Rivaroxaban G.l. Pharma

Leaflet included in the packaging: information for the user

Rivaroxaban G.L. Pharma, 10 mg, film-coated tablets
Rivaroxabanum

It is very important to read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept in case it needs to be read again.
• In case of any further doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any undesirable effects, including any undesirable effects not mentioned in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Rivaroxaban G.L. Pharma and what is it used for
• 2. Important information before taking Rivaroxaban G.L. Pharma
• 3. How to take Rivaroxaban G.L. Pharma
• 4. Possible side effects
• 5. How to store Rivaroxaban G.L. Pharma
• 6. Contents of the packaging and other information

1. What is Rivaroxaban G.L. Pharma and what is it used for

Rivaroxaban G.L. Pharma 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. The 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.

Rivaroxaban G.L. Pharma 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 Rivaroxaban G.L. Pharma

When not to take Rivaroxaban G.L. Pharma

• if the patient is allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6),
• if the patient has excessive bleeding,
• if the patient has 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 the patient is taking other medicines that prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), except when changing anticoagulant treatment or when heparin is administered to maintain the patency of a venous or arterial catheter,
• if the patient has liver disease that leads to an increased risk of bleeding,
• if the patient is pregnant or breastfeeding.

Do not take Rivaroxaban G.L. Pharma, and also inform your doctorif the patient suspects that any of the above circumstances have occurred.

Warnings and precautions

Before starting treatment with Rivaroxaban G.L. Pharma, the patient should discuss it with their doctor or pharmacist.

Special caution is required when taking Rivaroxaban G.L. Pharma

• if the patient has an increased risk of bleeding, in such conditions as:
• moderate or severe kidney disease, as kidney function may affect the amount of medicine acting in the patient's body,
• taking other medicines that prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), when changing anticoagulant treatment or when heparin is administered to maintain the patency of a venous or arterial catheter (see "Rivaroxaban G.L. Pharma 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 reflux disease of the esophagus (reflux of stomach acid into the esophagus),
• disease of the blood vessels of the back of the eye (retinopathy),
• pulmonary disease, in which the bronchi are dilated and filled with pus (bronchiectasis) or previous bleeding from the lungs,
• in patients with artificial heart valves,
• if the patient has a disorder called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clot formation), the patient should inform their doctor, who will decide on possible changes to the treatment,
• if the patient has been diagnosed with abnormal blood pressure or is scheduled for surgery or other treatment to remove a blood clot from the lungs.

If the patient suspects that any of the above conditions exist, they should inform their doctorbefore taking Rivaroxaban G.L. Pharma.The doctor will decide whether to use this medicine and whether the patient should be subject to special observation.

If the patient needs to undergo surgery:

• the patient should strictly follow the doctor's recommendations regarding the intake of Rivaroxaban G.L. Pharma at a precisely specified time before or after surgery,
• if spinal puncture or catheter insertion into the spinal cord is planned during surgery (e.g. for spinal or epidural anesthesia or for pain relief):
• the patient should strictly follow the doctor's recommendations regarding the intake of Rivaroxaban G.L. Pharma at a precisely specified time,
• the patient should immediately inform their doctor if, after the anesthesia is completed, they experience symptoms such as: numbness, weakness of the legs, disorders of bowel or bladder function, as immediate treatment may be necessary.

Children and adolescents

Rivaroxaban G.L. Pharma is not recommended for persons under 18 years of age. There is a lack of sufficient data on the use of the medicine in children and adolescents.

Rivaroxaban G.L. Pharma and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as about medicines they 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 locally on the skin,
• ketokonazole in 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 infection 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 any of the above points apply to the patient, they should inform their doctorbefore taking Rivaroxaban G.L. Pharma, as the effect of Rivaroxaban G.L. Pharma may be enhanced. The doctor will decide whether to use this medicine and whether the patient should be subject to special observation.
If the doctor believes that the patient is at increased risk of developing stomach or duodenal ulcers, they may use a medicine to prevent 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 to treat depression,
• rifampicin, which belongs to a group of antibiotics.

If any of the above points apply to the patient, they should inform their doctorbefore taking Rivaroxaban G.L. Pharma,as the effect of Rivaroxaban G.L. Pharma may be reduced. The doctor will decide whether to use Rivaroxaban G.L. Pharma and whether the patient should be subject to special observation.

Pregnancy and breastfeeding

Rivaroxaban G.L. Pharma should not be taken if the patient is pregnant or breastfeeding. If there is a risk that the patient may become pregnant, they should use an effective method of contraception while taking Rivaroxaban G.L. Pharma. If the patient becomes pregnant while taking this medicine, they should immediately inform their doctor, who will decide on further treatment.

Driving and operating machinery

Rivaroxaban G.L. Pharma may cause dizziness (common side effects) and fainting (uncommon side effects) (see section 4 "Possible side effects").
Patients who experience these side effects should not drive or operate machinery.

Rivaroxaban G.L. Pharma contains lactose and sodium.

If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.
The medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means it is "sodium-free".

3. How to take Rivaroxaban G.L. Pharma

This medicine should always be taken according to the doctor's recommendations. In case of doubts, the doctor or pharmacist should be consulted.

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 Rivaroxaban G.L. Pharma 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 in the veins of the legs and/or lungs. 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. The doctor has prescribed Rivaroxaban G.L. Pharma 10 mg once a day for the patient.

The tablet should be swallowed, preferably with water.
Rivaroxaban G.L. Pharma can be taken with or without food.
If the patient has difficulty swallowing the whole tablet, they should talk to their doctor about other ways to take Rivaroxaban G.L. Pharma. The tablet can be crushed and mixed with water or apple sauce, just before taking it.
If necessary, the doctor may administer the crushed Rivaroxaban G.L. Pharma tablet through a gastric tube.

When to take Rivaroxaban G.L. Pharma

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

The first tablet should be taken 6 to 10 hours after surgery.
Treatment usually lasts 5 weeks in patients after major hip surgery.
Treatment usually lasts 2 weeks in patients after major knee surgery.

Taking a higher dose of Rivaroxaban G.L. Pharma than recommended

If the patient has taken a higher dose of Rivaroxaban G.L. Pharma than recommended, they should immediately contact their doctor. Taking too high a dose of Rivaroxaban G.L. Pharma increases the risk of bleeding.

Missing a dose of Rivaroxaban G.L. Pharma

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

Stopping treatment with Rivaroxaban G.L. Pharma

The patient should not stop taking Rivaroxaban G.L. Pharma without consulting their doctor, as Rivaroxaban G.L. Pharma prevents the development of a serious disease.
In case of any further doubts related to the use of this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, Rivaroxaban G.L. Pharma can cause side effects, although not everybody gets them.
Like other medicines with similar effects (anticoagulants), Rivaroxaban G.L. Pharma can cause bleeding, which can potentially be life-threatening. Excessive bleeding can lead to a sudden drop in blood pressure (shock). Not all signs of bleeding will be obvious or visible.

Possible side effects that may be a sign of bleeding:

The doctor should be informed immediatelyif the patient experiences any of the following side effects:

• 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. Medical help should be sought immediately!),
• prolonged or excessive bleeding,
• unusual weakness, fatigue, pallor, dizziness, headache, swelling of unknown cause, shortness of breath, chest pain or angina pectoris, which may be signs of bleeding. The doctor may decide to closely monitor the patient or change the treatment.

Possible side effects that may be a sign of a skin reaction:

The doctor should be informed immediatelyif the patient experiences any of the following skin reactions:

• widespread, acute skin rash, blistering or changes in the mucous membranes, e.g. in the mouth or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis). The frequency of these side effects is very rare (may occur in less than 1 in 10,000 patients),
• 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 (may occur in less than 1 in 10,000 patients).

Possible side effects that may be a sign of a severe allergic reaction

The doctor should be informed immediatelyif the patient experiences any of the following side effects:

• swelling of the face, lips, mouth, tongue, or throat; difficulty swallowing; hives and difficulty breathing; sudden drop in blood pressure. The frequency of these side effects is very rare (anaphylactic reactions, including anaphylactic shock, may occur in less than 1 in 10,000 patients) and uncommon (angioedema and allergic edema may occur in less than 1 in 100 patients).

General list of possible side effects:

Common(may occur in 1 in 10 patients)

• decrease in 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 tract (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 limb,
• limb pain,
• kidney function disorders (may be observed in tests performed by the doctor)
• fever,
• stomach pain, nausea, 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, skin itching,
• increased activity of some liver enzymes, which may be visible in blood test results.

Uncommon(may occur in 1 in 100 patients)

• bleeding into the brain or inside the skull,
• bleeding into a joint, causing pain and swelling,
• thrombocytopenia (low platelet count, cells involved in blood clotting),
• allergic reactions, including allergic skin reactions,
• liver function disorders (may be observed in tests performed by the doctor),
• blood test results may show increased bilirubin levels, activity of some pancreatic or liver enzymes, or platelet count,
• fainting,
• malaise,
• rapid heartbeat,
• dry mouth,
• hives.

Rare(may occur in 1 in 1,000 patients)

• bleeding into a muscle,
• cholestasis (bile stasis), liver inflammation, 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 (pseudoaneurysm).

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 anticoagulants),
• increased pressure in the muscles of the legs and arms, which can lead to pain, swelling, changes in sensation, numbness, or paralysis (compartment syndrome after bleeding).

Reporting side effects

If any undesirable effects occur, including any undesirable effects not mentioned in the leaflet,

the doctor or pharmacist should be informed. Side effects can be reported directly to:
Department for Monitoring of Adverse Reactions of Medicinal Products
Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181 C
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.
Reporting side effects allows for the collection of more information on the safety of the medicine.

5. How to store Rivaroxaban G.L. Pharma

The medicine should be stored out of sight and reach of children.
The medicine should not be taken after the expiry date stated on the carton and each blister after EXP. The expiry date refers to the last day of the month stated.
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Rivaroxaban G.L. Pharma contains

• The active substance of the medicine is rivaroxaban. One film-coated tablet contains 10 mg of rivaroxaban.
• The medicine also contains: Tablet core: microcrystalline cellulose, lactose monohydrate, sodium lauryl sulfate, hypromellose 2910, sodium croscarmellose, magnesium stearate. Coating: hypromellose 2910, titanium dioxide (E 171), macrogol 3350, iron oxide red (E 172).

What Rivaroxaban G.L. Pharma looks like and what the pack contains

Rivaroxaban G.L. Pharma is a round, biconvex, pink tablet (6 mm in diameter) with "10" embossed on one side and smooth on the other.
Transparent blisters made of PVC/PVDC/Aluminum in a cardboard box.
The packaging contains: 5, 10, 14, 28, 30, 42, 45, 56, 60, 90, 98, or 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria

Manufacturer

S.C. Labormed-Pharma S.A.
Bd. Theodor Pallady nr. 44B, sector 3
032266 Bucharest
Romania
G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach, Austria
Adalvo Ltd.Malta Life Sciences Park
Building 1, Level 4, Sir Temi Zammit Buildings
SGN 3000 San Gwann
Malta

To obtain more detailed information, please contact the representative of the marketing authorization holder:

G.L. PHARMA POLAND Sp. z o.o.
Al. Jana Pawła II 61/313
01-031 Warsaw, Poland
Phone: 022/636 52 23; 636 53 02
[email protected]
Date of last revision of the leaflet:11.12.2023