Thinban

Package Leaflet: Information for the User

Thinban, 2.5 mg, Film-Coated Tablets

Rivaroxaban

Before Taking the Medication, Read the Contents of the Leaflet, as it Contains Important Information for the Patient.

• This leaflet should be kept in case it needs to be read again.
• In case of any further doubts, the doctor or pharmacist should be consulted.
• This medication has been prescribed to a specific person. It should not be given to others. The medication may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their 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

The patient has been given Thinban because

• they have been diagnosed with acute coronary syndrome (a condition that includes heart attack and unstable angina, acute chest pain) and have elevated levels of cardiac biomarkers.
• Thinban reduces the risk of another heart attack or reduces the risk of death due to heart or blood vessel disease in adults. Thinban will not be given to the patient as the only medication. The doctor will instruct the patient to also take:
• aspirin or
• aspirin and clopidogrel or ticlopidine.

or

• they have been diagnosed with a high risk of blood clots due to coronary artery disease or peripheral artery disease, which causes symptoms. Thinban reduces the risk of blood clots (atherothrombotic events) in adults. Thinban will not be given to the patient as the only medication. The doctor will instruct the patient to also take aspirin. In some cases, if the patient is receiving Thinban after a procedure to open up a narrowed or blocked artery in the leg to restore blood flow, the doctor may also prescribe clopidogrel for the patient to take for a short time in addition to aspirin.

Thinban contains the active substance rivaroxaban and belongs to a group of medicines called anticoagulants. Its action involves 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 blood clotting (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 (see "Thinban and other medications"),
• if the patient has had an acute coronary syndrome and has had bleeding or a blood clot in the brain (stroke),
• if the patient has coronary artery disease or peripheral artery disease and has had bleeding in the brain (stroke) or blockage of small arteries that supply blood to the tissues in the deep structures of the brain (sinus thrombosis) or if the patient has had a blood clot in the brain (ischemic stroke) in the last month),
• if the patient has liver disease that leads to an increased risk of bleeding,
• if the patient is pregnant or breastfeeding.

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

Warnings and precautions

Before starting to take Thinban, discuss it with your doctor or pharmacist. Thinban should not be taken with other medications that prevent blood clotting, such as prasugrel or ticagrelor, except for aspirin, clopidogrel, or ticlopidine.

When to exercise special caution when taking Thinban

• if the patient has an increased risk of bleeding, such as:
• severe kidney disease, as kidney function may affect the amount of medication that works in the patient's body,
• taking other medications that prevent blood clotting (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 medications"),
• bleeding disorders,
• very high blood pressure that does not decrease despite taking medications,
• stomach or intestinal diseases that may cause bleeding, such as inflammation of the intestines and stomach or esophagitis (throat and esophagus) due to gastroesophageal reflux disease (backflow of stomach acid into the esophagus), or tumors located in the stomach, intestines, genital, or urinary system,
• disease of the blood vessels in the back of the eye (retinopathy),
• lung disease, in which the airways are enlarged and filled with pus (bronchiectasis) or previous bleeding from the lungs,
• if the patient is over 75 years old,
• if the patient weighs less than 60 kg,
• coronary artery disease with severe symptomatic heart failure,
• 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 clots), the patient should inform their doctor, who will decide whether to change the treatment.

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

inform their doctorbefore taking Thinban. The doctor will decide whether to use this medication and whether the patient should be closely monitored.

If the patient needs to undergo surgery:

• they should carefully follow the doctor's instructions regarding the intake of Thinban at a specific 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, as instructed by the doctor
• due to the need for special caution, the doctor should be informed immediately if numbness or weakness of the legs, bowel or bladder dysfunction, or other symptoms occur after anesthesia.

Children and adolescents

Rivaroxaban 2.5 mg tablets are not recommended for persons under 18 years of age. There is a lack of sufficient data on their use in children and adolescents.

Thinban and other medications

The patient should tell their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take, including those that are available without a prescription.

• -If the patient is taking
• certain medications 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 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, prasugrel, and ticagrelor (see "Warnings and precautions")),
• anti-inflammatory and pain medications (e.g., naproxen or aspirin),
• 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 the patient suspects that they have any of the above conditions, they should

inform their doctorbefore taking Thinban, as the effect of Thinban may be enhanced. The doctor will decide whether to use this medication and whether the patient should be closely monitored.
If the doctor believes that the patient is at increased risk of developing stomach or intestinal ulcers, they may use preventive treatment to prevent ulcers.

• -If the patient is 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 the patient suspects that they have any of the above conditions, they should

inform their doctorbefore taking Thinban, as the effect of Thinban may be reduced. The doctor will decide whether to use Thinban and whether the patient should be closely monitored.

Pregnancy and breastfeeding

Do not take Thinban if the patient is pregnant or breastfeeding. If there is a risk that the patient may become pregnant, they should use effective contraception while taking Thinban. If the patient becomes pregnant while taking this medication, they should immediately inform their 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, ride a bike, or operate tools or machines.

Thinban contains lactose and sodium.

If the patient has previously been diagnosed with intolerance to some sugars, they should contact their 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 as directed by the doctor. In case of doubts, the doctor or pharmacist should be consulted.

How many tablets to take

The recommended dose is one 2.5 mg tablet twice a day. Thinban should be taken at approximately the same time every day (e.g., one tablet in the morning and one in the evening).
The medication can be taken with or without food.
If the patient has difficulty swallowing the whole tablet, they should discuss other ways of taking Thinban with their doctor. The tablet can be crushed and mixed with water or apple sauce, just before taking it.
If necessary, the doctor may administer the crushed Thinban tablet through a gastric tube.
Thinban will not be given to the patient as the only medication.
The doctor will instruct the patient to also take aspirin. If the patient is receiving Thinban after an acute coronary syndrome, the doctor may also instruct them to take clopidogrel or ticlopidine.
If the patient is receiving Thinban after a procedure to open up a narrowed or blocked artery in the leg to restore blood flow, the doctor may prescribe clopidogrel for the patient to take for a short time in addition to aspirin.
The doctor will tell the patient what dose of these medications to take (usually 75-100 mg of aspirin per day or a daily dose of 75-100 mg of aspirin plus a daily dose of 75 mg of clopidogrel or a standard daily dose of ticlopidine).

When to take Thinban

Treatment with Thinban after an acute coronary syndrome should be started as soon as possible after stabilization of the acute coronary syndrome, at the latest 24 hours after hospital admission and when parenteral (injectable) anticoagulant treatment would normally be discontinued.
The doctor will tell the patient when to start treatment with Thinban if they have been diagnosed with coronary artery disease or peripheral artery disease.
The doctor will decide how long to continue treatment.

Taking a higher dose of Thinban than recommended

If the patient has taken a higher dose of Thinban than recommended, they should immediately contact their doctor. Taking too much Thinban increases the risk of bleeding.

Missing a dose of Thinban

Do not take a double dose to make up for a missed dose. If the patient misses a dose, they should take the next dose at the scheduled time.

Stopping Thinban

Thinban should be taken regularly and for the duration recommended by the doctor.
Do not stop taking Thinban without first consulting the doctor. If the patient stops taking this medication, the risk of another heart attack, stroke, or death due to heart or blood vessel disease may increase.
In case of any further doubts about the use of this medication, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medications, Thinban can cause side effects, although not everyone will experience them.
Like other medications with similar anticoagulant effects, Thinban may cause bleeding, which can be life-threatening. Excessive bleeding can lead to a sudden drop in blood pressure (shock). These may not always be obvious or visible signs of bleeding.

The patient should immediately inform their doctor if they experience any of the following side effects:

Signs of bleeding

• bleeding into the brain or 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. Medical help should be sought immediately!),
• prolonged or excessive bleeding,
• unusual weakness, fatigue, pallor, dizziness, headache, unexplained swelling, shortness of breath, chest pain, or angina. The doctor may decide to closely monitor the patient or change the treatment.

Signs of severe skin reactions:

• widespread, acute skin rash, blistering, or changes to the mucous membranes, such as the tongue or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• 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 fewer 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 fewer than 1 in 10,000 patients) and uncommon (angioedema and allergic edema may occur in fewer than 1 in 100 patients).

General list of possible side effects:

Common(may occur in up to 1 in 10 patients)

• decrease in red blood cell count, which may cause pallor and be the cause of weakness or shortness of breath,
• bleeding from the stomach or intestines, 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),
• presence 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,
• pain in the limbs,
• 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 up),
• general decrease in strength and energy (weakness, fatigue), headache, dizziness,
• rash, itching of the skin,
• 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 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 levels of bilirubin, certain liver or pancreatic 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,
• accumulation of blood (hematoma) in the groin as a complication of cardiac catheterization, when a 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 granulocytic blood cells, which cause 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, which can cause pain, swelling, changes in sensation, numbness, or paralysis (compartment syndrome after bleeding).

Reporting side effects

If side effects occur, including any possible side effects not listed in this leaflet, the patient should consult their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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, more information can be gathered on the safety of the 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 expiration date stated on the carton after:
Expiration date and on each blister or bottle after: EXP. The expiration 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 in wastewater or household waste. The patient should ask their 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 2.5 mg of rivaroxaban.
• Thinban also contains: Tablet core: sodium lauryl sulfate, lactose monohydrate, hypromellose, sodium croscarmellose, magnesium stearate. Opadry II 85F22055 Yellow coating: polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, yellow iron oxide (E 172).

What Thinban looks like and contents of the pack

Thinban 2.5 mg is a yellow, film-coated, round tablet, approximately 8 mm in diameter, with the inscription "T" on one side of the tablet and "2R" on the other side.
The tablets are packaged in single-dose blisters: 28x1, 60x1.
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
To obtain more detailed information about the medication, the patient 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