Dabigatran sanexcel: detailed information

Package leaflet: Information for the patient

Dabigatran SaneXcel, 150 mg, hard capsules
Dabigatranum etexilatum
Please read 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, please ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

What Dabigatran SaneXcel is and what it is used for
Important information before taking Dabigatran SaneXcel
How to take Dabigatran SaneXcel
Possible side effects
How to store Dabigatran SaneXcel
Contents of the pack and other information

1. What Dabigatran SaneXcel is and what it is used for

Dabigatran SaneXcel contains dabigatran etexilate as the active substance and belongs to a group of medicines known as anticoagulants. It works by blocking a substance in the body that is involved in blood clot formation.

Dabigatran SaneXcel is used in adults for:

preventing blood clots in the brain (stroke) and in other blood vessels in the body when a patient has a type of irregular heartbeat called non-valvular atrial fibrillation and at least one additional risk factor
treating blood clots in the veins of the legs and lungs, and preventing recurrence of such clots.

Dabigatran SaneXcel is used in children for:

treatment of blood clots and prevention of recurrence of blood clots.

2. Important information before taking Dabigatran SaneXcel

When not to take Dabigatran SaneXcel

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 that increases the risk of major bleeding (e.g. gastric ulcer, brain injury or intracranial hemorrhage, 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 where heparin is administered through the catheter to maintain its patency, or restoring normal heart rhythm using a procedure called catheter ablation in atrial fibrillation.
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 fixed-dose combination medicine containing glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C virus infection.
if the patient has an artificial heart valve implanted that requires continuous use of blood-thinning medicines.

Warnings and precautions
Before starting treatment with Dabigatran SaneXcel, discuss this with your doctor. If symptoms occur during treatment with this medicine or if the patient has undergone surgery, consult a doctor.
The patient should inform the doctor if they currently have or have had any medical conditions or diseases, especially 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 “Dabigatran SaneXcel and other medicines”.
if the patient is taking nonsteroidal anti-inflammatory drugs (NSAIDs), such as diclofenac, ibuprofen, piroxicam.
if the patient has an infection within or around the heart (bacterial endocarditis).
if the patient has reduced kidney function or the patient is dehydrated (feeling thirsty and passing reduced amounts of dark [concentrated]/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 taking Dabigatran SaneXcel

if the patient needs to undergo surgery: In such cases, temporary discontinuation of Dabigatran SaneXcel is necessary due to increased risk of bleeding during and immediately after surgery. It is very important to take Dabigatran SaneXcel exactly as directed by the doctor both before and after surgery.
if surgery requires insertion of a catheter or administration of an injection into the spine (e.g. for epidural or spinal anesthesia, or for pain relief):
it is very important to take Dabigatran SaneXcel exactly as directed by the doctor both before and after surgery.
the patient should immediately inform the doctor if numbness or weakness in the lower limbs, or problems with the bowel or bladder occur after the anesthesia wears off, as urgent medical care may be needed.
if the patient falls or injures themselves during treatment, especially if the head is injured. Immediate medical help should be sought. Medical consultation may be necessary due to increased risk of bleeding.
if the patient has 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 a change in treatment is needed.

Dabigatran SaneXcel and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. In particular, tell the doctor before taking Dabigatran SaneXcel 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, itraconazole), unless these medicines are used only topically on the skin
Medicines used to treat heart rhythm disorders (e.g. amiodarone, dronedarone, quinidine, verapamil). For patients taking medicines containing verapamil, the doctor may recommend a lower dose of Dabigatran SaneXcel depending on the condition for which the medicine was prescribed. See section 3.
Medicines used to prevent rejection of a transplanted organ (e.g. tacrolimus, cyclosporine)
Fixed-dose 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)
Some medicines used to treat epilepsy (e.g. carbamazepine, phenytoin)

Pregnancy and breastfeeding
It is not known what effect Dabigatran SaneXcel has on pregnancy or the unborn child. This medicine should not be taken during pregnancy unless the doctor determines it is safe.
Women of childbearing potential should avoid becoming pregnant while taking Dabigatran SaneXcel.
Breastfeeding is not recommended during treatment with Dabigatran SaneXcel.

Driving and using machines
The effect of Dabigatran SaneXcel on the ability to drive and operate machinery is unknown.

3. How to take Dabigatran SaneXcel

Dabigatran SaneXcel capsules can be used in adults and children aged 8 years or older who are able to swallow capsules whole.
Other medicines containing dabigatran etexilate in an age-appropriate formulation may be used in children under 12 years of age when the child is able to swallow soft foods.

This medicine should always be taken according to the doctor's instructions. If in doubt, consult your doctor.

Dabigatran SaneXcel should be taken as follows:

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.

Patients taking medicines containing verapamil should receive Dabigatran SaneXcel at a reduced dose of 220 mg taken as one 110 mg capsule twice daily due to the potential increased risk of bleeding.

In patients with potentially increased risk of bleeding, the doctor may recommend treatment with a dose of 220 mg taken as one 110 mg capsule twice daily.

Treatment with this medicine may be continued if the patient requires restoration of normal heart function through a procedure called cardioversion or through a procedure called catheter ablation for atrial fibrillation. Dabigatran SaneXcel should be taken according to the doctor's instructions.

In the case of implantation of a medical device (stent) into a blood vessel to maintain its patency using a procedure known as percutaneous coronary intervention with stent implantation, the patient may receive treatment with Dabigatran SaneXcel after the doctor has confirmed adequate control of blood coagulation. Dabigatran SaneXcel should be taken according to the doctor's instructions.

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

Dabigatran SaneXcel 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. All other medications should be continued unless the doctor advises otherwise.

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

Table 1: Dosing table for Dabigatran SaneXcel capsules

Body weight and age ranges		Single dose in mg	Total daily dose in mg
Body weight in kg	Age in years	Single dose in mg	Total daily dose in mg
from 11 to less than 13 kg	from 8 to less than 9 years	75	150
from 13 to less than 16 kg	from 8 to less than 11 years	110	220
from 16 to less than 21 kg	from 8 to less than 14 years	110	220
from 21 to less than 26 kg	from 8 to less than 16 years	150	300
from 26 to less than 31 kg	from 8 to less than 18 years	150	300
from 31 to less than 41 kg	from 8 to less than 18 years	185	370
from 41 to less than 51 kg	from 8 to less than 18 years	220	440
from 51 to less than 61 kg	from 8 to less than 18 years	260	520
from 61 to less than 71 kg	from 8 to less than 18 years	300	600
from 71 to less than 81 kg	from 8 to less than 18 years	300	600
81 kg or more	from 10 to less than 18 years	300	600

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

How to take Dabigatran SaneXcel
Dabigatran SaneXcel 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 crush, chew or empty the pellets from the capsule, as this may increase the risk of bleeding.

Instructions for opening the bottle

To open the bottle, press down and turn the cap.
After removing a capsule and taking the dose, immediately close the bottle tightly with the cap.

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

Taking more Dabigatran SaneXcel than recommended
Taking too high a dose of this medicine increases the risk of bleeding. If you have taken too many capsules, contact your doctor immediately. Specific treatment methods are available.

Missed dose of Solifenacin SaneXcel
A missed dose may be taken if there is still at least 6 hours before the next scheduled dose.
If less than 6 hours remain before 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 Dabigatran SaneXcel
Dabigatran SaneXcel should be taken as directed by your doctor. Do not stop taking this medicine without first consulting your doctor, as the risk of developing blood clots may be higher if treatment is stopped prematurely. Contact your doctor if you experience gastrointestinal discomfort after taking Dabigatran SaneXcel.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
The medicine Dabigatran SaneXcel affects the blood clotting system; therefore, most adverse reactions
involve symptoms such as bruising or bleeding. Severe or major bleeding may occur, which is the most serious adverse reaction and, regardless of location, may lead to
disability, be life-threatening, or even result in death. In some cases, such bleeding 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), 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 reactions listed below are grouped according to their frequency of occurrence.

Prevention of thromboembolic events in the brain and body by preventing the formation of 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/vagina, or urinary tract (including pink or red urine due to presence of blood), or subcutaneous bleeding
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 hemorrhoids, rectum, or into the brain
Formation of hematomas
Coughing up blood or blood-stained sputum
Decrease in the number of platelets in the blood
Decrease in hemoglobin levels in the blood (the substance in red blood cells)
Allergic reaction
Sudden change in skin color and appearance
Itching
Stomach or intestinal ulcer (including esophageal ulceration)
Inflammation of the esophagus and stomach
Regurgitation of food from the stomach into the esophagus (reflux)
Vomiting
Difficulty swallowing
Abnormal liver function test results in laboratory tests

Rare (may occur in up to 1 in 1,000 people):

Bleeding into a joint, from a surgical incision site, wound, injection site, or site of intravenous catheter insertion may occur
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
Decrease in blood cell count
Increased liver enzyme activity
Yellowing of the skin or whites of the eyes caused by liver or blood disease

Frequency not known (frequency cannot be determined from available data):

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

In clinical trials, the incidence of heart attacks with Dabigatran SaneXcel was numerically higher compared to warfarin. The overall incidence was low.

Treatment of venous thrombosis in the legs and lungs and prevention of recurrence of venous thrombosis in the legs and (or) 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 presence of blood), or subcutaneous bleeding
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 hemorrhoids
Decrease in the number of red blood cells in the blood
Formation of hematomas
Coughing up blood or blood-stained sputum
Allergic reaction
Sudden change in skin color and appearance
Itching
Stomach or intestinal ulcer (including esophageal ulceration)
Inflammation of the esophagus and stomach
Regurgitation of food from the stomach into the esophagus (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 occur in up to 1 in 1,000 people):

Bleeding may occur from a surgical incision site, injection site, 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 due to an allergic reaction
Difficulty swallowing

Frequency not known (frequency cannot be determined from available data):

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

In clinical trials, the incidence of heart attacks with Dabigatran SaneXcel was numerically higher than with warfarin. The overall incidence was low.
No difference in the number of heart attacks was observed in patients treated with dabigatran compared to patients who received placebo.

Treatment of blood clots and prevention of recurrence of 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 due to an allergic reaction
Sudden change in skin color and appearance
Formation of hematomas
Nosebleeds
Regurgitation of food from the stomach into the esophagus (reflux)
Vomiting
Nausea
Frequent passage of loose or watery stools
Indigestion
Hair loss
Increased 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 anus, from the penis/vagina or urinary tract (including pink or red urine due to presence of blood), or subcutaneous bleeding
Decrease in hemoglobin levels in the blood (the substance in red blood cells)
Decrease in blood cell count
Itching
Coughing up blood or blood-stained sputum
Abdominal pain or stomach pain
Inflammation of the esophagus and stomach
Allergic reaction
Difficulty swallowing
Yellowing of the skin or whites of the eyes caused by liver or blood disease

Frequency not known (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 hemorrhoids
Stomach or intestinal ulcer (including esophageal ulceration)
Abnormal liver function test results in laboratory tests

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Dabigatran SaneXcel

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard packaging, blister
or bottle after: EXP. The expiry date refers to the last day of the stated month.
OPA/Aluminum/PVC/Aluminum foil blister:
Store in the original packaging to protect from moisture.
Store below 30°C.
OPA/Aluminum/PE blister with desiccant/Aluminum/PE:
Store in the original packaging to protect from moisture.
No special temperature storage requirements for this medicine.
Bottle: Store in the original packaging to protect from moisture.
Store below 30°C.
After opening, the medicine should be used within 6 months.
Keep the bottle tightly closed 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. Package contents and other information

What Dabigatran SaneXcel contains

The active substance is dabigatran etexilate. Each capsule contains 150 mg of dabigatran etexilate (as dabigatran etexilate mesilate).
The other ingredients are: hydroxypropyl cellulose (E 463), talc (E 553b), tartaric acid (in the form of 600 pellets) (E 334), gum arabic (E 414).
The capsule shell contains FD&C Blue 2/Indigo Carmine, titanium dioxide (E 171), carrageenan, potassium chloride, water (5%) – target moisture content, and hypromellose 2910.
The black printing ink contains shellac (E 904), black iron oxide (E 172), and potassium hydroxide (E 525).

What Dabigatran SaneXcel looks like and contents of the pack
Dabigatran SaneXcel 150 mg is a hard capsule (length: 21.3 ± 0.7 mm, width: 7.5 ± 0.3 mm), size 0, with a light blue opaque cap and a white opaque body, printed in black with "150".
This medicine is available in cardboard boxes containing 10, 30 or 60 hard capsules in blisters made of OPA/Aluminium/PVC/Aluminium, and in blisters made of OPA/Aluminium/PE with a desiccant/Aluminium/PE, as well as in a multipack containing 3 packs of 60 hard capsules (180 hard capsules).
This medicine is also available in white high-density polyethylene (HDPE) bottles with a polypropylene (PP) cap and a moisture-absorbing agent, and in white polypropylene (PP) bottles with a low-density polyethylene (LDPE) cap and a moisture-absorbing agent, containing 60 hard capsules in cardboard boxes.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
J.J. Bishop Health a.s.
Rybná 682/14, Staré Město
110 00 Prague 1
Czech Republic
e-mail: [email protected]

Manufacturer:
Pharmathen S.A.
Dervenakion 6
153 51 Pallini, Attiki
Greece
Pharmathen International S.A.
Industrial Park Sapes Rodopi Prefecture
Building Block No 5
693 00 Rodopi
Greece

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Poland: Dabigatran SaneXcel
Czech Republic: Dabigatran etexilate SaneXcel
Slovakia: Dabigartan SaneXcel 75 mg
Dabigartan SaneXcel 110 mg
Dabigartan SaneXcel 150 mg
Bulgaria: Дабигатран SaneXcel 75 mg, 110 mg and 150 mg твърди капсули
Hungary: Dabigartan SaneXcel 75 mg kemény kapszula
Dabigartan SaneXcel 110 mg kemény kapszula
Dabigartan SaneXcel 150 mg kemény kapszula
Romania: Dabigatran etexilat SaneXcel 110 mg capsule
Dabigatran etexilat SaneXcel 150 mg capsule
Dabigatran etexilat SaneXcel 75 mg capsule