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 for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your 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 pack 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 form of irregular heart rhythm 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 the blood clotting factor (factor Xa) and thereby 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 surgical procedure 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 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 you suspect that you have any of the above conditions.

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 conditions such 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 with 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 (backflow of stomach acid into the esophagus),
• blood vessel 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 disorder called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), the patient should inform the doctor, who will decide whether to change the treatment,
• if the patient has been diagnosed with abnormal blood pressure or a surgical procedure or other treatment is planned to remove a blood clot from the lungs.

If you suspect that you have any of the above conditions, you should inform your doctor

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

If you need to have surgery:

• you should carefully follow the doctor's instructions regarding the intake of Rivaroxaban G.L. Pharma at a precisely specified time before or after surgery,
• if a spinal puncture or catheter insertion into the spinal canal is planned during the surgical procedure (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,
• you should immediately inform your doctor if you experience symptoms such as: numbness, leg weakness, bowel or bladder function disorders after the anesthesia is completed, 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

You should 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 you are taking:
• certain medicines used to treat fungal infections (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are used only topically 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 you, you should inform your 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 monitored particularly closely.
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 you are 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 you, you should inform your 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 monitored particularly closely.

Pregnancy and breastfeeding

Rivaroxaban G.L. Pharma should not be taken if you are pregnant or breastfeeding. If there is a risk that you may become pregnant, you should use effective contraception during treatment with Rivaroxaban G.L. Pharma. If you become pregnant during treatment with this medicine, you should immediately inform your 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 you have previously been diagnosed with intolerance to some sugars, you should consult your 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 exactly as directed by your doctor. If you are unsure, you should consult your doctor or pharmacist.
The tablet(s) should be swallowed, preferably with water.
Rivaroxaban G.L. Pharma should be taken with food.
If you have difficulty swallowing whole tablets, you should discuss other ways of taking Rivaroxaban G.L. Pharma with your doctor. The tablet can be crushed and mixed with water or apple puree immediately before taking it.
If necessary, your doctor may also administer the crushed Rivaroxaban G.L. Pharma tablet through a nasogastric 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 daily. If the patient has kidney disease, the dose may be reduced to one Rivaroxaban G.L. Pharma 15 mg tablet once daily.

If the patient requires 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 daily (or one Rivaroxaban G.L. Pharma 10 mg tablet once daily 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 daily for the first 3 weeks. For treatment after 3 weeks, the recommended dose is one Rivaroxaban G.L. Pharma 20 mg tablet once daily. After at least 6 months of treatment for blood clots, your doctor may decide to continue treatment with either one 10 mg tablet once daily or one 20 mg tablet once daily. If the patient has kidney disease and is taking one Rivaroxaban G.L. Pharma 20 mg tablet once daily, the doctor may decide to reduce the dose to one Rivaroxaban G.L. Pharma 15 mg tablet once daily after 3 weeks of treatment, 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 your 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 daily.
• The recommended dose for children and adolescents with a body weight of 50 kg or moreis one Rivaroxaban G.L. Pharma 20 mgtablet once daily.

Each dose of Rivaroxaban G.L. Pharma should be taken with food, while drinking a liquid (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.
For parents or caregivers: you should observe the child to ensure that they have taken the entire dose. The dose of Rivaroxaban G.L. Pharma is based on body weight, so it is important 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, your doctor will adjust the dose. Do not divide the tablet to obtain a fraction of the dose. If a smaller dose is necessary, you should use another product containing rivaroxaban in the form of granules for oral suspension. For children and adolescents who are unable to swallow whole tablets, you should use another product containing rivaroxaban in the form of granules for oral suspension.
If the oral suspension is not available, you can crush the Rivaroxaban G.L. Pharma tablet and mix it with water or apple puree immediately before taking it. After this mixture, you should eat a meal. If necessary, your doctor may also administer the crushed Rivaroxaban G.L. Pharma tablet through a nasogastric tube.

If you spit out the dose or vomit

• less than 30 minutes after taking Rivaroxaban G.L. Pharma, you 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.

You should contact your doctor if you spit out the dose or vomit repeatedly after taking Rivaroxaban G.L. Pharma.

When to take Rivaroxaban G.L. Pharma

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

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

If you have taken a higher dose of Rivaroxaban G.L. Pharma than recommended, you should immediately contact your 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 you are taking one 20 mg or one 15 mg tablet once daily and you miss a dose, you 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 daily.
• Adults: If you are taking one 15 mg tablet twice daily and you miss a dose, you should take it as soon as possible. Do not take more than two 15 mg tablets in a 24-hour period. If you miss a dose, you can take two 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, you should continue taking one 15 mg tablet twice daily.

Stopping treatment with Rivaroxaban G.L. Pharma

You should not stop taking Rivaroxaban G.L. Pharma without consulting your doctor, as Rivaroxaban G.L. Pharma treats and prevents serious diseases.
If you have any further questions about the use of this medicine, you should consult your 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 can cause bleeding, which can potentially 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:

You should immediately inform your doctorif you or your 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 in the neck. This is a serious medical emergency. You 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. Your doctor may decide to monitor you particularly closely or change the treatment.

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

You should immediately inform your doctorif you or your 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 (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 (may occur in less than 1 in 10,000 patients).

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

You should immediately inform your doctorif you or your 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,
• swelling of the limbs,
• limb pain,
• kidney function disorders (may be observed in tests performed by your 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 tests performed by your 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,
• blood accumulation (hematoma) in the groin as a complication of cardiac catheterization, when the 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 anticoagulant therapy),
• increased pressure in the muscles of the legs and arms, occurring 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 terms of 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 you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist

Side effects can be reported directly to the:
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 will help to gather more information on the safety of this 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. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack 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 other ingredients are: Tablet core: microcrystalline cellulose, lactose monohydrate, sodium lauryl sulfate, hypromellose 2910, croscarmellose sodium, 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 side.
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 side.
Transparent blisters 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, you 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