Dabigatran sanexcel

Package leaflet: Information for the patient

Dabigatran SaneXcel, 75 mg, hard capsules
Dabigatranum etexilatum
Please read this leaflet carefully before using this medicine, as it contains
important information for you.

• Keep this leaflet so that you can read it again if necessary.
• 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. It may harm other people, even if their symptoms are the same as yours.
• 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 Dabigatran SaneXcel is and what it is used for
2. Important information before taking Dabigatran SaneXcel
3. How to take Dabigatran SaneXcel
4. Possible side effects
5. How to store Dabigatran SaneXcel
6. 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 called anticoagulants. It works by blocking a substance in the body that is involved in blood clot formation.
Dabigatran SaneXcel is used in adults to:

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

Dabigatran SaneXcel is used in children to:

• treat blood clots and to prevent 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 to any of the other ingredients of this medicine (listed in section 6).

• if the patient has severe kidney 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, which may be congenital, of unknown cause, or caused by taking 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
  for which heparin is administered through the catheter to maintain patency, or during a procedure
  called catheter ablation for 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 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 ongoing anticoagulant therapy.

Warnings and precautions
Before starting treatment with Dabigatran SaneXcel, the patient should discuss this with a doctor. If symptoms occur during treatment or if the patient undergoes surgery, the patient should consult a doctor.
The patient should inform the doctor if they currently have or have had in the past 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 within the last month.
• if the patient has suffered a serious injury (e.g. bone fracture, head injury, or any trauma requiring surgical treatment).
• if the patient has inflammation of the esophagus or stomach.
• if the patient has gastroesophageal reflux (stomach acid flowing back 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 non-steroidal anti-inflammatory drugs (NSAIDs), 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 less urine, which is dark (concentrated) and/or frothy).
• 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 has conditions diagnosed to 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 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 bowel or bladder function occur after the anesthesia wears off, as urgent medical care may be needed.

• if the patient falls or sustains an injury 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 autoimmune disorder causing increased risk of blood clots), the patient should inform their doctor, who will decide whether treatment adjustment is needed.

Dabigatran SaneXcel and other medicines
The patient should inform their doctor or pharmacist about all medicines currently or recently taken, as well as any medicines they plan to take. In particular, the patient should inform the doctor before taking Dabigatran SaneXcel 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 topically to the skin
• Medicines used to treat heart rhythm disorders (e.g. amiodarone, dronedarone, quinidine, verapamil). For patients taking medicines containing amiodarone, quinidine, or verapamil, the doctor may recommend a lower dose of Dabigatran SaneXcel 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 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 (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs)
• 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 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 operating machinery
The effect of Dabigatran SaneXcel on the ability to drive or 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 exactly as prescribed by the doctor. If in doubt, consult your doctor.

Dabigatran SaneXcel should be taken according to the following instructions:

Prevention of blood clots after surgery (hip or knee replacement)
The recommended dose is 220 mg once daily (taken as 2 capsules of 110 mg each).

If renal function is 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 each).

In patients taking medications containing amiodarone, quinidine, or verapamil, the recommended dose is 150 mg once daily (taken as 2 capsules of 75 mg each).

Patients taking verapamil-containing medications who also have reduced renal function by more than half should take a reduced dose of 75 mg of Dabigatran SaneXcel due to an increased risk of bleeding.

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

After knee joint replacement surgery
Treatment with Dabigatran SaneXcel should begin with one capsule taken 1 to 4 hours after completion of the surgical procedure. Then, two capsules should be taken once daily for a total of 10 days.

After hip joint replacement surgery
Treatment with Dabigatran SaneXcel should begin with one capsule taken 1 to 4 hours after completion of the surgical procedure. Then, two capsules should be taken once daily for a total of 28 to 35 days.

Treatment and prevention of recurrence of 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 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 prescribed medications unless your doctor advises otherwise.

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

Table 1: Dosing table for Dabigatran SaneXcel capsules

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 break, 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 than the recommended dose of Dabigatran SaneXcel
Taking too high a dose of this medicine increases the risk of bleeding. If a patient has taken too many capsules, contact a doctor immediately. Specific treatment methods are available.
Missed dose of Dabigatran SaneXcel
Prevention of blood clots after surgery (hip or knee replacement)
Continue taking the missed daily dose of Dabigatran SaneXcel at the same time on the following day.
Do not take a double dose to make up for a missed dose.
Treatment and prevention of recurrent 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, do not take the missed dose.
Do not take a double dose to make up for a missed dose.
Stopping Dabigatran SaneXcel
Dabigatran SaneXcel should be taken as directed by your doctor. Do not stop taking this medicine without consulting your doctor first, as the risk of developing a blood clot 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 effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Dabigatran SaneXcel affects the blood clotting system; therefore, most adverse effects involve 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, 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 effects listed below are grouped according to their frequency of occurrence:

Prevention of blood clots after hip or knee replacement surgery

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

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

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

• Bleeding from the nose, stomach or intestines, penis/vagina or urinary tract (including pink or red urine due to presence of blood), from haemorrhoids, rectum, under the skin, into joints, following injury or after surgery
• Bruising or haematomas occurring after surgery
• Blood in stool detected in laboratory tests
• Decreased number of red blood cells in the blood
• Decreased blood cell count
• Allergic reaction
• Vomiting
• Frequent passage of loose or watery stools
• Nausea
• Discharge from wound (fluid leakage from surgical wound)
• Increased liver enzyme activity
• Yellowing of the skin or whites of the eyes due to liver or blood disease

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

• Bleeding
• Bleeding 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 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 not known (frequency cannot be estimated from the 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 occur in up to 1 in 10 people):

• Decreased number of red blood cells in the blood
• Decreased platelet count in the blood
• Skin rash consisting of dark red, raised, itchy bumps due to an allergic reaction
• Sudden change in skin colour and appearance
• Bruising
• 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 occur in up to 1 in 100 people):

• Decreased number of white blood cells (which help fight infections)
• Bleeding into the stomach or intestines, brain, rectum, penis/vagina or urinary tract (including pink or red urine due to presence of blood), or bleeding under the skin
• Decreased haemoglobin levels in the blood (a substance in red blood cells)
• Decreased blood cell count
• 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 due to liver or blood disease

Frequency not known (frequency cannot be estimated from the 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 into joints, from wounds, surgical incision sites, injection sites, or sites of intravenous catheter insertion
• Bleeding 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 this medicine.

5. How to store the medicinal product Dabigatran SaneXcel

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box, blister pack, or bottle after: EXP. The expiry date refers to the last day of the stated month.

Blister made of OPA/Aluminum/PVC/Aluminum foil:
Store in the original packaging to protect from moisture.
Store below 30°C.

Blister made of OPA/Aluminum/PE with desiccant/Aluminum/PE:
Store in the original packaging to protect from moisture.
No special storage temperature 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 the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Dabigatran SaneXcel contains

• The active substance is dabigatran etexilate. Each capsule contains 75 mg of dabigatran etexilate (as dabigatran etexilate mesylate).
• The other ingredients are: hydroxypropylcellulose (E 463), talc (E 553b), tartaric acid (in the form of 600 pellets) (E 334), arabic gum (E 414).
• The capsule shell contains titanium dioxide (E 171), carrageenan, potassium chloride, water (5%) – target moisture content, and hypromellose 2910.
• The black printing ink contains shellac (E 904), iron oxide black (E 172) and potassium hydroxide (E 525).

What Dabigatran SaneXcel looks like and contents of the pack
Dabigatran SaneXcel 75 mg is a hard capsule (measuring 17.7 ± 0.6 mm in length and 6.2 ± 0.3 mm in width), size 2, with a white opaque cap and a white opaque body, printed in black with "75".
This medicinal product 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.
This medicinal product is also available in white high-density polyethylene (HDPE) bottles with a polypropylene (PP) cap and a desiccant, and in white polypropylene (PP) bottles with a low-density polyethylene (LDPE) cap and a desiccant, 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 European Economic Area member states under the following names:
Poland: Dabigatran SaneXcel
Czech Republic: Dabigatran etexilate SaneXcel
Slovakia: Dabigatran SaneXcel 75 mg
Dabigatran SaneXcel 110 mg
Dabigatran SaneXcel 150 mg
Bulgaria: Дабигатран SaneXcel 75 mg, 110 mg and 150 mg твърди капсули
Hungary: Dabigatran SaneXcel 75 mg kemény kapszula
Dabigatran SaneXcel 110 mg kemény kapszula
Dabigatran SaneXcel 150 mg kemény kapszula
Romania: Dabigatran etexilat SaneXcel 110 mg capsule
Dabigatran etexilat SaneXcel 150 mg capsule
Dabigatran etexilat SaneXcel 75 mg capsule