Thinban

Package Leaflet: Information for the User

Thinban, 10 mg, Film-Coated Tablets

Rivaroxaban
Read all of this leaflet carefully before taking this medicine because it contains important information for you.
Keep this leaflet. You may need to read it again.

• 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Pack and Other Information

• 1. What Thinban is and what it is used for
• 2. What you need to know before you take 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 blood clots forming in the veins after hip or knee replacement surgery. Your doctor has prescribed this medicine because after surgery there is an increased risk of blood clots forming.
• treat blood clots in the legs (deep vein thrombosis) and blood clots in the lungs (pulmonary embolism) and prevent new blood clots from forming in the legs and/or lungs.

Thinban belongs to a group of medicines called anticoagulants. Its action is to block factor Xa, which is involved in blood clotting, and so reduces the tendency of the blood to form clots.

2. What you need to know before you take Thinban

When not to take Thinban

• -if you are allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6),
• if you have bleeding that is not under control,
• if you have a disease or condition that increases the risk of serious bleeding (e.g. stomach ulcer, bleeding in the brain, recent brain or eye surgery, or bleeding in the spine),
• if you are taking other medicines that prevent blood clotting (e.g. warfarin, dabigatran, apixaban, or heparin), except when changing from one anticoagulant to another or when heparin is given to maintain a central venous or arterial line patency,
• if you have liver disease that leads to an increased risk of bleeding,

rivaroxaban.

• if you are pregnant or breast-feeding. Do not take Thinban and inform your doctor if you think you might be pregnant or are planning to become pregnant.

Warnings and precautions

Before taking Thinban, talk to your doctor or pharmacist if you have:

Special care is needed when taking Thinban

• if you have an increased risk of bleeding, such as:
• mild or moderate kidney disease, as kidney function may affect the amount of medicine in your body,
• if you are taking other medicines that prevent blood clotting (e.g. warfarin, dabigatran, apixaban, or heparin) when changing from one anticoagulant to another or when heparin is given to maintain a central venous or arterial line patency (see section "Thinban with other medicines"),
• bleeding disorders,
• very high blood pressure that is not controlled,
• stomach or intestinal disease that may cause bleeding (e.g. inflammatory bowel disease, stomach or intestinal ulcers, or cancer),
• retinal vascular disease (disease of the blood vessels in the eye),
• lung disease that may cause bleeding (e.g. bronchiectasis or pulmonary cavitation),
• previous bleeding from the spine or after a spinal or epidural injection,
• if you have a condition that increases the risk of bleeding, such as a condition that affects blood clotting (e.g. haemophilia),

If you think any of these conditions apply to you, tell your doctor before taking Thinban

before taking Thinban. Your doctor will decide whether to prescribe Thinban and whether you need to be closely monitored.

If you need to have an operation:

• you should carefully follow the instructions of your doctor regarding the intake of Thinban before or after surgery,
• if you are to undergo spinal or epidural injection (e.g. for pain reduction):
• you should carefully follow the instructions of your doctor regarding the intake of Thinban at a specific time,
• you should immediately inform your doctor if you experience any of the following symptoms after anaesthesia: numbness or weakness of the legs, problems with bowel or bladder control, or loss of bladder or bowel control, as these may be signs of spinal or epidural bleeding.

Children and adolescents

Rivaroxaban 10 mg tablets are not recommended for children under 18 years of age. There is limited data on the use of rivaroxaban in children and adolescents.

Thinban with other medicines

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

• - If you are taking:
• certain medicines for fungal infections (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are applied topically to the skin,
• ketokonazole tablets (used to treat Cushing's syndrome, where the body produces too much cortisol),
• certain medicines for bacterial infections (e.g. clarithromycin, erythromycin),
• certain antiviral medicines for HIV or AIDS (e.g. ritonavir),
• other medicines that prevent blood clotting (e.g. enoxaparin, clopidogrel, or vitamin K antagonists such as warfarin or acenocoumarol),
• anti-inflammatory or pain-relieving medicines (e.g. naproxen or acetylsalicylic acid),
• dronedarone, a medicine used to treat irregular heartbeat,
• certain medicines for depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin and noradrenaline reuptake inhibitors (SNRIs)).

If you think any of these conditions apply to you, tell your doctor before taking Thinban

before taking Thinban, as the effect of Thinban may be increased. Your doctor will decide whether to prescribe Thinban and whether you need to be closely monitored. If your doctor thinks that you are at increased risk of stomach or intestinal bleeding, he may prescribe a medicine to prevent this.

• - If you are taking:
• certain medicines for epilepsy (e.g. phenytoin, carbamazepine, phenobarbital),
• St. John's Wort (Hypericum perforatum), a herbal medicine used for depression,
• rifampicin, an antibiotic.

If you think any of these conditions apply to you, tell your doctor before taking Thinban

before taking Thinban, as the effect of Thinban may be reduced. Your doctor will decide whether to prescribe Thinban and whether you need to be closely monitored.

Pregnancy and breast-feeding

Do not take Thinban if you are pregnant or breast-feeding. If there is a chance that you may become pregnant, use a reliable method of contraception while taking Thinban. If you become pregnant while taking Thinban, tell your doctor immediately, who will decide on the continuation of the treatment.

Driving and using machines

Thinban may cause dizziness (common side effect) or fainting (uncommon side effect) (see section 4 "Possible side effects"). Patients who experience these side effects should not drive or use machines.

Thinban contains lactose and sodium

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. The medicine contains less than 1 mmol sodium (23 mg) per tablet, which is essentially "sodium-free".

3. How to take Thinban

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

How much to take

• To prevent blood clots forming in the veins after hip or knee replacement surgery, the recommended dose is one 10 mg Thinban tablet once a day.
• For the treatment of blood clots in the legs and blood clots in the lungs and to prevent new blood clots from forming, after at least 6 months of treatment for blood clots, the recommended dose is one 10 mg tablet once a day or one 20 mg tablet once a day. Your doctor has prescribed Thinban 10 mg once a day.

Swallow the tablet whole with water. You can take Thinban with or without food. If you have difficulty swallowing the tablet whole, talk to your doctor about taking Thinban in a different way. The tablet can be crushed and mixed with water or apple sauce, just before taking.

When to take Thinban

Take one tablet every day until your doctor decides to stop the treatment. It is recommended to take the tablet at the same time every day, as this will help you to remember to take it. Your doctor will decide how long you need to take Thinban.

If you take more Thinban than you should

If you take more Thinban than you should, contact your doctor immediately. Taking more Thinban than recommended may increase the risk of bleeding.

If you forget to take Thinban

If you forget to take a dose, take it as soon as you remember. Take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Thinban

Do not stop taking Thinban without talking to your doctor first. Thinban is used to prevent serious diseases. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Thinban can cause side effects, although not everybody gets them. As with other medicines that prevent blood clotting, Thinban may cause bleeding, which can be life-threatening. Severe bleeding may lead to a sudden drop in blood pressure (shock). Not all bleeding may be obvious, or may not be visible.

Tell your doctor immediately if you experience any of the following side effects:

Signs of bleeding

• bleeding into the brain or spinal cord (symptoms may include headache, one-sided weakness, vomiting, seizures, decreased consciousness, and stiffness of the neck. This is a serious medical emergency. Seek medical help immediately!),
• prolonged or excessive bleeding,
• unusual weakness, tiredness, paleness, dizziness, headache, unexplained swelling, shortness of breath, chest pain or angina ,Your doctor may decide to closely monitor you or change your treatment.
• Signs of severe skin reactions
• widespread, severe skin rash, blistering, or peeling of the skin (Stevens-Johnson syndrome, toxic epidermal necrolysis),
• drug reaction that causes rash, fever, inflammation of internal organs, blood cell abnormalities, and allergic reactions (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 less than 1 in 10,000 patients) and uncommon (angioedema and allergic oedema may occur in less than 1 in 100 patients).

General list of possible side effects:

Common(may affect up to 1 in 10 people)

• reduced number of red blood cells, which can cause pale skin and be the cause of weakness or shortness of breath,
• bleeding from the stomach or intestine, bleeding from the urinary tract (including blood in the urine and heavy menstrual bleeding), nosebleeds, bleeding gums,
• bleeding into the eye (including bleeding into the conjunctiva),
• bleeding into tissues or body cavities (haematoma, bruising),
• blood in the sputum when coughing (haemoptysis),
• bleeding from the skin or bleeding under the skin,
• bleeding after surgery,
• oozing of blood or fluid from the wound after surgery,
• swelling of the limbs,
• limb pain,
• kidney problems (which may be seen in tests performed by your doctor),
• fever,
• stomach pain, nausea (feeling sick) or vomiting, constipation, diarrhoea,
• low blood pressure (symptoms may include dizziness or fainting when standing up),
• general weakness and lack of energy (fatigue), headache, dizziness,
• rash, itching,
• increased activity of certain liver enzymes, which may be seen in blood test results.

Uncommon(may affect up to 1 in 100 people)

• bleeding into the brain or spinal cord (see above signs of bleeding),
• bleeding into a joint, causing pain and swelling,
• thrombocytopenia (low platelet count),
• allergic reactions, including allergic skin reactions,
• liver problems (which may be seen in tests performed by your doctor),
• blood test results may show increased levels of bilirubin, certain liver or pancreatic enzymes, or platelet count,
• fainting,
• feeling unwell,
• rapid heartbeat,
• dry mouth,
• hives.

Rare(may affect up to 1 in 1,000 people)

• bleeding into the muscle,
• cholestasis (reduced bile flow, bile stasis), hepatitis, including liver cell damage,
• jaundice (yellowing of the skin and eyes),
• local swelling,
• collection of blood (haematoma) in the groin as a complication of cardiac catheterisation 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 blood cell that causes inflammation in the lungs (eosinophilic pneumonia)

Side effects with 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 (drug-induced nephropathy),
• increased pressure in the muscles of the legs and arms after bleeding, which can cause pain, swelling, changes in sensation, numbness, or paralysis (compartment syndrome after bleeding).

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in the "Contact details for reporting side effects" section below. By reporting side effects, you can help provide more information on the safety of this medicine.

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 storage conditions for this medicine. Crushed tablets are stable in water or apple sauce 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 10 mg of rivaroxaban.
• The other ingredients are: Tablet core: sodium lauryl sulfate, lactose monohydrate, hypromellose, croscarmellose sodium, magnesium stearate. Tablet coating: Opadry II 85 F34156 Pink: polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, carmine (E120), yellow iron oxide (E 172), red iron oxide (E 172).

What Thinban looks like and contents of the pack

Thinban 10 mg is a pink, round, film-coated tablet, approximately 8 mm in diameter, with "T" engraved on one side and "1R" on the other. The tablets are packaged in blister packs: 30x1 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

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

Manufacturer

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, contact the Marketing Authorisation Holder: Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warszawa, tel.: (22) 345 93 00.

Date of last revision of the leaflet:November 2023