Dabigatran etexilate +pharma

Package leaflet: Information for the patient

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

• Keep this leaflet so that you can read it again if necessary.
• 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. The medicine may harm another person, even if their symptoms appear identical.
• If you experience any adverse effects, 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. Important information 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 responsible for blood clot formation.

Dabigatran etexilate +pharma is used in adults for:

• preventing blood clots in the brain (stroke) and in other blood vessels in the body when the patient has an irregular heart rhythm known as non-valvular atrial fibrillation and at least one additional risk factor
• treating blood clots in the veins of the legs and lungs, and preventing recurrence of such clots

Dabigatran etexilate +pharma is used in children for:

• treating blood clots and preventing 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 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. stomach ulcer, brain injury or intracranial haemorrhage, recent surgery on the brain or eyes)
• 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 via the catheter to maintain its patency, or during a procedure called catheter ablation for 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 organ transplant rejection
• 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 an artificial heart valve which requires continuous use of blood-thinning medicines

Warnings and precautions
Before starting treatment with Dabigatran etexilate +pharma, discuss this with your doctor. If
you experience any symptoms while taking this medicine or have undergone a surgical procedure,
contact your doctor.
You should inform your doctor if you 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 tissue removal (biopsy) within the last month
  • if you have suffered a serious injury (e.g. bone fracture, head injury or any injury requiring surgical treatment)
  • if you have inflammation of the oesophagus or stomach
  • if you have gastro-oesophageal reflux (acid reflux into the oesophagus)
  • if you are taking medicines that may increase the risk of bleeding. See below “Dabigatran etexilate +pharma and other medicines”.
  • if you are taking non-steroidal anti-inflammatory drugs (NSAIDs), such as diclofenac, ibuprofen, piroxicam
  • if you have an infection in the heart (bacterial endocarditis)
  • if you have reduced kidney function or are dehydrated (feeling thirsty and passing less urine, which is dark (concentrated) or foamy)
  • if you are over 75 years of age
  • if you are an adult weighing 50 kg or less
  • only when used in children: if the child has an infection around or within the brain.
• if you have had a heart attack or if you have conditions diagnosed by your doctor that increase the risk of heart attack
• if you have 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 your 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 for pain relief)
  • it is very important to take Dabigatran etexilate +pharma exactly as directed by your doctor before and after surgery
  • you must inform your doctor immediately if you experience numbness or weakness in the lower limbs or problems with bowel or bladder function 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 is required. The doctor will assess whether there may be an increased risk of bleeding.
• if the patient has a condition called antiphospholipid syndrome (an immune system disorder causing increased risk of blood clots), the patient should inform the doctor, who will decide whether a change in treatment is necessary.

Dabigatran etexilate +pharma and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take. Before taking Dabigatran etexilate +pharma, you should especially inform 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 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 organ transplant rejection (e.g. tacrolimus, cyclosporine)
• combination medicine containing glecaprevir and pibrentasvir (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 (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 and the unborn child. Do not take this medicine during pregnancy unless your doctor considers it safe. Women of childbearing age should avoid becoming pregnant while taking Dabigatran etexilate +pharma.
Breastfeeding must not be undertaken while taking Dabigatran etexilate +pharma.

Driving and operating machinery
Dabigatran etexilate +pharma has no 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, i.e. this medicine is considered "sodium-free".

3. How to take Dabigatran etexilate +pharma

Dabigatran etexilate +pharma capsules can be used in adults and children aged 8 years or older who are able to swallow capsules whole. Other age-appropriate formulations are available for the treatment of children under 8 years of age.
This medicine should always be taken exactly as prescribed by the doctor. In case of doubt, consult the doctor.
Take Dabigatran etexilate +pharma as follows:
Prevention of blood clots in blood vessels of the brain and body by preventing the formation of clots that may 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 +pharma of 220 mg, taken as one 110 mg capsule twice daily, due to the possible increased risk of bleeding.
For patients with potentially increased risk of bleeding, the doctor 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 +pharma should be taken as directed by the doctor.
In the 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 receive treatment with Dabigatran etexilate +pharma after the doctor confirms adequate control of blood coagulation. Dabigatran etexilate +pharma should be taken as directed by the doctor.

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. The doctor will determine the correct dose and may adjust it during treatment. Continue taking all other medications unless the 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 110 mg capsule
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 may be taken with or without food. The capsules should be swallowed whole with a glass of water to help them pass 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 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 medication
Do not switch anticoagulant medication without specific instructions from the 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 the doctor immediately. Specific treatment methods are available.

Missed dose of Dabigatran etexilate +pharma
A missed dose can be taken if there is still at least 6 hours before the next scheduled dose.
If less than 6 hours remain until 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 Dabigatran etexilate +pharma
Dabigatran etexilate +pharma should be taken as prescribed by the doctor. Do not stop taking this medicine without first consulting the doctor, as the risk of developing a blood clot may be higher if treatment is stopped prematurely.
Contact the doctor if gastrointestinal discomfort occurs 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 reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Dabigatran etexilate +pharma 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, may lead to disability, be life-threatening, or even result in death. In some cases, such bleeding may not be visible.
If bleeding occurs that does not stop spontaneously 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 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 reactions listed below are grouped according to their frequency of occurrence.

Prevention of blood clots in the brain and throughout the body by preventing clots that form due to irregular heart function

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

• 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 liquid stools
• Nausea

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

• 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 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 1000 patients)

• Bleeding may occur into a joint, from a surgical incision site, from a wound, from an injection site, or from the site where a venous catheter was inserted
• 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 or blood disease

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 trials, the number of heart attacks with dabigatran etexilate 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 lungs

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

• 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 patients)

• Bleeding
• Bleeding may occur into a joint or due to 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 liquid stools
• Abnormal liver function test results in laboratory tests
• Increased liver enzyme activity

Rare (may occur in up to 1 in 1000 patients)

• Bleeding may occur from a surgical incision site, from an injection site, from the site where a venous catheter was inserted, 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 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 levels in the blood (the 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 or blood disease
• Hair loss

In clinical trials, the number of heart attacks 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 patients)

• 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 liquid stools
• Indigestion
• Hair loss
• Increased liver enzyme activity

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

• Decrease in the number of white blood cells (which help fight infections)
• Bleeding may occur into the stomach or intestines, from the brain, from the rectum, 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, from a surgical incision site, from an injection site, or from the site where a venous catheter was inserted
• Bleeding may occur from haemorrhoids
• Stomach or intestinal ulcer (including oesophageal ulceration)
• Abnormal liver function test results in laboratory tests

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, 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 reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Dabigatran etexilate +pharma

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, blister, or bottle
following "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 organizers unless the capsules are kept
in the 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 organizers.
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 package and other information

What Dabigatran etexilate +pharma contains

• The active substance is dabigatran. Each hard capsule contains 150 mg of dabigatran etexilate (as mesylate).
• 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; printing ink: black ink containing 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 an opaque, pink, hard capsule with the imprint "DA150".
This medicine is available in packs of 10, 30 and 60 hard capsules, in multi-packs containing 3 packs of 60 hard capsules (180 hard capsules) or in multi-packs containing 2 packs of 50 hard capsules (100 hard capsules), in aluminium, perforated blisters with a desiccant, packed in a cardboard box.
This medicine is also available in white, opaque polyethylene (plastic) bottles containing 60 hard capsules, closed with a white polypropylene cap, with a desiccant, all contained in a cardboard box.
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 in the European Economic Area member states under the following names:
Czech Republic: Dabigatran etexilát +pharma
Croatia: Dabigatraneteksilat Genericon 150 mg tvrde kapsule
Austria: Dabigatranetexilat Genericon 150 mg Hartkapseln

For more detailed information about this medicine, please contact the representative of the Marketing Authorisation Holder:
+pharma Polska sp. z o.o.
ul. Podgórska 34
31-536 Kraków
Poland
tel: +48 12 262 32 36
e-mail: [email protected]