Dabigatran etexilate polpharma

Package leaflet: Information for the patient

Dabigatran etexilate Polpharma, 75 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 further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, 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.

Leaflet 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 that is involved in blood clot formation.
Dabigatran etexilate Polpharma is used in adults to:

• prevent the formation of blood clots in veins following hip or knee replacement surgery.

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 kidney function impairment.
• 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. gastric 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, inserting a venous or arterial catheter, when heparin is administered through the catheter to maintain its patency, or during restoration of normal heart rhythm by a procedure called catheter ablation in atrial fibrillation.
• if the patient has severe liver function impairment 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 combination medicine containing glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C virus infection.
• if the patient has had an artificial heart valve implanted, which requires ongoing use of blood-thinning medicines.

Warnings and precautions
Before starting treatment with Dabigatran etexilate Polpharma, patients should discuss this with their doctor.
If symptoms occur during treatment with this medicine or if the patient undergoes a surgical procedure, they should consult their doctor.
The patient should inform the doctor if they have or have previously 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 (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 "Dabigatran etexilate Polpharma and other medicines".
  • if the patient is taking nonsteroidal 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 previous heart attack or if the patient 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 exercise particular caution when using 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 a surgical procedure requires insertion of a catheter or administration of an injection into the spine (e.g. for epidural or spinal anaesthesia or for pain relief):
  • It is very important to take Dabigatran etexilate Polpharma exactly as directed by the doctor before and after surgery.
• The patient should immediately inform the doctor if numbness or weakness in the lower limbs or bowel or bladder dysfunction occurs after the anaesthesia wears off, as urgent medical care is required.
  • if the patient falls or sustains an injury during treatment, especially if the head is injured. Immediate medical attention should be sought. 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 the doctor, who will decide whether any change in treatment is needed.

Dabigatran etexilate Polpharma and other medicines
The patient should tell their doctor or pharmacist about all medicines they are currently taking, have recently taken, or plan to take. In particular, the patient should inform the doctor before taking Dabigatran etexilate Polpharma if they 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 topically to the skin only.
• Medicines used to treat heart rhythm disorders (e.g. amiodarone, dronedarone, quinidine, verapamil). In patients taking medicines containing amiodarone, quinidine or verapamil, the doctor may recommend a lower dose of Dabigatran etexilate Polpharma depending on the condition for which the medicine was prescribed. See also section 3.
• Medicines used to prevent rejection of transplanted organs (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 or 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 Dabigatran etexilate Polpharma.
Breastfeeding is not recommended during treatment with Dabigatran etexilate Polpharma.

Driving and operating machinery
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 treating children under 8 years of age.
This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor.
Take Dabigatran etexilate Polpharma exactly as directed below:
Prevention of blood clots after hip or knee replacement surgery
The recommended dose is 220 mg once daily (taken as 2 capsules of 110 mg).
If kidney function is reduced by more than half, or in patients aged 75 years or older, the recommended dose is 150 mg once daily (taken as 2 capsules of 75 mg).
In patients taking medicines containing amiodarone, quinidine, or verapamil, the recommended dose of Dabigatran etexilate Polpharma is 150 mg once daily (taken as 2 capsules of 75 mg).
Patients taking medicines containing verapamil who also have reduced kidney function by more than half should take a reduced dose of 75 mg of Dabigatran etexilate Polpharma due to an increased risk of bleeding.
In both types of surgery, treatment should not be started if there is active bleeding from the surgical site. If treatment cannot be initiated by the next day after surgery, it should be started at a dose of 2 capsules once daily.
After knee replacement surgery
Treatment with Dabigatran etexilate Polpharma should begin with one capsule taken 1 to 4 hours after completion of the surgical procedure. Then, take 2 capsules once daily for a total of 10 days.
After hip replacement surgery
Treatment with Dabigatran etexilate Polpharma should begin with one capsule taken 1 to 4 hours after completion of the surgical procedure. 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
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. Your doctor will determine the correct dose. Your doctor may adjust the dose during treatment. Continue taking all other prescribed medicines unless your doctor advises otherwise.
Table 1 shows the single and total daily doses of Dabigatran etexilate Polpharma in milligrams (mg). Doses are based 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. The 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 blisters
The following pictogram illustrates how to remove Dabigatran etexilate Polpharma capsules from the blister pack.

Detach the single dose along the perforated line.

Peel back the protective foil from the blister and remove the capsule.

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

Switching anticoagulant therapy
Do not switch anticoagulant medication without first obtaining detailed instructions from your doctor.

Taking more than the recommended dose of Dabigatran etexilate Polpharma
Taking too high a 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
Prevention of blood clots after surgery (hip or knee replacement)
Continue taking the missed daily dose of Dabigatran etexilate Polpharma at the usual time on the next day.
Do not take a double dose to make up for a missed dose.

Treatment and prevention of recurrence of blood clots in children
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 treatment with Dabigatran etexilate Polpharma
Dabigatran etexilate Polpharma should be taken exactly as prescribed by the doctor. Do not stop taking this medicine without first consulting your doctor, as the risk of developing a blood clot may be higher if treatment is stopped prematurely.
Contact your doctor if gastrointestinal discomfort occurs after taking Dabigatran etexilate Polpharma.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
Dabigatran etexilate Polpharma affects the blood clotting system; therefore, most adverse reactions involve symptoms such as bruising or bleeding. Severe or major bleeding may occur, which is the most serious adverse reaction, and regardless of location, it may lead to disability, be life-threatening, or even result in death. In some cases, such bleeding may not be visible.
If bleeding that does not stop spontaneously occurs, or symptoms of excessive bleeding (unusual weakness, fatigue, paleness, dizziness, headache, or unexplained swelling) appear, contact your doctor immediately. The doctor may decide to place the patient under close monitoring 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 reactions listed below are grouped according to their frequency of occurrence:

Prevention of blood clots after hip or knee replacement surgery
Common (may occur in up to 1 in 10 people):

• Decrease in haemoglobin levels in the blood (a substance in red blood cells)
• Abnormal liver function test results.

Uncommon (may occur in 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 pink or red-coloured urine due to the presence of blood), from haemorrhoids, from the rectum, under the skin, into joints, due to injury or after injury or surgery
• Formation of bruises or bruising following surgery
• Blood in stool detected in laboratory tests
• Decrease in the number of red blood cells in the blood
• Decrease in blood cell fraction
• Allergic reaction
• Vomiting
• Frequent passage of loose or watery stools
• Nausea
• Discharge from wound (fluid oozing from surgical wound)
• Increased liver enzyme activity
• Yellowing of the skin or whites of the eyes due to liver or blood disease.

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

• Bleeding
• Bleeding into the brain, from the surgical incision site, from the injection site, or from the site of intravenous catheter insertion
• Blood-tinged discharge from the site of intravenous catheter insertion
• Coughing up blood or blood-stained sputum
• Decrease in platelet count in blood
• Decrease in red blood cell count after surgery
• 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
• 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)
• Abdominal pain or stomach pain
• Indigestion
• Difficulty swallowing
• Fluid discharge from wound
• Fluid discharge from surgical wound.

Frequency unknown (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.

Treatment of blood clots and prevention of recurrent blood clots in children
Common (may occur in up to 1 in 10 people):

• Decrease in red blood cell count
• Decrease in platelet count
• Skin rash consisting of dark red, raised, itchy bumps due to an allergic reaction
• Sudden change in skin colour and appearance
• Bruising
• 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 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 pink or red-coloured urine due to the presence of blood), or under the skin
• Decrease in haemoglobin levels in the blood (a substance in red blood cells)
• Decrease in blood cell fraction
• 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 unknown (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 into joints, from wounds, from surgical incision sites, from injection sites, or from the site of intravenous catheter insertion
• Bleeding from haemorrhoids
• Stomach or intestinal ulcer (including oesophageal ulceration)
• Abnormal liver function test results.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the 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 reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this 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 pack after: EXP.
The expiry date refers to the last day of the stated month.
No special storage instructions apply for this medicine.
Medicines must 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 75 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), 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 75 mg is a hard capsule (approximately 18x6 mm in size) with an opaque white cap and an opaque white body. The imprint “75” appears on the body of the hard capsule.
The medicine is available in packs containing 10, 30 or 60 hard capsules in blisters made of OPA/Aluminium/PVC//Aluminium foil, packed in a cardboard box.
Single-dose blister:
This medicine is also available in packs containing 10x1, 30x1 or 60x1 hard capsules in perforated single-dose blisters made of OPA/Aluminium/PVC//Aluminium foil of the "peel off" type, packed 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 sale in the European Economic Area under the following names:
Germany: Dabigatran Welding 75mg Kapseln
France: Dabigatran etexilate Welding 75mg gelule
Italy: Dabigatran etexilato Welding Capsules
Luxembourg: Dabigatran Welding 75mg Capsules