a catheter is inserted into an artery in the leg.

Very rare(may affect up to 1 in 10,000 people):

• accumulation of eosinophils, a type of white granular blood cells, 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).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Adverse Reaction Monitoring of the 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 stated on the carton and blister. The expiry date refers to the last day of the month.
The inscription on the packaging after the abbreviation EXP means the expiry date.
There are no special precautions for storing the medicine.
Crushed tablets
Crushed tablets are stable in water or apple sauce for up to 4 hours.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Dovequa contains

• The active substance of Dovequa is rivaroxaban. Each film-coated tablet contains 2.5 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". Tablet coating (Opadry Yellow 03F12967): hypromellose type 2910 (6 mPas) (E464), titanium dioxide (E 171), talc (E553b), macrogol 8000 (E1521), yellow iron oxide (E 172).

What Dovequa looks like and contents of the pack

Dovequa, 2.5 mg are light yellow, round, biconvex film-coated tablets with a diameter of 8 mm, with the number "2.5" embossed on one side.
The tablets are in transparent blisters of PVC/PVDC/Aluminum, packed in cardboard boxes, containing 28 or 56 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.
Pelplińska 19
83-200 Starogard Gdański
Poland
phone: + 48 22 364 61 01

Date of last revision of the leaflet: