Dovequa

Package leaflet: Information for the patient

Dovequa, 10 mg, film-coated tablets
Rivaroxaban
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

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

Contents of the leaflet

1. What Dovequa is and what it is 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 Dovequa is and what it is used for

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

• prevent blood clots from forming in the veins after hip or knee replacement surgery. Your doctor has prescribed this medicine because your risk of developing blood clots 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 to prevent the recurrence of blood clots in the blood vessels of the legs and/or lungs.

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 increases the 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 anticoagulant medicines (e.g. warfarin, dabigatran, apixaban or heparin), except when switching anticoagulant therapy or if heparin is administered to maintain catheter patency in a vein or artery,
• if the patient has liver disease leading 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 conditions apply to you.
Warnings and precautions
Talk to your doctor or pharmacist before taking Dovequa.
Exercise caution when taking Dovequa:

• if the patient has an increased risk of bleeding, such as in the following conditions:
  • moderate or severe kidney disease, as kidney function may affect the amount of medicine acting in the patient's body,
  • if the patient is taking other anticoagulant medicines (e.g. warfarin, dabigatran, apixaban or heparin) when switching anticoagulant therapy or when heparin is administered to maintain catheter patency in a vein or artery (see section "Dovequa with other medicines"),
  • blood clotting disorders,
  • very high blood pressure that does not decrease despite treatment with medication,
  • diseases of the stomach or intestines 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,
  • vascular disease of the posterior part of the eyeball (retinopathy),
  • lung disease with bronchiectasis (dilated bronchi filled with pus) or previous pulmonary haemorrhage,
• in patients with prosthetic heart valves,
• if the patient has a disorder called antiphospholipid syndrome (an immune system disorder causing increased risk of blood clots), the patient should inform the doctor, who will decide whether a change in treatment is needed,
• if the patient has abnormal blood pressure or if surgery or another treatment to remove a pulmonary clot is planned. If you suspect that any of the above conditions apply to you, inform your doctor before using Dovequa. The doctor will decide whether to use this medicine and whether the patient requires particularly close monitoring.

If the patient needs surgery:

• strictly follow the doctor's instructions regarding the timing of taking Dovequa before and after surgery,
• if during surgery a catheter or spinal puncture is planned (e.g. for epidural or intrathecal anaesthesia or pain relief):
  • it is very important to take Dovequa 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 10 mg tablets are not recommended for patients under 18 years of age. There is insufficient data on the use of this medicine in children and adolescents.

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 used topically on the skin only,
  • 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 antidepressants (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 using Dovequa, as the effect of Dovequa may be increased. The doctor will decide whether to use this medicine and whether particularly close monitoring is required. If the doctor considers that the patient has an increased risk of developing stomach or intestinal ulcers, preventive treatment may be prescribed.

• 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,
  • rifampicin, an antibiotic.

If you suspect that any of the above conditions apply to you, inform your doctor before using Dovequa, as the effect of Dovequa may be reduced. The doctor will decide whether to use Dovequa and whether particularly close monitoring is required.

Pregnancy and breastfeeding
Do not use Dovequa if the patient is pregnant or breastfeeding. If there is a risk that the patient could 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, who will decide on further management.

Driving and operating machinery
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 been previously diagnosed with an 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; i.e. it is considered "sodium-free".

3. How to take Dovequa

This medicine should always be taken as directed by the doctor. In case of doubt, consult a doctor or pharmacist.

How many tablets to take

• To prevent the formation of blood clots in veins after hip or knee replacement surgery: The recommended dose is one Dovequa 10 mg tablet taken once daily.
• For the treatment of blood clots in the leg veins, blood clots in blood vessels of the lungs, and to prevent recurrence of blood clots:
• After at least 6 months of treatment for blood clots, the recommended dose is one 10 mg tablet once daily or one 20 mg tablet once daily. The doctor has prescribed the patient Dovequa 10 mg once daily.

Swallow the tablet whole, preferably with water.
Dovequa may be taken with or without food.
If the patient has difficulty swallowing the whole tablet, discuss alternative ways of taking Dovequa with the doctor. The tablet may be crushed and mixed with water or apple puree immediately before administration.
If necessary, the doctor may administer crushed Dovequa tablets via a gastric tube.

When to take Dovequa
Take one tablet every day until the doctor decides to stop treatment.
It is best to take the tablet at the same time each day, as this makes it easier to remember.
The doctor will decide how long treatment should continue.

To prevent blood clots in veins after hip or knee replacement surgery:
The first tablet should be taken between 6 and 10 hours after surgery.
In patients after major hip surgery, treatment usually lasts for 5 weeks.
In patients after major knee surgery, treatment usually lasts for 2 weeks.

Taking more Dovequa than prescribed
If the patient has taken more than the prescribed dose of Dovequa, contact the doctor immediately. Taking too high a dose of Dovequa increases the risk of bleeding.

If a dose of Dovequa is missed
If the patient forgets to take a dose, take the tablet as soon as remembered.
Take the next tablet the following day, then continue taking the tablets as usual, once daily.
Do not take a double dose to make up for a missed dose.

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

4. Possible adverse effects

Like any medicine, Dovequa can cause adverse effects, although not everyone will experience them.
As with other medicines with a similar anticoagulant effect, Dovequa may cause bleeding, which potentially can 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 contact your doctor if any of the following adverse effects occur:

• Signs of bleeding:
• intracranial or cerebral haemorrhage (symptoms may include headache, one-sided paralysis, vomiting, seizures, decreased level of consciousness and neck stiffness. A serious, acute medical emergency. Immediate medical assistance must be sought!),
• prolonged or excessive bleeding,
• unusual weakness, fatigue, pallor, dizziness, headache, unexplained swelling, shortness of breath, chest pain or angina. Your doctor may decide that close monitoring of the patient or a change in treatment is necessary.
  • Signs of severe skin reactions:
• extensive, 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 disorders and systemic involvement. The frequency of these adverse effects is very rare (occurring in up to 1 in 10,000 people).
  • Signs of serious allergic reactions:
• swelling of the face, lips, oral cavity, tongue or throat; difficulty swallowing; urticaria and breathing difficulties; sudden drop in blood pressure. The frequency of severe hypersensitivity 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 effects:
Common (may occur in up to 1 in 10 patients):

• decreased number of red blood cells, which may cause skin pallor and lead to weakness or shortness of breath,
• gastrointestinal or intestinal bleeding, genitourinary bleeding (including blood in urine and severe menstrual bleeding), nosebleeds, gum bleeding,
• ocular haemorrhage (including bleeding from the conjunctiva),
• bleeding into tissues or body cavities (haematoma, bruising),
• presence of blood in sputum (haemoptysis) during coughing,
• skin bleeding or subcutaneous haemorrhage,
• 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, diarrhoea,
• low blood pressure (symptoms may include dizziness or fainting upon standing),
• general decrease in strength and energy (weakness, fatigue), headache, dizziness,
• rash, skin itching,
• 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 haemorrhage (see signs of bleeding above),
• joint bleeding causing pain and swelling,
• thrombocytopenia (low platelet count, 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,
• dryness of the oral cavity,
• urticaria.

Rare (may occur in up to 1 in 1000 patients):

• muscle haemorrhage,
• cholestasis (bile stasis), hepatitis including liver cell damage,
• yellowing of the skin and eyes (jaundice),
• localised swelling,
• blood accumulation (haematoma) in the groin 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 determined from available data):

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

Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects 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 label on the packaging marked "EXP" indicates the expiry date.
No special storage conditions are required 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 in use. This will help protect the environment.

6. Contents of the pack and other information

What Dovequa contains

• The active substance is rivaroxaban. Each 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 (E171), lactose monohydrate, polyethylene glycol 3350 (E1521), triacetin (E1518), yellow iron oxide (E172), black iron oxide (E172), red iron oxide (E172).

What Dovequa looks like and contents of the pack
Dovequa 10 mg are pink, round, biconvex coated tablets with a diameter of 8 mm, imprinted with the number "10" on one side.
The tablets are contained in transparent PVC/PVDC/Aluminium blisters, packed in cardboard boxes containing 10, 28 or 30 coated tablets.
Not all pack sizes may be marketed.

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.
ul. Pelplińska 19
83-200 Starogard Gdański
Poland
Tel: +48 22 364 61 01