Rivaroxaban stada

Package leaflet: Information for the user

Rivaroxaban STADA, 15 mg, hard capsules
Rivaroxaban STADA, 20 mg, hard capsules
Initial treatment pack
Do not use in children
Rivaroxabanum
Please 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.
• If you have any further questions, please ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you personally. 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, please tell your doctor, pharmacist or nurse. See section 4.

Contents of the leaflet

1. What Rivaroxaban STADA is and what it is used for
2. What you need to know before you take Rivaroxaban STADA
3. How to take Rivaroxaban STADA
4. Possible side effects
5. How to store Rivaroxaban STADA
6. Contents of the pack and other information

1. What Rivaroxaban STADA is and what it is used for

Rivaroxaban STADA contains the active substance rivaroxaban and is used in adults for:

• treating blood clots in the deep veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism), and for preventing the recurrence of blood clots in the veins of the legs and/or lungs.

Rivaroxaban STADA 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 using Rivaroxaban STADA

When not to use Rivaroxaban STADA

• if the patient is allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6)
• if the patient has active 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 bleeding in the brain, recent surgery on the brain or eyes)
• if the patient is taking other medicines that prevent blood clots (e.g. warfarin, dabigatran, apixaban or heparin), except when switching anticoagulant therapy or if heparin is administered to maintain the patency of an intravenous or arterial catheter
• if the patient has a liver disease that increases the risk of bleeding
• if the patient is pregnant or breastfeeding.

Do not use Rivaroxaban STADA and inform your doctor if you
suspect any of the above conditions apply to you.
Warnings and precautions
Talk to your doctor or pharmacist before taking Rivaroxaban STADA.
When to exercise special caution with Rivaroxaban STADA

• if the patient has an increased risk of bleeding, such as: o severe kidney disease in adults or moderate to severe kidney disease in children and adolescents, as kidney function may affect the amount of medicine acting in the body o taking other medicines that prevent blood clots (e.g. warfarin, dabigatran, apixaban or heparin) when switching anticoagulant therapy or when heparin is administered to maintain the patency of an intravenous or arterial catheter (see section "Rivaroxaban STADA and other medicines") o blood clotting disorders o very high blood pressure that does not decrease despite medication o stomach or intestinal disorders that may cause bleeding, e.g. inflammation of the stomach and intestines or oesophagitis (throat and oesophagus), e.g. due to gastro-oesophageal reflux disease (acid reflux into the oesophagus) or tumours located in the stomach, intestines, genital or urinary tract o vascular disease of the posterior part of the eyeball (retinopathy) o lung disease with dilated bronchi filled with pus (bronchiectasis) or previous lung bleeding
• in patients with prosthetic heart valves
• 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 a change in treatment is necessary
• if the patient has abnormal blood pressure or if surgery or another treatment to remove a blood clot from the lungs is planned.

If the patient suspects any of the above conditions apply, inform your doctor
before taking Rivaroxaban STADA. 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 taking Rivaroxaban STADA before or after surgery
• if catheterisation or spinal puncture (e.g. for epidural or spinal anaesthesia or pain relief) is planned during surgery: o it is very important to take Rivaroxaban STADA at the exact times before and after the puncture or catheter removal, as directed by the doctor o inform the doctor immediately if, after the anaesthesia wears off, numbness or weakness in the legs, or disturbances in bowel or bladder function occur, as immediate treatment may be required.

Children and adolescents
The starter pack of Rivaroxaban STADA hard capsules is not recommended
for children under 18 years of age, as it is specifically intended for adult patients and is not suitable for use in children and adolescents.
Rivaroxaban STADA and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including those available without a prescription.

• If the patient is taking:

o certain antifungal medicines (e.g. fluconazole, itraconazole, voriconazole,
posaconazole), unless they are used only topically on the skin
o ketoconazole tablets (used in the treatment of Cushing's syndrome, in which the body produces too much cortisol)
o certain antibiotics (e.g. clarithromycin, erythromycin)
o certain antiviral medicines used in HIV infection or AIDS treatment (e.g. ritonavir)
o other medicines used to reduce blood clotting (e.g. enoxaparin, clopidogrel or
vitamin K antagonists such as warfarin or acenocoumarol)
o anti-inflammatory and pain-relieving medicines (e.g. naproxen or acetylsalicylic acid)
o dronedarone, a medicine used to treat heart rhythm disorders
o certain antidepressants (selective serotonin reuptake inhibitors (SSRI) or serotonin-noradrenaline reuptake inhibitors (SNRI))
If the patient suspects any of the above conditions apply, inform your doctor
before taking Rivaroxaban STADA, as the effect of Rivaroxaban
STADA may be enhanced. The doctor will decide whether to use this medicine and whether the patient requires particularly close monitoring.
If the doctor considers that the patient has an increased risk of developing stomach or intestinal ulcers, they may prescribe treatment to prevent peptic ulcer disease.

• If the patient is taking: o certain medicines used to treat epilepsy (phenytoin, carbamazepine, phenobarbital) o St John's wort ( Hypericum perforatum ), a herbal remedy used for depression o rifampicin, an antibiotic

If the patient suspects any of the above conditions apply, inform your doctor
before taking Rivaroxaban STADA, as the effect of Rivaroxaban
STADA may be reduced. The doctor will decide whether to use Rivaroxaban STADA
and whether the patient requires particularly close monitoring.
Pregnancy and breastfeeding
Do not use Rivaroxaban STADA if the patient is 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 Rivaroxaban STADA. If the patient becomes pregnant while taking this medicine, inform the doctor immediately, who will decide on further treatment.
Driving and using machines
Rivaroxaban STADA 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.
Rivaroxaban STADA contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.
Rivaroxaban STADA contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per capsule, meaning it is considered "sodium-free".

3. How to use Rivaroxaban STADA

Rivaroxaban STADA must always be taken as directed by the physician. If in doubt, consult a doctor or pharmacist.
Rivaroxaban STADA should be taken with food.
The capsule (i) should be swallowed whole, preferably with water.
If a patient has difficulty swallowing the entire capsule, discuss alternative methods of taking Rivaroxaban STADA with the physician. The contents of the capsule may be mixed with water or soft food such as apple puree immediately before administration. After consuming this mixture, the patient should eat a meal promptly. If necessary, the physician may administer the dissolved contents of the Rivaroxaban STADA capsule via a gastric tube.

How many capsules to take
The recommended dose is one 15 mg Rivaroxaban STADA capsule twice daily for the first 3 weeks. For treatment after the first 3 weeks, the recommended dose is one 20 mg Rivaroxaban STADA capsule once daily. The starter pack containing 15 mg and 20 mg Rivaroxaban STADA is intended for the first 4 weeks of treatment only. After completing the capsules from this pack, treatment will continue with Rivaroxaban STADA 20 mg once daily, following consultation with the physician.
If a patient has renal impairment, the physician may decide to reduce the dose after 3 weeks of treatment to one 15 mg Rivaroxaban STADA capsule once daily, if the risk of bleeding is greater than the risk of developing further blood clots.

When to take Rivaroxaban STADA
Take the capsule(s) every day until the physician decides to discontinue treatment. It is best to take the capsule(s) at the same time each day, as this makes it easier to remember. The duration of treatment will be determined by the physician.

Taking more Rivaroxaban STADA than prescribed
If a patient takes more Rivaroxaban STADA than prescribed, contact a doctor immediately. Taking too high a dose of Rivaroxaban STADA increases the risk of bleeding.

Missed dose of Rivaroxaban STADA

• If a patient takes one 15 mg capsule twice daily and a dose is missed, take the missed dose as soon as possible. Do not take more than two 15 mg capsules within one day. If a dose was forgotten, the patient may take two 15 mg capsules at the same time to achieve a total of two capsules (30 mg) taken within one day. The next day, resume the regular dosing schedule of one 15 mg capsule twice daily.
• If a patient takes one 20 mg capsule once daily and a dose is missed, take the missed dose as soon as possible. Do not take more than one 20 mg capsule in one day to make up for the missed dose. Take the next capsule the following day and continue with one capsule once daily thereafter.

Stopping Rivaroxaban STADA
Do not stop taking Rivaroxaban STADA without first consulting a doctor, as Rivaroxaban STADA treats and prevents a serious medical condition.
If there are any further questions about the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
As with other medicines of similar action that reduce blood clot formation, Rivaroxaban STADA 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 any of the following adverse reactions occur:

• Signs of bleeding
  o Bleeding into the brain or inside the skull (symptoms may include headache, one-sided weakness, vomiting, seizures, decreased level of consciousness and neck stiffness. A serious medical emergency. Seek immediate medical help!)
  o Prolonged or excessive bleeding
  o Unusual weakness, fatigue, paleness, dizziness, headache, unexplained swelling, shortness of breath, chest pain or angina
  Your doctor may decide that close monitoring of the patient or a change in treatment is necessary.

• Signs of severe skin reactions
  o Widespread, acute skin rash, formation of blisters or mucosal lesions, e.g. in the mouth or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis)
  o Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), characterized by rash, fever, internal organ inflammation, hematological disorders and systemic involvement.
  The frequency of these adverse reactions is very rare (up to 1 in 10,000 people).

• Signs of severe allergic reactions
  o Swelling of the face, lips, oral cavity, tongue or throat; urticaria and breathing difficulties; sudden drop in blood pressure.
  The frequency of severe hypersensitivity reactions is very rare (anaphylactic reactions, including anaphylactic shock, may occur in up to 1 in 10,000 people) and uncommon (angioedema and allergic edema may occur in 1 in 100 people).

General list of possible adverse reactions:
Common (may occur in 1 out of 10 patients)

• Decrease in red blood cells, which may cause paleness of the skin and lead to weakness or shortness of breath
• Bleeding from stomach or intestines, bleeding from the urinary or genital tract (including blood in urine and heavy menstrual bleeding), nosebleeds, bleeding gums
• Bleeding into the eye (including bleeding from the whites of the eye)
• Bleeding into tissues or body cavities (hematoma, bruising)
• Presence of blood in sputum (hemoptysis) during coughing
• Bleeding from the skin or under the skin
• Bleeding after surgery
• Oozing of blood or fluid from a surgical wound
• Swelling of limbs
• Limb pain
• Kidney function disorders (may be observed in tests performed by a doctor)
• Fever
• Stomach pain, indigestion, feeling of nausea or vomiting, constipation, diarrhea
• Low blood pressure (symptoms may include dizziness or fainting upon standing)
• General decrease in strength and energy (weakness, fatigue), headache, dizziness
• Rash, itching of the skin
• Increased activity of certain liver enzymes, which may be seen in blood test results

Uncommon (may occur in 1 out of 100 patients)

• Bleeding into the brain or inside the skull (see signs of bleeding above)
• Bleeding into a joint causing pain and swelling
• Thrombocytopenia (low platelet count, platelets being cells involved in blood 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 1 out of 1,000 patients)

• Bleeding into muscles
• Cholestasis (bile stasis), hepatitis including liver cell damage
• Yellowing of the skin and eyes (jaundice)
• Localized swelling
• Collection of blood (hematoma) in the groin as a complication of cardiac catheterization procedure, when the catheter is inserted into an artery in the leg (pseudoaneurysm)

Very rare (may occur in 1 out of 10,000 patients)

• Accumulation of eosinophils, a type of granulocyte white blood cells, causing inflammation in the lungs (eosinophilic pneumonia)

Frequency not known (frequency cannot be determined from available data)

• Kidney failure following severe bleeding
• Bleeding in the kidneys, sometimes with presence of blood in urine, leading to inability of kidneys to function properly (drug-induced anticoagulant-related nephropathy)
• Increased pressure in 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 reactions
If any adverse symptoms occur, including any adverse effects not listed in this leaflet, you should inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Rivaroxaban STADA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after EXP. The expiry date refers to the last day of the stated month.
No special storage conditions apply for this medicine.
The dissolved contents of the capsule remain 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 required. These measures help protect the environment.

6. Contents of the pack and other information

What Rivaroxaban STADA contains
The active substance is rivaroxaban.
Rivaroxaban STADA 15 mg, hard capsules
One hard capsule contains 15 mg of rivaroxaban.
Rivaroxaban STADA 20 mg, hard capsules
One hard capsule contains 20 mg of rivaroxaban.
Other ingredients are:

• Capsule contents: pregelatinized starch (maize), monohydrate lactose, sodium carboxymethyl starch (type A), sodium lauryl sulfate, colloidal anhydrous silica, magnesium stearate.
• Capsule shell 15 mg: erythrosine (E 127), yellow iron oxide (E 172), titanium dioxide (E 171), gelatin.
• Capsule shell 20 mg: red iron oxide (E 172), black iron oxide (E 172), yellow iron oxide (E 172), titanium dioxide (E 171), gelatin.

What Rivaroxaban STADA looks like and contents of the pack
Rivaroxaban STADA 15 mg are orange-red hard capsules filled with white or almost white powder.
Rivaroxaban STADA 20 mg are brown hard capsules filled with white or almost white powder.
The starter pack for the first 4 weeks of treatment contains 49 hard capsules in blisters within a cardboard package consisting of:

• 42 hard capsules of 15 mg rivaroxaban
• 7 hard capsules of 20 mg rivaroxaban.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
For further information about this medicinal product, please contact the Marketing Authorisation Holder's representative:
Stada Pharm Sp. z o.o.
ul. Krakowiaków 44
02-255 Warsaw
Tel. +48 22 737 79 20
Manufacturer/Importer:
STADA Arzneimittel AG
Stadastrasse 2-18,
61118 Bad Vilbel,
Germany
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Sweden: Rivaroxaban ALIUD
Czech Republic: Rivaroxaban STADA
Greece: Rivaroxaban/ STADA
Croatia: Rivaroksaban Stada
Hungary: Rivaroxaban STADA
Poland: Rivaroxaban STADA
Slovakia: Rivaroxaban STADA