Sianta

Package leaflet: Information for the patient

Sianta, 75 mg, hard capsules
Dabigatranum etexilatum
Please read the entire 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 others, even if their symptoms are identical.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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 in the body a substance responsible for blood clot formation.
Sianta is used in adults to:

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

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 a disease of any internal organ which increases the risk of major bleeding (e.g. stomach 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, when heparin is administered through the catheter to maintain its patency, or during restoration of normal heart rhythm using a procedure called catheter ablation in atrial fibrillation.
• if the patient has severe liver function impairment or liver disease which 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 fixed-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 ongoing 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, it may also be necessary to consult the doctor 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, especially 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 underwent 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 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 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 heart attack or if the patient has been diagnosed with conditions that increase 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 particular caution when using 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 the surgical procedure requires insertion of a catheter or administration of an 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 numbness or weakness in the legs, or problems with the bowel or bladder occur after the anaesthesia wears off, as urgent medical care is required.
• if the patient falls or injures themselves during treatment, especially if the head is injured. Immediate medical attention 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
Tell the doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take. In particular, the patient should tell 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 the medicine was prescribed. See also section 3.
• Medicines used to prevent rejection of transplanted organs (e.g. tacrolimus, cyclosporine).
• A fixed-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-noradrenaline 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
It is not known whether Sianta affects pregnancy or the unborn child. Sianta should not be taken during pregnancy unless the doctor determines it is safe. Women of childbearing potential should avoid becoming pregnant while taking Sianta.
Breastfeeding should not be undertaken while taking 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 after hip or knee replacement surgery
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 is 150 mg once daily (taken as 2 capsules of 75 mg).
In patients taking medicines containing verapamil and with renal function reduced by more than half, treatment should be initiated with a reduced dose of 75 mg of Sianta due to increased risk of bleeding.
In both types of surgical procedures, treatment should not be started if there is bleeding from the surgical site. If treatment cannot be initiated by the next day after surgery, it should be started with a dose of 2 capsules once daily.
After knee replacement surgery
Treatment with Sianta should be initiated by taking one capsule within 1 to 4 hours after the end of surgery. Then, two capsules should be taken once daily for a total of 10 days.
After hip replacement surgery
Treatment with Sianta should be initiated by taking one capsule within 1 to 4 hours after the end of surgery. Then, two capsules should be taken once daily for a total of 28 to 35 days.
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 be as close as possible to 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 medicines unless the doctor advises otherwise.
Table 1 shows the single and total daily doses of Sianta in milligrams (mg). 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 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 blister packs
The following pictogram shows how to remove Sianta capsules from the blister pack.

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

Peel off the backing foil and remove the capsule.

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

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

Taking more Sianta than prescribed
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 hip or knee replacement surgery
Continue taking the missed daily dose of Sianta at the usual time on the following day. Do not take a double dose to make up for a missed dose.

Treatment and prevention of recurrence of blood clots in children
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 Sianta
Sianta should be taken as directed by the doctor. Do not stop taking Sianta without first consulting your doctor, as the risk of developing a blood clot may be higher if treatment is stopped too early.

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 clotting 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, and regardless of location, may lead to disability, be life-threatening, or even result in death.
In some cases, these bleedings may not be visible.
If bleeding that does not stop spontaneously occurs, 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 monitoring 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 (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 urinary tract (including pink or red urine due to presence of blood), from haemorrhoids, from the rectum, under the skin, into joints, following trauma or after a surgical procedure
• Formation of bruises or bruising occurring after a surgical procedure
• Blood in stool detected in laboratory tests
• Decreased number of red blood cells in blood
• Decreased proportion of blood cells
• Allergic reaction
• Vomiting
• Frequent passage of loose or liquid stool
• Nausea
• Discharge from wound (fluid leakage from surgical wound)
• Increased liver enzyme activity
• Yellowing of the skin or whites of the eyes caused by liver disease or blood disorder

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 blood
• Decreased red blood cell count after surgery
• 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 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
• Fluid discharge from wound
• Fluid discharge from surgical wound

Frequency unknown (frequency cannot be estimated from available data)

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

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

Uncommon (may affect up to 1 in 100 people)

• Decreased white blood cell count (which help fight infections)
• Bleeding may occur into the stomach or intestines, brain, rectum, penis or vagina or urinary tract (including pink or red urine due to presence of blood), or under the skin
• Decreased haemoglobin levels in blood (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 disorder

Frequency unknown (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 joints, from wounds, surgical incision sites, injection sites, or sites 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 you experience any adverse effects, 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 authorisation holder.
By reporting adverse effects, additional information on the safety of the medicine’s use can be collected.

5. How to store Sianta medicine

Keep this medicine out of 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 a pharmacist how to properly dispose of medicines no longer in use. 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 86.48 mg of dabigatran etexilate
in the form of mesilate, equivalent to 75 mg of dabigatran etexilate.

• Other ingredients: 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) and hypromellose 2910 (6 cps).

What Sianta looks like and contents of the pack
Sianta 75 mg consists of white to almost white or pale yellow pellets contained in hard capsules
of white to off-white color, size 2.
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
Aluminum/OPA/Aluminum/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

The medicine is authorised in the European Economic Area countries 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

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/