Dovequa

Package Leaflet: Information for the Patient

Dovequa, 10 mg, Film-Coated Tablets

Rivaroxaban

Read the package leaflet carefully before taking the medicine, 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 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 package leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Package 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

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

• prevent the formation of blood clots in the veins after hip or knee replacement surgery. Your doctor has prescribed this medicine because the risk of blood clot formation is increased after surgery.
• treat blood clots in the veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism) and prevent the recurrence of blood clots in the veins of the legs and/or lungs.

Dovequa belongs to a group of medicines called anticoagulants. Its action is based on blocking the blood clotting factor (factor Xa) and thus reducing 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 severe 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 treatment or when heparin is given to maintain the patency of a venous or arterial catheter,
• 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 to take Dovequa, discuss it with your doctor or pharmacist.

Be particularly careful when taking Dovequa:

• if you have an increased risk of bleeding, such as:
• moderate or severe kidney disease, as kidney function may affect the amount of medicine that works in your body,
• if you are taking other medicines that prevent blood clotting (e.g., warfarin, dabigatran, apixaban, or heparin) when switching anticoagulant treatment 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,
• eye blood vessel disease (retinopathy),
• lung disease in which the airways are enlarged and filled with pus (bronchiectasis) or previous lung bleeding,
• in patients with artificial heart valves,
• if you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clot formation), you should inform your doctor, who will decide whether to change the treatment,
• if you have abnormal blood pressure or are 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. 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 strictly specified time before and after surgery,
• if catheterization or spinal puncture is planned during surgery (e.g., for epidural or spinal anesthesia or pain relief):
• it is very important to take Dovequa according to your doctor's instructions
• 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 disorders after anesthesia.

Children and adolescents

Dovequa 10 mg tablets are not recommended for persons under 18 years of age. There is a lack of sufficient data on the use of this medicine in children and adolescents.

Dovequa and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to 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 topically 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 suspect that you have any of the above conditions, inform

your doctorbefore taking Dovequa, as the effect of Dovequa may be enhanced. Your doctor will decide whether to use this medicine and whether you should be closely monitored.
If your doctor considers that you have an increased risk of stomach or intestinal ulcers, they may use preventive treatment.

• 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 belongs to a group of antibiotics.

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

before 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 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 (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 previously been diagnosed with intolerance to some sugars, you should contact your doctor before taking the 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

This medicine should always be taken exactly as your doctor has instructed. If you are unsure, ask your doctor or pharmacist.

How many tablets to take

• To prevent blood clots in the veins after hip or knee replacement surgery: The recommended dose is one 10 mg Dovequa tablet taken once a day.
• To treat blood clots in the veins of the legs, blood clots in the blood vessels of the lungs, and to prevent the recurrence of blood clots.

After at least 6 months of treatment for blood clots, the recommended dose is one 10 mg tablet once a day or one 20 mg tablet once a day. Your doctor has prescribed Dovequa 10 mg once a day for you.

• The tablet should be swallowed, preferably with water.
  Dovequa can be taken with or without food.
  If you have difficulty swallowing the whole tablet, you should 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 it.
  If necessary, your doctor may administer the crushed Dovequa tablet through a gastric tube.

When to take Dovequa

You should take one tablet every day until your doctor decides to stop the treatment.
It is best to take the tablet at the same time every day, as it will be easier to remember.
Your doctor will decide how long you should continue the treatment.
To prevent blood clots in the veins after hip or knee replacement surgery:

The first tablet should be taken 6 to 10 hours after the surgical procedure.
In patients after major hip surgery, treatment usually lasts 5 weeks.
In patients after major knee surgery, treatment usually lasts 2 weeks.

Taking more than the recommended dose of Dovequa

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

Missing a dose of Dovequa

If you have forgotten to take a dose, you should take the tablet as soon as you remember.
The next tablet should be taken the next day, and then the tablets should be taken as usual, once a day.
Do not take a double dose to make up for the missed dose.

Stopping the treatment with Dovequa

Do not stop taking Dovequa without first consulting your doctor, as Dovequa prevents the occurrence of a serious disease.
If you have any further questions about 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 with similar blood clot-reducing effects, Dovequa can cause bleeding, which can potentially 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. This is a serious medical emergency. You should immediately seek medical help!),
• prolonged or excessive bleeding,
• unusual weakness, fatigue, pallor, dizziness, headache, unexplained swelling, shortness of breath, chest pain, or angina pectoris. Your doctor may decide to closely monitor you or change the treatment.
• Signs of severe skin reactions:
• widespread, acute skin rash, blistering, or changes in the mucous membranes, e.g., on the tongue or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis),
• drug reaction causing rash, fever, inflammation of internal organs, hematological disorders, and systemic disorders (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 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):

• reduced red blood cell count, which may cause pallor and be the cause of weakness or shortness of breath,
• bleeding from the stomach or intestine, bleeding from the urinary or reproductive system (including blood in the urine and heavy menstrual bleeding), nosebleeds, bleeding gums,
• bleeding into the eye (including bleeding from the conjunctiva),
• bleeding into tissues or body cavities (hematoma, bruising),
• appearance of blood in sputum (hemoptysis) while 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, feeling of nausea (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 the 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, 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 the muscles,
• cholestasis (bile stasis), hepatitis, including liver cell damage,
• jaundice (yellowing of the skin and eyes),
• local swelling,
• blood accumulation (hematoma) in the groin as a complication of cardiac catheterization, when the catheter is inserted into the artery in the leg (pseudoaneurysm). Very rare(may affect up to 1 in 10,000 people):
• accumulation of eosinophils, a type of white granular blood cells, which 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 drugs),
• 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 package leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
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 medicine.

5. How to store Dovequa

The medicine should be stored 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 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 10 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 II Pink 33G34170): hypromellose type 2910 (6 mPas) (E464), titanium dioxide (E 171), lactose monohydrate, macrogol 3350 (E1521), triacetin (E1518), yellow iron oxide (E 172), black iron oxide (E 172), red iron oxide (E 172).

What Dovequa looks like and contents of the pack

Dovequa 10 mg is a pink, round, biconvex film-coated tablet with a diameter of 8 mm, with the number "10" embossed on one side.
The tablets are in transparent blisters made of PVC/PVDC/Aluminum, packed in cardboard boxes, containing 10, 28, 30 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
Poland
tel. + 48 22 364 61 01

Date of last revision of the package leaflet: