Rivaroxaban g.l. pharma

Package leaflet: Information for the user

Rivaroxaban G.L. Pharma, 15 mg, film-coated tablets
Rivaroxaban G.L. Pharma, 20 mg, film-coated tablets
Rivaroxabanum
Please read 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 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 any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Rivaroxaban G.L. Pharma is and what it is 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 Rivaroxaban G.L. Pharma is and what it is 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 body in patients with a type of irregular heartbeat called non-valvular atrial fibrillation.
• 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 veins or (and) lungs. Rivaroxaban G.L. Pharma is used in children and adolescents under 18 years of age and weighing 30 kg or more to:
• treat blood clots and prevent recurrence of blood clots in the veins or in the blood vessels of the lungs, after at least 5 days of initial treatment with injectable anticoagulant medicines.

Rivaroxaban G.L. Pharma belongs to a group of medicines called anticoagulants. It works by blocking a blood clotting factor (Factor Xa), thereby reducing the tendency to form blood clots.

2. Important information before taking Rivaroxaban G.L. Pharma

Do not take Rivaroxaban G.L. Pharma if

• you are allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6),
• you are currently experiencing uncontrolled bleeding,
• you have a disease or condition that increases the risk of serious bleeding (e.g. stomach ulcer, injury or bleeding in the brain, recent surgery on the brain or eyes),
• you are taking other anticoagulant medicines (e.g. warfarin, dabigatran, apixaban or heparin), except when switching anticoagulant therapy or if heparin is administered to maintain the patency of a venous or arterial catheter,
• you have a liver disease that increases the risk of bleeding,
• you are pregnant or breastfeeding.

Do not use Rivaroxaban G.L. Pharma and inform your doctor if you think any of the above conditions apply to you.

Warnings and precautions

Talk to your doctor or pharmacist before taking Rivaroxaban G.L. Pharma.

Exercise special caution when using Rivaroxaban G.L. Pharma if

• you have an increased risk of bleeding, such as in the following conditions:
• severe kidney disease in adults or moderate to severe kidney disease in children and adolescents, as kidney function may affect the amount of medicine acting in your body,
• taking other medicines that prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), when switching anticoagulant therapy or if heparin is administered to maintain the patency of a venous or arterial catheter (see section “Rivaroxaban G.L. Pharma with other medicines”),
• blood clotting disorders,
• very high blood pressure that does not decrease despite medication,
• stomach or intestinal disorders that may cause bleeding, e.g. inflammation of the intestine and stomach or oesophagitis (inflammation of the oesophagus), e.g. due to gastro-oesophageal reflux disease (acid reflux from the stomach into the oesophagus),
• blood vessel disease in the back of the eye (retinopathy),
• lung disease with dilated and pus-filled bronchi (bronchiectasis) or previous bleeding from the lungs,
• in patients with heart valve prostheses,
• if you have a disorder called antiphospholipid syndrome (an immune system disorder increasing the risk of blood clots), you should inform your doctor, who will decide whether a change in treatment is needed,
• if you have abnormal blood pressure or if you are scheduled for surgery or other treatment to remove a blood clot from the lungs.

If you think any of the above conditions apply to you, inform your doctor before taking Rivaroxaban G.L. Pharma. Your doctor will decide whether to use this medicine and whether you need particularly close monitoring.

If you need to undergo surgery:

• strictly follow your doctor’s instructions regarding when to take Rivaroxaban G.L. Pharma before or after surgery,
• if during surgery a lumbar puncture or placement of a catheter into the spinal canal is planned (e.g. for epidural or spinal anaesthesia or for pain relief):
• it is very important to take Rivaroxaban G.L. Pharma before and after the puncture or catheter removal as directed by your doctor,
• inform your doctor immediately if, after the anaesthesia wears off, you experience symptoms such as numbness, weakness in the legs, or problems with bowel or bladder function, as immediate treatment may be necessary.

Children and adolescents

Rivaroxaban G.L. Pharma is not recommended for children weighing less than 30 kg. There is insufficient data on the use of this medicine in children and adolescents for the indications approved in adults.

Rivaroxaban G.L. Pharma with other medicines

Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take, including those obtained without a prescription.

• If you are taking:
• certain antifungal medicines (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless used only topically on the skin,
• ketoconazole tablets (used to treat Cushing's syndrome, in which the body produces too much cortisol),
• certain antibiotics (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 antidepressants (selective serotonin reuptake inhibitors (SSRIs) or serotonin-noradrenaline reuptake inhibitors (SNRIs)).

If any of the above apply to you, inform your doctor before taking Rivaroxaban G.L. Pharma, as the effect of Rivaroxaban G.L. Pharma may be increased. Your doctor will decide whether to use this medicine and whether you need particularly close monitoring.

If your doctor considers that you have an increased risk of developing stomach or duodenal ulcers, they may prescribe treatment to prevent ulcer disease.

• If you are taking:
• certain antiepileptic medicines (phenytoin, carbamazepine, phenobarbital),
• St John's wort (Hypericum perforatum), a herbal remedy used for depression,
• rifampicin, which belongs to the group of antibiotics.

If any of the above apply to you, inform your doctor before taking Rivaroxaban G.L. Pharma, as the effect of Rivaroxaban G.L. Pharma may be reduced. Your doctor will decide whether to use Rivaroxaban G.L. Pharma and whether you need particularly close monitoring.

Pregnancy and breastfeeding

Do not use Rivaroxaban G.L. Pharma if you are pregnant or breastfeeding. If there is a risk that you may become pregnant, you should use an effective method of contraception during treatment with Rivaroxaban G.L. Pharma. If you become pregnant while taking this medicine, inform your doctor immediately. Your doctor 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 experiencing these side effects should not drive or operate machinery.

Rivaroxaban G.L. Pharma contains lactose and sodium.
If you have been previously diagnosed with intolerance to certain sugars, you should consult your doctor before taking this medicine.
The medicine contains less than 1 mmol sodium (23 mg) per tablet, which means it is essentially “sodium-free”.

3. How to take Rivaroxaban G.L. Pharma

This medicine should always be taken exactly as prescribed by your doctor. If you have any doubts, you should consult your doctor or pharmacist.
The tablet(s) should be swallowed whole, preferably with water.
Rivaroxaban G.L. Pharma should be taken with food.
If a patient has difficulty swallowing the whole tablet, they should discuss alternative ways of taking Rivaroxaban G.L. Pharma with their doctor. The tablet may be crushed and mixed with water or apple puree immediately before administration.
If necessary, a doctor may administer crushed Rivaroxaban G.L. Pharma tablets through a gastric tube.

How many tablets should be taken

• Adults

  • For 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 a patient requires a procedure to unblock blood vessels in the heart (called percutaneous coronary intervention – PCI with stent placement), there is limited evidence supporting 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 impaired kidney function), in combination with an antiplatelet agent such as clopidogrel.

• For the treatment of blood clots in the veins of the legs, blood clots in the blood vessels of the lungs, and prevention of recurrence of blood clots: The recommended dose is one Rivaroxaban G.L. Pharma 15 mg tablet twice daily for the first 3 weeks. After 3 weeks of treatment, the recommended dose is one Rivaroxaban G.L. Pharma 20 mg tablet once daily. After at least 6 months of treatment for blood clots, the 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 after 3 weeks of treatment to one Rivaroxaban G.L. Pharma 15 mg tablet once daily, if the risk of bleeding is greater than the risk of further blood clots.

• Children and adolescents The dose of Rivaroxaban G.L. Pharma depends on body weight and will be calculated by the doctor.

  • Recommended dose for children and adolescents with a body weight from 30 kg to below 50 kg is one Rivaroxaban G.L. Pharma 15 mg tablet once daily.
  • Recommended dose for children and adolescents with a body weight of 50 kg or more is one Rivaroxaban G.L. Pharma 20 mg tablet once daily.

Each dose of Rivaroxaban G.L. Pharma should be taken with food, accompanied by a drink (e.g. water or juice). Tablets should be taken every day at approximately the same time. It may be helpful to set an alarm as a reminder.
For parents or caregivers: You should observe the child to ensure they have taken the full dose.
The dose of Rivaroxaban G.L. Pharma depends on body weight; therefore, it is important to attend scheduled doctor’s appointments, as dose adjustments may be necessary due to changes in weight.
Never adjust the dose independently. If needed, the doctor will adjust the dose.
Do not split the tablet to achieve a partial dose. If a lower dose is required, another product containing rivaroxaban in the form of granules for oral suspension should be used. For children and adolescents who are unable to swallow whole tablets, another product containing rivaroxaban in the form of granules for oral suspension should be used.
If the oral suspension is not available, the Rivaroxaban G.L. Pharma tablet may be crushed and mixed with water or apple puree immediately before administration. After taking this mixture, the patient should consume a meal. If necessary, the doctor may also administer the crushed tablet via a gastric tube.

If a dose is vomited or spat out

• If vomiting or spitting out occurs less than 30 minutes after taking Rivaroxaban G.L. Pharma, take a new dose.
• If vomiting or spitting out occurs more than 30 minutes after taking Rivaroxaban G.L. Pharma, do not take another dose. In this case, take the next dose of Rivaroxaban G.L. Pharma at the usual time.

Contact your doctor if you repeatedly vomit or spit out the dose 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 treatment. It is best to take the tablet(s) at the same time each day, as this makes it easier to remember.
The doctor will decide how long treatment should continue.
For the prevention of blood clots in the brain (stroke) and other blood vessels in the body:
If a procedure (cardioversion) is required to restore normal heart rhythm, Rivaroxaban G.L. Pharma should be taken according to the timing advised by the doctor.

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

Missing a dose of Rivaroxaban G.L. Pharma

• Adults, children and adolescents: If a patient takes one 20 mg tablet or one 15 mg tablet once daily and a dose is missed, take the tablet as soon as possible. Do not take more than one tablet in one day to make up for the missed dose. Take the next tablet the following day, then continue taking one tablet once daily.
• Adults: If a patient takes one 15 mg tablet twice daily and a dose is missed, take the tablet as soon as possible. Do not take more than two 15 mg tablets in one day. If the patient forgot to take a dose, they may take two 15 mg tablets at the same time to achieve a total of two tablets (30 mg) taken within one day. The next day, continue taking one 15 mg tablet twice daily.

Stopping Rivaroxaban G.L. Pharma treatment
Do not stop taking Rivaroxaban G.L. Pharma without consulting your doctor, as this medicine treats and prevents serious medical conditions.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine may cause adverse reactions, although they do not occur in everyone.
Like other medicines with a similar action (anticoagulants), Rivaroxaban G.L. Pharma 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.

Possible adverse reactions which may indicate bleeding:
You must inform the doctor immediately if the patient or child experiences any of the following adverse reactions:

• 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. 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, which may indicate bleeding. The doctor may decide that very close monitoring of the patient is necessary or that the treatment should be changed.

Possible adverse reactions which may indicate a skin reaction:
You must inform the doctor immediately if the patient or child develops any of the following skin reactions:

• Widespread, severe skin rash, blistering or mucosal lesions, e.g. in the mouth or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis). The frequency of these adverse reactions is very rare (may occur in less than 1 in 10,000 patients),
• Drug reaction with eosinophilia and systemic symptoms (DRESS) characterized by rash, fever, internal organ inflammation, hematological disorders and systemic involvement. The frequency of these adverse reactions is very rare (may occur in less than 1 in 10,000 patients).

Possible adverse reactions which may indicate a serious allergic reaction:
You must inform the doctor immediately if the patient or child experiences any of the following adverse reactions:

• Swelling of the face, lips, mouth, tongue or throat; difficulty swallowing; urticaria and breathing difficulties; sudden drop in blood pressure. The frequency of these reactions 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 adverse reactions in adults, children and adolescents:
Common (may occur in up to 1 in 10 patients)

• Decrease in red blood cell count which may cause paleness of the skin and lead to weakness or shortness of breath,
• Bleeding from the stomach or intestine, bleeding from the urinary or genital tract (including blood in urine and heavy menstrual bleeding), nosebleeds, bleeding from gums,
• Bleeding into the eye (including bleeding from the sclera),
• 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 the surgical wound,
• Swelling of limbs,
• Limb pain,
• Kidney function disorders (may be observed in tests performed by the doctor),
• Fever,
• Stomach pain, indigestion, nausea or vomiting, constipation, diarrhea,
• Low blood pressure (symptoms may include dizziness or fainting upon standing),
• General decrease 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 patients)

• Bleeding into the brain or intracranial hemorrhage,
• Bleeding into joints causing pain and swelling,
• Thrombocytopenia (low platelet count, blood cells involved in blood clotting),
• Allergic reactions, including allergic skin reactions,
• Liver function disorders (may be observed in tests performed by the 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 patients)

• 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 procedure 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 following severe bleeding,
• Bleeding in the kidneys, sometimes with presence of blood in urine, leading to inability of the kidneys to function properly (drug-induced nephropathy associated with anticoagulants),
• Increased pressure in the muscles of arms and legs following bleeding, which may cause pain, swelling, altered sensation, tingling or paralysis (compartment syndrome following bleeding).

Adverse reactions in children and adolescents
In general, adverse reactions observed in children and adolescents treated with Rivaroxaban G.L. Pharma were similar in type to those observed in adults and were mainly mild to moderate in severity.
Adverse reactions observed more frequently in children and adolescents:
Very common (may occur in more than 1 in 10 people)

• Headache,
• Fever,
• Nosebleeds,
• Vomiting.

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

• Rapid heartbeat,
• Blood tests may show increased levels of bilirubin (a yellow pigment),
• Thrombocytopenia (low platelet count, blood cells that help in blood clotting),
• Excessive menstrual bleeding.

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

• Blood tests may show increased levels of a subcategory of bilirubin (direct bilirubin, a yellow pigment).

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, you should inform your doctor or pharmacist. Adverse reactions can be reported directly to:
Department of Monitoring Adverse Drug Reactions
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions may also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Rivaroxaban G.L. Pharma

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton and on each blister
after EXP. The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. These measures will help protect the
environment.

6. Contents of the package and other information

What Rivaroxaban G.L. Pharma contains

• The active substance is rivaroxaban. One coated tablet contains 15 mg or 20 mg of rivaroxaban.
• Other components are:
  Tablet core: microcrystalline cellulose, monohydrate lactose, sodium lauryl sulfate, hypromellose 2910, sodium croscarmellose, magnesium stearate.
  Coating: hypromellose 2910, titanium dioxide (E 171), polyethylene glycol 3350, iron oxide red (E 172).

What Rivaroxaban G.L. Pharma looks like and contents of the pack
Rivaroxaban G.L. Pharma 15 mg are round, biconvex, red tablets (diameter 5.6 mm) with "15" embossed on one side and smooth on the other.
Rivaroxaban G.L. Pharma 20 mg are round, biconvex, dark red tablets (diameter 6.5 mm) with "20" embossed on one side and smooth on the other.
Transparent PVC/PVDC/Aluminium blisters in cardboard outer cartons.
Pack contents: 5, 10, 14, 28, 30, 42, 45, 56, 60, 90, 98 or 100 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation 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

For further information, please 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, Poland
Tel: 022/ 636 52 23; 636 53 02
[email protected]