Sianta

Package Leaflet: Information for the Patient

Sianta, 110 mg, Hard Capsules

Dabigatranum etexilatum

Read the package leaflet carefully before taking the medicine, as it contains important information for you.

• 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.

Contents of the Package Leaflet

• 1. What Sianta is and what it is 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 Sianta is and what it is used for

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

• prevent blood clots in the veins after hip or knee replacement surgery.
• prevent blood clots in the brain (stroke) and other blood vessels in the body if the patient has a type of irregular heartbeat called atrial fibrillation not caused by heart valve problems and at least one additional risk factor.
• treat and prevent blood clots in the legs and lungs.

Sianta is used in children to:

• treat and prevent 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 problems.
• if you are currently bleeding.
• if you have a condition 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. This may be inherited, of unknown cause, or due to 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 catheter patency or when restoring normal heart function using a procedure called catheter ablation in atrial fibrillation.
• if you have severe liver problems 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 organ rejection.
• 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 ongoing anticoagulation.

Warnings and precautions

Before starting 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.
You should inform your doctorif you 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 "Sianta and other medicines" below.
• if you are taking anti-inflammatory or pain-relieving medicines such as diclofenac, ibuprofen, or piroxicam.
• if you have infective endocarditis (bacterial infection of the heart).
• if you have reduced kidney function or are dehydrated (feeling thirsty and producing less urine).
• if you are over 75 years old.
• if you are an adult and weigh 50 kg or less.
• only in children: if the child has an infection around or in the brain.
• if you have had a heart attack or 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 be extra careful while taking Sianta

• if you need to have surgery: In this case, it is necessary to stop taking 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 advised.
• if the surgery requires the insertion of a catheter or injection into the spine (e.g., for spinal or epidural anesthesia or pain relief):
• it is very important to take Sianta before and after surgery exactly as your doctor has advised.
• you should immediately inform your doctor if you experience numbness or weakness in your legs or problems with your bowels or bladder after the anesthesia has worn off, as urgent medical attention is necessary.
• if you fall or injure yourself while being treated, especially if you hit your head. You should seek urgent medical attention. Your doctor will examine you to see if there is 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 needed.

Sianta and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including those you have bought without a prescription.
In particular, before taking Sianta, tell your doctor if you are taking any of the following medicines:

• Medicines that prevent blood clotting (e.g., warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, aspirin).
• 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 section 3.
• Medicines used to prevent organ rejection (e.g., tacrolimus, cyclosporine).
• A combination medicine containing glecaprevir and pibrentasvir (an antiviral medicine used to treat hepatitis C).
• Anti-inflammatory or pain-relieving medicines (e.g., aspirin, 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.
You should not breastfeed while taking Sianta.

Driving and using machines

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

3. How to take Sianta

Sianta capsules can be taken by adults and children aged 8 years or older who can swallow the capsules whole.
There are other age-appropriate formulations of this medicine for children under 8 years old.
This medicine should always be taken exactly as your doctor has told you. If you are not sure, ask your doctor.

Take Sianta exactly 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).
For patients taking amiodarone, quinidine, or verapamil, the recommended dose of Sianta is 150 mg once a day(taken as 2 capsules of 75 mg each).
Patients taking verapamilwith reduced kidney functionof more than half should take a reduced dose of 75 mgof Sianta due to the increased risk of bleeding.
In both types of surgery, 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 surgery has finished. 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 surgery has finished. Then take 2 capsules once a day for a total of 28 to 35 days.
Prevention of blood clots in the brain and body due to irregular heartbeat and treatment of blood clots in the legs and lungs and prevention of repeat blood clots in the legs and lungs
The recommended dose is 300 mgtaken as one 150 mg capsule twice a day.
For patients 80 years old or older, the recommended dose is 220 mgtaken as one 110 mg capsule twice a day.
Patients taking verapamilshould receive a reduced dose of Sianta of 220 mgtaken as one 110 mg capsule twice a daydue to the increased risk of bleeding.
For patients at increased risk of bleeding, your doctor may recommend a dose of 220 mgtaken as one 110 mg capsule twice a day.
Sianta can be continued if the patient needs to restore normal heart function using a procedure called cardioversion. Sianta should be taken as advised by your doctor.
In the case of implantation of a medical device (stent) into a blood vessel to maintain its patency using a procedure called percutaneous coronary intervention with stent implantation, the patient may receive Sianta treatment after the doctor has confirmed that blood clotting is under control. Sianta should be taken as advised by your doctor.
Treatment of blood clots and prevention of repeat 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 each day. The interval between doses should be about 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 advises you to stop taking them.
Table 1 shows the single and total daily doses of Sianta in milligrams (mg). Doses are based on the patient's weight in kilograms (kg) and age in years.
Table 1: Sianta Dosing Table
Singles doses requiring 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 plus 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 help them reach the stomach. Do not break, chew, or empty the pellets from the capsule, as this may increase the risk of bleeding.

Instructions for opening the blister pack

The following diagram shows how to remove Sianta capsules from the blister pack.
Tear off the perforated line fragment of the blister pack containing a single dose of the medicine.

Peel off the protective foil and remove the capsule.

• Do not push the capsules through the blister pack foil.
• Do not peel off the foil from the blister pack until it is time to take the capsule.

Changing anticoagulant medicine

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

Taking more Sianta than prescribed

Taking too much Sianta increases the risk of bleeding. If you have taken too many Sianta capsules, contact your doctor immediately. There are specific treatments 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.
Use in adults: Prevention of blood clots in the brain and body due to irregular heartbeat and treatment of blood clots in the legs and lungs and prevention of repeat blood clots in the legs and lungs
Use in children: Treatment of blood clots and prevention of repeat blood clots
A 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 advised by your doctor. Do not stop taking this medicine 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 taking 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.
Major or severe bleeding can occur, which is the most serious side effect and can lead to disability, be life-threatening, or even fatal, regardless of the location, and in some cases, it may not be visible.
If you experience bleeding that does not stop by itself or signs of excessive bleeding (unusual weakness, tiredness, paleness, 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:

Prevention of blood clots after hip or knee replacement surgery
Common (may affect up to 1 in 10 people)

• Decreased hemoglobin levels in the blood (a substance in red blood cells)
• Abnormal liver function test results

Uncommon (may affect up to 1 in 100 people)

• Bleeding may occur from the nose, into the stomach or intestines, from the penis or vagina, or from the urinary tract (including urine discolored pink or red due to the presence of blood), or bleeding under the skin
• Formation of hematomas or bruising after surgery
• Blood in the stool, as detected by laboratory tests
• Decreased red blood cell count
• Decreased hematocrit
• Allergic reaction
• Vomiting
• Frequent loose or liquid stools
• Nausea
• Wound secretion (oozing of fluid from the surgical wound)
• Increased liver enzyme activity
• Jaundice (yellowing of the skin or whites of the eyes) due to liver or blood disease

Rare (may affect up to 1 in 1000 people)

• Bleeding
• Bleeding may occur into the brain, from the surgical wound, from the injection site, or from the catheter insertion site
• Blood-tinged secretion from the catheter insertion site
• Coughing up blood or blood-tinged sputum
• Decreased platelet count
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing facial or throat swelling
• Skin rash with red, raised, itchy patches due to an allergic reaction
• Sudden change in skin color or appearance
• Itching
• Stomach or intestinal ulcer (including esophageal ulceration)
• Esophagitis or gastritis
• Gastroesophageal reflux disease
• Abdominal pain or stomach pain
• Difficulty swallowing
• Wound secretion
• Wound secretion from the surgical wound

Frequency not known (frequency cannot be estimated from the available data)

• Difficulty breathing or wheezing
• Decreased white blood cell count (which helps fight infections)
• Hair loss

Prevention of blood clots in the brain and body due to irregular heartbeat
Common (may affect up to 1 in 10 people)

• Bleeding may occur from the nose, into the stomach or intestines, from the penis or vagina, or from the urinary tract (including urine discolored pink or red due to the presence of blood), or bleeding under the skin
• Decreased red blood cell count
• Abdominal pain or stomach pain
• Indigestion
• Frequent loose or liquid stools
• Nausea

Uncommon (may affect up to 1 in 100 people)

• Bleeding
• Bleeding may occur from hematomas, from the rectum, or into the brain
• Formation of hematomas
• Coughing up blood or blood-tinged sputum
• Decreased platelet count
• Decreased hemoglobin levels in the blood (a substance in red blood cells)
• Allergic reaction
• Sudden change in skin color or appearance
• Itching
• Stomach or intestinal ulcer (including esophageal ulceration)
• Esophagitis or gastritis
• Gastroesophageal reflux disease
• Vomiting
• Difficulty swallowing
• Abnormal liver function test results

Rare (may affect up to 1 in 1000 people)

• Bleeding may occur into the joint, from the surgical wound, from the injection site, or from the catheter insertion site
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing facial or throat swelling
• Skin rash with red, raised, itchy patches due to an allergic reaction
• Decreased hematocrit
• Increased liver enzyme activity
• Jaundice (yellowing of the skin or whites of the eyes) due to liver or blood disease

Frequency not known (frequency cannot be estimated from the available data)

• Difficulty breathing or wheezing
• Decreased white blood cell count (which helps fight infections)
• Hair loss

Treatment of blood clots in the legs and lungs and prevention of repeat blood clots in the legs and lungs
Common (may affect up to 1 in 10 people)

• Bleeding may occur from the nose, into the stomach or intestines, from the rectum, from the penis or vagina, or from the urinary tract (including urine discolored pink or red due to the presence of blood), or bleeding under the skin
• Indigestion

Uncommon (may affect up to 1 in 100 people)

• Bleeding
• Bleeding may occur into the joint or due to injury
• Bleeding may occur from hematomas
• Decreased red blood cell count
• Formation of hematomas
• Coughing up blood or blood-tinged sputum
• Allergic reaction
• Sudden change in skin color or appearance
• Itching
• Stomach or intestinal ulcer (including esophageal ulceration)
• Esophagitis or gastritis
• Gastroesophageal reflux disease
• Nausea
• Vomiting
• Abdominal pain or stomach pain
• Frequent loose or liquid stools
• Abnormal liver function test results
• Increased liver enzyme activity

Rare (may affect up to 1 in 1000 people)

• Bleeding may occur from the surgical wound, from the injection site, or from the catheter insertion site, or bleeding into the brain
• Decreased platelet count
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing facial or throat swelling
• Skin rash with red, raised, itchy patches due to an allergic reaction
• Difficulty swallowing

Frequency not known (frequency cannot be estimated from the available data)

• Difficulty breathing or wheezing
• Decreased hemoglobin levels in the blood (a substance in red blood cells)
• Decreased hematocrit
• Decreased white blood cell count (which helps fight infections)
• Jaundice (yellowing of the skin or whites of the eyes) due to liver or blood disease
• Hair loss

In clinical trials, the number of heart attacks in patients taking dabigatran etexilate was higher than in those taking warfarin. The overall number of events was small.
Treatment of blood clots and prevention of repeat blood clots in children
Common (may affect up to 1 in 10 people)

• Decreased red blood cell count
• Decreased platelet count
• Skin rash with red, raised, itchy patches due to an allergic reaction
• Sudden change in skin color or appearance
• Formation of hematomas
• Nosebleeds
• Gastroesophageal reflux disease
• Vomiting
• Nausea
• Frequent loose or liquid stools
• Indigestion
• Hair loss
• Increased liver enzyme activity

Uncommon (may affect up to 1 in 100 people)

• Decreased white blood cell count (which helps fight infections)
• Bleeding may occur into the stomach or intestines, into the brain, from the rectum, from the penis or vagina, or from the urinary tract (including urine discolored pink or red due to the presence of blood), or bleeding under the skin
• Decreased hemoglobin levels in the blood (a substance in red blood cells)
• Decreased hematocrit
• Itching
• Coughing up blood or blood-tinged sputum
• Abdominal pain or stomach pain
• Esophagitis or gastritis
• Allergic reaction
• Difficulty swallowing
• Jaundice (yellowing of the skin or whites of the eyes) due to liver or blood disease

Frequency not known (frequency cannot be estimated from the available data)

• Absence of white blood cells (which help fight infections)
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing facial or throat swelling
• Difficulty breathing or wheezing
• Bleeding
• Bleeding may occur into the joint, from the wound, from the surgical wound, from the injection site, or from the catheter insertion site
• Bleeding may occur from hematomas
• Stomach or intestinal ulcer (including esophageal ulceration)
• Abnormal liver function test results

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, Ministry of Health
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 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 or blister after "EXP".
The expiry date refers to the last day of that month.
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 is dabigatran. Each hard capsule contains 126.83 mg of dabigatran etexilate mesylate, which corresponds to 110 mg of dabigatran etexilate.

• The other ingredients are: tartaric acid, arabic gum, hypromellose 2910 (15 cps), dimethicone 350, talc, and hydroxypropylcellulose (100 cps)
• The capsule shell contains carrageenan, potassium chloride, titanium dioxide (E 171), hypromellose 2910 (6 cps), and indigo carmine (E 132).

What Sianta looks like and contents of the pack

Sianta 110 mg are white to light yellow pellets in blue hard capsules, size 1.
Sianta is available in packs containing:
10 x 1, 30 x 1, or 60 x 1 hard capsule in perforated unit dose blisters of aluminum/OPA/aluminum/PVC.
A multipack containing 3 packs of 60 x 1 hard capsule (180 hard capsules) or a multipack containing 2 packs of 50 x 1 hard capsule (100 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, please 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

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

Malta
Sianta 110 mg hard capsules
Bulgaria
Sianta 110 mg, капсула, твърда
Czech Republic
Sianta
Hungary
Sianta 100 mg, kemény kapszula
Poland
Sianta
Romania
Sianta 110 mg capsule
Slovakia
Sianta 110 mg, tvrdé kapsuly

Date of last revision of the leaflet:

Detailed information on this medicine is available on the website of the Ministry of Health
https://rejestrymedyczne.ezdrowie.gov.pl/