Dabigatran etexilate Normon 150 mg hard capsules EFG

Patient Information Leaflet

Introduction

Package Leaflet: Information for the Patient

Dabigatran Etexilate Normon 150 mg Hard Capsules EFG

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

• Keep this patient information leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only; do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Package leaflet contents

1. What Dabigatran etexilate Normon is and what it is used for
2. What you need to know before taking Dabigatran etexilate Normon
3. How to take Dabigatran etexilate Normon
4. Possible side effects
5. Storage of Dabigatran etexilate Normon
6. Contents of the pack and other information

1. What Dabigatrán etexilato Normon is and what it is used for

Dabigatrán etexilato Normon contains the active substance dabigatrán etexilato and belongs to a group of medicines called anticoagulants. It works by blocking a substance in the body involved in blood clot formation.

Dabigatrán etexilato is used in adults for:

• preventing 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.

• treating blood clots in the veins of your legs and lungs and to prevent the recurrence of blood clots in the veins of your legs and lungs.

Dabigatrán etexilato is used in children for:

• treating blood clots and preventing the recurrence of blood clots.

2. What you need to know before starting to take Dabigatran etexilate Normon

Do not take Dabigatran etexilate Normon

• if you are allergic to dabigatran etexilate or to any of the other ingredients of this medicine (listed in section 6).
• if your kidney function is severely reduced.
• if you are currently experiencing bleeding.
• if you have a disease in any organ of the body that increases the risk of serious bleeding (e.g., stomach ulcer, brain injury or intracranial hemorrhage, recent brain or eye surgery).
• if you are prone to bleeding. This tendency may be congenital, of unknown cause, or caused by other medicines.
• if you are taking medications to prevent blood clots (e.g., warfarin, rivaroxaban, apixaban, or heparin), except when switching between anticoagulant treatments, while you have a venous or arterial catheter and heparin is administered 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 impaired or if you have a liver disease that could be life-threatening.
• if you are taking oral ketoconazole or itraconazole, medicines used to treat fungal infections.
• if you are taking oral cyclosporine, a medicine used to prevent organ rejection after transplantation.
• if you are taking dronedarone, a medicine used to treat abnormal heart rhythm.
• if you are taking a combination product containing glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C.
• if you have had an artificial heart valve implanted that requires lifelong anticoagulant therapy.

Warnings and precautions

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

Inform your doctor if you currently have or have previously had any disorder or illness, especially any of the following:

• If you have an increased risk of bleeding, for example:

  • • if you have recently experienced bleeding.
  • • if you have undergone a surgical tissue removal (biopsy) within the last month.
  • • if you have suffered a severe injury (e.g., bone fracture, head injury, or any injury requiring surgical treatment).
  • • if you have inflammation of the esophagus or stomach.
  • • if you have problems with gastric juice reflux into the esophagus.
  • • if you are taking medications that may increase the risk of bleeding. See "Other medicines and Dabigatrán etexilato Normon" below.
  • • if you are using anti-inflammatory medicines such as diclofenac, ibuprofen, or piroxicam.
  • • if you have an infection in 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-colored [concentrated]/foamy urine).
  • • if you are over 75 years old.
  • • if you are an adult patient weighing 50 kg or less.
  • • only when used in children: if the child has an infection in or around the brain.

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

• If you have a liver disease associated with changes in blood test results. The use of this medicine is not recommended in such cases.

Exercise special caution with Dabigatran etexilate Normon

• if you need to undergo surgery:

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

• if surgery requires the placement of a catheter or an injection into the spinal column (e.g., for epidural or spinal anesthesia or for pain relief):

  • it is very important that you take Dabigatran etexilate before and after surgery exactly at the times indicated by your doctor.
  • inform your doctor immediately if you experience numbness or weakness in the legs or bowel or bladder problems after the anesthesia wears off, as this situation requires urgent medical attention.

• if you fall or suffer an injury during treatment, especially if you hit your head. Seek urgent medical assistance. You may need to be examined by a doctor, as you may have an increased risk of bleeding.

• if you know you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor so they can decide whether your treatment needs to be adjusted.

Other medicines and Dabigatran etexilate Normon

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. In particular, you must inform 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 when applied only to the skin
• Medicines used in the treatment of abnormal heart rhythm (e.g., amiodarone, dronedarone, quinidine, verapamil)

If you are taking medicines containing verapamil, your doctor may instruct you to use a reduced dose of Dabigatran etexilate depending on the condition for which it has been prescribed. See section 3.

• Medicines used to prevent organ rejection after transplantation (e.g., tacrolimus, cyclosporine)

• A combination product of glecaprevir and pibrentasvir (an antiviral medicine used to treat hepatitis C)

• Anti-inflammatory and pain-relieving medicines (e.g., acetylsalicylic acid, ibuprofen, diclofenac)

• St. John’s wort, a herbal remedy for depression

• Antidepressant medicines called selective serotonin reuptake inhibitors or serotonin and norepinephrine reuptake inhibitors

• Rifampicin or clarithromycin (two antibiotics)

• Antiviral medicines for AIDS (e.g., ritonavir)

• Certain medicines used to treat epilepsy (e.g., carbamazepine, phenytoin)

Pregnancy and breastfeeding

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

Breastfeeding is not recommended during treatment with Dabigatran etexilate.

Driving and operating machinery

Dabigatran etexilate has no known effects on the ability to drive or operate machinery.

3. How to take Dabigatran etexilate Normon

Dabigatran etexilate capsules can be used in adults and children 8 years of age or older who are able to swallow the capsules whole. Other more appropriate pharmaceutical forms are available for the treatment of children under 8 years of age.

Always follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor again.

Take Dabigatran etexilate as recommended for the following conditions:

Prevention of stroke or systemic embolism due to blood clots caused by 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.

The recommended dose is 300 mg administered as one 150 mg capsule twice daily.

If you are 80 years of age or older, the recommended dose is 220 mg administered as one 110 mg capsule twice daily.

If you are taking medications containing verapamil, you should be prescribed a reduced dose of Dabigatran etexilate of 220 mg taken as one 110 mg capsule twice daily, as your risk of bleeding may increase.

If you have a potentially higher risk of bleeding, your doctor may decide to prescribe you a dose of Dabigatran etexilate of 220 mg administered as one 110 mg capsule twice daily.

You may continue taking this medicine if you require restoration of normal heart rhythm through a procedure called cardioversion or through a catheter ablation procedure for atrial fibrillation. Take Dabigatran etexilate exactly as directed by your doctor.

If you have had a medical device (vascular stent) implanted in a blood vessel to keep it open during a procedure called percutaneous coronary intervention with stent placement, you may receive treatment with this medicine once your doctor has determined that normal blood coagulation control has been achieved. Take Dabigatran etexilate exactly as directed by your doctor.

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

Dabigatran etexilate should be taken twice daily, one dose in the morning and one dose in the evening, approximately at the same time each day. The dosing interval should be as close as possible to 12 hours.

The recommended dose depends on body weight and age. Your doctor will determine the correct dose. Your doctor may adjust your dose during treatment. Continue taking all other medications unless your doctor specifically instructs you to stop any of them.

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: Dosing table for Dabigatran etexilate

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

Single doses requiring 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 take Dabigatran etexilate Normon

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.

Instructions for opening the blister packs

The following images illustrate how to remove the Dabigatran etexilate capsules from the blister pack:

Separate an individual blister from the blister strip along the perforated line.

Peel back the backing foil and remove the capsule.

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

Changing anticoagulant treatment

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

If you take more Dabigatran etexilate Normon than you should

Taking too much of this medicine increases the risk of bleeding. Contact your doctor immediately if you have taken too many Dabigatran etexilate capsules. Specific treatment options are available.

In case of overdose or accidental ingestion, consult your doctor or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Dabigatran etexilate Normon

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

A missed dose should be omitted if less than 6 hours remain before the next dose. Do not take a double dose to make up for a forgotten dose.

If you interrupt treatment with Dabigatran etexilate Normon

Take Dabigatran etexilate exactly as prescribed for you. Do not stop your treatment with Dabigatran etexilate without first consulting your doctor, as the risk of developing a blood clot may be higher if you stop treatment too early.

Contact your doctor if you experience indigestion after taking this medicine.

If you have any further questions about the use of this medicine, ask 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 acts on blood coagulation; therefore, most adverse effects are related to signs such as bruising or bleeding.

Major or serious bleeding episodes may occur, which represent the most serious adverse effects and, regardless of their location, may lead to disability, may be potentially fatal, or even result in death. In some cases, these bleedings may not be evident.

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

Inform your doctor immediately if you experience a severe allergic reaction causing difficulty in breathing or dizziness.

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

Prevention of stroke or systemic embolism due to blood clots occurring after irregular heartbeat

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

• Bleeding may occur from the nose, stomach or intestines, penis/vagina, or urinary tract (including blood in urine which may turn urine pink or red), or under the skin
• Decrease in the number of red blood cells in the blood
• Abdominal pain or stomach ache
• Indigestion
• Frequent loose or watery stools
• Feeling nauseous

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

• Bleeding
• Bleeding may occur from hemorrhoids, rectum, or brain
• Bruising
• Coughing up blood or sputum with blood streaks
• 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 the skin affecting color and physical appearance
• Itching
• Ulcer in the stomach or intestines (including esophageal ulcer)
• Inflammation of the esophagus and stomach
• Gastric juice reflux into the esophagus
• Vomiting
• Difficulty swallowing
• Abnormal liver function tests

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

• Bleeding may occur in a joint, at a surgical incision site, at a wound, at the site of an injection, or at 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 with dark red, raised, itchy bumps caused by an allergic reaction
• Decrease in blood cell count
• Increased liver enzymes
• Yellowing 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 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 your legs and lungs, including prevention of recurrence of blood clots in the veins of your legs and/or lungs

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

• Bleeding may occur from the nose, stomach or intestines, rectum, penis/vagina, or urinary tract (including blood in urine which may turn 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 wound
• Bleeding may occur from hemorrhoids
• Decrease in the number of red blood cells in the blood
• Bruising
• Coughing up blood or sputum with blood streaks
• Allergic reaction
• Sudden change in the skin affecting color and physical appearance
• Itching
• Ulcer in the stomach or intestines (including esophageal ulcer)
• Inflammation of the esophagus and stomach
• Gastric juice reflux into the esophagus
• Feeling nauseous
• Vomiting
• Abdominal pain or stomach ache
• Frequent loose or watery stools
• Abnormal liver function tests
• Increased liver enzymes

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

• Bleeding may occur at a surgical incision site, at the site of an injection, at 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 with dark red, raised, 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 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, 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 warfarina. 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

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 with dark red, raised, itchy bumps caused by an allergic reaction
• Sudden change in the skin affecting color and physical appearance
• Bruising
• Nosebleeds
• Gastric juice reflux into the esophagus
• Vomiting
• Feeling nauseous
• Frequent loose or watery 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 intestines, brain, rectum, penis/vagina, or urinary tract (including blood in urine which may turn 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 blood cell count
• Itching
• Coughing up blood or sputum with blood streaks
• Abdominal pain or stomach ache
• Inflammation of the esophagus and stomach
• Allergic reaction
• Difficulty swallowing
• Yellowing 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 causing difficulty breathing or dizziness
• Severe allergic reaction causing swelling of the face or throat
• Difficulty breathing or wheezing
• Bleeding
• Bleeding may occur in a joint or wound, at a surgical incision site, at the site of an injection, or at the site where a venous catheter was inserted
• Bleeding may occur from hemorrhoids
• Ulcer in the stomach or intestines (including esophageal ulcer)
• Abnormal liver function tests

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is an adverse reaction not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaRAM.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Dabigatran Etexilate Normon

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

Do not use this medicine after the expiry date which is stated on the carton or blister after “EXP”. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Keep in the original packaging to protect from moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point located at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Dabigatran Etexilate Normon

The active substance is dabigatran. Each hard capsule contains 172.95 mg of dabigatran etexilate (as mesilate) equivalent to 150 mg of dabigatran etexilate.

• The other components are tartaric acid, arabic gum, hypromellose 2910, dimethicone 350, talc, and hydroxypropylcellulose.

• The capsule shell contains carrageenan, potassium chloride, titanium dioxide (E-171), hypromellose 2910, and indigo carmine (E-132).

Appearance of the Product and Contents of the Package

Dabigatran etexilate Normon 150 mg are hard capsules with a blue cap and a white to off-white body, size 0, containing off-white to pale yellow pellets.

This medicine is available in packages containing 10, 30, or 60 hard capsules in single-dose blisters made of perforated aluminum/OPA-ALU-PVC.

A multiple pack containing 3 packages of 60 hard capsules (180 hard capsules) or a multiple pack containing 2 packages of 50 hard capsules (100 hard capsules) in single-dose blisters made of perforated aluminum/OPA-ALU-PVC.

Only certain package sizes may be marketed.

Marketing Authorization Holder and Manufacturing Responsible Party

Marketing Authorization Holder:

Laboratorios Normon, S.A.

Ronda de Valdecarrizo, 6

Tres Cantos, 28760, Madrid

Manufacturers:

Galenicum health, s.l.u.

Sant Gabriel, 50

08950 – Esplugues de Llobregat (Barcelona)

Spain

O

Sag manufacturing s.l.u

Highway N-i, km 36

28750 San Agustín de Guadalix,

Madrid – Spain

Date of the last approval of this leaflet: 12/2023

Detailed information about this medicinal product is available on the website of the Spanish Agency of Medicaments and Medical Devices (AEMPS) (http://www.aemps.gob.es/).