Sianta

Package leaflet: Information for the patient

Sianta, 150 mg, hard capsules
Dabigatranum etexilatum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the 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. It works by blocking a substance in the body responsible for blood clot formation.
Sianta is used in adults to:

• prevent formation of blood clots in the brain (stroke) and in other blood vessels in the body when the patient has an irregular heart rhythm called non-valvular atrial fibrillation and at least one additional risk factor.
• treat blood clots in the veins of the legs and lungs, and to prevent recurrence of blood clots in the veins of the legs and lungs.

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. stomach ulcer, brain injury or intracranial hemorrhage, recent brain or eye surgery).
• if the patient has an increased tendency to bleed, which may be congenital, of unknown cause, or caused by other medications.
• 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 catheter ablation procedures for atrial fibrillation to restore normal heart rhythm.
• if the patient has severe liver dysfunction 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 organ transplant rejection.
• 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 a mechanical heart valve requiring continuous anticoagulant therapy.

Warnings and precautions
Before starting treatment with Sianta, discuss this with your doctor. During treatment with
Sianta, it may also be necessary to consult your doctor if symptoms occur or if surgery is required.
The patient should inform the doctor if the patient has or has 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 (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 esophagus or stomach.
  • if the patient has gastroesophageal reflux (acid reflux into the esophagus).
  • 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 of 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 foamy 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 had a previous heart attack or if the patient has been diagnosed with conditions increasing the risk of heart attack.
• if the patient has liver disease affecting blood test results. In such cases, use of this medicine is not recommended.

When to exercise special caution when using Sianta

• if the patient needs to undergo surgery:

In such cases, temporary discontinuation of Sianta is necessary due to 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 requires insertion of a catheter or injection into the spine (e.g. for epidural or spinal anesthesia or 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 numbness or weakness in the legs or problems with bowel or bladder function occur after the anesthesia wears off, as urgent medical care is required.
• if the patient has fallen or sustained an injury during treatment, especially if the head was injured. Immediate medical attention should be sought. The doctor will assess whether there may be 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), the patient should inform their doctor, who will decide whether treatment adjustment is needed.

Sianta and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take. In particular,
before taking Sianta, tell your doctor if the patient is 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, itraconazol), unless these medicines 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 the medicine was prescribed. See section 3.
• Medicines used to prevent organ transplant rejection (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. Do not take Sianta during pregnancy unless your doctor determines it is safe. Women of reproductive age should avoid becoming pregnant while taking Sianta.
Breastfeeding should not be performed during treatment with Sianta.

Driving and operating machinery
The effect of Sianta on the ability to drive or 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. Other age-appropriate formulations of the medicine are available for children under 8 years of age.
This medicine should always be taken as prescribed by the doctor. If in doubt, consult the doctor.
Sianta should be taken according to the following recommendations:
Prevention of blood clots in blood vessels of the brain and body by preventing the formation of clots that occur due to irregular heart function, and treatment of blood clots in the veins of the legs and lungs, as well as prevention of recurrence of 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 older, the recommended dose is 220 mg taken as one 110 mg capsule twice daily.
In patients taking medicines containing verapamil, treatment with a reduced dose of Sianta of 220 mg taken as one 110 mg capsule twice daily is recommended due to a potentially increased risk of bleeding.
In patients with a 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 function through a procedure called cardioversion or a procedure called catheter ablation for atrial fibrillation. Sianta should be taken as directed by the doctor.
In 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 be treated with Sianta after the doctor has confirmed adequate control of blood coagulation. Sianta should be taken as directed by the doctor.
Treatment of blood clots 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 the dose during treatment. All other medications should be continued unless the 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 a 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 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 pictogram below shows how to remove Sianta capsules from the blister pack.

Peel off the blister fragment containing a single dose along the perforated line.

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 medication without receiving specific instructions from your doctor.

Accidental overdose of Sianta
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
A missed dose may be taken up to 6 hours before the next scheduled dose.
If less than 6 hours remain before the next scheduled dose, the missed dose should not be taken. Do not take a double dose to make up for a missed dose.

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

Contact your doctor if you experience indigestion 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 any medicine, this medicine can cause adverse effects, although not everyone will experience them.
Sianta affects the blood clotting system; therefore, most adverse effects are related to symptoms such as bruising or bleeding.
Severe or extensive bleeding may occur, which is the most serious adverse effect. Regardless of the location, such bleeding may lead to disability, be life-threatening, or even result in death.
In some cases, this bleeding may not be visible.
If bleeding occurs that does not stop spontaneously, or symptoms of excessive bleeding (unusual weakness, fatigue, paleness, dizziness, headache, or unexplained swelling) appear, 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 thromboembolism in the brain and other parts of the body by preventing the formation of blood clots that occur due to irregular heart function

Common (may occur in 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 pink or red urine due to the presence of blood), or bleeding under the skin
• Decrease in the number of red blood cells in the blood
• Abdominal pain or stomach pain
• Indigestion
• Frequent passage of loose or watery stools
• Nausea

Uncommon (may occur in up to 1 in 100 people)

• Bleeding
• Bleeding may occur from haemorrhoids, from the rectum, or into the brain
• Formation of bruises (haematomas)
• Coughing up blood or bloody sputum
• Decrease in the number of platelets in the blood
• Decrease in haemoglobin levels in the blood (a 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

Rare (may occur in up to 1 in 1000 people)

• Bleeding may occur into a joint, from a surgical incision site, from a wound, from an injection site, or from the 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 consisting of dark red, raised, itchy bumps occurring as a result of an allergic reaction
• Decrease in blood cell count
• Increase in liver enzyme activity
• Yellowing of the skin or whites of the eyes (jaundice) caused by liver or blood disease

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

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

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

Treatment of venous blood clots in the legs and lungs, and prevention of recurrence of venous blood clots in the legs and lungs

Common (may occur in up to 1 in 10 people)

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

Uncommon (may occur in up to 1 in 100 people)

• Bleeding
• Bleeding may occur into a joint or following injury
• Bleeding may occur from haemorrhoids
• Decrease in the number of red blood cells in the blood
• Formation of bruises (haematomas)
• Coughing up blood or bloody 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
• Increase in liver enzyme activity

Rare (may occur in up to 1 in 1000 people)

• Bleeding may occur from a surgical incision site, from an injection site, from the site of intravenous catheter insertion, or bleeding into the brain
• Decrease in the number of platelets in the blood
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing swelling of the face or throat
• Skin rash consisting of dark red, raised, itchy bumps occurring as a result of an allergic reaction
• Difficulty swallowing

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

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

In clinical studies, 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 in patients treated with dabigatran compared to patients receiving placebo.

Treatment of blood clots and prevention of recurrent blood clots in children

Common (may occur in up to 1 in 10 people)

• Decrease in the number of red blood cells in the blood
• Decrease in the number of platelets in the blood
• Skin rash consisting of dark red, raised, itchy bumps occurring as a result of an allergic reaction
• Sudden change in skin colour and appearance
• Formation of bruises (haematomas)
• Nosebleeds
• Regurgitation of stomach contents into the oesophagus (reflux)
• Vomiting
• Nausea
• Frequent passage of loose or watery stools
• Indigestion
• Hair loss
• Increase in liver enzyme activity

Uncommon (may occur in up to 1 in 100 people)

• Decrease in the number of white blood cells (which help fight infections)
• Bleeding may occur into the stomach or intestines, into the brain, from the rectum, from the penis/vagina or urinary tract (including pink or red urine due to the presence of blood), or bleeding under the skin
• Decrease in haemoglobin levels in the blood (a substance in red blood cells)
• Decrease in blood cell count
• Itching
• Coughing up blood or bloody 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 (jaundice) caused by liver or blood disease

Frequency not known (frequency cannot be estimated 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, from a surgical incision site, from an injection site, or from the site of intravenous catheter insertion
• Bleeding may occur from haemorrhoids
• Stomach or intestinal ulcer (including oesophageal ulceration)
• Abnormal liver function test results

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, 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 authorisation holder.
Reporting adverse effects helps provide more information on the safety of the 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.
Store 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 package and other information

What the medicine Sianta contains
The active substance is dabigatran. Each hard capsule contains 172.95 mg of dabigatran etexilate in the form of mesilate, equivalent to 150 mg of dabigatran etexilate.

• Other ingredients: 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), hypromellose 2910 (6 cps) and indigo carmine (E 132).

What Sianta looks like and contents of the pack
Sianta 150 mg consists of white to pale yellowish pellets contained in hard capsules with a blue cap and a white to off-white body, size 0.
The medicine 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 capsule (180 hard capsules)
or a multipack containing 2 packs of 50 x 1 hard capsule (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

Manufacturers:
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, 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 countries under the following names:
Malta Sianta 150 mg hard capsules
Bulgaria Sianta 150 mg, капсула, твърда
Czech Republic Sianta
Hungary Sianta 150 mg, kemény kapszula
Poland Sianta
Romania Sianta 150 mg capsule
Slovakia Sianta 150 mg, tvrdé kapsuly

Detailed information about 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/