Vasedoc

1. What is Wasedoc and what is it used for

Wasedoc 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.
Wasedoc is used in adults to:

• prevent the formation of blood clots in the veins after hip or knee replacement surgery.
• prevent the formation of blood clots in the brain (stroke) and other blood vessels in the patient's body, if the patient has a type of irregular heartbeat called atrial fibrillation not caused by a heart valve problem and at least one additional risk factor.
• treat blood clots in the veins of the legs and lungs and prevent the recurrence of blood clots in the veins of the legs and lungs.

Wasedoc is used in children to:

• treat blood clots and prevent the recurrence of blood clots.

2. Important information before taking Wasedoc

When not to take Wasedoc

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

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• if you have severe kidney problems.
• if you are currently bleeding.
• if you have a disease of any internal organ that increases the risk of major bleeding (e.g. stomach ulcer disease, brain injury or bleeding into the brain, recent brain or eye surgery).
• if you have an increased tendency to bleed. This may be inherited, of unknown cause or caused by the use of other medicines.
• if you are taking anticoagulant medicines (e.g. warfarin, rivaroxaban, apixaban or heparin), except when switching anticoagulant treatment, introducing a catheter into a vein or artery, when heparin is administered to the catheter to maintain its patency or when restoring normal heart function using a procedure called catheter ablation in atrial fibrillation.
• if you have severe liver problems or liver disease that may lead to death.
• if you are taking oral ketoconazole or itraconazole, medicines used to treat fungal infections.
• if you are taking oral cyclosporine, a medicine used to prevent organ rejection.
• if you are taking dronedarone, a medicine used to treat heart rhythm disorders.
• if you are taking a combination medicine containing glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C virus infection.
• if you have a heart valve prosthesis that requires continuous anticoagulant treatment.

Warnings and precautions

Before starting treatment with Wasedoc, you should discuss it with your doctor. If you have experienced symptoms or undergone surgery during treatment with this medicine, you should consult your doctor.
You should inform your doctorif you have or have had any medical conditions or diseases, especially those listed below:

• if you have an increased risk of bleeding, such as:
• if you have recently had bleeding.
• if you have had a surgical biopsy within the last month.
• if you have had a serious injury (e.g. bone fracture, head injury or any injury requiring surgical treatment).
• if you have esophagitis or gastritis.
• if you have gastroesophageal reflux disease.
• if you are taking medicines that may increase the risk of bleeding. See "Wasedoc and other medicines" below.
• if you are taking anti-inflammatory medicines, such as diclofenac, ibuprofen, piroxicam.
• if you have infective endocarditis (bacterial infection of the heart).
• if you have decreased kidney function or are dehydrated (feeling thirsty and producing a small amount of dark, concentrated urine).
• if you are over 75 years old.
• if you are an adult and weigh 50 kg or less.
• only in the case of use in children: if the child has an infection around or in the brain.

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• if you have had a heart attack or have been diagnosed with conditions that increase the risk of heart attack.
• if you have liver disease that affects blood test results. In this case, the use of this medicine is not recommended.

When to exercise special caution when taking Wasedoc

• if you need to undergo surgery: In this case, it is necessary to discontinue Wasedoc treatment due to the increased risk of bleeding during and after surgery. It is very important to take Wasedoc before and after surgery exactly as your doctor has instructed.

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

Wasedoc and other medicines

You should tell your doctor or pharmacist about all medicines you are taking, have recently taken or might take, including those you have bought without a prescription.
In particular, before taking Wasedoc, you should tell your doctor if you are taking any of the following medicines:

• medicines that prevent blood clotting (e.g. warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, aspirin)
• medicines used to treat fungal infections (e.g. ketoconazole, itraconazole), unless they are used only on the skin
• medicines used to treat heart rhythm disorders (e.g. amiodarone, dronedarone, quinidine, verapamil)
• if you are taking medicines containing amiodarone, quinidine or verapamil, your doctor may recommend a lower dose of Wasedoc, 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 virus infection)
• 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

It is not known what effect Wasedoc has on pregnancy and the unborn child. You should not take this medicine during pregnancy unless your doctor considers it necessary.
Women of childbearing age should avoid becoming pregnant while taking Wasedoc.
You should not breastfeed while taking Wasedoc.

Driving and using machines

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Wasedoc has no or negligible influence on the ability to drive and use machines.

Wasedoc contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means it is essentially 'sodium-free'.

3. How to take Wasedoc

Wasedoc capsules can be used in adults and children aged 8 years or older who can swallow the capsules whole. There are other age-appropriate formulations for the treatment of children under 8 years of age.
This medicine should always be taken exactly as your doctor has instructed. If you are unsure, you should ask your doctor.

You should take Wasedoc as follows:

Prevention of blood clots after hip or knee replacement surgery (arthroplasty)
The recommended dose is 220 mg once a day (taken as 2 capsules of 110 mg each).
If kidney function is severely reduced or if you are over 75 years old, the recommended dose is 150 mg once a day (taken as 2 capsules of 75 mg each).
If you are taking medicines containing amiodarone, quinidine or verapamil, the recommended dose is 150 mg once a day (taken as 2 capsules of 75 mg each).
Patients taking medicines containing verapamil, with severely reduced kidney function, should take a reduced dose of 75 mg of Wasedoc due to the increased risk of bleeding.
In both types of surgery, treatment should not be started if there is bleeding from the surgical site. If it is not possible to start treatment the day after surgery, it should be started with a dose of 2 capsules once a day.
After knee replacement surgery
Wasedoc treatment should be started with a dose of 1 capsule within 1 to 4 hours after the end of surgery. Then, 2 capsules should be taken once a day for a total of 10 days.
After hip replacement surgery
Wasedoc treatment should be started with a dose of 1 capsule within 1 to 4 hours after the end of surgery. Then, 2 capsules should be taken once a day for a total of 28 to 35 days.
Prevention of blood clots in the brain and body, by preventing the formation of clots that occur during irregular heartbeats, and treatment of blood clots in the veins of the legs and lungs and prevention of recurrence of blood clots in the veins of the legs and lungs
The recommended dose is 300 mg taken as 1 capsule of 150 mg twice a day.
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In patients over 80 years old, the recommended dose is 220 mg taken as 1 capsule of 110 mg twice a day.
Patients taking medicines containing verapamil should receive a reduced dose of 220 mg of Wasedoc taken as 1 capsule of 110 mg twice a day due to the increased risk of bleeding.
In patients with potentially increased risk of bleeding, your doctor may recommend a dose of 220 mg of Wasedoc taken as 1 capsule of 110 mg twice a day.
Treatment with this medicine can be continued if there is a need to restore normal heart function using a procedure called cardioversion. You should take Wasedoc as instructed by your 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 Wasedoc, after the doctor has confirmed that adequate blood clotting control has been achieved. You should take Wasedoc as instructed by your doctor.
Treatment of blood clots and prevention of recurrence of blood clots in children
Wasedoc should be taken twice a day, one dose in the morning and one dose in the evening, at approximately the same time each day. The interval between doses should be approximately 12 hours.
The recommended dose depends on body weight and age. Your doctor will determine the correct dose. Your doctor may adjust the dose during treatment. You should continue to take all other medicines unless your doctor instructs you to stop taking them.
Table 1 shows the single and total daily doses of Wasedoc in milligrams (mg). The doses depend on the patient's body weight in kilograms (kg) and age in years.

Doses that require the combination of more than one capsule:
300 mg:
two capsules of 150 mg or four capsules of 75 mg
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260 mg:
one capsule of 110 mg and one capsule of 150 mg or
one capsule of 110 mg and two capsules of 75 mg
220 mg:
two capsules of 110 mg
185 mg:
one capsule of 75 mg and one capsule of 110 mg
150 mg:
one capsule of 150 mg or two capsules of 75 mg

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.
They should not be broken, chewed or the pellets emptied from the capsule, as this may increase the risk of bleeding.

Changing anticoagulant medicine

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

Taking a higher dose of Wasedoc than recommended

Taking too much of this medicine increases the risk of bleeding. If you have taken too many capsules, you should immediately contact your doctor. There are specific treatments available.

Missing a dose of Wasedoc

Prevention of blood clots after hip or knee replacement surgery (arthroplasty)
Continue taking the missed daily dose of Wasedoc at the same time the next day. Do not take a double dose to make up for the missed dose.
Use in adults: Prevention of blood clots in the brain and body, by preventing the formation of clots that occur during irregular heartbeats, and treatment of blood clots in the veins of the legs and lungs and prevention of recurrence of blood clots in the veins of the legs and lungs
Use in children: Treatment of blood clots and prevention of recurrence of blood clots.
A missed dose can be taken up to 6 hours before the next scheduled dose.
If there are less than 6 hours before the next scheduled dose, do not take the missed dose. Do not take a double dose to make up for the missed dose.

Stopping treatment with Wasedoc

Wasedoc should be taken as instructed by your doctor. You should not stop taking this medicine without first consulting your doctor, as the risk of blood clot formation may be higher if treatment is stopped prematurely. You should contact your doctor if you experience indigestion after taking Wasedoc.
If you have any further questions on the use of this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
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Wasedoc 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.
In case of bleeding that does not stop by itself, or symptoms of excessive bleeding (exceptional weakness, fatigue, pallor, dizziness, headache or unexplained swelling), you should immediately contact your doctor. Your doctor may decide to closely monitor you or change your medicine.
In case of a severe allergic reaction that can cause breathing difficulties or dizziness, you should immediately contact your doctor.
Side effects are listed below by frequency:

• Common (may affect up to 1 in 10 people):
• decrease in hemoglobin 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 urine discolored pink or red due to the presence of blood), or bleeding under the skin
• formation of hematomas or bruising after surgery
• blood in the stool, as detected by laboratory tests
• decrease in red blood cell count
• decrease in hematocrit
• allergic reaction
• vomiting
• diarrhea
• nausea
• wound secretion
• wound secretion after surgery
• increase in liver enzyme activity
• jaundice of the skin or eyes due to liver or blood disease

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

• bleeding
• bleeding may occur into the brain, from the surgical site, from the injection site or from the catheter insertion site
• bleeding from the catheter insertion site into a vein
• coughing up blood or sputum discolored with blood
• decrease in platelet count
• decrease in red blood cell count after surgery
• severe allergic reaction causing breathing difficulties 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
• sudden change in skin color or appearance

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• itching
• stomach or intestinal ulcer (including esophageal ulceration)
• esophagitis or gastritis
• gastroesophageal reflux disease
• abdominal pain or stomach pain
• indigestion
• difficulty swallowing
• wound secretion
• wound secretion after surgery

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

• breathing difficulties or wheezing
• decrease in white blood cell count (which help fight infections)
• hair loss

In clinical trials, the number of heart attacks in patients taking Wasedoc was higher than in patients taking warfarin. The overall number of events was small.
Treatment of blood clots in the veins of the legs and lungs and prevention of recurrence of blood clots in the veins of 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 anus, from the penis/vagina or urinary tract (including urine discolored 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
• decrease in red blood cell count
• formation of hematomas
• coughing up blood or sputum discolored with blood
• allergic reaction
• sudden change in skin color or appearance
• itching
• stomach or intestinal ulcer (including esophageal ulceration)
• esophagitis or gastritis
• gastroesophageal reflux disease
• nausea
• vomiting
• abdominal pain or stomach pain
• diarrhea
• abnormal liver function test results
• increase in liver enzyme activity

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

• bleeding may occur from the surgical site, from the injection site or from the catheter insertion site into a vein or bleeding into the brain
• decrease in platelet count
• severe allergic reaction causing breathing difficulties 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):

• breathing difficulties or wheezing
• decrease in hemoglobin levels in the blood (a substance in red blood cells)
• decrease in hematocrit
• decrease in white blood cell count (which help fight infections)
• jaundice of the skin or eyes due to liver or blood disease
• hair loss

In clinical trials, the number of heart attacks in patients taking Wasedoc was higher than in patients taking warfarin. The overall number of events 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 affect up to 1 in 10 people):

• decrease in red blood cell count
• decrease in 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
• formation of hematomas
• bleeding from the nose
• gastroesophageal reflux disease
• vomiting
• nausea
• diarrhea
• indigestion
• hair loss
• increase in liver enzyme activity

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

• decrease in white blood cell count (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 urine discolored pink or red due to the presence of blood), or bleeding under the skin
• decrease in hemoglobin levels in the blood (a substance in red blood cells)
• decrease in hematocrit
• itching
• coughing up blood or sputum discolored with blood
• abdominal pain or stomach pain
• esophagitis or gastritis
• allergic reaction
• difficulty swallowing
• jaundice of the skin or 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 breathing difficulties or dizziness
• severe allergic reaction causing facial or throat swelling
• breathing difficulties or wheezing
• bleeding

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• bleeding may occur into a joint, from a wound, from the surgical site, from the injection site or from the catheter insertion site into a vein
• bleeding may occur from hematomas
• stomach or intestinal ulcer (including esophageal ulceration)
• abnormal liver function test results

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Aleje Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309,
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Wasedoc

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 and blister after "EXP". The expiry date refers to the last day of the month.
Blister: The medicine does not require any special storage conditions. The capsules should not be placed in pill boxes or organizers unless they can be stored in their original packaging.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines no longer required. These measures 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 mesylate).
• The other ingredients 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 red iron oxide (E 172), titanium dioxide and hypromellose.
• The black ink used for printing contains shellac, propylene glycol, concentrated ammonia solution, iron oxide black (E 172) and potassium hydroxide.

What Wasedoc looks like and contents of the pack

Wasedoc is hard capsules.
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Wasedoc 110 mg is pink, hard capsules with the imprint "DA110".
Wasedoc 110 mg is available in packs of 30 or 60 hard capsules or in multipacks containing 3 packs of 60 hard capsules (180 hard capsules) in aluminum perforated blisters Aluminum/OPA/Aluminum/PE with a desiccant, in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder

Ranbaxy (Poland) Sp. z o.o.
ul. Idzikowskiego 16
00-710 Warsaw

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 medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Romania: Wasedoc
Portugal: Wasedoc
Date of last revision of the leaflet: 04.08.2023