DABIGATRAN ETEXILATE STADA 75 mg HARD CAPSULES

Introduction

Package Leaflet:informationforthepatient

Dabigatran Etexilate Stada 75 mg hard capsules EFG

Readtheentirepackageleafletscarefullybeforeyoustarttakingthismedication,asitcontainsimportantinformationforyou.

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

Contentsofthepackageleaflet

1. What is Dabigatran Etexilate Stada and what is it used for
2. What you need to know before you take Dabigatran Etexilate Stada
3. How to take Dabigatran Etexilate Stada
4. Possible side effects
5. Storage of Dabigatran Etexilate Stada
6. Package contents and further information

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

This medication 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 you take Dabigatran Etexilate Stada

Do not takeDabigatranEtexilateStada

• 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 clot formation (e.g., warfarin, rivaroxaban, apixaban, or heparin), except when switching from one anticoagulant treatment to another, while having a venous or arterial catheter and being 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 impaired 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 doctor if 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 a 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 Stada" 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 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.

Be particularly careful with Dabigatran Etexilate Stada

• If you need to undergo surgery:

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.

• 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 your legs or bowel or bladder problems after the end of anesthesia, as this situation requires urgent attention.

• If you fall or injure yourself during treatment, especially if you hit your head. Seek urgent medical attention. You may need a doctor to examine you, as you may have an increased risk of bleeding.
• If you know you have a disease called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor so that they can decide if it is necessary to modify the treatment.

Other medications and Dabigatran Etexilate Stada

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medications.

In particular, you must inform 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, acetylsalicylic acid)
• 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 that contain amiodarone, quinidine, or verapamil, your doctor may instruct you to 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)
• Anti-inflammatory and pain-relieving medications (e.g., acetylsalicylic acid, 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

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

The effects of dabigatran etexilate on pregnancy and the fetus are unknown. You should not use this medication 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 using machines

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

Dabigatran Etexilate Stada contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per capsule; this is essentially "sodium-free".

3. How to take Dabigatran Etexilate Stada

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 the treatment of children under 8 years.

Follow the administration instructions of this medication exactly as indicated 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 in the form of 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 in the form of 2 capsules of 75 mg).

If you are using medications that contain amiodarone, quinidine, or verapamil, the recommended dose is 150 mg once daily(administered in the form of 2 capsules of 75 mg).

If you are using medications that contain 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 the operation, dosing should be started with 2 capsules once daily.

After knee replacement surgery

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

After hip replacement surgery

You should start treatment with dabigatran etexilate 1-4 hours after the operation, 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. It is possible that your doctor will 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 capsules

Doses that require combinations of more than one capsule:

300 mg: two capsules of 150 mg or

four capsules of 75 mg

260 mg: one capsule of 110 mg plus one capsule of 150 mg or

one capsule of 110 mg plus two capsules of 75 mg

220 mg: two capsules of 110 mg

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

150 mg: one capsule of 150 mg or

two capsules of 75 mg

How to take Dabigatran Etexilate Stada

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 the bottle

• Press and turn to open.
• After removing the capsule, put the cap back on the bottle and close it immediately after taking your dose.

Changing anticoagulant treatment with Dabigatran Etexilate Stada

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

If you take more Dabigatran Etexilate Stada than you should

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

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

If you forget to take Dabigatran Etexilate Stada

Prevention of blood clot formation after knee or hip replacement surgery Take the remaining daily doses of dabigatran etexilate at the same time the next day.

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

Treatment of blood clots and prevention of their formation in children

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

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

If you stop taking Dabigatran Etexilate Stada

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

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

4. Possible Adverse Effects

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

Severe Adverse Effects

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 severe adverse effects and, regardless of their location, can cause disability, be potentially life-threatening, or even cause death. In some cases, these bleedings may not be apparent.

• If you experience any episode of bleeding that does not stop 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.

Other Adverse Effects

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

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, stomach, or intestine, from the penis/vagina or urinary tract (including blood in the urine that turns the urine pink or red), from hemorrhoids, 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 of nausea
• Wound secretion (discharge of fluid from a surgical wound)
• Increased liver enzymes
• Yellowish discoloration of the skin or whites of the eyes, caused by liver or blood problems

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

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

Frequency Not Known(frequency cannot be estimated from available data):

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

Treatment of blood clots and prevention of 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 physical appearance
• Formation of hematomas
• Nosebleeds
• Reflux of gastric juice into the esophagus
• Vomiting
• Feeling of nausea
• Frequent loose or liquid stools
• Indigestion
• Hair loss
• Increased liver enzymes

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

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

Frequency Not Known(frequency cannot be estimated from available data):

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

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: 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 Stada

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

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

Blister: Store below 30°C.

Bottle: Store below 30°C. Keep in the original package to protect from moisture. Once opened, the medicine must be used within 60 days.

Follow these instructions to remove the capsules from the bottle:

• The cap is opened by pressing and turning.
• After removing the capsule, the cap must be put back on the bottle immediately and the bottle must be closed tightly.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

• The active ingredient is dabigatran. Each hard capsule contains 75 mg of dabigatran etexilate (as mesilate).
• The other ingredients are tartaric acid (E334), hypromellose, talc, hydroxypropylcellulose (E463), croscarmellose sodium, and magnesium stearate (E470b).

The capsule shell contains titanium dioxide (E171) and hypromellose.

Black printing ink: shellac (E904), propylene glycol (E1520), iron oxide black (E172), and potassium hydroxide (E525).

Appearance of the Product and Package Contents

Dabigatran etexilate Stada 75 mg are hard capsules with an opaque white cap and an opaque white body, size "2" (17.50 ± 0.40 mm), containing a mixture of white to pale yellow pellets and a pale yellow granulate. The capsules are printed with black ink with the letters "MD" on the cap and the inscription "75" on the body.

This medicine is available in packages containing OPA/Al/desiccant PE-Al/PE blisters of 10, 30, 60, or 180 hard capsules.

This medicine is also available in 120 ml and 150 ml polypropylene bottles with a child-resistant closure and silica gel as a desiccant, containing 60 hard capsules.

Only some package 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

info@stada.es

Manufacturer

Pharmadox Healthcare Ltd,

KW20A Kordin Industrial Park, Paola, PLA 3000,

Malta

or

STADA Arzneimittel AG

Stadastrasse 2 - 18

61118 Bad Vilbel

Germany

or

STADA Arzneimittel GmbH

Muthgasse 36

1190 Wien

Austria

or

Centrafarm Services B.V.

Van de Reijtstraat 31 E,

4814NE Breda,

Netherlands

or

Clonmel Healthcare Ltd.

Waterford Road

Clonmel, Co. Tipperary

Ireland

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

Date of Last Revision of this Leaflet:

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