Sianta

Leaflet accompanying the packaging: patient information

Sianta, 150 mg, hard capsules

Dabigatran etexilate

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

• Keep this leaflet, so you can read it again if you need to.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Sianta and what is it used for

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

Sianta is used in adults to:

• prevent blood clots in the brain (stroke) and other blood vessels in the patient's body, if the patient has a type of irregular heart rhythm called atrial fibrillation not caused by a heart valve problem and at least one additional risk factor.
• treat blood clots in the legs and lungs and prevent repeated blood clots in the legs and lungs.

Sianta is used in children to:

• treat blood clots and prevent repeated blood clots.

2. Important information before taking Sianta

When not to take 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 impairment.
• if the patient is currently bleeding.
• if the patient has a disease of an internal organ that increases the risk of major bleeding (e.g., stomach ulcer, brain injury or bleeding into the brain, recent brain or eye surgery).
• if the patient has an increased tendency to bleed. This may be congenital, of unknown cause, or caused by the use of other medicines.
• if the patient is taking anticoagulant medicines (e.g., warfarin, rivaroxaban, apixaban, or heparin), except when changing anticoagulant treatment, introducing a venous catheter, or restoring normal heart function using a procedure called catheter ablation in atrial fibrillation.
• if the patient has severe liver 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 organ 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.
• if the patient has a mechanical heart valve that requires continuous anticoagulation.

Warnings and precautions

Before starting Sianta, the patient should discuss it with their doctor. During treatment with Sianta, it may also be necessary to talk to a doctor if the patient experiences symptoms or needs surgery.

The patient should inform their doctorif they have or have 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 had bleeding.
• if the patient has had a surgical biopsy within the last month.
• if the patient has had a serious injury (e.g., bone fracture, head injury, or any injury requiring surgical treatment).
• if the patient has esophagitis or gastritis.
• if the patient has gastroesophageal reflux disease.
• if the patient is taking medicines that may increase the risk of bleeding. See "Sianta and other medicines" below.
• if the patient is taking anti-inflammatory medicines such as diclofenac, ibuprofen, or 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 producing less dark, concentrated, or foamy urine).
• if the patient is over 75 years old.
• if the patient is an adult and weighs 50 kg or less.
• only in the case of use in children: if the child has an infection around or in the brain.
• if the patient has had a heart attack or has been diagnosed with conditions that increase the risk of heart attack.
• if the patient has liver disease that affects blood test results. In such cases, the use of this medicine is not recommended.

When to be particularly careful when taking Sianta

• if the patient needs to undergo surgery:

In such cases, it is necessary to discontinue Sianta temporarily due to the increased risk of bleeding during and after surgery. It is very important to take Sianta before and after surgery exactly as the doctor has instructed.

• if the surgical procedure requires the insertion of a catheter or injection into the spine (e.g., for spinal or epidural anesthesia or to reduce pain):
• it is very important to take Sianta before and after surgery exactly as the doctor has instructed.
• the patient should immediately inform their doctor if they experience numbness or weakness in their lower limbs or problems with their bowels or bladder after the anesthesia has worn off, as urgent medical attention may be necessary.
• if the patient has fallen or injured themselves during treatment, especially if they have injured their head. The patient should seek urgent medical attention. The doctor will examine the patient to determine if there is an increased risk of bleeding.
• if the patient knows they have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), the patient should inform their doctor, who will decide if a change in treatment is necessary.

Sianta and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

In particular, before taking Sianta, the patient should tell their doctor if they are taking any of the following medicines:

• medicines that reduce blood clotting (e.g., warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, aspirin).
• medicines used to treat fungal infections (e.g., ketoconazole, itraconazole), unless these medicines are used only on 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 organ rejection (e.g., tacrolimus, cyclosporine).
• a combination medicine containing glecaprevir and pibrentasvir (an antiviral medicine used to treat hepatitis C).
• anti-inflammatory and pain-relieving medicines (e.g., 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. Sianta should not be taken during pregnancy unless the doctor considers it safe. Women of childbearing age should avoid becoming pregnant while taking Sianta.

While taking Sianta, the patient should not breastfeed.

Driving and using machines

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

3. How to take Sianta

Sianta in the form of hard capsules can be taken by adults and children aged 8 years or older who are able to swallow the capsules whole. There are other age-appropriate pharmaceutical forms of the medicine for children under 8 years old.

This medicine should always be taken exactly as the doctor has instructed. In case of doubts, the patient should consult their doctor.

Take Sianta as follows:

Preventing blood clots in the brain and body by preventing the formation of clots that occur during irregular heart rhythm and treating blood clots in the legs and lungs and preventing repeated blood clots in the legs and lungs

The recommended dose is 300 mg taken as one 150 mg capsule twice a day.

For patients aged 80 years or older, the recommended dose is 220 mg taken as one 110 mg capsule twice a day.

If the patient is taking medicines containing verapamil, they should receive Sianta at a reduced dose of 220 mg taken as one 110 mg capsule twice a daydue to the possible increased risk of bleeding.

For patients with potentially increased risk of bleeding, the doctor may recommend taking Sianta at a dose of 220 mg taken 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 or catheter ablation in atrial fibrillation. Sianta should be taken as instructed by the 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 be treated with Sianta after the doctor has confirmed that normal blood clotting control has been achieved. Sianta should be taken as instructed by the doctor.

Treating blood clots and preventing repeated blood clots in children

Sianta should be taken twice a day, one dose in the morning and one dose in the evening, at approximately the same time every day. The interval between doses should be approximately 12 hours.

The recommended dose depends on the patient's weight and age. The doctor will determine the correct dose. The doctor may adjust the dose during treatment. The patient should continue to take all other medicines unless the doctor instructs them to stop taking any of them.

Table 1 shows the single and total daily doses of Sianta in milligrams (mg). The doses depend on the patient's weight in kilograms (kg) and age in years.

Doses requiring the combination of more than one capsule:

300 mg: two 150 mg capsules or four 75 mg capsules

260 mg: one 110 mg capsule and one 150 mg capsule or one 110 mg capsule and two 75 mg capsules

220 mg: two 110 mg capsules

185 mg: one 75 mg capsule 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 facilitate passage into the stomach. They should not be broken, chewed, or the pellets emptied from the capsule, as this may increase the risk of bleeding.

Instructions for opening blisters

The following diagram shows how to remove Sianta capsules from the blister.

Peel off the rear foil and remove the capsule.

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

Changing anticoagulant medicine

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

Taking a higher dose of Sianta than recommended

Taking too much Sianta increases the risk of bleeding. If the patient has taken too many Sianta capsules, they should contact their doctor immediately. There are specific treatment methods available.

Missing a dose of Sianta

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, the missed dose should not be taken. A double dose should not be taken to make up for a missed dose.

Stopping Sianta

Sianta should be taken as instructed by the doctor. The patient should not stop taking this medicine without consulting their doctor first, as the risk of blood clots may be higher if treatment is stopped too early.

The patient should contact their doctor if they experience indigestion after taking Sianta.

If the patient has any further doubts about taking this medicine, they should consult their 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 may occur, which is the most serious side effect and can lead to disability, be life-threatening, or even fatal, regardless of the location.

In some cases, these bleedings may not be visible.

If bleeding occurs that does not stop on its own or symptoms of excessive bleeding (exceptional weakness, fatigue, pallor, dizziness, headache, or unexplained swelling) occur, the patient should contact their doctor immediately. The doctor may decide to monitor the patient closely or change the medicine.

If a severe allergic reaction occurs that can cause difficulty breathing or dizziness, the patient should contact their doctor immediately.

The following side effects are listed according to their frequency:

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 that is 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, the rectum, or the brain
• Hematoma formation
• Coughing up blood or sputum that is blood-stained
• 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 ulcers (including esophageal ulcers)
• Esophagitis or gastritis
• Gastroesophageal reflux disease
• Vomiting
• Difficulty swallowing
• Abnormal liver function test results

Rare (may affect up to 1 in 1,000 people)

• Bleeding may occur into a joint, from a surgical wound, from an injury, from an injection site, or from a catheter insertion site
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing facial or throat swelling
• Skin rash in the form of dark red, raised, itchy bumps due to an allergic reaction
• Decreased red blood cell count
• Increased liver enzyme activity
• Jaundice 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

In clinical trials, the number of heart attacks in patients taking dabigatran etexilate was higher than in patients taking warfarin. The overall number of events was small.

Treating blood clots in the legs and lungs and preventing repeated 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/vagina, or from the urinary tract (including urine that is 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 a joint or due to injury
• Bleeding may occur from hematomas
• Decreased red blood cell count
• Hematoma formation
• Coughing up blood or sputum that is blood-stained
• Allergic reaction
• Sudden change in skin color or appearance
• Itching
• Stomach or intestinal ulcers (including esophageal ulcers)
• 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 1,000 people)

• Bleeding may occur from a surgical wound, from an injection site, or from a 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 in the form of dark red, raised, itchy bumps 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 red blood cell count
• Decreased white blood cell count (which helps fight infections)
• Jaundice of the skin or whites of the eyes due to liver or blood disease
• Hair loss

Treating blood clots and preventing repeated blood clots in children

Common (may affect up to 1 in 10 people)

• Decreased red blood cell count
• Decreased platelet count
• Skin rash in the form of dark red, raised, itchy bumps due to an allergic reaction
• Sudden change in skin color or appearance
• Hematoma formation
• 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/vagina, or from the urinary tract (including urine that is 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 red blood cell count
• Itching
• Coughing up blood or sputum that is blood-stained
• Abdominal pain or stomach pain
• Esophagitis or gastritis
• Allergic reaction
• Difficulty swallowing
• Jaundice 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 helps 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 a joint, from a wound, from a surgical wound, from an injection site, or from a catheter insertion site, or bleeding from hematomas
• Stomach or intestinal ulcers (including esophageal ulcers)
• Abnormal liver function test results

Reporting side effects

If side effects occur, including any not listed in this leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych

Al. Jerozolimskie 181C, 02-222 Warsaw

Tel.: +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

The medicine should be stored out of sight and reach of children.

Do not use this medicine after the expiry date stated on the carton or blister after "EXP".

The expiry date refers to the last day of the month stated.

Do not store above 30°C.

Store in the original packaging to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Sianta contains

The active substance of Sianta is dabigatran. Each hard capsule contains 172.95 mg of dabigatran etexilate mesylate, equivalent to 150 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 150 mg are white to pale yellow pellets in hard capsules with a blue cap and a white to pale white body, size 0.

The medicine is available in packs containing 10 x 1, 30 x 1, or 60 x 1 hard capsules in perforated unit dose blisters of aluminum/OPA/aluminum/PVC.

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 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, the patient should contact the local representative of the marketing authorization holder:

EGIS Polska Sp. z o.o.

ul. Komitetu Obrony Robotników 45D

02-146 Warsaw

Tel.: +48 22 417 92 00

The medicine is authorized in European Economic Area member states 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

Date of last revision of the leaflet:

Detailed information on this medicine is available on the website of Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych

https://rejestrymedyczne.ezdrowie.gov.pl/