Rivahib

Package leaflet: Information for the patient

Varodoax, 10 mg, film-coated tablets
Rivaroxabanum
This medicinal product will be subject to additional monitoring. This will allow for rapid
identification of new safety information. You, as a user of this medicine, can help by
reporting any side effects that occur after using the medicine. For information on how to report side effects – see section 4.
It is important to read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult 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 side effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

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

1. What Varodoax is and what it is used for

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

• prevent the formation of blood clots in veins following hip or knee replacement surgery. Your doctor has prescribed this medicine because the 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.

Varodoax 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 Varodoax

When not to take Varodoax

• 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 leads to an increased risk of serious bleeding (e.g. stomach ulcer, trauma or bleeding into the brain, recent surgery on the brain or eyes),
• if the patient is taking other medicines that prevent blood clots (e.g. warfarin, dabigatran, apixaban or heparin), except when switching anticoagulant therapy or if heparin is administered to maintain the patency of a catheter in a vein or artery,
• if the patient has liver disease that leads to an increased risk of bleeding,
• if the patient is pregnant or breastfeeding.

Do not use Varodoax and inform your doctor if you suspect any of the above conditions have occurred.
Warnings and precautions
Before starting treatment with Varodoax, discuss this with your doctor or pharmacist.
When to exercise special caution when using Varodoax

• 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 drug acting in the patient's body,
  • if the patient is taking other medicines that prevent blood clots (e.g. warfarin, dabigatran, apixaban or heparin), except when switching anticoagulant therapy or if heparin is administered to maintain the patency of a catheter in a vein or artery (see section "Varodoax and other medicines"),
  • blood clotting disorders,
  • very high blood pressure that does not decrease despite medication,
  • stomach or intestinal diseases that may cause bleeding, e.g. inflammation of the intestine 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 or intestines or in the genital or urinary system,
  • blood vessel disease in the back of the eye (retinopathy),
  • lung disease in which 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 abnormal blood pressure or if surgery or another treatment to remove a blood clot from the lungs is planned.

If the patient suspects any of the above conditions, they should inform the doctor before using Varodoax. 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:

• strictly follow the doctor's instructions regarding the timing of taking Varodoax before or after surgery,
• if during surgery the patient is scheduled to undergo lumbar puncture or placement of a catheter into the spinal canal (e.g. for epidural or spinal anaesthesia or for pain relief):
• strictly follow the doctor's instructions regarding the timing of taking Varodoax,
• immediately inform the doctor if, after the anaesthesia ends, the patient experiences symptoms such as: numbness, weakness in the legs, disturbances in bowel movements or bladder function, as immediate treatment may be required.

Children and adolescents
Varodoax 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.
Varodoax and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take, including those available without a prescription.

• If the patient is 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 in the treatment of Cushing's syndrome, in which the body produces too much cortisol),
• certain antibiotics used to treat bacterial infections (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 (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs)).

If the patient suspects any of the above apply to them, they should inform the doctor before using Varodoax, as the effect of Varodoax may be increased. 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 duodenal ulcers, they may prescribe preventive treatment for peptic ulcer disease.

• If the patient is taking:
• certain medicines used to treat epilepsy (phenytoin, carbamazepine, phenobarbital),
• St John's wort (Hypericum perforatum), a herbal medicine used for depression,
• rifampicin, which belongs to the group of antibiotics.

If the patient suspects any of the above apply to them, they should inform the doctor before using Varodoax, as the effect of Varodoax may be reduced when taken together with the above-mentioned medicines. The doctor will decide whether to use Varodoax and whether the patient should be placed under particularly close observation.
Pregnancy and breastfeeding
Do not use Varodoax 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 Varodoax. If the patient becomes pregnant while taking this medicine, she should inform the doctor immediately, who will decide on further management.
Driving and operating machinery
Varodoax may cause dizziness (common side effects) and 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.
Varodoax contains lactose and sodium.
If the patient has previously been diagnosed with intolerance to certain sugars, they should contact their doctor before taking this medicine.
The medicine contains less than 1 mmol of sodium (23 mg) per tablet, meaning the medicine is considered "sodium-free".

3. How to take Varodoax

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

• To prevent blood clots in the veins following hip or knee replacement surgery: The recommended dose is one Varodoax 10 mg tablet taken 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 10 mg tablet once daily or one 20 mg tablet once daily. The doctor has prescribed Varodoax 10 mg once daily for the patient.

The tablet should be swallowed whole, preferably with water.
Varodoax may be taken with or without food.
If the patient has difficulty swallowing the whole tablet, discuss with the doctor alternative
methods of taking Varodoax. The tablet may be crushed and mixed with water or apple puree immediately before administration.
If necessary, the doctor may administer crushed Varodoax tablets via a gastric tube.
When to take Varodoax
One tablet should be taken every day until the doctor decides to discontinue 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 the leg veins after hip or knee replacement surgery:
The first tablet should be taken between 6 and 10 hours after surgery.
In patients undergoing major hip replacement surgery, treatment usually lasts 5 weeks.
In patients undergoing major knee replacement surgery, treatment usually lasts 2 weeks.
Taking more than the recommended dose of Varodoax
If the patient has taken more than the recommended dose of Varodoax, contact the doctor immediately. Taking too high a dose of Varodoax increases the risk of bleeding.
Missed dose of Varodoax
If the patient forgets to take a dose, take the tablet as soon as remembered.
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 Varodoax treatment
Do not stop taking Varodoax without first talking to the doctor, as Varodoax helps prevent serious illness.
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like any medicine, this medicine may cause adverse effects, although not in everyone.
As with other medicines of similar action that reduce blood clot formation, Varodoax
may cause bleeding, which potentially could be life-threatening. Excessive bleeding may
lead to a sudden drop in blood pressure (shock). Signs of bleeding may not always be 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, reduced level of consciousness and neck stiffness. A serious, sudden medical emergency. Immediate medical assistance must be called!),
  • 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, formation of blisters or changes in mucous membranes, e.g. in the tongue 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 occurrence of these adverse 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; 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 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 people)

• reduction in the number of red blood cells, which may cause paleness of the skin and lead to weakness or shortness of breath,
• bleeding from the stomach or intestines, bleeding from the urinary or genital tract (including blood in urine and heavy menstrual bleeding), nosebleeds, bleeding from the gums,
• bleeding into the eye (including bleeding from the white part of the eye),
• bleeding into tissues or body cavities (hematoma, bruising),
• presence of blood in sputum (hemoptysis) during coughing,
• bleeding from the skin or subcutaneous bleeding,
• bleeding after surgery,
• oozing of blood or fluid from a surgical wound,
• swelling of limbs,
• limb pain,
• impaired kidney function (may be observed in tests performed by a doctor),
• fever,
• stomach pain, indigestion, nausea or vomiting, constipation, diarrhea,
• low arterial blood pressure (symptoms may include dizziness or fainting upon standing),
• general reduction in strength and energy (weakness, fatigue), headache, dizziness,
• rash, itching of the skin,
• increased activity of certain liver enzymes, which may be evident in blood test results.

Uncommon (may occur in 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, blood cells involved in blood clotting),
• allergic reactions, including allergic skin reactions,
• impaired liver function (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,
• dry mouth,
• urticaria.

Rare (may occur in up to 1 in 1,000 people)

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

Frequency not known (frequency cannot be determined from available data)

• kidney failure following severe bleeding,
• bleeding in the kidneys, sometimes with presence of blood in urine, leading to impaired kidney function (nephropathy associated with anticoagulant medicines),
• increased pressure in the muscles of the legs and arms occurring after bleeding, which may lead to pain, swelling, altered sensation, tingling or paralysis (compartment syndrome following bleeding).

Reporting of adverse effects
If you experience any adverse effects, including any not listed in this leaflet, you should inform your doctor, pharmacist or nurse. 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 may 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 Varodoax

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard package and on each blister after "EXP". The expiry date refers to the last day of the stated month.
No special storage instructions apply 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 the sewage system or household waste bins. 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 Varodoax contains

• The active substance is rivaroxaban. Each tablet contains 10 mg of rivaroxaban.
• Other ingredients are:
  Tablet core: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, hypromellose (E 5), sodium lauryl sulfate, magnesium stearate.
  Coating: Aqua Polish P white [composition: hypromellose (E 5), hypromellose (E 15), hydroxypropylcellulose, polyethylene glycol 8000, titanium dioxide (E 171)], iron oxide red (E 172).

What Varodoax looks like and contents of the pack
Varodoax 10 mg are light red, round, biconvex coated tablets with a monogram "10" embossed on one side.
The cardboard box contains: 10 coated tablets in PVC/PVDC 90/Aluminium blisters.

Marketing Authorisation Holder
G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria

Manufacturer
Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice
G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria

For further information about this medicine, contact the local representative of the Marketing Authorisation Holder:
G.L. PHARMA POLAND Sp. z o.o.
Al. Jana Pawła II 61/313
01-031 Warsaw
Tel: 022/ 636 52 23; 636 53 02
[email protected]