Dabigatran etexilate polpharma

Package leaflet: Information for the patient

Dabigatran etexilate Polpharma, 150 mg, hard capsules
dabigatran etexilate
Please read this leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult 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, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Dabigatran etexilate Polpharma is and what it is used for
2. What you need to know before taking Dabigatran etexilate Polpharma
3. How to take Dabigatran etexilate Polpharma
4. Possible side effects
5. How to store Dabigatran etexilate Polpharma
6. Contents of the pack and other information

1. What Dabigatran etexilate Polpharma is and what it is used for

Dabigatran etexilate Polpharma 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.

Dabigatran etexilate Polpharma 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 who have 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 recurrence of blood clots in the veins of the legs and lungs.

Dabigatran etexilate Polpharma is used in children to:

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

2. Important information before taking Dabigatran etexilate Polpharma

When not to take Dabigatran etexilate Polpharma

• 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 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, which 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 through the catheter to maintain its patency, or during a procedure called catheter ablation for atrial fibrillation.
• if the patient has severe impairment of liver function or a 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 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 Dabigatran etexilate Polpharma, discuss this with your doctor.
If you have experienced symptoms or undergone a surgical procedure while being treated with this medicine, consult your doctor.
The patient should inform the doctor if they 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 tissue 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 (stomach acid flowing back into the oesophagus).
  • if the patient is taking medicines that may increase the risk of bleeding. See below “Dabigatran etexilate Polpharma 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) and/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.
• if the patient has had a heart attack or 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 take special care with Dabigatran etexilate Polpharma

• if the patient needs to undergo surgery: In such cases, temporary discontinuation of Dabigatran etexilate Polpharma is necessary due to the increased risk of bleeding during and immediately after surgery. It is very important to take Dabigatran etexilate Polpharma exactly as directed by the doctor before and after surgery.
• if surgery requires insertion of a catheter or injection into the spine (e.g. for epidural or spinal anaesthesia or pain relief):
  • It is very important to take Dabigatran etexilate Polpharma exactly as directed by the doctor before and after surgery.
• Immediately inform the doctor if the patient experiences numbness or weakness in the lower limbs or bowel or bladder problems 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 there is 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.

Dabigatran etexilate Polpharma and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. In particular, tell the doctor before taking Dabigatran etexilate Polpharma 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 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 Dabigatran etexilate Polpharma depending on the condition for which the medicine was prescribed. See section 3.
• Medicines used to prevent rejection of a transplanted organ (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-noradrenaline 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 Dabigatran etexilate Polpharma has on pregnancy and the unborn child. This medicine should not be taken during pregnancy unless the doctor considers it safe. Women of childbearing potential should avoid becoming pregnant while taking Dabigatran etexilate Polpharma.
Breastfeeding is not recommended during treatment with Dabigatran etexilate Polpharma.

Driving and using machines
Dabigatran etexilate Polpharma has no influence on the ability to drive or operate machinery.

3. How to take Dabigatran etexilate Polpharma

Dabigatran etexilate Polpharma 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 treatment of children under 8 years of age.
This medicine should always be taken as prescribed by the doctor. If in doubt, consult the doctor.
Take Dabigatran etexilate Polpharma exactly as directed below:
Prevention of blood clots in blood vessels of the brain and body by preventing the formation of clots that occur due to irregular heart function, and treatment of blood clots in the veins of the legs and lungs, as well as prevention of recurrence of such clots.
The recommended dose is 300 mg taken as one 150 mg capsule twice daily.
For 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 a reduced dose of Dabigatran etexilate Polpharma of 220 mg taken as one 110 mg capsule twice daily, due to a possible increased risk of bleeding.
For patients with potentially increased risk of bleeding, the physician may recommend treatment with 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 through a procedure called cardioversion or through a procedure called catheter ablation for atrial fibrillation. Dabigatran etexilate Polpharma should be taken as directed by the physician.
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 implantation, the patient may receive treatment with Dabigatran etexilate Polpharma after the physician confirms adequate control of blood coagulation. Dabigatran etexilate Polpharma should be taken as directed by the physician.
Treatment of blood clots and prevention of recurrent blood clots in children
Dabigatran etexilate Polpharma 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 be as close as possible to 12 hours.
The recommended dose depends on body weight and age. The physician will determine the correct dose and may adjust it during treatment. Continue taking all other medications unless the physician advises otherwise.
Table 1 shows the single and total daily doses of Dabigatran etexilate Polpharma in milligrams (mg). Doses depend on the patient's body weight in kilograms (kg) and age in years.
Table 1: Dosing table for Dabigatran etexilate Polpharma 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: 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

How to take Dabigatran etexilate Polpharma
Dabigatran etexilate Polpharma can be taken with or without food. 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.

Instructions for opening blister packs
The following pictogram illustrates how to remove Dabigatran etexilate Polpharma capsules from the blister.

Detach the required dose along the perforated line.
Peel back the protective foil from the blister and remove the capsule.

• Do not push capsules through the foil.
• Do not peel back the foil until the capsule is needed.

Switching anticoagulant medication
Do not switch anticoagulant medication without receiving detailed instructions from your doctor.

Accidental overdose of Dabigatran etexilate Polpharma
Taking more than the recommended 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 Dabigatran etexilate Polpharma
A missed dose may be taken if there is still at least 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 Dabigatran etexilate Polpharma
Dabigatran etexilate Polpharma should be taken as directed by the doctor. Do 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. Contact your doctor if dyspepsia occurs after taking Dabigatran etexilate Polpharma.

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.
Dabigatran etexilate Polpharma affects the blood coagulation system; therefore, most adverse effects are related to symptoms such as bruising or bleeding. Severe or profuse bleeding may occur, which is the most serious adverse effect. Regardless of the site, such bleeding may lead to disability, be life-threatening, or even result in death. In some cases, these bleedings may not be visible.
If bleeding occurs that does not stop spontaneously, or if symptoms of excessive bleeding appear (unusual weakness, fatigue, paleness, dizziness, headache, or unexplained swelling), 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 thromboembolism in blood vessels of the brain and body by preventing the formation of clots caused by 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 levels in the blood (the substance in red blood cells)
• Allergic reaction
• Sudden change in skin color 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 analyses

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

• Bleeding may occur into a joint, from a surgical incision, wound, injection site, or 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 characterized by 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 or blood disease

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

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

In clinical trials, the number of heart attacks observed with Dabigatran etexilate Polpharma was higher than with warfarin. The overall number of events was small.

Treatment of venous thrombosis in legs and lungs and prevention of recurrence of venous thrombosis in legs and 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 color 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 analyses
• Increased liver enzyme activity

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

• Bleeding may occur from a surgical incision, injection site, site of intravenous catheter insertion, 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 characterized by 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 levels in the blood (the substance in red blood cells)
• Decrease in blood cell count
• Decrease in, or even absence of, white blood cells (which help fight infections)
• Yellowing of the skin or whites of the eyes due to liver or blood disease
• Hair loss

In clinical trials, the number of heart attacks observed with dabigatran etexilate 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 those receiving placebo.

Treatment of blood clots 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 characterized by dark red, raised, itchy bumps due to an allergic reaction
• Sudden change in skin color 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 levels in the blood (the 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 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, surgical incision, injection site, or site of intravenous catheter insertion
• Bleeding may occur from haemorrhoids
• Stomach or intestinal ulcer (including oesophageal ulceration)
• Abnormal liver function test results in laboratory analyses

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. 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
Phone: +48 22 49 21 301
Fax: +48 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 to provide more information on the safety of the medicine.

5. How to store Dabigatran etexilate Polpharma

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 indicated by EXP.
The expiry date refers to the last day of the stated month.
No special storage instructions apply.
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 Dabigatran etexilate Polpharma contains

• The active substance is dabigatran. Each hard capsule contains 150 mg of dabigatran etexilate (in the form of mesilate).
• The other ingredients are: tartaric acid, arabic gum, hypromellose 2910, dimethicone 350, talc and hydroxypropylcellulose.
• The capsule shell contains carrageenan, potassium chloride, titanium dioxide (E 171), indigo carmine (E 132), purified water and hypromellose 2910.
• The black printing ink contains shellac, iron oxide black (E 172) and potassium hydroxide.

What Dabigatran etexilate Polpharma looks like and contents of the pack
Dabigatran etexilate Polpharma 150 mg is a hard capsule (approximately 22x8 mm) with an opaque light blue cap and an opaque white body. The imprint "150" appears on the body of the hard capsule.
The medicine is available in packs containing 10, 30, 60, 100 or 180 hard capsules, in a multipack containing 3 packs of 60 hard capsules (180 hard capsules) or in a multipack containing 2 packs of 50 hard capsules (100 hard capsules), in blisters made of OPA/Aluminium/PVC//Aluminium foil, in a cardboard box.
Single-dose blister:
This medicine is available in packs containing 10x1, 30x1, 60x1, 100x1, 180x1 hard capsules, in a multipack containing 3 packs of 60x1 hard capsules (180 hard capsules) or in a multipack containing 2 packs of 50x1 hard capsules (100 hard capsules), in perforated single-dose blisters made of OPA/Aluminium/PVC//Aluminium foil of the "peel off" type, in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. +48 22 364 61 01

Importer
Laboratori Fundacio Dau
Poligono Industrial Zona - De La Zona Franca De Barcelona
Carrer Lletra C De La Zona Franca 12-14
08040 Barcelona
Spain
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park
Paola PLA 3000
Malta

This medicine is authorised for marketing in the European Economic Area countries under the following names:
Germany: Dabigatran Welding 150mg Kapseln
France: Dabigatran etexilate Welding 150mg gelule
Italy: Dabigatran etexilato Welding Capsules
Luxembourg: Dabigatran Welding 150mg Capsules