Thinban

Package Leaflet: Information for the User

Thinban, 20 mg, Film-Coated Tablets

Rivaroxaban

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any further questions, you should ask your doctor or pharmacist.
• This medication has been prescribed for a specific person. Do not pass it on to others. The medication may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any possible side effects not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet:

• 1. What is Thinban and what is it used for
• 2. Important information 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 is Thinban and what is it 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 patient's body, if the patient has a type of irregular heart rhythm called atrial fibrillation not caused by heart valve problems.
• 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.

Thinban is used in children and adolescents under 18 years of age and weighing 30 kg or more to:

• treat and prevent blood clots in the veins or blood vessels in the lungs, after at least 5 days of initial treatment with injectable medications used to treat blood clots.

Thinban belongs to a group of medicines called anticoagulants. Its action is based on blocking a blood clotting factor (factor Xa) and thereby reducing the tendency to form blood clots.

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 medication (listed in section 6),
• if the patient has excessive bleeding,
• if the patient has a disease or condition of the body that leads to an increased risk of serious bleeding (e.g., stomach ulcer, injury or bleeding into the brain, recent brain or eye surgery),

if the patient is taking other medications that prevent the formation of blood clots (e.g., warfarin, dabigatran, apixaban, or heparin), except when changing anticoagulant treatment or when heparin is administered to maintain the patency of a venous or arterial catheter,

Do not take Thinban and inform your doctorif you suspect that any of the above conditions apply to you.

Warnings and precautions

Before starting to take Thinban, you should discuss it with your doctor or pharmacist.

When to be particularly careful when taking Thinban

• 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 medication acting in the patient's body,
• taking other medications that prevent the formation of blood clots (e.g., warfarin, dabigatran, apixaban, or heparin) when changing anticoagulant treatment or when heparin is administered to maintain the patency of a venous or arterial catheter (see "Thinban and other medications"),
• bleeding disorders,
• very high blood pressure that does not decrease despite taking medications,
• 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) or tumors located in the stomach or intestines or genital or urinary system
• 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 prosthetic heart valves,
• if the patient has a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clot formation), the patient should inform the doctor, who will decide on possible changes to the treatment,
• if the patient has been diagnosed with abnormal blood pressure or a surgical procedure is planned to remove a blood clot from the lungs.

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

before taking Thinban. The doctor will decide whether to use this medication and whether the patient should be subject to particularly close monitoring.

If you need to have surgery:

• you should carefully follow the doctor's instructions regarding the intake of Thinban at a precisely specified time before or after surgery,
• if catheterization or spinal puncture is planned during surgery (e.g., for epidural or spinal anesthesia or pain relief):
• it is very important to take Thinban before and after the puncture or catheter removal, according to the doctor's instructions,
• due to the need for special caution, you should immediately inform your doctor if you experience numbness or weakness of the legs, bowel or bladder disorders after the anesthesia is completed.

Children and adolescents

Rivaroxaban is not recommended for children with a body weight below 30 kg. There is a lack of sufficient data on the use of rivaroxaban in children and adolescents for indications in adults.

Thinban and other medications

You should tell your doctor or pharmacist about all medications you are currently taking or have recently taken, as well as medications you plan to take, including those that are available without a prescription.

• -If you are taking:
• certain medications 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 medications used to treat bacterial infections (e.g., clarithromycin, erythromycin),
• certain antiviral medications used to treat HIV or AIDS (e.g., ritonavir),
• other medications used to reduce blood clotting (e.g., enoxaparin, clopidogrel, or vitamin K antagonists, such as warfarin or acenocoumarol),
• anti-inflammatory and pain medications (e.g., naproxen or acetylsalicylic acid),
• dronedarone, a medication used to treat heart rhythm disorders,
• certain medications used to treat depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs)).

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

before taking Thinban, as the effect of Thinban may be enhanced if it is taken with the above medications. The doctor will decide whether to use this medication and whether the patient should be subject to particularly close monitoring.

• -If you are taking
• certain medications used to treat epilepsy (phenytoin, carbamazepine, phenobarbital),
• St. John's Wort ( Hypericum perforatum), a herbal remedy used to treat depression,
• rifampicin, which belongs to a group of antibiotics.

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

before taking Thinban, as the effect of Thinban may be reduced if it is taken with the above medications. The doctor will decide whether to use Thinban and whether the patient should be subject to particularly close monitoring.

Pregnancy and breastfeeding

Do not takeThinban if you are pregnant or breastfeeding. If there is a risk that you may become pregnant, you should use effective contraception during Thinban treatment. If you become pregnant while taking Thinban, you should immediately inform your doctor, who will decide on further treatment.

Driving and using machines

Thinban may cause dizziness (frequent side effects) and fainting (uncommon side effects) (see section 4 "Possible side effects"). Patients who experience these side effects should not drive vehicles, ride bicycles, or operate tools or machines.

Thinban contains lactose and sodium.

If you have previously been diagnosed with intolerance to some sugars, you should contact your doctor before taking this medication. The medication contains less than 1 mmol of sodium (23 mg) per tablet, which means it is essentially "sodium-free".

3. How to take Thinban

This medication should always be taken according to the doctor's instructions. If you have any doubts, you should ask your doctor or pharmacist. Thinban should be taken with food. The tablet(s) should be swallowed, preferably with water. If you have difficulty swallowing the whole tablet, you should talk to your doctor about other ways to take Thinban. The tablet can be crushed and mixed with water or soft food, such as apple sauce, immediately before intake. After such a mixture, you should eat a meal immediately.

How many tablets to take

Adults

• In preventing the formation of blood clots in the brain (stroke) and other blood vessels in the body: The recommended dose is one Thinban 20 mg tablet once a day. If you have kidney problems, the dose may be reduced to one Thinban 15 mg tablet once a day.

If the patient requires a procedure to open up blood vessels in the heart (called percutaneous coronary intervention - PCI with stent placement), there is limited evidence to support a dose reduction to one Thinban 15 mg tablet once a day (or one Thinban 10 mg tablet once a day in case of kidney function disorder) in combination with an antiplatelet medication such as clopidogrel. In treating blood clots in the veins of the legs, blood clots in the blood vessels of the lungs, and preventing the recurrence of blood clots: The recommended dose is one Thinban 15 mg tablet twice a day for the first 3 weeks. For treatment after 3 weeks, the recommended dose is one Thinban 20 mg tablet once a day. After at least 6 months of treatment for blood clots, the doctor may decide to continue treatment using one 10 mg tablet once a day or one 20 mg tablet once a day. If you have kidney problems and are taking one Thinban 20 mg tablet once a day, the doctor may decide to reduce the dose after 3 weeks of treatment to one Thinban 15 mg tablet once a day, if the risk of bleeding is greater than the risk of further blood clot formation.

Children and adolescents

The dose of Thinban depends on body weight and will be calculated by the doctor.

• The recommended dose for children and adolescents with a body weight of 30 kg to less than 50 kgis one Thinban 15 mg tabletonce a day.
• The recommended dose for children and adolescents with a body weight of 50 kg or moreis one Thinban 20 mg tabletonce a day.

Each Thinban dose should be taken with food, washed down with a drink (e.g., water or juice). Tablets should be taken daily at approximately the same time. It's a good idea to set an alarm to remind you. For parents or caregivers: you should observe the child to make sure they have taken the entire dose. The dose of Thinban is dependent on body weight, so it's essential to attend scheduled doctor's appointments, as it may be necessary to adjust the dose due to weight changes. Never adjust the dose yourself. If necessary, the doctor will adjust the dose. Do not divide the tablet to obtain a partial dose. If a smaller dose is necessary, you should use a different pharmaceutical form. For children and adolescents who are unable to swallow whole tablets, you should use a different pharmaceutical form. If a different pharmaceutical form is not available, you can crush the Thinban tablet and mix it with water or apple sauce immediately before intake. After such a mixture, you should eat a meal. If necessary, the doctor may also administer the crushed tablet through a gastric tube.

If you spit out the dose or vomit

• less than 30 minutes after taking Thinban, you should take a new dose.
• more than 30 minutes after taking Thinban, do not takea new dose. In this case, the next Thinban dose should be taken at the usual time.

You should contact your doctor if you spit out the dose or vomit repeatedly after taking Thinban.

When to take Thinban

The tablet(s) should be taken every day until the doctor decides to stop the treatment. It's best to take the tablet(s) at the same time every day, as it's easier to remember. The doctor will decide how long you should continue the treatment. Preventing the formation of blood clots in the brain (stroke) and other blood vessels in the body: If the heart rhythm needs to be restored using a procedure called cardioversion, Thinban should be taken at the time specified by the doctor.

Missing a dose of Thinban

Adults, children, and adolescents:

• If you are taking one 20 mg or one 15 mg tablet once a day and you miss a dose, you should take it as soon as possible. Do not takemore than one tablet in one day to make up for the missed dose. The next tablet should be taken the next day, and then you should take one tablet once a day.

Adults: If you are taking one 15 mg tablet twice a day and you miss a dose, you should take it as soon as possible. Do not takemore than two 15 mg tablets in one day. If you forget to take a dose, you can take two 15 mg tablets at the same time to get a total of two tablets (30 mg) taken in one day. The next day, you should continue taking one 15 mg tablet twice a day.

Taking more than the recommended dose of Thinban

If you take more than the recommended dose of Thinban, you should immediatelycontact your doctor. Taking too much Thinban increases the risk of bleeding.

Stopping Thinban treatment

Do not stoptaking Thinban without first consulting your doctor, as Thinban treats and prevents serious diseases. If you have any further doubts about the use of Thinban, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medications, Thinban can cause side effects, although not everybody gets them. Like other medications with a similar effect of reducing blood clot formation, Thinban can cause bleeding, which can potentially be life-threatening. Excessive bleeding can lead to a sudden drop in blood pressure (shock). Not all of these will be obvious or visible signs of bleeding.

You should immediately inform your doctor if you experience any of the following side effects:

Signs of bleeding

• bleeding into the brain or within the skull (symptoms may include headache, one-sided weakness, vomiting, seizures, decreased level of consciousness, and stiffness of the neck. This is a serious medical emergency. You should immediately seek medical help!),
• prolonged or excessive bleeding,
• unusual weakness, fatigue, pallor, dizziness, headache, unexplained swelling, shortness of breath, chest pain, or angina, which may be signs of bleeding.

Signs of severe skin reactions:

• widespread, acute skin rash, blistering, or changes to the mucous membranes, e.g., mouth or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• a drug reaction that causes a rash, fever, inflammation of internal organs, blood disorders, and systemic symptoms (DRESS syndrome). The frequency of these side effects 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, hives, and

difficulty breathing; 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 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 intestine, bleeding from the urinary or genital system (including blood in the 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),
• appearance of blood in sputum (hemoptysis) while coughing,
• 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 (can be observed in tests performed by the doctor),
• fever,
• stomach pain, nausea (nausea) or vomiting, constipation, diarrhea,
• low blood pressure (symptoms may include dizziness or fainting when standing),
• general weakness and lack of energy (weakness, fatigue), headache, dizziness,
• skin rash, itching,
• increased activity of certain liver enzymes, which can be seen in blood test results.

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

• bleeding into the brain or within the skull (see above signs of bleeding),
• 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 (can be observed in tests performed by the doctor),
• blood test results may show increased bilirubin levels, activity of certain pancreatic or liver enzymes, or platelet count,
• fainting,
• malaise,
• rapid heartbeat,
• dry mouth,
• hives.

Rare(may occur in up to 1 in 1,000 patients)

• bleeding into the muscles,
• cholestasis (bile stasis), hepatitis, including liver cell damage,
• jaundice (yellowing of the skin and eyes),
• local swelling,
• blood accumulation (hematoma) in the groin as a complication of heart 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 white granular blood cells, which causes inflammation in the lungs (eosinophilic pneumonia)

Frequency not known(frequency cannot be estimated from the available data)

• kidney failure after severe bleeding,
• bleeding in the kidneys, sometimes with blood in the urine, leading to kidney failure (nephropathy associated with anticoagulant medications),
• 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

Generally, the side effects observed in children and adolescents treated with Thinban were similar in 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)
• excessive menstrual bleeding

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

• blood test results may show increased direct bilirubin levels

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, you should inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of 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. By reporting side effects, you can help provide more information on the safety of this medication. Side effects can also be reported to the marketing authorization holder.

5. How to store Thinban

The medication should be stored out of sight and reach of children. Do not use this medication after the expiry date stated on the carton after "EXP". The expiry date refers to the last day of the month stated. There are no special precautions for the storage of the medicinal product. Crushed tablets: Crushed tablets are stable in water or apple sauce for up to 4 hours. Medications should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Thinban contains

• The active substance of Thinban is rivaroxaban. Each film-coated tablet contains 20 mg of rivaroxaban.
• In addition, Thinban contains: Tablet core: sodium lauryl sulfate, lactose monohydrate, hypromellose, croscarmellose sodium, 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 is a red, film-coated, round tablet, approximately 8 mm in diameter, with the inscription "T" on one side of the tablet and "7R" on the other side. The tablets are available in single-dose blisters: 30x1, 90x1. Not all pack sizes may be marketed.

Marketing authorization holder

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

Manufacturer/Importer

Teva Operations Poland Sp. z o.o., ul. Mogilska 80, 31-546 Krakow, Balkanpharma-Dupnitsa AD, 3 Samokovsko Shosse Str., 2600 Dupnitsa, Bulgaria, Actavis Group PTC ehf, Dalshraun 1, Hafnarfjoerdur, 220, Iceland. For more information on this medication, you should contact the representative of the marketing authorization holder: Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, tel.: (22) 345 93 00. Date of last revision of the leaflet: November 2023