Thinban

Package Leaflet: Information for the User

Thinban, 15 mg, Film-Coated Tablets

Rivaroxaban

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, 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.

Table of Contents of the 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 form of irregular heart rhythm called atrial fibrillation not caused by a heart valve problem.
• 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 medicines used to treat blood clots.

Thinban belongs to a group of medicines called anticoagulants. Its action is based on blocking the 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 medicine (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 medicines that prevent the formation of blood clots (e.g. warfarin, dabigatran, apixaban or heparin), except when changing anticoagulant treatment or when heparin is given to maintain the patency of a vein or artery catheter,

Do not take Thinban and inform your doctorif you suspect that the above circumstances have occurred.

Warnings and precautions

Before starting to take Thinban, 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 such conditions as:
• severe kidney disease, in the case of adults, and moderate or severe kidney disease in the case of children and adolescents, as kidney function may affect the amount of medicine acting in the patient's body,
• taking other medicines that prevent the formation of blood clots (e.g. warfarin, dabigatran, apixaban or heparin) when changing anticoagulant treatment or when heparin is given to maintain the patency of a vein or artery catheter (see "Thinban and other medicines"),
• bleeding disorders,
• very high blood pressure that does not decrease despite taking medicines,
• 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,
• disease of the blood vessels in the back of the eyeballs (retinopathy),
• pulmonary disease in which the bronchi are dilated and filled with pus (bronchiectasis) or previous bleeding from the lungs,
• in patients with prosthetic valves,
• if the patient has a disorder 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 or other treatment is planned to remove a blood clot from the lungs.

If the patient suspects that they have the above conditions, they should inform

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

If the patient needs to undergo surgery:

• they should 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, in accordance with the doctor's instructions,
• due to the need for special caution, the doctor should be informed immediately if numbness or weakness of the legs, bowel or bladder disorders occur after the end of anesthesia.

Children and adolescents

Rivaroxaban tablets are 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 medicines

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

• - If you are taking:
• certain medicines used to treat fungal infections (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are used only locally on the skin,
• ketokonazole in tablets (used to treat Cushing's syndrome, in which the body produces too much cortisol),
• certain medicines used to treat bacterial infections (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 medicines used to treat depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin and noradrenaline reuptake inhibitors (SNRIs)).

If the patient suspects that they have the above conditions, they should

inform their doctorbefore taking Thinban, as the action of Thinban may be enhanced if taken with the above medicines. The doctor will decide whether to use this medicine and whether the patient should be subject to particularly close monitoring. If the doctor believes that the patient is at increased risk of developing stomach or duodenal ulcers, they may use treatment to prevent ulcer disease.

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

If the patient suspects that they have the above conditions, they should inform their doctor

before taking Thinban, as the action of Thinban may be reduced if taken with the above medicines. 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 while taking Thinban. If you become pregnant while taking Thinban, you should inform your doctor immediately, 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, ride a bicycle, 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 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

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. Thinban should be taken with food. Swallow the tablet(s) whole, preferably with water. If you have difficulty swallowing whole tablets, 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 puree, immediately before taking. After such a mixture, you should eat a meal immediately.

How many tablets to take

Adults

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

If the patient requires a procedure to clear the blood vessels in the heart (called percutaneous coronary intervention - PCI with stent placement), there is limited evidence to support a dose reduction to one 15 mg Thinban tablet once daily (or one 10 mg Thinban tablet once daily in case of kidney function disorder) in combination with an antiplatelet medicine such as clopidogrel. In the treatment of blood clots in the veins of the legs, blood clots in the blood vessels of the lungs, and to prevent the recurrence of blood clots: The recommended dose is one 15 mg Thinban tablet twice daily for the first 3 weeks. For treatment after 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 using one 10 mg tablet once daily or one 20 mg tablet once daily. If you have kidney problems and are 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 clot formation.

Children and adolescents

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

• The recommended dose for children and adolescents with a body weight of 30 kg to less than 50 kgis one Thinban 15 mgtablet once daily.
• The recommended dose for children and adolescents with a body weight of 50 kgor more is one Thinban 20 mgtablet once daily.

Each Thinban dose should be taken with food, 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 the dose may need to be adjusted due to weight changes. Never adjust the dose yourself.If necessary, the doctor will adjust the dose. Do not divide the tablet to get a partial dose. If a smaller dose is needed, other pharmaceutical forms are available. For children and adolescents who are unable to swallow whole tablets, other pharmaceutical forms should be used. If other pharmaceutical forms are not available, the Thinban tablet can be crushed and mixed with water or apple puree immediately before taking. After this mixture, you should eat a meal. If necessary, the doctor may also administer the crushed Thinban tablet through a gastric tube.

In case of spitting up a dose or vomiting

• less than 30 minutes after taking Thinban, you should take a new dose.
• more than 30 minutes after taking Thinban, do nottake a new dose. In this case, the next Thinban dose should be taken at the usual time.

You should contact your doctor in case of repeated spitting up of a dose or vomiting after taking Thinban.

When to take Thinban

Tablet(s) should be taken every day until your doctor decides to stop 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 treatment. Prevention of blood clot formation in the brain (stroke) and other blood vessels in the body: If your heart rhythm needs to be restored with a procedure called cardioversion, you should take Thinban as directed by your doctor.

Missing a dose of Thinban

Adults, children, and adolescents:

• If you are taking one 20 mg or one 15 mg tablet once daily 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 daily.

Adults: If you are taking one 15 mg tablet twice daily 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 daily.

Taking more than the recommended dose of Thinban

If you have taken 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 questions about taking Thinban, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Thinban can cause side effects, although not everybody gets them. Like other medicines with a similar action to reduce 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, severe 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).

Common(may affect up to 1 in 10 people)

• reduction in 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) when 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 affect up to 1 in 100 people)

• 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 affect up to 1 in 1,000 people)

• bleeding into the muscles,
• cholestasis (bile stagnation), hepatitis, including liver cell damage,
• jaundice (yellowing of the skin and eyes),
• local swelling,
• hematoma (blood accumulation) in the groin as a complication of heart catheterization, when a catheter is inserted into an artery in the leg (pseudoaneurysm).

Very rare(may affect up to 1 in 10,000 people)

• accumulation of eosinophils, a type of white granular blood cell, 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 drugs),
• 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 mainly mild to moderate. Side effects observed more frequently in children and adolescents: Very common(may affect more than 1 in 10 people)

• headache
• fever
• nosebleeds
• vomiting

Common(may affect up to 1 in 10 people)

• rapid heartbeat
• blood test results may show increased bilirubin levels
• thrombocytopenia (low platelet count)
• excessive menstrual bleeding

Uncommon(may affect up to 1 in 100 people)

• blood test results may show increased direct bilirubin levels

Reporting side effects

If you experience any side effects, including any 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 medicine. Side effects 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 which is stated on the carton after EXP. The expiry date refers to the last day of that month. There are no special precautions for storage of the medicinal product. 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 required. These measures will help protect the environment.

6. Contents of the pack and other information

What Thinban contains

• The active substance is rivaroxaban. Each film-coated tablet contains 15 mg of rivaroxaban.
• The other ingredients are: Tablet core: sodium lauryl sulfate, lactose monohydrate, hypromellose, croscarmellose sodium, magnesium stearate. Film 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 pack

Thinban 15 mg is an orange, film-coated, round tablet, approximately 7 mm in diameter, with the inscription "T" on one side of the tablet and "3R" on the other side. The tablets are available in blister packs of 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, Poland; Balkanpharma-Dupnitsa AD, 3 Samokovsko Shosse Str., 2600 Dupnitsa, Bulgaria; Actavis Group PTC ehf, Dalshraun 1, Hafnarfjoerdur, 220, Iceland. For further information on this medicine, please contact 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