Dabigatran etexilate Stadaframa 75 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Dabigatran etexilate Stadafarma 75 mg hard capsules EFG

Read the entire leaflet carefully before you start taking 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, as it could 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 Stadafarma is and what it is used for
2. What you need to know before taking Dabigatran etexilate Stadafarma
3. How to take Dabigatran etexilate Stadafarma
4. Possible side effects
5. How to store Dabigatran etexilate Stadafarma
6. Contents of the pack and other information

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

This medicine 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 blood clot formation.

Dabigatran etexilate is used in adults for:

• preventing the formation of blood clots in the veins following knee or hip replacement surgery.

Dabigatran etexilate is used in children for:

• treating blood clots and preventing new blood clots from forming.

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

Do not take Dabigatran etexilate Stadafarma

• 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 currently have bleeding.
• if you have a disease in an organ of your body that increases the risk of serious bleeding (e.g., stomach ulcer, brain injury or 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 impaired 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 of 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

Talk to your doctor before starting to take Dabigatran etexilate Stadafarma. 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.

Tell 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 had bleeding.
  • if you have undergone surgical tissue removal (biopsy) within the last month.
  • if you have suffered a serious 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 receiving medicines that may increase the risk of bleeding. See “Other medicines and Dabigatran etexilate Stadafarma” 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 (concentrated)/foamy urine).
  • if you are over 75 years old.
  • if you are an adult 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 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 tests. The use of this medicine is not recommended in this case.

Take special care with Dabigatran etexilate Stadafarma

• If you need to undergo surgery:

In this case, dabigatran etexilate should 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 instructed by your doctor.

• If surgery requires the placement of a catheter or an injection into the spine (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 instructed by your doctor.

• Inform your doctor immediately if you experience numbness or weakness in the legs or bowel or bladder problems after anesthesia ends, as this situation requires urgent medical attention.

• If you fall or get injured during treatment, especially if you hit your head. Seek urgent medical help. 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 Stadafarma

Tell 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 treating 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 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-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. You must not use this medicine 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 dabigatran etexilate.

Breastfeeding is not recommended during treatment with dabigatran etexilate.

Driving and use of machines

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

3. How to take Dabigatran etexilate Stadafarma

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

Always follow exactly the dosing instructions for this medicine as given by your doctor. If you are unsure, consult your doctor again.

Take dabigatran etexilate as recommended for the following situations

Prevention of blood clots 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 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 medicines containing amiodarone, quinidine, or verapamil, the recommended dose is 150 mg once daily (administered as 2 capsules of 75 mg).

If you are taking medicines containing verapamil and your kidney function is reduced by more than half, you should be prescribed a reduced dose of dabigatran etexilate of 75 mg, as your risk of bleeding may increase.

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

After knee replacement surgery

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

After hip replacement surgery

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

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 age and body weight. Your doctor will determine the correct dose. Your doctor may adjust your dose during treatment. Continue taking all other medications unless your doctor tells you to stop.

Single dose of dabigatran etexilate to be administered twice daily in milligrams (mg) according to body weight in kilograms (kg) and age in years of the patient:

Weight [kg]	Age in years
	8 to <9	9 to <10	10 to <11	11 to <12	12 to <13	13 to <14	14 to <15	15 to <16	16 to <17	17 to <18
>81		300 mg in two 150 mg capsules or four 75 mg capsules
71 to <81
61 to <71
51 to <61	260 mg in one 110 mg capsule plus one 150 mg capsule or one 110 mg capsule plus two 75 mg capsules
41 to <51	220 mg in two 110 mg capsules
31 to <41	185 mg in one 75 mg capsule plus one 110 mg capsule
26 to <31	150 mg in one 150 mg capsule or two 75 mg capsules
21 to <26
16 to <21	One 110 mg capsule
13 to <16
11 to <13	One capsule of 75 mg

Means that no dosage recommendation can be made

How to take Dabigatrán etexilato Stadafarma

Dabigatrán etexilato 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 remove the capsules of Dabigatrán etexilato Stadafarma 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 of 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 Dabigatrán etexilato Stadafarma than you should

Taking too much dabigatrán etexilato increases the risk of bleeding. In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount of dabigatrán etexilato ingested. Specific treatment options are available.

If you forget to take Dabigatrán etexilato Stadafarma

Prevention of blood clots after knee or hip replacement surgery

Take the remaining daily doses of dabigatrán etexilato at the usual time on the following day. Do not take a double dose to make up for a missed dose.

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

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 stop taking Dabigatrán etexilato Stadafarma

Take dabigatrán etexilato exactly as prescribed. Do not stop your treatment with dabigatrán etexilato 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 dabigatrán etexilato.

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 experiences 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 switch your medication.

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

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

Prevention of blood clots 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)
• Abnormalities in liver function tests

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

• Bleeding 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 following an injury or surgery
• Bruising or bruise formation after surgery
• Detection of blood in stool during laboratory testing
• Decrease in the number of red blood cells in the blood
• Decrease in the proportion of blood cells
• Allergic reaction
• Vomiting
• Frequent loose or watery stools
• Feeling nauseous
• Wound discharge (leakage of fluid from a surgical wound)
• Increased liver enzymes
• Yellowing of the skin or whites of the eyes, caused by liver or blood-related problems

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

• Bleeding
• Bleeding may occur in the brain, at a surgical incision site, at an injection site, 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 due to 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 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 of, or even absence of, white blood cells (which help fight infections)
• Hair loss

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, raised, itchy bumps due to an allergic reaction
• Sudden change in the skin affecting color and physical appearance
• Bruising
• Nosebleed
• Reflux of gastric juice 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 intestine, brain, rectum, penis/vagina, or 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
• Yellowing of the skin or whites of the eyes, caused by liver or blood-related 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 an injection site, or at the site of a venous catheter insertion
• Bleeding 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 a possible adverse reaction not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Dabigatran Etexilate Stadafarma

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

Do not use this medicine after the expiry date stated on the carton or blister pack 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 containers and medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dabigatran Etexilate Stadafarma

• The active substance is dabigatran. Each hard capsule contains 75 mg of dabigatran etexilate (as mesilate).
• The other components are tartaric acid, arabic gum, hypromellose, dimethicone 350, talc, and hydroxypropylcellulose.
• The capsule shell contains carrageenan, potassium chloride, titanium dioxide (E-171), and hypromellose.

Appearance of the product and contents of the pack

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

Dabigatran Etexilate Stadafarma is available in packs containing 1 x 10, 3 x 10, or 6 x 10 hard capsules in perforated aluminum/OPA-ALU-PVC blisters.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Laboratorio STADA, S. L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer:

Galenicum Health, S.L.U.

Sant Gabriel, 50

Esplugues de Llobregat

08950 – Barcelona

Spain

or

SAG Manufacturing S.L.U

Crta. N-I, KM 36

28750 San Agustin de Guadalix,

Madrid

Spain

or

STADA Arzneimittel AG

Stadastr. 2-18

61118 Bad Vilbel

Germany

or

Pharmadox Healthcare Limited

Kkw46 Kordin Industrial Park, Paola, PLA 3000,

Malta

Date of the most recent review of this leaflet: June 2023

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