Sianta

Package Leaflet: Information for the Patient

Sianta, 75 mg, Hard Capsules

Dabigatranum etexilatum

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 those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Sianta and what is it used for
• 2. Important information before taking Sianta
• 3. How to take Sianta
• 4. Possible side effects
• 5. How to store Sianta
• 6. Contents of the pack and other information

1. What is Sianta and what is it used for

Sianta contains dabigatran etexilate as the active substance and belongs to a group of medicines called anticoagulants. Its action is to block the substance in the body responsible for the formation of blood clots.
Sianta is used in adults to:

• prevent the formation of blood clots in the veins after hip or knee replacement surgery.

Sianta is used in children to:

• treat blood clots and prevent recurrence of blood clots.

2. Important information before taking Sianta

When not to take Sianta

• if you are allergic to dabigatran etexilate or any of the other ingredients of this medicine (listed in section 6).
• if you have severe kidney impairment.
• if you are currently bleeding.
• if you have a disease of any internal organ that increases the risk of major bleeding (e.g. stomach ulcer, brain injury or bleeding, recent brain or eye surgery).
• if you have an increased tendency to bleed. It may be congenital, of unknown cause, or caused by the use of other medicines.
• if you are taking anticoagulant medicines (e.g. warfarin, rivaroxaban, apixaban, or heparin), except when switching anticoagulant treatment, introducing a catheter into a vein or artery, when heparin is administered to maintain its patency or when restoring normal heart function using a procedure called catheter ablation in atrial fibrillation.

or artery, when heparin is administered to maintain its patency or when restoring normal heart function using a procedure called catheter ablation in atrial fibrillation.

• if you have severe liver impairment or liver disease that may lead to death.
• if you are taking oral ketoconazole or itraconazole, medicines used to treat fungal infections.
• if you are taking oral cyclosporine, a medicine used to prevent rejection of a transplanted organ.
• if you are taking dronedarone, a medicine used to treat heart rhythm disorders.
• if you are taking a combination medicine containing glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C.
• if you have a mechanical heart valve that requires continuous anticoagulation.

Warnings and precautions

Before starting treatment with Sianta, discuss it with your doctor. During treatment with Sianta, it may also be necessary to talk to your doctor if you experience symptoms or need surgery.
The patient should inform the doctorif they have or have had any medical conditions or diseases, especially any of the following:

• if you have an increased risk of bleeding, such as:
• if you have recently had bleeding.
• if you have had a surgical biopsy within the last month.
• if you have had a serious injury (e.g. bone fracture, head injury, or any injury requiring surgical treatment).
• if you have esophagitis or gastritis.
• if you have gastroesophageal reflux disease.
• if you are taking medicines that may increase the risk of bleeding. See also "Sianta and other medicines" below.
• if you are taking anti-inflammatory medicines such as diclofenac, ibuprofen, piroxicam.
• if you have an infection of the heart (bacterial endocarditis).
• if you have reduced kidney function or are dehydrated (feeling thirsty and producing a small amount of dark, concentrated urine).
• if you are over 75 years old.
• if you are an adult and weigh 50 kg or less.
• only in the case of use in children: if the child has an infection around or in the brain.
• if you have had a heart attack or if you have been diagnosed with conditions that increase the risk of heart attack.
• if you have liver disease that affects blood test results. In this case, the use of this medicine is not recommended.

When to exercise special caution when taking Sianta

• if you need to undergo surgery: In this case, it is necessary to discontinue Sianta temporarily due to the increased risk of bleeding during and after surgery. It is very important to take Sianta before and after surgery exactly as your doctor has instructed.
• if the surgical procedure requires the insertion of a catheter or injection into the spine (e.g. for spinal or epidural anesthesia or to relieve pain):
• it is very important to take Sianta before and after surgery exactly as your doctor has instructed.
• you should immediately inform your doctor if you experience numbness or weakness of the lower limbs or problems with the intestines or bladder after the anesthesia has worn off, as urgent medical attention is necessary.
• if you have fallen or injured yourself during treatment, especially if you have injured your head. You should seek urgent medical attention. Your doctor will examine you to see if you may have an increased risk of bleeding.
• if you know you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), you should inform your doctor, who will decide if a change in treatment is necessary.

Sianta and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take. In particular, tell your doctor before taking Sianta if you are taking any of the following medicines:

• medicines that prevent blood clotting (e.g. warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid).
• medicines used to treat fungal infections (e.g. ketoconazole, itraconazole), unless they are used only on the skin.
• medicines used to treat heart rhythm disorders (e.g. amiodarone, dronedarone, quinidine, verapamil). If you are taking medicines containing amiodarone, quinidine, or verapamil, your doctor may recommend a lower dose of Sianta, depending on the condition for which it was prescribed. See also section 3.
• medicines used to prevent rejection of a transplanted organ (e.g. tacrolimus, cyclosporine).
• a combination medicine containing glecaprevir and pibrentasvir (an antiviral medicine used to treat hepatitis C).
• anti-inflammatory and pain-relieving medicines (e.g. acetylsalicylic acid, ibuprofen, diclofenac).
• St. John's Wort, a herbal medicine used to treat depression.
• antidepressant medicines called selective serotonin reuptake inhibitors or selective norepinephrine reuptake inhibitors.
• rifampicin or clarithromycin (both antibiotics).
• antiviral medicines used to treat AIDS (e.g. ritonavir).
• certain medicines used to treat epilepsy (e.g. carbamazepine, phenytoin).

Pregnancy and breastfeeding

The effect of Sianta on pregnancy and the unborn child is not known. You should not take Sianta during pregnancy unless your doctor considers it necessary. Women of childbearing age should avoid becoming pregnant while taking Sianta.
Do not breastfeed while taking Sianta.

Driving and using machines

The effect of Sianta on the ability to drive and use machines is not known.

3. How to take Sianta

Sianta in the form of hard capsules can be used in adults and children aged 8 years or older who are able to swallow the capsules whole. There are other age-appropriate pharmaceutical forms of the medicine for children under 8 years of age.
This medicine should always be taken exactly as your doctor has instructed. If you are unsure, ask your doctor.

Take Sianta as follows:

Prevention of blood clots after hip or knee replacement surgery
The recommended dose is 220 mg once a day(taken as 2 capsules of 110 mg each).
If kidney function is reducedby more than half or if you are 75 years old or older, the recommended dose is 150 mg once a day(taken as 2 capsules of 75 mg each).
If you are taking medicines containing amiodarone, quinidine, or verapamil, the recommended dose is 150 mg once a day(taken as 2 capsules of 75 mg each).
If you are taking verapamil and have reduced kidney functionby more than half, you should be treated with a reduced dose of 75 mgof Sianta due to the increased risk of bleeding.
In both types of surgical procedures, do not start treatment if there is bleeding from the surgical site. If it is not possible to start treatment the day after surgery, start with a dose of 2 capsules once a day.
After knee replacement surgery
Start treatment with Sianta by taking one capsule within 1 to 4 hours after the end of the surgical procedure. Then take 2 capsules once a day for a total of 10 days.
After hip replacement surgery
Start treatment with Sianta by taking one capsule within 1 to 4 hours after the end of the surgical procedure. Then take 2 capsules once a day for a total of 28 to 35 days.
Treatment of blood clots and prevention of recurrence of blood clots in children
Sianta should be taken twice a day, one dose in the morning and one dose in the evening, at approximately the same time every day. The interval between doses should be approximately 12 hours.
The recommended dose depends on body weight and age. Your doctor will determine the correct dose. Your doctor may adjust the dose during treatment. You should continue to take all other medicines unless your doctor instructs you to stop taking them.
Table 1 shows the single and total daily doses of Sianta in milligrams (mg). The doses depend on the patient's body weight in kilograms (kg) and age in years.
Table 1: Sianta dosing table

Doses requiring the combination of more than one capsule:
300 mg:
two 150 mg capsules or four 75 mg capsules
260 mg:
one 110 mg capsule and one 150 mg capsule or
one 110 mg capsule and two 75 mg capsules
220 mg:
two 110 mg capsules
185 mg:
one 75 mg capsule and one 110 mg capsule
150 mg:
one 150 mg capsule or two 75 mg capsules

How to take Sianta

Sianta can be taken with or without food. The capsules should be swallowed whole with a glass of water to facilitate passage into the stomach. Do not break, chew, or empty the pellets from the capsule, as this may increase the risk of bleeding.

Instructions for opening blisters

The following diagram shows how to remove Sianta capsules from the blister pack.
Tear off the part of the blister that contains a single dose of the medicine along the perforated line.

Remove the protective foil and take out the capsule.

• Do not push the capsules through the blister pack foil.
• Do not remove the foil from the blister pack until it is necessary to take the capsule.

Changing anticoagulant medicine

Do not change your anticoagulant medicine without receiving detailed instructions from your doctor.

Taking a higher dose of Sianta than recommended

Taking too much Sianta increases the risk of bleeding. If you have taken too many Sianta capsules, contact your doctor immediately. There are specific treatment methods available.

Missing a dose of Sianta

Prevention of blood clots after hip or knee replacement surgery
Continue taking the missed daily dose of Sianta at the same time the next day. Do not take a double dose to make up for the missed dose.
Treatment of blood clots and prevention of recurrence of blood clots in children
The missed dose can be taken up to 6 hours before the next scheduled dose.
If there are less than 6 hours until the next scheduled dose, do not take the missed dose.
Do not take a double dose to make up for the missed dose.

Stopping Sianta treatment

Sianta should be taken as instructed by your doctor. Do not stop taking Sianta without consulting your doctor first, as the risk of blood clots may be higher if treatment is stopped too early.
Contact your doctor if you experience indigestion after taking Sianta.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Sianta can cause side effects, although not everybody gets them.
Sianta affects the blood clotting system, so most side effects are related to symptoms such as bruising or bleeding.
Severe or heavy bleeding may occur, which is the most serious side effect and can lead to disability, be life-threatening, or even fatal, regardless of the location.
In some cases, these bleedings may not be visible.
If you experience bleeding that does not stop on its own or symptoms of excessive bleeding (exceptional weakness, fatigue, pallor, dizziness, headache, or unexplained swelling), contact your doctor immediately. Your doctor may decide to monitor you closely or change your medicine.
If you experience a severe allergic reaction that can cause difficulty breathing or dizziness, contact your doctor immediately.
The following side effects are grouped by frequency:

• Frequent (may affect up to 1 in 10 people)
• Rare (may affect up to 1 in 1000 people)

Not known (frequency cannot be estimated from the available data)

• Difficulty breathing or wheezing
• Decreased number of white blood cells (which help fight infections)
• Hair loss

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please 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
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Sianta

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or blister after "EXP".
The expiry date refers to the last day of the month stated.
Do not store above 30°C.
Store in the original package to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Sianta contains

The active substance of Sianta is dabigatran. Each hard capsule contains 86.48 mg of dabigatran etexilate mesylate, equivalent to 75 mg of dabigatran etexilate.

• The other ingredients are: tartaric acid, acacia gum, hypromellose 2910 (15 cps), dimethicone 350, talc, and hydroxypropylcellulose (100 cps)
• The capsule shell contains carrageenan, potassium chloride, titanium dioxide (E 171), and hypromellose 2910 (6 cps).

What Sianta looks like and contents of the pack

Sianta, 75 mg are white to pale yellow pellets contained in white to off-white hard capsules, size 2.
The medicine is available in packs containing:
10 x 1, 30 x 1, or 60 x 1 hard capsules in perforated unit dose blisters of aluminum/OPA/aluminum/PVC.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Egis Pharmaceuticals PLC
Keresztúri út 30-38
1106 Budapest
Hungary

Manufacturer

Galenicum Health, S.L.U.
Sant Gabriel, 50

• 08950 – Esplugues de Llobregat (Barcelona) Spain

SAG Manufacturing S.L.U
Crta. N-I, Km 36
28750 San Agustin de Guadalix, Madrid
Spain
To obtain more detailed information on this medicine, contact the local representative of the marketing authorization holder:
EGIS Polska Sp. z o.o.
ul. Komitetu Obrony Robotników 45D
02-146 Warsaw
Phone: +48 22 417 92 00

The medicine is authorized in the Member States of the European Economic Area under the following names:

Malta
Sianta 75 mg hard capsules
Bulgaria
Sianta 75 mg, капсула, твърда
Czech Republic
Sianta
Hungary
Sianta 75 mg, kemény kapszula
Poland
Sianta
Romania
Sianta 75 mg capsule
Slovakia
Sianta 75 mg, tvrdé kapsuly

Date of last revision of the leaflet:

Detailed information on this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
https://rejestrymedyczne.ezdrowie.gov.pl/