Rivaroxaban G.l. Pharma

Leaflet included in the packaging: information for the user

Rivaroxaban G.L. Pharma, 15 mg, film-coated tablets
Rivaroxaban G.L. Pharma, 20 mg, film-coated tablets
Rivaroxabanum

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you by a doctor for a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms 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.
Rivaroxaban G.L. Pharma is used in adults to:

• prevent the formation of blood clots in the brain (stroke) and other blood vessels in the patient's body, if the patient has a type of irregular heartbeat called atrial fibrillation not caused by a heart valve problem.
• treat blood clots in the veins of the legs (deep vein thrombosis) and blood vessels in the lungs (pulmonary embolism) and prevent the recurrence of blood clots in the blood vessels of the legs and/or lungs. Rivaroxaban G.L. Pharma is used in children and adolescents under 18 years of age and weighing 30 kg or more to:
• treat and prevent the recurrence of blood clots in the veins or blood vessels in the lungs, after at least 5 days of initial treatment with injectable medicines used to treat blood clots.

Rivaroxaban G.L. Pharma belongs to a group of medicines called anticoagulants. Its action is based on blocking a 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 an organ that increases the risk of serious bleeding (e.g. stomach ulcer, injury or bleeding in 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 switching anticoagulant treatment or when heparin is given to maintain catheter patency in a vein or artery,
• if the patient has a liver disease that increases the risk of bleeding,
• if the patient is pregnant or breastfeeding.

Do not take Rivaroxaban G.L. Pharma, and also inform your doctorif any of the above conditions apply to you.

Warnings and precautions

Before starting treatment with Rivaroxaban G.L. Pharma, you should discuss it with your doctor or pharmacist.

You should be particularly careful when taking Rivaroxaban G.L. Pharma

• if the patient has an increased risk of bleeding, in such conditions as:
• severe kidney disease in adults and moderate or severe kidney disease in children and adolescents, as kidney function may affect the amount of medicine that works in the patient's body,
• 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 catheter patency in a vein or artery (see "Rivaroxaban G.L. Pharma and other medicines"),
• bleeding disorders,
• very high blood pressure that does not decrease despite treatment,
• 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 (backflow of stomach acid into the esophagus),
• vascular disease in the back of the eye (retinopathy),
• pulmonary disease in which the airways are dilated and filled with pus (bronchiectasis) or previous bleeding from the lungs,
• in patients with artificial heart valves,
• if the patient has a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), the patient should inform their doctor, who will decide whether to change 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 they have any of the above conditions, they should inform their doctor

before taking Rivaroxaban G.L. Pharma. The doctor will decide whether to use this medicine and whether the patient should be closely monitored.

If the patient needs to undergo surgery:

• they should carefully follow the doctor's instructions regarding the intake of Rivaroxaban G.L. Pharma at a specific time before or after surgery,
• if a spinal puncture or catheter insertion into the spinal cord is planned during surgery (e.g. for spinal or epidural anesthesia or pain relief):
• it is very important to take Rivaroxaban G.L. Pharma before and after the puncture or catheter removal, according to the doctor's instructions,
• the patient should immediately inform their doctor if they experience symptoms such as numbness, leg weakness, bowel or bladder function disorders after the anesthesia is finished, as immediate treatment may be necessary.

Children and adolescents

Rivaroxaban G.L. Pharma is not recommended for children with a body weight below 30 kg. There is a lack of sufficient data on the use of the medicine in children and adolescents for indications in adults.

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 any medicines they plan to take, including those that are 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 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 noradrenaline 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 increased. The doctor will decide whether to use this medicine and whether the patient should be closely monitored.
If the doctor believes that the patient is at increased risk of developing stomach or duodenal ulcers, they may use preventive treatment for stomach ulcers.

• 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 closely monitored.

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 effective contraception during treatment with Rivaroxaban G.L. Pharma. If the patient becomes pregnant during treatment with this medicine, they should immediately inform their doctor, who will decide on further treatment.

Driving and using machines

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 instructions. In case of doubts, the patient should consult their doctor or pharmacist.
The tablet(s) should be swallowed, preferably with water.
Rivaroxaban G.L. Pharma should be taken during meals.
If the patient has difficulty swallowing whole tablets, they should discuss other ways of taking Rivaroxaban G.L. Pharma with their doctor. The tablet can be crushed and mixed with water or apple sauce immediately before intake.
If necessary, the doctor may also administer the crushed Rivaroxaban G.L. Pharma tablet through a gastric tube.

How many tablets to take

• Adults
• In the prevention of blood clots in the brain (stroke) and other blood vessels in the body. The recommended dose is one Rivaroxaban G.L. Pharma 20 mg tablet once a day. If the patient has kidney disease, the dose may be reduced to one Rivaroxaban G.L. Pharma 15 mg tablet once a day.

If the patient needs a procedure to open up the blood vessels in the heart (called percutaneous coronary intervention - PCI with stent placement), there is limited evidence to support a dose reduction to one Rivaroxaban G.L. Pharma 15 mg tablet once a day (or one Rivaroxaban G.L. Pharma 10 mg tablet once a day in case of kidney function impairment) in combination with an antiplatelet medicine such as clopidogrel.

• In the treatment of blood clots in the veins of the legs, blood clots in the lungs, and to prevent the recurrence of blood clots. The recommended dose is one Rivaroxaban G.L. Pharma 15 mg tablet twice a day for the first 3 weeks. After 3 weeks, the recommended dose is one Rivaroxaban G.L. Pharma 20 mg tablet once a day. After at least 6 months of treatment for blood clots, the doctor may decide to continue treatment with one Rivaroxaban G.L. Pharma 10 mg tablet once a day or one Rivaroxaban G.L. Pharma 20 mg tablet once a day. If the patient has kidney disease and is taking one Rivaroxaban G.L. Pharma 20 mg tablet once a day, the doctor may decide to reduce the dose after 3 weeks of treatment to one Rivaroxaban G.L. Pharma 15 mg tablet once a day, if the risk of bleeding is higher than the risk of recurrent blood clots.
• Children and adolescentsThe dose of Rivaroxaban G.L. Pharma depends on body weight and will be calculated by the doctor.
• The recommended dose for children and adolescents with a body weight of 30 kg to less than 50 kgis one Rivaroxaban G.L. Pharma 15 mgtablet once a day.
• The recommended dose for children and adolescents with a body weight of 50 kg or moreis one Rivaroxaban G.L. Pharma 20 mgtablet once a day.

Each dose of Rivaroxaban G.L. Pharma should be taken with food, washed down with a drink (e.g. water or juice). The tablets should be taken daily at approximately the same time. It is recommended to set an alarm to remind you to take the medicine.
For parents or caregivers: you should observe the child to make sure they have taken the entire dose.
The dose of Rivaroxaban G.L. Pharma is based on body weight, so it is essential to attend scheduled doctor's appointments, as the dose may need to be adjusted based on weight changes.
Never adjust the dose yourself. If necessary, the doctor will adjust the dose. Do not divide the tablet to get a fraction of the dose. If a smaller dose is needed, a different product containing rivaroxaban in the form of an oral suspension should be used. For children and adolescents who are unable to swallow whole tablets, a different product containing rivaroxaban in the form of an oral suspension should be used.
If the oral suspension is not available, the Rivaroxaban G.L. Pharma tablet can be crushed and mixed with water or apple sauce immediately before intake. After this mixture, the patient should eat a meal. If necessary, the doctor may also administer the crushed Rivaroxaban G.L. Pharma tablet through a gastric tube.

If a dose is spat out or vomited

• less than 30 minutes after taking Rivaroxaban G.L. Pharma, the patient should take a new dose.
• more than 30 minutes after taking Rivaroxaban G.L. Pharma, do nottake a new dose. In this case, the next dose of Rivaroxaban G.L. Pharma should be taken at the usual time.

The patient should consult their doctor if they spit out or vomit a dose repeatedly after taking Rivaroxaban G.L. Pharma.

When to take Rivaroxaban G.L. Pharma

The tablet(s) should be taken every day until the doctor decides to stop the treatment.
It is best to take the tablet(s) at the same time every day, as it will be easier to remember.
The doctor will decide how long to continue the treatment.
Prevention of blood clots in the brain (stroke) and other blood vessels in the body:
If the patient's heart rhythm needs to be restored with a procedure called cardioversion, Rivaroxaban G.L. Pharma should be taken as directed by the doctor.

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 consult their doctor. Taking too much Rivaroxaban G.L. Pharma increases the risk of bleeding.

Missing a dose of Rivaroxaban G.L. Pharma

• Adults, children, and adolescents: If the patient is taking one Rivaroxaban G.L. Pharma 20 mg tablet or one Rivaroxaban G.L. Pharma 15 mg tablet once a day and misses a dose, they should take it as soon as possible. Do not take more than one tablet in a 24-hour period to make up for the missed dose. The next tablet should be taken at the usual time the next day, and then one tablet should be taken once a day.
• Adults: If the patient is taking one Rivaroxaban G.L. Pharma 15 mg tablet twice a day and misses a dose, they should take it as soon as possible. Do not take more than two Rivaroxaban G.L. Pharma 15 mg tablets in a 24-hour period. If the patient misses a dose, they can take two Rivaroxaban G.L. Pharma 15 mg tablets at the same time to get a total of two tablets (30 mg) taken in a 24-hour period. The next day, they should continue taking one Rivaroxaban G.L. Pharma 15 mg tablet twice a day.

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 treats and prevents serious diseases.
If the patient has any further questions about the use of this medicine, they should consult their doctor or pharmacist.

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 may cause bleeding, which can be life-threatening. Excessive bleeding can lead to a sudden drop in blood pressure (shock). It may not always be obvious or visible signs of bleeding.

Possible side effects that may be a sign of bleeding:

The patient should immediately inform their doctorif they or their child experience any of the following side effects:

• bleeding into the brain or 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. The patient should immediately call for medical help!),
• prolonged or excessive bleeding,
• unusual weakness, fatigue, pallor, dizziness, headache, swelling of unknown cause, shortness of breath, chest pain or angina, 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 patient should immediately inform their doctorif they or their child experience any of the following skin reactions:

• widespread, severe skin rash, blistering, or changes to 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 (they may occur in less than 1 in 10,000 patients),
• a drug reaction that causes a rash, fever, inflammation of internal organs, hematological disorders, and systemic disorders (DRESS syndrome). The frequency of these side effects is very rare (they may occur in less than 1 in 10,000 patients).

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

The patient should immediately inform their doctorif they or their child experience 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 in adults, children, and adolescents:

Common(may occur in up to 1 in 10 patients)

• reduced red blood cell count, which may cause pallor and be the cause of weakness or shortness of breath,
• bleeding from the stomach or intestines, 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 when coughing (hemoptysis),
• bleeding from the skin or subcutaneous bleeding,
• bleeding after surgery,
• oozing of blood or fluid from the wound after surgery,
• finger or toe swelling,
• finger or toe pain,
• kidney function disorders (may be observed in laboratory 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, itching of the skin,
• increased activity of some liver enzymes, which may be visible in blood test results.

Uncommon(may occur in up to 1 in 100 patients)

• bleeding into the brain or 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 laboratory tests performed by the doctor),
• blood test results may show increased bilirubin levels, liver or pancreatic enzyme activity, or platelet count,
• fainting,
• malaise,
• rapid heartbeat,
• dry mouth,
• hives.

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

• bleeding into a muscle,
• cholestasis (bile flow obstruction), liver inflammation, including liver cell damage,
• jaundice (yellowing of the skin and eyes),
• local swelling,
• collection of blood (hematoma) in the groin as a complication of cardiac 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,
• kidney bleeding, sometimes with blood in the urine, leading to kidney failure (nephropathy associated with anticoagulants),
• increased pressure in the muscles of the legs and arms after bleeding, which can lead to pain, swelling, changes in sensation, numbness, or paralysis (compartment syndrome after bleeding).

Side effects in children and adolescents

Overall, the side effects observed in children and adolescents treated with Rivaroxaban G.L. Pharma were similar in type to those observed in adults and were mostly mild to moderate.
Side effects observed more frequently in children and adolescents:

Very common(may occur in more than 1 in 10 patients)

• headache
• fever
• nosebleeds,
• vomiting

Common(may occur in up to 1 in 10 patients)

• rapid heartbeat
• blood test results may show increased bilirubin levels,
• thrombocytopenia (low platelet count, cells involved in blood clotting)
• excessive menstrual bleeding

Uncommon(may occur in up to 1 in 100 patients)

• blood test results may show increased levels of a bilirubin subtype (direct bilirubin).

Reporting side effects

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

the patient should inform their doctor or pharmacist. Side effects can be reported directly to:
Department of Post-Marketing Surveillance of Adverse Reactions to Medicinal Products, Medical Devices, and Biocides
Al. Jerozolimskie 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 can help gather 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.
Do not use this medicine 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 15 mg or 20 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 contents of the pack

Rivaroxaban G.L. Pharma 15 mg is a round, biconvex, red film-coated tablet (diameter 5.6 mm) with "15" embossed on one side and smooth on the other.
Rivaroxaban G.L. Pharma 20 mg is a round, biconvex, dark red film-coated tablet (diameter 6.5 mm) with "20" embossed on one side and smooth on the other.
Transparent blisters made of PVC/PVDC/Aluminum in cardboard boxes.
The pack 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, the patient should 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:28.12.2023