Sianta

Package leaflet: Information for the patient

Sianta, 110 mg, hard capsules
Dabigatranum etexilatum
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, ask your doctor or pharmacist.
• 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 get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Sianta is and what it is used for
2. What you need to know before you take 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. It works by blocking a substance in the body that is involved in 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 in other blood vessels in patients who have a type of irregular heartbeat called non-valvular atrial fibrillation and at least one additional risk factor.
• treat blood clots in the legs and lungs and to prevent recurrence of such clots.

Sianta is used in children to:

• treat blood clots and to prevent recurrence of blood clots.

2. Important information before using Sianta

When not to use Sianta

• if the patient is allergic to dabigatran etexilate or any of the other ingredients of this medicine (listed in section 6).
• if the patient has severe kidney function impairment.
• if the patient is currently experiencing bleeding.
• if the patient has an internal organ disease that increases the risk of major bleeding (e.g. gastric ulcer, brain injury or intracranial haemorrhage, recent brain or eye surgery).
• if the patient has an increased tendency to bleed. This may be congenital, of unknown cause, or caused by taking other medicines.
• if the patient is taking anticoagulant medicines (e.g. warfarin, rivaroxaban, apixaban or heparin), except when switching anticoagulant therapy, inserting a venous or arterial catheter with heparin administered through the catheter to maintain patency, or during a procedure called catheter ablation for atrial fibrillation to restore normal heart rhythm.
• if the patient has severe liver function impairment or liver disease that may lead to death.
• if the patient is taking oral ketoconazole or itraconazole, medicines used to treat fungal infections.
• if the patient is taking oral cyclosporine, a medicine used to prevent rejection of a transplanted organ.
• if the patient is taking dronedarone, a medicine used to treat heart rhythm disorders.
• if the patient is taking a combination medicine containing glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C virus infection.
• if the patient has had a mechanical heart valve implanted, which requires continuous use of blood-thinning medicines.

Warnings and precautions
Before starting treatment with Sianta, the patient should discuss this with their doctor. During treatment with Sianta, consultation with a doctor may also be necessary if symptoms occur or if surgery is required.
The patient should inform the doctor if they have or have previously had any medical conditions or diseases, particularly any of the following:

• if the patient has an increased risk of bleeding, such as:
  • if the patient has recently experienced bleeding.
  • if the patient has undergone a surgical tissue biopsy within the last month.
  • if the patient has suffered a serious injury (e.g. bone fracture, head injury or any injury requiring surgical treatment).
  • if the patient has inflammation of the oesophagus or stomach.
  • if the patient has gastro-oesophageal reflux (stomach acid flowing back into the oesophagus).
  • if the patient is taking medicines that may increase the risk of bleeding. See below "Sianta and other medicines".
  • if the patient is taking non-steroidal anti-inflammatory drugs such as diclofenac, ibuprofen, piroxicam.
  • if the patient has an infection in the heart (bacterial endocarditis).
  • if the patient has reduced kidney function or is dehydrated (feeling thirsty and passing reduced amounts of dark (concentrated) and/or frothy urine).
  • if the patient is over 75 years of age.
  • if the patient is an adult weighing 50 kg or less.
  • only when used in children: if the child has an infection around or within the brain.
• if the patient has previously had a heart attack or if the patient has conditions that increase the risk of a heart attack.
• if the patient has liver disease affecting blood test results. In such cases, use of this medicine is not recommended.

When to take special care with Sianta

• if the patient needs to undergo surgery: In such cases, temporary discontinuation of Sianta is necessary due to the increased risk of bleeding during and immediately after surgery. It is very important to take Sianta exactly as directed by the doctor before and after surgery.
• if surgery involves insertion of a catheter or injection into the spine (e.g. for epidural or spinal anaesthesia or for pain relief):
  • it is very important to take Sianta exactly as directed by the doctor before and after surgery.
  • the patient should immediately inform the doctor if they experience numbness or weakness in the legs or problems with bowel or bladder function after the anaesthesia wears off, as urgent medical attention is required.
• if the patient falls or sustains an injury during treatment, especially if the head is injured. Immediate medical help should be sought. The doctor will assess whether there is an increased risk of bleeding.
• if the patient knows they have a condition called antiphospholipid syndrome (an immune system disorder causing increased risk of blood clots), they should inform their doctor, who will decide whether a change in treatment is needed.

Sianta and other medicines
The patient should tell their doctor or pharmacist about all medicines they are currently taking, have recently taken, or plan to take. In particular, the patient should inform the doctor before taking Sianta if they are taking any of the following medicines:

• Medicines that reduce 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 these are applied only to the skin.
• Medicines used to treat heart rhythm disorders (e.g. amiodarone, dronedarone, quinidine, verapamil). If the patient is taking medicines containing amiodarone, quinidine or verapamil, the doctor may recommend a lower dose of Sianta depending on the condition for which it was prescribed. See section 3.
• Medicines used to prevent rejection of transplanted organs (e.g. tacrolimus, cyclosporine).
• A combination medicine containing glecaprevir and pibrentasvir (an antiviral medicine used to treat hepatitis C virus infection).
• 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 known as selective serotonin reuptake inhibitors or serotonin-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 unknown. Sianta should not be taken during pregnancy unless the doctor considers it safe. Women of childbearing potential should avoid becoming pregnant while taking Sianta.
Breastfeeding should not be undertaken during treatment with Sianta.

Driving and operating machinery
The effect of Sianta on the ability to drive and operate machinery is unknown.

3. How to take Sianta

Sianta capsules can be used in adults and children aged 8 years or older who are able to swallow capsules whole. There are other age-appropriate pharmaceutical forms of this medicine available for children under 8 years of age.
This medicine should always be taken as prescribed by your doctor. If in doubt, consult your doctor.
Sianta should be taken according to the following instructions:

Prevention of blood clots after hip or knee replacement surgery (arthroplasty)
The recommended dose is 220 mg once daily (taken as 2 capsules of 110 mg).
In patients with renal function reduced by more than half or in patients aged 75 years or older, the recommended dose is 150 mg once daily (taken as 2 capsules of 75 mg).
In patients taking medicines containing amiodarone, quinidine, or verapamil, the recommended dose of Sianta is 150 mg once daily (taken as 2 capsules of 75 mg).
Patients taking medicines containing verapamil who also have renal function reduced by more than half should take a reduced dose of Sianta of 75 mg due to an increased risk of bleeding.

In both types of surgical procedures, treatment should not be initiated if there is bleeding from the surgical site. If treatment cannot be started until the day after surgery, it should be initiated with a dose of 2 capsules once daily.

After knee replacement surgery
Treatment with Sianta should be started by taking one capsule within 1 to 4 hours after the end of surgery. Then, take two capsules once daily for a total of 10 days.

After hip replacement surgery
Treatment with Sianta should be started by taking one capsule within 1 to 4 hours after the end of surgery. Then, take two capsules once daily for a total of 28 to 35 days.

Prevention of thromboembolic events in blood vessels of the brain and body by preventing clot formation due to abnormal heart function, and treatment and prevention of recurrent blood clots in the veins of the legs and lungs
The recommended dose is 300 mg taken as one 150 mg capsule twice daily.
In patients aged 80 years or above, the recommended dose is 220 mg taken as one 110 mg capsule twice daily.
Patients taking medicines containing verapamil should receive a reduced dose of Sianta of 220 mg taken as one 110 mg capsule twice daily due to a possible increased risk of bleeding.
In patients with potentially increased risk of bleeding, the doctor may recommend treatment with Sianta at a dose of 220 mg taken as one 110 mg capsule twice daily.

Treatment with Sianta may be continued if the patient requires restoration of normal heart rhythm by a procedure called cardioversion. Sianta should be taken as directed by the doctor.

In patients undergoing implantation of a medical device (stent) into a blood vessel to maintain its patency using a procedure called percutaneous coronary intervention with stent implantation, treatment with Sianta may be initiated once the doctor has confirmed adequate control of blood coagulation. Sianta should be taken as directed by the doctor.

Treatment and prevention of recurrent blood clots in children
Sianta should be taken twice daily, one dose in the morning and one in the evening, approximately at the same time each day. The interval between doses should ideally be 12 hours.
The recommended dose depends on body weight and age. The doctor will determine the correct dose and may adjust it during treatment. Continue taking all other medications unless your doctor advises otherwise.

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

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

How to take Sianta
Sianta may 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 blister packs
The following pictogram shows how to remove Sianta capsules from the blister pack.

Tear off along the perforated line the section of the blister containing a single dose of the medicine.

Peel back the protective backing foil and remove the capsule.

• Do not push the capsules through the blister foil.
• Do not peel back the foil from the blister earlier than necessary before taking the capsule.

Switching anticoagulant therapy
Do not switch anticoagulant therapy without receiving detailed instructions from your doctor.

Taking more Sianta than recommended
Taking too high a dose of Sianta increases the risk of bleeding. If a patient has taken too many Sianta capsules, contact a doctor immediately. Specific treatment methods are available.

Missed dose of Sianta
Prevention of blood clots after surgery (joint replacement) of the hip or knee
Continue taking the missed daily dose of Sianta at the same time on the following day. Do not take a double dose to make up for a missed dose.

Use in adults: Prevention of thromboembolic events in blood vessels of the brain and body by preventing formation of clots due to abnormal heart rhythm, and treatment of blood clots in the veins of the legs and lungs, as well as prevention of recurrence of such clots
Use in children: Treatment of blood clots and prevention of recurrent blood clots

A missed dose may be taken up to 6 hours before the next scheduled dose.
If less than 6 hours remain until the next scheduled dose, do not take the missed dose.
Do not take a double dose to make up for a missed dose.

Stopping treatment with Sianta
Sianta should be taken exactly as prescribed by the doctor. Do not stop taking this medicine without first consulting your doctor, as the risk of developing a blood clot may be greater if treatment is stopped prematurely.

Contact your doctor if you experience gastrointestinal discomfort after taking Sianta.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Sianta affects the blood coagulation system; therefore, most adverse effects are related to symptoms such as bruising or bleeding.
Severe or major bleeding may occur, which is the most serious adverse effect. Regardless of its location, such bleeding may lead to disability, be life-threatening, or even result in death.
In some cases, these bleedings may not be visible.
If bleeding occurs that does not stop spontaneously, or if symptoms of excessive bleeding appear (unusual weakness, fatigue, paleness, dizziness, headache, or unexplained swelling), contact your doctor immediately. The doctor may decide to place the patient under close observation or change the treatment.
In case of a serious allergic reaction, which may cause difficulty breathing or dizziness, contact your doctor immediately.

The possible adverse effects listed below are grouped according to their frequency of occurrence:

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

• Decreased haemoglobin levels in the blood (the substance in red blood cells)
• Abnormal liver function test results in laboratory tests

Uncommon (may affect up to 1 in 100 people)

• Bleeding may occur from the nose, stomach or intestines, penis or vagina, or urinary tract (including pink or red urine due to presence of blood), from haemorrhoids, rectum, under the skin, into a joint, following injury or after a surgical procedure
• Development of haematomas or bruising occurring after surgery
• Blood in stool detected in laboratory tests
• Decreased number of red blood cells in the blood
• Decreased proportion of blood cells
• Allergic reaction
• Vomiting
• Frequent passage of loose or watery stools
• Nausea
• Presence of discharge from the wound (oozing of fluid from the surgical wound)
• Increased liver enzyme activity
• Yellowing of the skin or whites of the eyes caused by liver disease or blood disorders

Rare (may affect up to 1 in 1000 people)

• Bleeding
• Bleeding may occur into the brain, from the surgical incision site, injection site, or site of intravenous catheter insertion
• Blood-tinged discharge from the site of intravenous catheter insertion
• Coughing up blood or blood-stained sputum
• Decreased platelet count in the blood
• Decreased number of red blood cells in the blood after surgery
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing swelling of the face or throat
• Skin rash appearing as dark red, raised, itchy bumps due to an allergic reaction
• Sudden change in skin colour and appearance
• Itching
• Stomach or intestinal ulcer (including oesophageal ulceration)
• Inflammation of the oesophagus and stomach
• Regurgitation of stomach contents into the oesophagus (reflux)
• Abdominal pain or stomach pain
• Indigestion
• Difficulty swallowing
• Discharge of fluid from the wound
• Discharge of fluid from the surgical wound

Frequency unknown (frequency cannot be determined from available data)

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

Prevention of thromboembolic events in the brain and body by preventing clot formation due to irregular heart function
Common (may affect up to 1 in 10 people)

• Bleeding may occur from the nose, stomach or intestines, penis or vagina, urinary tract (including pink or red urine due to presence of blood), or under the skin
• Decreased number of red blood cells in the blood
• Abdominal pain or stomach pain
• Indigestion
• Frequent passage of loose or watery stools
• Nausea

Uncommon (may affect up to 1 in 100 people)

• Bleeding
• Bleeding may occur from haemorrhoids, rectum, or into the brain
• Formation of haematomas
• Coughing up blood or blood-stained sputum
• Decreased platelet count in the blood
• Decreased haemoglobin levels in the blood (the substance in red blood cells)
• Allergic reaction
• Sudden change in skin colour and appearance
• Itching
• Stomach or intestinal ulcer (including oesophageal ulceration)
• Inflammation of the oesophagus and stomach
• Regurgitation of stomach contents into the oesophagus (reflux)
• Vomiting
• Difficulty swallowing
• Abnormal liver function test results in laboratory tests

Rare (may affect up to 1 in 1000 people)

• Bleeding may occur into a joint, from the surgical incision site, wound, injection site, or site of intravenous catheter insertion
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing swelling of the face or throat
• Skin rash appearing as dark red, raised, itchy bumps due to an allergic reaction
• Decreased proportion of blood cells
• Increased liver enzyme activity
• Yellowing of the skin or whites of the eyes caused by liver disease or blood disorders

Frequency unknown (frequency cannot be determined from available data)

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

In clinical trials, the number of heart attacks with dabigatran etexilate was numerically higher than with warfarin. The overall number of events was low.

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

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

Uncommon (may affect up to 1 in 100 people)

• Bleeding
• Bleeding may occur into a joint or following injury
• Bleeding may occur from haemorrhoids
• Decreased number of red blood cells in the blood
• Formation of haematomas
• Coughing up blood or blood-stained sputum
• Allergic reaction
• Sudden change in skin colour and appearance
• Itching
• Stomach or intestinal ulcer (including oesophageal ulceration)
• Inflammation of the oesophagus and stomach
• Regurgitation of stomach contents into the oesophagus (reflux)
• Nausea
• Vomiting
• Abdominal pain or stomach pain
• Frequent passage of loose or watery stools
• Abnormal liver function test results in laboratory tests
• Increased liver enzyme activity

Rare (may affect up to 1 in 1000 people)

• Bleeding may occur from the surgical incision site, injection site, site of intravenous catheter insertion, or into the brain
• Decreased platelet count in the blood
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing swelling of the face or throat
• Skin rash appearing as dark red, raised, itchy bumps due to an allergic reaction
• Difficulty swallowing

Frequency unknown (frequency cannot be determined from available data)

• Difficulty breathing or wheezing
• Decreased haemoglobin levels in the blood (the substance in red blood cells)
• Decreased proportion of blood cells
• Decreased number or even absence of white blood cells (which help fight infections)
• Yellowing of the skin or whites of the eyes caused by liver disease or blood disorders
• Hair loss

In clinical trials, the number of heart attacks with dabigatran etexilate was numerically higher than with warfarin. The overall number of events was low. No difference in the number of heart attacks was observed between patients treated with dabigatran and those receiving placebo.

Treatment of blood clots and prevention of recurrence of blood clots in children
Common (may affect up to 1 in 10 people)

• Decreased number of red blood cells in the blood
• Decreased platelet count in the blood
• Skin rash appearing as dark red, raised, itchy bumps due to an allergic reaction
• Sudden change in skin colour and appearance
• Formation of haematomas
• Nosebleeds
• Regurgitation of stomach contents into the oesophagus (reflux)
• Vomiting
• Nausea
• Frequent passage of loose or watery stools
• Indigestion
• Hair loss
• Increased liver enzyme activity

Uncommon (may affect up to 1 in 100 people)

• Decreased number of white blood cells (which help fight infections)
• Bleeding may occur into the stomach or intestines, brain, rectum, penis or vagina, urinary tract (including pink or red urine due to presence of blood), or under the skin
• Decreased haemoglobin levels in the blood (the substance in red blood cells)
• Decreased proportion of blood cells
• Itching
• Coughing up blood or blood-stained sputum
• Abdominal pain or stomach pain
• Inflammation of the oesophagus and stomach
• Allergic reaction
• Difficulty swallowing
• Yellowing of the skin or whites of the eyes caused by liver disease or blood disorders

Frequency unknown (frequency cannot be determined from available data)

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

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects 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 effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to gather more information on the safety of this medicine.

5. How to store Sianta medicine

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or blister pack following "EXP".
The expiry date refers to the last day of the stated month.
Do not store above 30°C.
Keep in the original packaging to protect from moisture.
Medicines must 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 packaging and other information

What the medicine Sianta contains
The active substance is dabigatran. Each hard capsule contains 126.83 mg of dabigatran etexilate as mesilate, equivalent to 110 mg of dabigatran etexilate.

• Other ingredients: tartaric acid, acacia gum, hypromellose 2910 (15 cps), dimethicon 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 consists of whitish to pale yellow pellets contained in blue hard capsules of size 1.
Sianta is available in packs containing:
10 x 1, 30 x 1, or 60 x 1 hard capsule in single-dose perforated blisters made of Aluminium/OPA/Aluminium/PVC foil.
A multipack containing 3 packs of 60 x 1 hard capsules (180 hard capsules) or a multipack containing 2 packs of 50 x 1 hard capsules (100 hard capsules) in single-dose perforated blisters made of Aluminium/OPA/Aluminium/PVC foil.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
EGIS Polska Sp. z o.o.
ul. Komitetu Obrony Robotników 45D
02-146 Warsaw
Tel.: +48 22 417 92 00

This medicine is authorised in the European Economic Area under the following names:
Malta Sianta 110 mg hard capsules
Bulgaria Sianta 110 mg, hard capsule
Czech Republic Sianta
Hungary Sianta 100 mg, hard capsule
Poland Sianta
Romania Sianta 110 mg capsule
Slovakia Sianta 110 mg, hard capsules

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/