Dabigatran etexilate medical valley: detailed information

Patient Information Leaflet

Dabigatran etexilate Medical Valley, 150 mg, hard capsules
Dabigatranum etexilatum
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. 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.

Table of contents

What Dabigatran etexilate Medical Valley is and what it is used for
What you need to know before taking Dabigatran etexilate Medical Valley
How to take Dabigatran etexilate Medical Valley
Possible side effects
How to store Dabigatran etexilate Medical Valley
Contents of the pack and other information

1. What Dabigatran etexilate Medical Valley is and what it is used for

Dabigatran etexilate Medical Valley 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 Medical Valley is used in adults to:

prevent formation of blood clots in the brain (stroke) and in other blood vessels in the body in patients with a type of irregular heartbeat called non-valvular atrial fibrillation and at least one additional risk factor.
treat blood clots in the legs and lungs and to prevent recurrence of blood clots in the legs and lungs.

Dabigatran etexilate Medical Valley is used in children to:

treat blood clots and to prevent recurrence of blood clots.

2. Important information before taking Dabigatran etexilate Medical Valley

When not to take Dabigatran etexilate Medical Valley

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 a procedure called catheter ablation for atrial fibrillation to restore normal heart rhythm.
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 fixed-dose combination medicine containing glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C virus infection.
if the patient has a mechanical heart valve requiring continuous anticoagulant therapy.

Warnings and precautions
Before starting treatment with Dabigatran etexilate Medical Valley, discuss this with your doctor.
If the patient experiences symptoms during treatment with this medicine or 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 (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 (acid reflux into the oesophagus).
- if the patient is taking medicines that may increase the risk of bleeding. See below “Dabigatran etexilate Medical Valley 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 of 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 frothy urine).
- if the patient is over 75 years of age.
- if the patient is an adult weighing 50 kg or less.
- only when used in children: if the child has an infection around or within the brain.
if the patient has had a heart attack or has been diagnosed with a condition increasing the risk of myocardial infarction.
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 Medical Valley

if the patient needs to undergo surgery: In such cases, temporary discontinuation of Dabigatran etexilate Medical Valley is necessary due to the increased risk of bleeding during and immediately after surgery. It is very important to take Dabigatran etexilate Medical Valley exactly as directed by the doctor both 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 Medical Valley exactly as directed by the doctor both before and after surgery.
- The patient should immediately inform the doctor if numbness or weakness in the legs or problems with the bowels or bladder occur after the anaesthetic wears off, as urgent medical care is required.
if the patient falls or injures themselves during treatment, especially if the head is injured. 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 the doctor, who will decide whether treatment adjustment is needed.

Dabigatran etexilate Medical Valley 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 Medical Valley 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 medicines 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 Medical Valley depending on the condition for which the medicine was prescribed. See section 3.
Medicines used to prevent rejection of transplanted organs (e.g. tacrolimus, cyclosporine).
A fixed-dose combination medicine containing glecaprevir and pibrentasvir (an antiviral medicine used to treat hepatitis C virus infection).
Anti-inflammatory and pain-relieving medicines (e.g. acetylsalicylic acid, ibuprofen, diclofenac).
St John’s wort, a herbal medicine used to treat depression.
Antidepressant medicines known as selective serotonin reuptake inhibitors or serotonin-norepinephrine 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 Medical Valley 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 Medical Valley.
Breastfeeding is not recommended during treatment with Dabigatran etexilate Medical Valley.

Driving and operating machinery
Dabigatran etexilate Medical Valley has no effect or a negligible effect on the ability to drive and operate machinery.

3. How to take Dabigatran etexilate Medical Valley

Dabigatran etexilate Medical Valley capsules can be used in adults and children aged 8 years or older who are able to swallow capsules whole. Other age-appropriate strengths and pharmaceutical forms are available for the treatment of children under 8 years of age.
This medicine should always be taken as prescribed by the doctor. In case of doubt, consult the doctor.
Take Dabigatran etexilate Medical Valley exactly as directed below:
Prevention of blood clots in the 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 blood clots in the veins of the legs and lungs.
The recommended dose is 300 mg taken as one 150 mg capsule twice daily.
In patients aged 80 years or older, the recommended dose is 220 mg taken as one 110 mg capsule twice daily.
Patients taking medicines containing verapamil should receive a reduced dose of Dabigatran etexilate Medical Valley of 220 mg taken as one 110 mg capsule twice daily, due to a possible increased risk of bleeding.
In 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 via a procedure called cardioversion or via a procedure called catheter ablation for atrial fibrillation. Dabigatran etexilate Medical Valley should be taken as directed by the doctor.
In patients undergoing implantation of a medical device (stent) into a blood vessel to maintain its patency using a procedure called percutaneous coronary intervention with stent implantation, treatment with Dabigatran etexilate Medical Valley may be initiated once the physician has confirmed adequate control of blood coagulation. Dabigatran etexilate Medical Valley should be taken as directed by the doctor.
Treatment of blood clots and prevention of recurrent blood clots in children
Dabigatran etexilate Medical Valley 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. The doctor may adjust the dose during treatment. Continue taking all other medications unless the doctor advises otherwise.
Table 1 shows the single and total daily doses of dabigatran etexilate 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 in capsule form

Body weight and age ranges		Single dose in mg	Total daily dose in mg
Body weight in kg	Age in years	Single dose in mg	Total daily dose in mg
from 11 to less than 13 kg	from 8 to less than 9 years	75	150
from 13 to less than 16 kg	from 8 to less than 11 years	110	220
from 16 to less than 21 kg	from 8 to less than 14 years	110	220
from 21 to less than 26 kg	from 8 to less than 16 years	150	300
from 26 to less than 31 kg	from 8 to less than 18 years	150	300
from 31 to less than 41 kg	from 8 to less than 18 years	185	370
from 41 to less than 51 kg	from 8 to less than 18 years	220	440
from 51 to less than 61 kg	from 8 to less than 18 years	260	520
from 61 to less than 71 kg	from 8 to less than 18 years	300	600
from 71 to less than 81 kg	from 8 to less than 18 years	300	600
81 kg or more	from 10 to less than 18 years	300	600

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 Medical Valley
Dabigatran etexilate Medical Valley can be used in adults and children aged 8 years or older who are able to swallow capsules whole.
Dabigatran etexilate Medical Valley may 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.

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

Overdose of Dabigatran etexilate Medical Valley
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 Medical Valley
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 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 treatment with Dabigatran etexilate Medical Valley
Dabigatran etexilate Medical Valley should be taken exactly as prescribed by the doctor.
Do not stop taking this medicine without first consulting your doctor, as the risk of blood clot formation may increase if treatment is stopped prematurely.
Contact your doctor if you experience indigestion after taking Dabigatran etexilate Medical Valley.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Dabigatran etexilate Medical Valley affects the blood coagulation system, therefore most of the adverse reactions involve symptoms such as bruising or bleeding. Severe or profuse 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, these bleedings may not be visible.
If bleeding that does not stop spontaneously or symptoms of excessive bleeding (unusual weakness, fatigue, paleness, dizziness, headache, or unexplained swelling) occur, 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 side effects listed below are grouped according to their frequency of occurrence.

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

Common (may affect 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 ache
Indigestion
Frequent passage of loose or watery stools
Nausea

Uncommon (may affect 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 (a substance in red blood cells)
Allergic reaction
Sudden change in skin colour and appearance
Itching
Stomach or intestinal ulcer (including oesophageal ulceration)
Inflammation of the oesophagus and stomach
Regurgitation of stomach contents into the oesophagus (reflux)
Vomiting
Difficulty swallowing
Abnormal liver function test results in laboratory analyses

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

Bleeding into a joint, from a surgical incision site, from a wound, from an injection site, or from the site of insertion of a venous catheter
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, occurring as a result of 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 disorders

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 myocardial infarctions with dabigatran use was higher than with warfarin use. The overall incidence was low.

Treatment of venous thrombosis in legs and lungs, and prevention of recurrence of venous thrombosis in legs and lungs

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

Bleeding
Bleeding may occur into a joint or following injury
Bleeding from haemorrhoids may occur
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 ache
Frequent passage of loose or watery stools
Abnormal liver function test results in laboratory analyses
Increased liver enzyme activity

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

Bleeding from a surgical incision site, or from an injection site or site of insertion of a venous catheter, or bleeding into the brain
Decrease in the number of platelets in the blood
Severe allergic reaction causing difficulty breathing or dizziness
Severe allergic reaction causing swelling of the face or throat
Skin rash characterized by dark red, raised, itchy bumps, occurring as a result of 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 (a 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 disorders
Hair loss

In clinical trials, the number of myocardial infarctions with dabigatran use was higher than with warfarin use. The overall incidence was low. No difference in the number of myocardial infarctions was observed in patients treated with dabigatran compared to patients receiving placebo.

Treatment of blood clots and prevention of recurrence of blood clots in children

Common (may affect 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, occurring as a result of an allergic reaction
Sudden change in skin colour and appearance
Formation of bruises (haematomas)
Nosebleeds
Regurgitation of stomach contents into the oesophagus (reflux)
Vomiting
Nausea
Frequent passage of loose or watery stools
Indigestion
Hair loss
Increased liver enzyme activity

Uncommon (may affect 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 (a substance in red blood cells)
Decrease in blood cell count
Itching
Coughing up blood or blood-stained sputum
Abdominal pain or stomach ache
Inflammation of the oesophagus and stomach
Allergic reaction
Difficulty swallowing
Yellowing of the skin or whites of the eyes due to liver or blood disorders

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

Absence of white blood cells (which help fight infections)
Severe allergic reaction causing difficulty breathing or dizziness
Severe allergic reaction causing swelling of the face or throat
Difficulty breathing or wheezing
Bleeding
Bleeding may occur into a joint, from a wound, from a surgical incision site, from an injection site, or from the site of insertion of a venous catheter
Bleeding from haemorrhoids may occur
Stomach or intestinal ulcer (including oesophageal ulceration)
Abnormal liver function test results in laboratory analyses

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Dabigatran etexilate Medical Valley

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or blister pack following:
"Expiry date (EXP)". The expiry date refers to the last day of the stated month.
Aluminium-Aluminium (OPA/Aluminium/PVC//Aluminium) foil blisters: Do not store above 30°C.
Aluminium blisters with moisture-absorbing coating - Aluminium (OPA/Aluminium/PE//PE/Aluminium/LDPE): No special storage instructions for this medicine.
White HDPE bottle: Store in the original packaging to protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Dabigatran etexilate Medical Valley contains

The active substance is dabigatran etexilate. Each hard capsule contains dabigatran etexilate in the form of mesilate, corresponding to 150 mg of dabigatran etexilate.

The other ingredients are:

Capsule contents: tartaric acid (in the form of pellets), hypromellose, hydroxypropylcellulose, talc.
Capsule shell: indigo carmine, aluminium lake of indigo carmine (E 132), carrageenan, potassium chloride, titanium dioxide (E 171), hypromellose.

What Dabigatran etexilate Medical Valley looks like and contents of the pack
Capsules of size 0, approximately 22 mm long, with a light blue, opaque cap and a white, opaque body, filled with pellets ranging from white to pale yellow in colour.
The capsules are packed in blisters made of moisture-absorbing aluminium foil – Aluminium (OPA/Aluminium/PE//PE/Aluminium/LDPE) and aluminium blisters – Aluminium (OPA/Aluminium/PVC//Aluminium), or in a white HDPE bottle with a moisture absorber in the form of silica gel in the cap (PP).
Pack sizes:
Blisters containing 10, 30, 30x1 (unit dose blister), 60, 60x1 (unit dose blister), 100 and 180 hard capsules, in cardboard boxes.
Bottle containing 100 hard capsules, in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Medical Valley Invest AB
Brädgårdsvägen 28
236 32 Höllviken
Sweden
email: [email protected]

Importer/Manufacturer
Laboratorios Liconsa S.A
Avda. Miralcampo 7
Polígono Industrial Miralcampo
Azuqueca de Henares
19200 Guadalajara
Spain

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Croatia: Dabigatraneteksilat Liconsa 150 mg tvrde kapsule
Denmark: Dabigatran etexilate Medical Valley
Spain: Dabigatran etexilate Liconsa 150 mg
Netherlands: Dabigatran etexilaat Xiromed 150 mg harde capsules
Iceland: Dabigatran etexilate Medical Valley 150 mg hörð hylki
Ireland: Dabigatran Etexilate Rowa 150 mg hard capsules
Germany: Dabigatranetexilat AXiromed 150 mg Hartkapseln
Norway: Dabigatran etexilate Medical Valley
Poland: Dabigatran etexilate Medical Valley
Romania: Dabigatran etexilate Liconsa 150 mg capsule
Sweden: Dabigatran etexilate Medical Valley 150 mg hårda kapslar