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Package leaflet: Information for the patient

Wasedoc, 110 mg, hard capsules
dabigatran etexilate
Please read the entire leaflet carefully before taking this medicine, because it contains
important information for the patient.

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

Table of contents of the leaflet

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

1. What Wasedoc is and what it is used for

Wasedoc 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 responsible for blood clot formation.
Wasedoc is used in adults to:

prevent the formation of blood clots in the veins following hip or knee replacement surgery.
prevent the formation of blood clots in the brain (stroke) and in other blood vessels in the body in patients who have a type of irregular heartbeat called non-valvular atrial fibrillation and at least one additional risk factor.
treat blood clots in the legs and lungs and to prevent recurrence of such clots.

Wasedoc is used in children to:

treat blood clots and to prevent recurrence of blood clots.

2. Important information before taking Wasedoc

When not to take Wasedoc

if the patient is allergic to dabigatran etexilate or any of the other ingredients of this medicine (listed in section 6).

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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 via the catheter to maintain its patency, or during a procedure called catheter ablation for 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 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 Wasedoc, discuss this with your doctor. If symptoms occur or the
patient has undergone surgery while taking this medicine, 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 those listed below:

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 oesophagus or stomach.
if the patient has gastro-oesophageal reflux (acid reflux into the oesophagus).
if the patient is taking medicines that may increase the risk of bleeding. See below “Wasedoc and other medicines”.
if the patient is taking anti-inflammatory medicines such as diclofenac, ibuprofen, piroxicam.
if the patient has an infection in or around the heart (bacterial endocarditis).
if the patient has reduced kidney function or is dehydrated (feeling thirsty and passing reduced amounts of dark [concentrated] 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.

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if the patient has previously had a 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 Wasedoc

if the patient needs to undergo surgery: In such cases, temporary discontinuation of Wasedoc is necessary due to the increased risk of bleeding during and immediately after surgery. It is very important to take Wasedoc exactly as directed by the doctor before and after surgery.

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if the surgical procedure requires insertion of a catheter or injection into the spine (e.g. for epidural or spinal anaesthesia or for pain relief):
it is very important to take Wasedoc exactly as directed by the doctor 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 anaesthesia wears off, as urgent medical care is required.
if the patient falls or sustains an injury during treatment, especially if the head is injured. Immediate medical attention should be sought. The doctor will assess whether the patient may have an increased risk of bleeding.
if the patient has a condition called antiphospholipid syndrome (an immune system disorder causing an increased risk of blood clots), the patient should inform the doctor, who will decide whether a change in treatment is necessary.

Wasedoc 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 Wasedoc, tell the 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, itraconazole), unless these medicines are used only on the skin
Medicines used to treat heart rhythm disorders (e.g. amiodarone, dronedarone, quinidine, verapamil)
In patients taking medicines containing amiodarone, quinidine or verapamil, the doctor may recommend a lower dose of Wasedoc depending on the condition for which the medicine was prescribed. See 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 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 Wasedoc has on pregnancy or on the unborn child. This medicine
should not be taken during pregnancy unless the doctor determines it is safe.
Women of childbearing age should avoid becoming pregnant while taking Wasedoc.
Breastfeeding is not recommended while taking Wasedoc.
Driving and operating machinery
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Wasedoc has no effect or has a negligible effect on the ability to drive and operate machinery.
Wasedoc contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, meaning the medicine is considered "sodium-free".

3. How to take Wasedoc

Wasedoc capsules can be used in adults and children aged 8 years or older who are able to swallow capsules whole. Other age-appropriate pharmaceutical forms are available for treating children under 8 years of age.
This medicine should always be taken as directed by the physician. In case of doubt, consult your doctor.
Wasedoc should be taken as follows:

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).
Patients taking medicines containing verapamil, who also have reduced renal function by more than half, should take a reduced dose of 75 mg of Wasedoc due to an increased risk of bleeding.

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

After knee replacement surgery
Initiate Wasedoc treatment by taking one capsule within 1 to 4 hours after completion of surgery. Then take two capsules once daily for a total of 10 days.

After hip replacement surgery
Initiate Wasedoc treatment by taking one capsule within 1 to 4 hours after completion of surgery. Then take two capsules once daily for a total of 28 to 35 days.

Prevention of thromboembolism in blood vessels of the brain and body by preventing clot formation due to abnormal heart function, and treatment and prevention of recurrent blood clots in the veins of the legs and lungs
The recommended dose is 300 mg taken as one 150 mg capsule twice daily.
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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 Wasedoc at the reduced dose of 220 mg taken as one 110 mg capsule twice daily due to a possible increased risk of bleeding.
In patients with potentially increased risk of bleeding, the physician may recommend treatment with Wasedoc at 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. Wasedoc should be taken as directed by the physician.

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 Wasedoc after the physician confirms adequate control of blood coagulation. Wasedoc should be taken as directed by the physician.

Treatment and prevention of recurrent blood clots in children
Wasedoc 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 physician will determine the correct dose and may adjust it during treatment. All other medications should be continued unless otherwise advised by the physician.

Table 1 shows the single and total daily doses of Wasedoc in milligrams (mg). Doses depend on the patient's body weight in kilograms (kg) and age in years.
Table 1: Dosing table for Wasedoc 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
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260 mg: one 110 mg capsule and one 150 mg capsule or
one 110 mg capsule and two 75 mg capsules
220 mg: as two 110 mg capsules
185 mg: as one 75 mg capsule and one 110 mg capsule
150 mg: as one 150 mg capsule or two 75 mg capsules

How to take Wasedoc
Wasedoc 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.

Changing anticoagulant therapy
Do not change anticoagulant medication without receiving specific instructions from your doctor.

Taking more Wasedoc than prescribed
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 Wasedoc
Prevention of blood clots after surgery (joint replacement) of the hip or knee
Continue taking the missed daily dose of Wasedoc at the usual time on the following day. Do not take a double dose to make up for a missed dose.

Use in adults: Prevention of thromboembolism in blood vessels of the brain and body by preventing formation of blood clots caused by abnormal heart function, and treatment of blood clots in the veins of the legs and lungs, as well as prevention of recurrence of such clots.
Use in children: Treatment of blood clots and prevention of recurrent blood clots.

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 Wasedoc
Wasedoc should be taken as directed by the 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 indigestion after taking Wasedoc.

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.
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Wasedoc affects the blood clotting system; therefore, most adverse effects relate 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 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 affect up to 1 in 10 people):

Decrease in haemoglobin levels in the blood (a 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/vagina or urinary tract (including pink or red urine due to presence of blood), from haemorrhoids, from the rectum, under the skin, into a joint, following injury or trauma, or after a surgical procedure
Formation of haematomas or bruises occurring after a surgical procedure
Blood in stool detected in laboratory tests
Decrease in the number of red blood cells in the blood
Decrease in blood cell count
Allergic reaction
Vomiting
Frequent passage of loose or watery stools
Nausea
Presence of discharge from the wound (fluid oozing from the surgical wound)
Increased liver enzyme activity
Yellowing of the skin or whites of the eyes caused by liver or blood disease

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

Bleeding
Bleeding may occur into the brain, from the surgical incision site, from the injection site, or from the site where a venous catheter was inserted
Blood-tinged discharge from the site where a venous catheter was inserted
Coughing up blood or blood-tinged sputum
Decrease in the number of platelets in the blood
Decrease in the number of red blood cells in the blood after a surgical procedure
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
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
Discharge of fluid from the wound
Discharge of fluid from the surgical wound

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

Prevention of thromboembolic events in the brain and body by preventing clot formation due to abnormal heart function
Common (may affect 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 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 affect up to 1 in 100 people):

Bleeding
Bleeding may occur from haemorrhoids, from the rectum, or into the brain
Formation of haematomas
Coughing up blood or blood-tinged 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 affect up to 1 in 1,000 people):

Bleeding may occur into a joint, from the surgical incision site, from a wound, from the injection site, or from the site where a venous catheter was inserted
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
Increased liver enzyme activity
Yellowing of the skin or whites of the eyes caused by liver or blood disease

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 clinical studies, the number of heart attacks with Wasedoc was numerically higher than with warfarin. The overall number of events was low.
Treatment of blood clots in the legs and lungs and prevention of recurrence of blood clots in the legs and (or) lungs
Common (may affect 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 under the skin
Indigestion

Uncommon (may affect 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 haematomas
Coughing up blood or blood-tinged 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
Increased liver enzyme activity

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

Bleeding may occur from the surgical incision site, from the injection site, from the site where a venous catheter was inserted, or from 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

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 caused by liver or blood disease
Hair loss

In clinical studies, the number of heart attacks with Wasedoc was numerically higher than with warfarin. The overall number of events was low. No difference in the number of heart attacks was observed between patients treated with dabigatran and patients receiving placebo.
Treatment of blood clots and prevention of recurrent blood clots in children
Common (may affect 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 haematomas
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 affect 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 presence of blood), or 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 blood-tinged 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 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 the surgical incision site, from the injection site, or from the site where a venous catheter was inserted
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, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 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 Wasedoc

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack after:
"EXP". The expiry date refers to the last day of the stated month.
Blister pack: This medicine requires no special storage conditions. Do not transfer the capsules to
pill boxes or medication organizers if they cannot be stored in their original packaging.
Medicines must not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Wasedoc contains

The active substance is dabigatran. Each hard capsule contains 110 mg of dabigatran etexilate (as mesilate).
The other components are: microcrystalline cellulose, sodium croscarmellose, crospovidone (type A), tartaric acid (in the form of pellets), hydroxypropylcellulose (470 cp), mannitol, talc and magnesium stearate.
The capsule shell contains iron oxide red (E 172), titanium dioxide and hypromellose.
The black printing ink contains shellac, propylene glycol, concentrated ammonium hydroxide, iron oxide black (E 172) and potassium hydroxide.

What Wasedoc looks like and contents of the pack
Wasedoc is a hard capsule.
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Wasedoc 110 mg is an opaque, pink hard capsule printed with "DA110".
Wasedoc 110 mg is available in packs containing 30 or 60 hard capsules
or in multipacks containing 3 packs of 60 hard capsules each (180
hard capsules) in perforated aluminium/OPA/aluminium/PE blisters with a desiccant,
in a cardboard carton.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Ranbaxy (Poland) Sp. z o.o.
ul. Idzikowskiego 16
00-710 Warszawa
Importer
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park
Paola, PLA 3000
Malta
TOWA PHARMACEUTICAL EUROPE, S.L.
C/ de Sant Martí, 75-97
08107 Martorelles (Barcelona)
Spain
Terapia S.A.
Str. Fabricii nr. 124
400632, Cluj-Napoca
Romania

This medicinal product is authorised in the European Economic Area and in the United Kingdom (Northern Ireland)
under the following brand names:
Romania: Wasedoc
Portugal: Wasedoc