DABIGATRAN ETEXILATE NORMON 75 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Dabigatran Etexilate Normon 75 mg Hard Capsules EFG

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

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Dabigatran Etexilate Normon and what is it 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. Package contents and additional information

1. What is Dabigatran Etexilate Normon and what is it used for

Dabigatran Etexilate Normon contains the active substance dabigatran etexilate and belongs to a group of medications 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 knee or hip replacement surgery.

Dabigatran etexilate is used in children to:

• treat blood clots and prevent them from forming again.

2. What you need to know before taking Dabigatran Etexilate Normon

Normon

• if you are allergic to dabigatran etexilate or any of the other ingredients of this medication (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 severe bleeding (e.g., stomach ulcer, brain injury or bleeding, recent brain or eye surgery).
• if you are prone to bleeding. This tendency may be congenital, of unknown cause, or caused by other medications.
• if you are taking medications to prevent blood clotting (e.g., warfarin, rivaroxaban, apixaban, or heparin), except when switching anticoagulant treatment, while having a venous or arterial catheter and being administered heparin through this catheter to keep it open, or while your normal heart rhythm is being restored through 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, medications used to treat fungal infections.
• if you are taking oral cyclosporine, a medication used to prevent organ rejection after a transplant.
• if you are taking dronedarone, a medication used to treat abnormal heart rhythm.
• if you are taking a combination product of glecaprevir and pibrentasvir, an antiviral medication used to treat hepatitis C.
• if you have had an artificial heart valve implanted that requires permanent anticoagulant treatment.

Warnings and Precautions

Consult your doctor before starting to take Dabigatran Etexilate. During treatment with this medication, 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 tissue removal (biopsy) in the last month.
  • if you have had a severe injury (e.g., a bone fracture, a head injury, or any injury that required surgical treatment).
  • if you have inflammation of the esophagus or stomach.
  • if you have problems with gastric juice reflux in the esophagus.
  • if you are taking medications that may increase the risk of bleeding. See "Other medications and Dabigatran Etexilate Normon" below.
  • if you are using anti-inflammatory medications such as diclofenac, ibuprofen, or piroxicam.
  • if you have a heart infection (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 urine).
  • 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 a brain infection or around the brain.
• 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 medication is not recommended in this case.

Normon

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

• • it is very important that you take Dabigatran Etexilate before and after surgery 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 end of anesthesia, as this situation requires urgent attention.

Other medications and Dabigatran Etexilate Normon

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

• Medications to reduce blood clotting (e.g., warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, aspirin)
• Medications for the treatment of fungal infections (e.g., ketoconazole, itraconazole), except if only applied to the skin
• Medications used in the treatment of abnormal heart rhythm (e.g., amiodarone, dronedarone, quinidine, verapamil) If you are using medications containing amiodarone, quinidine, or verapamil, your doctor may indicate that you use a reduced dose of Dabigatran Etexilate depending on the disease for which it was prescribed. See also section 3.

• Medications for the prevention of organ rejection after a transplant (e.g., tacrolimus, cyclosporine)
• A combination product of glecaprevir and pibrentasvir (an antiviral medication used to treat hepatitis C)

• Pain-relieving and anti-inflammatory medications (e.g., aspirin, ibuprofen, diclofenac)
• St. John's Wort, a herbal remedy for depression
• Antidepressant medications called selective serotonin reuptake inhibitors or selective serotonin and norepinephrine reuptake inhibitors
• Rifampicin or clarithromycin (two antibiotics)
• Antiviral medications for HIV (e.g., ritonavir)
• Certain medications for the treatment of 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 tells you it is safe to do so. If you are of childbearing age, you should avoid becoming pregnant during treatment with this medication.

Breastfeeding 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 Normon

Dabigatran Etexilate capsules can be used in adults and children aged 8 years or older who are able to swallow the capsules whole. There are other pharmaceutical forms suitable for children under 8 years of age.

Follow your doctor's instructions for taking this medication exactly. If you are unsure, consult your doctor again.

Take Dabigatran Etexilate Normon 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 kidney function is reducedby 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 using medications containing amiodarone, quinidine, or verapamil, the recommended dose is 150 mg once daily(administered as 2 capsules of 75 mg).

If you are using medications containing verapamil and your kidney function is reducedby 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 surgery, dosing should be started with 2 capsules once daily.

After knee replacement surgery

Treatment with Dabigatran Etexilate should be started 1-4 hours after surgery, taking a single capsule. Afterward, 2 capsules should be taken once daily for a total of 10 days.

After hip replacement surgery

Treatment with Dabigatran Etexilate should be started 1-4 hours after surgery, taking a single capsule. Afterward, 2 capsules should be taken once daily for a total of 28-35 days.

Treatment of blood clots and prevention of their formation 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 every day. The administration interval should be as close to 12 hours as possible.

The recommended dose depends on weight and age. Your doctor will determine the correct dose. Your doctor may adjust the dose during treatment. Continue using all other medications unless your doctor tells you to stop using any.

Table 1 shows the single 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

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 blisters

The following images illustrate how to extract the Dabigatran Etexilate capsules from the blister:

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

Remove the rear foil and extract the capsule.

• Do not press the capsules through the blister foil.
• Do not remove the blister foil until the capsule is needed.

Changing Anticoagulant Treatment

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

If You Take Too Much Dabigatran Etexilate Normon

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, contact your doctor or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If You Forget to Take Dabigatran Etexilate Normon

Prevention of blood clot formation after knee or hip replacement surgery

Continue with the remaining daily doses of Dabigatran Etexilate at the same time the next day. Do not take a double dose to make up for missed doses.

Treatment of blood clots and prevention of their formation in children

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

A missed 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 missed doses.

If You Stop Taking Dabigatran Etexilate Normon

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

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

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 fatal, or even cause death. In some cases, these bleedings may not be apparent.

If you experience any episode of bleeding that does not stop by itself 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 arthroplasty

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, in the stomach or intestine, from the penis/vagina or urinary tract (including blood in the urine that stains the urine pink or red), from hemorrhoids, from the rectum, under the skin, from a joint, or after an injury or surgery
• 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 like vomiting
• Wound suppuration (secretion of fluid from a surgical wound)
• Increased liver enzymes
• Yellowing 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 entry in a vein
• Bloody suppuration at the site of a catheter entry 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 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

Treatment of blood clots and prevention of new blood clot formation 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 appearance
• Formation of hematomas
• Nosebleeds
• Reflux of gastric juice into the esophagus
• Vomiting
• Feeling like vomiting
• 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
• 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 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 wound, in a surgical incision, at the site of an injection, or at the site of a catheter entry 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 an 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 Normon

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 it from moisture.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Composition of Dabigatran Etexilate Normon

Package Contents and Additional Information

The active ingredient is dabigatran. Each hard capsule contains 86.48 mg of dabigatran etexilate (as mesilate) equivalent to 75 mg of dabigatran etexilate.

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

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

Appearance and Package Contents of the Product

Dabigatran Etexilate Normon 75 mg are hard white or off-white capsules, size 2, containing white or pale yellow pellets.

This medicine is available in packages containing:

10, 30, or 60 hard capsules in single-dose perforated aluminum/OPA-ALU-PVC blisters.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

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

Or

SAG Manufacturing S.L.U

Crta. N-i, km 36

28750 San Agustin de Guadalix,

Madrid – Spain

Date of the Last Revision of this Leaflet:12/2023

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