Thinban

Package leaflet: Information for the user

Thinban, 20 mg, coated tablets
rivaroxaban
Read the entire leaflet carefully before taking this medicine, as it contains important information for the patient.

• Keep this leaflet for future reference.
• If you have any further questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist immediately. See section 4.

Table of contents of the leaflet:

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 the formation of blood clots in the brain (stroke) and other blood vessels in the body in patients who have a type of irregular heartbeat known as 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 with body weight of 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 has 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 catheter in a vein or artery,
• if the patient has 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 the patient suspects that any of the above conditions apply.
Warnings and precautions
Before starting Thinban, discuss this with your doctor or pharmacist.
When to exercise special caution when using 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 catheter in a vein or artery (see section "Thinban with other medicines"),
• blood clotting disorders,
• very high blood pressure that does not decrease despite treatment with medication,
• diseases of the stomach or intestines that may cause bleeding, e.g. inflammation of the intestines and stomach or inflammation of the oesophagus (throat and oesophagus), e.g. due to gastro-oesophageal reflux disease (backflow of stomach acid into the oesophagus), or tumours located in the stomach, intestines, genital or urinary system,
• blood vessel disease in the back of the eye (retinopathy),
• lung disease in which the bronchi are dilated and filled with pus (bronchiectasis) or previous bleeding from the lungs,
• in patients with prosthetic heart valves,
• if the patient has a disorder called antiphospholipid syndrome (an immune system disorder causing increased risk of blood clots), the patient should inform the doctor, who will decide whether a change in treatment is necessary,
• if the patient has abnormal blood pressure or if surgery or another treatment to remove a blood clot from the lungs is planned.

If the patient suspects that any of the above conditions apply, they should inform the doctor
before taking Thinban. The doctor will decide whether to use this medicine and whether the
patient should be placed under particularly close observation.
If the patient needs to undergo surgery:

• strictly follow the doctor's instructions regarding the timing of taking Thinban before or after surgery,
• if during surgery catheterization or spinal puncture is planned (e.g. for epidural or intrathecal anaesthesia or pain relief):
• it is very important to take Thinban before and after the puncture or removal of the catheter, as directed by the doctor,
• due to the need for special caution, the doctor should be informed immediately if numbness or weakness in the legs, or disturbances in bowel or bladder function occur after the anaesthesia ends.

Children and adolescents
Rivaroxaban is not recommended for children weighing less than 30 kg.
There is insufficient data on the use of rivaroxaban in children and adolescents for indications approved in adults.
Thinban with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including medicines the patient plans to take, even those 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 topically on the skin,
• ketoconazole tablets (used in the treatment of Cushing's syndrome, in which the body produces too much cortisol),
• certain antibiotics used to treat bacterial infections (e.g. clarithromycin, erythromycin),
• certain antiviral medicines used to treat HIV infection 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 (SSRI) or serotonin-noradrenaline reuptake inhibitors (SNRI)).

If the patient suspects that any of the above conditions apply, they should inform the doctor
before taking Thinban, because the effect of Thinban may be enhanced when taken together with the above-mentioned medicines.
The doctor will decide whether to use this medicine and whether the patient should be placed under particularly close observation.
If the doctor considers that the patient has an increased risk of developing stomach or duodenal ulcers, they may prescribe treatment to prevent peptic ulcer disease.

• If the patient is taking
• certain medicines used to treat epilepsy (phenytoin, carbamazepine, phenobarbital),
• St John's wort ( Hypericum perforatum ), an herbal medicine used for depression,
• rifampicin, which belongs to the group of antibiotics.

If the patient suspects that any of the above conditions apply, they should inform the doctor
before taking Thinban, because the effect of Thinban may be reduced when taken together with the above-mentioned medicines. The doctor will decide whether to use Thinban and whether the patient should be placed under particularly close observation.
Pregnancy and breastfeeding
Do not use Thinban if the patient is pregnant or breastfeeding. If there is a risk that the patient may become pregnant, an effective method of contraception should be used during treatment with Thinban. If the patient becomes pregnant while taking Thinban, they should inform the doctor immediately, who will decide on further treatment.
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 the patient has previously been diagnosed with intolerance to certain sugars, they should contact their 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 your 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 the patient has difficulty swallowing the whole tablet, discuss alternative ways of taking
Thinban with your doctor. The tablet may be crushed and mixed with water or soft food,
such as apple puree, immediately before administration. After taking this mixture, a meal
should be consumed promptly.
If necessary, your doctor may administer crushed Thinban tablets via 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 the patient requires a procedure to open blocked blood vessels in the heart
(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 agent such as clopidogrel.
For 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 15 mg Thinban tablet twice daily for the first 3 weeks.
After 3 weeks of treatment, the recommended dose is one 20 mg Thinban 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 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 of 30 kg to less than 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 every day 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.
Since the dose of Thinban depends on body weight, it is important to attend scheduled
appointments with the doctor, as dose adjustments may be necessary due to changes in
weight. Never adjust the dose independently. Your doctor will adjust the dose if needed.
Do not split the tablet to achieve a partial dose. If a lower dose is required, use a different
formulation. For children and adolescents who cannot swallow whole tablets, an alternative
pharmaceutical form should be used.
If an alternative formulation is not available, the Thinban tablet may be crushed and
mixed with water or apple puree immediately before administration. After taking this
mixture, a meal should be consumed promptly. If necessary, your doctor may also
administer crushed tablets via 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 your 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. Your doctor
will decide how long treatment should continue.
Prevention of blood clots in the brain (stroke) and other blood vessels in the body:
If heart rhythm needs to be restored by a procedure called cardioversion, Thinban should
be taken as directed by your 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 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 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 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.

Taking more than the recommended dose of Thinban
If the patient has taken more than the recommended dose of Thinban, contact your doctor immediately.
Overdosing on Thinban increases the risk of bleeding.

Stopping Thinban treatment
Do not stop taking Thinban without first consulting your doctor, as 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 all medicines, this medicine can cause adverse reactions, although not everyone will experience them.

As with other medicines with a similar mechanism of action that reduce blood clot formation, 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.

Contact your doctor immediately 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 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, pallor, dizziness, headache, unexplained swelling, shortness of breath, chest pain or angina, which may indicate bleeding. Your doctor may decide that close monitoring or a change in treatment is necessary.

Signs of severe skin reactions:

• Widespread, acute skin rash, formation of blisters 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, oral cavity, tongue or throat; difficulty swallowing, urticaria (hives), 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)

• 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 intestines, bleeding from the urinary or genital tract (including blood in urine and heavy 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,
• 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),
• Generalized weakness and fatigue (asthenia, tiredness), 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 inside the skull (see signs of bleeding above),
• Bleeding into a joint causing pain and swelling,
• Thrombocytopenia (low platelet count, platelets being blood cells involved in 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,
• 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 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 not known (frequency cannot be estimated from available data)

• Kidney failure following severe bleeding,
• Bleeding in the kidneys, sometimes with blood in urine, leading to impaired kidney function (drug-induced anticoagulant-related nephropathy),
• Increased pressure in the muscles of arms and legs following bleeding, which may cause pain, swelling, altered sensation, numbness or paralysis (compartment syndrome following bleeding).

Adverse reactions in children and adolescents

In general, 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 people)

• Headache
• Fever
• Nosebleeds
• Vomiting

Common (may occur in 1 in 10 people)

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

Uncommon (may occur in 1 in 100 people)

• 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 Drug Reactions 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 provide 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 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 for storage of the medicinal product are required.
Crushed tablets
Crushed tablets are stable in water or apple puree for up to 4 hours.
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 packaging and other information

What Thinban contains

• The active substance is rivaroxaban. Each coated tablet contains 20 mg of rivaroxaban.
• Other ingredients are:
  Tablet core: sodium lauryl sulfate, lactose monohydrate, hypromellose, sodium croscarmellose, magnesium stearate
  Film coating Opadry II 85F25401 Red: polyvinyl alcohol, macrogol 3350, talc, iron oxide red (E 172)

What Thinban looks like and contents of the pack
Thinban 20 mg are red, film-coated, round tablets of approximately 8 mm in diameter, with the imprint “T” on one side and “7R” on the other side of the tablet.
The tablets are packed 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 medicinal product, please contact the representative of the Marketing Authorisation Holder:
Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, Poland,
tel.: (22) 345 93 00.