Dabigatran etexilate Normon 110 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Dabigatran etexilate Normon 110 mg hard capsules EFG

Read the entire leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this 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, and you should not give it to others, even if they have the same symptoms as you, since 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 starting to take 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 veins after knee or hip replacement surgery.

• preventing the formation of blood clots in the brain (stroke) and in other blood vessels in 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 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 an 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 medicines to prevent blood clots (e.g., warfarin, rivaroxaban, apixaban, or heparin), except when switching anticoagulant therapy, 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 reduced or 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 treatment.

Warnings and precautions

Consult your doctor before starting Dabigatran etexilate. 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 have or have 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 removal of tissue (biopsy) within the last month.
  • if you have suffered a severe injury (e.g., a bone fracture, head injury, or any injury requiring surgical treatment).
  • if you have inflammation of the oesophagus or stomach.
  • if you have problems with gastric juice reflux into the oesophagus.
  • if you are taking medications that may increase the risk of bleeding. See “Other medicines and Dabigatran etexilate 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 suffer from dehydration (symptoms include feeling thirsty and passing small amounts of dark-coloured [concentrated]/foamy urine).
  • if you are over 75 years of age.
  • if you are an adult patient and weigh 50 kg or less.
  • only if used in children: if the child has an infection in or around the brain.

• If you have had a heart attack or if you 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 are undergoing 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 a surgical procedure 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 the surgical procedure exactly at the times indicated by your doctor.
  • inform your doctor immediately if you experience numbness or weakness in the legs or intestinal or bladder problems after the anesthesia wears off, as this situation requires urgent medical attention.

• if you fall or sustain 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 determine 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 Normon 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 to treat abnormal heart rhythm (e.g., amiodarone, dronedarone, quinidine, verapamil)

If you are taking medicines containing amiodarone, quinidine, or verapamil, your doctor may advise you to take a reduced dose of Dabigatran etexilate Normon, 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 containing 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 HIV (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. Dabigatran etexilate must not be used during pregnancy unless your doctor specifically indicates that it is safe to do so. If you are of childbearing age, you must avoid becoming pregnant during treatment with this medication.

Breastfeeding is not recommended during treatment with Dabigatran etexilate.

Driving and operating machinery

Dabigatran etexilate has no known effects on the ability to drive and 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. There are other appropriate pharmaceutical forms according to age for the treatment of children under 8 years of age.

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

Take Dabigatran etexilate as recommended for the following situations:

Prevention of blood clot formation after knee or hip replacement surgery

The recommended dose is 220 mg once daily (administered as 2 capsules of 110 mg).

If your renal function is reduced by more than half or if you are 75 years of age or older, the recommended dose is 150 mg once daily (administered as 2 capsules of 75 mg).

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

If you are taking medications containing verapamil and your renal function is reduced by more than half, you should be prescribed a reduced dose of Dabigatran etexilate of 75 mg, because your risk of bleeding may increase.

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

After knee replacement surgery

Begin treatment with Dabigatran etexilate 1–4 hours after surgery by taking one single capsule. Then take 2 capsules once daily for a total of 10 days.

After hip replacement surgery

Begin treatment with Dabigatran etexilate 1–4 hours after surgery by taking one single capsule. Then take 2 capsules once daily for a total of 28–35 days.

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 such clots

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 of Dabigatran etexilate 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, because 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 it becomes necessary to restore your normal heart rhythm through a procedure called cardioversion. Take Dabigatran etexilate exactly as directed by your doctor.

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

Treatment of blood clots and prevention of recurrent 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 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 are based on patient 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 its release in the stomach. Do not break, chew, or open the capsule to take 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 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 medication and the amount ingested.

If you forget to take Dabigatran etexilate Normon

Prevention of blood clots after knee or hip replacement surgery

Continue with the remaining daily doses of Dabigatran etexilate at the usual time on the following day. Do not take a double dose to make up for a missed dose.

Use in adults: Prevention of cerebral or systemic embolism due to blood clots caused by abnormal heart rhythm, and treatment of venous blood clots in the legs and lungs, including prevention of recurrence of such clots.

Use in children: Treatment of blood clots and prevention of recurrence of blood clots.

A missed dose may 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 missed 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 observation or change your medication.

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

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

Prevention of blood clot formation after knee or hip replacement surgery

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

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

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

• Bleeding may occur from the nose, stomach or intestine, penis/vagina, or urinary tract (including blood in urine turning urine pink or red), from hemorrhoids, rectum, under the skin, from a joint, or at the site of injury or after surgery
• Formation of bruises 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 nauseous
• Wound discharge (leakage 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 venous catheter insertion
• Blood-tinged discharge from the site of a venous catheter insertion
• Coughing up blood or sputum with blood streaks
• 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 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
• Sudden change in the skin affecting color and physical appearance
• Itching
• Ulcer in the stomach or intestine (including esophageal ulcer)
• Inflammation of the esophagus and stomach
• Reflux of gastric juice into the esophagus
• Abdominal pain or stomach ache
• Indigestion
• Difficulty swallowing
• Fluid discharge from a wound
• Fluid discharge 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 leukocytes (which help fight infections)
• Hair loss

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

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

• Bleeding may occur from the nose, stomach or intestine, penis/vagina, urinary tract (including blood in urine turning 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 liquid 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 intestine (including esophageal ulcer)
• Inflammation of the esophagus and stomach
• Reflux of gastric juice into the esophagus
• Vomiting
• Difficulty swallowing
• Abnormalities 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, at a wound, at the site of an injection, or at the site of a venous catheter insertion
• 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 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 leukocytes (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 intestine, rectum, penis/vagina, urinary tract (including blood in urine turning 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 intestine (including esophageal ulcer)
• Inflammation of the esophagus and stomach
• Reflux of gastric juice into the esophagus
• Feeling nauseous
• Vomiting
• Abdominal pain or stomach ache
• Frequent loose or liquid stools
• Abnormalities 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, at the site of a venous catheter insertion, 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 the proportion of blood cells
• Decrease in the number or even absence of leukocytes (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 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
• Nasal bleeding
• Reflux of gastric juice into the esophagus
• Vomiting
• Feeling nauseous
• 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 leukocytes (which help fight infections)
• Bleeding may occur in the stomach or intestine, brain, rectum, penis/vagina, urinary tract (including blood in urine turning 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 streaks
• Abdominal pain or stomach ache
• 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 leukocytes (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, at the site of an injection, or at the site of a venous catheter insertion
• Bleeding may occur from hemorrhoids
• Ulcer in the stomach or intestine (including esophageal ulcer)
• Abnormalities in 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 Medicines: 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 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 unused medicines and their containers at the SIGRE Point in your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Dabigatran Etexilate Normon

• The active substance is dabigatran. Each hard capsule contains 126.83 mg of dabigatran etexilate (as mesilate), equivalent to 110 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 pack

Dabigatran etexilate Normon 110 mg are size 1 hard capsules of blue color, containing off-white to pale yellow pellets.

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

Multiple packs containing 3 packs of 60 hard capsules (180 hard capsules) or multiple packs containing 2 packs of 50 hard capsules (100 hard capsules) in perforated unit-dose blisters of aluminum/OPA-ALU-PVC.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturing Responsibility

Marketing Authorization Holder:

Laboratorios Normon, S.A.

Ronda de Valdecarrizo, 6

Tres Cantos, 28760, Madrid

Manufacturers:

Galenicum health, s.l.u.

Saint 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 review of this leaflet: 12/2023

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