Thinban

Package leaflet: Information for the user

Thinban, 2.5 mg, coated tablets
rivaroxaban
Please read the entire leaflet carefully before taking this medicine, as it contains important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please 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 someone else, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of 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

The patient has been prescribed Thinban because:

• They have been diagnosed with acute coronary syndrome (a condition including heart attack and unstable angina, i.e. acute chest pain) and elevated levels of cardiac biomarkers have been confirmed.
• Thinban reduces the risk of another heart attack or the risk of death due to heart- or blood vessel-related disease in adults. Thinban will not be given to the patient as the only medication. The doctor will also prescribe the patient to take:
  • acetylsalicylic acid, or
  • acetylsalicylic acid and clopidogrel or ticlopidine.

or

• They have been diagnosed with a high risk of blood clots due to coronary artery disease or peripheral arterial disease causing symptoms. Thinban reduces the risk of blood clots (atherosclerotic thrombotic events) in adults. Thinban will not be given to the patient as the only medication. The doctor will also prescribe the patient to take acetylsalicylic acid. In certain cases, if the patient is receiving Thinban after a procedure to unblock a narrowed or blocked artery in the lower limb to restore blood flow, the doctor may also prescribe clopidogrel to be taken in addition to acetylsalicylic acid for a short period.

Thinban contains the active substance rivaroxaban and 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 increases the risk of serious bleeding (e.g., stomach ulcer, trauma or intracranial bleeding, recent brain or eye surgery),
• if the patient is taking other medicines that prevent blood clotting (e.g., warfarin, dabigatran, apixaban, or heparin), except when switching anticoagulant therapy or if heparin is administered to maintain catheter patency in a vein or artery,
• if the patient has been diagnosed with acute coronary syndrome and previously experienced bleeding or cerebral blood clot (stroke),
• if the patient has been diagnosed with coronary artery disease or peripheral arterial disease and previously had intracranial bleeding (stroke), blockage of small arteries supplying blood to deep brain structures (lacunar stroke), or a non-lacunar ischemic stroke within the past month,
• if the patient has a liver disease that increases the risk of bleeding,
• if the patient is pregnant or breastfeeding.

Do not use Thinban and inform your doctor if you suspect any of the above-mentioned conditions apply.

Warnings and precautions

Before starting Thinban, discuss it with your doctor or pharmacist. Thinban should not be used in combination with anticoagulant medicines other than acetylsalicylic acid, clopidogrel, or ticlopidine, such as prasugrel or ticagrelor.

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, as kidney function may affect the amount of medicine acting in the patient’s body,
• use of other medicines that prevent blood clotting (e.g., warfarin, dabigatran, apixaban, or heparin), when switching anticoagulant therapy or when heparin is administered to maintain catheter patency in a vein or artery (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 and intestines or esophagus (e.g., due to gastroesophageal reflux disease – backflow of stomach acid into the esophagus), or tumors located in the stomach, intestines, genital or urinary system,
• vascular disease of the posterior part of the eyeball (retinopathy),
• lung disease with dilated bronchi filled with pus (bronchiectasis) or previous lung bleeding,
• if the patient is over 75 years of age,
• if the patient weighs less than 60 kg,
• coronary artery disease with severe symptomatic heart failure,
• in patients with heart valve prostheses,
• 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 treatment adjustment is necessary.

If you suspect any of the above conditions apply, 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 intake before or after surgery,
• if spinal catheterization or puncture (e.g., for epidural or intrathecal anesthesia 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, immediately inform the doctor if numbness or weakness in the legs, or disturbances in bowel or bladder function occur after the anesthesia wears off.

Children and adolescents

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

Thinban with other medicines

Inform 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 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, prasugrel and ticagrelor (see section "Warnings and precautions")),
• anti-inflammatory and pain medicines (e.g., naproxen or acetylsalicylic acid),
• dronedarone, a medicine used to treat heart rhythm disorders,
• certain antidepressants (selective serotonin reuptake inhibitors (SSRI) or serotonin-norepinephrine reuptake inhibitors (SNRI)).

If you suspect any of the above conditions apply, inform your doctor before taking Thinban, as the effect of Thinban may be increased. The doctor will decide whether to use this medicine and whether the patient requires particularly close monitoring. If the doctor considers the patient at increased risk of developing stomach or intestinal ulcers, preventive treatment 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, an antibiotic.

If you suspect any of the above conditions apply, inform your doctor before taking Thinban, as the effect of Thinban may be reduced. 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 the patient may become pregnant, an effective method of contraception should be used during treatment with Thinban. If pregnancy occurs during treatment with this medicine, 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 the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine. The medicine contains less than 1 mmol of sodium (23 mg) per tablet, which essentially means it is "sodium-free".

3. How to take Thinban

This medicine should always be taken as directed by the physician. If in doubt, consult
your doctor or pharmacist.
How many tablets to take
The recommended dose is one 2.5 mg tablet twice daily. Thinban should be taken
approximately at the same time each day (for example, one tablet in the morning and one in the evening).
This medicine may be taken with or without food.
If a patient has difficulty swallowing the whole tablet, discuss alternative methods of taking Thinban with the doctor. The tablet may be crushed and mixed with water or apple puree immediately before administration.
If necessary, the doctor may administer crushed Thinban tablets via a gastric tube.
Thinban will not be given to the patient as the only medication.
Your doctor will prescribe acetylsalicylic acid for you to take. If you are receiving Thinban after an acute coronary syndrome, your doctor may also prescribe clopidogrel or ticlopidine.
If you are receiving Thinban after a procedure to restore blood flow in a narrowed or blocked artery of the lower limb, your doctor may also prescribe clopidogrel for a short period in addition to acetylsalicylic acid.
Your doctor will advise you on the dose of these medications to take (usually 75–100 mg of acetylsalicylic acid per day, or a daily dose of 75–100 mg acetylsalicylic acid plus a daily dose of 75 mg clopidogrel, or the standard daily dose of ticlopidine).
When to take Thinban
Treatment with Thinban after acute coronary syndrome should be initiated as soon as possible after stabilization of the acute coronary event, no earlier than 24 hours after hospital admission and at the time when parenteral (injected) anticoagulant therapy would normally be discontinued.
Your doctor will advise you when to start treatment with Thinban if coronary artery disease or peripheral arterial disease has been diagnosed.
Your doctor will decide how long treatment should continue.
Taking more Thinban than recommended
If a patient has taken more than the recommended dose of Thinban, contact a doctor immediately. Taking too high a dose of 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 a dose is missed, 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 your doctor. Stopping this medicine may increase the risk of another heart attack, stroke, or death due to heart- or blood vessel-related disease.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like any medicine, Thinban may cause adverse effects, 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.
You should contact your doctor immediately if you experience any of the following adverse effects:

• 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, paleness, dizziness, headache, unexplained swelling, shortness of breath, chest pain or angina.
• Signs of severe skin reactions:
• widespread, acute skin rash, blistering or mucosal changes, 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 effects is very rare (may occur in no more than 1 in 10,000 patients).
• Signs of serious allergic reactions
• swelling of the face, lips, oral cavity, 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 effects:

Common (may occur in no more than 1 in 10 patients)

• reduced number of red blood cells, which may cause paleness of the skin and lead to weakness or shortness of breath,
• gastrointestinal bleeding or intestinal bleeding, bleeding from the urinary or genital tract (including blood in urine and heavy menstrual bleeding), nosebleeds, gum bleeding,
• ocular bleeding (including bleeding from the white part of the eye),
• 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 doctor),
• 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 no more than 1 in 100 patients)

• intracranial or cerebral bleeding (see signs of bleeding above),
• bleeding into a joint causing pain and swelling,
• thrombocytopenia (low platelet count, 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,
• dryness of the mouth,
• urticaria.

Rare (may occur in no more than 1 in 1,000 patients)

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

Very rare (may occur in no more than 1 in 10,000 patients)
accumulation of eosinophils, a type of white granulocytic 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 presence of blood in urine, leading to impaired kidney function (drug-induced anticoagulant-related nephropathy),
• increased pressure within the muscles of arms and legs following bleeding, which may lead to pain, swelling, altered sensation, numbness or paralysis (compartment syndrome following bleeding).

Reporting of adverse effects
If you experience any adverse effects, including any possible adverse effects not listed in this leaflet, you should contact your doctor or pharmacist. Adverse effects 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 effects helps to gather more information on the safety of the medicine. Adverse effects 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 outer carton following:
Expiry date and on each blister or bottle following: EXP. The expiry date refers to the last
day of the stated month.
There are no special requirements for storage of this medicinal product.
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 in use. This 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 2.5 mg of rivaroxaban.
• Other ingredients are:
  Tablet core: sodium lauryl sulfate, lactose monohydrate, hypromellose, sodium croscarmellose, magnesium stearate.
  Coating (Opadry II 85F22055 Yellow): 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 are yellow, coated, round tablets, approximately 8 mm in diameter, with the imprint “T” on one side and “2R” on the other side of the tablet.
The tablets are contained in unit dose blisters: 28x1, 60x1.
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, tel.: (22) 345 93 00.