Wasedoc

PT/H/2645/001-003/IB/006

Package leaflet: Information for the user

Wasedoc, 150 mg, hard capsules
dabigatran etexilate
Please read all of this 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, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

1. What Wasedoc is and what it is used for
2. Important information before taking Wasedoc
3. How to take Wasedoc
4. Possible side effects
5. How to store Wasedoc
6. 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 responsible for blood clot formation.
Wasedoc is used in adults to:

• prevent the formation of blood clots in the brain (stroke) and in other blood vessels of the body in patients with an irregular heart rhythm known as non-valvular atrial fibrillation and at least one additional risk factor.
• treat blood clots in the veins of the legs and lungs, and to prevent the recurrence of blood clots in the veins of the legs and lungs.

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).
• if the patient has severe impairment of kidney function.
• if the patient is currently experiencing bleeding.
• if the patient has a disease of any internal organ which increases

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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, during insertion of a venous or arterial catheter when heparin is administered through the catheter to maintain its patency, or during catheter ablation procedures for atrial fibrillation to restore normal heart rhythm.
• if the patient has severe impairment of liver function or liver disease which 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 fixed-dose 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 continuous use of blood-thinning medicines.

Warnings and precautions
Before starting treatment with Wasedoc, discuss this with your doctor. If you experience any symptoms or have undergone a surgical procedure while taking this medicine, you should contact your doctor.
The patient should inform the doctor if they currently have or have had 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 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 oesophagitis or gastritis.
• if the patient has gastroesophageal 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 non-steroidal anti-inflammatory drugs (NSAIDs), such as diclofenac, ibuprofen, piroxicam.
• if the patient has an infection in the heart (bacterial endocarditis).
• if the patient has reduced kidney function or is dehydrated (feeling thirsty and passing reduced amounts of dark (concentrated) or frothy 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.
• if the patient has previously had a heart attack or has conditions diagnosed to increase the risk of heart attack.

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• if the patient has liver disease affecting blood test results. In such cases, use of this medicine is not recommended.

When to be especially careful with Wasedoc

• if the patient needs to undergo surgery: In such cases, temporary discontinuation of Wasedoc is necessary due to 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.
• if the surgical procedure requires insertion of a catheter or administration of a spinal injection (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 they experience numbness or weakness in the lower limbs, or problems with bowel or bladder function after the anaesthesia wears off, as urgent medical care may be needed.
• if the patient falls or injures themselves during treatment, especially if they injure their head. Immediate medical evaluation is required. The doctor will assess whether the patient may have an 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 a change in treatment is necessary.

Wasedoc and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take. In particular, before taking Wasedoc, tell your doctor if you 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 to the skin
• Medicines used to treat heart rhythm disorders (e.g. amiodarone, dronedarone, quinidine, verapamil)
• In patients taking medicines containing verapamil, the doctor may recommend a lower dose of Wasedoc depending on the condition for which the medicine has been prescribed. See section 3.
• Medicines used to prevent rejection of transplanted organs (e.g. tacrolimus, cyclosporine)
• A fixed-dose 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 remedy used to treat depression
• Antidepressant medicines known as selective serotonin reuptake inhibitors (SSRIs) or serotonin-noradrenaline reuptake inhibitors (SNRIs)
• Rifampicin or clarithromycin (both antibiotics)
• Antiviral medicines used to treat AIDS (e.g. ritonavir)

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• Some 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. 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 Wasedoc.
Breastfeeding is not recommended while taking Wasedoc.

Driving and operating machinery
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 it 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 prescribed by the doctor. In case of doubt, consult your doctor.
Take Wasedoc exactly as directed below:
Prevention of thromboembolic events in blood vessels of the brain and body by preventing the formation of blood clots that occur due to irregular heart function, and treatment and prevention of recurrence of venous thromboembolism (blood clots in the veins of the legs and lungs).
The recommended dose is 300 mg taken as one 150 mg capsule twice daily.
In patients aged 80 years or older, the recommended dose of Wasedoc is 220 mg taken as one 110 mg capsule twice daily.
Patients taking medicines containing verapamil should receive a reduced dose of Wasedoc of 220 mg taken as one 110 mg capsule twice daily due to a potentially increased risk of bleeding.
In patients with potentially increased risk of bleeding, the doctor 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 rhythm via a procedure called cardioversion or catheter ablation for atrial fibrillation. Wasedoc should be taken as directed by the doctor.
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In case of implantation of a medical device (stent) into a blood vessel to maintain its patency using a procedure known as percutaneous coronary intervention with stent placement, the patient may be treated with Wasedoc after the doctor has confirmed adequate control of blood coagulation. Wasedoc should be taken as directed by the doctor.
Treatment and prevention of recurrence of 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 doctor will determine the correct dose and may adjust it during treatment. Continue taking all other medications unless your doctor advises otherwise.
Table 1 shows the single and total daily doses of Wasedoc in milligrams (mg). Doses are based on the patient's body weight in kilograms (kg) and age in years.
Table 1: Dosing table for Wasedoc 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: 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
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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. Do not break, crush, or empty the pellets from the capsule, as this may increase the risk of bleeding.
Switching anticoagulant medication
Do not switch anticoagulant medication without receiving detailed 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
Wasedoc capsules, they should contact their doctor immediately. Specific treatment methods are available.
Missed dose of Wasedoc
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 Wasedoc treatment
Wasedoc should be taken as directed by the doctor. Do not stop taking this medicine without first consulting
your doctor, as the risk of blood clots may be higher if treatment is stopped prematurely. Contact your doctor
if gastrointestinal discomfort occurs after taking Wasedoc.
If you have any further questions regarding 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.
Wasedoc affects the blood clotting system; therefore, most adverse effects are related to symptoms such as bruising or bleeding. Severe or major bleeding may occur, which is the most serious adverse effect. Regardless of location, such bleeding may lead to disability, be life-threatening, or even result in death. In some cases, this bleeding may not be visible.
If you experience bleeding that does not stop spontaneously, or symptoms of excessive bleeding (unusual weakness, fatigue, paleness, dizziness, headache, or unexplained swelling), contact your doctor immediately. Your doctor may decide to place you under close observation or change your treatment.

If a serious allergic reaction occurs, 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 thromboembolism in blood vessels of the brain and body by preventing clots that form due to irregular heart function

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

• Bleeding
• Bleeding may occur from haemorrhoids, from the rectum, or into the brain
• Formation of bruises (haematomas)
• Coughing up blood or blood-stained sputum
• Decrease in the number of platelets in the blood
• Decrease in haemoglobin content 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 in laboratory tests

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

• Bleeding may occur into a joint, from a surgical incision site, from a wound, from an injection site, or from the site of intravenous catheter insertion
• 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
• Decrease in blood cell count
• Increased liver enzyme activity
• Yellowing of the skin or whites of the eyes due to liver disease or blood disorders

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

• Difficulty breathing or wheezing
• Decrease in number or even absence of white blood cells (which help fight infections)
• Hair loss

In clinical studies, the number of heart attacks observed with Wasedoc was numerically higher than with warfarin. The overall number of events was small.

Treatment of blood clots in the legs and lungs, and prevention of recurrence of blood clots in the legs and (or) lungs

Common (may occur in 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 occur in 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 bruises (haematomas)
• Coughing up blood or blood-stained 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 in laboratory tests
• Increased liver enzyme activity

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

• Bleeding may occur from a surgical incision site, or from an injection site or site of intravenous catheter insertion, or bleeding into 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 due to an allergic reaction
• Difficulty swallowing

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

• Difficulty breathing or wheezing
• Decrease in haemoglobin content in the blood (a substance in red blood cells)
• Decrease in blood cell count
• Decrease in number or even absence of white blood cells (which help fight infections)
• Yellowing of the skin or whites of the eyes due to liver disease or blood disorders
• Hair loss

In clinical studies, the number of heart attacks observed 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 who received placebo.

Treatment and prevention of recurrence of blood clots in children

Common (may occur in 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 due to an allergic reaction
• Sudden change in skin colour and appearance
• Formation of bruises (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 occur in 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 anus, from the penis/vagina or urinary tract (including pink or red urine due to presence of blood), or under the skin
• Decrease in haemoglobin content in the blood (a substance in red blood cells)
• Decrease in 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 disease or blood disorders

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 a surgical incision site, from an injection site, or from the site of intravenous catheter insertion
• Bleeding may occur from haemorrhoids
• Stomach or intestinal ulcer (including oesophageal ulceration)
• Abnormal liver function test results in laboratory tests

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. 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.: 22 49-21-301, Fax: 22 49-21-309, Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder. Reporting adverse effects helps provide more information on the safety of this medicine.

5. How to store Wasedoc

Keep this medicine 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 stated month.
Blister: This medicine does not require special storage conditions. Do not place the capsules in pill boxes or medication organizers if they cannot be stored in the original packaging.
Medicines must not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What Wasedoc contains

• The active substance is dabigatran. Each hard capsule contains 150 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 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.
Wasedoc 150 mg are opaque, pink hard capsules marked with "DA150".
Wasedoc 150 mg is available in packs containing 30 or 60 hard capsules
or in multi-packs containing 3 packs of 60 hard capsules (180
hard capsules) in perforated aluminium blisters Aluminium/OPA/Aluminium/PE with a desiccant,
in a cardboard box.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Ranbaxy (Poland) Sp. z o.o.
ul. Idzikowskiego 16
00-710 Warsaw
Importer
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park
Paola, PLA 3000
PT/H/2645/001-003/IB/006
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 countries of the European Economic Area and in the United Kingdom (Northern Ireland)
under the following names:
Romania: Wasedoc
Portugal: Wasedoc