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.

Wasedoc is used in children to:

• treat blood clots and prevent recurrent 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, recent brain or eye surgery).
• if you have an increased tendency to bleed. 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 maintain catheter patency or when restoring normal heart function using a procedure called catheter ablation in atrial fibrillation.

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• 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 a mechanical heart valve that requires continuous anticoagulation.

Warnings and precautions

Before starting Wasedoc, discuss it with your doctor. If you have experienced symptoms or undergone surgery during treatment with this medicine, 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 producing less 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.
• in the case of a history of myocardial infarction or if you have been diagnosed with conditions that increase the risk of myocardial infarction.
• if you have liver disease that affects blood test results. In such cases, the use of this medicine is not recommended.

When to exercise special caution when taking Wasedoc

• if you need to undergo surgery: In such cases, it is necessary to discontinue Wasedoc temporarily due to the increased risk of bleeding during and after surgery. It is very

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important to take Wasedoc before and after surgery exactly as your doctor has instructed.

• if the surgical procedure requires the insertion of a catheter or injection into the spine (e.g. for epidural or spinal anesthesia or to reduce 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 required.
• 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 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

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.
In particular, before taking Wasedoc, 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)
• For patients 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 also 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. 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

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.
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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 it is essentially "sodium-free".

3. How to take Wasedoc

Wasedoc can be used in adults and children aged 8 years or older who can swallow 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, ask your doctor.

Take Wasedoc as follows:

Prevention of blood clots after hip or knee replacement surgery (arthroplasty)
The recommended dose is 220 mg once daily(taken as 2 capsules of 110 mg).
If kidney function is reducedby more than half or if you are 75 years of age or older, the recommended dose is 150 mg once daily(taken as 2 capsules of 75 mg).
For patients taking medicines containing amiodarone, quinidine, or verapamil, the recommended dose is 150 mg once daily(taken as 2 capsules of 75 mg).
Patient taking medicines containing verapamil, with reduced kidney function, should take a reduced dose of 75 mgof Wasedoc due to increased risk of bleeding.
In both types of surgery, do not start treatment if there is bleeding from the surgical site. If it is not possible to start treatment the day after surgery, start with a dose of 2 capsules once daily.
After knee replacement surgery
Take Wasedoc starting with one capsule within 1 to 4 hours after the end of surgery. Then take 2 capsules once daily for a total of 10 days.
After hip replacement surgery
Take Wasedoc starting with one capsule within 1 to 4 hours after the end of surgery. Then take 2 capsules once daily for a total of 28 to 35 days.
Treatment of blood clots and prevention of recurrent blood clots in children
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Take Wasedoc twice daily, 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. Your doctor will determine the correct dose. Your doctor may adjust the dose during treatment. 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.
Table 1: Wasedoc dosing table in capsule form

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. Swallow the capsules whole with a glass of water to help them reach the stomach.
Do not break, chew, or empty the pellets 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, contact your doctor immediately. 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.
Treatment of blood clots and prevention of recurrent blood clots in children.
A missed dose can be taken up to 6 hours before the next scheduled dose.
If it is less than 6 hours until the next scheduled dose, do not take the missed dose.
Do not take a double dose to make up for the missed dose.

Stopping Wasedoc treatment

Wasedoc should be taken as instructed by your doctor. Do 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. Contact your doctor if you experience nausea after taking Wasedoc.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Wasedoc 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 bleedings may not be visible.
If you experience bleeding that does not stop on its own or signs of excessive bleeding (exceptional weakness, fatigue, paleness, dizziness, headache, or unexplained swelling), contact your doctor immediately. Your doctor may decide to monitor you closely or change your medicine.
If you experience a severe allergic reaction that can cause difficulty breathing or dizziness, contact your doctor immediately.
Side effects are listed below by frequency of occurrence.
Prevention of blood clots after hip or knee replacement surgery (arthroplasty)
Common (may affect up to 1 in 10 people):

• Decreased 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, stomach, or intestines, from the penis/vagina or urinary tract (including urine discoloration due to blood), from hematomas, from the rectum, bleeding under the skin, into a joint, due to injury, or after surgery
• Formation of hematomas or bruising after surgery
• Blood in the stool detected by laboratory tests
• Decreased red blood cell count
• Decreased hematocrit
• Allergic reaction
• Vomiting
• Frequent loose or liquid stools
• Nausea
• Wound secretion (oozing from the surgical wound)
• Increased liver enzyme activity
• Jaundice or yellowing of the skin and 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
• Secretion from the catheter insertion site discolored with blood
• Coughing up blood or sputum discolored with blood
• Decreased platelet count
• Decreased red blood cell count after surgery
• Severe allergic reaction causing difficulty breathing 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 and appearance
• Itching
• Stomach or intestinal ulcers (including esophageal ulcers)
• Esophagitis and gastritis
• Gastroesophageal reflux disease
• Abdominal pain or stomach pain
• Nausea
• Difficulty swallowing
• Wound secretion
• Surgical wound secretion

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

• Difficulty breathing or wheezing
• Decreased or absent white blood cell count (which helps fight infections)
• Hair loss

Treatment of blood clots and prevention of recurrent 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 due to an allergic reaction
• Sudden change in skin color and appearance
• Formation of hematomas
• Nosebleeds
• Gastroesophageal reflux disease
• Vomiting
• Nausea
• Frequent 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 helps fight infections)
• Bleeding may occur into the stomach, brain, rectum, penis/vagina, or urinary tract (including urine discoloration due to blood), or bleeding under the skin
• Decreased hemoglobin levels in the blood (a substance in red blood cells)
• Decreased hematocrit
• Itching
• Coughing up blood or sputum discolored with blood
• Abdominal pain or stomach pain
• Esophagitis and gastritis
• Allergic reaction
• Difficulty swallowing
• Jaundice or yellowing of the skin and eyes due to liver or blood disease

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

• Absent white blood cell count (which helps fight infections)
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing facial or throat swelling
• Difficulty breathing or wheezing
• Bleeding
• Bleeding may occur into a joint, from a wound, from the surgical site, from the injection site, or from the catheter insertion site
• Bleeding may occur from hematomas
• Stomach or intestinal ulcers (including esophageal ulcers)
• Abnormal liver function test results

Reporting side effects

If you experience any side effects, including any not listed in the package leaflet, tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, 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.
Reporting side effects will help to gather 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 which is stated on the carton and blister after "EXP". The expiry date refers to the last day of that month.
Blister: This medicine does not require any special storage conditions. Do not store capsules 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. 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 75 mg of dabigatran etexilate (as mesilate).
• 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 a hard capsule.
Wasedoc, 75 mg, is a non-transparent, pink hard capsule with the imprint "DA75".
Wasedoc, 75 mg, is available in packs containing 10 or 30 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

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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 package leaflet: 04.08.2023