DABIGATRAN ETEXILATE ADAMED 110 mg HARD CAPSULES

Introduction

Package Leaflet:information for the patient

Dabigatran etexilate Adamed110 mg hard capsules EFG

Read all of this leaflet carefully before you start taking this medicine,because it contains important information for you.

• Keep this leaflet, you may need to read it again.

• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Dabigatran etexilate Adamed is and what it is used for
2. What you need to know before you take Dabigatran etexilate Adamed
3. How to take Dabigatran etexilate Adamed
4. Possible side effects

5 Storage of Dabigatran etexilate Adamed

1. Contents of the pack and other information

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

Dabigatran etexilate Adamed contains the active substance dabigatran etexilate and belongs to a group of medicines called anticoagulants. It works by blocking a substance in the body involved in the formation of blood clots.

Dabigatran etexilate is used in adults to:

• prevent the formation of blood clots in the veins after a knee or hip replacement operation.

• prevent the formation of blood clots in the brain (stroke) and in other blood vessels of the

body if you have a type of irregular heartbeat called non-valvular atrial fibrillation and have at least one additional risk factor.

• treat blood clots in the veins of your legs and lungs and to prevent them from happening again in the veins of your legs and lungs.

Dabigatran etexilate is used in children aged 8 years and older to:

• treat blood clots and prevent them from happening again.

2. What you need to know before you take Dabigatran etexilate Adamed

Do not takeDabigatran etexilate Adamed

• if you are allergic to dabigatran etexilate or any of the other ingredients of this medicine (listed in section 6).
• if your kidney function is severely reduced.
• if you are currently bleeding.
• if you have any disease in an organ of the body that increases the risk of serious bleeding (e.g. stomach ulcer, injury or bleeding in the brain, recent brain or eye surgery).

if you are prone to bleeding. This tendency may be inherited, of unknown cause or caused by other medicines.

• if you are taking medicines to prevent blood clots (e.g. warfarin, rivaroxaban, apixaban or heparin), except when switching from one anticoagulant treatment to another, while having a venous or arterial catheter and being given heparin through this catheter to keep it open or while your normal heart rhythm is being restored by a procedure called catheter ablation for atrial fibrillation.

if your liver function is severely reduced or you have a life-threatening liver disease.

• if you are taking oral ketoconazole or itraconazole, medicines used to treat fungal infections.
• if you are taking oral ciclosporin, a medicine used to prevent organ rejection after a transplant.

if you are taking dronedarone, a medicine used to treat irregular heartbeat.

• if you are taking a combination product of glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C.

if you have been implanted with an artificial heart valve that requires permanent anticoagulant treatment.

Warnings and precautions

Consult your doctor before starting to take this medicine. During treatment with this medicine, you may also need to consult your doctor if you experience any symptoms or if you need to undergo surgery.

Tell your doctorif you have or have had any disorder or disease, especially any of the following:

• If you have an increased risk of bleeding, for example:
• if you have recently had bleeding.
• if you have had surgical removal of tissue (biopsy) in the last month.
• if you have had a serious injury (e.g. a bone fracture, a head injury or any injury that required surgical treatment).

• if you have inflammation of the oesophagus or stomach.
• if you have problems with stomach acid flowing back into the oesophagus.
• if you are taking medicines that may increase the risk of bleeding. See "Other medicines and Dabigatran etexilate Adamed" below.

• if you are using anti-inflammatory medicines such as diclofenac, ibuprofen or piroxicam.

if you have an infection of the heart (bacterial endocarditis).

• if you know you have reduced kidney function, or if you are dehydrated (symptoms include feeling thirsty and passing small amounts of dark-coloured urine [concentrated]/with foam).

if you are over 75 years old.

• if you are an adult patient and weigh 50 kg or less.
• only if used in children: if the child has an infection in the brain or around it.

• If you have had a heart attack or if you have been diagnosed with diseases that increase the risk of having a heart attack.

if you have a liver disease associated with changes in blood tests. The use of this medicine is not recommended in this case.

Be careful withDabigatran etexilate Adamed

• If you need to have an operation:

In this case, dabigatran etexilate must be temporarily stopped due to an increased risk of bleeding during and shortly after an operation. It is very important that you take dabigatran etexilate before and after the operation exactly at the times indicated by your doctor.

• If an operation requires the insertion of a catheter or an injection into the spinal column (e.g. for epidural or spinal anaesthesia or for pain relief):

• It is very important that you take dabigatran etexilate before and after the operation exactly at the times indicated by your doctor.
• Tell your doctor immediately if you experience numbness or weakness in your legs or bowel or bladder problems after the anaesthesia has ended, as this situation requires urgent attention.

if you fall or injure yourself during treatment, especially if you hit your head. Seek urgent medical attention. You may need a doctor to examine you, as you may have a higher risk of bleeding.

• if you know you have a disease called antiphospholipid syndrome (a disorder of the immune system that increases the risk of blood clots), inform your doctor so that they can decide whether it may be necessary to modify the treatment.

Other medicines andDabigatran etexilate Adamed

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular, you must tell your doctor before taking dabigatran etexilate if you are taking any of the following medicines:

• Medicines to reduce blood clotting (e.g. warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid)

• Medicines for the treatment of fungal infections (e.g. ketoconazole, itraconazole), except if only applied to the skin
• Medicines used in the treatment of irregular heartbeat (e.g. amiodarone, dronedarone, quinidine, verapamil)

If you are taking medicines containing amiodarone, quinidine or verapamil, your doctor may instruct you to use a reduced dose of this medicine depending on the disease for which it has been prescribed. See section 3.

• Medicines for the prevention of organ rejection after a transplant (e.g. tacrolimus, ciclosporin)

• A combination product of glecaprevir and pibrentasvir (an antiviral medicine used to treat hepatitis C)
• Pain-relieving and anti-inflammatory medicines (e.g. acetylsalicylic acid, ibuprofen, diclofenac)

• St. John's Wort, a herbal medicine for depression
• Antidepressant medicines called selective serotonin reuptake inhibitors or selective serotonin and norepinephrine reuptake inhibitors
• Rifampicin or clarithromycin (two antibiotics)
• Antiviral medicines for HIV (e.g. ritonavir)
• Certain medicines for the treatment of epilepsy (e.g. carbamazepine, phenytoin)

Pregnancy and breast-feeding

The effects of dabigatran etexilate on pregnancy and the fetus are not known. You should not use this medicine if you are pregnant unless your doctor advises you that it is safe to do so. If you are of childbearing age, you should avoid becoming pregnant during treatment with dabigatran etexilate.

Breast-feeding is not recommended during treatment with dabigatran etexilate.

Driving and using machines

Dabigatran etexilate has no known effects on the ability to drive and use machines.

3. How to take Dabigatran etexilate Adamed

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

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor again.

Take Dabigatran etexilate Adamedas recommended for the following situations:

Prevention of blood clot formation after knee or hip arthroplasty

The recommended dose is 220 mg once a day(administered in the form of 2 capsules of 110 mg).

If your renal function is decreasedby more than half or if you are 75 years of age or older, the recommended dose is 150 mg once a day(administered in the form of 2 capsules of 75 mg).

If you are taking medications containing amiodarone, quinidine, or verapamil, the recommended dose is 150 mg once a day(administered in the form of 2 capsules of 75 mg).

If you are taking medications containing verapamil and your renal function is decreasedby more than half, you should be indicated a reduced dose of dabigatran etexilate of 75 mgbecause your risk of bleeding may increase.

In both types of surgery, treatment should not be started if there is bleeding at the surgical site. If treatment cannot be started until the day after the operation, dosing should be started with 2 capsules once a day.

After knee arthroplasty

You should start treatment with dabigatran etexilate 1-4 hours after the operation, taking a single capsule. Afterward, 2 capsules should be taken once a day for a total of 10 days.

After hip arthroplasty

You should start treatment with dabigatran etexilate 1-4 hours after the operation, taking a single capsule. Afterward, 2 capsules should be taken once a day for a total of 28-35 days.

Preventionof cerebral or systemic vascular obstructionby blood clot formationdeveloped after abnormal heart rhythmand treatment of blood clots in the veins of your legs and lungs, including prevention of recurrence of blood clots in the veins of your legs and lungs

The recommended dose is 300 mg administeredin the form of one 150 mg capsule twice a day.

If you are 80 years of age or older, the recommended dose is 220 mg administeredin the form of one 110 mg capsule twice a day.

If you are taking medications containing verapamil, you should be indicated a reduced dose of dabigatran etexilate of 220 mgtaken in the form of one 110 mg capsule twice a day, because your risk of bleeding may increase.

If you have a potentially higher risk of bleeding, your doctor may decide to prescribe a dose of 220 mgadministered in the form of one 110 mg capsule twice a day.

You can continue taking this medication if it is necessary to restore your normal heart rhythm through a procedure called cardioversion. Take dabigatran etexilate as your doctor has indicated.

If you have been fitted with a medical device (vascular endoprosthesis) in a blood vessel to keep it open in a procedure called percutaneous coronary intervention with vascular endoprosthesis placement, you may receive treatment with dabigatran etexilate once your doctor has decided that normal blood coagulation control has been achieved. Take dabigatran etexilate as your doctor has indicated.

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

Dabigatran etexilateshould be taken twice a day, one dose in the morning and one dose in the evening, approximately at the same time every day. The administration interval should be as close as possible to 12 hours.

The recommended dose depends on weight and age. Your doctor will determine the correct dose. It is possible that your doctor will adjust the dose during treatment. Continue using all other medications unless your doctor indicates that you should stop using one.

Table 1 shows the single doses and total daily doses of dabigatran etexilate in milligrams (mg). The doses depend on the patient's weight in kilograms (kg) and age in years.

Table 1: Dosage table for Dabigatran etexilate capsules

Doses that require combinations of more than one capsule:

300 mg: two 150 mg capsules or four 75 mg capsules

260 mg: one 110 mg capsule plus one 150 mg capsule or one 110 mg capsule plus two 75 mg capsules

220 mg: two 110 mg capsules

185 mg: one 75 mg capsule plus one 110 mg capsule

150 mg: one 150 mg capsule or two 75 mg capsules

How to takeDabigatran etexilate Adamed

Dabigatran etexilate can be taken with or without food. The capsule should be swallowed whole with a glass of water to ensure release in the stomach. Do not break, chew, or open the capsule to take only its contents, as this may increase the risk of bleeding.

Change of anticoagulant treatment

Do not change your anticoagulant treatment without specific instructions from your doctor.

If you take moreDabigatran etexilate Adamedthan you should

Taking too much of this medication increases the risk of bleeding. Contact your doctor immediately if you have taken too many capsules. There are specific treatment options available.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to takeDabigatran etexilate Adamed

Prevention of blood clot formation after knee or hip arthroplasty

Take the remaining daily doses of dabigatran etexilate at the same time the next day.

Do not take a double dose to make up for forgotten doses.

Adult use: Prevention of cerebral or systemic vascular obstruction by blood clot formation developed after abnormal heart rhythm and treatment of blood clots in the veins of your legs and lungs, including prevention of recurrence of blood clots in the veins of your legs and lungs

Children use: Treatment of blood clots and prevention of recurrence of blood clots

A forgotten dose can be taken up to 6 hours before the next dose.

A forgotten dose should be omitted if the time remaining before the next dose is less than 6 hours.

Do not take a double dose to make up for forgotten doses.

If you interrupt treatment withDabigatran etexilate Adamed

Take dabigatran etexilate exactly as prescribed. Do not interrupt your treatment with this medication without consulting your doctor first, as the risk of developing a blood clot may be higher if you interrupt treatment too soon.

Contact your doctor if you experience indigestion after taking dabigatran etexilate.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Dabigatran etexilate acts on blood coagulation; therefore, most adverse effects are related to signs such as bruising or bleeding.

Episodes of major or severe bleeding may occur, which are the most serious adverse effects and, regardless of their location, can cause disability, be potentially life-threatening, or even cause death. In some cases, these bleedings may not be apparent.

If you experience any episode of bleeding that does not stop on its own or if you experience signs of excessive bleeding (exceptional weakness, fatigue, paleness, dizziness, headache, or unexplained swelling), consult your doctor immediately. Your doctor may decide to keep you under close observation or change your medication.

Inform your doctor immediately if you experience a severe allergic reaction that causes

difficulty breathing or dizziness.

The possible adverse effects are detailed below, grouped according to their frequency.

Prevention of blood clot formation after knee or hip replacement surgery

Frequent (may affect up to 1 in 10 people):

• Decrease in the amount of hemoglobin in the blood (the substance present in red blood cells)
• Anomalies in liver function tests

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

• Bleeding may occur from the nose, stomach, or intestine, from the penis/vagina or urinary tract (including blood in the urine that stains the urine pink or red), or under the skin
• Formation of hematomas or bruising after surgery
• Detection of blood in stool in a laboratory test
• Decrease in the number of red blood cells in the blood
• Decrease in the proportion of blood cells
• Allergic reaction
• Vomiting
• Frequent loose or liquid stools
• Feeling of nausea
• Purulent discharge from a wound (secretion of fluid from a surgical wound)
• Increased liver enzymes
• Yellowish discoloration of the skin or whites of the eyes, caused by liver or blood problems

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

• Bleeding
• Bleeding may occur in the brain, at the site of a surgical incision, at the site of an injection, or at the site of a catheter in a vein
• Purulent discharge from the site of a catheter in a vein
• Coughing up blood or sputum with blood spots
• Decrease in the number of platelets in the blood
• Decrease in the number of red blood cells in the blood after surgery
• Severe allergic reaction that causes difficulty breathing or dizziness
• Severe allergic reaction that causes swelling of the face or throat
• Skin rash with dark red, prominent, and itchy bumps, caused by an allergic reaction
• Sudden change in skin color and physical appearance
• Itching
• Ulcer in the stomach or intestine (including ulcer in the esophagus)
• Inflammation of the esophagus and stomach
• Reflux of gastric juice into the esophagus
• Abdominal pain or stomach pain
• Indigestion
• Difficulty swallowing
• Fluid leaking from a wound
• Fluid leaking from a wound after surgery

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

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

Prevention of cerebral or systemic vascular obstruction by blood clot formation

developed after abnormal heart rhythm

Frequent (may affect up to 1 in 10 people):

• Bleeding may occur from the nose, stomach, or intestine, from the penis/vagina or urinary tract (including blood in the urine that stains the urine pink or red), or under the skin
• Decrease in the number of red blood cells in the blood
• Abdominal pain or stomach pain
• Indigestion
• Frequent loose or liquid stools
• Feeling of nausea

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

• Bleeding
• Bleeding may occur from hemorrhoids, rectum, or brain
• Formation of hematomas
• Coughing up blood or sputum with blood spots
• Decrease in the number of platelets in the blood
• Decrease in the amount of hemoglobin in the blood (the substance present in red blood cells)

• Allergic reaction
• Sudden change in skin color and physical appearance
• Itching
• Ulcer in the stomach or intestine (including ulcer in the esophagus)
• Inflammation of the esophagus and stomach
• Reflux of gastric juice into the esophagus
• Vomiting
• Difficulty swallowing
• Anomalies in liver function tests

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

• Bleeding may occur in a joint, at the site of a surgical incision, in a wound, at the site of an injection, or at the site of a catheter in a vein

• Severe allergic reaction that causes difficulty breathing or dizziness
• Severe allergic reaction that causes swelling of the face or throat
• Skin rash with dark red, prominent, and itchy bumps, caused by an allergic reaction
• Decrease in the proportion of blood cells
• Increased liver enzymes
• Yellowish discoloration of the skin or whites of the eyes, caused by liver or blood problems

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

• Difficulty breathing or wheezing
• Decrease in the number or even absence of white blood cells (which help fight infections)

• Hair loss

In a clinical trial, the rate of heart attacks with dabigatran etexilate was numerically higher than with warfarin. The overall incidence was low.

Treatment of blood clots in the veins of the legs and lungs, including

prevention of recurrence of blood clots in the veins of the legs and/or lungs

Frequent (may affect up to 1 in 10 people):

• Bleeding may occur from the nose, stomach, or intestine, from the rectum, penis/vagina, or urinary tract (including blood in the urine that stains the urine pink or red), or under the skin
• Indigestion

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

• Bleeding
• Bleeding may occur in a joint or in a wound
• Bleeding may occur from hemorrhoids
• Decrease in the number of red blood cells in the blood
• Formation of hematomas
• Coughing up blood or sputum with blood spots
• Allergic reaction
• Sudden change in skin color and physical appearance
• Itching
• Ulcer in the stomach or intestine (including ulcer in the esophagus)
• Inflammation of the esophagus and stomach
• Reflux of gastric juice into the esophagus
• Feeling of nausea
• Vomiting
• Abdominal pain or stomach pain
• Frequent loose or liquid stools
• Anomalies in liver function tests
• Increased liver enzymes

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

• Bleeding may occur at the site of a surgical incision, at the site of an injection, or at the site of a catheter in a vein, or from the brain

• Decrease in the number of platelets in the blood
• Severe allergic reaction that causes difficulty breathing or dizziness
• Severe allergic reaction that causes swelling of the face or throat
• Skin rash with dark red, prominent, and itchy bumps, caused by an allergic reaction
• Difficulty swallowing

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

• Difficulty breathing or wheezing
• Decrease in the amount of hemoglobin in the blood (the substance present in red blood cells)
• Decrease in the proportion of blood cells
• Decrease in the number or even absence of white blood cells (which help fight infections)
• Yellowish discoloration of the skin or whites of the eyes, caused by liver or blood problems
• Hair loss

In the clinical trial program, the rate of heart attacks with dabigatran etexilate was higher than with warfarin. The overall incidence was low. No imbalance in the rate of heart attacks was observed in patients treated with dabigatran compared to patients treated with placebo.

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

Frequent (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 with dark red, prominent, and itchy bumps, caused by an allergic reaction
• Sudden change in skin color and physical appearance
• Formation of hematomas
• Nasal bleeding
• Reflux of gastric juice into the esophagus
• Vomiting
• Feeling of nausea
• Frequent loose or liquid stools
• Indigestion
• Hair loss
• Increased liver enzymes

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

• Decrease in the number of white blood cells (which help fight infections)
• Bleeding may occur in the stomach or intestine, brain, rectum, penis/vagina, or urinary tract (including blood in the urine that stains the urine pink or red), or under the skin
• Decrease in the amount of hemoglobin in the blood (the substance present in red blood cells)
• Decrease in the proportion of blood cells
• Itching
• Coughing up blood or sputum with blood spots
• Abdominal pain or stomach pain
• Inflammation of the esophagus and stomach
• Allergic reaction
• Difficulty swallowing
• Yellowish discoloration of the skin or whites of the eyes, caused by liver or blood problems

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

• Absence of white blood cells (which help fight infections)
• Severe allergic reaction that causes difficulty breathing or dizziness
• Severe allergic reaction that causes swelling of the face or throat
• Difficulty breathing or wheezing
• Bleeding
• Bleeding may occur in a joint or in a wound, in a surgical incision, at the site of an injection, or at the site of a catheter in a vein
• Bleeding may occur from hemorrhoids
• Ulcer in the stomach or intestine (including ulcer in the esophagus)
• Anomalies in liver function tests

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Dabigatran Etexilate Adamed

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date stated on the carton or blister after "EXP". The expiration date is the last day of the month indicated.

Do not store above 30°C. Store in the original packaging to protect from light and moisture.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package Contents and Additional Information

Composition ofDabigatran Etexilate Adamed

The active ingredient is dabigatran. Each hard capsule contains 110 mg of dabigatran etexilate (in the form of mesilate).

The other ingredients are tartaric acid, arabic gum, hypromellose, dimethicone, talc, and hydroxypropylcellulose.

The capsule shell contains carrageenan, potassium chloride, titanium dioxide (E171), indigo carmine (E132), water, and hypromellose.

The black printing ink contains shellac, iron oxide black (E172), and potassium hydroxide.

Appearance and Package Contents of the Product

Dabigatran Etexilate Adamed 110 mg is presented in the form of hard capsules with a blue opaque cap with "D110" printed in black and a blue opaque body, which contain yellowish granules.

This medicine is presented in cardboard boxes containing 10, 30, 60, 100, or 180 hard capsules in blisters of Polyamide/Aluminum/PVC//Aluminum.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Adamed Pharma S.A.

ul. M. Adamkiewicza 6A, Pienków

05-152 Czosnów

Poland

Manufacturer

Adamed Pharma S.A.

Ul. Marszalka Jósefa Pilsudskiego 5

95-200 Pabianice, Lodzkie

Poland

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of the last revision of thisleaflet: February 2024

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)