Dabigatran etexilate +pharma

Package leaflet: Information for the patient

Dabigatran etexilate +pharma, 75 mg, hard capsules
Dabigatran etexilate
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

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

1. What Dabigatran etexilate +pharma is and what it is used for

Dabigatran etexilate +pharma 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 responsible for blood clot formation.
Dabigatran etexilate +pharma is used in adults to:

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

Dabigatran etexilate +pharma is used in children to:

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

2. Important information before using Dabigatran etexilate +pharma

When not to use Dabigatran etexilate +pharma

• 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 problems
• if the patient is currently experiencing bleeding
• if the patient has 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)
• if the patient has an increased tendency to bleed. This may be inherited, 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 liver problems or liver disease that 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 lifelong anticoagulant therapy

Warnings and precautions
Before starting treatment with Dabigatran etexilate +pharma, discuss this with your doctor.
If symptoms occur during treatment with this medicine or if the patient has undergone surgery, consult a doctor.
The patient should inform the doctor if they currently 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 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 gastroesophageal reflux (acid reflux)
  • if the patient is taking medicines that may increase the risk of bleeding. See below “Dabigatran etexilate +pharma 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 less urine, which may be dark, concentrated, or frothy)
  • if the patient is over 75 years old
  • 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 conditions diagnosed as 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 special caution when using Dabigatran etexilate +pharma

• if the patient needs to undergo surgery – in such cases, temporary discontinuation of Dabigatran etexilate +pharma is necessary due to the increased risk of bleeding during and immediately after surgery. It is very important to take Dabigatran etexilate +pharma exactly as directed by the doctor before and after surgery.
• if surgery involves inserting a catheter or administering an injection into the spine (e.g. for epidural or spinal anaesthesia or for pain relief)
  • it is very important to take Dabigatran etexilate +pharma exactly as directed by the doctor before and after surgery.
  • the patient should inform the doctor immediately if they experience numbness or weakness in the legs, or problems with the bowels or bladder after the anaesthetic 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 attention is required. The doctor will assess whether there is an increased risk of bleeding.
• if the patient has a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), the patient should inform their doctor, who will decide whether treatment needs to be changed.

Dabigatran etexilate +pharma and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take. In particular, tell the doctor before taking Dabigatran etexilate +pharma 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 amiodarone, quinidine or verapamil, the doctor may recommend a lower dose of Dabigatran etexilate +pharma depending on the condition for which the medicine has been prescribed. See also 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 remedy used to treat depression)
• antidepressant medicines known as selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors
• rifampicin or clarithromycin (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 +pharma has on pregnancy or the unborn child. This medicine should not be used during pregnancy unless the doctor considers it safe. Women of childbearing age should use effective contraception to prevent pregnancy while taking Dabigatran etexilate +pharma.
Breastfeeding is not recommended during treatment with Dabigatran etexilate +pharma.

Driving and operating machinery
Dabigatran etexilate +pharma has no effect or negligible effect on the ability to drive and operate machinery.

Dabigatran etexilate +pharma contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per capsule; therefore, this medicine is considered "sodium-free".

3. How to take Dabigatran etexilate +pharma

Capsules of Dabigatran etexilate +pharma 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 the doctor. In case of doubt, consult your doctor.
You must take Dabigatran etexilate +pharma as follows:
Prevention of blood clots after surgery (joint replacement) of the hip or knee joint
The recommended dose is 220 mg once daily (taken as 2 capsules of 110 mg).
If renal 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 +pharma is 150 mg once daily (taken as 2 capsules of 75 mg).
Patients taking medicines containing verapamil who also have reduced renal function should take a reduced dose of 75 mg of Dabigatran etexilate +pharma due to an increased risk of bleeding.
In both types of surgery, treatment should not be initiated if there is bleeding from the surgical site. If treatment cannot be started by the next day after surgery, it should be initiated with a dose of 2 capsules once daily.
After knee joint replacement surgery
Treatment with Dabigatran etexilate +pharma should begin with one capsule taken within 1 to 4 hours after completion of surgery. Then take two capsules once daily for a total of 10 days.
After hip joint replacement surgery
Treatment with Dabigatran etexilate +pharma should begin with one capsule taken within 1 to 4 hours after completion of surgery. Then take two 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 +pharma 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 age and body weight. Your doctor will determine the correct dose and may adjust it during treatment. Continue taking all other prescribed medications unless your doctor advises otherwise.
Single dose of Dabigatran etexilate +pharma to be administered twice daily, in milligrams (mg), according to the patient's body weight in kilograms (kg) and age in years:
Age in years
8 to <9 9 to 10 11 12 13 14 15 16 17
<10 to to to to to to to to
<11 <12 <13 <14 <15 <16 <17 <18
>81 300 mg

71 to <81 as two 150 mg capsules
or
61 to <71
four 75 mg capsules
260 mg
as one 110 mg capsule plus one 150 mg capsule
51 to <61
or
one 110 mg capsule plus two 75 mg capsules
Body weight [kg]
220 mg
41 to <51
as two 110 mg capsules
185 mg
31 to <41
as one 75 mg capsule plus one 110 mg capsule
150 mg
26 to <31
as one 150 mg capsule
or

21 to <26
two 75 mg capsules
16 to <21

One capsule 110 mg
13 to <16

One

11 to <13 capsule
75 mg
Indicates that dosing recommendations cannot be provided.

How to take Dabigatran etexilate +pharma
Dabigatran etexilate +pharma 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 crush, chew, or empty the pellets from the capsule, as this may increase the risk of bleeding.
Instructions for opening the bottle

• To open the bottle, press down and turn the cap.
• After removing a capsule and taking the dose, immediately close the bottle tightly with the cap.

Switching anticoagulant medicines
Do not switch anticoagulant medicines without receiving specific instructions from your doctor.
Taking more than the recommended dose of Dabigatran etexilate +pharma
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 +pharma
Prevention of blood clots after surgery (joint replacement) of the hip or knee
Continue taking the missed daily dose of Dabigatran etexilate +pharma at the usual time the next day.
Do not take a double dose to make up for a missed dose.
Treatment of blood clots and prevention of recurrent blood clots in children. A missed dose may be taken if there are still at least 6 hours before the next scheduled dose.
If less than 6 hours remain until the next scheduled dose, do not take the missed dose.
Do not take a double dose to make up for a missed dose.
Stopping treatment with Dabigatran etexilate +pharma
Dabigatran etexilate +pharma should be taken exactly as prescribed by your doctor. Do not stop taking this medicine without consulting your doctor first, as the risk of developing a blood clot may be higher if treatment is stopped prematurely.
Contact your doctor if you experience gastrointestinal discomfort after taking Dabigatran etexilate +pharma.
If you have any further questions about 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 +pharma affects the blood clotting system; therefore, most adverse effects involve symptoms such as bruising or bleeding. Severe or major bleeding may occur, which is the most serious adverse effect. 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 or symptoms of excessive bleeding occur (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 categorized 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 patients)

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

Uncommon (may occur in up to 1 in 100 patients)

• Bleeding, which may occur from the nose, stomach or intestines, penis/vagina, or urinary tract (including pink or red urine due to presence of blood),
• From hemorrhoidal nodules, rectum, under the skin, into joints, due to injury or following injury, or after a surgical procedure
• Formation of hematomas or bruising following surgery
• Blood in stool detected in laboratory tests
• Decrease in red blood cell count
• Decrease in blood cell proportion
• 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 1000 patients)

• Bleeding
• Bleeding into the brain, from the surgical incision site, injection site, or site of intravenous catheter insertion may occur
• 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 nodules due to an allergic reaction
• Sudden change in skin color and appearance
• Itching
• Stomach or intestinal ulcer (including esophageal ulceration)
• Inflammation of the esophagus and stomach
• Regurgitation of stomach contents into the esophagus (reflux)
• Abdominal pain or stomach pain
• Indigestion
• Difficulty swallowing
• Fluid discharge from wound
• Fluid discharge from surgical wound.

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

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

Treatment and prevention of recurrence of blood clots in children

Common (may occur in up to 1 in 10 patients)

• Decrease in red blood cell count
• Decrease in platelet count
• Skin rash consisting of dark red, raised, itchy nodules due to an allergic reaction
• Sudden change in skin color and appearance
• Formation of hematomas
• Nosebleeds
• Regurgitation of stomach contents into the esophagus (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 patients)

• Decrease in white blood cell count (which help fight infections)
• Bleeding may occur from the stomach or intestines, brain, rectum, penis/vagina or urinary tract (including pink or red urine due to presence of blood), or under the skin
• Decrease in hemoglobin levels in blood (a substance in red blood cells)
• Decrease in blood cell proportion
• Itching
• Coughing up blood or blood-stained sputum
• Abdominal pain or stomach pain
• Inflammation of the esophagus 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 joints, from wounds, surgical incision sites, injection sites, or intravenous catheter insertion sites
• Bleeding from hemorrhoidal nodules may occur
• Stomach or intestinal ulcer (including esophageal ulceration)
• Abnormal liver function test results.

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 of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +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 provide more information on the safety of this medicine.

5. How to store Dabigatran etexilate +pharma

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, blister, or bottle after "EXP". The expiry date refers to the last day of the stated month.
Blister
Store in the original packaging to protect from moisture. Do not transfer capsules to other containers or pill organisers unless the capsules remain in their original packaging.
Bottle
Shelf life after first opening the bottle: 4 months.
Keep the bottle tightly closed. Store the medicine in the original packaging to protect from moisture.
Do not transfer capsules to other containers or pill organisers.
Medicines must not be disposed of via the sewage system 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 package and other information

What Dabigatran etexilate +pharma contains

• The active substance is dabigatran. Each hard capsule contains 75 mg of dabigatran etexilate (in the form of mesilate).
• The other ingredients are: capsule contents: microcrystalline cellulose, sodium croscarmellose, crospovidone, tartaric acid (granulate), hydroxypropylcellulose, mannitol, magnesium stearate, talc; capsule shell: iron oxide red (E 172), titanium dioxide (E 171), hypromellose; black printing ink: shellac, propylene glycol, concentrated ammonium hydroxide, iron oxide black (E 172), potassium hydroxide.

What Dabigatran etexilate +pharma looks like and contents of the pack
Dabigatran etexilate +pharma is a medicine that comes as opaque, pink, hard capsules with the imprint "DA75".
This medicine is available in packs containing 10, 30 and 60 hard capsules in aluminium perforated blisters with a desiccant, in a cardboard carton.
This medicine is also available in white, opaque polyethylene (plastic) bottles containing 60 hard capsules, closed with a white polypropylene cap and containing a desiccant, all in a cardboard carton.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
+pharma arzneimittel gmbh
Hafnerstraße 211
8054 Graz
Austria

Importer
TOWA Pharmaceutical Europe, S.L.
C/de Sant Martí 75-97
08107 Martorelles
Barcelona
Spain
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park
Malta - PLA3000 Paola

This medicinal product is authorised for marketing in the European Economic Area countries under the following names:
Czech Republic: Dabigatran etexilát +pharma
Croatia: Dabigatraneteksilat Genericon 75 mg tvrde kapsule
Austria: Dabigatranetexilat Genericon 75 mg Hartkapseln

For further information about this medicine, please contact the marketing authorisation holder's representative:
+pharma Polska sp. z o.o.
ul. Podgórska 34
31-536 Kraków
Poland
Tel: +48 12 262 32 36
E-mail: [email protected]