Rivaroxaban g.l. pharma

Package leaflet: Information for the user

Rivaroxaban G.L. Pharma, 10 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 personally. Do not give it 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 this 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 and is used in adults to:

• prevent blood clots in the veins after hip or knee replacement surgery. Your doctor has prescribed this medicine because your risk of developing blood clots is increased after surgery.
• treat blood clots in the deep 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.

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 for blood clots to form.

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),
• if you are currently experiencing active bleeding,
• if you have a disease or condition that increases the risk of severe bleeding (e.g. stomach ulcer, trauma or bleeding in the brain, recent surgery on the brain or eyes),
• if 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 catheter patency in a vein or artery,
• if you have liver disease that increases the risk of bleeding,
• if you are pregnant or breastfeeding.

Do not take 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 taking Rivaroxaban G.L. Pharma

• if you have an increased risk of bleeding, such as in the following conditions:
• moderate or severe kidney disease, 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 catheter patency in a vein or artery (see section "Rivaroxaban G.L. Pharma and other medicines"),
• blood clotting disorders,
• very high uncontrolled blood pressure,
• stomach or intestinal diseases that may cause bleeding, e.g. inflammation of the stomach or intestines, or inflammation of the oesophagus (gullet and oesophagus), e.g. due to gastro-oesophageal reflux disease (acid reflux),
• retinal vascular disease (retinopathy),
• lung disease with bronchiectasis (dilated airways filled with pus) 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 treatment adjustment is needed,
• if you have abnormal blood pressure or if you are scheduled for surgery or other treatment to remove a 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 require particularly close monitoring.

If you need to undergo surgery:

• strictly follow your doctor's instructions regarding the timing of taking Rivaroxaban G.L. Pharma before or after surgery,
• if during surgery a spinal puncture or epidural catheter placement is planned (e.g. for epidural or spinal anaesthesia or pain relief):
• strictly follow your doctor's instructions regarding the timing of taking Rivaroxaban G.L. Pharma,
• 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 required.

Children and adolescents

Rivaroxaban G.L. Pharma is not recommended for individuals under 18 years of age. There is insufficient data on the use of this medicine in children and adolescents.

Rivaroxaban G.L. Pharma and other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, 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 in the treatment of Cushing's syndrome, in which the body produces too much cortisol),
• certain antibiotics (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-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 require particularly close monitoring.

If your doctor considers you to be at increased risk of developing stomach or duodenal ulcers, they may prescribe preventive treatment for peptic ulcer disease.

• If you are taking:
• certain medicines used to treat epilepsy (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 require particularly close monitoring.

Pregnancy and breastfeeding

Do not take 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 using machines

Rivaroxaban G.L. Pharma may cause dizziness (common side effect) and fainting (uncommon side effect) (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, consult your doctor before taking this medicine.

The medicine contains less than 1 mmol sodium (23 mg) per tablet, i.e. essentially "sodium-free".

3. How to take Rivaroxaban G.L. Pharma

This medicine should always be taken as prescribed by your doctor. If you have any doubts, you should consult your doctor or pharmacist.

How many tablets should be taken

• To prevent the formation of blood clots in the veins after hip or knee replacement surgery: The recommended dose is one tablet of Rivaroxaban G.L. Pharma 10 mg 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. Your doctor has prescribed Rivaroxaban G.L. Pharma 10 mg once daily.

The tablet should be swallowed whole, preferably with water.
Rivaroxaban G.L. Pharma may be taken with or without food.
If you have difficulty swallowing the whole tablet, talk to your doctor about other ways of taking Rivaroxaban G.L. Pharma. The tablet may be crushed and mixed with water or apple puree immediately before administration.
If necessary, your doctor may administer crushed Rivaroxaban G.L. Pharma tablets through a gastric tube.

When to take Rivaroxaban G.L. Pharma

You should take one tablet every day until your doctor decides to stop treatment.
It is best to take the tablet at the same time each day, as this makes it easier to remember.
Your 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.
For patients undergoing major hip surgery, treatment usually lasts 5 weeks.
For patients undergoing major knee surgery, treatment usually lasts 2 weeks.

Taking more than the recommended dose of Rivaroxaban G.L. Pharma

If you have taken more than the prescribed dose of Rivaroxaban G.L. Pharma, contact your doctor immediately. Taking too high a dose of Rivaroxaban G.L. Pharma increases the risk of bleeding.

Missed dose of Rivaroxaban G.L. Pharma

If you forget to take a dose, take the tablet as soon as you remember. 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 dose.

Stopping Rivaroxaban G.L. Pharma

Do not stop taking Rivaroxaban G.L. Pharma without consulting your doctor, as this medicine prevents the occurrence of serious illness.

If you have any further questions or uncertainties regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not in everyone.
Like other medicines with a similar action (anticoagulants), Rivaroxaban G.L. Pharma may cause
bleeding, which potentially could 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 be signs of bleeding:
You should contact your doctor immediately if any of the following adverse reactions occur:

• 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. Seek immediate medical help!),
• prolonged or excessive bleeding,
• unusual weakness, fatigue, paleness, dizziness, headache, unexplained swelling, shortness of breath, chest pain or angina, which may be signs of bleeding. Your doctor may decide that close monitoring of the patient or a change in treatment is necessary.

Possible adverse reactions which may be signs of skin reactions:
You should immediately inform your doctor if the following skin reactions occur:

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

Possible adverse reactions which may be signs of a serious allergic reaction:
You should immediately inform your doctor if the following adverse reactions occur:

• swelling of the face, lips, oral cavity, tongue or throat; difficulty swallowing, urticaria and breathing difficulties; sudden drop in blood pressure. The frequency of occurrence 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:
Common (may occur in 1 out of 10 patients)

• 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 genitourinary system (including blood in urine and heavy menstrual bleeding), nosebleeds, bleeding from the gums,
• bleeding into the eye (including bleeding from the conjunctiva),
• 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 a 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 1 out of 100 patients)

• bleeding into the brain or inside the skull,
• bleeding into a joint causing pain and swelling,
• thrombocytopenia (low number of platelets, blood cells involved in blood clotting),
• allergic reactions, including allergic skin reactions,
• liver function disorders (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,
• dryness of the mouth,
• urticaria.

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

• bleeding into muscles,
• cholestasis (bile stasis), liver inflammation including liver cell damage,
• yellowing of the skin and eyes (jaundice),
• local swelling,
• accumulation 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 unknown (frequency cannot be determined from available data)

• kidney failure following severe bleeding,
• bleeding in the kidneys, sometimes with blood in the urine, leading to kidneys being unable to function properly (drug-induced nephropathy associated with anticoagulants),
• increased pressure in the muscles of the arms and legs occurring after bleeding, which may lead to pain, swelling, altered sensation, tingling or paralysis (compartment syndrome following bleeding).

Reporting of adverse reactions
If you experience any adverse symptoms, 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
Phone: +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.
By reporting adverse reactions, more information on the safety of the medicine can be collected.

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 cardboard packaging and
on each blister pack after EXP. The expiry date refers to the last day of the stated month.
There are no special requirements for the storage of this medicine.
Medicines must not be disposed of via wastewater or household waste. You should ask your
pharmacist how to dispose of medicines no longer required. This 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 10 mg of rivaroxaban.
• Other ingredients are:
  Tablet core: microcrystalline cellulose, monohydrate lactose, 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 is a round, biconvex, pink tablet (6 mm in diameter) with an embossed "10" on one side and smooth on the other side.
Clear blisters made of PVC/PVDC/Aluminium in a cardboard box.
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, contact the 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]