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 the formation of blood clots.

Wasedoc is used in adults to:

• prevent the formation of blood clots in the brain (stroke) and other blood vessels in the patient's body, if the patient has a form of irregular heart rhythm called atrial fibrillation not associated with a heart valve defect 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).
• if you have severe kidney impairment.
• 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, brain injury or bleeding into the brain, recent brain or eye surgery).

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ryzyko dużego krwawienia (np. choroba wrzodowa żołądka, uraz mózgu lub krwawienie
do mózgu, niedawno przebyta operacja mózgu lub oczu).

• if you have an increased tendency to bleeding. It may be congenital, 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 changing 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 impairment 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.
• if you have been fitted with an artificial heart valve that requires continuous anticoagulation.

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.

The patient should inform the doctorif they 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 experienced bleeding.
• if you have undergone 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 reduced kidney function or are dehydrated (feeling thirsty and passing less urine than usual).
• 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.
• in the case of a history of myocardial infarction or if the patient has been diagnosed with conditions that increase the risk of myocardial infarction.

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• if you have liver disease that affects blood test results. In this case, the use of this medicine is not recommended.

When to be particularly careful when taking Wasedoc

• if you need to undergo surgery: In this case, it is necessary to discontinue the use of Wasedoc due to the increased risk of bleeding during and after surgery. It is very important to take Wasedoc before and after surgery exactly as prescribed by your doctor.
• if the surgical procedure requires the insertion of a catheter or injection into the spine (e.g. for spinal or epidural anesthesia or to relieve pain):
• it is very important to take Wasedoc before and after surgery exactly as prescribed by your doctor.
• you should immediately inform your doctor if you experience numbness or weakness of the lower limbs or problems with the intestines 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. The 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 the treatment.

Wasedoc and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

In particular, before taking Wasedoc, you should tell your doctor if you are taking any of the following medicines:

• anticoagulant medicines (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)
• if you are taking medicines containing verapamil, your 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 organ rejection (e.g. tacrolimus, cyclosporine)
• a combination medicine containing glecaprevir and pibrentasvir (an antiviral medicine used to treat hepatitis C)
• anti-inflammatory and pain-relieving medicines (e.g. acetylsalicylic acid, 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)

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• certain medicines used to treat epilepsy (e.g. carbamazepine, phenytoin)

Pregnancy and breastfeeding

The effect of Wasedoc on pregnancy and the unborn child is not known. You should not take this medicine during pregnancy, unless your doctor considers it safe.

Women of childbearing age should avoid becoming pregnant while taking Wasedoc.

You should not breastfeed while taking Wasedoc.

Driving and using machines

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 that 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 pharmaceutical forms for the treatment of children under 8 years of age.

This medicine should always be taken exactly as prescribed by your doctor. If you are unsure, you should consult your doctor.

You should take Wasedoc as follows:

Prevention of blood clots in the brain and body, by preventing the formation of clots that occur during abnormal heart function, 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 one 150 mg capsule twice a day.

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

Patient taking medicines containing verapamilshould receive a reduced dose of Wasedoc, 220 mg taken as one 110 mg capsule twice a day, due to the possible increased risk of bleeding.

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

Treatment can be continued if the patient needs to restore normal heart function using a procedure called cardioversion or using a procedure called catheter ablation in atrial fibrillation. Wasedoc should be taken as prescribed by your doctor.

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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. Wasedoc should be taken as prescribed 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 every day. The interval between doses should be approximately 12 hours.

The recommended dose depends on body weight and age. The doctor will determine the correct dose. The doctor may adjust the dose during treatment. You should continue to take all other medicines, unless your doctor advises you to stop taking any of 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 requiring the combination of more than one capsule:

300 mg:

two 150 mg capsules or four 75 mg capsules

260 mg:

one 110 mg capsule and one 150 mg capsule or

one 110 mg capsule and two 75 mg capsules

220 mg:

two 110 mg capsules

185 mg:

one 75 mg capsule and one 110 mg capsule

150 mg:

one 150 mg capsule or two 75 mg capsules

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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 spilled 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 Wasedoc capsules, you should immediately contact your doctor. There are specific treatments available.

Missing a dose of Wasedoc

A missed dose can be taken up to 6 hours before the next scheduled dose.

If there are less than 6 hours until the next scheduled dose, you should not take the missed dose. You should not take a double dose to make up for a missed dose.

Stopping treatment with Wasedoc

Wasedoc should be taken as prescribed by your doctor. You should not stop taking this medicine without consulting your doctor first, as the risk of blood clot formation may be higher if treatment is stopped prematurely. You should contact your doctor if you experience nausea after taking Wasedoc.

If you have any further questions about 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.

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 bleeding events may not be visible.

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

If you experience a severe allergic reaction that can cause breathing difficulties or dizziness, you should immediately contact your doctor.

The following side effects are grouped by frequency:

Prevention of blood clots in the brain and body, by preventing the formation of clots that occur during abnormal heart function

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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 urine discolored pink or red due to the presence of blood), or bleeding under the skin
• Decreased red blood cell count
• Abdominal pain or stomach pain
• Nausea
• Frequent passage of loose or liquid stools
• Vomiting

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

• Bleeding
• Bleeding may occur from hematomas, from the rectum or into the brain
• Hematoma formation
• Coughing up blood or sputum discolored with blood
• Decreased platelet count
• Decreased hemoglobin levels in the blood (a substance in red blood cells)
• Allergic reaction
• Sudden change in skin color or appearance
• Itching
• Stomach or intestinal ulcer (including esophageal ulceration)
• Esophagitis and gastritis
• Gastroesophageal reflux disease
• Vomiting
• Difficulty swallowing
• Abnormal liver function test results

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

• Bleeding may occur into a joint, from a surgical wound, from a wound, from an injection site or from a catheter insertion site
• 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 caused by an allergic reaction
• Decreased white blood cell count
• Increased liver enzyme activity
• Jaundice of the skin or whites of the eyes caused by liver or blood disease

Unknown frequency (cannot be estimated from the available data):

• Breathing difficulties or wheezing
• Decreased 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 low.

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

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

• Bleeding may occur from the nose, into the stomach or intestines, from the rectum, from the penis/vagina or urinary tract (including urine discolored pink or red due to the presence of blood), or bleeding under the skin
• Nausea

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

• Bleeding
• Bleeding may occur into a joint or due to injury
• Bleeding may occur from hematomas
• Decreased red blood cell count
• Hematoma formation
• Coughing up blood or sputum discolored with blood
• Allergic reaction
• Sudden change in skin color or appearance
• Itching
• Stomach or intestinal ulcer (including esophageal ulceration)
• Esophagitis and gastritis
• Gastroesophageal reflux disease
• Nausea
• Vomiting
• Abdominal pain or stomach pain
• Frequent passage of loose or liquid stools
• Abnormal liver function test results
• Increased liver enzyme activity

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

• Bleeding may occur from a surgical wound, from an injection site or from a catheter insertion site, or bleeding into the brain
• Decreased platelet count
• Severe allergic reaction causing breathing difficulties or dizziness
• Severe allergic reaction causing facial or throat swelling
• Skin rash in the form of dark red, raised, itchy bumps caused by an allergic reaction
• Difficulty swallowing

Unknown frequency (cannot be estimated from the available data):

• Breathing difficulties or wheezing
• Decreased hemoglobin levels in the blood (a substance in red blood cells)
• Decreased red blood cell count
• Decreased white blood cell count (which help fight infections)
• Jaundice of the skin or whites of the eyes caused by 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):

• Decreased red blood cell count
• Decreased platelet count
• Skin rash in the form of dark red, raised, itchy bumps caused by an allergic reaction
• Sudden change in skin color or appearance
• Hematoma formation
• Nosebleeds
• Gastroesophageal reflux disease
• Vomiting
• Nausea
• Frequent passage of loose or liquid stools
• Nausea
• Hair loss
• Increased liver enzyme activity

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

• Decreased white blood cell count (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 urine discolored pink or red due to the presence of blood), or bleeding under the skin
• Decreased hemoglobin levels in the blood (a substance in red blood cells)
• Decreased red blood cell count
• Itching
• Coughing up blood or sputum discolored with blood
• Abdominal pain or stomach pain
• Esophagitis and gastritis
• Allergic reaction
• Difficulty swallowing
• Jaundice of the skin or whites of the eyes caused by liver or blood disease

Unknown 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
• Bleeding may occur into a joint, from a wound, from a surgical wound, from an injection site or from a catheter insertion site
• 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 Monitoring 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

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 stated.

Blister: The medicine does not require special storage conditions. The capsules should not be placed in pill boxes or pill organizers unless they can be stored in their original packaging.

Medicines should not be disposed of via wastewater. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Wasedoc contains

• The active substance of Wasedoc is dabigatran. Each hard capsule contains 150 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, black iron oxide (E 172) and potassium hydroxide.

What Wasedoc looks like and contents of the pack

Wasedoc is a hard capsule.

Wasedoc, 150 mg is a non-transparent, pink hard capsule with the imprint "DA150".

Wasedoc, 150 mg is available in packs containing 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