Diwleiz

Patient Information Leaflet

Diwleiz, 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. 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 you personally. Do not pass it on to others. It may harm others, even if their symptoms are the same as yours.
• If you get any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Leaflet Contents

1. What Diwleiz is and what it is used for
2. What you need to know before you take Diwleiz
3. How to take Diwleiz
4. Possible side effects
5. How to store Diwleiz
6. Contents of the pack and other information

1. What Diwleiz is and what it is used for

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

• prevent blood clots 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 recurrence of blood clots in the blood vessels of the legs and/or lungs.

Diwleiz 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 Diwleiz

When not to use Diwleiz

• 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 serious bleeding (e.g. stomach ulcer, trauma or bleeding in the brain, recent surgery on the brain or eyes)
• if the patient is taking other medicines that prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), except when switching anticoagulant therapy or if heparin is administered to maintain the patency of an intravenous or arterial catheter
• if the patient has a liver disease that increases the risk of bleeding
• if the patient is pregnant or breastfeeding. Diwleiz must not be used and the doctor must be informed if the patient suspects any of the above circumstances apply.

Warnings and precautions
Before starting treatment with Diwleiz, discuss this with your doctor or pharmacist.
When to exercise special caution when using Diwleiz

• 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 medicines that prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), except when switching anticoagulant therapy or if heparin is administered to maintain the patency of an intravenous or arterial catheter (see section "Diwleiz with other medicines")
  • bleeding disorders
  • very high blood pressure that does not decrease despite medication
  • diseases of the stomach or intestines that may cause bleeding, e.g. inflammation of the intestines and stomach or 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 or intestines, or in the reproductive or urinary system
  • disease of blood vessels at the back of the eye (retinopathy)
  • lung disease in which the bronchi are dilated and filled with pus (bronchiectasis) or previous bleeding from the lungs
• in patients with prosthetic heart valves
• if the patient has a disorder called antiphospholipid syndrome (an immune system disorder causing an increased risk of blood clots), the patient should inform the doctor, who will decide whether a change in treatment is necessary
• if the patient has been diagnosed with abnormal blood pressure or is scheduled for surgery or other treatment aimed at removing a blood clot from the lungs.

If the patient suspects any of the above conditions apply, the doctor should be informed
before using Diwleiz. The doctor will decide whether to use this medicine and whether the
patient should be placed under particularly close observation.
If the patient needs to undergo surgery

• it is essential to strictly follow the doctor's instructions regarding the timing of Diwleiz administration before or after surgery.
• If during surgery the patient is scheduled to undergo a lumbar puncture or have a catheter inserted into the spine (e.g. for epidural or spinal anaesthesia or for pain relief):
  • it is essential to strictly follow the doctor's instructions regarding the timing of Diwleiz administration
  • the doctor should be informed immediately if, after the anaesthesia has ended, the patient experiences symptoms such as: numbness, weakness of the lower limbs, disturbances in bowel movements or bladder function, as immediate treatment will then be necessary.

Children and adolescents
Diwleiz 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.
Diwleiz with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including those available without a prescription.

• If the patient is taking
  • certain antifungal medicines (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are used only topically on the skin
  • ketoconazole tablets (used in the treatment of Cushing's syndrome - a condition 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 medicines used to treat depression (selective serotonin reuptake inhibitors (SSRI) or serotonin-noradrenaline reuptake inhibitors (SNRI)). If any of the above situations apply to the patient, the doctor should be informed before using Diwleiz, as the effect of Diwleiz may be enhanced. The doctor will decide whether to use this medicine and whether the patient should be placed under particularly close observation. 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, which belongs to the group of antibiotics.

If the patient suspects any of the above conditions apply, the doctor should be informed
before using Diwleiz, as the effect of Diwleiz may be reduced. The doctor will decide whether to use Diwleiz and whether the patient should be placed under particularly close observation.
Pregnancy and breastfeeding
Do not use Diwleiz if the patient is pregnant or breastfeeding. If there is a risk that the patient may become pregnant, an effective method of contraception should be used during treatment with Diwleiz. If the patient becomes pregnant while taking this medicine, the doctor should be informed immediately, who will decide on further treatment.
Driving and operating machinery
Diwleiz 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.
Diwleiz contains lactose and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact the doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Diwleiz

This medicine should always be taken as directed by the physician. In case of doubt, consult
your doctor or pharmacist.
How many tablets to take

• To prevent blood clots in veins after hip or knee replacement surgery: The recommended dose is one tablet of Diwleiz 10 mg once daily.
• For the treatment of blood clots in the leg veins, blood clots in the 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 tablet of 10 mg once daily or one tablet of 20 mg once daily. Your doctor has prescribed Diwleiz 10 mg to be taken once daily.

Swallow the tablet whole, preferably with water.
Diwleiz may be taken with or without food.
If you have difficulty swallowing the whole tablet, talk to your doctor about alternative ways
of taking Diwleiz. The tablet may be crushed and mixed with water or apple puree immediately before administration.
If necessary, your doctor may administer crushed Diwleiz tablets via a gastric tube.
When to take Diwleiz
Take one tablet every day until your 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.
Your doctor will decide how long treatment should continue.
To prevent blood clots in leg veins after hip or knee replacement surgery:
The first tablet should be taken between 6 and 10 hours after surgery.
For patients undergoing major hip surgery, treatment usually lasts 5 weeks.
For patients undergoing major knee surgery, treatment usually lasts 2 weeks.
Taking more Diwleiz than prescribed
If you have taken more Diwleiz than prescribed, contact your doctor immediately.
Taking too high a dose of Diwleiz increases the risk of bleeding.
If you forget to take Diwleiz
If you forget to take a dose, take it as soon as you remember.
Take the next tablet the following day, and then continue taking the tablets as usual, once daily.
Do not take a double dose to make up for a missed tablet.
Stopping Diwleiz
Do not stop taking Diwleiz without first talking to your doctor, as Diwleiz helps prevent a serious condition.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like any medicine, Diwleiz may cause adverse effects, although not everyone experiences them.
As with other medicines of similar action that reduce blood clot formation, Diwleiz may cause bleeding, which could potentially 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 inform your doctor if any of the following adverse effects occur:

• Signs of bleeding
  • bleeding into the brain or inside the skull (symptoms may include headache, one-sided paralysis, vomiting, seizures, decreased level of consciousness, and neck stiffness. This is a serious medical emergency. Seek immediate medical help!)
  • prolonged or excessive bleeding
  • unusual weakness, fatigue, paleness, 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
  • widespread, 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 abnormalities, and systemic illness. The frequency of these adverse effects is very rare (occurring in no more than 1 in 10,000 people).
• Signs of severe allergic reactions
  • swelling of the face, lips, mouth, oral cavity, tongue, or throat; difficulty swallowing; urticaria and breathing difficulties; sudden drop in blood pressure. The frequency of severe allergic reactions is very rare (anaphylactic reactions, including anaphylactic shock; may occur in no more than 1 in 10,000 people) and uncommon (angioedema and allergic edema; may occur in no more than 1 in 100 people).

General list of possible adverse effects
Common (may occur in no more than 1 in 10 people)

• reduced number of red blood cells, which may cause paleness of the skin and lead to weakness or shortness of breath
• gastrointestinal or intestinal bleeding, bleeding from the urinary or genital tract (including blood in urine and heavy menstrual bleeding), nosebleeds, gum bleeding
• bleeding into the eye (including subconjunctival hemorrhage)
• bleeding into tissues or body cavities (hematoma, bruising)
• coughing up blood
• bleeding from the skin or subcutaneous bleeding
• postoperative bleeding
• oozing of blood or fluid from a surgical wound
• limb swelling
• limb pain
• kidney function disorders (may be observed in tests ordered by a doctor)
• fever
• stomach pain, indigestion, nausea or vomiting, constipation, diarrhea
• low blood pressure (symptoms may include dizziness or fainting upon standing)
• general loss of strength and energy (weakness, fatigue), headache, dizziness
• rash, skin itching
• increased activity of certain liver enzymes, which may be seen in blood test results

Uncommon (may occur in no more than 1 in 100 people)

• bleeding into the brain or within the skull (see above, signs of bleeding)
• bleeding into a joint causing pain and swelling
• thrombocytopenia (low platelet count, the blood cells involved in blood clotting)
• allergic reactions, including allergic skin reactions
• liver function disorders (may be observed in tests ordered 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 mouth
• urticaria

Rare (may occur in no more than 1 in 1,000 people)

• bleeding into muscles
• cholestasis (bile stasis), hepatitis including liver cell damage
• yellowing of the skin and eyes (jaundice)
• localized swelling
• blood collection (hematoma) 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 no more than 1 in 10,000 people):

• 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
• bleeding in the kidneys, sometimes with blood in the urine, leading to impaired kidney function (drug-induced anticoagulant-related nephropathy)
• increased pressure in the muscles of the 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 any not listed in this leaflet, you should inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
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 Diwleiz

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, on each blister, or on the bottle after: EXP. The expiry date refers to the last day of the stated month.
There are no special storage instructions for this medicine.
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. This will help protect the environment.

6. Contents of the packaging and other information

What Diwleiz contains

• The active substance is rivaroxaban. Each coated tablet contains 10 mg of rivaroxaban.
• The other ingredients are:
  Tablet core: monohydrate lactose, microcrystalline cellulose (PH 102), sodium croscarmellose, sodium lauryl sulfate, hypromellose 2910, magnesium stearate. See section 2 "Diwleiz contains lactose and sodium".
  Tablet coating: hypromellose 2910 (E 464), titanium dioxide (E 171), macrogol 4000 (E 1521), iron oxide red (E 172).

What Diwleiz looks like and contents of the pack
Diwleiz 10 mg coated tablets are pink, round, biconvex, with the imprint "R" on one side and "10" on the other side.
Available in:
aluminum blisters packed in cardboard boxes containing 10, 28, 30, 98 or 100 coated tablets (with calendar blister or without), or
single-dose perforated blisters packed in cardboard boxes containing 30 x 1 or 100 x 1 coated tablet.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
MSN Labs Europe Limited
KW20A Corradino Park
Paola, PLA 3000
Malta
Tel.: (+48) 699 711 147

Manufacturer/Importer:
Pharmadox Healthcare Limited
KW20A Kordin Industrial Estate
Paola, PLA 3000
Malta
MSN Labs Europe Limited
KW20A Corradino Park
Paola, PLA 3000
Malta

This medicinal product is authorised in the European Economic Area countries under the following names:
Germany: Rivaroxaban MSN 10 mg Filmtabletten
ENR: 7008335
Bulgaria: Дивлейз 10 mg филмирани таблетки
Czech Republic: Diwleiz
Hungary: Diwleiz 10 mg filmtabletta
Poland: Diwleiz
Romania: Diwleiz 10 mg comprimate filmate
Slovakia: Diwleiz 10 mg