Thinban

Patient Information Leaflet

Thinban, 15 mg, film-coated tablets
rivaroxaban
Please read this leaflet carefully before taking this medicine, as 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 pass it on to others. It may harm someone else, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Thinban is and what it is used for
2. What you need to know before taking Thinban
3. How to take Thinban
4. Possible side effects
5. How to store Thinban
6. Contents of the pack and other information

1. What Thinban is and what it is used for

Thinban contains the active substance rivaroxaban and is used in adults to:

• prevent blood clots in the brain (stroke) and in other blood vessels in the body in patients who have 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 the recurrence of blood clots in the veins of the legs and/or lungs.

Thinban 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 medicines used to treat blood clots.

Thinban 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 Thinban

When not to take Thinban:

• if the patient is allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6),
• if the patient is experiencing excessive bleeding,
• if the patient has a disease or condition of an organ that leads to an increased risk of serious bleeding (e.g. stomach ulcer, trauma or bleeding into the brain, recent surgery on the brain or eyes),
• if the patient is taking other medicines that prevent blood clots (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,
• if the patient has a liver disease leading to an increased risk of bleeding,
• if the patient is pregnant or breastfeeding.

Do not use Thinban and inform your doctor if you suspect that any of the above circumstances apply to you.
Warnings and precautions
Talk to your doctor or pharmacist before taking Thinban.
When to exercise special caution when taking Thinban

• if the patient has 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 the patient's body,
• taking other medicines that prevent blood clots (e.g. warfarin, dabigatran, apixaban, or heparin) when switching anticoagulant therapy or when heparin is administered to maintain the patency of a venous or arterial catheter (see section "Thinban with other medicines"),
• blood clotting disorders,
• very high blood pressure that does not decrease despite medication,
• stomach or intestinal diseases that may cause bleeding, e.g. inflammation of the stomach or intestines, or inflammation of the oesophagus (throat and oesophagus), e.g. due to gastro-oesophageal reflux disease (acid reflux into the oesophagus), or tumours located in the stomach, intestines, genital or urinary system,
• blood vessel disease of the back of the eye (retinopathy),
• lung disease with bronchiectasis (enlarged airways filled with pus) or previous lung bleeding,
• in patients with heart valve prostheses,
• if the patient has a disorder called antiphospholipid syndrome (an immune system disorder causing an increased risk of blood clots), the patient should inform the doctor, who will decide whether a change in treatment is needed,
• if the patient has abnormal blood pressure or is scheduled for surgery or other treatment aimed at removing a blood clot from the lungs.

If you suspect that any of the above conditions apply to you, inform your doctor
before taking Thinban. The doctor will decide whether to use this medicine and whether the patient requires particularly close monitoring.
If the patient needs to undergo surgery:

• strictly follow the doctor's instructions regarding the timing of Thinban administration before or after surgery,
• if spinal catheterisation or puncture (e.g. for epidural or intrathecal anaesthesia or pain relief) is planned during surgery:
• it is very important to take Thinban before and after the puncture or catheter removal exactly as directed by the doctor,
• due to the need for special caution, inform the doctor immediately if numbness or weakness in the legs, or bowel or bladder dysfunction occurs after the anaesthesia wears off.

Children and adolescents
Rivaroxaban tablets are not recommended for children weighing less than 30 kg.
There is insufficient data on the use of rivaroxaban in children and adolescents for the indications approved in adults.
Thinban with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take, including those available without a prescription.

• If the patient is taking:
• certain antifungal medicines (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are 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 (SSRI) or serotonin-noradrenaline reuptake inhibitors (SNRI)).

If you suspect that any of the above conditions apply to you, inform your doctor
before taking Thinban, because the effect of Thinban may be enhanced when taken together with the above medicines.
The doctor will decide whether to use this medicine and whether the patient requires particularly close monitoring.
If the doctor considers that the patient has an increased risk of developing stomach or duodenal ulcers, preventive treatment for peptic ulcer disease may be prescribed.

• If the patient is 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 you suspect that any of the above conditions apply to you, inform your doctor
before taking Thinban, because the effect of Thinban may be reduced when taken together with the above medicines.
The doctor will decide whether to use Thinban and whether the patient requires particularly close monitoring.
Pregnancy and breastfeeding
Do not use Thinban 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 Thinban. If you become pregnant while taking Thinban, inform your doctor immediately, who will decide on further management.
Driving and operating machinery
Thinban 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, ride a bicycle, or operate tools or machinery.
Thinban 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 of sodium (23 mg) per tablet, which means it is essentially "sodium-free".

3. How to take Thinban

This medicine should always be taken as instructed by the doctor. If in doubt, consult
your doctor or pharmacist.
Thinban should be taken with food.
The tablet(s) should be swallowed whole, preferably with water.
If a patient has difficulty swallowing the whole tablet, discuss alternative ways of taking Thinban
with the doctor. The tablet may be crushed and mixed with water or soft food such as apple puree
immediately before administration. A meal should be consumed promptly after taking this mixture.
If necessary, the doctor may administer crushed Thinban tablets through a gastric tube.

How many tablets to take
Adults

• For prevention of blood clots in the brain (stroke) and other blood vessels in the body: The recommended dose is one 20 mg Thinban tablet once daily. If the patient has kidney problems, the dose may be reduced to one 15 mg Thinban tablet once daily.

If a procedure to open blocked blood vessels in the heart is required (called percutaneous coronary intervention – PCI with stent placement), there is limited evidence supporting dose reduction to one 15 mg Thinban tablet once daily (or one 10 mg Thinban tablet once daily in case of renal impairment), in combination with an antiplatelet medicine such as clopidogrel.
For treatment of blood clots in the veins of the legs, blood clots in the blood vessels of the lungs, and to prevent recurrence of blood clots:
The recommended dose is one 15 mg Thinban tablet twice daily for the first 3 weeks. For treatment beyond 3 weeks, the recommended dose is one 20 mg Thinban 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 problems and is taking one 20 mg Thinban tablet once daily, the doctor may decide to reduce the dose after 3 weeks of treatment to one 15 mg Thinban tablet once daily, if the risk of bleeding is greater than the risk of further blood clots.

Children and adolescents
The dose of Thinban 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 15 mg Thinban tablet once daily.
• Recommended dose for children and adolescents with a body weight of 50 kg or more is one 20 mg Thinban tablet once daily.

Each dose of Thinban should be taken with a meal and with a drink (e.g. water or juice).
Tablets should be taken daily at approximately the same time. Consider setting an alarm as a reminder.
For parents or caregivers: observe the child to ensure the full dose has been taken.
The dose of Thinban is based on body weight, so it is important to attend scheduled doctor appointments, as dose adjustments may be needed due to changes in weight.
Never adjust the dose on your own. The doctor will adjust the dose if necessary.
Do not split tablets to achieve partial doses. If a lower dose is required, other pharmaceutical forms are available.
For children and adolescents who cannot swallow whole tablets, other pharmaceutical forms should be used.
If other pharmaceutical forms are not available, the Thinban tablet may be crushed and mixed with water or apple puree immediately before administration. A meal should be consumed after taking this mixture. If necessary, the doctor may also administer crushed Thinban tablets through a gastric tube.

If a dose is vomited or spat out

• Less than 30 minutes after taking Thinban: take a new dose.
• More than 30 minutes after taking Thinban: do not take another dose. In this case, take the next dose of Thinban at the usual time.

Contact your doctor if vomiting or spitting out the dose occurs repeatedly after taking Thinban.

When to take Thinban
Tablets should be taken every day until the doctor decides to stop treatment. It is best to take the tablets at the same time each day, as this makes it easier to remember. The doctor will decide how long treatment should continue.
For prevention of blood clots in the brain (stroke) and other blood vessels in the body:
If heart rhythm needs to be restored to normal rhythm by a procedure called cardioversion, Thinban should be taken as directed by the doctor.

Missed dose of Thinban
Adults, children and adolescents:

• If the 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 a single day to make up for the missed dose. Take the next tablet the following day, then continue taking one tablet once daily.

Adults:
If the 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 a single 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.

Taking more than the recommended dose of Thinban
If a patient has taken more than the recommended dose of Thinban, seek immediate medical advice from a doctor. Taking too high a dose of Thinban increases the risk of bleeding.

Stopping Thinban
Do not stop taking Thinban without first consulting your doctor, because Thinban 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 medicinal product may cause adverse reactions, although they do not occur in everyone.
As with other medicines with a similar anticoagulant effect, Thinban 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.
You should immediately inform your doctor if any of the following adverse reactions occur:

Signs of bleeding

• bleeding into the brain or inside the skull (symptoms may include headache, one-sided weakness, vomiting, seizures, decreased level of consciousness, and neck stiffness. A serious, sudden medical emergency. Seek immediate medical help!),
• prolonged or excessive bleeding,
• unusual weakness, fatigue, pallor, dizziness, headache, unexplained swelling, shortness of breath, chest pain, or angina, which may indicate bleeding. The physician may decide that close monitoring of the patient or a change in treatment is necessary.

Signs of severe skin reactions:

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

Signs of severe allergic reactions

• swelling of the face, lips, mouth, tongue, or throat; difficulty swallowing; urticaria and breathing difficulties; sudden drop in blood pressure. The frequency of severe allergic reactions is very rare (anaphylactic reactions, including anaphylactic shock, may occur in no more than 1 in 10,000 patients) and uncommon (angioedema and allergic edema may occur in no more 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)

• decreased number of red blood cells, which may cause paleness of the skin and lead to weakness or shortness of breath,
• gastrointestinal or intestinal bleeding, bleeding from the urinary or genital tract (including blood in urine and severe menstrual bleeding), nosebleeds, gum bleeding,
• bleeding into the eye (including conjunctival hemorrhage),
• bleeding into tissues or body cavities (hematoma, bruising),
• presence of blood in sputum (hemoptysis) during coughing,
• skin bleeding or subcutaneous bleeding,
• postoperative bleeding,
• oozing of blood or fluid from a surgical wound,
• limb swelling,
• limb pain,
• kidney function disorders (may be observed in tests performed by a physician),
• fever,
• stomach pain, indigestion, nausea or vomiting, constipation, diarrhea,
• low arterial blood pressure (symptoms may include dizziness or fainting upon standing),
• general decrease in strength and energy (weakness, fatigue), headache, dizziness,
• rash, skin itching,
• 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 inside the skull (see signs of bleeding above),
• bleeding into a joint causing pain and swelling,
• thrombocytopenia (low platelet count, the blood cells involved in blood clotting),
• allergic reactions, including allergic skin reactions,
• liver function disorders (may be observed in tests performed by a physician),
• 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 area as a complication of cardiac catheterization when the catheter is inserted into an artery in the leg (pseudoaneurysm).

Very rare (may occur in up to 1 in 10,000 patients)

• accumulation of eosinophils, a type of granulocytic white blood cells, causing lung inflammation (eosinophilic pneumonia).

Frequency unknown (frequency cannot be determined from available data)

• kidney failure following severe bleeding,
• bleeding in the kidneys, sometimes with blood in urine, leading to impaired kidney function (drug-induced nephropathy associated with anticoagulant medicines),
• increased pressure within the muscle compartments of arms or legs following bleeding, which may cause pain, swelling, altered sensation, numbness, or paralysis (compartment syndrome following bleeding).

Adverse reactions in children and adolescents
Overall, adverse reactions observed in children and adolescents treated with Thinban 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 individuals)

• headache,
• fever,
• nosebleeds,
• vomiting.

Common (may occur in 1 in 10 individuals)

• rapid heartbeat,
• blood tests may show increased levels of bilirubin (a bile pigment),
• thrombocytopenia (low platelet count, the cells involved in blood clotting),
• excessive menstrual bleeding.

Uncommon (may occur in 1 in 100 individuals)

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

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

5. How to store Thinban

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box after: Expiry date and on each blister or bottle after: EXP. The expiry date refers to the last day of the stated month.
No special precautions regarding storage of the medicinal product are required.
Crushed tablets
Crushed tablets are stable in water or apple puree for up to 4 hours.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures help protect the environment.

6. Contents of the packaging and other information

What Thinban contains

• The active substance is rivaroxaban. Each coated tablet contains 15 mg of rivaroxaban.
• Other ingredients are:
  Tablet core: sodium lauryl sulfate, monohydrate lactose, hypromellose, sodium croscarmellose, magnesium stearate
  Coating Opadry II 85F230074 Orange: polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, yellow iron oxide (E 172), red iron oxide (E 172)

What Thinban looks like and contents of the packaging
Thinban 15 mg are orange, coated, round tablets approximately 7 mm in diameter, with the imprint "T" on one side and "3R" on the other side.
The tablets are contained in unit dose blisters: 30x1, 90x1
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Teva GmbH, Graf-Arco-Str. 3, 89079 Ulm, Germany

Manufacturer/Importer
Teva Operations Poland Sp. z o.o., ul. Mogilska 80, 31-546 Kraków, Poland
Balkanpharma-Dupnitsa AD, 3 Samokovsko Shosse Str., 2600 Dupnitsa, Bulgaria
Actavis Group PTC ehf, Dalshraun 1, Hafnarfjoerdur, 220, Iceland

For further information about this medicine, please contact the representative of the Marketing Authorisation Holder:
Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, tel.: (22) 345 93 00.